Ethical Challenges of Preexposure Prophylaxis for HIV

On July 16, 2012, emtricitabine/tenofovir (Truvada) became the first drug approved by the US Food and Drug Administration for preexposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) for adults at high risk. While PrEP appears highly effective with consistent adherence, effective implementation poses ethical challenges for the medical and public health community. For PrEP users, it is necessary to maintain adherence, safe sex practices, and routine HIV testing and medical monitoring, to maximize benefits and reduce risks. On a population level, comparative cost-effectiveness should guide priority-setting, while safety measures must address drug resistance concerns without burdening patients' access. Equitable distribution will require addressing the needs of underserved populations, women (for whom efficacy data are mixed) and people living in developing countries with high HIV incidence; meanwhile, it is necessary to consider the fair use of drugs for treatment vs. prevention and the appropriate design of new HIV prevention studies.