title: Infant outcomes after maternal antiretroviral exposure in resource-limited settings.
abstract: OBJECTIVE
  The impact of maternal antiretrovirals (ARVs) during pregnancy, labor, and postpartum on infant outcomes is unclear.
  
  
  METHODS
  Infants born to HIV-infected mothers in ARV studies were followed for 18 months.
  
  
  RESULTS
  Between June 2006 and December 2008, 236 infants enrolled from Africa (n = 36), India (n = 47), Thailand (n = 152), and Brazil (n = 1). Exposure to ARVs in pregnancy included ≥ 3 ARVs (10%), zidovudine/intrapartum ARV (81%), and intrapartum ARV (9%). There were 4 infant infections (1 in utero, 3 late postpartum) and 4 deaths with 1.8% mortality (95% confidence interval [CI], 0.1%-3.5%) and 96.4% HIV-1-free survival (95% CI, 94.0%-98.9%). Birth weight was ≥ 2.5 kg in 86%. In the first 6 months, Indian infants (nonbreastfed) had lowest median weights and lengths and smallest increases in growth. After 6 months, African infants had the lowest median weight and weight-for-age z scores. Infants exposed to highest maternal viral load had the lowest height and height-for-age z scores. Serious adverse events occurred in 38% of infants, did not differ by country, and correlated with less maternal ARV exposure. Clinical diagnoses were seen in 84% of Thai, 31% of African, and 9% of Indian infants. Congenital defects/inborn errors of metabolism were seen in 18 (7.6%) infants, of which 17 were Thai (11%: 95% CI, 6.7%-17.0%); none had first trimester ARV exposure.
  
  
  CONCLUSIONS
  Infant follow-up in large international cohorts is feasible and provides important safety and HIV transmission data following maternal ARV exposure. Increased surveillance increases identification of congenital/inborn errors.
authors.affiliation: Department of Pediatrics, Division of Infectious Diseases, David Geffen UCLA School of Medicine, MDCC 22-442, 10833 LeConte Ave, Los Angeles, CA 90095, USA. knielsen@mednet.ucla.edu
authors.forename: Karin
authors.initials: K
authors.lastname: Nielsen-Saines
authors.forename: Lauren
authors.initials: L
authors.lastname: Komarow
authors.forename: Susan
authors.initials: S
authors.lastname: Cu-Uvin
authors.forename: Gonzague
authors.initials: G
authors.lastname: Jourdain
authors.forename: Karin L
authors.initials: KL
authors.lastname: Klingman
authors.forename: David E
authors.initials: DE
authors.lastname: Shapiro
authors.forename: Lynne
authors.initials: L
authors.lastname: Mofenson
authors.forename: Laura
authors.initials: L
authors.lastname: Moran
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Campbell
authors.forename: Jane
authors.initials: J
authors.lastname: Hitti
authors.forename: Susan
authors.initials: S
authors.lastname: Fiscus
authors.forename: Judith
authors.initials: J
authors.lastname: Currier
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D003906:Developing Countries / Q000191:economics; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy / Q000191:economics / Q000453:epidemiology*; D015497:HIV-1; D006295:Health Resources / Q000191:economics; D006801:Humans; D007223:Infant; D018445:Infectious Disease Transmission, Vertical / Q000191:economics / Q000517:prevention & control; D038622:Internationality; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000191:economics / Q000453:epidemiology*; D011446:Prospective Studies; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents