HIV/AIDS in Ethiopia: - Clinton Health Access Initiatives

HIV/AIDS in Ethiopia:The Clinton Health Access Initiative and UNITAID

HIV/AIDS in Ethiopia:The Clinton Health Access Initiative and UNITAIDAugust 2011CLINTON HEALTH ACCESS INITIATIVEP.O. Box 3297 Code 1250Addis Ababa, EthiopiaTel: +251 11 416 69 93Tel: +251 11 416 69 95© 2011 Clinton Health Access Initiative

table of contentsAbbreviations and Acronyms........................................................................................................iExecutive Summary.........................................................................................................................1Introduction.......................................................................................................................................3i) CHAI: A new model for philanthropy....................................................................................3ii) UNITAID: A new model for global health................................................................................4iii) Ethiopia: HIV/AIDs Landscape...............................................................................................5iv) The Relationship: CHAI-Ethiopia & UNITAID....................................................................6Initiative 1: Pediatric Antiretroviral Scale Up.......................................................................7Initiative 2: Adult 2nd Line Antiretroviral Scale Up..........................................................13Initiative 3: Ready-to-Use Therapeutic Food (RUTF).......................................................19Initiative 4: Lab and Diagnostics.............................................................................................23The Future of CHAI/UNITAID in Ethiopia...............................................................................29Acknowledgments.........................................................................................................................29ABBREVIATIONS and acronyms3TC LamivudineABC AbacavirART Antiretroviral therapyARV AntiretroviralsAZT ZidovidineCHAI Clinton Health Access Initiatived4T StavudineDBS Dried Blood SpotDNA-PCR Deoxyribonucleic Acid-Polymer Chain ReactionEHNRI Ethiopian Health and Nutrition Research InstituteEID Early Infant DiagnosisFDC Fixed Dose Combination drugsFHAPCO Federal HIV/AIDS Prevention and Control OfficeFMOH Federal Ministry of HealthHIV/AIDS Human Immunodeficiency Virus/Acquired Immunodeficiency SyndromeICAP International Center for AIDS Care and Treatment ProgramLPV/r Lopinovir/ritonavirMSH Management Sciences for HealthODA Official Development AssistanceOI Opportunistic InfectionPFSA Pharmaceutical Fund and Supply AgencyPMTCT Prevention of Mother to Child Transmission of HIVRHB Regional Health BureauRUTF Ready to Use Therapeutic FoodSAM Severe Acute MalnourishmentSCMS Supply Chain Management SystemsSMS Short Message ServiceSNNPR Southern Nations and Nationalities People’s RegionTDF Tenofoviri

EXECUTIVE SUMMARYSince the turn of the century, the global ecosystem of world’s most studied disease—HIV/AIDS—has experienced vital transformation. Motivated in no small part by generous increasesin disease-specific official development assistance (ODA) and a re-committed focus by worldleaders, major advancements in the fight to control HIV/AIDS have begun to take hold. InEthiopia, these transformations have produced deep and widespread changes in the nationallandscape of public health.Playing a major role in combating HIV/AIDS in Ethiopia are newly emergent internationalactors who, despite ever-increasing budget tightening and global financial uncertainty, havedeveloped innovative ways to finance solutions to some of our generation’s greatest globalhealth challenges. No better organization fits this description than UNITAID. Arising from anunwavering commitment to develop unique and innovative financing solutions to combatHIV/AIDS, malaria and tuberculosis, UNITAID has provided over $1.5 billion in health funding,effectively treating nearly 50 million people throughout 94 countries worldwide. 1In Ethiopia alone, UNITAID—in collaboration with The Clinton Health Access Initiative—hasfunded the procurement of nearly $15 million USD worth of HIV/AIDS commodities betweenJune 2007 and May 2011. This report is a summary of the progress made in the diagnosis andtreatment of HIV/AIDS in Ethiopia with the contribution of those funds.develop new guidelines for the use of ready-tousetherapeutic food (RUTF)—more commonlyknown as Plumpy’nut. Starting in 2009, RUTFwas fully incorporated into the Ethiopia’spharmaceutical supply and distribution system.LABORATORY SERVICESLaboratory Services coordinates with theEthiopian Health and Nutrition ResearchInstitute (EHNRI) to implement programsaimed at improving the quality of the nation’slaboratory system. The SMS Printer Projectis an example of such an initiative. Piloted in2009 with funding from UNITAID, SMS printersimprove patient care by expediting test resultsfrom central labs to rural health facilities.Currently, 25 health facilities are equipped withthe new technology. The pediatric HIV testinginitiative known as Early Infant Diagnosis (EID)is another laboratory program facilitated byCHAI and funded by UNITAID with operationsin health facilities nationwide. By scaling upcapacity in the EID program—1,840 tests wereperformed in 2007 and 24,500 are estimatedto be performed in 2011—thousands ofotherwise-undiagnosed Ethiopian children areable to receive essential ARV treatment. 3SUMMARY OF UNITAID COMMODITY FUNDING * CHAI and UNITAID in Ethiopia 2Since the launch of the CHAI/UNITAID Pediatricantiretroviral therapy (ART) program in 2007,Ethiopia has experienced a 486% increasethe number of children receiving therapy.This equates to over 14,000 HIV positivechildren receiving ART today. On a globalscale, CHAI/UNITAID initiatives have led to thedevelopment of fixed-dose combination drugs(FDCs) for pediatric ART. Quickly adoptedand recommended as the primary method ofpediatric treatment by the Ethiopian FederalMinistry of Health (FMoH), FDCs offerednumerous advantages over existing syrupformulations, showing marked improvementin patient compliance and distribution. Today,full access to free pediatric ART is providedthroughout Ethiopia.1SUMMARY OF PROGRAM ACCOMPLISHMENTSpediatric ARV SCALE UPAdult 2nd line ARV SCALE UPIn 2007, the price of 2nd line ART regimenswere roughly 10 times more expensive than1st line therapies. As 1st line treatmentpopulations grew and patients continuedto live longer, so, too, grew the demand for2nd line ART. By addressing inefficiencies inthe relatively nascent-stage 2nd line therapymarket, in less than five years, CHAI/UNITAIDeffectively reduced the annual cost of treatingpatients with a combination of Tenofovir (TDF),Lamivudine (3TC) and Lopinovir/ritonavir (LPV/r)—a popular 2nd line ART regimen—by over50%. 2Ready-to-use therapeuticfoodChild malnutrition is a major public healthconcern in Ethiopia. In an effort to improveexisting treatment programs for HIVpositive children suffering from severeacute malnutrition (SAM), CHAI/UNITAIDcollaborated with the Ethiopian government toSource: 1 UNITAID; 2 2007 WHO GPRM pricing for Low Income countries and 2011 lowest UNITAID pricing; 3 EHNRIINITIATIVE 2007 2008 2009 2010 2011 GRAND TOTAL PEDIATRIC ART $819,791 $1,921,518 $1,095,899 $1,720,731 $464,022 $6,021,961 2ND LINE ADULT ART $543,482 $1,041,223 $1,644,007 $555,657 $0 $3,784,369 RUTF $215,824 $1,373,404 $934,950 $498,525 $0 $3,022,703 LAB & DIAGNOSTICS $122,281 $360,299 $478,519 $852,383 $143,024 $1,956,506 $1,701,378 $4,696,444 $4,153,375 $3,627,296 $607,046 $14,785,539 UNITAID CONTRIBUTION BY PROGRAMPEDIATRIC ART 2ND LINE ART LAB & DIAGNOSTICS RUTF * The stated number reflects commitments for products purchased in the noted budget year. Actual paymentsagainst orders are made as products are delivered, so some payments will be made in the following year.

CHAIA NEW MODEL FOR PHILANTHROPYUNITAIDA NEW MODEL FOR FUNDING GLOBAL HEALTHThe Clinton Health Access Initiative (CHAI)was launched in 2002 by President Clinton asthe Clinton HIV/AIDS Initiative to address theHIV/AIDS crisis in the developing world andto strengthen health systems there. Takingthe lead from governments and working withpartners, CHAI has improved markets formedicines and diagnostics, lowered the costsof treatments, and expanded access to lifesavingtechnologies — creating a sustainablemodel that can be owned and maintainedby governments. CHAI has since expandedthis model to increase access to high-qualitytreatment for malaria, accelerate the rolloutof new vaccines, and lower infant mortality.CHAI-ETHIOPIASince the establishment of a country officein 2005, CHAI-Ethiopia has focused on thescale up of quality HIV/AIDS treatment andcare, with special emphasis on improvingthe strength of Ethiopia’s national healthsystem. To achieve these goals, CHAI works atnational and regional levels with the FederalMinistry of Health (FMOH) and RegionalHealth Bureaus (RHBs) to improve andimplement policy. CHAI’s role is to supportthe Government of Ethiopia in achieving itsoverarching goal of advancing healthcarefor all Ethiopians. Pursuing directives bythe Ministry of Health, CHAI-Ethiopia’swork is currently structured into seven coreinitiatives: the Drug Access and NutritionProgram; the Ethiopian Hospital ManagementInitiative (EHMI); the Ethiopian MillenniumRural Initiative (EMRI); the Global HealthFinancing Initiative; the Laboratory ServicesProgram; the Maternal, Newborn and ChildHealth (MNCH) Program; and the VaccinesInitiative. At present over 100 employeeswork for CHAI-Ethiopia nationwide.“Every time I visit Ethiopia, I am amazedat the progress being made, and amreminded of how much we all can do.”~ President Bill Clinton, Founder of theWilliam J. Clinton Foundation and 42nd President ofthe United States“Innovative financing for health, ofwhich UNITAID is a shining example, ismaking a difference not only because itprovides additional funds for our globalwork, but because it represents a newway of doing business in development.”~ Philippe Douste-Blazy, Chairman ofUNITAID“UNITAID, the first laboratory ofinnovative financing, has opened a newway and proved that its mechanismscan help us achieve the MDGs by savinghundreds of thousands of lives eachyear.”~ Ban Ki-moon, Secretary-General of the UnitedNationsFormed in 2006, UNITAID is a global healthinitiative that aims to provide sustainableand catalytic financing for the purchase ofdrugs and diagnostics for HIV/AIDS, malaria,and tuberculosis for people with the greatestneed in developing countries. UNITAIDraises funds from long-term, sustainable andpredictable sources, principally through alevy on airline tickets.UNITAID’s mission is to scale up accessto treatment of HIV/AIDS, TB and malariaby lowering prices of key medicinesand diagnostics, expanding supply, andaccelerating the pace at which commoditiesare made available in developing countries.This is done by identifying marketinefficiencies and underfunded commodityareas and addressing them by providinga large amount of time-limited, catalyticfunding to fill these niches.UNITAID – through its international partners– focuses on three main objectives:• Ensuring affordable and sustainably pricedmedicines, diagnostics and preventionproducts, made available in sufficientquantities and with fast delivery to patients.• Increasing access to safe, effective productsof assured quality.• Supporting development of productstargeting niche markets and specific groups,such as children.UNITAID’s innovative financing model hascommitted over $1.5 billion to global health.Impacting lives in 94 countries, UNITAIDfunds have helped to provide treatment fornearly 50 million people worldwide. 1Source: 1 UNITAID3 CHAI and UNITAID in Ethiopia 4

ETHIOPIAHIV/AIDS LANDSCAPETHE RELATIONSHIPCHAI-ETHIOPIA AND UNITAIDIn Ethiopia, there are currently 1.2 millionpeople living with HIV/AIDS (PLWHA). Ofthose, roughly 760,000 live in urban areas.Comprising 2.4% of the total adult population(ages 15 – 49 yrs), the prevalence of HIV islower than many countries in sub-SaharanAfrica. Notwithstanding, the disease stillinflicts a substantial burden on the localway of life—at present, nearly 400,000PLWHA require antiretroviral therapy. 1Ethiopia’s size in population and landmass,ethnic diversity, economic productivityand resource availability create immensechallenges for treating HIV/AIDS.Geographically, Ethiopia is the eighthlargest country in Africa and its populationof approximately 90 million people—comprised of over 80 different ethnicgroups—makes it the second most populouscountry in sub-Saharan Africa. The countryis divided into nine ethnically based regionalstates and two city administrations,which are further separated into 103zones, 800 woredas (districts) and 15,000kebeles (communities). The vast majorityof Ethiopians live in rural areas and itspopulation is the 9th fastest growing in theworld with an annual growth rate of 2.6%.Ethiopia’s Health Sector DevelopmentProgram (currently in Phase IV) outlined astrategic plan for combating HIV/AIDS, whichhas led to a robust expansion of the existinghealthcare infrastructure and improvedprotocol. While the spread of HIV continuesto grow—over 123,000 adults and 14,000children were newly infected in 2010—theEthiopian government, in collaborationwith myriad partner organizations, havecommitted vast resources in an effort tocurb the spread of the disease and aid inthe plight of those already infected. 2In 2006, CHAI was selected as the leadimplementing partner for UNITAID and begandirecting the procurement and supply ofpediatric and 2nd line HIV/AIDS commoditiesworldwide. Globally, UNITAID-financedand CHAI-implemented HIV programsprovide essential health commodities to 40beneficiary countries. In Ethiopia, the CHAIhas worked closely with the Federal Ministryof Health to increase access to care andtreatment for people living with HIV/AIDS,focusing specifically on two areas requiringspecial attention—pediatric ART scale upand adult 2nd line therapy.Since June 2007, through its Drug Accessand Nutrition program, CHAI-Ethiopia beganprocuring 100% of Ethiopia’s pediatricand adult 2nd line HIV medicines, as wellas a number of additional commoditiesrelated to the diagnosis, treatment andcare of children requiring ART. Thesesupplementary commodities include: Readyto use therapeutic food, (also known by itsbrand name, Plumpy’nut), for the treatmentof severe acute malnourishment in children;Co-trimoxazole, a prophylactic aimed atpreventing opportunistic infections in HIVweakened immune systems; and laboratorydiagnostic equipment, essential in the processof early detection and effective treatment ofHIV/AIDs.UNITAID, procured a total of $14,785,539USD worth of these commodities betweenJune 2007 and May 2011. At the end of2011, CHAI-Ethiopia’s Drug Access andNutrition program will phase out, handingover its activities to appropriate governmentcounterparts and partner organizations.Continued funding for these commoditieshas been secured through The Global Fundto Fight AIDS, Tuberculosis and Malaria.Source: 1 ETHARC 2010 National Factsheet sourcing Single Point HIV Prevalence Estimate, Federal HIV/AIDSPrevention and Control Office (FHAPCO); 2 UNAIDS5 CHAI and UNITAID in Ethiopia6

Initiative 1- Pediatric antiretroviral scale upBACKGROUNDBy the end of 2005, 700,000 HIV positive adults, or 1-in-8 of those in need, were receivingHIV/AIDS treatment in the world. This represented a four-fold increase in coverage from 2001but the worldwide momentum in adult treatment scale up did not translate to the pediatricpopulation. In Ethiopia, despite the introduction of free antiretroviral therapy (ART) services tothe general public in 2005, a similar trend ensued. In the following year alone, approximately30,000 Ethiopian babies were born with HIV, adding to the 43,000 that were already eligiblefor antiretroviral therapy. With limited access to ARVs, less than 3,000 were initiated on ART.Without treatment, the odds were working against these young Ethiopians; estimates show thatnearly 75% of untreated HIV-infected children will die before their fifth birthday. To address thisgap, UNITAID partnered with CHAI-Ethiopia’s Pediatric HIV/AIDS Program in 2006 to acheive arapid, catalytic scale up of pediatric ART. 1>90PERCENT DECREASE IN THEPRICE OF PEDIATRIC ARVS587PERCENT INCREASE IN THENUMBER OF CHILDRENRECEIVING ARVS (2007-2011)PROGRAM ACCOMPLISHMENTSINCREASING ACCESSToday, 100% of the 38.8 million children (age0-14 years 2 ) living in Ethiopia have access toWHO prequalified Fixed Dose Combination(FDC) 1st line ART. Quite remarkably, ittook less than five years for this rather boldobjective of full pediatric ART coverage tobecome reality. And with 85% of Ethiopiansliving in rural areas, providing a highly dispersepopulation of children with access to essentialHIV therapy was certainly no small task. Inorder to develop a supply chain systemcapable of achieving this goal, CHAI-Ethiopiacoordinated with the Ethiopian Government’sPharmaceutical Fund and Supply Agency(PFSA) and Supply Chain Management Systems(SCMS) to establish a fully operational systemof pediatric ARV procurement and supply—one proficient in precise quantification andexpeditious delivery.As CHAI-Ethiopia worked in-country to developthe mechanism in charge of delivering pediatricART, UNITAID’s role was unfolding on a globalscale. With the financial capability to alterexisting markets for pediatric HIV, UNITAIDleveraged its buying power to lower prices ofpediatric drugs, thereby increasing the volumeof available treatment, while simultaneouslydeveloping standards that demanded higherquality medicines and a wider breadth ofSource: 1 ICAP Ethiopia; 2 CIA World Factbook; 3 KidsStattreatment options in the nascent stage marketof pediatric ART. The fruits of these efforts areunmistakable. The fully stocked pediatric HIVsupply chain system operated by PFSA is nowone of the most developed in Africa, effectivelydelivering FDC HIV treatment to each of the11 regions nationwide, reaching thousands ofEthiopian children once left to fight the diseasewithout antiretroviral therapy.pediatric TREATMENT scale up 3A 486% increasein the number ofchildren receivingtreatment2,389 4,492 7,307 10,020 *data taken from january of each year14,019 2007 2008 2009 2010 2011 7 CHAI and UNITAID in Ethiopia8

INCREASING TREATMENT OPTIONS: SYRUPS TO FIXED DOSE COMBINATION DRUGS (FDCs)At the time countries began providing pediatricHIV treatment, pediatric doses of ARVs wereeither limited or, for many formulations anddosages, entirely unavailable. Adult tabletswere often split to form pediatric dosesand the limited formulations available werepredominately in syrup form—a bulky, highvolume, hard to accurately measure and moreexpensive method of dosing. Due to theselimitations, syrups represented challenges notonly monetarily, but also in terms of storage,transport and administration to youngchildren. Fixed Dose Combinations are singlepill formulations of multiple drugs; multiple2-in-1 and 3-in-1 pediatric FDCs have beenquality certified since 2005. Once approvedfor use, protocols recommending FDCs as theprimary method of pediatric treatment wererapidly adopted in more than 30 countries.FDCs offer a major advantage to prescriptionand adherence patterns for pediatric ARVs byreducing the risks of measurement error, dosageinaccuracies and product loss. Crushable anddispersible tablets also simplify administration,and the reduction in volume and weight fromthe older syrup formulations helps patientsmaintain confidentiality regarding their status.By increasing demand, UNITAID funding hashelped bring five new WHO prequalifiedpediatric ARV formulations to market in recentyears. The CHAI/UNITAID partnership hashelped introduce new and improved products,specifically the expedited launch of pediatricFDC ARVs. In early 2008, stavudine (d4T) basedFDCs were introduced in Ethiopia, providing50% of children on first-line treatment withaccess to FDCs. Two years later, when thezidovidine (AZT) based FDC became available onthe global market at the start of 2010, Ethiopiabecame a procurement leader in the sub-Saharan Africa region, promptly introducingthese FDCs to healthcare centers nationwide,thereby providing the other 50% of childrenaccess to FDCs. Altogether, the combinedefforts of the d4t and AZT FDC initiatives haveallowed the CHAI/UNITAID partnership toachieve its primary objective: to provide fullcoverage for pediatric 1st line treatment toevery child in Ethiopia.REDUCING THE COST OF TREATMENTBy aggregating demand for Pediatric ART andacting as a high-volume purchaser, UNITAIDeliminates market inefficiencies, effectivelyreducing the price of medicine and encouragingcompetition. Since 2004, the price of 1st linepediatric ART has decreased 91%.Per Person cost of 1 st line pediatricHIV treatment Regimen 1$600$500$400$300$200$100$0$560$522004 2011ANNUAL UNITAID COMMODITY DONATION: CHAI PEDIATRIC ANTIRETROVIRAL SCALE UP INITIATIVE$819,791 $1,921,518 $1,095,899 $1,720,731 $464,022 $6,021,9612007 2008 2009 2010 2011 totalSource: 1 CHAI (Pediatric Regimen: d4T + 3TC + NVP)9 CHAI and UNITAID in Ethiopia10

STORIES FROM THE FIELDMeet Mekdes and her baby boy, Leelet. Along with Mekdes’husband, the entire family is HIV positive. Visibly concernedwith the health of her family, each month Mekdes faithfullytakes her 1 year and 11 month old son in for his regular pediatricHIV checkup at the health center in Wereillu. Locatedroughly 32 kilometers away from her home in the small villageof Woinamba, the arduous monthly journey through the centralpart of the Amhara region has become a major burden to herfamily—physically, emotionally and financially. “I would like toaccess these services in my village”, Mekdes remarks, “but thisis the closest place to receive medicine. For my son, the trip isworth it.”Unfortunately, Mekdes story is all too familiar in Ethiopia. Withroughly 85% of the population living in rural areas, providingnationwide access to essential health services and medicinecomes with its own unique set of challenges. Due, in part, tothese challenges, there was once a time when lifesaving ARTfor Ethiopian children like Leelet wasn’t available at all in ruralEthiopia. When asked about the changes in pediatric HIV treatmentat the Wereillu health center, Mesfin, the resident pharmacistat the facility over the last four years, stated, “We areno longer faced with interruptions in drug supply. The drugswe now use are better, more tolerable and easier for patientsto take.”Along with improved access to pediatric ART, Mesfin also expressedappreciation for the evolution in HIV treatment fromsyrups to FDCs: “The pills are easier to take than syrups, thereare fewer mistakes in dosing, and they are much easier for thepatients to take home with them.” Mekdes agrees. When Leeletwas born, she would leave the health center with numerousbulky jars of syrups, having not only to deal with the stigma ortransporting them home, but having to remember the differentdosing regimen for three separate medications taken bothmorning and night. Now she receives one small jar of FDC pills,administering one pill to Leelet, morning and night.11 CHAI and UNITAID in Ethiopia12

Initiative 2- adult 2 nd line antiretroviral scale upBACKGROUNDAntiretroviral treatment, once initiated, is a life-long commitment for people living with HIV.Over time, the virus inevitably becomes resistant to the 1st line of prescribed treatment andpatients must move to a newer, more potent class of 2nd line ARV drugs. Unfortunately, at atime when more and more HIV positive patients are requiring 2nd line treatment, the new-tomarketclass of 2nd line drugs remains significantly more expensive than established generic1st line treatments. In early 2007, at the start of the UNITAID/CHAI 2nd line ART scale up, theprice of a 2nd line antiretroviral treatment regimen was roughly 10 times higher than a suitable1st line therapy. Under this type of pricing structure, the ARV treatment cost of a populationdoubles when only 10 percent of patients come to require 2nd line therapy. Recognizing thesituation as untenable, UNITAID and CHAI moved forward with the mindset of altering theexisting pharmaceutical landscape for 2nd line HIV. Putting forward a plan to increase access totreatment in 25 countries, the initiative concentrated on two primary objectives—reducing theprice of 2nd line therapy and increasing the number of suppliers.>50PERCENT DECREASE IN THECOST OF 2ND LINE ARV 13,958ETHIOPIAN ADULTS ON 2NDLINE THERAPY (2007-2010)PROGRAM ACCOMPLISHMENTSREDUCING THE COST OF TREATMENTUnlike the pediatric ARV program, the objectiveof the UNITAID funded and CHAI-Ethiopiaimplemented adult 2nd line ARV initiative was notfocused on placing more patients on treatment.Indeed, the goal of Ethiopia’s nationwide HIVtreatment program is to minimize the numberof patients requiring a switch from 1st to 2ndline ARVs. Notwithstanding, after synthesizingepidemiological data and national protocolsfor ARV treatment, CHAI’s forecasting modelindicated an impending change in the demandfor key 2nd line products as patients migratedin increasing numbers from 1st line to 2nd lineregimens.The need for increased access to 2nd linetreatment was clear; the barrier was price.To overcome this hurdle, the adult 2nd lineARV initiative addressed existing marketinefficiencies, with the intention of minimizingthe cost of treating these patients and enablingsystem-wide savings over time by brokeringsignificant reductions in price. By tappinginto CHAI’s existing global forecasting andquantification system, as well as the existingrelationships formed with governments toplan donations and procurements, UNITAIDcould successfully engage manufacturers of2nd line pharmaceuticals by offering globallycoordinatedbulk purchases that would, ineffect, achieve the overarching objective oflowering prices. Beginning in 2007, UNITAIDfunding served as the impetus to a catalyticshift in the affordability and accessibility ofadult 2nd line ARVs, leading to the followingprice reductions for some of the world’s mostefficacious 2nd line drugs:Tenofovir (TDF) Reduced 63% Abacavir (ABC) Reduced 61% Lopinavir/r (LPV/r) Reduced 20% Note: 1 2007 WHO GPRM pricing for Low Income countries and 2011 lowest UNITAID pricing13 CHAI and UNITAID in Ethiopia14

UNITAID GENERATED PRICE REDUCTIONS IN 2 ND LINE ARV TREATMENTFixed Dose Combina:on (FDC) TDF+ABC+LPV/r Lopinavir/r 200/50mg capsule Abacavir 300mg tablet Tenofovir 300mg tablet $1,151 FDC PRICE REDUCTION:TDF+3TC+LPV/r$965 $204 $447 $500 $75 $174 $396 $645 $728 $654 $579 $492 2006 2011 2006 2007 2008 2009 May 2011 REGIONAL BREAKDOWN OF PATIENTSON 2 ND LINE ARV 1HIV-RELATED MORTALITY IN ETHIOPIA 2100% Somail90%Gambella80%Benshangul70%Afar60%Harari50%DireDawa40%SNNPR30%Tigray20%Oromia10%Amhara0%Addis160,000140,000120,000100,000ADULTSCHILDREN80,00060,00040,00020,00002005 2007 2009ANNUAL UNITAID COMMODITY DONATION: CHAI ADULT 2 ND LINE ANTIRETROVIRAL SCALE UP INITIATIVE$543,482 $1,041,223 $1,644,007 $555,657 -- $3,784,3692007 2008 2009 2010 2011 totalSource: 1 MSH/USAID Data taken Jan 7th - Feb 9th 2011; 2 Federal HIV/AIDS Prevention and Control Office (FHAPCO), 201115 CHAI and UNITAID in Ethiopia16

STORIES FROM THE FIELDThe view from the windows in the Infectious Disease Ward onthe 8th floor of Black Lion Hospital—the largest public hospitalin Ethiopia—can be quite daunting. Clearly visible below aregatherings of the sick and weary, lining walkways by the hundredsas they wait patiently for the opportunity to receive care.Without question, working at Black Lion can be incredibly demanding,but, for those with the commitment to see it through,a rewarding experience as well.One such physician who has chosen to face the daily challengeshead-on at Black Lion Hospital is Dr. Guta Zenebe. As a ConsultantPhysician in the Infectious Disease Ward, Dr. Guta is one ofthe hospital’s resident experts in treating adult patients infectedwith HIV and plays a pivotal role in determining when it’s timefor a patient failing on 1st line medication to be switched to2nd line therapy. Noting the difficulties in diagnosing HIV treatmentfailure, Dr. Guta believes, “It’s not always easy to knowwhen a drug is failing, and when you do, it can be very hardto determine which drug is failing.” Speaking to the fact thatmost patients on HIV therapy are receiving two or three differentARVs, Dr. Guta has seen firsthand the importance of lookingat various indicators of treatment failure, as well as havingnumerous options in one’s arsenal when treating HIV patients.“A number of things go into determining treatment failure. Welook at immunologic failure through CD4 testing, virologic failurethrough viral load, and clinical failure by examining patientresponse. Every patient is different. When you guess, it can bedangerous.”When asked to describe in a word the impact made by CHAI/UNITAID’s 2nd line ARV initiative in Ethiopia, he gave two- “Verysignificant.” remarked Dr. Guta, adding, “The longer patientswith HIV continue to live, the greater the need for 2nd linetreatment. Without it, many more could die.”17 CHAI and UNITAID in Ethiopia18

Initiative 3- Ready-To-USE Therapeutic Food (RUTF)BACKGROUNDChildhood malnutrition is a major public health concern throughout the developing world.Recent estimates indicate that malnutrition is an underlying factor in over 50% of the 10 milliondeaths from preventable causes in children under the age of five each year. Additionally, thetreatment of HIV-positive children is frequently complicated by high rates of acute malnutrition.Worldwide, severe acute malnutrition (SAM) affects 19 million children under five, resulting inat least 1-2 million deaths annually. 1CHAI-Ethiopia pioneered the use of ready-to-use therapeutic foods (RUTF) for the treatment ofHIV-positive children with SAM in 2007. A fortified paste that tastes like peanut butter, RUTF’sease of caretaker administration and palatable flavor for children has made treatment possiblein the home, rather than exclusively in specialized health facilities. Today, CHAI/UNITAID isthe third largest buyer of RUTF globally and has helped to increase the number of companiessupplying the product locally, helping to reduce product costs and create a more competitive,high-quality marketplace in a number of African countries.PROGRAM ACCOMPLISHMENTSA NEW SOLUTION FOR TREATING SEVERE ACUTE MALNUTRITION IN ETHIOPIA500CALORIES OF NUTRITION INONE SACHET OF PLUMPY’NUT251,539TOTAL NUMBER OF ETHIOPIANPLWHA QUALIFYING FOR RUTFBy working with the Ethiopian government todevelop policy and treatment guidelines forRUTF, CHAI-Ethiopia is facilitating increaseddemand for a revolutionary new way to combatSAM in children. Partnering with UNITAIDto scale up the RUTF (Plumpy’nut) Programthroughout the country, Save the Children US(Save US) and CHAI-Ethiopia have collaboratedsince mid-2007 by supporting Ethiopia’snational Community-based Therapeutic CareProgram in the treatment of SAM. Save US hasoperated as the implementing partner, which,in part, has entailed the delivery and trainingof healthcare professions, as well as programoversight and the provision of treatment inboth outpatient and inpatient clinical settingsthroughout Addis Ababa, Oromia, and DireDawa. CHAI-Ethiopia has supported Save USthrough the quantification and procurement ofRUTF for use in Save US-supported sites, whilealso providing technical program assistance byperforming periodic site visits, assisting withmonitoring and evaluation, and completingannual program reports since 2008.In early 2009, access to Plumpy’nut in Ethiopiagrew as the product was incorporated intoPFSA’s regular distribution system. At present,over 60 healthcare sites are supplied—theOromia Region being the largest recipient—with Plumpy’nut nationwide. As a result ofintegrating RUTF into the nation’s existingpharmaceutical supply chain, CHAI-Ethiopia’sNutrition Program was able to quickly respondto the country’s food crisis in 2009 by securingadditional funds and matching the previousyear’s donation of 85 metric tons of Plumpy’nutto the FMOH within two weeks of the originalrequest.ANNUAL UNITAID COMMODITY DONATION: CHAI READY-TO-USE-THERAPEUTIC FOOD (RUTF) INITIATIVE$215,824 $1,373,404 $934,950 $498,525 -- $3,111,1952007 2008 2009 2010 2011 totalSource: 1 Clinton Foundation website19 CHAI and UNITAID in Ethiopia20

