Missing the Target #5: Improving AIDS Drug Access ... - CD8 T cells

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MalawiBy Lot Nyirenda and Grace BongololoCommonly used ARVs in MalawiThe four most commonly used ARV regimens in Malawi includetenofovir (TDF), efavirenz (EFV), lopinavir/ritonavir (LPV/r, asKaletra capsules), and fixed-dose Triomune (stavudine [d4T]+lamivudine [3TC]+ nevirapine [NVP]). These medicines are currently used forchildren and adults in first- and second-line regimens. Emtricitabine (FTC)and Atripla (a fixed-dose combination of efavirenz [EFV] + tenofovir [TDF] +emtricitabine [FTC]) are not used in Malawi. Ritonavir (r), meanwhile, is onlyavailable as part of FDCs.According to the MoH 1 , the Triomune FDC is the usual first-line regimen.Alternative first-line regimens are available as well. One such alternative, consistingof zidovudine (AZT) + lamivudine (3TC) + nevirapine (NVP), is usually providedto patients who experience side effects stemming from stavudine (such as severeperipheral neuropathy, pancreatitis, and lactic acidosis/lipodystrophy syndrome).Patients who experience nevirapine-related side effects (such as skin reactions andhepatitis) may use yet another alternative first-line regimen: stavudine (d4T) +lamivudine (3TC) + efavirenz (EFV).The available second-line regimen for adults consists of zidovudine (AZT) +lamivudine (3TC) + tenofovir (TDF) + lopinavir/ritonavir (LPV/r). Children,meanwhile, have access to didanosine (ddI) + abacavir (ABC) + lopinavir/ritonavir(LPV/r) as a second-line regimen.Cost of ARVsThe cost per patient per month of first-line regimens varies from $12 (suppliedby Hetero) to $18 (supplied by Cipla). In addition, Cipla supplies all second-lineregimens. Second-line regimens cost $20 per patient per month.Drug procurementThe UN Children’s Fund (UNICEF) has overseen procurement since Global Fundstarted supporting the roll-out of free ARVs in Malawi. The organization will nolonger be the automatic choice in the future, however, in light of the exorbitant1 As cited in the Ministry of Health’s 2006 publication, “Treatment of AIDS: Guidelines for use ofantiretroviral therapy in Malawi, 2nd edition.”77
prices it charges for handling drug procurement and distribution. Current planscall for the World Bank to advertise for a procurement entity and for a tenderingprocess to follow.There are official guidelines in Malawi as to which ARVs and combinationsto prescribe. However, some private institutions are allowed to use differentcombinations as long as the drugs are certified by the Pharmacy, Medicines andPoisons Board, a government regulatory body.Drug registrationMalawi uses Global Fund money to purchase ARVs and all drugs used in publichospitals must be WHO-certified. This means that the procurement entity(currently UNICEF) cannot purchase and supply ARVs that have not passed WHO’sprequalification process.There have been problems related to this requirement. In 2004, for example, WHOde-listed some ARVs from Ranbaxy because of improper bioequivalence testing.That occurred after UNICEF had already purchased a large supply of the affectedmedicines. UNICEF subsequently was forced to identify an alternative supplierand chose Cipla—and then had to wait for nearly six months for the replacementmedicines to arrive. Fortunately, at the time Malawi had just started rolling out thefree ART program and only a small number of patients had initiated treatment.Since then, there have been no reports of service providers facing problems relatedto drug registration.Originator vs. generic drugsMALAWIDrugs from originator firms do not come as complete regimens in FDCs (Atripla, forexample, is currently unavailable in Malawi). That means patients may need to takeup to three separate tablets at a time. In contrast, several generic producers supplyan entire three-drug regimen in a single tablet. Triomune, the most commonlyprescribed first-line regimen in Malawi, is an FDC. Because they are easier to take,single-pill combinations are known to promote adherence and thus decrease therisk of developing resistance. They are also cheaper and facilitate easier stock andprocurement management, two other important reasons they are widely recognizedas a core element in efforts to scale up ART in developing countries.Malawi’s emphasis on using generic drugs has allowed more people to be on ART.It is estimated that if it were restricted to using originator drugs, Malawi could onlyhave put around 25,000 people on ART by 2008. However, with generic drugs,at least 120,000 are currently on ART in Malawi. That is still short of meeting thetotal estimated need of about 170,000 individuals (as of October 2007), but it doesappear that Malawi is on the right track.78
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Missing the Target #5:Improving AID
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ArgentinaDr. María Lorena Di Giano
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Executive SummaryAt the G8 meeting
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• UN agencies should provide incr
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Price should not be a barrier when
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The Global Fund and UNITAID: The Fu
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The real cost of free treatmentBy a
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Remaining work for asuccessful prog
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DOMINICAN REPUBLICto access rapid t
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DOMINICAN REPUBLICIn Santo Domingo
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ZIMBABWEtreatment, representing 35
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ZIMBABWEAccording to the Medicines
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ZIMBABWEZimbabwe’s application fo
Page 34 and 35: ZIMBABWENational government• Addr
Page 36 and 37: RUSSIAMigrantsRussia, with the seco
Page 38 and 39: a person with HIV will die very qui
Page 40 and 41: FamiliesIn Kenya, families are the
Page 42 and 43: INDIA2. Provide pediatric formulati
Page 44 and 45: Linking nutrition and treatmentBy W
Page 46 and 47: Most people living with advanced HI
Page 48 and 49: only available in the capital, Yaou
Page 50 and 51: ZAMBIAFindings in particular provin
Page 52 and 53: The DACA for Chadiza District was a
Page 54 and 55: Many health care workers are inadeq
Page 56 and 57: DRUG REGISTRATION BARRIERS & LOGJAM
Page 58 and 59: Country ATV RLPV/rLPV/r(HS)TDFArgen
Page 60 and 61: development and registration. Likew
Page 62 and 63: Capacity issues and delays in the W
Page 64 and 65: Lack of post-approval quality assur
Page 66 and 67: ARV PROCUREMENT, REGISTRATION,AND S
Page 68 and 69: ARGENTINAParallel importingRelating
Page 70 and 71: ARGENTINAAccess to ARVsNo difficult
Page 72 and 73: Viral load tests are available, but
Page 74 and 75: Cambodiaby Mony PenOnly pharmacists
Page 76 and 77: ChinaBy anonymous Missing the Targe
Page 78 and 79: CHINAThe current process for regist
Page 80 and 81: Dominican RepublicBy Eugene Schiff
Page 82 and 83: IndiaBy Abraham KK, Celina D’Cost
Page 86 and 87: MALAWIStock-outsAccording to an ext
Page 88 and 89: MoroccoBy Othman MelloukMorocco has
Page 90 and 91: Determine the patent status of all
Page 92 and 93: MOROCCOThe shortage occurred becaus
Page 94 and 95: As of November 2007, the unit cost
Page 96 and 97: NIGERIADiagnostic testsDiagnostic t
Page 98 and 99: The government’s initial inabilit
Page 100 and 101: Increase training and capacity buil
Page 102 and 103: treatment practice. The Minster ann
Page 104 and 105: Ugandaby Richard Hasunira, Prima Ka
Page 106 and 107: UGANDAExtracts from the MoH’s rep
Page 108 and 109: ZAMBIAIn gathering this information
Page 110 and 111: However, since manufacturing prices
Page 112 and 113: 105SHORT SUMMARY
Page 114: PAKISTANAccess for marginalized gro
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