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BRIEFLY EnID VázqUEz Moises Agosto >> the following is from a statement from Moises Agosto, Director of treatment education, Adherence, and Mobilization for the National Minority AiDs Council (NMAC): “While PrEP shows substantial promise as a supplement to current HIV prevention efforts, it is by no means a panacea and is only effective when used in conjunction with traditional prevention and risk reduction strategies, such as condom usage. “Anti-retroviral medications, like Truvada, are extremely powerful drugs with the potential for serious side effects. As such, PrEP should only be used by individuals who are highly vulnerable to HIV infection, including those in sero-discordant couples, sex workers, and gay men. Its efficacy is also directly related to an individual’s adherence to a regimen, and should only be used by those who can commit to taking it regularly. Finally, use of PrEP by individuals who may already be HIV-positive could increase the risk of drug resistance. “In recent years, there have been a number of promising developments in biomedical interventions—from treatment as prevention and pre-exposure prophylaxis to microbicides and vaccine research. These advances have resulted in the greatest expansion of HIV prevention tools than at any other time in the history of this epidemic. Coupled with the reforms included in the Patient Protection and Affordable Care Act, as well as the National HIV/AIDS Strategy, we are in a position for the first time in over three decades to finally end this epidemic. Today’s decision is another important step in realizing that goal.” Dolutegravir/Epzicom superior to Atripla? Shionogi-ViiV Healthcare LLC announced that initial results from its Phase 3 study SINGLE (ING114467) show superiority of its investigational HIV medication dolutegravir plus Epzicom over Atripla, one of the most widely prescribed antiviral medications in the country. At 48 weeks, 88% of study participants on the dolutegravir regimen achieved undetectable viral load (less than 50 copies/mL) vs. 81% of those on Atripla, a statistically significant difference. The company said the difference was primarily driven by a higher rate of discontinuation due to adverse events in the Atripla arm. All individuals in the study were taking antiviral therapy for the first time, a group that does the best in HIV treatment. There were 414 individuals put on dolutegravir and 419 put on Atripla. Overall, 2% of those on the dolutegravir-based regimen discontinued due to adverse events vs. 10% of those receiving the Atripla regimen. The most common adverse events while on Atripla were neurological (reported by 41% of Atripla recipients vs. 15% of participants receiving the dolutegravir), while the most common drug-related adverse events with dolutegravir were in the gastrointestinal system (reported by 22% of people on dolutegravir vs. 22% of those given Atripla). Dolutegravir is an investigational integrase inhibitor (INSTI), the same class as Isentress, the only INSTI currently on the market. Rapid home HIV test approved In June, the Food and Drug Administration (FDA) approved the oraQuick in-Home Hiv test, an Hiv self-test kit that does not require sending a sample to a laboratory for analysis. The kit, which tests a swab from your mouth, is approved for sale in stores and online to anyone age 17 and older. (Although HIV is not found in saliva, evidence of exposure to the virus—called HIV antibodies—is found in the mouth and indicates infection.) A positive result at home must then be followed up with a confirmatory blood test from a laboratory. The FDA said the test can be falsely negative for reasons that include the occurrence of HIV infection within three months before testing. People who engage in behaviors that put them at increased risk of getting HIV—including having unprotected sex with new partners, or injecting illegal drugs—should be re-tested on a regular basis. They should not interpret a negative test to indicate that engaging in high risk behavior is safe. 14 SEPTEMBER+OCTOBER 2012 POSiTivElyAwARE.COM
FRom THE wEEkLY E-nEwS Website offers access to HIV meds for uninsured HarborPath, a new non-profit organization, has been established to create a program that offers a single place where uninsured Hiv-positive people who otherwise qualify for manufacturersponsored patient assistance programs (PAPs) can apply for and receive their medications. The “one stop shop” portal will provide a streamlined, online process to qualify individuals and deliver the donated medications through a mailorder pharmacy. HarborPath will pilot the program in states with high need, including Alabama, Texas, and Virginia. To create the portal, HarborPath worked closely with the National Alliance of State and Territorial AIDS Directors (NASTAD) and the Clinton Health Access Initiative (CHAI), which provided the seed funding for the organization. On World AIDS Day 2011, President Bill Clinton noted the need to fight HIV/AIDS in the U.S. “I am proud that my foundation is partnering with NASTAD and other pharmaceutical manufacturers to make sure Americans living with HIV have access to the life-saving medications they need,” said President Clinton. “This E-NEWS | is an important step forward in our fight against the disease.” ViiV Healthcare is the first pharmaceutical company to support the program with HIV/AIDS medications and funding. The goal of HarborPath is to get all HIV/AIDS medications into the program and serve uninsured individuals with: n An easy-to-use website with a single portal to determine eligibility for the program and to fill prescriptions for participating companies’ HIV/AIDS medications. n Automatic notifications for both the individual and the case manager of qualification for the program. n A pharmacy that ships a 3-month supply of all participating medications in one package within two business days of final approval and confirms delivery of the medications. n Renewal reminders to individuals and case managers to improve medication adherence. n A fully automated portal that case managers can access at any time for up-to-the-minute status of an individual’s application or shipment. If needed, live support is also available through a toll-free call center. Murray Penner, Deputy Executive Director at NASTAD, said, “Under the current PAP process, an individual or their case manager has to apply separately to each company’s program for these medications, which can be complex and time-consuming. Missing doses or failing to fill prescriptions because of complications sometimes associated with these processes may result in serious health consequences, or even death, in addition to increased transmission of the virus. HarborPath is designed to address this urgent need in the U.S.” Sign up for the weekly email newSletter of poSitively aware. go to positivelyaware.com Studies find once-daily ‘Quad’ is safe and effective The findings of two large international randomized studies published in The Lancet medical journal indicate that the new once-daily pill combining three antiretrovirals and a booster molecule is a safe and effective alternative to two widely used drug regimens for newly diagnosed Hiv-positive adults who have had no previous treatment. The study results also indicate that the new “Quad” pill is faster acting, doesn’t have the neuropsychiatric side effects associated with other combinations, and could improve compliance with treatment. “Patient adherence to medication is vital, especially for patients with HIV, where missed doses can quickly lead to the virus becoming resistant to medication. Older HIV treatment regimens involve taking several pills multiple times a day,” explains Paul Sax from Brigham and Women’s Hospital, Harvard Medical School, lead author of the first study. “Our results provide an additional highly potent, well-tolerated treatment option, and highlight the simplicity of treatment resulting from combining several antiretrovirals in a single pill. Studies have shown that single pill treatments improve both adherence and patient satisfaction, and help prevent prescription errors, thereby reducing the likelihood of treatment failure and drug resistance.” The first study randomly assigned 700 patients from centers across North America to start treatment with two different single tablet regimens—either the Quad, combining the new integrase inhibitor elvitegravir (EVG) boosted with cobicistat (a new pharmacoenhancer; COBI) plus emtricitabine/tenofovir (Emtriva/Viread), or Atripla (efavirenz/ emtricitabine/tenofovir), the current gold standard regimen approved by the FDA in 2006. After 48 weeks of treatment, 88% >> POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 15
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