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Atazanavir exposure in utero and neurodevelopment in infants: a comparative safety study

Ellen C Caniglia1, Kunjal Patel, Yanling Huo

  • 1aHarvard T.H. Chan School of Public Health, Boston, Massachusetts bDepartment of Psychiatry and Behavioral Sciences, University of Southern California Keck School of Medicine, Los Angeles, California cNational Institutes of Health, National Institute of Mental Health, Bethesda, Maryland dUniversity of Illinois at Chicago College of Medicine, Chicago, Illinois eTulane University School of Medicine, New Orleans, Louisiana fHarvard-MIT Division of Health Sciences and Technology, Boston, Massachusetts, USA.

AIDS (London, England)
|February 12, 2016
PubMed

Insights

In-utero exposure to atazanavir antiretroviral drugs may slightly impact language and social-emotional development in perinatally HIV-exposed but uninfected (PHEU) infants, though the overall effect is small.

Area of Science:

  • Pediatric HIV/AIDS research
  • Neurodevelopmental toxicology
  • Antiretroviral drug safety

Background:

  • Perinatally HIV-exposed but uninfected (PHEU) infants are a vulnerable population.
  • Antiretroviral therapy (ART) is crucial for managing HIV in pregnant women.
  • The safety of specific ART drugs, like atazanavir, during pregnancy requires thorough evaluation.

Purpose of the Study:

  • To assess the safety of in-utero exposure to atazanavir.
  • To evaluate the impact of atazanavir on neurodevelopment in PHEU infants.
  • To compare neurodevelopmental outcomes between infants exposed to atazanavir-containing and non-atazanavir-containing ART regimens.

Main Methods:

  • Prospective cohort study of mother-PHEU infant pairs within the Pediatric HIV/AIDS Cohort Study.
  • Neurodevelopmental assessment using the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III) at 9-15 months.
  • Statistical analysis using inverse probability weighting to adjust for covariates and missing data.

Main Results:

  • Infants exposed in utero to atazanavir-containing regimens showed small, potentially adverse differences in language and social-emotional domains.
  • Adjusted mean differences in Bayley-III scores for first-trimester atazanavir exposure: cognitive -1.5, language -3.3, motor -2.9, social-emotional 0.1, adaptive behavior -0.1.
  • Adjusted mean differences for second or third-trimester atazanavir exposure: cognitive 0.4, language -3.4, motor 0.3, social-emotional -5.9, adaptive behavior -2.5.

Conclusions:

  • In-utero exposure to atazanavir-containing ART regimens may be associated with minor adverse effects on language and social-emotional development in PHEU infants.
  • The observed differences in neurodevelopmental outcomes are small in absolute terms.
  • