title: Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission.
abstract: 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.
authors.affiliation: University of North Carolina, Chapel Hill, NC 27599-7420, USA. mhudgens@bios.unc.edu
authors.forename: Michael G
authors.initials: MG
authors.lastname: Hudgens
authors.forename: Taha E
authors.initials: TE
authors.lastname: Taha
authors.forename: Saad B
authors.initials: SB
authors.lastname: Omer
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Jamieson
authors.forename: Hana
authors.initials: H
authors.lastname: Lee
authors.forename: Lynne M
authors.initials: LM
authors.lastname: Mofenson
authors.forename: Charles
authors.initials: C
authors.lastname: Chasela
authors.forename: Athena P
authors.initials: AP
authors.lastname: Kourtis
authors.forename: Newton
authors.initials: N
authors.lastname: Kumwenda
authors.forename: Andrea
authors.initials: A
authors.lastname: Ruff
authors.forename: Abubaker
authors.initials: A
authors.lastname: Bedri
authors.forename: J Brooks
authors.initials: JB
authors.lastname: Jackson
authors.forename: Philippa
authors.initials: P
authors.lastname: Musoke
authors.forename: Robert C
authors.initials: RC
authors.lastname: Bollinger
authors.forename: Nikhil
authors.initials: N
authors.lastname: Gupte
authors.forename: Michael C
authors.initials: MC
authors.lastname: Thigpen
authors.forename: Allan
authors.initials: A
authors.lastname: Taylor
authors.forename: Charles
authors.initials: C
authors.lastname: van der Horst
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D001942:Breast Feeding / Q000706:statistics & numerical data; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control* / Q000706:statistics & numerical data; D053208:Kaplan-Meier Estimate; D008297:Male; D008895:Milk, Human / Q000821:virology*; D019829:Nevirapine / Q000008:administration & dosage*; D012307:Risk Factors
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine