Ethical Allocation of Preexposure HIV Prophylaxis

Abstract

CIVIL SOCIETY–LED MOVEMENTS TRANSFORMED GLOBAL AIDS action from deep skepticism about extending antiretroviral (ARV) treatment in lowand middle-income countries to a historic scaling up of treatment toward universal access. During its first phase (2003-2008), the US President’s Emergency Plan for AIDS Relief (PEPFAR)—the largest national commitment to combat a single disease—supported treatment for more than 2 million people, care for more than 10 million people, and prevention of mother-to-child transmission in 16 million pregnancies. The Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), a unique international financing institution, has committed $19.3 billion in 144 countries to support large-scale prevention, treatment, and care, with most resources devoted to AIDS treatment. The AIDS movement, however, is at an inflection point due to the interplay of key health and economic determinants—the global financial downturn, tight foreign aid budgets, and intense resource competition. Even with historic global engagement, human immunodeficiency virus (HIV) treatment is insufficient in resource-poor settings. Although 5.2 million individuals currently receive treatment for HIV infection, 10 million more are in immediate need and 64% of those in need live in lowand middle-income countries. PEPFAR’s fiscal-year 2011 budget proposes only a 2% increase, which will result in future treatment enrollment freezes and a growing waiting list among 14 million treatment-eligible individuals. Similarly, Global Fund pledges reached only $11.7 billion for 2011-2013, failing to meet the fund’s lowest “austerity-level” target of $13 billion—the amount needed to sustain current treatment rates. A report by the Institute of Medicine concluded that because treatment can only reach a fraction of those in need, it is “not sustainable for the foreseeable future.” Policy makers will now have to consider implementing a new intervention, ie, preexposure prophylaxis (PrEP). Recent studies suggest that PrEP could mean a shift of ARVs from treatment to prevention. For instance, the iPrEx study found that men who have sex with men (MSM) taking tenofovir/emtricitabine were 44% less likely to become infected with HIV than those taking a placebo. The CAPRISA 004 trial (a proof-of-concept study) found that vaginal tenofovir disoproxil fumarate gel reduced the risk of contracting HIV by 39%, and the CDC 4323 study (an extended safety study) confirmed that oral tenofovir disoproxil fumarate was safe for use as PrEP in MSM. Although it will take several years to fully establish the clinical efficacy of PrEP in varying populations, these encouraging early results have accelerated global dialogue on its proof of deliverability.