Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis.

(Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation number, NCT00458393.).ĭonnell D, Baeten JM, Kiarie J, et al. Detectable blood levels strongly correlated with the prophylactic effect. Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. The two groups had similar rates of serious adverse events (P=0.57). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). 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 (95% confidence interval, 15 to 63 P=0.005). The study subjects were followed for 3324 person-years (median, 1.2 years maximum, 2.8 years).

All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. 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. Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition.

Monica Susan Laborde