STORIES FROM THE FIELDAs a pediatric HIV specialist overseeing 25 health centersthroughout Addis Ababa, Dr. Meseret Gebre certainly has herwork cut out for her. Formerly a Pediatrician at ALERT Hospital—oneof Ethiopia’s foremost centers for pediatric HIV treatment—Dr.Meseret was drawn to helping HIV positive childrenearly on in her medical career, and has played an important rolein the scale up of pediatric HIV treatment in Ethiopia. Takingpride in the progress already made, she was proud to say that“In the beginning, a total of 48 children were on treatment inall the Regional Health Centers combined. Now there are over3,000 on care. The program has really grown.”While Dr. Meseret will be the first to speak to the significanceof ARVs in the treatment of pediatric HIV, she also recognizesthe importance of numerous other components, such as diet,to the health of an infected child. “When we see malnourishedchildren with poor metabolism, often times they won’t be ableto tolerate the medicine. It’s very difficult to treat a child likethat.” Seeing the importance in getting malnourished childrenup to a healthy bodyweight, Dr. Meseret is a strong proponentof Ethiopia’s budding RUTF program. “For acute malnutritionin children over six months of age, I recommend between 1.5and 6 sachets of Plumpy’nut per day,” she remarks, “and oncethey begin treatment, you can see the child develop; you cansee they have more energy.”Once a child reaches an acceptable bodyweight, Dr. Meseretdiscontinues the use of RUTF therapy, but continues to monitorthe child’s weight carefully. In this way, RUTF serves a medicalpurpose for her patients and is not used as a food substitutein otherwise healthy children. Knowing all too well thedeleterious effects that malnourishment can have on children,RUTF has become an integral component in her practice, asshe strives to provide her young patients with the very best intreatment and care.21 CHAI and UNITAID in Ethiopia22

Initiative 4- laboratory servicesBACKGROUNDStarting in 2005, CHAI-Ethiopia implemented its first health access initiative by providinglaboratory services support to the Ethiopian Health and Nutrition Research Institute (EHNRI).Initially given the responsibility of providing technical assistance to Ethiopia’s emerging ARTmonitoring program for HIV treatment and care, over time the program grew, and in 2007—atthe request of the Ethiopian FMOH—CHAI-Ethiopia’s Laboratory Services program was born.CHAI-Ethiopia’s Laboratory services team plays an important, gap-filling role in strengtheningthe nation’s healthcare laboratory system from the central level. Primary aims of the initiativeinclude laboratory systems quality improvement through capacity building within thegovernment, technical assistance through human resource support and allocation, introductionof new technologies and global partnerships for shared knowledge and best practices.PROGRAM ACCOMPLISHMENTS>500HEALTH CENTERS PROVIDEEARLY INFANT DIAGNOSIS (EID)NATIONWIDE>30,000HIV-EXPOSED INFANTS HAVERECEIVED EID SERVICESLEVERAGING TECHNOLOGY TO DELIVER RESULTS FASTER: THE SMS PRINTER PROJECTIn Africa, the advent of the new millenniumbrought with it a technology that is therevolutionizing the continent—the mobilephone. As advancements in mobile healthcontinued to emerge, CHAI-Ethiopia activelypursued opportunities to leverage newtechnology to improve health outcomes. In2009, with the financial backing of UNITAID,the SMS Printer Project was piloted in Ethiopia.Originally, the pilot program was launchedin four health facilities and one regionallaboratory. The technology was first utilizedfor early infant diagnostics (EID); over 70 resultswere evaluated and transmitted via SMS. Aftera successful trial-run, EHNRI approved a scaleup of the program—today, SMS Printers delivertest results in 25 health centers nationwide.Led by EHNRI, the project is highly collaborative;numerous actors, including Regional HealthBureaus and the South African NationalHealth Laboratory Services—the team thatfirst introduced the technology—have cometogether to support this new and potentiallytransformative health innovation. Throughthe use of mobile phone based technology,the SMS printer is used to convey the resultsof important laboratory tests from highlytechnical, centralized labs to patients in ruralhealth facilities. The technology has led toenhancements in patient care as substantialreductions in turnaround time have beenrealized when labs are testing DNA-PCR for EIDand liquid culture for tuberculosis. Dependingon the type of testing performed, the SMSprinter program has expedited the delivery ofresults by one to seven weeks.23 CHAI and UNITAID in Ethiopia24

EARLY INFANT DIAGNOSIS AND DRY BLOOD SPOT TESTINGIf left undiagnosed, half of all HIV-positivechildren will die before their second birthday.Recognizing the importance of knowing thestatus of HIV-exposed infants, the Early InfantDiagnosis (EID) program, funded by UNITAIDand managed by CHAI-Ethiopia’s LaboratoryServices team was started in 2007. Playing apivotal role in the Pediatric HIV/AIDS Programby helping to scale up treatment, over 30,000tests have been performed since the program’sinception, allowing thousands of otherwiseundiagnosedchildren the opportunity toreceive essential antiretroviral therapy.Unlike rapid HIV testing for adults, diagnosinginfants presents with its own unique set ofchallenges. Because exposed infants carry theirHIV-positive mother’s antibodies, conventionaltesting will often lead to a false HIV-positivediagnosis. Avoiding this error requires theuse of a highly-specialized laboratory test notwidely available in developing countries knownas DNA-PCR. To perform the test, centrallaboratories use blood samples taken frominfants via a process called Dry Blood Spotcollection (DBS). While DBS collection is simpleto administer on a clinical level—a small prickon the base of an infant’s foot will suffice—the process of testing DNA-PCR in the lab ismore complex. To ease implementation andmitigate error throughout, the CHAI-Ethiopiateam has packaged all the required diagnosticsupplies into what are known as “DBS bundles”and “Laboratory Consumable bundles”.Improving the materials, specifications andquality standards of these bundles has been ofpinnacle importance to CHAI throughout thelifespan of the project.The CHAI/UNITAID partnership recognizes theimportance of taking a holistic approach tolab development in Ethiopia. Working closelywith EHNRI, the Laboratory Services teamcontinues to build capacity in the EID programby improving access to essential diagnostictools and integrating higher quality standardsinto laboratory protocol. Since establishment,the program’s primary objective remainsthe same: to provide a catalytic scale up ofEID through the development of centralizedforecasting, procurement and distributionmechanisms in hopes that someday operationswill be managed entirely at a national level, thusensuring nationwide access to vital HIV/AIDsdiagnostic services for the next generation ofEthiopian children.EARLY INFANT DIAGNOSIS SCALE UPLABORATORY TESTING SUPPLY SCALE UP 1 184060000245005000040000300001300020000100004330700002007 2008 2009 2010 20112007 2008 2009 2010 2011*AMPLICOR TESTS DBS TESTS LAB CONSUMABLE TESTS *ProjectedANNUAL UNITAID COMMODITY DONATION: CHAI LABORATORY SERVICES INITIATIVE$122,281 $360,299 $478,519 $852,383 $143,024 $1,956,5062007 2008 2009 2010 2011 totalSource: 1 EHNRI25 CHAI and UNITAID in Ethiopia26

STORIES FROM THE FIELDIn Ethiopia, achieving nationwide access to medicines for pediatricHIV is only half the battle—literally. “Diagnosing HIV hasbeen a big challenge”, says Dr. Solomon Memire of ColumbiaUniversity’s International Center for AIDS Care and TreatmentProgram (ICAP), “In Ethiopia, we provide free ART, but only52% of HIV positive children are on treatment. Identifying theinfected in high-risk populations is necessary if we are to moveforward.”The statistics do not lie. Without a fully operational lab diagnosticsprogram, government-managed warehouses filled withART are unable to provide potentially lifesaving therapy to childrenrequiring treatment. As one of the men working on thefrontlines of HIV/AIDS in Ethiopia, Dr. Solomon has watched asparticipation in HIV therapy has grown through the developmentof new drug regimens and streamlined administrationprocedures that have improved palatability and adherence. Henow looks to progressive diagnostic programs such as EID andpreventative measures such as PMTCT to originate future gainsin the treatment of HIV. “PMTCT and EID will increase pediatricenrollment”, he notes, “currently, we have six regional labsand one central lab performing 850 EID tests per month. A fewyears ago, we didn’t have this kind of capacity.”It is the belief of public health leaders like Dr. Solomon that asmore Ethiopian healthcare workers are trained to perform diagnosticprocedures and capacity for laboratory testing continuesto rise, so too will the participation rates in Ethiopia’s pediatricHIV treatment program. Providing ARVs to HIV positivechildren was integral to the initial phase of pediatric HIV treatmentscale up; bringing new approaches to prevention and diagnosisinto the fold is key to advancement in the future.27 CHAI and UNITAID in Ethiopia28

THE FUTURE OF CHAI/UNITAID IN ETHIOPIASince inception, the UNITAID scale up of HIV-related commodities in Ethiopiawas designed to be time-limited. As Ethiopia’s HIV treatment capabilities continue togrow, the UNITAID financing model will move forward, channeling funds towards strategicgaps in access in a new generation of developing healthcare markets. By the end of 2011, allHIV related commodities procured by UNITAID donations will be transitioned to funding fromThe Global Fund to Fight AIDS, Tuberculosis and Malaria. CHAI will continue to support theGovernment of Ethiopia in its mission to strengthen the national health system and achieve itsoverarching goal of advancing healthcare for all Ethiopians.ACKNOWLEDGMENTSThis report is dedicated to the Federal Ministry of Health in the Ethiopian government,UNITAID and all CHAI staff who have contributed to the achievements described in thesepages. All photos of President Clinton are courtesy of the Clinton Foundation.Federal Ministry of HealthCLINTON HEALTH ACCESS INITIATIVEP.O. Box 3297 Code 1250Addis Ababa, EthiopiaTel: +251 11 416 69 93Tel: +251 11 416 69 95© 2011 Clinton Health Access Initiative29