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Safety of Perinatal Exposure to Antiretroviral Medications: Developmental Outcomes in Infants.
MedLine Citation:
PMID:  23340561     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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 SMARTT, 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, 16% Hispanic. Seventy-nine percent were exposed to regimens containing protease inhibitors (PIs; 9% of PI-containing regimens also included non-nucleoside reverse transcriptase inhibitors [NNRTIs]), 5% to regimens containing NNRTIs (without PI), and 14% to regimens containing only nucleoside reverse transcriptase inhibitors (NRTIs). 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:
Patricia A Sirois; Yanling Huo; Paige L Williams; Kathleen Malee; Patricia A Garvie; Betsy Kammerer; Kenneth Rich; Russell B Van Dyke; Molly L Nozyce;
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-21
Journal Detail:
Title:  The Pediatric infectious disease journal     Volume:  -     ISSN:  1532-0987     ISO Abbreviation:  Pediatr. Infect. Dis. J.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8701858     Medline TA:  Pediatr Infect Dis J     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
1Tulane University School of Medicine, 2Harvard School of Public Health, 3Northwestern University Feinberg School of Medicine, 4Consulting Psychologist, 5Children's Hospital Boston, 6University of Illinois at Chicago, 7Jacobi Medical Center, Albert Einstein College of Medicine.
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