title: Safety of in utero and neonatal antiretroviral exposure: cognitive and academic outcomes in HIV-exposed, uninfected children 5-13 years of age.
abstract: BACKGROUND
  Long-term effects of in utero and neonatal antiretroviral (ARV) exposure on cognitive and academic development in HIV-exposed, uninfected school-age children are unknown.
  
  
  METHODS
  HIV-exposed, uninfected children, ages 5-13 years, in Pediatric HIV/AIDS Cohort Study Surveillance Monitoring for Antiretroviral Treatment Toxicities, a US-based multisite cohort study, completed age-appropriate Wechsler intelligence and academic scales (WPPSI-III, WASI, WIAT-II-A). Associations between cognitive and academic outcomes and in utero ARV exposure by regimen, class and individual ARVs were evaluated, adjusting for potential confounders.
  
  
  RESULTS
  Children completing WPPSI-IIIs (n = 350) were 49% male, 74% Black, 25% Hispanic; WASI (n = 337) and WIAT-II-A (n = 415) cohorts were similar. The percentage exposed to combination ARV (cARV) was 84% (WPPSI-III), 64% (WASI) and 67% (WIAT-II-A). Among ARV-exposed children, there were no significant associations between any ARV regimen or class and any cognitive or academic outcome. In addition, in both unadjusted models and after adjustment for caregiver IQ, sociodemographic factors and maternal health and substance use during pregnancy, no individual ARV drug was associated with significantly lower cognitive or academic scores. Factors typically associated with lower cognitive and academic scores in the general population, such as prematurity, small for gestational age, maternal alcohol use and lower maternal cognitive status, were also associated with lower scores in this study.
  
  
  CONCLUSIONS
  Overall, the safety of prenatal and neonatal ARV use was supported.
authors.affiliation: From the *Jacobi Medical Center, Albert Einstein College of Medicine, New York, NY; †Harvard School of Public Health, Boston, MA; ‡National Institute of Mental Health, Bethesda; §Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD; ¶University of California, San Diego, CA; ‖University of Chicago; **University of Illinois, Chicago, IL; ††Tulane University School of Medicine, New Orleans, LA.
authors.forename: Molly L
authors.initials: ML
authors.lastname: Nozyce
authors.forename: Yanling
authors.initials: Y
authors.lastname: Huo
authors.forename: Paige L
authors.initials: PL
authors.lastname: Williams
authors.forename: Suad
authors.initials: S
authors.lastname: Kapetanovic
authors.forename: Rohan
authors.initials: R
authors.lastname: Hazra
authors.forename: Sharon
authors.initials: S
authors.lastname: Nichols
authors.forename: Scott
authors.initials: S
authors.lastname: Hunter
authors.forename: Renee
authors.initials: R
authors.lastname: Smith
authors.forename: George R
authors.initials: GR
authors.lastname: Seage
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Sirois
mesh_terms: D000293:Adolescent; D044966:Anti-Retroviral Agents / Q000009:adverse effects*; D002648:Child; D002657:Child Development; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D004522:Educational Status; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007360:Intelligence / Q000187:drug effects*; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011297:Prenatal Exposure Delayed Effects; D014888:Wechsler Scales
chemical_list: D044966:Anti-Retroviral Agents