Journal article
Pooled Individual Data Analysis of 5 Randomized Trials of Infant Nevirapine Prophylaxis to Prevent Breast-Milk HIV-1 Transmission
Clinical infectious diseases, Vol.56(1), pp.131-139
Editor's choice
01/01/2013
DOI: 10.1093/cid/cis808
PMCID: PMC3518881
PMID: 22997212
Abstract
A pooled analysis of individual data from >5000 human immunodeficiency virus type 1 (HIV-1)–infected mothers and their infants from Africa and India who participated in 5 randomized trials shows that extended prophylaxis with nevirapine or with nevirapine and zidovudine significantly reduces postnatal HIV-1 infection.
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.
Details
- Title: Subtitle
- Pooled Individual Data Analysis of 5 Randomized Trials of Infant Nevirapine Prophylaxis to Prevent Breast-Milk HIV-1 Transmission
- Creators
- Michael G Hudgens - University of North Carolina atTaha E Taha - Johns Hopkins UniversitySaad B Omer - Emory UniversityDenise J Jamieson - Centers for Disease Control and PreventionHana Lee - University of North Carolina atLynne M Mofenson - Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of HealthCharles Chasela - University of North Carolina ProjectAthena P Kourtis - Centers for Disease Control and PreventionNewton Kumwenda - Johns Hopkins UniversityAndrea Ruff - Johns Hopkins UniversityAbubaker Bedri - Addis Ababa UniversityJ. Brooks Jackson - Johns Hopkins UniversityPhilippa Musoke - Makerere University–Johns Hopkins University Research CollaborationRobert C Bollinger - Johns Hopkins UniversityNikhil Gupte - Johns Hopkins UniversityMichael C Thigpen - Centers for Disease Control and PreventionAllan Taylor - Centers for Disease Control and PreventionCharles van der Horst - University of North Carolina at
- Resource Type
- Journal article
- Publication Details
- Clinical infectious diseases, Vol.56(1), pp.131-139
- Publisher
- Oxford University Press
- Series
- Editor's choice
- DOI
- 10.1093/cid/cis808
- PMID
- 22997212
- PMCID
- PMC3518881
- ISSN
- 1058-4838
- eISSN
- 1537-6591
- Language
- English
- Date published
- 01/01/2013
- Academic Unit
- Pathology; Obstetrics and Gynecology; VPMA - Administration
- Record Identifier
- 9984046831802771
Metrics
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