Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission

Michael G. Hudgens, Taha E. Taha, Saad B. Omer, Denise J. Jamieson, Hana Lee, Lynne M. Mofenson, Charles Chasela, Athena P. Kourtis, Newton Kumwenda, Andrea Ruff, Abubaker Bedri, J. Brooks Jackson, Philippa Musoke, Robert C. Bollinger, Nikhil Gupte, Michael C. Thigpen, Allan Taylor, Charles Van Der Horst

Research output: Contribution to journalArticlepeer-review

20 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)131-139
Number of pages9
JournalClinical Infectious Diseases
Issue number1
StatePublished - Jan 1 2013
Externally publishedYes

Bibliographical note

Funding Information:
Financial support. The Breastfeeding, Antiretrovirals and Nutrition (BAN) study was supported by the Prevention Research Centers Special Interest Project of the CDC (SIP 13-01 U48-CCU409660-09, SIP 26-04 U48-DP000059-01, and SIP 22-09 U48-DP001944), the National Institute of Allergy and Infectious Diseases (NIAID), the University of North Carolina Center for AIDS Research (P30-AI50410), the NIH Fogarty AIDS International Training and Research Program (DHHS/NIH/FIC 5-D43 TW001039 and 5-R24 TW007988), Abbott Laboratories, GlaxoSmithK-line, Boehringer Ingelheim, Roche Pharmaceuticals, Bristol-Myers Squibb, the Elizabeth Glaser Pediatric AIDS Foundation, the United Nations Children’s Fund, the World Food Program, the Malawi Ministry of Health and Population, Johnson & Johnson, and the US Agency for International Development. The SWEN study was supported by grants from the NIH, NIAID (R01AI45462, R01AI3857601A, R01AI34235) and the NIH Fogarty International Center NIH Program of International Training Grants in Epidemiology Related to AIDS (D43-TW0000). The PEPI study was supported by a Cooperative Agreement (5 U50 PS022061-05; award U50/CC0222061) from the CDC and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH. The CDC and NIH were sponsors of the studies included in this pooled analysis.


  • HIV
  • breast milk
  • nevirapine


Dive into the research topics of 'Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission'. Together they form a unique fingerprint.

Cite this