Safety of perinatal exposure to antiretroviral medications: Developmental outcomes in infants

Patricia A. Sirois*, Yanling Huo, Paige L. Williams, Kathleen Malee, Patricia A. Garvie, Betsy Kammerer, Kenneth Rich, Russell B. Van Dyke, Molly L. Nozyce

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

54 Scopus citations


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 A RV 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.

Original languageEnglish (US)
Pages (from-to)648-655
Number of pages8
JournalPediatric Infectious Disease Journal
Issue number6
StatePublished - Jun 2013


  • Antiretroviral
  • Developmental assessment
  • HIV
  • Infant
  • Neurodevelopment

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases
  • Pediatrics, Perinatology, and Child Health


Dive into the research topics of 'Safety of perinatal exposure to antiretroviral medications: Developmental outcomes in infants'. Together they form a unique fingerprint.

Cite this