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

Price should not be a barrier when there is the opportunity to provide a significantlyimproved drug regimen. In addition, costs must be reduced over time through theentry of multiple manufacturers and through increased volume of demand. We alsoneed a revision in calculations of the cost of scaling up access to treatment so thatcountries do not have to choose between rationing first-line treatment with a moreexpensive regimen or continuing to use a cheaper combination with more toxic sideeffects. People living with HIV/AIDS and civil society should be involved with debateover the trade offs and in the decision making process at country level.In China, the lack of fixed-dose combinations (FDCs) for first-line treatment andthe slow introduction of lamivudine (3TC) as part of the national free ARV programhas sometimes resulted in non-standard combinations being used, such as suchas didanosine (ddI) + stavudine (d4T) + nevirapine (NVP) (not recommendeddue to excess toxicity). This situation arose because of GlaxoSmithKline’s patentmonopoly on 3TC in China and the high price the company charged; it remains aproblem because of the Chinese government’s reluctance to approve generic FDCscontaining 3TC, even after the Glaxo patent expired in October 2006.The high price of efavirenz reported in the Dominican Republic and China, thistime due to a patent monopoly by Merck, is a barrier to access. Identifying ways tointroduce competition and lower prices, such as through compulsory licensing forefavirenz, 3TC, and other products, should be an important priority.Second-line treatmentThe revised WHO guidelines also contain new preferred options for standardizedsecond-line treatment built around a ritonavir-boosted protease inhibitor such asheat-stable lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r). (The price ofATV/r is eventually expected to be 40-60% less than LPV/r, according to the ClintonFoundation). Currently, high prices, patent barriers, and registration delays allcomplicate access to such products.For most countries in this sample, tenofovir and abacavir (where available) are onlyused for second-line treatment.Recommendations:The new WHO guidelines for optimized first-line treatment and standardizedsecond-line treatment will be a useful tool for improving treatment safety andquality, but also for increasing demand for certain preferred but underutilizedmedicines, providing an incentive to generic manufacturers to increase productionand reduce prices for these drugs. Until then, because of high prices, patentbarriers, lack of competition, registration barriers, and lack of information aboutoptions among policy makers, clinicians, and people living with HIV/AIDS, manycountries are likely to continue using sub-optimal combinations.9