title: Twelve-month follow-up of Six Week Extended Dose Nevirapine randomized controlled trials: differential impact of extended-dose nevirapine on mother-to-child transmission and infant death by maternal CD4 cell count.
abstract: OBJECTIVE
  We previously reported combined analysis of 6-week and 6-month endpoints of three randomized controlled trials [Six Week Extended Dose Nevirapine (SWEN) trials] that compared extended-dose nevirapine through 6 weeks of age to single-dose nevirapine to prevent HIV transmission via breastfeeding and mortality. We now present endpoints through 12 months of age.
  
  
  METHODS
  Infants in Ethiopia, India, and Uganda born to HIV-infected women who chose to breastfeed were randomized to receive single-dose or extended-dose nevirapine.
  
  
  RESULTS
  HIV transmission, mortality, HIV transmission or death.
  
  
  RESULTS
  Primary analysis included 987 and 903 infants in the single-dose and the extended-dose arms, respectively. HIV transmission was 8.9% in the extended-dose group compared to 10.4% in the single-dose group, but the difference was not significant [risk ratio: 0.87, 95% confidence interval (CI): 0.65-1.15]. Cumulative mortality at 12 months was half in the extended-dose group compared to the single-dose group (risk ratio: 0.53, 95% CI: 0.32-0.85). The impact of extended-dose nevirapine was highest in infants of mothers with CD4 cell count more than 350 cells/μl. Risk ratios for death (risk ratio: 0.38, 95% CI: 0.17-0.84) and HIV transmission or death (risk ratio: 0.54, 95% CI: 0.35-0.85) were statistically significant for the CD4 cell counts more than 350 cells/μl category, whereas none of the risk ratios were significant for the CD4 cell counts 200 cells/μl or less and CD4 cell counts 201-350 cells/μl categories.
  
  
  CONCLUSIONS
  For populations with limited access to HAART, our results provide evidence for the use of extended-dose regimens to prevent infant deaths and increase HIV-free survival in infants of HIV-infected breastfeeding women, particularly for infants of women with CD4 cell counts more than 350 cells/μl.
authors.affiliation: Emory University, Atlanta, Georgia, USA. somer@emory.edu
authors.forename: Saad B
authors.initials: SB
authors.lastname: Omer
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active; D001942:Breast Feeding / Q000009:adverse effects*; D018791:CD4 Lymphocyte Count; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control / Q000635:transmission; D015497:HIV-1; D006297:Health Services Accessibility / Q000592:standards*; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D009035:Mothers; D019829:Nevirapine / Q000008:administration & dosage*; D011247:Pregnancy; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine