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positivelyaware.com<br />

september+october 2012<br />

CURE NEWS FROM<br />

AIDS 2012<br />

FACINg Up<br />

tO lIpOAtROphy<br />

POSITIVE<br />

WOmEn<br />

MAkINg DECISIONS, CREAtINg<br />

pOlICy, AND IMpROvINg lIvES


ABOUT PREZISTA ®<br />

PREZISTA ® (darunavir) is a prescription medicine. It is one treatment option<br />

in the class of HIV (human immunodefi ciency virus) medicines known as<br />

protease inhibitors.<br />

PREZISTA ® is always taken with and at the same time as ritonavir (Norvir ® ),<br />

in combination with other HIV medicines for the treatment of HIV infection<br />

in adults. PREZISTA ® should also be taken with food.<br />

• <strong>The</strong> use of other medicines active against HIV in combination with<br />

PREZISTA ® /ritonavir (Norvir ® ) may increase your ability to fi ght HIV.<br />

Your healthcare professional will work with you to fi nd the right<br />

combination of HIV medicines<br />

• It is important that you remain under the care of your healthcare<br />

professional during treatment with PREZISTA ®<br />

PREZISTA ® does not cure HIV infection or AIDS and you may<br />

continue to experience illnesses associated with HIV-1 infection,<br />

including opportunistic infections. You should remain under the<br />

care of a doctor when using PREZISTA. ®<br />

Please read Important Safety Information below, and talk to your<br />

healthcare professional to learn if PREZISTA ® is right for you.<br />

IMPORTANT SAFETY INFORMATION<br />

What is the most important information I should know<br />

about PREZISTA ® ?<br />

• PREZISTA ® can interact with other medicines and cause<br />

serious side effects. See “Who should not take PREZISTA ® ?”<br />

• PREZISTA ® may cause liver problems. Some people taking<br />

PREZISTA, ® together with Norvir ® (ritonavir), have developed liver<br />

problems which may be life-threatening. Your healthcare professional<br />

should do blood tests before and during your combination treatment<br />

with PREZISTA. ® If you have chronic hepatitis B or C infection, your<br />

healthcare professional should check your blood tests more often<br />

because you have an increased chance of developing liver problems<br />

• Tell your healthcare professional if you have any of these signs and<br />

symptoms of liver problems: dark (tea-colored) urine, yellowing<br />

of your skin or whites of your eyes, pale-colored stools (bowel<br />

movements), nausea, vomiting, pain or tenderness on your right<br />

side below your ribs, or loss of appetite<br />

• PREZISTA ® may cause a severe or life-threatening skin<br />

reaction or rash. Sometimes these skin reactions and skin rashes<br />

can become severe and require treatment in a hospital. You should<br />

call your healthcare professional immediately if you develop a rash.<br />

However, stop taking PREZISTA ® and ritonavir combination treatment<br />

and call your healthcare professional immediately if you develop any<br />

skin changes with these symptoms: fever, tiredness, muscle or joint<br />

pain, blisters or skin lesions, mouth sores or ulcers, red or infl amed<br />

eyes, like “pink eye.” Rash occurred more often in patients taking<br />

PREZISTA ® and raltegravir together than with either drug separately,<br />

but was generally mild<br />

Who should not take PREZISTA ® ?<br />

• Do not take PREZISTA ® if you are taking the following<br />

medicines: alfuzosin (Uroxatral ® ), dihydroergotamine (D.H.E.45, ®<br />

Embolex, ® Migranal ® ), ergonovine, ergotamine (Cafergot, ® Ergomar ® ),<br />

methylergonovine, cisapride (Propulsid ® ), pimozide (Orap ® ), oral<br />

midazolam, triazolam (Halcion ® ), the herbal supplement St. John’s wort<br />

(Hypericum perforatum), lovastatin (Mevacor, ® Altoprev, ® Advicor ® ),<br />

simvastatin (Zocor, ® Simcor, ® Vytorin ® ), rifampin (Rifadin, ® Rifater, ®<br />

Rifamate, ® Rimactane ® ), sildenafi l (Revatio ® ) when used to treat<br />

pulmonary arterial hypertension, indinavir (Crixivan ® ), lopinavir/<br />

ritonavir (Kaletra ® ), saquinavir (Invirase ® ), boceprevir (Victrelis ),<br />

or telaprevir (Incivek )<br />

• Before taking PREZISTA, ® tell your healthcare professional if you are<br />

taking sildenafi l (Viagra, ® Revatio ® ), vardenafi l (Levitra, ® Staxyn ® ),<br />

tadalafi l (Cialis, ® Adcirca ® ), atorvastatin (Lipitor ® ), rosuvastatin<br />

(Crestor ® ), pravastatin (Pravachol ® ), or colchicine (Colcrys, ®<br />

Col-Probenecid ® ). Tell your healthcare professional if you are taking<br />

estrogen-based contraceptives (birth control). PREZISTA ® might reduce<br />

the effectiveness of estrogen-based contraceptives. You must take<br />

additional precautions for birth control, such as condoms<br />

This is not a complete list of medicines. Be sure to tell your<br />

healthcare professional about all the medicines you are taking or<br />

plan to take, including prescription and nonprescription medicines,<br />

vitamins, and herbal supplements.<br />

What should I tell my doctor before I take PREZISTA ® ?<br />

• Before taking PREZISTA, ® tell your healthcare professional if you have<br />

any medical conditions, including liver problems (including hepatitis B<br />

or C), allergy to sulfa medicines, diabetes, or hemophilia<br />

• Tell your healthcare professional if you are pregnant or planning<br />

to become pregnant, or are breastfeeding<br />

— <strong>The</strong> effects of PREZISTA ® on pregnant women or their unborn<br />

babies are not known. You and your healthcare professional will<br />

need to decide if taking PREZISTA ® is right for you<br />

— Do not breastfeed. It is not known if PREZISTA ® can be passed<br />

to your baby in your breast milk and whether it could harm your<br />

baby. Also, mothers with HIV should not breastfeed because HIV<br />

can be passed to your baby in the breast milk<br />

What are the possible side effects of PREZISTA ® ?<br />

• High blood sugar, diabetes or worsening of diabetes, and increased<br />

bleeding in people with hemophilia have been reported in patients<br />

taking protease inhibitor medicines, including PREZISTA ®<br />

• Changes in body fat have been seen in some patients taking HIV<br />

medicines, including PREZISTA. ® <strong>The</strong> cause and long-term health<br />

effects of these conditions are not known at this time<br />

• Changes in your immune system can happen when you start taking<br />

HIV medicines. Your immune system may get stronger and begin<br />

to fi ght infections that have been hidden<br />

• <strong>The</strong> most common side effects related to taking PREZISTA ® include<br />

diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is<br />

not a complete list of all possible side effects. If you experience these<br />

or other side effects, talk to your healthcare professional. Do not stop<br />

taking PREZISTA ® or any other medicines without fi rst talking to your<br />

healthcare professional<br />

You are encouraged to report negative side effects of<br />

prescription drugs to the FDA. Visit www.fda.gov/medwatch,<br />

or call 1-800-FDA-1088.<br />

Please refer to the ritonavir (Norvir ® ) Product Information (PI and PPI)<br />

for additional information on precautionary measures.<br />

Please read accompanying Patient Information for PREZISTA ®<br />

and discuss any questions you have with your doctor.<br />

28PRZDTC0288R8


IS THE PREZISTA ®<br />

EXPERIENCE<br />

RIGHT FOR YOU?<br />

T<strong>here</strong> is no other person in the world who is exactly like you. And<br />

no HIV treatments are exactly alike, either. That’s why you should<br />

ask your healthcare professional about PREZISTA ® (darunavir).<br />

Once-Daily PREZISTA ® taken with ritonavir and in combination<br />

with other HIV medications can help lower your viral load<br />

and keep your HIV under control over the long term.<br />

In a clinical study* of almost 4 years (192 weeks), 7 out of 10<br />

adults who had never taken HIV medications before<br />

maintained undetectable † viral loads with PREZISTA ®<br />

plus ritonavir and Truvada. ®<br />

Find out if the PREZISTA ® EXPERIENCE is right for you.<br />

Ask your healthcare professional and learn more<br />

at DiscoverPREZISTA.com<br />

Please read the Important Safety Information and<br />

Patient Information on adjacent pages.<br />

Snap a quick pic of our logo to show your<br />

doctor and get the conversation started.<br />

*A randomized open label Phase 3 trial comparing PREZISTA ® /ritonavir 800/100 mg<br />

once daily (n=343) vs. Kaletra ® /ritonavir 800/200 mg/day (n=346).<br />

†Undetectable was defi ned as a viral load of less than 50 copies per mL.<br />

Registered trademarks are the property of their respective owners.<br />

Janssen <strong>The</strong>rapeutics,<br />

Division of Janssen Products, LP<br />

© Janssen <strong>The</strong>rapeutics, Division of Janssen Products, LP<br />

2012 06/12 28PRZ12036G


PREZISTA (pre-ZIS-ta)<br />

(darunavir)<br />

Oral Suspension<br />

PREZISTA (pre-ZIS-ta)<br />

(darunavir)<br />

Tablets<br />

Read this Patient Information before you start taking PREZISTA and<br />

each time you get a refill. T<strong>here</strong> may be new information. This<br />

information does not take the place of talking to your healthcare<br />

provider about your medical condition or your treatment.<br />

Also read the Patient Information leaflet for NORVIR ® (ritonavir).<br />

What is the most important information I should<br />

know about PREZISTA?<br />

• PREZISTA can interact with other medicines and cause serious<br />

side effects. It is important to know the medicines that should not be<br />

taken with PREZISTA. See the section “Who should not take<br />

PREZISTA?”<br />

• PREZISTA may cause liver problems. Some people taking PREZISTA<br />

in combination with NORVIR ® (ritonavir) have developed liver<br />

problems which may be life-threatening. Your healthcare provider<br />

should do blood tests before and during your combination treatment<br />

with PREZISTA. If you have chronic hepatitis B or C infection, your<br />

healthcare provider should check your blood tests more often<br />

because you have an increased chance of developing liver problems.<br />

• Tell your healthcare provider if you have any of the below signs and<br />

symptoms of liver problems.<br />

• Dark (tea colored) urine<br />

• yellowing of your skin or whites of your eyes<br />

• pale colored stools (bowel movements)<br />

• nausea<br />

• vomiting<br />

• pain or tenderness on your right side below your ribs<br />

• loss of appetite<br />

PREZISTA may cause severe or life-threatening skin reactions or rash.<br />

Sometimes these skin reactions and skin rashes can become severe<br />

and require treatment in a hospital. You should call your healthcare<br />

provider immediately if you develop a rash. However, stop taking<br />

PREZISTA and ritonavir combination treatment and call your healthcare<br />

provider immediately if you develop any skin changes with symptoms<br />

below:<br />

• fever<br />

• tiredness<br />

• muscle or joint pain<br />

• blisters or skin lesions<br />

• mouth sores or ulcers<br />

• red or inflamed eyes, like “pink eye” (conjunctivitis)<br />

Rash occurred more often in patients taking PREZISTA and raltegravir<br />

together than with either drug separately, but was generally mild.<br />

See “What are the possible side effects of PREZISTA?” for more<br />

information about side effects.<br />

What is PREZISTA?<br />

PREZISTA is a prescription anti-HIV medicine used with ritonavir and<br />

other anti-HIV medicines to treat adults with human immunodeficiency<br />

virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a<br />

protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune<br />

Deficiency Syndrome).<br />

When used with other HIV medicines, PREZISTA may help to reduce<br />

the amount of HIV in your blood (called “viral load”). PREZISTA may<br />

also help to increase the number of white blood <strong>cells</strong> called CD4 (T) cell<br />

which help fight off other infections. Reducing the amount of HIV and<br />

increasing the CD4 (T) cell count may improve your immune system.<br />

This may reduce your risk of death or infections that can happen when<br />

your immune system is weak (opportunistic infections).<br />

PREZISTA does not cure HIV infection or AIDS and you may continue to<br />

experience illnesses associated with HIV-1 infection, including<br />

opportunistic infections. You should remain under the care of a doctor<br />

when using PREZISTA.<br />

Avoid doing things that can spread HIV-1 infection.<br />

• Do not share needles or other injection equipment.<br />

• Do not share personal items that can have blood or body fluids on<br />

them, like toothbrushes and razor blades.<br />

IMPORTANT PATIENT INFORMATION<br />

• Do not have any kind of sex without protection. Always practice<br />

safe sex by using a latex or polyurethane condom to lower the<br />

chance of sexual contact with semen, vaginal secretions, or blood.<br />

Ask your healthcare provider if you have any questions on how to<br />

prevent passing HIV to other people.<br />

Who should not take PREZISTA?<br />

Do not take PREZISTA with any of the following medicines:<br />

• alfuzosin (Uroxatral ® )<br />

• dihydroergotamine (D.H.E. 45 ® , Embolex ® , Migranal ® ), ergonovine,<br />

ergotamine (Cafergot ® , Ergomar ® ) methylergonovine<br />

• cisapride<br />

• pimozide (Orap ® )<br />

• oral midazolam, triazolam (Halcion ® )<br />

• the herbal supplement St. John’s Wort (Hypericum perforatum)<br />

• the cholesterol lowering medicines lovastatin (Mevacor ® , Altoprev ® ,<br />

Advicor ® ) or simvastatin (Zocor ® , Simcor ® , Vytorin ® )<br />

• rifampin (Rifadin ® , Rifater ® , Rifamate ® , Rimactane ® )<br />

• sildenafil (Revatio ® ) only when used for the treatment of pulmonary<br />

arterial hypertension.<br />

Serious problems can happen if you take any of these medicines with<br />

PREZISTA.<br />

What should I tell my doctor before I take PREZISTA?<br />

PREZISTA may not be right for you. Before taking PREZISTA, tell your<br />

healthcare provider if you:<br />

• have liver problems, including hepatitis B or hepatitis C<br />

• are allergic to sulfa medicines<br />

• have high blood sugar (diabetes)<br />

• have hemophilia<br />

• are pregnant or planning to become pregnant. It is not known if<br />

PREZISTA will harm your unborn baby.<br />

Pregnancy Registry: You and your healthcare provider will need to<br />

decide if taking PREZISTA is right for you. If you take PREZISTA<br />

while you are pregnant, talk to your healthcare provider about how<br />

you can be included in the Antiretroviral Pregnancy Registry. <strong>The</strong><br />

purpose of the registry is follow the health of you and your baby.<br />

• are breastfeeding or plan to breastfeed. Do not breastfeed. We do<br />

not know if PREZISTA can be passed to your baby in your breast<br />

milk and whether it could harm your baby. Also, mothers with HIV-1<br />

should not breastfeed because HIV-1 can be passed to the baby in<br />

the breast milk.<br />

Tell your healthcare provider about all the medicines you take including<br />

prescription and nonprescription medicines, vitamins, and herbal<br />

supplements. Using PREZISTA and certain other medicines may affect<br />

each other causing serious side effects. PREZISTA may affect the way<br />

other medicines work and other medicines may affect how PREZISTA<br />

works.<br />

Especially tell your healthcare provider if you take:<br />

• medicine to treat HIV<br />

• estrogen-based contraceptives (birth control). PREZISTA might<br />

reduce the effectiveness of estrogen-based contraceptives. You<br />

must take additional precautions for birth control such as a condom.<br />

• medicine for your heart such as bepridil, lidocaine (Xylocaine<br />

Viscous ® ), quinidine (Nuedexta ® ), amiodarone (Pacerone ® ,<br />

Cardarone ® ), digoxin (Lanoxin ® ), flecainide (Tambocor ® ),<br />

propafenone (Rythmol ® )<br />

• warfarin (Coumadin ® , Jantoven ® )<br />

• medicine for seizures such as carbamazepine (Carbatrol ® , Equetro ® ,<br />

Tegretol ® , Epitol ® ), phenobarbital, phenytoin (Dilantin ® , Phenytek ® )<br />

• medicine for depression such as trazadone and desipramine<br />

(Norpramin ® )<br />

• clarithromycin (Prevpac ® , Biaxin ® )<br />

• medicine for fungal infections such as ketoconazole (Nizoral ® ),<br />

itraconazole (Sporanox ® , Onmel ® ), voriconazole (VFend ® )<br />

• colchicine (Colcrys ® , Col-Probenecid ® )<br />

• rifabutin (Mycobutin ® )<br />

• medicine used to treat blood pressure, a heart attack, heart failure,<br />

or to lower pressure in the eye such as metoprolol (Lopressor ® ,<br />

Toprol-XL ® ), timolol (Cosopt ® , Betimol ® , Timoptic ® , Isatolol ® ,<br />

Combigan ® )<br />

• midazolam administered by injection<br />

• medicine for heart disease such as felodipine (Plendil ® ), nifedipine<br />

(Procardia ® , Adalat CC ® , Afeditab CR ® ), nicardipine (Cardene ® )


• steroids such as dexamethasone, fluticasone (Advair Diskus ® ,<br />

Veramyst ® , Flovent ® , Flonase ® )<br />

• bosentan (Tracleer ® )<br />

• medicine to treat chronic hepatitis C such as boceprevir<br />

(Victrelis TM ), telaprevir (Incivek TM )<br />

• medicine for cholesterol such as pravastatin (Pravachol ® ),<br />

atorvastatin (Lipitor ® ), rosuvastatin (Crestor ® )<br />

• medicine to prevent organ transplant failure such as cyclosporine<br />

(Gengraf ® , Sandimmune ® , Neoral ® ), tacrolimus (Prograf ® ), sirolimus<br />

(Rapamune ® )<br />

• salmeterol (Advair ® , Serevent ® )<br />

• medicine for narcotic withdrawal such as methadone (Methadose ® ,<br />

Dolophine Hydrochloride), buprenorphine (Butrans ® , Buprenex ® ,<br />

Subutex ® ), buprenorphine/naloxone (Suboxone ® )<br />

• medicine to treat schizophrenia such as risperidone (Risperdal ® ),<br />

thioridazine<br />

• medicine to treat erectile dysfunction or pulmonary hypertension<br />

such as sildenafil (Viagra ® , Revatio ® ), vardenafil (Levitra ® , Staxyn ® ),<br />

tadalafil (Cialis ® , Adcirca ® )<br />

• medicine to treat anxiety, depression or panic disorder such as<br />

sertraline (Zoloft ® ), paroxetine (Paxil ® )<br />

This is not a complete list of medicines that you should tell your<br />

healthcare provider that you are taking. Ask your healthcare provider<br />

or pharmacist if you are not sure if your medicine is one that is listed<br />

above. Know the medicines you take. Keep a list of them to show your<br />

doctor or pharmacist when you get a new medicine. Do not start any<br />

new medicines while you are taking PREZISTA without first talking with<br />

your healthcare provider.<br />

How should I take PREZISTA?<br />

• Take PREZISTA every day exactly as prescribed by your healthcare<br />

provider.<br />

• You must take ritonavir (NORVIR ® ) at the same time as PREZISTA.<br />

• Do not change your dose of PREZISTA or stop treatment without<br />

talking to your healthcare provider first.<br />

• Take PREZISTA and ritonavir (NORVIR ® ) with food.<br />

• Swallow PREZISTA tablets whole with a drink. If you have difficulty<br />

swallowing PREZISTA tablets, PREZISTA oral suspension is also<br />

available. Your health care provider will help determine whether<br />

PREZISTA tablets or oral suspension is right for you.<br />

• PREZISTA oral suspension should be given with the supplied oral<br />

dosing syringe. Shake the suspension well before each usage.<br />

• If you take too much PREZISTA, call your healthcare provider or go<br />

to the nearest hospital emergency room right away.<br />

What should I do if I miss a dose?<br />

People who take PREZISTA one time a day:<br />

• If you miss a dose of PREZISTA by less than 12 hours, take your<br />

missed dose of PREZISTA right away. <strong>The</strong>n take your next dose of<br />

PREZISTA at your regularly scheduled time.<br />

• If you miss a dose of PREZISTA by more than 12 hours, wait and then<br />

take the next dose of PREZISTA at your regularly scheduled time.<br />

People who take PREZISTA two times a day<br />

• If you miss a dose of PREZISTA by less than 6 hours, take your<br />

missed dose of PREZISTA right away. <strong>The</strong>n take your next dose of<br />

PREZISTA at your regularly scheduled time.<br />

• If you miss a dose of PREZISTA by more than 6 hours, wait and then<br />

take the next dose of PREZISTA at your regularly scheduled time.<br />

If a dose of PREZISTA is skipped, do not double the next dose. Do not<br />

take more or less than your prescribed dose of PREZISTA at any one<br />

time.<br />

What are the possible side effects of PREZISTA?<br />

PREZISTA can cause side effects including:<br />

• See “What is the most important information I should know about<br />

PREZISTA?”<br />

• Diabetes and high blood sugar (hyperglycemia). Some people who<br />

take protease inhibitors including PREZISTA can get high blood<br />

sugar, develop diabetes, or your diabetes can get worse. Tell your<br />

healthcare provider if you notice an increase in thirst or urinate<br />

often while taking PREZISTA.<br />

• Changes in body fat. <strong>The</strong>se changes can happen in people who take<br />

anti retroviral therapy. <strong>The</strong> changes may include an increased<br />

amount of fat in the upper back and neck (“buffalo hump”), breast,<br />

and around the back, chest, and stomach area. Loss of fat from the<br />

legs, arms, and face may also happen. <strong>The</strong> exact cause and longterm<br />

health effects of these conditions are not known.<br />

IMPORTANT PATIENT INFORMATION<br />

• Changes in your immune system (Immune Reconstitution Syndrome)<br />

can happen when you start taking HIV medicines. Your immune<br />

system may get stronger and begin to fight infections that have been<br />

hidden in your body for a long time. Call your healthcare provider<br />

right away if you start having new symptoms after starting your HIV<br />

medicine.<br />

• Increased bleeding for hemophiliacs. Some people with hemophilia<br />

have increased bleeding with protease inhibitors including<br />

PREZISTA.<br />

<strong>The</strong> most common side effects of PREZISTA include:<br />

• diarrhea • headache<br />

• nausea • abdominal pain<br />

• rash • vomiting<br />

Tell your healthcare provider if you have any side effect that bothers<br />

you or that does not go away.<br />

<strong>The</strong>se are not all of the possible side effects of PREZISTA. For more<br />

information, ask your health care provider.<br />

Call your doctor for medical advice about side effects. You may report<br />

side effects to the FDA at 1-800-FDA-1088.<br />

How should I store PREZISTA?<br />

• Store PREZISTA oral suspension and tablets at room temperature<br />

[77°F (25°C)].<br />

• Do not refrigerate or freeze PREZISTA oral suspension.<br />

• Keep PREZISTA away from high heat.<br />

• PREZISTA oral suspension should be stored in the original container.<br />

Keep PREZISTA and all medicines out of the reach of children.<br />

General information about PREZISTA<br />

Medicines are sometimes prescribed for purposes other than those<br />

listed in a Patient Information leaflet. Do not use PREZISTA for a<br />

condition for which it was not prescribed. Do not give PREZISTA to<br />

other people even if they have the same condition you have. It may<br />

harm them.<br />

This leaflet summarizes the most important information about<br />

PREZISTA. If you would like more information, talk to your healthcare<br />

provider. You can ask your healthcare provider or pharmacist for<br />

information about PREZISTA that is written for health professionals.<br />

For more information, call 1-800-526-7736.<br />

What are the ingredients in PREZISTA?<br />

Active ingredient: darunavir<br />

Inactive ingredients:<br />

PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline<br />

cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric<br />

acid monohydrate, sucralose, masking flavor, strawberry cream flavor,<br />

hydrochloric acid (for pH adjustment), purified water.<br />

PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide,<br />

crospovidone, magnesium stearate, microcrystalline cellulose. <strong>The</strong> film<br />

coating contains: OPADRY ® White (polyethylene glycol 3350, polyvinyl<br />

alcohol-partially hydrolyzed, talc, titanium dioxide).<br />

PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide,<br />

crospovidone, magnesium stearate, microcrystalline cellulose. <strong>The</strong> film<br />

coating contains: OPADRY ® Orange (FD&C Yellow No. 6, polyethylene<br />

glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).<br />

This Patient Information has been approved by the U.S Food and Drug<br />

Administration.<br />

Manufactured by:<br />

PREZISTA Oral Suspension<br />

Janssen Pharmaceutica, N.V.<br />

Beerse, Belgium<br />

PREZISTA Tablets<br />

Janssen Ortho LLC, Gurabo, PR 00778<br />

Manufactured for:<br />

Janssen <strong>The</strong>rapeutics, Division of Janssen Products, LP, Titusville NJ<br />

08560<br />

NORVIR ® is a registered trademark of its respective owner.<br />

PREZISTA ® is a registered trademark of Janssen Pharmaceuticals<br />

© Janssen Pharmaceuticals, Inc. 2006<br />

Revised: June 2012 986588P


5537 N. broadway st.<br />

chicago, il 60640<br />

phone: (773) 989–9400<br />

fax: (773) 989–9494<br />

email: inbox@tpan.com<br />

www.positivelyaware.com<br />

editor-iN-chief Jeff Berry<br />

associate editor Enid vázquez<br />

copy editors Sue Saltmarsh,<br />

Jason lancaster<br />

web master Joshua thorne<br />

creative director Rick guasco<br />

coNtributiNg writers<br />

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© 2012. positively aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network<br />

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Distribution of Positively AwAre is supported in part through an unrestricted grant from viiv Healthcare.<br />

4 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


SEP+OCT 2012<br />

VoLUmE 24 nUmBER 6<br />

departmeNts<br />

6 iN boX<br />

6 readers’ poll<br />

7 editor’s Note<br />

What is a woman?<br />

13 briefly<br />

FDA approves Truvada for HIV prevention. Rapid<br />

home HIV test approved. Initial study results find<br />

dolutegravir/Epzicom is superior to Atripla.<br />

34 coNfereNce update<br />

News from the XIX International AIDS Conference in<br />

Washington, D.C.<br />

44 ask the hiv specialist<br />

Safe sex is for seniors, too.<br />

45 wholistic picture<br />

Battle of the sexes?<br />

cover features<br />

22 Securing care for HIV-positive women<br />

Challenges and solutions for women living with HIV.<br />

26 Black women, society, and HIV<br />

An expert talks about the context of infection.<br />

28 ‘Everyone needs a support system’<br />

How one therapist helps HIV-positive women learn<br />

to take care of themselves.<br />

30 Nine months to birth day<br />

HIV and pregnancy—keeping yourself and your<br />

baby healthy.<br />

feature<br />

41 <strong>The</strong> mirror has two faces<br />

A personal account of using facial filler for lipoatrophy.<br />

oN the cover aNd this page:<br />

TamaRa wILSon, HIV-PoSITIVE SIncE 1999,<br />

PHoTogRaPHED BY cHRIS knIgHT<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 5


In BOx joIn THE conVERSaTIon: iNboX@tpaN.com anD @posaware<br />

HIV testing in prison?<br />

First let me say this is<br />

strictly my opinion in<br />

answer to your reader’s<br />

poll question concerning<br />

HIV testing in prison.<br />

I believe it should be<br />

required upon entering<br />

and leaving prison.<br />

Prior to my incarceration,<br />

I worked at Prevention<br />

Point Philadelphia (a needle<br />

exchange program), the Gay<br />

& Lesbian AIDS Education<br />

Initiative, and I spoke at various events<br />

about HIV/AIDS in the prison system. I’ve<br />

been positive for 18 years and for the last<br />

11 years I’ve been trying to get as many<br />

people tested as possible.<br />

At present, I have three and a half years<br />

left on my sentence. During my incarceration,<br />

I have been a Peer Educator teaching<br />

a class called Positive Voices behind the<br />

Walls (a little plug never hurts!) and an<br />

advocate for testing. I’m open about my<br />

HIV status, so HIV can have a “face” that<br />

defies the expectations of some of the<br />

men in <strong>here</strong>.<br />

After taking my class for 16 weeks, I<br />

have seen men’s attitudes change completely<br />

because they see me living healthy,<br />

happy, with a loving family, and looking<br />

forward to a long life.<br />

So, yes, testing should be mandatory,<br />

along with education and good information<br />

about prevention.<br />

—larry<br />

wHITE DEER, PEnnSYLVanIa<br />

you’re not the only one<br />

Finally, I’ve found relief! On May 21st, I<br />

read my first ever issue of PoSITIVELY<br />

awaRE—the March+April Drug Guide.<br />

I had no idea that anyone<br />

has the same problems as<br />

me. <strong>The</strong> issue touched me<br />

deeply.<br />

Simply knowing you’re<br />

t<strong>here</strong>, that I can reach out<br />

to someone for information<br />

seems to make everything a<br />

little bit better. I’m not sure<br />

how to receive future issues,<br />

but put me on your mailing<br />

list if at all possible!<br />

—Dwayne e.<br />

FLoRIDa<br />

good wishes<br />

Comment on July+August Editor’s Note:<br />

Thank you for the uplifting article, “Wish<br />

HIV Away.” Though easier said than done, I<br />

know that I’ll be able to pick my head up in<br />

the morning and continue on with a positive<br />

outlook on the day. I’m not at the stage<br />

yet w<strong>here</strong> people can know, only because<br />

I’m just two months into this disease, but I<br />

know I will get t<strong>here</strong> (fingers crossed).<br />

—steven<br />

VIa THEBoDY.com<br />

hidden no more<br />

I have to let you guys know how much<br />

I appreciated the article, “<strong>The</strong> Hidden<br />

People,” in your January+February 2012<br />

issue. I would love to have the Muslim<br />

brothers come to Memphis to speak in the<br />

very near future. My southern hat goes off<br />

to the writer Sue Saltmarsh for the article.<br />

And love to Karim Rush, Shadeed Jenkins,<br />

and Iman Boyd.<br />

Great job, PoSITIVELY awaRE! You<br />

guys rock!<br />

—Anthony Hardaway<br />

VIa THE InTERnET<br />

dO ThE WRITE ThInG. PoSITIVELY awaRE treats all communications (letters, e-mail,<br />

etc.) as letters to the editor unless otherwise instructed. We reserve the right to edit for<br />

length, style, or clarity. Unless you tell us not to, we will use your name and city.<br />

POSITIVELY AWARE<br />

5537 n. BRoaDwaY ST.<br />

cHIcago, IL 60640<br />

inbox@tpan.com<br />

WE REAd YOu.<br />

SHaRE YoUR commEnTS<br />

aBoUT oUR aRTIcLES aT<br />

positivelyaware.com<br />

REAdERS’ POLL<br />

In THE jULY+aUgUST ISSUE, wE aSkED<br />

Before you tested hIv-positive,<br />

did you think you were at risk?<br />

yes, but i<br />

practiced<br />

safer sex.<br />

24%<br />

i didn’t<br />

think<br />

about it.<br />

16%<br />

your commeNts:<br />

“I barebacked all the way after my first<br />

encounter—I have no one to blame but<br />

myself and my lack of self-esteem.”<br />

“After I found out, I wanted to kill myself—<br />

my partner never told me he had HIV.”<br />

“Before I tested positive, I always<br />

practiced safe sex. But I also remember<br />

feeling like no matter how much of a<br />

good boy I was, HIV was going to get me.”<br />

“I practiced safer sex until depression<br />

and drugs got in my way.”<br />

“I never thought about it. I suspect I<br />

was infected in 1986. At that time, t<strong>here</strong><br />

wasn’t much information available<br />

about infection and I had no idea what<br />

behavior was risky and what wasn’t.”<br />

“I thought those who caught HIV led<br />

reckless lives, taking drugs and having<br />

many anonymous partners and<br />

unprotected sex. I was naïve to believe<br />

I would be OK if I limited myself to one<br />

casual partner every few months.”<br />

this issue’s poll questioN:<br />

Who is more stigmatized<br />

because of hIv?<br />

cast your vote at<br />

POSITIVELYAWARE.COm<br />

6 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM<br />

No.<br />

8%<br />

yes, but i<br />

didn’t care.<br />

19%<br />

yes, but i<br />

thought i was<br />

at low risk.<br />

33%


PHOTO: CHRiS KnigHT<br />

EdITOR’S nOTE<br />

jEFF BERRY<br />

@PaEDIToR<br />

What is a woman?<br />

I’VE hAd mAnY TEAChERS In LIfE, InCLudInG WOmEn<br />

who have taught me particularly important lessons about<br />

courage, strength, resilience, caring, and compassion.<br />

Cindy, the oldest of my three sisters, realized at an<br />

early age that it was her job to help look after the other<br />

four kids in the Berry clan. My sister Barb became a<br />

veterinarian, the first doctor in our family. <strong>The</strong> one who<br />

was closest to me in age, Wendy, became my best friend<br />

growing up. My mother Norma went back to work when<br />

I started preschool in the early 1960’s, and continued<br />

working as a schoolteacher and elementary school principal<br />

until she retired. And my grandmother, Ruby, lived<br />

to be 101, and would often recount to us colorful stories<br />

from her life, such as the one about traveling all day in<br />

a covered wagon to see the Wright Brothers perform<br />

breathtaking feats in their amazing flying machines.<br />

All these women and others demonstrated to me<br />

wonderful qualities that I respected and admired, and<br />

sought to emulate and incorporate into my own sense<br />

of values and ideals. T<strong>here</strong> are countless examples in<br />

our culture of strong, courageous women and their<br />

many accomplishments and contributions to the world.<br />

So why is it that so many women who are in positions<br />

of power and leadership appear threatening to so many<br />

who live in our male-dominated society?<br />

A recurring theme at this year’s International AIDS<br />

Conference was the role of women in ending the<br />

epidemic. In her address at the conference opening<br />

plenary, Secretary of State Hillary Clinton talked about<br />

the essential role of communities, especially people living<br />

with HIV, in turning the tide on the epidemic. “And it<br />

will come as no surprise to you,” Clinton told the packed<br />

audience, “that I would like to highlight the particular<br />

role that women play.”<br />

Clinton pointed out that in Sub-Saharan Africa<br />

women account for 60% of people living with HIV.<br />

“Women want to protect themselves, and they want<br />

adequate health care, and we need to answer their call,”<br />

said Clinton. “Every woman should be able to decide<br />

when and whether to have children. This is true if she is<br />

HIV-positive or not. Women need and deserve a voice in<br />

the decisions that affect their lives.”<br />

In a lively morning plenary session by a panel made<br />

up of mostly women, HIV-positive<br />

educator and activist Linda Scruggs<br />

said it best by stating she wasn’t<br />

going to ask for anything, because<br />

women have been asking to be<br />

counted in for the last two decades. “Today I stand <strong>here</strong><br />

to give you some directions. We’ve decided to stop asking,<br />

and maybe you just need the recipe.”<br />

Scruggs called for meaningful involvement of women<br />

at every level, from the government to local communities<br />

and organizations, and also made it clear that women are<br />

not just asking for male-run organizations that “tolerate” a<br />

women’s program. “We need the support and resources…<br />

to give us the power to heal our sisters, to change our<br />

men. We are the mothers of the earth.”<br />

In her talk, Scruggs also shared part of what she says<br />

got her to the stage that day. She learned she was HIVpositive<br />

while visiting a perinatal clinic and was 13-weeks<br />

pregnant, and had to decide whether to terminate the<br />

pregnancy and live five years, or have the baby and possibly<br />

live three. She says she’s glad that day the doctor<br />

was wrong, and her son, Isaiah, was born free of HIV,<br />

and he just recently turned 21.<br />

“I could’ve made the decision to have an abortion.<br />

An abortion would not have been the first one I had had,<br />

but I had an experience with God. I had an experience<br />

that…made me really look and reflect about women.<br />

After all, what is a woman who thinks she’s ugly? What<br />

is a woman who feels she has no self-value? What is a<br />

woman who allows not one, but two men to rape her in<br />

silence? What is a woman who allows an uncle to molest<br />

her and others and still be silent?... What is a woman<br />

who feels that she’s been broken and voiceless? What is<br />

a woman who’s afraid of understanding herself? What<br />

is a woman who spent a lifetime trying to be someone<br />

other than herself?<br />

“I’ll tell you, that cold November day, that woman<br />

was me, but it was through the support of this community<br />

that I was able to find a voice and a place, that<br />

I could be just who I say I am. I am a woman.”<br />

Take care of yourself, and each other.<br />

t<strong>here</strong> are<br />

countless<br />

examples in<br />

our culture of<br />

strong, courageous<br />

women<br />

and their<br />

many accomplishments<br />

and contributions<br />

to the<br />

world. so why<br />

is it that so<br />

many women<br />

who are in<br />

positions<br />

of power<br />

and leadership<br />

appear<br />

threatening<br />

to so many<br />

who live in<br />

our maledominated<br />

society?<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 7


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POSITIVELY AWARE


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POSITIVELY AWARE


PHOTO: JOSHuA THORnE<br />

BRIEFLY<br />

EnID VázqUEz<br />

FDA approves Truvada for PrEP<br />

<strong>The</strong> Food and Drug Administration (FDA)<br />

in July approved truvada as the first<br />

medication to help prevent Hiv infection.<br />

As expected, the approval came<br />

with restrictions.<br />

Truvada, a combination of tenofovir<br />

(Viread) and emtricitabine (Emtriva), is<br />

one of the most prescribed medications<br />

for HIV in this country. For HIV prevention,<br />

the use of Truvada is called “PrEP,”<br />

for “pre-exposure prophylaxis.”<br />

“[We] commend the FDA’s approval of<br />

[Truvada] for the use of [PrEP] to prevent<br />

HIV transmission. This approach can<br />

prevent many new infections and could<br />

dramatically impact HIV transmission<br />

worldwide,” said Kenneth H. Mayer, MD,<br />

Medical Research Director and Co-chair<br />

of <strong>The</strong> Fenway Institute at Fenway Health.<br />

“My colleagues and I are delighted to have<br />

helped to demonstrate the utility of this<br />

promising approach for HIV prevention.”<br />

David Ernesto Munar, President/CEO<br />

of the AIDS Foundation of Chicago, said,<br />

“Our challenge now is to implement PrEP<br />

as strategically as possible, and to ensure<br />

the people who need it most, those who<br />

are most at risk for HIV, have access.”<br />

“This is an enormous turning point, a<br />

real game changer, in the fight against<br />

HIV,” said Jim Pickett, AFC’s Director<br />

of Prevention Advocacy and Gay Men’s<br />

Health. “<strong>The</strong> toolbox we have now has<br />

Truvada as PrEP. We can look forward to<br />

more sex acts being protected, especially<br />

among individuals who have already<br />

chosen, for whatever reason, to not use<br />

condoms consistently.”<br />

According to a press release from the<br />

FDA, “Truvada is to be used for [PrEP] in<br />

combination with safer sex practices to<br />

prevent sexually-acquired HIV infection in<br />

adults at high risk.”<br />

<strong>The</strong> FDA said Truvada for PrEP should<br />

be used as part of a comprehensive<br />

HIV prevention plan that includes risk<br />

reduction counseling, consistent and<br />

correct condom use, regular HIV testing,<br />

and screening for and treatment of other<br />

sexually-transmitted infections, stating<br />

that “Truvada is not a substitute for safer<br />

sex practices.”<br />

Truvada now carries a Boxed Warning<br />

on its drug label alerting health care<br />

professionals and uninfected individuals<br />

that Truvada for PrEP must only be used<br />

by people confirmed to be HIV-negative<br />

before being prescribed the drug and<br />

tested at least every three months during<br />

use to reduce the risk of developing<br />

drug resistance. Both the antiviral and the<br />

PrEP dose is one pill taken once daily.<br />

Truvada maker Gilead Sciences worked<br />

with the FDA to create a Risk Evaluation<br />

and Mitigation Strategy (REMS) for<br />

Truvada PrEP. <strong>The</strong> REMS focuses on a prescriber<br />

training and education program<br />

in counseling and managing individuals<br />

who are taking or considering Truvada for<br />

PrEP. <strong>The</strong> REMS looks at the elements of<br />

a comprehensive HIV prevention strategy,<br />

the importance of adhering to the recommended<br />

daily dosing regimen, and the<br />

serious risks of taking Truvada for PrEP if<br />

already infected with HIV or of becoming<br />

infected while taking it.<br />

According to the press release,<br />

“Truvada’s safety and efficacy for PrEP<br />

were demonstrated in two large, randomized,<br />

double-blind, placebo-controlled<br />

clinical trials. <strong>The</strong> iPrEx trial evaluated<br />

Truvada in 2,499 HIV-negative men<br />

or transgender women who have sex<br />

with men and with evidence of high<br />

risk behavior for HIV infection... Results<br />

showed Truvada was effective in reducing<br />

the risk of HIV infection by 42% compared<br />

with placebo in this population.<br />

Efficacy was strongly correlated with<br />

drug ad<strong>here</strong>nce in this trial.”<br />

It was also shown in iPrEX that t<strong>here</strong><br />

was a 92% reduction of risk for HIV in<br />

participants who<br />

took Truvada in the<br />

prescribed oncedaily<br />

dose.<br />

“<strong>The</strong> Partners<br />

PrEP trial was conducted<br />

in 4,758 heterosexual couples,<br />

w<strong>here</strong> one partner was HIV-infected and<br />

the other was not (serodiscordant couples),”<br />

the press release continued. “<strong>The</strong><br />

trial evaluated the efficacy and safety of<br />

[both] Truvada and [Viread] tenofovir<br />

versus placebo in preventing HIV infection<br />

in the uninfected male or female partner.<br />

Results showed Truvada reduced the risk<br />

of becoming infected by 75% compared<br />

with placebo.<br />

“No new side effects were identified<br />

in the clinical trials evaluating Truvada<br />

for the PrEP indication. <strong>The</strong> most common<br />

side effects reported with Truvada<br />

include diarrhea, nausea, abdominal<br />

pain, headache, and weight loss. Serious<br />

adverse events in general, as well as<br />

those specifically related to kidney or<br />

bone toxicity, were uncommon.”<br />

As a condition of approval, Gilead<br />

Sciences is required to collect and<br />

analyze samples from individuals who<br />

become infected with HIV while taking<br />

Truvada to see if they’ve developed drug<br />

resistance. <strong>The</strong> company is also required<br />

to collect data on women who become<br />

pregnant while taking Truvada for PrEP<br />

and to conduct other research.<br />

“Today’s decision is the culmination<br />

of almost 20 years of research involving<br />

investigators, academic and medical<br />

institutions, funding agencies, and nearly<br />

20,000 trial participants around the<br />

world, and Gilead is proud to have been<br />

a partner in this effort,” said Norbert<br />

Bischofberger, PhD, Executive Vice<br />

President, Research and Development<br />

and Chief Scientific Officer, Gilead<br />

Sciences. >><br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 13


BRIEFLY<br />

EnID VázqUEz<br />

Moises Agosto<br />

>> the following is from a statement<br />

from Moises Agosto, Director of<br />

treatment education, Ad<strong>here</strong>nce, and<br />

Mobilization for the National Minority<br />

AiDs Council (NMAC):<br />

“While PrEP shows substantial promise as<br />

a supplement to current HIV prevention<br />

efforts, it is by no means a panacea and<br />

is only effective when used in conjunction<br />

with traditional prevention and risk reduction<br />

strategies, such as condom usage.<br />

“Anti-retroviral medications, like<br />

Truvada, are extremely powerful drugs<br />

with the potential for serious side<br />

effects. As such, PrEP should only be<br />

used by individuals who are highly vulnerable<br />

to HIV infection, including those<br />

in sero-discordant couples, sex workers,<br />

and gay men. Its efficacy is also directly<br />

related to an individual’s ad<strong>here</strong>nce to<br />

a regimen, and should only be used by<br />

those who can commit to taking it regularly.<br />

Finally, use of PrEP by individuals<br />

who may already be HIV-positive could<br />

increase the risk of drug resistance.<br />

“In recent years, t<strong>here</strong> have been a<br />

number of promising developments in<br />

biomedical interventions—from treatment<br />

as prevention and pre-exposure<br />

prophylaxis to microbicides and vaccine<br />

research. <strong>The</strong>se advances have resulted<br />

in the greatest expansion of HIV prevention<br />

tools than at any other time in the<br />

history of this epidemic. Coupled with the<br />

reforms included in the Patient Protection<br />

and Affordable Care Act, as well as the<br />

National HIV/AIDS Strategy, we are in a<br />

position for the first time in over three<br />

decades to finally end this epidemic.<br />

Today’s decision is another important<br />

step in realizing that goal.”<br />

Dolutegravir/Epzicom<br />

superior to Atripla?<br />

Shionogi-ViiV Healthcare LLC announced<br />

that initial results from its Phase 3 study<br />

SINGLE (ING114467) show superiority of<br />

its investigational HIV medication dolutegravir<br />

plus Epzicom over Atripla, one of<br />

the most widely prescribed antiviral medications<br />

in the country. At 48 weeks, 88%<br />

of study participants on the dolutegravir<br />

regimen achieved undetectable viral<br />

load (less than 50 copies/mL) vs. 81% of<br />

those on Atripla, a statistically significant<br />

difference. <strong>The</strong> company said the difference<br />

was primarily driven by a higher<br />

rate of discontinuation due to adverse<br />

events in the Atripla arm. All individuals<br />

in the study were taking antiviral therapy<br />

for the first time, a group that does the<br />

best in HIV treatment. T<strong>here</strong> were 414<br />

individuals put on dolutegravir and 419<br />

put on Atripla. Overall, 2% of those on the<br />

dolutegravir-based regimen discontinued<br />

due to adverse events vs. 10% of those<br />

receiving the Atripla regimen. <strong>The</strong> most<br />

common adverse events while on Atripla<br />

were neurological (reported by 41% of<br />

Atripla recipients vs. 15% of participants<br />

receiving the dolutegravir), while the<br />

most common drug-related adverse<br />

events with dolutegravir were in the gastrointestinal<br />

system (reported by 22% of<br />

people on dolutegravir vs. 22% of those<br />

given Atripla).<br />

Dolutegravir is an investigational<br />

integrase inhibitor (INSTI), the same class<br />

as Isentress, the only INSTI currently on<br />

the market.<br />

Rapid home<br />

HIV test approved<br />

In June, the Food and Drug<br />

Administration (FDA) approved the<br />

oraQuick in-Home Hiv test, an Hiv<br />

self-test kit that does not require sending<br />

a sample to a laboratory for analysis. <strong>The</strong><br />

kit, which tests a swab from your mouth,<br />

is approved for sale in stores and online<br />

to anyone age 17 and older. (Although<br />

HIV is not found in saliva, evidence of<br />

exposure to the virus—called HIV antibodies—is<br />

found in the mouth and indicates<br />

infection.) A positive result at home<br />

must then be followed up with a confirmatory<br />

blood test from a laboratory.<br />

<strong>The</strong> FDA said the test can be falsely<br />

negative for reasons that include the<br />

occurrence of HIV infection within three<br />

months before testing. People who<br />

engage in behaviors that put them at<br />

increased risk of getting HIV—including<br />

having unprotected sex with new partners,<br />

or injecting illegal drugs—should be<br />

re-tested on a regular basis. <strong>The</strong>y should<br />

not interpret a negative test to indicate<br />

that engaging in high risk behavior is<br />

safe.<br />

14 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


FRom THE wEEkLY E-nEwS<br />

Website offers<br />

access to HIV meds<br />

for uninsured<br />

HarborPath, a new non-profit organization,<br />

has been established to create a<br />

program that offers a single place w<strong>here</strong><br />

uninsured Hiv-positive people who<br />

otherwise qualify for manufacturersponsored<br />

patient assistance programs<br />

(PAPs) can apply for and receive their<br />

medications. <strong>The</strong> “one stop shop” portal<br />

will provide a streamlined, online process<br />

to qualify individuals and deliver the<br />

donated medications through a mailorder<br />

pharmacy. HarborPath will pilot the<br />

program in states with high need, including<br />

Alabama, Texas, and Virginia.<br />

To create the portal, HarborPath<br />

worked closely with the National Alliance<br />

of State and Territorial AIDS Directors<br />

(NASTAD) and the Clinton Health Access<br />

Initiative (CHAI), which provided the seed<br />

funding for the organization. On World<br />

AIDS Day 2011, President Bill Clinton noted<br />

the need to fight HIV/AIDS in the U.S.<br />

“I am proud that my foundation is<br />

partnering with NASTAD and other<br />

pharmaceutical manufacturers to make<br />

sure Americans living with HIV have<br />

access to the life-saving medications<br />

they need,” said President Clinton. “This<br />

E-NEWS |<br />

is an important step forward in our fight<br />

against the disease.”<br />

ViiV Healthcare is the first pharmaceutical<br />

company to support the program<br />

with HIV/AIDS medications and funding.<br />

<strong>The</strong> goal of HarborPath is to get all<br />

HIV/AIDS medications into the program<br />

and serve uninsured individuals with:<br />

n An easy-to-use website with a single<br />

portal to determine eligibility for the<br />

program and to fill prescriptions for<br />

participating companies’ HIV/AIDS<br />

medications.<br />

n Automatic notifications for both the<br />

individual and the case manager of<br />

qualification for the program.<br />

n A pharmacy that ships a 3-month supply<br />

of all participating medications in<br />

one package within two business days<br />

of final approval and confirms delivery<br />

of the medications.<br />

n Renewal reminders to individuals and<br />

case managers to improve medication<br />

ad<strong>here</strong>nce.<br />

n A fully automated portal that case<br />

managers can access at any time<br />

for up-to-the-minute status of an<br />

individual’s application or shipment. If<br />

needed, live support is also available<br />

through a toll-free call center.<br />

Murray Penner, Deputy Executive<br />

Director at NASTAD, said, “Under the current<br />

PAP process, an individual or their<br />

case manager has to apply<br />

separately to each company’s<br />

program for these<br />

medications, which can be<br />

complex and time-consuming.<br />

Missing doses or failing<br />

to fill prescriptions because<br />

of complications sometimes<br />

associated with these processes<br />

may result in serious<br />

health consequences, or<br />

even death, in addition to<br />

increased transmission of<br />

the virus. HarborPath is<br />

designed to address this<br />

urgent need in the U.S.”<br />

Sign up for the weekly email newSletter of<br />

poSitively aware. go to positivelyaware.com<br />

Studies find<br />

once-daily ‘Quad’<br />

is safe and effective<br />

<strong>The</strong> findings of two large international<br />

randomized studies published in <strong>The</strong><br />

Lancet medical journal indicate that the<br />

new once-daily pill combining three<br />

antiretrovirals and a booster molecule is<br />

a safe and effective alternative to two<br />

widely used drug regimens for newly<br />

diagnosed Hiv-positive adults who have<br />

had no previous treatment. <strong>The</strong> study<br />

results also indicate that the new “Quad”<br />

pill is faster acting, doesn’t have the neuropsychiatric<br />

side effects associated with<br />

other combinations, and could improve<br />

compliance with treatment.<br />

“Patient ad<strong>here</strong>nce to medication is<br />

vital, especially for patients with HIV,<br />

w<strong>here</strong> missed doses can quickly lead to<br />

the virus becoming resistant to medication.<br />

Older HIV treatment regimens<br />

involve taking several pills multiple times<br />

a day,” explains Paul Sax from Brigham<br />

and Women’s Hospital, Harvard Medical<br />

School, lead author of the first study.<br />

“Our results provide an additional highly<br />

potent, well-tolerated treatment option,<br />

and highlight the simplicity of treatment<br />

resulting from combining several antiretrovirals<br />

in a single pill. Studies have<br />

shown that single pill treatments improve<br />

both ad<strong>here</strong>nce and patient satisfaction,<br />

and help prevent prescription errors,<br />

t<strong>here</strong>by reducing the likelihood of treatment<br />

failure and drug resistance.”<br />

<strong>The</strong> first study randomly assigned<br />

700 patients from centers across North<br />

America to start treatment with two<br />

different single tablet regimens—either<br />

the Quad, combining the new integrase<br />

inhibitor elvitegravir (EVG) boosted with<br />

cobicistat (a new pharmacoenhancer;<br />

COBI) plus emtricitabine/tenofovir<br />

(Emtriva/Viread), or Atripla (efavirenz/<br />

emtricitabine/tenofovir), the current gold<br />

standard regimen approved by the FDA<br />

in 2006.<br />

After 48 weeks of treatment, 88% >><br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 15


BRIEFLY<br />

EnID VázqUEz<br />

of patients given the Quad had suppressed<br />

viral loads (less than 50 copies/<br />

mL), compared with 84% in the Atripla<br />

group.<br />

Adverse events that led to patients<br />

discontinuing treatment were infrequent<br />

and similar in both groups. Mild nausea<br />

was more common with the Quad, but<br />

patients were less likely to have dizziness,<br />

abnormal dreams, insomnia, and rash<br />

compared with the Atripla regimen.<br />

<strong>The</strong> second trial included 708<br />

treatment-naïve adults from 146 medical<br />

centers across Australia, Europe, North<br />

America, and Thailand. Patients were<br />

randomly assigned to receive a once-daily<br />

Quad or a popular and recommended<br />

twice-daily combination of Norvirboosted<br />

Reyataz (atazanavir/ritonavir)<br />

plus Truvada (emtricitabine/tenofovir).<br />

<strong>The</strong> primary endpoint, to achieve viral<br />

levels below 50 copies/mL by week 48,<br />

was reached by 90% of people in the<br />

Quad group compared with 87% in the<br />

atazanavir/ritonavir/emtricitabine/tenofovir<br />

group.<br />

<strong>The</strong> safety of the two regimens was<br />

also similar.<br />

PA’s editor debuts<br />

blog on HuffPo<br />

PoSITIVELY awaRE editor Jeff Berry has<br />

joined other AIDS activists and journalists<br />

such as <strong>The</strong> <strong>Body</strong>’s Kellee Turrell, the AIDS<br />

Foundation of Chicago’s David Ernesto<br />

Munar, and others in becoming a blogger<br />

published by the Huffington Post.<br />

In advance of the upcoming AIDS 2012<br />

World AIDS Conference, Berry wrote<br />

“Reflections from an Epidemic: Carrying<br />

the Torch to AIDS 2012.” In it, he talks<br />

about the significance of this being the<br />

Simplify your life.<br />

first conference to be held in the U.S.<br />

since President Obama lifted the travel<br />

ban on HIV-positive people, his anticipation<br />

of such events as displays of the<br />

AIDS Memorial Quilt, a planned march<br />

and demonstration, the performance<br />

of the Tony Award-winning play <strong>The</strong><br />

Normal Heart, as well as the many global<br />

leaders in AIDS policy, advocacy, and<br />

treatment advances that presented at the<br />

conference.<br />

Did he get infected?<br />

In the July+August issue of PoSITIVELY<br />

awaRE, a young man in Chicago, Chris,<br />

was anxiously awaiting the results of his<br />

HIV tests following a potential exposure<br />

through sex (“PrEPing,” July+August).<br />

Two months later, he remains<br />

HIV-negative.<br />

Turn your assorted prescription medicine bottles into single-dose packs.<br />

Easy to remember. Easy to take. Each pack contains all the pills of a single dose.<br />

Free FedEx shipping anyw<strong>here</strong> in the continental U.S.<br />

J Discount Pharmacy<br />

Call to plaCE yoUr FirSt ordEr:<br />

(773) 278-5337<br />

16 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


PHOTO: MATTHEw gARSTECK<br />

TPan, publisher of PoSITIVELY awaRE, is commemorating<br />

25 years of service to chicago’s HIV community.<br />

JoiN Jamar rogers, of Nbc’s “the voice,” for a special performaNce.<br />

OCTOBER 4, 2012<br />

5:30–8:30 Pm | cHIcago cULTURaL cEnTER<br />

TIckETS aVaILaBLE aT www.tpan.com<br />

EVEnT SPOnSORS<br />

$100,000 anD aBoVE<br />

alphawood Foundation<br />

Bristol-myers Squibb<br />

$25,000 anD aBoVE<br />

abbott Virology<br />

EmD Serono<br />

Lloyd a. Fry Foundation<br />

ViiV Healthcare<br />

walgreens<br />

AnnIVERSARY PARTnERS<br />

$50,000 anD aBoVE<br />

janssen <strong>The</strong>rapeutics<br />

$10,000 anD aBoVE<br />

aIDS Foundation of chicago<br />

Blue cross and Blue Shield<br />

of Illinois<br />

cheetah gyms<br />

gilead Sciences, Inc.<br />

macy’s<br />

millercoors<br />

Steamworks


INDICATION<br />

COMPLERA ® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate<br />

300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA ®<br />

(emtricitabine), EDURANT (rilpivirine), and VIREAD ® (tenofovir disoproxil fumarate)<br />

combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat<br />

HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before.<br />

COMPLERA does not cure HIV and has not been shown to prevent passing HIV<br />

to others. It is important to always practice safer sex, use latex or polyurethane<br />

condoms to lower the chance of sexual contact with any body fl uids, and to never<br />

re-use or share needles. Do not stop taking COMPLERA unless directed by your<br />

healthcare provider. See your healthcare provider regularly.<br />

IMPORTANT SAFETY INFORMATION<br />

Contact your healthcare provider right away if you get the following side effects<br />

or conditions while taking COMPLERA:<br />

• Nausea, vomiting, unusual muscle pain, and/or weakness. <strong>The</strong>se may be<br />

signs of a buildup of acid in the blood (lactic acidosis), which is a serious<br />

medical condition<br />

• Light-colored stools, dark-colored urine, and/or if your skin or the whites of your<br />

eyes turn yellow. <strong>The</strong>se may be signs of serious liver problems (hepatotoxicity),<br />

with liver enlargement (hepatomegaly), and fat in the liver (steatosis)<br />

• If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly<br />

get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without<br />

fi rst talking to your healthcare provider. Your healthcare provider will monitor<br />

your condition<br />

COMPLERA may affect the way other medicines work, and other medicines may<br />

affect how COMPLERA works, and may cause serious side effects.<br />

COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil<br />

fumarate) is a prescription medicine used as a complete<br />

single-tablet regimen to treat HIV-1 in adults who have<br />

never taken HIV medicines before. COMPLERA does not<br />

cure HIV or AIDS or help prevent passing HIV to others.<br />

one<br />

<strong>The</strong> for me<br />

Patient model. Pill shown is not actual size.<br />

Do not take COMPLERA if you are taking the following medicines:<br />

• other HIV medicines (COMPLERA provides a complete treatment for HIV infection.)<br />

• the anti-seizure medicines carbamazepine (Carbatrol ® , Equetro ® , Tegretol ® ,<br />

Tegretol-XR ® , Teril ® , Epitol ® ), oxcarbazepine (Trileptal ® ), phenobarbital (Luminal ® ),<br />

phenytoin (Dilantin ® , Dilantin-125 ® , Phenytek ® )<br />

• the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater ® ,<br />

Rifamate ® , Rimactane ® , Rifadin ® ) and rifapentine (Priftin ® )<br />

• a proton pump inhibitor medicine for certain stomach or intestinal problems,<br />

including esomeprazole (Nexium ® , Vimovo ® ), lansoprazole (Prevacid ® ),<br />

omeprazole (Prilosec ® ), pantoprazole sodium (Protonix ® ), rabeprazole (Aciphex ® )<br />

• more than 1 dose of the steroid medicine dexamethasone or dexamethasone<br />

sodium phosphate<br />

• St. John’s wort (Hypericum perforatum)<br />

• other medicines that contain tenofovir (VIREAD ® , TRUVADA ® , ATRIPLA ® )<br />

• other medicines that contain emtricitabine or lamivudine (EMTRIVA ® , Combivir ® ,<br />

Epivir ® or Epivir-HBV ® , Epzicom ® , Trizivir ® )<br />

• rilpivirine (Edurant )<br />

• adefovir (HEPSERA ® )<br />

In addition, also tell your healthcare provider if you take:<br />

• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium<br />

carbonate. Take antacids at least 2 hours before or at least 4 hours after you<br />

take COMPLERA<br />

• a histamine-2 blocker medicine, including famotidine (Pepcid ® ), cimetidine<br />

(Tagamet ® ), nizatidine (Axid ® ), or ranitidine hydrochloride (Zantac ® ). Take these<br />

medicines at least 12 hours before or at least 4 hours after you take COMPLERA<br />

• the antibiotic medicines clarithromycin (Biaxin ® ), erythromycin (E-Mycin ® , Eryc ® ,<br />

Ery-Tab ® , PCE ® , Pediazole ® , Ilosone ® ), and troleandomycin (TAO ® )<br />

• an antifungal medicine by mouth, including fl uconazole (Difl ucan ® ), itraconazole<br />

(Sporanox ® ), ketoconazole (Nizoral ® ), posaconazole (Noxafi l ® ), voriconazole (Vfend ® )<br />

• methadone (Dolophine ® )<br />

This list of medicines is not complete. Discuss with your healthcare provider all<br />

prescription and nonprescription medicines, vitamins, or herbal supplements you<br />

are taking or plan to take.


Save up to<br />

$200<br />

per month<br />

Before taking COMPLERA, tell your healthcare provider if you:<br />

• have liver problems, including hepatitis B or C virus infection<br />

• have kidney problems<br />

• have ever had a mental health problem<br />

• have bone problems<br />

• are pregnant or plan to become pregnant. It is not known if COMPLERA can harm<br />

your unborn child<br />

• are breastfeeding; women with HIV should not breast-feed because they can pass<br />

HIV through their milk to the baby<br />

Contact your healthcare provider right away if you experience any of the<br />

following serious or common side effects:<br />

Serious side effects associated with COMPLERA:<br />

• New or worse kidney problems can happen in some people who take COMPLERA.<br />

If you have had kidney problems in the past or take other medicines that can cause<br />

kidney problems, your healthcare provider may need to do blood tests to check your<br />

kidneys during your treatment with COMPLERA<br />

• Depression or mood changes can happen in some people who take COMPLERA.<br />

Tell your healthcare provider right away if you have any of the following symptoms:<br />

feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of<br />

hurting yourself (suicide) or have tried to hurt yourself<br />

• Bone problems can happen in some people who take COMPLERA. Bone problems<br />

include bone pain, softening or thinning (which may lead to fractures). Your<br />

healthcare provider may need to do additional tests to check your bones<br />

• Changes in body fat can happen in people taking HIV medicine. <strong>The</strong>se changes<br />

may include increased amount of fat in the upper back and neck (“buffalo hump”),<br />

breast, and around the main part of your body (trunk). Loss of fat from the legs,<br />

arms and face may also happen. <strong>The</strong> cause and long-term health effect of these<br />

conditions are not known<br />

• Changes in your immune system (Immune Reconstitution Syndrome) can happen<br />

when you start taking HIV medicines. Your immune system may get stronger and<br />

begin to fi ght infections that have been hidden in your body for a long time. Tell<br />

your healthcare provider if you start having new symptoms after starting your<br />

HIV medicine<br />

You may be able to save on the co-pay for<br />

your COMPLERA prescription with a Gilead<br />

HIV Co-pay Assistance Card.<br />

Call 1-877-505-6986 for more information<br />

or visit www.COMPLERA.com.*<br />

COMPLERA. A complete HIV treatment in only 1 pill a day.<br />

Ask your healthcare provider if it’s the one for you.<br />

Common side effects associated with COMPLERA:<br />

• trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea,<br />

nausea, rash, tiredness, and depression<br />

Other side effects associated with COMPLERA:<br />

• vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles),<br />

and pain<br />

Tell your healthcare provider if you have any side effect that bothers you or that<br />

does not go away. <strong>The</strong>se are not all the possible side effects of COMPLERA. For more<br />

information, ask your healthcare provider or pharmacist. Call your healthcare provider<br />

for medical advice about side effects.<br />

You are encouraged to report negative side effects of prescription drugs to the<br />

FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.<br />

Take COMPLERA exactly as your healthcare provider tells you to take it<br />

• Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to<br />

help get the right amount of medicine in your body. A protein drink does not replace<br />

a meal<br />

• Stay under the care of your healthcare provider during treatment with<br />

COMPLERA and see your healthcare provider regularly<br />

Please see Patient Information for COMPLERA on the following pages.<br />

* <strong>The</strong> co-pay program covers up to $200 per month for 1 year from card activation or until the<br />

card expires, up to $2400 in a calendar year. <strong>The</strong> program is subject to change or cancellation<br />

at any time.<br />

Learn more at www.COMPLERA.com


FDA-Approved Patient Labeling<br />

Patient Information<br />

COMPLERA ® (kom-PLEH-rah)<br />

(emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets<br />

Important: Ask your doctor or pharmacist about medicines that should not be<br />

taken with COMPLERA. For more information, see the section “What should I tell my<br />

healthcare provider before taking COMPLERA?”<br />

Read this Patient Information before you start taking COMPLERA and each time you<br />

get a refill. T<strong>here</strong> may be new information. This information does not take the place of<br />

talking to your healthcare provider about your medical condition or treatment.<br />

What is the most important information I should know about COMPLERA?<br />

COMPLERA can cause serious side effects, including:<br />

1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in<br />

some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic<br />

acidosis is a serious medical emergency that can lead to death.<br />

Lactic acidosis can be hard to identify early, because the symptoms could seem like<br />

symptoms of other health problems. Call your healthcare provider right away if you<br />

get any of the following symptoms which could be signs of lactic acidosis:<br />

• feeling very weak or tired<br />

• have unusual (not normal) muscle pain<br />

• have trouble breathing<br />

• have stomach pain with<br />

- nausea (feel sick to your stomach)<br />

- vomiting<br />

• feel cold, especially in your arms and legs<br />

• feel dizzy or lightheaded<br />

• have a fast or irregular heartbeat<br />

2. Severe liver problems. Severe liver problems can happen in people who take<br />

COMPLERA or similar medicines. In some cases these liver problems can lead to death.<br />

Your liver may become large (hepatomegaly) and you may develop fat in your liver<br />

(steatosis) when you take COMPLERA.<br />

Call your healthcare provider right away if you have any of the following symptoms<br />

of liver problems:<br />

• your skin or the white part of your eyes turns yellow (jaundice).<br />

• dark “tea-colored” urine<br />

• light-colored bowel movements (stools)<br />

• loss of appetite for several days or longer<br />

• nausea<br />

• stomach pain<br />

You may be more likely to get lactic acidosis or severe liver problems if you are<br />

female, very overweight (obese), or have been taking COMPLERA or a similar<br />

medicine containing nucleoside analogs for a long time.<br />

3. Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection<br />

and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A<br />

“flare-up” is when your HBV infection suddenly returns in a worse way than before.<br />

COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV<br />

therapy with your healthcare provider.<br />

• Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare<br />

provider before your COMPLERA is all gone.<br />

• Do not stop taking COMPLERA without first talking to your healthcare provider.<br />

• If you stop taking COMPLERA, your healthcare provider will need to check your health<br />

often and do regular blood tests to check your HBV infection. Tell your healthcare<br />

provider about any new or unusual symptoms you may have after you stop taking<br />

COMPLERA.<br />

What is COMPLERA?<br />

COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine that:<br />

• is used to treat HIV-1 in adults who have never taken HIV medicines before. HIV is the<br />

virus that causes AIDS (Acquired Immunodeficiency Syndrome).<br />

• contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate)<br />

combined in one tablet. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency<br />

virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and EDURANT is an<br />

HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI).<br />

It is not known if COMPLERA is safe and effective in children under the age of 18 years.<br />

COMPLERA may help:<br />

• Reduce the amount of HIV in your blood. This is called your “viral load”.<br />

• Increase the number of white blood <strong>cells</strong> called CD4+ (T) <strong>cells</strong> that help fight off<br />

other infections.<br />

Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your<br />

immune system. This may reduce your risk of death or infections that can happen when<br />

your immune system is weak (opportunistic infections).<br />

COMPLERA does not cure HIV infections or AIDS.<br />

• Always practice safer sex.<br />

• Use latex or polyurethane condoms to lower the chance of sexual contact with any<br />

body fluids such as semen, vaginal secretions, or blood.<br />

• Never re-use or share needles.<br />

Ask your healthcare provider if you have any questions about how to prevent passing<br />

HIV to other people.<br />

Who should not take COMPLERA?<br />

• Do not take COMPLERA if your HIV infection has been previously treated with<br />

HIV medicines.<br />

• Do not take COMPLERA if you are taking certain other medicines. For more<br />

information about medicines that must not be taken with COMPLERA, see “What<br />

should I tell my healthcare provider before taking COMPLERA?”<br />

What should I tell my healthcare provider before taking COMPLERA?<br />

Before you take COMPLERA, tell your healthcare provider if you:<br />

• have liver problems, including hepatitis B or C virus infection<br />

• have kidney problems<br />

• have ever had a mental health problem<br />

• have bone problems<br />

• are pregnant or plan to become pregnant. It is not known if COMPLERA can harm<br />

your unborn child<br />

Pregnancy Registry. T<strong>here</strong> is a pregnancy registry for women who take antiviral<br />

medicines during pregnancy. Its purpose is to collect information about the health<br />

of you and your baby. Talk to your healthcare provider about how you can take part<br />

in this registry.<br />

• are breast-feeding or plan to breast-feed. <strong>The</strong> Centers for Disease Control and<br />

Prevention recommends that mothers with HIV not breastfeed because they can pass<br />

the HIV through their milk to the baby. It is not known if COMPLERA can pass through<br />

your breast milk and harm your baby. Talk to your healthcare provider about the best<br />

way to feed your baby.<br />

Tell your healthcare provider about all the medicines you take, including prescription<br />

and nonprescription medicines, vitamins, and herbal supplements.<br />

COMPLERA may affect the way other medicines work, and other medicines may<br />

affect how COMPLERA works, and may cause serious side effects. If you take certain<br />

medicines with COMPLERA, the amount of COMPLERA in your body may be too low and<br />

it may not work to help control your HIV infection. <strong>The</strong> HIV virus in your body may become<br />

resistant to COMPLERA or other HIV medicines that are like it.<br />

Do not take COMPLERA if you also take these medicines:<br />

• COMPLERA provides a complete treatment for HIV infection. Do not take other HIV<br />

medicines with COMPLERA.<br />

• the anti-seizure medicines carbamazepine (CARBATROL ® , EQUETRO ® , TEGRETOL ® ,<br />

TEGRETOL-XR ® , TERIL ® , EPITOL ® ), oxcarbazepine (TRILEPTAL ® ), phenobarbital<br />

(LUMINAL ® ), phenytoin (DILANTIN ® , DILANTIN-125 ® , PHENYTEK ® )<br />

• the anti-tuberculosis medicines rifabutin (MYCOBUTIN ® ), rifampin (RIFATER ® ,<br />

RIFAMATE ® , RIMACTANE ® , RIFADIN ® ) and rifapentine (PRIFTIN ® )<br />

• a proton pump inhibitor medicine for certain stomach or intestinal problems,<br />

including esomeprazole (NEXIUM ® , VIMOVO ® ), lansoprazole (PREVACID ® ), omeprazole<br />

(PRILOSEC ® ), pantoprazole sodium (PROTONIX ® ), rabeprazole (ACIPHEX ® )<br />

• more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium<br />

phosphate<br />

• St. John’s wort (Hypericum perforatum)<br />

If you are taking COMPLERA, you should not take:<br />

• other medicines that contain tenofovir (VIREAD ® , TRUVADA ® , ATRIPLA ® )<br />

• other medicines that contain emtricitabine or lamivudine (EMTRIVA ® , COMBIVIR ® ,<br />

EPIVIR ® or EPIVIR-HBV ® , EPZICOM ® , TRIZIVIR ® )<br />

• rilpivirine (EDURANT )<br />

• adefovir (HEPSERA ® )


Also tell your healthcare provider if you take:<br />

• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium<br />

carbonate. Take antacids at least 2 hours before or at least 4 hours after you take<br />

COMPLERA.<br />

• a histamine-2 blocker medicine, including famotidine (PEPCID ® ), cimetidine<br />

(TAGAMET ® ), nizatidine (AXID ® ), or ranitidine hydrochloride (ZANTAC ® ). Take these<br />

medicines at least 12 hours before or at least 4 hours after you take COMPLERA.<br />

• the antibiotic medicines clarithromycin (BIAXIN ® ), erythromycin (E-MYCIN ® , ERYC ® ,<br />

ERY-TAB ® , PCE ® , PEDIAZOLE ® , ILOSONE ® ), and troleandomycin (TAO ® )<br />

• an antifungal medicine by mouth, including fluconazole (DIFLUCAN ® ), itraconazole<br />

(SPORANOX ® ), ketoconazole (NIZORAL ® ), posaconazole (NOXAFIL ® ), voriconazole<br />

(VFEND ® )<br />

• methadone (DOLOPHINE ® )<br />

Ask your healthcare provider or pharmacist if you are not sure if your medicine is<br />

one that is listed above.<br />

Know the medicines you take. Keep a list of your medicines and show it to your<br />

healthcare provider and pharmacist when you get a new medicine. Your healthcare<br />

provider and your pharmacist can tell you if you can take these medicines with<br />

COMPLERA. Do not start any new medicines while you are taking COMPLERA without<br />

first talking with your healthcare provider or pharmacist. You can ask your healthcare<br />

provider or pharmacist for a list of medicines that can interact with COMPLERA.<br />

How should I take COMPLERA?<br />

• Stay under the care of your healthcare provider during treatment with COMPLERA.<br />

• Take COMPLERA exactly as your healthcare provider tells you to take it.<br />

• Always take COMPLERA with a meal. Taking COMPLERA with a meal is important<br />

to help get the right amount of medicine in your body. A protein drink does not<br />

replace a meal.<br />

• Do not change your dose or stop taking COMPLERA without first talking with your<br />

healthcare provider. See your healthcare provider regularly while taking COMPLERA.<br />

• If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take<br />

your dose of COMPLERA with a meal as soon as possible. <strong>The</strong>n, take your next dose<br />

of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by<br />

more than 12 hours of the time you usually take it, wait and then take the next dose<br />

of COMPLERA at the regularly scheduled time.<br />

• Do not take more than your prescribed dose to make up for a missed dose.<br />

• When your COMPLERA supply starts to run low, get more from your healthcare provider<br />

or pharmacy. It is very important not to run out of COMPLERA. <strong>The</strong> amount of virus in<br />

your blood may increase if the medicine is stopped for even a short time.<br />

• If you take too much COMPLERA, contact your local poison control center or go to the<br />

nearest hospital emergency room right away.<br />

What are the possible side effects of COMPLERA?<br />

COMPLERA may cause the following serious side effects, including:<br />

• See “What is the most important information I should know about COMPLERA?”<br />

• New or worse kidney problems can happen in some people who take COMPLERA.<br />

If you have had kidney problems in the past or take other medicines that can cause<br />

kidney problems, your healthcare provider may need to do blood tests to check your<br />

kidneys during your treatment with COMPLERA.<br />

• Depression or mood changes. Tell your healthcare provider right away if you have<br />

any of the following symptoms:<br />

- feeling sad or hopeless<br />

- feeling anxious or restless<br />

- have thoughts of hurting yourself (suicide) or have tried to hurt yourself<br />

• Bone problems can happen in some people who take COMPLERA. Bone problems<br />

include bone pain, softening or thinning (which may lead to fractures). Your<br />

healthcare provider may need to do additional tests to check your bones.<br />

• Changes in body fat can happen in people taking HIV medicine. <strong>The</strong>se changes may<br />

include increased amount of fat in the upper back and neck (“buffalo hump”), breast,<br />

and around the main part of your body (trunk). Loss of fat from the legs, arms and<br />

face may also happen. <strong>The</strong> cause and long term health effect of these conditions are<br />

not known.<br />

• Changes in your immune system (Immune Reconstitution Syndrome) can happen<br />

when you start taking HIV medicines. Your immune system may get stronger<br />

and begin to fight infections that have been hidden in your body for a long time.<br />

Tell your healthcare provider if you start having new symptoms after starting your<br />

HIV medicine.<br />

<strong>The</strong> most common side effects of COMPLERA include:<br />

• trouble sleeping (insomnia)<br />

• abnormal dreams<br />

• headache<br />

• dizziness<br />

• diarrhea<br />

• nausea<br />

• rash<br />

• tiredness<br />

• depression<br />

Additional common side effects include:<br />

• vomiting<br />

• stomach pain or discomfort<br />

• skin discoloration (small spots or freckles)<br />

• pain<br />

Tell your healthcare provider if you have any side effect that bothers you or that does<br />

not go away.<br />

<strong>The</strong>se are not all the possible side effects of COMPLERA. For more information, ask your<br />

healthcare provider or pharmacist.<br />

Call your doctor for medical advice about side effects. You may report side effects to<br />

FDA at 1-800-FDA-1088 (1-800-332-1088).<br />

How do I store COMPLERA?<br />

• Store COMPLERA at room temperature 77 °F (25 °C).<br />

• Keep COMPLERA in its original container and keep the container tightly closed.<br />

• Do not use COMPLERA if the seal over the bottle opening is broken or missing.<br />

Keep COMPLERA and all other medicines out of reach of children.<br />

General information about COMPLERA:<br />

Medicines are sometimes prescribed for purposes other than those listed in a Patient<br />

Information leaflet. Do not use COMPLERA for a condition for which it was not prescribed.<br />

Do not give COMPLERA to other people, even if they have the same symptoms you have.<br />

It may harm them.<br />

This leaflet summarizes the most important information about COMPLERA. If you<br />

would like more information, talk with your healthcare provider. You can ask your<br />

healthcare provider or pharmacist for information about COMPLERA that is written<br />

for health professionals. For more information, call (1-800-445-3235) or go to<br />

www.COMPLERA.com.<br />

What are the ingredients of COMPLERA?<br />

Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil<br />

fumarate<br />

Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline<br />

cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. <strong>The</strong><br />

tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate,<br />

triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow<br />

#6 aluminum lake.<br />

This Patient Information has been approved by the U.S. Food and Drug Administration<br />

Manufactured and distributed by:<br />

Gilead Sciences, Inc.<br />

Foster City, CA 94404<br />

Issued: August 2011<br />

COMPLERA, the COMPLERA Logo, EMTRIVA, HEPSERA, TRUVADA, VIREAD, GILEAD, and<br />

the GILEAD Logo are trademarks of Gilead Sciences, Inc. or its related companies.<br />

ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other<br />

trademarks referenced <strong>here</strong>in are the property of their respective owners.<br />

© 2012 Gilead Sciences, Inc. All rights reserved.<br />

202123-GS-000 02AUG2011 CON12383 3/12


Securing care<br />

for Women<br />

living With hiv<br />

Challenges and solutions for Hiv-positive women<br />

by NaiNa khaNNa<br />

FIVE YEaRS ago, womEn HaD THE DUBIoUS<br />

distinction of surpassing men as the majority of people<br />

in the world living with HIV. And in some countries,<br />

including Cambodia, Mozambique, and Rwanda, women<br />

now comprise nearly two-thirds of people living with the virus.<br />

In the U.S., the HIV epidemic looks<br />

very different. Women comprise over a<br />

quarter of the estimated 1.2 million people<br />

living with HIV in the U.S.—not including<br />

transgender women, for whom no accurate<br />

data are available. In 1984, women<br />

represented only 8% of HIV infections in<br />

the U.S. Thus, even at a national level, the<br />

trend is troubling. Data from 2012 show<br />

that in the District of Columbia, rates of<br />

new HIV diagnosis among black women<br />

have doubled. In Maryland, 35% of all AIDS<br />

diagnoses are among women, and in the<br />

U.S. Virgin Islands, 36.4% of people with<br />

an AIDS diagnosis were women in 2009.<br />

And when you drill down further, particularly<br />

in the U.S. South, in some counties,<br />

HIV infection rates among females may<br />

be even higher. Let’s be clear: this is not a<br />

numbers game anyone wants to win.<br />

Of even more concern, in the United<br />

States, HIV acquisition among women<br />

is correlated with race, poverty, experience<br />

of trauma, mental illness, substance<br />

use, and vulnerability to assorted social<br />

stigmas—the same factors that reduce<br />

likelihood of positive health outcomes in<br />

people living with HIV. That is, these socioeconomic<br />

factors increase vulnerability to<br />

poor health outcomes, with or without an<br />

HIV diagnosis. U.S. women living with HIV<br />

are disproportionately likely to be women<br />

of color (over 80%), especially black and<br />

Latina, and living in poverty, compared<br />

to men living with HIV. According to the<br />

HIV Cost Services and Utilization Study<br />

(HCSUS), 64% of HIV-positive women in<br />

ongoing medical care had annual incomes<br />

under $10,000, compared with 41% of<br />

HIV-positive men in care. More than twice<br />

as many HIV-positive women (76%) as<br />

HIV-positive men (34%) are living with and<br />

caring for at least one child under the age<br />

of 18. Thus, care systems for HIV-positive<br />

women must account for caretaking<br />

responsibilities, including provisions for<br />

minor children.<br />

Alarmingly, data show that ad<strong>here</strong>nce<br />

to anti-retroviral therapy tends to<br />

decrease among women living with HIV<br />

as the number of children under 18 living<br />

in the home increases. This is no real surprise.<br />

As women, we tend to prioritize caring<br />

for others over ourselves. Sometimes<br />

it’s a matter of practicality—we only have<br />

so many dollars to go around and hours<br />

in the day and bus vouchers. Sometimes<br />

it’s a matter of stigma—we don’t want<br />

others to see us taking our meds or going<br />

to medical appointments. And frequently<br />

it’s a reflection of how we value ourselves,<br />

especially as poor women, women of<br />

22 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM<br />

PHoTo: © IaS/STEVE SHaPIRo-commERcIaLImagE.nET<br />

ORGAnIzInG PRInCIPAL: Megaphone in hand,


Naina Khanna, Director of Policy and Community Organizing, WORLD, rallies demonstrators at the International AIDS Conference in July.<br />

color, women living with HIV. We have<br />

internalized that our health, our wellness,<br />

our wellbeing is too often not a priority for<br />

our society and political leaders—so why<br />

should we make it a priority for us?<br />

Transgender women are especially<br />

likely to live in extreme poverty, to face<br />

exceptional barriers to safe housing,<br />

employment, and access to quality health<br />

care, and, if HIV-positive, are less likely<br />

than other populations to receive antiretroviral<br />

therapy and more likely to experience<br />

negative interactions with health care<br />

providers. Transgender women are also<br />

disproportionately likely to face violence in<br />

their communities.<br />

Although researchers within the U.S.<br />

and internationally have known for years<br />

that women who have experienced violence<br />

and trauma are at elevated risk of<br />

acquiring HIV (even in non-conflict settings),<br />

new data released in 2012 show<br />

that women with HIV in the U.S. are<br />

twice as likely to have been victims of<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 23


Women’s bodies are not only about making babies.<br />

Fully upholding our human rights includes upholding our right<br />

to be sexual beings who experience joy and erotic pleasure.<br />

intimate partner violence and suffer posttraumatic<br />

stress disorder at a rate five<br />

times greater than HIV-negative women.<br />

Rates of violence faced by transgender<br />

women are likely to be even higher—data<br />

released in 2011 by the National Coalition<br />

of Anti-Violence Programs showed that<br />

transwomen comprised 44% of all LGBTQ<br />

murder victims. <strong>The</strong> same study found<br />

that over half of LGBTQ violence survivors<br />

did not even report attacks, with the highest<br />

rates of non-reporting being among<br />

transgender women of color. Not that<br />

surprising, given that transwomen also<br />

face disproportionate sexual, physical, and<br />

verbal harassment at the hands of police,<br />

according to Injustice at Every Turn—A<br />

Report of the National Transgender<br />

Discrimination Study. Research shows that<br />

women, including transwomen, who have<br />

experienced trauma are less likely to be<br />

ad<strong>here</strong>nt to medication and are more likely<br />

to face multiple barriers to care overall.<br />

Systemic violence against women also<br />

persists. Women living with HIV in the U.S.<br />

continue to report significant reproductive<br />

rights violations, despite medical progress<br />

and research and treatment advances that<br />

clearly demonstrate HIV-positive people<br />

can live a long and healthy life, avoid passing<br />

the virus to children with appropriate<br />

care and treatment, and even avoid passing<br />

the virus to their sexual partners, when<br />

viral load is suppressed and other factors<br />

that increase vulnerability (such as genital<br />

sores or ulcers) are not present.<br />

Importantly, for many women living<br />

with HIV, motherhood may be one of the<br />

only socially valued identities available to<br />

them. As described by Michelle Berger in<br />

Workable Sisterhood, many women living<br />

with HIV in the U.S. already exist at the<br />

intersection of race, class, and gender<br />

oppression, in addition to societal stigma<br />

about any behaviors they engage in, or life<br />

experiences they have had—even prior to<br />

HIV diagnosis. “When they became HIVpositive<br />

all the positions they occupied—<br />

drug user, sex worker, poor woman, were<br />

already concentrated, or saturated, with<br />

a set of representations and assumptions<br />

about those positions.” Thus, HIV becomes<br />

just another one of several stigmatizing<br />

social markers. Yet having a socially valued<br />

identity may impact HIV-positive women’s<br />

feelings about themselves and may inspire<br />

them to take better care of themselves. In<br />

one study, HIV-positive women reported<br />

that pregnancy and childrearing provided<br />

them a socially sanctified feeling of being<br />

important and valued. Motherhood<br />

became a highly valued identity that<br />

helped mitigate regret related to HIV<br />

acquisition and other life circumstances.<br />

One study, published in AIDS Patient<br />

Care and STDs in May 2010, demonstrated<br />

that of 181 predominantly African<br />

American HIV-positive women in care in<br />

two urban HIV medical clinics, only 31%<br />

reported a personalized discussion with<br />

their HIV provider about their own fertility<br />

desires and intentions. Of those 31%, 64%<br />

had initiated the conversation themselves<br />

with their providers. <strong>The</strong> same study<br />

found that age was a strong predictor of<br />

provider-patient communication about<br />

pregnancy, with women under the age of<br />

30 being six times more likely to have had<br />

a general conversation about pregnancy<br />

with their providers. Another study of 118<br />

HIV-positive women conducted at the<br />

University of Rochester found that 54%<br />

of participants in that study had been<br />

sterilized. <strong>The</strong> study found high rates of<br />

“tubal regret” among participants, and<br />

pointed to a need to counsel women living<br />

with HIV about reversible methods of<br />

contraception. And research conducted by<br />

the U.S. Positive Women’s Network found<br />

that women living with HIV self-reported<br />

high rates of coerced abortion, tubal ligation,<br />

and sterilization. When HIV-positive<br />

women do have conversations with providers<br />

about their fertility plans, some health<br />

care providers perceive the pregnancyrelated<br />

needs of women living with HIV<br />

to be limited exclusively to the prevention<br />

of vertical transmission. In addition, data<br />

collected by the U.S. Positive Women’s<br />

Network suggest that HIV criminalization<br />

laws, currently on the books in 36 states<br />

and U.S. territories, may deter women<br />

from HIV testing, from accessing care, and<br />

may intimidate them with regard to disclosing<br />

sexual behavior to providers.<br />

Despite the fact that t<strong>here</strong> are many<br />

other diseases and genetic disorders with<br />

higher risk of parent to child transmission,<br />

and that assisted reproduction is not only<br />

permitted but often encouraged in such<br />

cases, HIV status has been used as a special<br />

reason to deny HIV-positive women the<br />

right to conceive naturally or with assistance;<br />

the right to comprehensive family<br />

planning and counseling service; and the<br />

right to retain custody of their children.<br />

Given last year’s HPTN 052 data, which<br />

demonstrated a 96% reduction in HIV<br />

transmission among heterosexual serodiscordant<br />

partners when viral load was<br />

suppressed, people living with HIV and/<br />

or their partners who want to conceive<br />

should be counseled about a range of<br />

options, including natural conception and<br />

now pre-exposure prophylaxis (PrEP) for<br />

the negative partner. Prevention justice<br />

demands that a range of HIV prevention<br />

options be available, including options that<br />

are controlled by women. But women’s<br />

bodies are not only about making babies.<br />

Fully upholding our human rights includes<br />

upholding our right to be sexual beings<br />

who experience joy and erotic pleasure.<br />

And for some of us, that means not using<br />

condoms, with our partner’s knowledge<br />

and consent. This will require a conscious<br />

effort of providers counseling patients<br />

who have experienced stigma, sometimes<br />

multiple concurrent stigmas, to provide<br />

accurate information about risk.<br />

Despite the significant epidemic among<br />

U.S. women—it is estimated that 300,000<br />

women are living with HIV in the U.S., and<br />

25% is no minor proportion—the National<br />

HIV/AIDS Strategy, released in July 2010,<br />

failed to articulate a single goal specifically<br />

for women. It does not detail how to<br />

24 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


HIV care is more than just medical care. It must be coupled with<br />

services designed to uphold sexual and reproductive rights and<br />

to address the impact of violence and trauma in women’s lives.<br />

reduce new HIV infections among women,<br />

to increase access to care, or a strategy to<br />

improve women’s health outcomes. <strong>The</strong><br />

Strategy similarly failed to articulate the<br />

relationship between violence or trauma<br />

and HIV for women. And now<strong>here</strong> in the<br />

Strategy was the need to strengthen<br />

sexual health and reproductive choice for<br />

women living with HIV even mentioned.<br />

And just this year, although the<br />

President’s proposed domestic HIV budget<br />

for FY 2013 was relatively good, the Part D<br />

program was the only part of Ryan White<br />

for which a decrease was proposed. Part<br />

D is the only program within Ryan White<br />

specifically designed to meet the needs of<br />

women, youth, and families. This is indicative<br />

of an alarming trend away from women-centered<br />

care and supportive services<br />

when they are more critical than ever.<br />

Thus, not only are we faced with a<br />

well-documented social and political<br />

“war on women” from the far right, with<br />

all women’s rights and body sovereignty<br />

being utilized as a political football in the<br />

2012 election cycle—but women living with<br />

HIV are literally facing disproportionate<br />

wars: violence, and a battle for their lives,<br />

health, and dignity in their own communities,<br />

neighborhoods, and homes.<br />

And in the midst of all this, somew<strong>here</strong><br />

along the way we lost our will to address<br />

the gender nuances of the domestic HIV<br />

epidemic.<br />

2011’s HPTN 052 results demonstrated<br />

that achieving viral suppression in people<br />

living with HIV can effectively reduce<br />

onward transmission of HIV. Thus, ensuring<br />

high-quality care and access to voluntary<br />

treatment for people living with HIV should<br />

be one of our primary goals as an HIV community—to<br />

achieve the National HIV/AIDS<br />

Strategy’s prevention and care goals.<br />

In July, the International AIDS<br />

Conference (AIDS 2012) returned to the<br />

U.S. after a 22-year absence. <strong>The</strong> theme of<br />

AIDS 2012 was Turning the Tide Together—<br />

meaning that we have the science to end<br />

new HIV infections and to keep people<br />

living with HIV healthy. Now we have to<br />

muster the political will and resources to<br />

make this possibility a reality. Just last<br />

June, the Supreme Court of the United<br />

States upheld the Affordable Care Act<br />

(ACA)—a piece of legislation that holds<br />

great promise for all women, and especially<br />

for women living with HIV. But HIV<br />

care and treatment is more than just medication<br />

and more than just medical care,<br />

especially for women. It must be coupled<br />

with services designed to uphold sexual<br />

and reproductive rights and to address the<br />

impact of violence and trauma in women’s<br />

lives. Women living with HIV still face<br />

unique vulnerabilities in 2012 and turning<br />

the tide on the epidemic for women will<br />

require a gender-sensitive response.<br />

Because women’s access to health<br />

care and ability to ad<strong>here</strong> to medication<br />

is related in large part to other life factors,<br />

including our physical, psychological, and<br />

emotional safety, addressing logistical barriers<br />

to care and promoting safety for women<br />

is central to achieving the National HIV/AIDS<br />

Strategy’s goals and to achieving the promise<br />

of the Affordable Care Act for women.<br />

Through ACA implementation, we must<br />

also keep in place services that facilitate<br />

access to care for women living with HIV,<br />

including but not limited to psychosocial<br />

support, peer-based services, transportation,<br />

and childcare.<br />

Thankfully, President Obama’s March<br />

30 release of a memorandum establishing<br />

a federal interagency working group to<br />

address the intersection of HIV/AIDS, violence<br />

against women and girls, and gender-related<br />

health disparities presents a<br />

new opportunity to align the domestic HIV<br />

response with international standards and<br />

to rectify some of these serious oversights.<br />

<strong>The</strong> workgroup is charged with, among<br />

other things:<br />

n Integrating sexual and reproductive<br />

health services, gender-based violence<br />

services, and HIV/AIDS services, w<strong>here</strong><br />

research demonstrates that doing so<br />

will result in improved and sustained<br />

health outcomes.<br />

n Promoting research to better understand<br />

the intersection of the biological,<br />

behavioral, and social science bases<br />

for the relationship between increased<br />

HIV/AIDS risk, domestic violence, and<br />

gender-related health disparities.<br />

2012 marks a critical moment in the<br />

global HIV response. It’s time we truly<br />

commit to upholding women’s rights and<br />

the rights of all people living with and<br />

disproportionately impacted by HIV as an<br />

essential component to turning the tide of<br />

the epidemic. This must include:<br />

n Meaningful and visible leadership of<br />

women living with HIV in all aspects of<br />

decision-making.<br />

n Research on and funding for womencontrolled<br />

prevention options—tools<br />

which a woman can use without the<br />

consent or even the knowledge of her<br />

partner, and which uphold our full<br />

rights to sexual pleasure and sexual<br />

and reproductive health.<br />

n Bold action, including a plan and a<br />

timeline from the White House Office<br />

of National AIDS Policy to address<br />

the intersections of violence against<br />

women, HIV, sexual and reproductive<br />

rights, and women’s health.<br />

NaiNa khaNNa is the policy director at<br />

Women Organized to Respond to Lifethreatening<br />

Disease (WORLD) in Oakland,<br />

California and coordinates the U.S. Positive<br />

Women’s Network (PWN). She was<br />

appointed to President Obama’s Advisory<br />

Council on HIV/AIDS (PACHA) in 2010.<br />

She has presented and advised on women’s<br />

rights and achieving gender-sensitive,<br />

human rights-grounded policies informed<br />

by people living with HIV. Ms. Khanna was<br />

diagnosed with HIV in 2002.<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 25


lack WOmEn,<br />

SOcIETy,<br />

and HIV<br />

An expert talks about<br />

the context of infection<br />

takeN from aN iNterview with<br />

adaora a. adimora, md, mph<br />

editor’s Note: Adaora A. Adimora, MD, MPH, received her medical degree from<br />

Yale University School of Medicine and Master’s in Public Health in epidemiology<br />

(the study of how disease spreads among people) from the University of North<br />

Carolina at Chapel Hill (UNC). Dr. Adimora’s work as both a physician and an epidemiologist<br />

has focused on infectious disease, particularly HIV and its disproportionate<br />

effect on minority populations. Her groundbreaking research includes the<br />

publishing of the first national data on concurrent sexual partnerships in women<br />

and analysis of the contextual (social, economic, and environmental) factors that<br />

promote concurrent sexual partnerships among African Americans in the United<br />

States. She has testified before a Congressional committee on the HIV epidemic<br />

and, for World AIDS Day in 2010, was invited to the White House to speak in a<br />

panel discussion. <strong>The</strong> following is taken from an interview with Dr. Adimora.<br />

—EnID VázqUEz<br />

In THE mID-1900S, THERE waS<br />

the rise of so-called “risk factor<br />

epidemiology.” People became<br />

much more focused on individual<br />

determinants, the individual behaviors and<br />

characteristics of people that put them<br />

at risk for disease. And these things are<br />

important.<br />

But it turns out t<strong>here</strong>’s increasing<br />

evidence that in order to really make headway<br />

with the HIV epidemic in this country,<br />

and in the world, t<strong>here</strong>’s going to need<br />

to be more attention paid to some of the<br />

social factors that drive people’s behavior<br />

and also set them up to acquire infection.<br />

26 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


It appears, for example, that the connections<br />

between black people in the U.S.<br />

differ to some extent compared to the<br />

connections among white people in the<br />

sense that t<strong>here</strong> are more disassortative<br />

relationships, or relationships between<br />

people with different risk factors. T<strong>here</strong>’s<br />

more of a tendency for African Americans<br />

to have relationships with people who<br />

have much greater risk for HIV than they<br />

themselves do. T<strong>here</strong>’s also the issue of<br />

partnerships that overlap in time, or sexual<br />

concurrency. In addition, they tend to find<br />

partners within their communities, which<br />

are often segregated. Sexual concurrency<br />

TAmARA WILSOn, HIV-PoSITIVE SIncE 1999, VoLUnTEERS aT<br />

cHIcago womEn’S aIDS PRojEcT. SHE cREDITS HER moTHER<br />

wITH HELPIng HER To managE HER HIV, anD TPan FoR<br />

HELPIng To SaVE HER LIFE. PHoTogRaPH BY cHRIS knIgHT<br />

has been found to put people<br />

at greater risk for HIV than<br />

serial monogamy, even if<br />

people in both groups have<br />

had the same number of<br />

partners over the same<br />

period of time.<br />

THE THIng THaT<br />

is really, really<br />

important is the<br />

observation that<br />

it is the social context of<br />

life in the United States that<br />

really contributes to those<br />

partnership patterns. It’s<br />

pretty clear that black people<br />

as a whole tend to live under<br />

very different circumstances<br />

in the United States than<br />

white people do. And some<br />

of these characteristics that<br />

we have been studying, like<br />

incarceration for example,<br />

not only contribute to HIV,<br />

but they’re also emblematic<br />

of the oppression that<br />

minority populations are<br />

living under in the United<br />

States. A history of incarceration,<br />

for example, which is<br />

experienced by black men<br />

more than any other group,<br />

primarily as a result of the war on drugs,<br />

lowers the possibility of employment and<br />

increases the risk of poverty, while at the<br />

same time disrupting the stability of longterm<br />

partnerships. Incarceration and death<br />

due to violence and disease in black men<br />

lead more black women to enter into relationships<br />

with men who have greater risk<br />

factors for HIV than they do.<br />

This doesn’t mean that each and<br />

every minority, each and every African<br />

American, in the United States is poor and<br />

oppressed. But as a whole, it is these types<br />

of factors that contribute to the spread<br />

of HIV, STDs, and in fact different rates of<br />

other diseases, such as diabetes and heart<br />

disease. Black people are at greater risk<br />

of acquiring HIV infection independent of<br />

their own low-risk behavior compared to<br />

other groups.<br />

I<br />

woULD aLSo EmPHaSIzE THaT<br />

we do have personal responsibility for<br />

our behavior. However, I think some<br />

people tend to look at this work and<br />

say, “Oh, they’re just blaming the environment,<br />

blaming the majority population.”<br />

That’s really not exactly it. While we do<br />

have personal responsibility for our behavior,<br />

I think it’s very critically important to<br />

realize that black people have substantially<br />

increased risks than other populations,<br />

even with the same behavior. And this has<br />

been demonstrated. This is true for black<br />

gay men as well as for black heterosexual<br />

men and women.<br />

I would say to black women living with<br />

HIV, keep the faith. Teach your sons and<br />

daughters all the lessons you’ve learned.<br />

You have a wealth of experience, and certainly<br />

resiliency.<br />

We need to work in whatever ways we<br />

can to change the social and economic<br />

factors that are putting our people at risk,<br />

and putting our children at risk.<br />

It would help if everyone in the United<br />

States had health care. It’s astonishing to<br />

me that, apparently, health care is not a<br />

right. It remains an open question in the<br />

United States that people should have<br />

health coverage, even though it’s clearly<br />

most cost effective for the nation as a<br />

whole. This is a civil rights issue. That’s<br />

what I mean by working to change the<br />

economic factors that put people at risk.<br />

Health care availability, affordability for<br />

all, would make a huge difference in terms<br />

of transmission of HIV, and also in terms<br />

of the personal health of people who are<br />

living with HIV.<br />

go To positivelyaware.com To REaD<br />

PUBLISHED STUDIES anD aBSTRacTS.<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 27


‘everyone needS a Support<br />

How one therapist helps<br />

Hiv-positive women learn<br />

to take care of themselves<br />

by eNid vázquez<br />

FOR MORE THAN 10 YEARS,<br />

psychotherapist Kesha<br />

Burch, LCPC, has<br />

counseled HIV-positive<br />

women at the Chicago Women’s<br />

AIDS Project (CWAP). Whether<br />

positive or negative, the women<br />

she counsels face similar<br />

problems, she says, with health<br />

being an added and important<br />

concern for those living with<br />

HIV or any other chronic illness.<br />

“<strong>The</strong> HIV-positive women I work with<br />

have the same types of issues, but it’s even<br />

more important that they address emotional<br />

and life concerns because their health<br />

depends on it,” says Burch. While women<br />

often focus on interpersonal problems and<br />

family stress, improved health is always an<br />

underlying goal of Burch’s work at CWAP.<br />

“Stress that comes from emotional and<br />

psychological problems can be a threat to<br />

a woman with HIV,” she says, pointing out<br />

that stress and depression are known to<br />

increase mortality for positive women.<br />

Nevertheless, she finds that many<br />

women worry about their lovers and families<br />

more than they do about themselves,<br />

even in the face of HIV.<br />

“Women in our society are rewarded<br />

for taking care of other people,” Burch<br />

said. “We often don’t think about taking<br />

care of ourselves independent of someone<br />

helping us with that or coaching us<br />

through it. We may not be socialized to be<br />

assertive. And of course, all of that really<br />

comes through in thinking about how to<br />

28 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM<br />

PHOTO: PROEllEMEnTS PHOTOgRAPHy


SyStem’<br />

negotiate safe sex practices and so on and<br />

so forth.<br />

“You don’t want to get away from all<br />

the nurturing,” she notes, “but how do you<br />

take care of other people and take care of<br />

yourself as well? T<strong>here</strong> has to be some balance.<br />

Hopefully, counseling helps women<br />

achieve greater balance. It’s about feeling<br />

empowered enough to be themselves and<br />

to pursue things that they’re worthy of<br />

having in their lives,” says Burch.<br />

Instead, she finds that many women<br />

settle for less than they deserve, which can<br />

begin a cycle of more unhappiness in their<br />

lives. Others have problems establishing<br />

healthy relationships and may have negative<br />

coping skills, experiencing difficulty<br />

with attachment (including having many<br />

sexual partners) and figuring out who is<br />

worthy of being with them. <strong>The</strong>se women<br />

often feel that they have to accept bad<br />

behavior in order to be in a relationship or<br />

are confused about what they have to do<br />

to be in one.<br />

“T<strong>here</strong> are also issues around disclosure<br />

and that relates back to self-esteem and<br />

self-worth. It’s important for them to communicate<br />

with partners for their own health<br />

and also so that they can be truly known<br />

and accepted and loved,” she said. “This is<br />

similar to the things that other people are<br />

dealing with, being true to themselves.”<br />

Once a woman has a healthier relationship<br />

with herself, her other relationships<br />

are healthier too. Burch cites support<br />

groups and support buddies as being<br />

important for positive women, along with<br />

caring friends, family members, and supportive<br />

partners.<br />

“We were created to be in relationships<br />

with each other. It’s not just about<br />

romantic relationships, but about learning<br />

how to be a good parent and how<br />

to have a healthy friendship…all kinds of<br />

relationships that are essential to human<br />

existence,” she says. “Everyone needs a<br />

support system, and the healthier your<br />

support system, the better off you are.<br />

It’s about the people in your life who<br />

are for you and support you. That helps<br />

anybody’s mental health and physiological<br />

health as well. It helps anybody to become<br />

more resilient and do better.”<br />

What’s different for people living with a<br />

chronic illness like HIV, she says, is that the<br />

same skills they use for creating healthy<br />

relationships also work in managing their<br />

health care.<br />

“Sometimes negative issues can seep<br />

into their attitudes towards their health,<br />

their health care, and their provider.<br />

When I talk to them about using skills in a<br />

relationship, I recognize that those assertiveness<br />

skills can help them ask for what<br />

they need from their medical provider so<br />

they don’t just think that they go to their<br />

doctor and are told what to do, but report<br />

things that are of concern to them and<br />

ask, can we check into this?” Burch said.<br />

“Sometimes I rehearse with them. ‘What<br />

would you like to say when you go to the<br />

doctor?’ I had a client who felt that her<br />

doctor wasn’t listening to her. T<strong>here</strong> were<br />

some things that she thought needed to<br />

be addressed, but she was complaining<br />

about it to other people and not taking it<br />

back to the doctor to say ‘this really worries<br />

me’ or ‘I wish that at my last appointment<br />

we could have talked about this.’<br />

“So I helped her narrow down her complaints<br />

and her concerns to three things<br />

per visit, because t<strong>here</strong>’s some reality<br />

t<strong>here</strong> too. <strong>The</strong> doctor cannot spend 90<br />

minutes on a visit. <strong>The</strong> alternative was for<br />

her to feel consistently frustrated with her<br />

experience with the doctor,” Burch said.<br />

“She didn’t realize she could ask for what<br />

she wants. For the first item on her list, she<br />

was able to get a referral to a specialist.<br />

That also then reduced her anxiety and<br />

worry about what was going on with her.”<br />

She notes that not being able to communicate<br />

with a provider or understand<br />

what was being asked of them could lead<br />

some people to not take their medication<br />

correctly.<br />

Burch pointed to other practical things<br />

people can do to support their self-worth<br />

and value. “It could be as simple as putting<br />

on make-up. It could be signing up to take<br />

a class or to stop talking to someone who<br />

is not doing right by them—any behavioral<br />

steps that reinforce the message that<br />

they’re of value.”<br />

Going for counseling, she believes, is<br />

one big step towards self-care.<br />

“When you show up to therapy, that’s<br />

just in and of itself an affirmation that<br />

you’re worthy of a better life and this is<br />

part of what you are going to do about it,”<br />

Burch says. “T<strong>here</strong>’s always some kind of<br />

spark I see that pulls women in, something<br />

I can’t describe that gives them just a little<br />

bit of hope that things could be different.<br />

Especially for the women who are dealing<br />

with addiction, it’s that little piece of<br />

themselves that helps to pull them out,<br />

to show up on the doorstep of a detox or<br />

drug treatment program. T<strong>here</strong>’s a ton<br />

of internal strength and resiliency t<strong>here</strong>,<br />

and that’s something that I reflect back to<br />

them sometimes. ‘Look at all that you’ve<br />

been through to get to this point.’<br />

“When you see that spark, that’s the<br />

essence of who that person really is,” says<br />

Burch. “<strong>The</strong> trick is to get them to see it,<br />

despite their circumstances.”<br />

She sometimes suggests that people<br />

make positive affirmations, keep a journal,<br />

and read certain books or authors. While<br />

she can help weed out negative beliefs<br />

people have about themselves that they<br />

may not even be aware of, these activities<br />

can keep people focused on messages<br />

that are the opposite of the negative<br />

beliefs and feelings. “It’s about changing<br />

that message,” she said.<br />

She sometimes has clients take time<br />

to just relax and sit silently. Many people<br />

are often too busy running around doing<br />

everything they have to do to give themselves<br />

time for reflection and hearing<br />

what’s inside them, she said.<br />

Perhaps the most important part of<br />

her work, she believes, is treating people<br />

with kindness and respect. “That’s really<br />

at the core of the Chicago Women’s AIDS<br />

Project,” she notes. “<strong>The</strong> mission statement<br />

is about empowering women, seeing<br />

the value in each and every woman.”<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 29


nine monthS to Birt<br />

Hiv and pregnancy—keeping yourself and your baby healthy<br />

by JohN verNa, ms, pa-c<br />

WELL, aS YoU SUSPEcTED, YoUR PREgnancY<br />

test is positive. Congratulations! Pregnancy can<br />

be an exciting time, and a really wonderful experience.<br />

Of course, now that you’re expecting, you<br />

probably have lots of questions, some of which relate to how your<br />

HIV-positive status will impact your pregnancy and your baby.<br />

<strong>The</strong> goal in every pregnancy is to keep<br />

both mom and baby healthy—and I’m<br />

happy to say that this is a goal that’s well<br />

within your reach. Just because you have<br />

HIV does not mean you can’t have a happy,<br />

healthy pregnancy, and a happy, healthy<br />

baby. Basically, the same things that keep<br />

you healthy will keep your baby healthy.<br />

Risks of transmitting the virus to your baby<br />

decrease as your own viral load decreases.<br />

In fact, if you are on HIV medication<br />

and take the medications as prescribed,<br />

t<strong>here</strong>’s only a 1% chance of passing HIV<br />

to your baby. In my 11 years as an HIV<br />

specialist, and having seen over 150 pregnant<br />

patients with HIV, I have never had<br />

a patient pass HIV to her baby. However,<br />

if you’re not on HIV meds, or don’t take<br />

them like you’re supposed to, t<strong>here</strong>’s<br />

a 25% chance (basically a one in four<br />

chance) that you will pass HIV to the baby.<br />

Even medication at the last minute, at the<br />

time of labor, cuts the risk and some states<br />

have laws about testing mothers during<br />

labor if an HIV test result is not on file for<br />

the pregnancy.<br />

So let’s talk about what you need to<br />

do to keep both you and your little one<br />

healthy. Many women wonder how HIV<br />

can be transmitted to the baby. HIV can<br />

be transmitted during pregnancy, during<br />

labor and delivery, or by breastfeeding.<br />

We’ll talk about what you can do during<br />

pregnancy, during labor, and after your<br />

baby is born to decrease the chances of<br />

transmitting the virus.<br />

hOW TO REduCE ThE RISk Of<br />

TRAnSmITTInG hIV TO YOuR<br />

BABY duRInG PREGnAnCY<br />

KEEPIng YoUR VIRaL LoaD<br />

low is important during pregnancy<br />

to reduce the risk of<br />

transmission. Regardless of<br />

what is recommended based solely on<br />

your CD4+ and VL levels, you may want to<br />

start taking HIV meds as soon as you learn<br />

you are pregnant. Yes, t<strong>here</strong> are guidelines<br />

from the Department of Health and<br />

Human Services (DHHS) that recommend<br />

when to start treatment based on CD4+<br />

and VL, but t<strong>here</strong> are groups of people<br />

for which treatment is recommended no<br />

matter what. Pregnant women are one of<br />

those groups. We are trying to prevent<br />

your baby from becoming infected.<br />

Earlier initiation of therapy may<br />

be more effective in reducing in utero<br />

transmission. In fact, a 2010 study conducted<br />

in France found that “early and<br />

sustained control of HIV viral replication is<br />

associated with decreased residual risk of<br />

transmission and favors initiating HAART<br />

drugs as early in pregnancy as possible<br />

for all women.” In other words, starting<br />

HAART (highly active antiretroviral<br />

therapy) drugs early to control the viral<br />

load as much as possible decreased the<br />

chances that the virus would be transmitted<br />

to the baby. In fact, we know that having<br />

an undetectable viral load substantially<br />

lowers the risk of transmission of HIV to<br />

the fetus and lessens the need for consideration<br />

of cesarean delivery (C-section).<br />

That’s why I have always suggested that<br />

my patients start HAART immediately<br />

after learning about their pregnancy.<br />

So, if you are not currently taking HIV<br />

medications (whether you are treatmentnaïve<br />

or have taken them in the past), tell<br />

your HIV specialist about what medications<br />

you’ve taken in the past and provide<br />

all laboratory tests (genotypes, phenotypes,<br />

HLA B*5701) and be honest about<br />

any ad<strong>here</strong>nce issues that you’ve had in<br />

the past. Also talk about any tolerability<br />

issues and drug allergies you have had<br />

with any old regimen(s).<br />

As soon as you learn that you’re pregnant,<br />

you should contact your HIV specialist<br />

to discuss your options for medication<br />

and to review what you’re currently taking<br />

to make sure your medications are safe<br />

for the baby. If you are taking HIV medication,<br />

like HAART, your clinician will likely<br />

continue your treatment. However, if you<br />

are taking a regimen that contains efavirenz<br />

(Sustiva, which is also a component<br />

of Atripla), you’ll need to make a change.<br />

Efavirenz is a Pregnancy Category D medication,<br />

meaning it should not be taken<br />

30 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


h day<br />

while pregnant, especially during the<br />

first trimester of your pregnancy.<br />

It’s reassuring, however, to know<br />

that of 14 studies with 1,345<br />

pregnant women on efavirenz<br />

published in the journal AIDS<br />

two years ago, t<strong>here</strong> was only<br />

one infant born with a birth<br />

defect, a rate no different<br />

from the general population<br />

of pregnant women.<br />

Many women wonder<br />

if HIV medications are<br />

going to harm their<br />

babies or themselves.<br />

Several HIV medications<br />

have been found<br />

to be safe for pregnant<br />

women and babies. As<br />

a matter of fact, t<strong>here</strong> is<br />

an international registry<br />

(the Antiretroviral Pregnancy<br />

Registry) that monitors<br />

for potential<br />

birth defects<br />

in infants<br />

exposed to<br />

HIV medications<br />

in<br />

utero. <strong>The</strong><br />

Department<br />

of Health and<br />

Human Services<br />

(DHHS) currently<br />

recommends Kaletra<br />

and Combivir taken twice<br />

a day. Ask your HIV specialist<br />

what is going to be best for<br />

you and keep in mind that<br />

results of any past or current<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 31<br />

PHOTO © JAni BRySOn


You should have discussions with both your obstetrician and HIV specialist<br />

to help determine what is best for you and your baby. If you don’t have a<br />

specialist, now might be a good time to seek one out.<br />

genotype test will also be considered. If<br />

you have a viral load of more than 1,000<br />

copies, your provider will order a genotype<br />

before starting you on medications.<br />

Any drug resistance found by the test may<br />

limit your treatment options.<br />

So t<strong>here</strong> is a lot to consider <strong>here</strong>, and<br />

you should have discussions with both<br />

your obstetrician and HIV specialist to<br />

help determine what is best for you and<br />

your baby. Assuming that you have an<br />

HIV specialist, your specialist will refer<br />

you to an obstetrician who has experience<br />

with HIV-positive mothers. If you don’t<br />

have a specialist, now might be a good<br />

time to seek one out. You can visit the<br />

websites of the American Academy of HIV<br />

Medicine (www.aahivm.org) and the Gay<br />

and Lesbian Medical Association (http://<br />

glma.org), or call the National AIDS Hotline<br />

(open 24 hours a day every day of the<br />

year) at 1-800-CDC-INFO (232-4636).<br />

ThE RIGhT dOCTOR<br />

And ThE RIGhT TESTS<br />

IT can BE VERY HELPFUL To<br />

have an obstetrician with experience<br />

treating HIV-positive women, in part<br />

because the decisions regarding<br />

whether to use certain “invasive” genetic<br />

tests can be difficult. Many pregnant<br />

women undergo a variety of screening<br />

tests. During the first trimester these tests<br />

include a fetal ultrasound and a blood<br />

test for mom. This screening process can<br />

help determine the risk of the fetus having<br />

certain birth defects (Down syndrome, trisomy<br />

18, or trisomy 13). Second trimester<br />

prenatal screening may include additional<br />

blood testing (of mom) called Multiple<br />

Markers. <strong>The</strong>se include alpha-fetoprotein<br />

(AFP), hCG, estriol, and inhibin. <strong>The</strong>se<br />

markers provide information about a<br />

woman’s risk of having a baby with genetic<br />

conditions or birth defects. This screening<br />

is usually performed between the 15th and<br />

20th weeks of pregnancy.<br />

If the results of these tests are<br />

abnormal, genetic counseling is recommended.<br />

Additional testing may be<br />

needed for an accurate diagnosis. <strong>The</strong>se<br />

tests include chorionic villus sampling<br />

(CVS) and amniocentesis, both of which<br />

are considered “invasive.” During amniocentesis,<br />

a small amount of amniotic fluid<br />

is removed by inserting a long, thin needle<br />

through your belly and into the womb.<br />

In CVS, chorionic villi <strong>cells</strong> are removed<br />

from the placenta, either in the same way<br />

amniocentesis is performed or through the<br />

cervix using a catheter and gentle suction.<br />

Because these tests are invasive, they<br />

involve at least a theoretical increased<br />

risk of transmitting the virus to the baby.<br />

To date, t<strong>here</strong> have been 159 reported<br />

invasive procedures on HIV-positive moms<br />

with no transmission of HIV to the baby.<br />

In all cases, women were on HAART with<br />

undetectable viral loads and though no<br />

transmissions of HIV have occurred, a<br />

small increase in risk can’t be ruled out.<br />

T<strong>here</strong>fore, any HIV-positive woman undergoing<br />

any invasive procedure should be<br />

on HAART and have an undetectable viral<br />

load at the time of the procedure.<br />

Some experts consider CVS too risky<br />

to offer to their HIV-positive patients and<br />

recommend limiting invasive procedures<br />

to amniocentesis only, but existing data<br />

on transmission risk associated with<br />

these procedures are limited. Invasive<br />

testing procedures should be discussed<br />

thoroughly with your OB and between<br />

you and your partner. Your OB (or genetic<br />

counselor) will discuss the pros and cons<br />

of invasive testing with you. But ultimately,<br />

whether to test (or not to test) is a personal<br />

decision.<br />

LOWERInG ThE RISk<br />

duRInG LABOR And dELIVERY<br />

AgaIn, THE goaL IS To<br />

limit the baby’s exposure to<br />

the virus. So it’s probably not<br />

surprising that your options<br />

for labor and delivery depend upon your<br />

viral load (another important reason to<br />

take your HIV meds as prescribed). <strong>The</strong><br />

American College of Obstetricians and<br />

Gynecologists (ACOG) has recommended<br />

considering a scheduled C-section delivery<br />

for HIV-positive women since 1999. A<br />

scheduled C-section is recommended for<br />

women with a viral load that’s greater than<br />

1,000 copies/mL near the time of delivery<br />

(36 weeks’ gestation) and for any woman<br />

with an unknown viral load. It is also<br />

recommended for women who did not<br />

receive HIV medication during pregnancy.<br />

In these situations, ACOG recommends a<br />

scheduled C-section at 38 weeks’ gestation<br />

in order to decrease the likelihood of<br />

onset of labor or rupture of membranes<br />

before delivery.<br />

For women with a viral load that’s<br />

less than 1,000 copies/mL near time of<br />

delivery, a scheduled C-section is not<br />

routinely recommended. So, if your viral<br />

load is less than 1,000 copies/mL near the<br />

time of delivery, your choices for labor<br />

and delivery are essentially the same as<br />

a woman who doesn’t have the virus, and<br />

you can have a vaginal delivery. <strong>The</strong> risk<br />

of perinatal transmission of HIV in women<br />

with an undetectable viral load (at 36<br />

weeks gestation) is 1% or less, even with a<br />

vaginal delivery. No evidence is available<br />

to show that this risk can be lowered further<br />

by performing a scheduled C-section.<br />

Remember, a C-section is major surgery<br />

and has its own risk of complications, compared<br />

with vaginal delivery.<br />

Under new DHHS guidelines, only<br />

women with viral loads of more than 400<br />

copies/mL should be given IV zidovudine<br />

(AZT) continuously, even if your genotype<br />

shows resistance for this drug. <strong>The</strong><br />

use of AZT is recommended because of<br />

its unique characteristics and its proven<br />

record in reducing transmission.<br />

To help prevent transmission, your<br />

baby will be given liquid AZT immediately<br />

after birth and this will be continued (by<br />

you at home) twice a day for six weeks.<br />

32 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


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EmaIL aDDRESS<br />

Women in the U.S. with HIV should not breastfeed their babies<br />

due to increased risk of transmitting the virus. Baby formula<br />

is a safe and healthy alternative.<br />

Unfortunately, women in the U.S. with<br />

HIV should not breastfeed their babies<br />

due to increased risk of transmitting the<br />

virus. Baby formula is a safe and healthy<br />

alternative to breast milk and t<strong>here</strong> are<br />

many brands and options that are available<br />

to you. Also, while the risk is very<br />

low, HIV can also be transmitted to a baby<br />

through food that was pre-chewed by an<br />

HIV-positive mother (or caretaker). To be<br />

completely safe, babies should not be fed<br />

pre-chewed food.<br />

dOES ThE BABY hAVE hIV?<br />

THERE aRE Two TYPES oF<br />

tests that will be performed on<br />

your baby to find out if he or she<br />

has HIV. <strong>The</strong> first is the HIV antibody<br />

test. All babies born to a mom with<br />

HIV will test positive for the first several<br />

❑ Enclosed is my donation of<br />

❑ $25 ❑ $50 ❑ $100 ❑ $250 ❑ $500 ❑ $_______<br />

months of their lives. This does not mean<br />

that they have HIV. Rather, it means that<br />

the baby has simply been exposed to his/<br />

her mother’s HIV. <strong>The</strong> second test, PCR<br />

testing, looks for the virus and not just the<br />

antibodies to the virus. It is this test that<br />

can tell whether the baby has HIV or not.<br />

This test will be done during the first few<br />

days of his/her life.<br />

<strong>The</strong> PCR test will be repeated several<br />

times on your baby. To know for certain<br />

that your baby is not infected with HIV, the<br />

baby must not be breastfeeding and must<br />

have two negative PCR tests, the first at<br />

one month (or older) and the second at<br />

four months (or older). Many experts confirm<br />

the HIV-negative status of the baby<br />

with an HIV antibody test at age 12 to 18<br />

months. To be diagnosed with HIV, a baby<br />

must have two positive PCR tests.<br />

Bill to:<br />

CARd nuMBER ExPiRES<br />

nAME On CARd<br />

SignATuRE (REquiREd)<br />

charge my: ❑ Visa ❑ MasterCard ❑ American Express<br />

total amouNt: $___________<br />

Charges will appear on your credit card statement as TPA Network. test Positive<br />

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support and information to all people affected by HIV.<br />

Ship to:<br />

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POSiTivElyAwARE.COM cHIcago, IL 60640 SEPTEMBER+OCTOBER 2012 33<br />

nAME<br />

AgEnCy (if APPliCABlE)<br />

AddRESS<br />

Again, just because you have HIV does<br />

not mean you can’t have a healthy pregnancy<br />

and baby. In fact, just this past year<br />

I had an HIV-positive patient who followed<br />

her regimen and had a healthy pregnancy,<br />

and an uncomplicated vaginal birth. She<br />

and her husband welcomed a healthy<br />

HIV-negative baby into the world. It can be<br />

done, and it is done by lots of women just<br />

like you every day. So, again, congratulations!<br />

JohN verNa has spent his entire professional<br />

career providing health care to individuals<br />

with HIV. For the past three years,<br />

he has worked at Access Community<br />

Health Network in Chicago. John knows<br />

just how special (and scary) pregnancy<br />

can be, as he and his wife recently welcomed<br />

their first child.<br />

CiTy STATE ZiP


COnfEREnCE uPdATE<br />

AIdS 2012<br />

washiNgtoN, d.c.<br />

CuRE CAuCuS: (above, from left) Sharon Lewin, MD, PhD; Rowena Johnston, vice president of research, amfAR; Steven Deeks, MD,<br />

University of California San Francisco; Françoise Barré-Sinoussi, new president of the International AIDS Society; Mark Harrington,<br />

Treatment Action Group; and UNAIDS executive director Michel Sidibé review developments in HIV cure research.<br />

After a 22-year absence, the International<br />

AIDS Conference returned to the U.S. following<br />

President Obama’s lifting of the federal immigration<br />

and travel ban against people from outside the<br />

U.S. with HIV/AIDS. An estimated 22,000 activists,<br />

advocates, clinicians, and others converged on<br />

Washington, D.C. in July. For conference webcasts<br />

and transcripts go to www.aids2012.org.<br />

IAS cure workshop highlights<br />

advances and challenges<br />

by Jeff berry<br />

At this year’s conference we<br />

heard about exciting advances<br />

in cure research, as well as<br />

the launch of the International<br />

AIDS Society’s (IAS) “Towards<br />

an HIV Cure” global scientific<br />

strategy. A two-day pre-conference<br />

workshop brought<br />

together researchers and<br />

community advocates to preview<br />

some of these advances<br />

and provide insight into work<br />

being done in the seven different<br />

areas of research that<br />

the agenda has identified as<br />

highest priority.<br />

<strong>The</strong> workshop, cochaired<br />

by Steven Deeks,<br />

MD, University of California,<br />

San Francisco, and IAS<br />

president and Nobel laureate<br />

Françoise Barré-Sinoussi,<br />

Pasteur Institute, Paris, was<br />

opened by Dr. Anthony S.<br />

Fauci, Director of the National<br />

Institute of Allergy and<br />

Infectious Diseases, NIH. In<br />

his opening remarks, Fauci<br />

stated that a cure that only<br />

benefits 0.01% of the population<br />

is not going to excite<br />

anyone—it has to be scalable.<br />

During the community<br />

literacy session Australian<br />

researcher Sharon Lewin, MD,<br />

PhD, gave an overview presentation<br />

addressing major<br />

barriers to a cure, including<br />

what actually defines a<br />

cure and potential targets<br />

and mechanisms, as well as<br />

underscoring the importance<br />

of assays for future research<br />

and the need for these tests<br />

to undergo rigorous standardization<br />

with labs before<br />

going into wider use.<br />

Activist and PoSITIVELY<br />

awaRE contributor Matt<br />

Sharp talked about his experiences<br />

as a cure research<br />

study participant, and the<br />

challenges that lie ahead,<br />

including ethical study<br />

design, Analytical Treatment<br />

Interruptions (ATI), and<br />

informed consent.<br />

Sharp noted that some<br />

cure research may be quite<br />

risky, with little chance for<br />

benefit. He asked what the<br />

“reasonable” risks are for HIVpositive<br />

individuals who will<br />

be participating in early and<br />

potentially dangerous cure<br />

studies, and how can we best<br />

protect them? Developing<br />

guidelines for determining<br />

when potentially risky<br />

treatment interruptions are<br />

appropriate is a critical next<br />

step, said Sharp, and community<br />

input and community<br />

advisory boards are essential<br />

in ensuring ethical, patientoriented<br />

studies.<br />

An elegant presentation<br />

given by Robert Siliciano, MD,<br />

PhD, Johns Hopkins University<br />

School of Medicine, was perhaps<br />

one of the clearest and<br />

most concise presentations<br />

I’ve ever seen on the basics<br />

of immunology, HIV infection,<br />

34 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM<br />

PHOTOS: ©iAS/STEvE SHAPiRO-COMMERCiAliMAgE.nET


and the multiple molecular<br />

mechanisms which maintain<br />

HIV latency. HIV is not completely<br />

eradicated from the<br />

body by standard antiretroviral<br />

therapy because some of it<br />

lies resting in memory CD4+T<strong>cells</strong>,<br />

which can proliferate for<br />

an average of 73.4 years in<br />

the human body. However, if<br />

you stop taking therapy, the<br />

virus typically comes roaring<br />

back within a matter of weeks.<br />

One eradication approach<br />

would be to remain on standard<br />

ARV therapy to keep<br />

the virus suppressed, while at<br />

the same time purging these<br />

latent reservoirs and blocking<br />

them from infecting new<br />

<strong>cells</strong>, so that they would have<br />

now<strong>here</strong> to go and eventually<br />

die off, ridding the body of<br />

HIV. But it’s complicated—the<br />

number of latently infected<br />

<strong>cells</strong> may be much higher<br />

than previously thought, by as<br />

much as 50-fold, according to<br />

Siliciano.<br />

Sarah Palmer, PhD, Swedish<br />

Institute for Communicable<br />

Disease Control and Karolinska<br />

Institute, gave a presentation<br />

on measuring persistent HIV<br />

infection, including an excellent<br />

slide outlining some of the<br />

advantages and disadvantages<br />

of the four currently available<br />

assays which measure persistence.<br />

In concluding her talk,<br />

Palmer emphasized that “looking<br />

ahead, to determine the<br />

effectiveness of curative strategies,<br />

our field will need to<br />

develop a more standardized<br />

assay system which is sensitive,<br />

efficient, less costly, and<br />

adaptable in local settings.”<br />

Other presentations<br />

covered recent advances in<br />

the development of accurate<br />

animal models for<br />

use in future cure<br />

research, vaccine<br />

and immune-based<br />

therapies and the role<br />

of immune activation<br />

and inflammation in<br />

viral persistence.<br />

<strong>The</strong> conference<br />

ended with a slightly<br />

unorthodox, yet<br />

immensely informative<br />

and entertaining<br />

presentation by Fred<br />

Verdult of Amsterdam<br />

on the psychosocial<br />

benefits of a cure for<br />

HIV. Verdult, after<br />

finding out he had HIV<br />

in 1998, started Volle<br />

Maan, an organization<br />

that conducts studies<br />

and communication projects<br />

on health and disease to<br />

encourage people to live full<br />

and worthwhile lives. Volle<br />

conducted a survey of 458<br />

individuals in the Netherlands<br />

asking how important to them<br />

a cure for HIV is, why a cure is<br />

important, and which type of<br />

cure is preferred.<br />

<strong>The</strong> majority of the survey<br />

respondents indicated they<br />

were in good health, with<br />

only 14% stating that their<br />

health was poor. Seventy-two<br />

percent said that it was very<br />

important to them to be cured<br />

of HIV, while another 22% said<br />

it was somewhat important.<br />

Yet when asked about how a<br />

cure might look, participants<br />

had varying responses. 95%<br />

thought that a total cure<br />

without any risk of future<br />

transmission or infection very<br />

desirable, while only 41% considered<br />

it desirable to have a<br />

cure that had no risk of future<br />

transmission but carried a risk<br />

ShARP TuRn: PA contributor Matt<br />

Sharp talks about his experiences as a<br />

cure research study participant.<br />

of future infection. <strong>The</strong> survey<br />

also asked about disadvantages<br />

of living with HIV—the<br />

risk of experiencing health<br />

problems in the future was<br />

the number one answer, while<br />

psychosocial effects such as<br />

stigma and the risk of infecting<br />

someone else were also<br />

highly ranked.<br />

Deeks closed the twoday<br />

workshop by declaring<br />

Verdult’s presentation the<br />

“highlight of the meeting,”<br />

and remarking on the spirit<br />

of collaboration among the<br />

attendees. Barré-Sinoussi said<br />

that next steps include the<br />

efforts of the working groups,<br />

including a newly added<br />

social sciences research team<br />

and an ethics working group,<br />

as well as a call for more cure<br />

research funding and collaboration.<br />

<strong>The</strong> next IAS Towards<br />

an HIV Cure workshop is<br />

scheduled for immediately<br />

prior to the 2013 international<br />

conference in Kuala Lumpur,<br />

Malaysia.<br />

Other news on<br />

the cure front<br />

A group of patients in France<br />

who became infected with<br />

HIV and then started on<br />

antiretroviral therapy (ART)<br />

early in the post-infection<br />

period have shown no signs<br />

of a resurgence of their Hiv<br />

infection seven years after<br />

being taken off therapy.<br />

“<strong>The</strong>se results suggest<br />

that…antiretroviral treatment<br />

should be started very early<br />

after infection,” said Charline<br />

Bacchus, lead researcher<br />

of the study at the French<br />

National Agency for Research<br />

on AIDS and Viral Hepatitis<br />

(ANRS).<br />

<strong>The</strong> patients in the ANRS<br />

EP47 VISCONTI cohort (known<br />

as the Visconti Cohort) have<br />

an extremely low reservoir of<br />

HIV in their <strong>cells</strong> similar to that<br />

of “HIV controller” patients.<br />

HIV controllers are those who<br />

are able to control their HIV<br />

infection without the use of<br />

ART for an extended period of<br />

time, and represent about one<br />

out of every 300 people who<br />

have HIV.<br />

In the study, 12 patients<br />

started therapy within 10<br />

weeks of infection, were on<br />

therapy for an average of<br />

three years, and were able to<br />

control HIV after an average<br />

of seven years off therapy.<br />

At a press conference Asier<br />

Saez-Cirión, one of the study<br />

investigators, said they<br />

were interested in finding<br />

out whether HIV controller<br />

status could be induced. He<br />

estimated that 5–15% of those<br />

treated early could eventually<br />

control HIV off therapy. But<br />

don’t stop those HIV meds<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 35


COnfEREnCE uPdATE<br />

AIdS 2012<br />

washiNgtoN, d.c.<br />

just yet—not only would we<br />

need to figure out how to<br />

identify who would have this<br />

type of response to early<br />

treatment, but also get those<br />

individuals onto treatment<br />

immediately following infection.<br />

<strong>The</strong> other question one<br />

might ask is, could some of<br />

those in the study already<br />

have been HIV controllers to<br />

begin with? While the genetic<br />

alleles commonly associated<br />

with HIV controllers was not<br />

found in these patients t<strong>here</strong><br />

may be other factors playing<br />

a role, which researchers now<br />

are trying to uncover.<br />

Another study looked<br />

at two men who had been<br />

infected with Hiv for many<br />

years, on suppressive antiretroviral<br />

therapy (ART), and<br />

who underwent treatment of<br />

lymphoma via an allogenic<br />

(meaning foreign, or from<br />

another donor) stem cell<br />

transplantation. Both patients<br />

received a milder form of<br />

chemotherapy, known as the<br />

conditioning regimen, prior<br />

to transplant, which allowed<br />

them to stay on their ART during<br />

and after the transplant.<br />

One patient was on Atripla,<br />

the other on Isentress/<br />

Truvada. HIV was detectable<br />

in their <strong>cells</strong> immediately after<br />

the transplant, but the transplanted<br />

donor <strong>cells</strong> replaced<br />

the patients’ own lymphocytes<br />

over time. <strong>The</strong> amount<br />

of HIV DNA in their blood<br />

<strong>cells</strong> decreased and became<br />

undetectable, for up to two<br />

years now in one patient and<br />

three-and-a-half years in the<br />

other. CD4s declined in both<br />

patients initially, followed by<br />

a robust CD4 increase in one<br />

patient, and the stabilization<br />

and no further decline of<br />

CD4s in the other.<br />

Unlike Timothy Ray<br />

Brown, the “Berlin” patient,<br />

who received <strong>cells</strong> that were<br />

resistant to HIV because they<br />

lacked the CCR5 receptor,<br />

these patients received <strong>cells</strong><br />

that were CCR5+. It is believed<br />

that the antiretroviral treatment<br />

protected the donor<br />

<strong>cells</strong> from becoming infected,<br />

leading one researcher to refer<br />

to it as “a form of PrEP [preexposure<br />

prophylaxis] at the<br />

cellular level.” Further tissue<br />

sampling and analytic treatment<br />

interruption will need to<br />

be conducted to assess the full<br />

extent of the reduction of HIV<br />

in the reservoir.<br />

At a press conference<br />

held the same day these two<br />

studies were presented, David<br />

Margolis, MD, University of<br />

North Carolina at Chapel<br />

Hill, was asked by a reporter<br />

about the media’s role in<br />

reporting on cure advances<br />

responsibly and accurately,<br />

while at the same time not<br />

giving too much hope or creating<br />

complacency.<br />

“That’s your job,” said<br />

Margolis. “We are very<br />

careful about what we say<br />

[as researchers], and we’ve<br />

defined cure several different<br />

ways. Different kinds of<br />

cure and eradication mean<br />

different things to different<br />

people, and have different<br />

levels of value. Perhaps we<br />

should come up with a word,<br />

like ‘complicated-eradicationchemo-immunotherapy,’<br />

to<br />

slow people down. But you<br />

can’t argue with the goal and<br />

you can’t get t<strong>here</strong> without<br />

working on it—and I can’t say<br />

how long it will take.”<br />

Drug updates<br />

by eNid vázquez<br />

Complera, the newest single<br />

tablet regimen (STR), comprised<br />

of rilpivirine (Edurant)<br />

plus emtricitabine/tenofovir<br />

(Truvada), continues to hold<br />

its own. Previously, it had<br />

been shown to be non-inferior<br />

to Atripla, another STR, made<br />

of efavirenz (Sustiva) plus<br />

emtricitabine/tenofovir. This<br />

time, however, it has been<br />

shown to maintain an undetectable<br />

viral load (of less<br />

than 50 copies/mL) in people<br />

who were switching from<br />

a Norvir-boosted protease<br />

inhibitor (PI) combination.<br />

<strong>The</strong>se were 24-week<br />

results in nearly 500 individuals,<br />

of whom two-thirds were<br />

switched to Complera and the<br />

rest maintained on their PI<br />

regimen. Overall total cholesterol,<br />

LDL (“bad cholesterol”),<br />

and triglycerides decreased<br />

to a greater extent among<br />

those switched than on those<br />

maintained on their PI. <strong>The</strong><br />

differences were statistically<br />

significant.<br />

“We all know that regimen<br />

simplification improves quality<br />

of life,” said Frank Palella, MD,<br />

of Northwestern University<br />

when he presented these<br />

results from the SPIRIT study.<br />

Also continuing to do<br />

well: the still investigational<br />

elvitegravir and dolutegravir,<br />

both integrase inhibitor medications<br />

(INSTIs). In 96-week<br />

results from Study 145, elvitegravir<br />

continued to be noninferior<br />

(as it was in earlier<br />

48-week results) to Isentress,<br />

the only INSTI currently on<br />

the market. Development of<br />

INSTI drug resistance was<br />

low (about 7%) and similar<br />

with both medications. <strong>The</strong><br />

700 participants in this study<br />

were treatment-experienced,<br />

so they were less likely to<br />

achieve undetectable viral<br />

load. Overall, 47.6% of the 351<br />

participants on dolutegravir<br />

had undetectable viral loads,<br />

compared to 45% of those on<br />

Isentress.<br />

In 48-week results from<br />

the SPRING-2 study, dolutegravir<br />

was as effective as<br />

Isentress, with 88% vs. 85% of<br />

participants in the two groups<br />

achieving undetectable viral<br />

load. <strong>The</strong> participants were<br />

treatment-naïve (first time<br />

on HIV therapy), See more<br />

dolutegravir news in Briefly.<br />

GETTInG A BOOST<br />

<strong>The</strong> investigational drug cobicistat<br />

(COBI), which boosts<br />

drug levels (a “pharmacoenhancer”),<br />

was given with<br />

Reyataz plus Truvada and<br />

compared to Norvir-boosted<br />

Reyataz plus Truvada, a<br />

preferred regimen under<br />

U.S. treatment guidelines. In<br />

Phase 3 study results after 48<br />

weeks, cobicistat-boosted<br />

reyataz was non-inferior<br />

to Norvir-boosted reyataz,<br />

with high rates of virologic<br />

success (viral loads of less<br />

than 50 copies per mL) and<br />

similar safety and tolerability.<br />

Nearly 700 individuals participated<br />

in Study 114.<br />

“Cobicistat appears to be<br />

an effective drug for boosting<br />

36 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


PHOTO: © iAS/RyAn RAyBuRn-COMMERCiAliMAgE.nET<br />

protease inhibitor levels,<br />

with greater potential for coformulation,”<br />

said presenter<br />

Joel Gallant, MD, MPH of<br />

Johns Hopkins University<br />

School of Medicine. He noted<br />

the various co-formulations<br />

of cobicistat with protease<br />

inhibitors that are in development.<br />

Moreover, he pointed<br />

out that, “[Norvir]-boosted<br />

Reyataz is known to be a<br />

lipid-friendly regimen and<br />

cobicistat is no different.”<br />

“This is all good news,”<br />

said session co-facilitator<br />

Christine Katlama, MD, of<br />

Hospitalier Pitie-Salpetriere in<br />

Paris, “because all the drugs<br />

work and when they don’t<br />

work t<strong>here</strong> is no resistance.”<br />

Risky business<br />

for sex workers<br />

Several sessions looked at<br />

abuses that put sex workers<br />

at risk for HIV—and we’re not<br />

talking sex.<br />

Instead, it’s police actions<br />

around the world—including<br />

<strong>here</strong> in the United States—to<br />

confiscate condoms and<br />

to use them as evidence<br />

of prostitution that puts<br />

sex workers at risk for HIV.<br />

Advocates<br />

said the situation is<br />

such that many sex<br />

workers are afraid<br />

to carry condoms<br />

because of the police<br />

harassment this can<br />

cause. In fact, even<br />

outreach workers<br />

have been followed<br />

by the police so that<br />

sex workers can be<br />

arrested when they<br />

take the condoms<br />

offered. As advocates<br />

pointed out, it is<br />

not illegal to carry<br />

condoms. Rather,<br />

confiscation serves as another<br />

avenue of illegal detention<br />

and intimidation.<br />

Moreover, criminalization<br />

of consensual sex work keeps<br />

workers under dangerous conditions.<br />

In the “Criminalizing<br />

Condoms and Sex Work”<br />

session, Acasia Shields, author<br />

of Criminalizing Condoms, a<br />

report from the Open Society<br />

Foundation, said, “Police<br />

routinely search sex workers<br />

to confiscate and destroy condoms.<br />

This affects their ability<br />

to practice safe sex and they<br />

know it.”<br />

Of the U.S. sex workers<br />

surveyed, 52% said they<br />

were afraid to carry condoms<br />

because of fear of police<br />

harassment. Shields said<br />

other abuses include<br />

threats of arrest to<br />

exhort sex,<br />

and beating<br />

or raping sex<br />

workers.<br />

Discussing<br />

the findings<br />

from the first<br />

national congress<br />

of sex workers in<br />

Bangladesh, Simon<br />

mY BOdY, mY BuSInESS: Discussing sex workers’ issues.<br />

Risen, MD, MPH, PhD, of Save<br />

the Children, said, “Violence<br />

against female sex workers<br />

spreads far beyond individual<br />

incidents and factually is gender-based<br />

violence.” Among<br />

other recommendations, Save<br />

the Children in Bangladesh<br />

says behavioral change campaigns<br />

should be aimed at<br />

changing community perceptions<br />

and creating acceptance<br />

of sex workers in mainstream<br />

society, and that maternal and<br />

child services should focus<br />

more on issues related to sex<br />

workers.<br />

Darby Hickey of the Los<br />

Angeles chapter of SWOP<br />

(Sex Workers Outreach<br />

Project), said, “We think<br />

sometimes that countries like<br />

the United States are a world<br />

apart from countries like<br />

Bangladesh, but unfortunately,<br />

we face the same issues.<br />

It is about law and about<br />

policy change, but also about<br />

how police operate outside<br />

the range of law. So we need<br />

to change policies, holding<br />

police accountable, and<br />

address the wider societal<br />

indifference and downright<br />

hostility.” She said efforts to<br />

“rescue and save” sex workers<br />

should be called “arrest<br />

and abuse.”<br />

In the session titled “<strong>The</strong><br />

Oldest Profession: Is Sex<br />

Work Work?,” Naomi Akers<br />

said equating sex work with<br />

human trafficking is insulting<br />

and hurts both sex workers,<br />

who are targeted by raids,<br />

and victims of trafficking,<br />

who aren’t helped at all.<br />

“When you’re doing sex work,<br />

of course you see it as work.<br />

It buys you food and helps<br />

you take care of your family,”<br />

she said, calling trafficking<br />

“horrible.”<br />

Deanna Kerrigan of the<br />

Johns Hopkins Bloomberg<br />

School of Public Health in<br />

Baltimore detailed findings<br />

of higher HIV risk among sex<br />

workers around the world, and<br />

said support for sex workers’<br />

groups, as well as human and<br />

health rights is critical for all<br />

sex workers, including men<br />

and transgender people.<br />

Labor rights, the focus of the<br />

session, would help to eliminate<br />

stigma and discrimination<br />

and increase HIV prevention<br />

efforts for this group of workers,<br />

she said. Richard Howard<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 37


COnfEREnCE uPdATE<br />

AIdS 2012<br />

washiNgtoN, d.c.<br />

of the International Labour<br />

Office (ILO) said, “Decent<br />

work [as outlined by ILO]<br />

should exist for all human<br />

beings, regardless of whether<br />

it’s legal or not, whether it<br />

takes place in a formal or<br />

informal environment.”<br />

Underscoring the human<br />

rights issues affecting sex<br />

workers were protests against<br />

the U.S. Consulate for denying<br />

them visas to attend the<br />

conference.<br />

In the final analysis, the<br />

sex workers movement advocates<br />

for decriminalization of<br />

sex work as the most important<br />

way of protecting their<br />

human rights.<br />

“<strong>The</strong> epidemic is not<br />

driven by the lack of a pill<br />

or a gadget, the epidemic is<br />

driven by repression,” said<br />

plenary speaker Cheryl Overs,<br />

Senior Research Fellow at<br />

the Michael Kirby Centre for<br />

Public Health and Human<br />

Rights at Monash University<br />

in Melbourne.<br />

She founded a sex workers’<br />

rights organization in<br />

Australia in the ‘80s and the<br />

Global Network of Sex Work<br />

Projects in the ‘90s. She has<br />

worked in HIV policy and programming<br />

for male, female,<br />

and transgender sex workers<br />

in more than 20 developing<br />

countries. “And that brings<br />

me to law and policy,” she<br />

continued. “Sex workers<br />

from Sweden to Singapore<br />

to Swaziland all say that the<br />

greatest threat to their health<br />

and human rights is the law<br />

that makes it impossible to<br />

find safe places to work, and<br />

prevents them from having<br />

the same protections as other<br />

workers and other citizens.”<br />

At the center of research<br />

A look behind the National institutes of Health<br />

story aNd photographs by rick guasco<br />

With an annual budget<br />

approaching $31 billion, the<br />

National Institutes of Health<br />

(NIH) is the medical research<br />

agency of the federal government<br />

and the largest source of<br />

funding in the world for medical<br />

research. the NiH is also<br />

a driving force behind AiDs<br />

and Hiv vaccine research;<br />

10% of the agency’s budget<br />

—$3 billion—goes toward<br />

HIV/AIDS, funding research<br />

conducted at academic, commercial,<br />

and private labs, as<br />

well as at NIH headquarters in<br />

Bethesda, Maryland.<br />

Some 75 buildings are<br />

scattered throughout the<br />

312-acre NIH campus. During<br />

the International AIDS<br />

Conference, the agency<br />

hosted a press tour of two<br />

of those buildings, offering a<br />

closer look at the role the NIH<br />

plays in clinical research and<br />

treatment.<br />

ThE VACCInE CEnTER<br />

Opened in 2000, the Vaccine<br />

Research Center is a five-story<br />

facility w<strong>here</strong> research is done<br />

to find vaccines not only for<br />

HIV, but for influenza, Ebola<br />

virus, and other diseases that<br />

pose global health risks.<br />

Gary J. Nabel, MD, PhD,<br />

director of the Vaccine<br />

Research Center, opened the<br />

tour, explaining how the facility<br />

serves as an “intellectual<br />

hub” by putting all the stages<br />

of vaccine research and<br />

development under one roof.<br />

Basic research is<br />

first conducted to find a<br />

promising vaccine candidate.<br />

A vaccine is of<br />

little use, however, if it<br />

can’t be efficiently and<br />

safely mass-produced,<br />

so it undergoes test<br />

production for good<br />

manufacturing practices<br />

and quality control.<br />

From t<strong>here</strong>, a successful<br />

candidate then goes<br />

to clinical trials to<br />

determine how safe it is<br />

for patient use. Results<br />

from the trials are<br />

reviewed in a series of<br />

assessments. If the vaccine<br />

candidate doesn’t<br />

pass this process with<br />

flying colors, it goes<br />

back to basic research,<br />

and the cycle begins<br />

again. <strong>The</strong> three-phase<br />

cycle can take 10–18 years<br />

for a would-be<br />

vaccine to complete.<br />

Nabel said that the search<br />

for a vaccine has been<br />

elusive, because, “HIV is constantly<br />

mutating, changing its<br />

genetic make-up and protein<br />

structure.”<br />

“HIV is a sugar-coated<br />

virus,” Nabel explained.<br />

Sugars produced by the body<br />

are converted into proteins by<br />

the virus. “This makes it invisible<br />

to the body’s immune<br />

system, which does not perceive<br />

the virus as a threat.”<br />

However, Nabel offered<br />

some perspective on the<br />

VACCInE ChIEf: <strong>The</strong> NIH’s Vaccine<br />

Research Center is headed by<br />

Dr. Gary J. Nabel.<br />

search for an HIV vaccine.<br />

Although it took 17 years to<br />

develop a vaccine against<br />

hepatitis B, he pointed out<br />

that a polio vaccine took<br />

45 years.<br />

“A vaccine is at least 10<br />

years into our future,” Nabel<br />

said. “What we’ve learned is<br />

that HIV is a very crafty virus.”<br />

While one or two vaccine<br />

candidates look promising, it<br />

will be at least until mid-2013<br />

before an assessment can be<br />

made, and a little longer to<br />

evaluate more mature data,<br />

Nabel said. Even if a vaccine<br />

38 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


were discovered today, it<br />

would take at least four years<br />

of additional testing and evaluation<br />

before it could become<br />

publicly available.<br />

ThE CLInICAL<br />

RESEARCh CEnTER<br />

Next stop on the tour was<br />

the Mark O. Hatfield Clinical<br />

Research Center, a hospital<br />

w<strong>here</strong> 1,500 clinical trials for<br />

a variety of illnesses (including<br />

HIV/AIDS) are conducted.<br />

Opened in 2005, the Hatfield<br />

Clinical Research Center is<br />

connected to the Warren<br />

Grant Magnuson Clinical<br />

Center, built in 1953, to form<br />

the largest hospital in the U.S.<br />

dedicated to clinical research.<br />

<strong>The</strong> Clinical Research<br />

Center has spawned numerous<br />

treatments, from the<br />

first pediatric chemotherapy<br />

to development of AZT,<br />

the first anti-HIV drug. <strong>The</strong><br />

center houses an HIV clinic<br />

that treats 500 patients, only<br />

one or two of whom are ever<br />

in-patients.<br />

Dr. Henry Masur is the<br />

research center’s Director of<br />

Critical Care Medicine, but has<br />

focused the major part of his<br />

career on HIV and its associated<br />

complications. Although<br />

a research institution, Masur<br />

said the clinic recognizes the<br />

importance of keeping HIVpositive<br />

patients connected<br />

to care. That’s why while<br />

half the clinic’s nursing staff<br />

is in research, the other half<br />

of the nurses are also case<br />

managers.<br />

Hepatitis C is a major concern<br />

for people who are HIVpositive,<br />

Masur said. T<strong>here</strong><br />

are 3–5 million people who<br />

have hep C out of 314 million<br />

Americans. While the current<br />

standard of care for hepatitis<br />

C can sometimes be difficult<br />

to tolerate and only helps to<br />

clear the virus in about onethird<br />

to one-half of patients,<br />

recent advances have raised<br />

the cure rate to 75% and<br />

higher. Masur said advances<br />

in treatment look even more<br />

promising, comparing them to<br />

the advent of protease inhibitors<br />

and combination therapy<br />

for HIV that came in 1995.<br />

As people are now living<br />

longer with HIV, Masur said<br />

the research center is beginning<br />

to look at aging and<br />

other complications. “We’ll<br />

soon be examining neurocognitive<br />

issues,” he said.<br />

“Beyond anecdotally, does it<br />

happen, and if so, what can<br />

we do to reverse it?”<br />

“Knowledge is bi-directional,”<br />

Masur said. “What<br />

we learn in the lab will help<br />

patients. But t<strong>here</strong> is a lot we<br />

can learn from patients and<br />

put to use.”<br />

CLInICAL CARE: Dr. Henry Masur (above) introduces Senora<br />

Mitchell, a medical clerk who has been with the Hatfield Clinical<br />

Research Center’s HIV clinic since 1987. “I love my work,” Mitchell<br />

said. “I get to make a difference every day.”<br />

mOdEST ACCOmmOdATIOnS: You might expect that an<br />

examination room in the most prominent medical research<br />

hospital in the country, if not the world, would look better than<br />

this. But Masur noted that taxpayers pay for NIH facilities, so the<br />

exam room looks the same as at any other doctor’s office.<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 39


