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Head of the Infectious Diseases Department, Saint-Louis Hospital in Paris
Senior Scientist at French National Institute for Medical Research
Pfizer Chair on Translational HIV Research, Université de Montréal
Emeritus Director of the McGill University AIDS Centre
Pr at APHP Hôpital Tenon
Director, HIV Prevention Research, Beth Israel Deaconess Hospital
Assistant Professor of Medicine, Division of Infectious Diseases, Emory University School of Medicine
Medical Director of Prevention Programs at Montefiore AIDS Center
Deputy Director, Science at Amsterdam Institute for Global Health and Development
Director of the Centre for the AIDS Program of Research in South Africa (CAPRISA)
Medical Research Council Clinical Trials Unit at UCL, and 56 Dean Street Sexual Health Clinic, London UK
Vice Chair and Professor, Dept of Global Health, University of Washington
President, Australian Federation of AIDS Organisations
Associate Director of the UCLA Center for Clinical AIDS Research & Education
Associate Professor, Dept of Obstetrics, Gynecology and Reproductive Sciences at University of Pittsburgh School of Medicine
HIV and Infectious Diseases consultant at the Toronto General Hospital
Board of Directors, San Francisco AIDS Foundation
Professor of Medicine at UCSF
Assistant Professor of Medicine at Johns Hopkins University
Deputy Director, Research & Partnership Advancement Unit, College of Health Sciences, Obafemi Awolowo University
Research Fellow at Imperial College London
Assistant Professor at Massachusetts General Hospital/ Harvard Medical School
Senior Researcher on Public Health at Oswaldo Cruz Foundation
Associate Vice Chancellor at University of North Carolina
Senior Fellow at University of Washington
Senior Researcher at Wits RHI
Clinical Research Director at Bridge HIV, San Francisco Dept of Public Health
Vice President for Program Development, AMSA
Medical Student at University of Pennsylvania
Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen.
We conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections.
Of the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P = 0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P = 0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P = 0.002) and renal adverse events (18% vs. 10%, P = 0.03).
The use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT01473472.)
Head of the Infectious Diseases Department, Saint-Louis Hospital in Paris
Senior Scientist at French National Institute for Medical Research
Pfizer Chair on Translational HIV Research, Université de Montréal
Emeritus Director of the McGill University AIDS Centre
Pr at APHP Hôpital Tenon
Director, HIV Prevention Research, Beth Israel Deaconess Hospital
Assistant Professor of Medicine, Division of Infectious Diseases, Emory University School of Medicine
Medical Director of Prevention Programs at Montefiore AIDS Center
Deputy Director, Science at Amsterdam Institute for Global Health and Development
Director of the Centre for the AIDS Program of Research in South Africa (CAPRISA)
Medical Research Council Clinical Trials Unit at UCL, and 56 Dean Street Sexual Health Clinic, London UK
Vice Chair and Professor, Dept of Global Health, University of Washington
President, Australian Federation of AIDS Organisations
Associate Director of the UCLA Center for Clinical AIDS Research & Education
Associate Professor, Dept of Obstetrics, Gynecology and Reproductive Sciences at University of Pittsburgh School of Medicine
HIV and Infectious Diseases consultant at the Toronto General Hospital
Board of Directors, San Francisco AIDS Foundation
Professor of Medicine at UCSF
Assistant Professor of Medicine at Johns Hopkins University
Deputy Director, Research & Partnership Advancement Unit, College of Health Sciences, Obafemi Awolowo University
Research Fellow at Imperial College London
Assistant Professor at Massachusetts General Hospital/ Harvard Medical School
Senior Researcher on Public Health at Oswaldo Cruz Foundation
Associate Vice Chancellor at University of North Carolina
Senior Fellow at University of Washington
Senior Researcher at Wits RHI
Clinical Research Director at Bridge HIV, San Francisco Dept of Public Health
Vice President for Program Development, AMSA
Medical Student at University of Pennsylvania