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Title: Preexposure chemoprophylaxis for HIV prevention in men who have sex with men
Authors: 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 Chariyalertsak
Linda Gail Bekker
Kenneth H. Mayer
Esper Georges Kallás
K. Rivet Amico
Kathleen Mulligan
Lane R. Bushma
Robert J. Hance
Carmela Ganoza
Patricia Defechereux
Brian Postle
Furong Wang
Jeff McConnell
Jia Hua Zheng
Jeanny Lee
James F. Rooney
Howard S. Jaff
Ana I. Martinez
David N. Burns
David V. Glidden
Keywords: Medicine
Issue Date: 30-Dec-2010
Abstract: 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; number, NCT00458393.). © 2010 Massachusetts Medical Society.
ISSN: 15334406
Appears in Collections:CMUL: Journal Articles

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