Preexposure prophylaxis for HIV infection among African women

L. Van Damme, A. Corneli, K. Ahmed, K. Agot, J. Lombaard, S. Kapiga, M. Malahleha, F. Owino, R. Manongi, J. Onyango, L. Temu, M.C. Monedi, P. Mak'oketch, M. Makanda, I. Reblin, S.E. Makatu, L. Saylor, H. Kiernan, S. Kirkendale, C. WongR. Grant, A. Kashuba, K. Nanda, J. Mandala, K. Fransen, J. Deese, T. Crucitti, T.D. Mastro, D. Taylor

    Research output: Contribution to journalA1: Web of Science-article

    Abstract

    Background: Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. Methods: In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety. Results: HIV infections occurred in 33 women in the TDF-FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P=0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF-FTC group (P=0.04, P
    Original languageEnglish
    JournalNew England Journal of Medicine
    Volume367
    Issue number5
    Pages (from-to)411-422
    Number of pages12
    ISSN0028-4793
    DOIs
    Publication statusPublished - 2012

    Keywords

    • Viral diseases
    • HIV
    • AIDS
    • Pre-exposure
    • Prophylaxis
    • Women
    • Effectiveness
    • Assessment
    • Combination therapy
    • Tenofovir
    • Disoproxil
    • Fumarate
    • Emtricitabine
    • Transmission prevention
    • Safety
    • Evaluation
    • Adverse effects
    • Hepatic
    • Renal function
    • Randomized controlled trials
    • Randomized clinical trials
    • Kenya
    • Tanzania
    • Africa-East
    • South Africa
    • Africa-Southern

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