Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

Bibliographic Data

ID23313616
AuthorsRobert M Grant (0000-0002-0851-7085, Gladstone Institutes), Javier R Lama (0000-0002-4983-5725, Asociación Civil Impacta Salud y Educación), Peter L Anderson (0000-0002-1200-8494, University of Colorado Denver), Vanessa McMahan (0000-0003-2331-7206, Institute of Virology of the Slovak Academy of Sciences), Albert Y Liu, Albert Liu (0000-0003-0320-823X, University of California, San Francisco), Lorena Vargas (0000-0002-7965-3498, EsSALUD), Pedro Goicochea (Institute of Virology of the Slovak Academy of Sciences), Martín Casapía, Martín Casapía-Morales (0000-0002-5972-0948, Asociación para la Conservación de la Cuenca Amazónica), Juan V Guanira (0000-0002-2746-3086, Asociación Civil Impacta Salud y Educación), Juan Vicente Guanira-Carranza, Maria Esther Ramirez-Cardich (Asociación Civil Impacta Salud y Educación), Orlando Montoya-Herrera (Instituto Ecuatoriano de Enfermedades Digestivas), Telmo Fernández (Instituto Ecuatoriano de Enfermedades Digestivas), Valdilea G Veloso (0000-0002-6622-3165, Instituto Evandro Chagas), Susan Buchbinder (0000-0003-2404-0712, University of California, San Francisco), Susan P Buchbinder, Suwat Chariyalertsak (0000-0002-4998-7841, Chiang Mai University), Mauro Schechter (0000-0003-2362-9170, Universidade Federal do Rio de Janeiro), Linda-Gail Bekker (0000-0002-0755-4386, Desmond Tutu HIV Foundation), Kenneth H Mayer (0000-0001-7460-733X, Brown University), Esper G Kallás (0000-0003-2026-6925, Universidade de São Paulo), K Rivet Amico (0000-0002-4458-6934, University of Connecticut), Kathleen Mulligan (0000-0001-7249-2823, University of California, San Francisco), Lane R Bushman (University of Colorado Denver), Robert J Hance, Robert Hance (Institute of Virology of the Slovak Academy of Sciences), Carmela Ganoza (0000-0001-6238-8504, Asociación Civil Impacta Salud y Educación), Patricia Defechereux (Institute of Virology of the Slovak Academy of Sciences), Brian Postle, Brian S Postle, Furong Wang (0000-0001-8693-7301, University of California, San Francisco), J Jeff Mcconnell (Institute of Virology of the Slovak Academy of Sciences), Jia‐Hua Zheng (0000-0003-1737-524X, University of Colorado Denver), Jia-Hua Zheng, Jeanny Lee (Institute of Virology of the Slovak Academy of Sciences), James F Rooney (0000-0003-3261-0711, Gilead Sciences (United States)), Howard S Jaffe (Gilead Sciences (United States)), Ana I Martinez (National Institutes of Health), David Burns (0000-0002-1617-596X, National Institutes of Health), David N Burns, David V Glidden (0000-0001-5888-1419, University of California, San Francisco)
Year2010
Volume363
Issue27
Pages2587-2599
Publication date2010-12-30
Peer ReviewedYes
Open AccessNo
TypeARTICLE
VenueNew England Journal of Medicine (JOURNAL)
Journal identifiersISSN: 0028-4793 • E-ISSN: 1533-4406
PublisherMassachusetts Medical Society (PUBLISHER • US)
DOI10.1056/nejmoa1011205
PMID21091279
PMCIDPMC3079639
OpenAlexW2103920597
LanguageEN
Citations received912
References cited30

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.).

Adverse effect · Alternative medicine · Antiretroviral therapy · Chemoprophylaxis · Confidence interval · Emtricitabine · Human immunodeficiency virus (HIV) · Incidence (geometry) · Men who have sex with men · Placebo · Pre-exposure prophylaxis · Syphilis · Viral load · HIV-related health complications and treatments · HIV/AIDS drug development and treatment · HIV/AIDS Research and Interventions · Immunology · Internal Medicine · Medicine

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