Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.

Abstract (PubMed)

Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (hazard ratio, 0.56; 95% confidence interval [CI], 0.37 to 0.85; P=0.005). In a subgroup analysis, participants with detectable blood levels of the study drug had a 92% reduction in the risk of acquiring HIV (hazard ratio, 0.08; 95% CI, 0.02 to 0.33). The study drug was generally safe; the most common side effects were nausea and unintentional weight loss, which were transient. The rate of serious adverse events was similar in the two study groups. A combination pill of FTC-TDF can be used as prophylaxis to reduce the risk of HIV acquisition in men who have sex with men.