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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission
Clinical Infectious Diseases, Volume 56, No. 1, Year 2013
Notification
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Description
Background. In resource-limited settings, mothers infected with human immunodeficiency virus type 1 (HIV-1) face a difficult choice: breastfeed their infants but risk transmitting HIV-1 or not breastfeed their infants and risk the infants dying of other infectious diseases or malnutrition. Recent results from observational studies and randomized clinical trials indicate daily administration of nevirapine to the infant can prevent breast-milk HIV-1 transmission.Methods. Data from 5396 mother-infant pairs who participated in 5 randomized trials where the infant was HIV-1 negative at birth were pooled to estimate the efficacy of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission. Four daily regimens were compared: nevirapine for 6 weeks, 14 weeks, or 28 weeks, or nevirapine plus zidovudine for 14 weeks.Results. The estimated 28-week risk of HIV-1 transmission was 5.8% (95% confidence interval [CI], 4.3%-7.9%) for the 6-week nevirapine regimen, 3.7% (95% CI, 2.5%-5.4%) for the 14-week nevirapine regimen, 4.8% (95% CI, 3.5%-6.7%) for the 14-week nevirapine plus zidovudine regimen, and 1.8% (95% CI, 1.0%-3.1%) for the 28-week nevirapine regimen (log-rank test for trend, P <. 001). Cox regression models with nevirapine as a time-varying covariate, stratified by trial site and adjusted for maternal CD4 cell count and infant birth weight, indicated that nevirapine reduces the rate of HIV-1 infection by 71% (95% CI, 58%-80%; P <. 001) and reduces the rate of HIV infection or death by 58% (95% CI, 45%-69%; P <. 001).Conclusions. Extended prophylaxis with nevirapine or with nevirapine and zidovudine significantly reduces postnatal HIV-1 infection. Longer duration of prophylaxis results in a greater reduction in the risk of infection. © 2012 The Author.
Authors & Co-Authors
Hudgens, Michael G.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Taha, Taha E.
United States, Baltimore
Johns Hopkins University
Omer, Saad B.
United States, Atlanta
Emory University
Jamieson, Denise J.
United States, Atlanta
Centers for Disease Control and Prevention
Lee, Hana
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Mofenson, Lynne M.
United States, Bethesda
National Institute of Child Health and Human Development Nichd
Chasela, Charles S.
Malawi, Lilongwe
Unc Project-malawi
Kourtis, Athena P.
United States, Atlanta
Centers for Disease Control and Prevention
Kumwenda, Newton I.
United States, Baltimore
Johns Hopkins University
Ruff, Andrea J.
United States, Baltimore
Johns Hopkins University
Bedri, Abubaker
Ethiopia, Addis Ababa
Addis Ababa University
Jackson, J. Brooks
United States, Baltimore
Johns Hopkins University
Musoke, Philippa Martha
Uganda, Kampala
Makerere University
Bollinger, Robert Cyril
United States, Baltimore
Johns Hopkins University
Gupte, Nikhil Anil
United States, Baltimore
Johns Hopkins University
Thigpen, Michael C.
United States, Atlanta
Centers for Disease Control and Prevention
Taylor, Allan W.
United States, Atlanta
Centers for Disease Control and Prevention
van der Horst, Charles Michael
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Statistics
Citations: 21
Authors: 18
Affiliations: 8
Identifiers
Doi:
10.1093/cid/cis808
ISSN:
10584838
e-ISSN:
15376591
Research Areas
Food Security
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial