title: Safety of perinatal exposure to antiretroviral medications: developmental outcomes in infants.
abstract: BACKGROUND
  This study evaluated effects of perinatal exposure to antiretroviral (ARV) medications on neurodevelopment of HIV-exposed, uninfected infants.
  
  
  METHODS
  HIV-exposed, uninfected infants (age 9-15 months) enrolled in Surveillance Monitoring for Antiretroviral Therapy Toxicities, a multisite prospective surveillance study, completed the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III), assessing cognition, language, motor skills, social-emotional development and adaptive behavior. Linear regression models were used to evaluate associations between Bayley-III outcomes in infants with and without perinatal and neonatal ARV exposure, by regimen (combination ARV [cARV] versus non-cARV), type of regimen (defined by drug class) and individual ARVs (for infants with cARV exposure), adjusting for maternal and infant health and demographic covariates.
  
  
  RESULTS
  As of May 2010, 374 infants had valid Bayley-III evaluations. Median age at testing was 12.7 months; 49% male, 79% black and 16% Hispanic. Seventy-nine percent were exposed to regimens containing protease inhibitors (9% of protease inhibitor-containing regimens also included non-nucleoside reverse transcriptase inhibitors), 5% to regimens containing non-nucleoside reverse transcriptase inhibitors (without protease inhibitor) and 14% to regimens containing only nucleoside reverse transcriptase inhibitors. Overall, 83% were exposed to cARV. No Bayley-III outcome was significantly associated with overall exposure to cARV, ARV regimen or neonatal prophylaxis. For individual ARVs, following sensitivity analyses, the adjusted group mean on the Language domain was within age expectations but significantly lower for infants with perinatal exposure to atazanavir (P = 0.01).
  
  
  CONCLUSIONS
  These results support the safety of perinatal ARV use. Continued monitoring for adverse neurodevelopmental outcomes in older children is warranted, and the safety of atazanavir merits further study.
authors: Department of Pediatrics, Tulane University School of Medicine, New Orleans, LA 70112, USA. psirois@tulane.edu
authors: Patricia A
authors: PA
authors: Sirois
authors: Yanling
authors: Y
authors: Huo
authors: Paige L
authors: PL
authors: Williams
authors: Kathleen
authors: K
authors: Malee
authors: Patricia A
authors: PA
authors: Garvie
authors: Betsy
authors: B
authors: Kammerer
authors: Kenneth
authors: K
authors: Rich
authors: Russell B
authors: RB
authors: Van Dyke
authors: Molly L
authors: ML
authors: Nozyce
mesh_terms: D044966:Anti-Retroviral Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002657:Child Development / Q000187:drug effects*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008137:Longitudinal Studies; D008297:Male; D009420:Nervous System / Q000187:drug effects* / Q000254:growth & development*; D018743:Perinatal Care; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011446:Prospective Studies
chemical_list: D044966:Anti-Retroviral Agents