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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Preexposure prophylaxis for HIV infection among African women
New England Journal of Medicine, Volume 367, No. 5, Year 2012
Notification
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Description
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<0.001, and P = 0.03, respectively). Rates of drug discontinuation because of hepatic or renal abnormalities were higher in the TDF-FTC group (4.7%) than in the placebo group (3.0%, P = 0.051). Less than 40% of the HIV-uninfected women in the TDF-FTC group had evidence of recent pill use at visits that were matched to the HIV-infection window for women with seroconversion. The study was stopped early, on April 18, 2011, because of lack of efficacy. CONCLUSIONS: Prophylaxis with TDF-FTC did not significantly reduce the rate of HIV infection and was associated with increased rates of side effects, as compared with placebo. Despite substantial counseling efforts, drug adherence appeared to be low. (Supported by the U.S. Agency for International Development and others; FEM-PrEP ClinicalTrials.gov number, NCT00625404.) Copyright © 2012 Massachusetts Medical Society.
Authors & Co-Authors
van Damme, Lut
Unknown Affiliation
Corneli, Amy L.
Unknown Affiliation
Ahmed, Khatija
Unknown Affiliation
Agot, Kawango E.
Unknown Affiliation
Lombaard, Johan J.
Unknown Affiliation
Kapiga, Saidi Hussein
Unknown Affiliation
Malahleha, Mookho
Unknown Affiliation
Owino, Fredrick
Unknown Affiliation
Manongi, Rachel N.
Unknown Affiliation
Onyango, Jacob
Unknown Affiliation
Temu, Lucky
Unknown Affiliation
Monedi, Modie Constance
Unknown Affiliation
Mak'Oketch, Paul
Unknown Affiliation
Makanda, Mankalimeng
Unknown Affiliation
Reblin, Ilse
Unknown Affiliation
Makatu, Shumani
Unknown Affiliation
Saylor, Lisa
Unknown Affiliation
Kiernan, Haddie
Unknown Affiliation
Kirkendale, Stella
Unknown Affiliation
Wong, Christina Misa
Unknown Affiliation
Grant, Robert M.
Unknown Affiliation
Kashuba, Angela D.M.
Unknown Affiliation
Nanda, Kavita
Unknown Affiliation
Mandala, Justin
Unknown Affiliation
Fransen, Katrien
Unknown Affiliation
Deese, Jennifer
Unknown Affiliation
Crucitti, Tania
Unknown Affiliation
Mastro, Timothy D.
Unknown Affiliation
Taylor, Douglas J.
Unknown Affiliation
Statistics
Citations: 1,473
Authors: 29
Affiliations: 10
Identifiers
Doi:
10.1056/NEJMoa1202614
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Disability
Environmental
Infectious Diseases
Study Design
Cohort Study
Study Locations
Kenya
South Africa
Tanzania
Participants Gender
Female