title: Birth defects among a cohort of infants born to HIV-infected women on antiretroviral medication.
abstract: To determine rate of and risk factors for birth defects in infants born to HIV-infected women receiving nucleoside and protease inhibitor antiretroviral (ARV) therapy.
  
  
  
  Birth defects were evaluated among infants on the Pediatric AIDS Clinical Trials Group 316 trial that studied addition of peripartum nevirapine to established ARV regimen for prevention of mother-to-child transmission. Maternal therapy was categorized by trimester of earliest exposure. Birth defects were coded using conventions of the Antiretroviral Pregnancy Registry.
  
  
  
  Birth defects were detected in 60/1414 (4.2%; 95% CI 3.3-5.4%) infants including 30/636 (4.7%; 95% CI 3.2-6.7%) with first trimester ARV exposure and 30/778 (3.9%; 95% CI 2.6-5.5%) with exposure only after the first trimester (P=0.51). Rates of classes of defects were similar between first trimester compared to later exposure groups except heart defects which occurred in 16 (2.5%; 95% CI 1.4-4.1%) with first trimester ARV exposure and in six (0.8%; 95% CI 0.3-1.7%) infants with later exposure (P=0.02). Exposure to ARV was not associated with specific types of heart defects. Two cases of cardiomyopathy were noted.
  
  
  
  ARV use in early pregnancy was not associated with an increased risk of birth defects overall. The possible association of ARV exposure with heart defects requires further surveillance.
authors.affiliation: Eunice Kennedy Shriver National Institute for Child Health and Human Development, Bethesda, MD, USA. hw59i@nih.gov
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
authors.forename: Sharon
authors.initials: S
authors.lastname: Huang
authors.forename: Mary
authors.initials: M
authors.lastname: Culnane
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Kaiser
authors.forename: Angela
authors.initials: A
authors.lastname: Scheuerle
authors.forename: Lynne
authors.initials: L
authors.lastname: Mofenson
authors.forename: Kenneth
authors.initials: K
authors.lastname: Stanley
authors.forename: Marie-Louise
authors.initials: ML
authors.lastname: Newell
authors.forename: Laurent
authors.initials: L
authors.lastname: Mandelbrot
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Delfraissy
authors.forename: Coleen K
authors.initials: CK
authors.lastname: Cunningham
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects*; D015331:Cohort Studies; D000013:Congenital Abnormalities / Q000453:epidemiology / Q000209:etiology*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy* / Q000635:transmission; D006330:Heart Defects, Congenital / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D019829:Nevirapine / Q000009:adverse effects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D012307:Risk Factors
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine