Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. | Read by QxMD (original) (raw)

Journal Article

Multicenter Study

Randomized Controlled Trial

Research Support, N.I.H., Extramural

Research Support, Non-U.S. Gov't

Robert M Grant, Javier R Lama, Peter L Anderson, Vanessa McMahan, Albert Y Liu, Lorena Vargas, Pedro Goicochea, Martín Casapía, Juan Vicente Guanira-Carranza, Maria E Ramirez-Cardich, Orlando Montoya-Herrera, Telmo Fernández, Valdilea G Veloso, Susan P Buchbinder, Suwat Chariyalertsak, Mauro Schechter, Linda-Gail Bekker, Kenneth H Mayer, Esper Georges Kallás, K Rivet Amico, Kathleen Mulligan, Lane R Bushman, Robert J Hance, Carmela Ganoza, Patricia Defechereux, Brian Postle, Furong Wang, J Jeff McConnell, Jia-Hua Zheng, Jeanny Lee, James F Rooney, Howard S Jaffe, Ana I Martinez, David N Burns, David V Glidden

BACKGROUND: Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition.

METHODS: 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.

RESULTS: 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 (95% confidence interval, 15 to 63; P=0.005). 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). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57).

CONCLUSIONS: Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

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