ScEnES<br />

FROm<br />

A WEEk<br />

THAT WAS<br />

words & images<br />

by rick guasco<br />

BEYonD THE HEaDLInEmaking<br />

sessions of<br />

the International AIDS<br />

Conference, t<strong>here</strong> was much to<br />

see and do inside and away from<br />

Washington, D.C.’s convention<br />

center. “What would an AIDS<br />

conference be without a little<br />

protesting?” said an unflappable<br />

Secretary of State Hilary Clinton<br />

as a small group of demonstrators<br />

rose and chanted when she took<br />

the stage on opening day.<br />

During a panel discussion<br />

addressing the efficiency of<br />

overseas anti-AIDS efforts, Bill<br />

Gates spoke candidly: “<strong>The</strong><br />

amount of money we have [now]<br />

is not enough to treat everyone.<br />

We’re in a period of incredible<br />

uncertainty about how much this<br />

funding will stay strong. Even the<br />

uncertainty creates instability in<br />

how the investment ahead will<br />

be made. <strong>The</strong> voices of the AIDS<br />

community are going to have to<br />

be louder than ever.”<br />

<strong>The</strong> week of the conference<br />

offered opportunities to honor<br />

the fallen and plea for the living.<br />

Visitors to the AIDS Memorial<br />

Quilt, displayed on the Mall, could<br />

not only see the panels, but also<br />

recite the names of those memorialized<br />

by the Quilt.<br />

In the streets, approximately<br />

1,000 marchers took their messages<br />

to the White House.<br />

Discordant voices—demonstrating<br />

for sex workers’ rights, against<br />

Wall Street, opposing HIV criminalization<br />

laws—were united by<br />

one refrain, “cure AIDS now.”<br />

40 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM


the mirror haS<br />

tWo faceS<br />

A personal account of using facial filler for lipoatrophy<br />

by Jeff berry<br />

eVER SIncE IT FIRST BEgan aPPEaRIng wITH<br />

some regularity in people with HIV in the mid 1990’s,<br />

lipoatrophy has earned its well deserved reputation<br />

as the Scarlet Letter of HIV, also known as “the look.”<br />

Lipoatrophy is the loss of subcutaneous fat under the skin, most<br />

notably in the face, but also in the butt, arms, and legs, and is<br />

thought to be part of a larger syndrome called lipodystrophy,<br />

which is the redistribution of fat in the body and can include buffalo<br />

hump, enlarged breasts, and visceral fat in the abdomen.<br />

It can sometimes be extremely disfiguring,<br />

and almost always causes some level<br />

of emotional distress, even depression,<br />

and oftentimes self-imposed isolation in<br />

those who suffer from its stigmatizing<br />

effects. It can also affect ad<strong>here</strong>nce to HIV<br />

medications, and deter people from starting<br />

treatment in the first place.<br />

<strong>The</strong> cause of lipoatrophy has been<br />

linked to certain HIV medications, most<br />

notably d4T (Zerit, stavudine) and to a lesser<br />

extent AZT (Retrovir, zidovudine) and<br />

ddI (Videx, didanosine); other HIV meds,<br />

including some protease inhibitors; and it<br />

has also been linked to HIV itself. D4T is<br />

rarely prescribed in the U.S. anymore, but is<br />

still widely used in many developing countries<br />

due to its availability and low cost.<br />

While we don’t see as many new cases of<br />

lipoatrophy <strong>here</strong> in the U.S. with those who<br />

have since initiated therapy using newer<br />

and less-toxic antiretrovirals, it is still prevalent<br />

among those using d4T in developing<br />

countries, although d4T continues to fall<br />

out of favor with providers and is used less<br />

and less as more and newer drugs become<br />

available in those regions.<br />

For those who have been treated with<br />

some of these older, more toxic drugs<br />

(when that was all that was available),<br />

many have developed the sunken cheeks,<br />

veiny arms and legs, and loss of fat in the<br />

butt to the point w<strong>here</strong> it is uncomfortable<br />

to sit for more than a short period of time.<br />

Once you discontinue taking a drug like<br />

d4T, you can sometimes stop the lipoatrophy<br />

from progressing any further, but it<br />

can take a long time to see any reversal of<br />

its effects, if ever, so some people will turn<br />

to using facial fillers to replace the fat in<br />

the face that has been lost.<br />

I have written several articles in the<br />

past, for both PoSITIVELY awaRE and<br />

<strong>The</strong><strong>Body</strong>.com, about my experiences<br />

dealing with the physical and emotional<br />

aspects of having lipoatrophy and its<br />

stigmatizing effects, as well as my experience<br />

using a facial filler, Sculptra (known<br />

then as New-Fill) back in 2001. <strong>The</strong> results<br />

I saw in 2001 were only moderate, and<br />

disappeared within about six months to<br />

a year, mainly due to the fact that I only<br />

received two treatments because that was<br />

all that I could afford.<br />

In THE FaLL oF LaST YEaR, I<br />

decided to revisit the idea of receiving<br />

another round of facial filler<br />

treatments, and I went to see Dr. Dan<br />

Berger of Northstar Medical Center in<br />

Chicago for a consultation. Dr. Berger, who<br />

also writes for PoSITIVELY awaRE, and<br />

has over 12 years of experience providing<br />

Sculptra, recommended that I undergo<br />

five or six “sessions” due to the level of<br />

facial lipoatrophy that I had. Facial lipoatrophy<br />

is graded on a scale of 1 to 5, with 1<br />

being mild, and 5 being severe—mine was<br />

severe, between grade 4 and 5. During<br />

each session, I was to receive injections of<br />

two vials, or one “kit” of Sculptra, one vial<br />

for each side of my face.<br />

Sculptra, or injectable poly-L-lactic<br />

acid, is one of only two FDA approved<br />

treatments in the U.S. for HIV-associated<br />

facial lipoatrophy, the other being<br />

Radiesse. Both of these injectables work<br />

by being absorbed into the body and<br />

stimulating the growth of the body’s own<br />

collagen, so they are not permanent fillers.<br />

T<strong>here</strong> are other fillers available (see<br />

table, page 43) that are also used for<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 41


FAcE On: Berry before his initial treatment, and three months after the sixth and last session.<br />

facial lipoatrophy, but they are permanent<br />

and can sometimes cause serious side<br />

effects and allergic reactions (as can both<br />

Sculptra and Radiesse). Only one is FDA<br />

approved (Silikon 1000) and none are<br />

approved for use in HIV. Anecdotally, I’ve<br />

heard of people who have used them and<br />

are pleased with their results, but personally<br />

I did not want to use something that<br />

was going to be permanent.<br />

I felt comfortable using Sculptra because<br />

I had used it before and I already knew what<br />

to expect, but also because I would be getting<br />

six treatments instead of two, so I was<br />

hoping to experience better results this time<br />

around. Plus, as Dr. Berger explained it, after<br />

getting six treatments, my face would never<br />

go back to the way it was before receiving<br />

Sculptra, and I would only require a “touchup”<br />

session once a year.<br />

<strong>The</strong> cost of Sculptra is expensive, running<br />

about $1,700 for one kit (two vials),<br />

or $850 per 367.5 mg vial, which also<br />

includes the cost for the session—doctor,<br />

time, and procedure. Most insurance<br />

companies still consider its use to be a<br />

cosmetic treatment and are t<strong>here</strong>fore<br />

likely to refuse to cover the drug as well as<br />

the procedure. However, if you are initially<br />

denied, you should appeal and see if you<br />

can get them to recognize it as a medical<br />

necessity (which it really is). Recognizing<br />

the high cost and lack of coverage by most<br />

plans, and the great need of those who<br />

have this condition, the manufacturer created<br />

a patient assistance program (PAP)<br />

for people with HIV that assists in helping<br />

to pay for Sculptra. However, a new<br />

company (Valeant) recently took over the<br />

PAP, and it now only covers those with up<br />

to $61,940 in annual income, and provides<br />

just two kits plus one follow up kit after a<br />

two-year period. Under the PAP Sculptra is<br />

free for those with an annual income less<br />

than 200% of the Federal Povery Level<br />

($22,340 for an individual, slightly higher<br />

based on family size and in Alaska and<br />

Hawaii), and then on a sliding scale above<br />

this amount and up to $61,940. <strong>The</strong> staff<br />

at Northstar was very helpful in getting<br />

me set up with the PAP, and in November<br />

of 2011 I received my first treatment.<br />

IT IS VERY ImPoRTanT THaT THE<br />

physician who is performing the procedure<br />

be trained specifically in the<br />

use of Sculptra and how to properly<br />

inject it, which requires a certain threading,<br />

or tunneling, technique. According to the<br />

package label, “during the first injection<br />

session with Sculptra, only a limited correction<br />

should be made. <strong>The</strong> contour deficiency<br />

should be under-corrected, never<br />

fully corrected or overcorrected (overfilled)<br />

during any injection session. Re-evaluate<br />

the patient no sooner than two weeks after<br />

the injection session to determine if additional<br />

correction is needed.”<br />

Each session only takes around 40-45<br />

minutes, and it would begin with Dr.<br />

Berger marking my face with a white<br />

pencil to guide him while injecting the<br />

Sculptra. Starting with ice packs on my<br />

face to minimize the swelling, and then<br />

a local anesthetic to numb my face, he<br />

would begin injecting the filler into different<br />

areas of my face, using his hands<br />

to help “move” the filler into place once it<br />

was injected. Even with the local anesthetic,<br />

I experienced a good deal of discomfort<br />

when the needles went in and he tunneled,<br />

especially during the first couple of sessions<br />

when t<strong>here</strong> was little fat in my face<br />

for him to work with. But the discomfort<br />

was only temporary, and when the session<br />

was over, I was left with some temporary<br />

swelling, a few marks, and on occasion,<br />

some slight bruising, but the swelling went<br />

down in a few hours and any marks or<br />

bruising were gone within a day or two.<br />

Following each session, and according<br />

to the package label, I was to “massage in<br />

a circular fashion the treated areas for five<br />

minutes, five times per day for five days,”<br />

in an effort to stimulate collagen growth<br />

and “even out” the facial filler under my<br />

42 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM<br />

“AfTER” PHOTO: CHRiS KnigHT


SOuRCE: fACiAlwASTing.ORg<br />

FAcE OFF: Commonly used options for HIV-related facial lipoatrophy<br />

PRoDUcT TYPE/SESSIonS aPPRoVED? coST<br />

Sculptra<br />

Poly-L-lactic acid<br />

Radiesse<br />

Calcium hydroxylapatite<br />

(CaHA) microsp<strong>here</strong>s<br />

Silikon 1000<br />

Microdroplets<br />

Bioalcamid<br />

Polyalkylimide gel<br />

pMMA<br />

Polymethylmethacrylate<br />

skin. I went back for five more sessions,<br />

one every four weeks.<br />

Non-permanent;<br />

3–7 or more sessions<br />

needed.<br />

Non-permanent;<br />

2–3 or more sessions<br />

needed.<br />

Permanent;<br />

4–6 or more sessions<br />

needed.<br />

Permanent;<br />

1–2 sessions needed.<br />

Permanent;<br />

1–2 sessions needed.<br />

PaTIEnTS aRE aDVISED THaT<br />

after the initial treatment and<br />

within a week the effects will<br />

completely disappear, and the<br />

contour of the face returns to how it was<br />

before. With each subsequent session,<br />

however, you begin to see the cumulative<br />

benefit of each successive treatment, and<br />

the effects are more noticeable and last<br />

longer. By the third or fourth treatment, I<br />

was really looking more and more like my<br />

old self, and couldn’t wait for each following<br />

treatment, pain or no pain!<br />

Treatment advocate Nelson Vergel<br />

warns that not everyone experiences the<br />

same level of results. “Some people in my<br />

online discussion group, especially those<br />

with moderate to more advanced cases of<br />

facial lipoatrophy, have complained of poor<br />

response with Sculptra after spending a few<br />

thousand dollars for several sessions that<br />

did not end up restoring their faces.” Vergel,<br />

founder of FacialWasting.org and pozhealth<br />

at yahoogroups.com, says that some of<br />

them end up getting silicone microdroplets<br />

in the U.S. or flying to Mexico to get permanent<br />

options like PMMA (see table, above).<br />

FDA approved. Patient Assistance for product only<br />

(under $61,940 yearly income):<br />

www.needymeds.org/papforms/<br />

sculpt1039.pdf. Labor cost average<br />

$400 per session. Full price: $1,100<br />

per session for product.<br />

FDA approved. Patient Assistance available: www.<br />

radiesse-fl.com/Physician-section/<br />

Patient-access-program/<br />

Full price: $1,200 per session.<br />

Off-label use; FDA approved for<br />

intraocular injections to treat<br />

CMV-related retinal detachment.<br />

Not FDA approved. Available in<br />

Canada, Mexico, and Europe.<br />

Not FDA approved. Available in<br />

Mexico and Brazil. American version<br />

Artefil is too expensive for<br />

the amount required.<br />

Of course, nothing is perfect, and t<strong>here</strong><br />

are side effects associated with Sculptra.<br />

<strong>The</strong> most common side effects reported<br />

in studies are bruising, swelling, discomfort,<br />

and rash, but these typically resolve<br />

within a few days to a few weeks. T<strong>here</strong> is<br />

a “device-related adverse event” called an<br />

injection site subcutaneous papule, which<br />

is a small lump or bump under the skin, the<br />

onset of which can occur anyw<strong>here</strong> from<br />

a few weeks to a few years afterward. I<br />

experienced several of these lumps, one<br />

under my left eye, and two under my<br />

right temple (sometimes if you get these<br />

papules you can feel them under your<br />

skin, but they are barely noticeable—other<br />

times they can be more visible). T<strong>here</strong> are<br />

also more serious adverse events that can<br />

potentially occur, so be sure to read the<br />

full package label.<br />

In THE EnD, FoR mE THE FEw<br />

small lumps, the cost of treatment,<br />

and the pain were all a small price to<br />

pay for what it has ultimately done for<br />

my self-esteem. I feel better about myself<br />

overall, because I look healthier. <strong>The</strong> effect<br />

for me was subtle, most people didn’t really<br />

notice or say anything, other than “you look<br />

rested” or “you look really great!”<br />

No Patient Assistance Program.<br />

$400–800 per session, depending on<br />

the physician.<br />

$4,500 average total. Two sessions.<br />

Infections reported after 3–4 years.<br />

$2,000 average cost for total reconstruction.<br />

Patient assistance in Tijuana:<br />

www.MedicalPMMA.com<br />

I realize that I am very lucky to have a<br />

decent-paying job that has afforded me the<br />

ability to benefit from this treatment, and<br />

that many others are not as fortunate. I also<br />

realize that even though the HIV treatments<br />

available today are much less likely to<br />

cause facial lipoatrophy (if at all), the fear<br />

of developing facial lipoatrophy still may<br />

deter some people from ever starting treatment,<br />

or may cause those who are on treatment<br />

to be less than fully ad<strong>here</strong>nt to their<br />

regimen. While Medicare finally agreed to<br />

cover the procedure a few years ago, the<br />

amount that they reimburse is well below<br />

what providers charge. That is why I plan to<br />

continue to advocate for insurance companies,<br />

Medicare, and Medicaid to cover this<br />

procedure at a reasonable amount, much<br />

in the same way that breast reconstruction<br />

is provided to women with breast cancer<br />

who have undergone a mastectomy. <strong>The</strong><br />

benefit of these treatments is vital to the<br />

psychological well-being and quality of life<br />

for so many people living with HIV who are<br />

affected by this condition.<br />

go to www.sculptra.us for more<br />

information. For a list of providers trained<br />

in the use of Sculptra, visit www.sculptraaesthetic.com.<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 43


SEARCh<br />

fOR An hIV<br />

SPECIALIST<br />

Finding an Hiv<br />

specialist<br />

is easy with<br />

AAHivM’s<br />

referral link:<br />

www.aahivm.org.<br />

enter your ZiP<br />

code on the<br />

home page,<br />

and click<br />

on the “Go”<br />

button for<br />

a list of Hiv<br />

specialists<br />

near you.<br />

ASk ThE hIV SPECIALIST<br />

HELEn c. koEnIg, mD, mPH<br />

Safe sex is<br />

for seniors, too<br />

Q:<br />

i am a 65-year-old womaN.<br />

I lost my husband six years ago and<br />

have finally decided to enter the dating<br />

world again. My friends have convinced<br />

me to go on a cruise especially for single seniors,<br />

but my daughter is giving me all kinds of warnings<br />

about sexually transmitted diseases and HIV. HIV didn’t<br />

even exist back when I first became sexually active.<br />

Seriously, how great is my risk of contracting such<br />

diseases? After all, we are all going to be senior citizens<br />

and I’m not going on this cruise intending to “hook up”<br />

(as they say). Is all this safe sex stuff really necessary?<br />

A:<br />

as you head for the suN,<br />

the all-you-can-eat buffets, and the<br />

cruise festivities, don’t forget to pack<br />

some condoms with your sun block.<br />

While the risk of bringing home HIV or another sexually<br />

transmitted infection (STI) is not high, it’s not zero<br />

either. You are joining a growing population of women<br />

who are sexually active in their 60s and 70s and, unfortunately<br />

seeing a higher rate of STIs than ever before.<br />

What really is your risk of acquiring an STI? This<br />

depends entirely on the partner or partners with whom<br />

you choose to be sexually active, what type of sex you<br />

choose to have (oral, vaginal, or anal) and whether<br />

you choose to use protection or not. You have no way<br />

of knowing the sexual history of the men you’ll meet<br />

or their risk of having an STI. Studies have shown that<br />

even doctors, after taking a complete sexual history in<br />

a medical setting, are still terrible at predicting whether<br />

someone has HIV. Your prospective partners may<br />

not know they have STIs, as many can be present for<br />

months or years without symptoms, including HIV.<br />

Women who have been in a monogamous relationship<br />

for the last 20 or 30 years, or for whom sex hasn’t<br />

been an issue, may find it difficult to think about buying<br />

and asking their partner to use condoms. But <strong>here</strong> are<br />

some good reasons to brave that aisle at the drug store<br />

before you hit the high seas, as well as empowering<br />

yourself enough to make sure they’re used:<br />

44 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM<br />

n<br />

3,500 women over age 45 were diagnosed with<br />

AIDS in 2009. People over the age of 50 now<br />

account for 15% of new HIV/AIDS diagnoses, and<br />

over 35% of all deaths from AIDS.<br />

n <strong>The</strong> highest percentage of trichomoniasis (a parasitic<br />

infection, considered the most common curable STI)<br />

is now actually in women over 50. Also on the menu<br />

are syphilis, gonorrhea, chlamydia, hepatitis B and C,<br />

herpes, and human papilloma virus.<br />

n Postmenopausal women are at a particularly high<br />

risk of acquiring HIV and other STIs because the<br />

vaginal wall is thinner as a result of lower estrogen<br />

levels and the immune system is not as strong as it<br />

used to be.<br />

You can’t control the risk of STIs in your partners,<br />

but you can control the risk of bringing one home<br />

yourself with correct condom use. Perhaps you think it’s<br />

“the man’s job” to come prepared with protection, but<br />

I encourage you to bring your own as backup! Chances<br />

are, the condom colors, flavors, and textures out t<strong>here</strong><br />

have changed a bit since you last looked. Lubricants<br />

now also come in wider varieties and are important<br />

if you experience vaginal dryness, both for your own<br />

comfort and to prevent condoms from tearing. So pack<br />

some protection and enjoy the festivities ahead!<br />

illuSTRATiOn © KARlKOTASinC


PHOTO: CHERyl MAnn<br />

WhOLISTIC PICTuRE<br />

SUE SaLTmaRSH<br />

Battle of the sexes?<br />

with all the evideNce that t<strong>here</strong> is iNdeed<br />

a “war on women” being waged by “conservatives,”<br />

it’s hard not to feel a “feministic” response. I am not a<br />

feminist. But I am also not in favor of any woman being<br />

forced to have a child she cannot support financially,<br />

emotionally, physically, or spiritually, just as no man<br />

should be forced into fatherhood that he doesn’t want<br />

and can’t do well.<br />

But I digress. Some feminists have been heard to<br />

say that no man would be <strong>here</strong> without his mother’s<br />

body having created him. I have to wonder how they<br />

could have missed the fact that a man (the sperm had<br />

to come from one of them, after all) was also involved<br />

in that creation. But then, I thought, couldn’t such<br />

biological criteria be used to argue the case for the<br />

opposite side of every agenda? Women have testosterone<br />

too and yet the number of female-only causes<br />

far outweighs male-only ones. At this stage of human<br />

history, I doubt that t<strong>here</strong> is any black or white person<br />

who doesn’t carry a gene inherited from an ancestor of<br />

the other color and yet we have racism from both sides.<br />

And, as I’ve said before, aren’t people who develop<br />

cancer after years of chain smoking just as deserving of<br />

the medical care and treatment they need to survive as<br />

people who acquire HIV after years of unprotected sex<br />

with multiple partners?<br />

When feminists angrily accuse me of misogyny, I<br />

stand by my belief that BOTH sexes are as valuable and<br />

as worthy of living as the other. And yet, if a man published<br />

a calendar called “How is a jar of Vaseline better<br />

than a woman?” I’ve no doubt he would be verbally castrated<br />

by the very women who publish “How is a cucumber<br />

better than a man?” And, by the way, the word for<br />

the female equivalent of misogyny, misandry, rarely sees<br />

the light of day, though both obviously exist in full force.<br />

I have frequently been amazed by the number of<br />

commercials on PBS and other progressive media<br />

sources that tout the urgent need to get more girls to<br />

become scientists, engineers, and mathematicians.<br />

What about the boys who are truly, innately passionate<br />

about math and science? And w<strong>here</strong> are the commercials<br />

urging more boys to become nurses, teachers, and<br />

dancers? Fact is that each sex has natural tendencies<br />

and the problem is not in getting<br />

people to go against those natural<br />

leanings, but in the rest of us<br />

accepting whatever choices they<br />

make. As a former girl, I can tell you<br />

that t<strong>here</strong> is nothing on Earth that<br />

could’ve induced me to become a<br />

scientist, engineer, or mathematician.<br />

Why should I have been forced<br />

into a field I had no interest in? Why<br />

should any boy be forced to take<br />

Home Ec over Shop, to play the flute instead of football,<br />

or vice versa against his own interest?<br />

Throughout history, t<strong>here</strong> have been courageous<br />

activists of both sexes fighting for things that were<br />

good for everybody. Without Elizabeth Cady Stanton<br />

and Susan B. Anthony, the issue of women voting might<br />

never have come to the forefront, but it took 56 men in<br />

Congress to pass the amendment that gave women the<br />

right to vote. Rosa Parks and Martin Luther King were<br />

both crucial to the civil rights movement, but it was<br />

Lyndon Johnson, a white guy from Texas, who made it<br />

the law of the land.<br />

We need to stop putting each other in neat little<br />

boxes. People—every sex, every race, every religion,<br />

every size, every age, with every illness—have to decide<br />

for themselves what’s worth fighting for in this lifetime.<br />

Since 2009, we’ve had a lot of people, many who call<br />

themselves Christians and/or Republicans, deciding<br />

that the only thing worth fighting for is whatever goes<br />

against everyone who doesn’t look, believe, or act<br />

like them. But now we also have more, including some<br />

Christians/Republicans, waking up, shaking off complacency,<br />

and standing together in all their glorious varieties<br />

to fight for justice, equality, and the things that are<br />

best for the Whole.<br />

“Men should be advocates for all and not just their<br />

own gender!” feminists stridently shout. Shouldn’t<br />

women? Shouldn’t we all? Regardless of the composition<br />

of our chromosomes, we are all human. None of us<br />

would be <strong>here</strong> without the contributions of both male<br />

and female. So I propose we stop being “feminists” or<br />

“masculinists” (See? not even a word for it!) and do our<br />

best to become humanists.<br />

Breathe deep. Live Long.<br />

we need to<br />

stop putting<br />

each<br />

other in neat<br />

little boxes.<br />

regardless<br />

of the composition<br />

of<br />

our chromosomes,<br />

we are all<br />

human.<br />

POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 45


On September 21,<br />

take your best shot<br />

against HIV.<br />

a day with hiv<br />

Whether we’re positive or negative, we are all affected by HIV. Take your best shot<br />

against HIV/AIDS—take part in A Day with HIV, the HIV awareness and anti-stigma<br />

campaign presented by PoSITIVELY awaRE. On Sept. 21, use your smartphone or digital<br />

camera and take a snapshot of a moment of your life. Upload your picture and story to<br />

ADaywithHIV.com or email them to photo@adaywithhiv.com. Select<br />

pictures will appear in a special section of the November+December<br />

issue of PoSITIVELY awaRE. Additional pictures will be featured on<br />

ADayWithHIV.com.<br />

GET In ThE PICTuRE.<br />

aDaywithHIV.com

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