Ethical Allocation of Preexposure HIV Prophylaxis

Civil society-led movements transformed global AIDS action from deep skepticism about extending anti-retroviral (ARV) treatment in low and middle-income countries to an historic scaling up of treatment towards universal access. 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. Policy makers will now have to consider implementation of a new intervention—pre-exposure prophylaxis (PrEP), which could mean a diversion of ARVs from treatment to prevention. The principle underlying PrEP is that ARVs could prevent HIV infection among people who are HIV-negative and at high risk. Unlike existing prevention strategies such as voluntary counseling and testing (VCT), condoms, and male circumcision, PrEP is a continuous biomedical intervention. Although it will take several years to fully establish the clinical efficacy of PrEP in varying populations, the encouraging early results from CAPRISA, iPrEx, and CDC 4323 have accelerated global dialogue on its proof of deliverability. The studies encompass diverse populations, including injecting drug users (IDUs), MSM, serodiscordant heterosexual couples, and sex workers. These studies will be completed at different times, raising the question: if a trial demonstrates effectiveness for a given study group, should PrEP be used for others? The ethical issues raised by PrEP are difficult, but not insurmountable. Examining comparative cost-effectiveness, good governance, overcoming access barriers, and ensuring quality improvement would help ensure ethical allocation under circumstances of scarcity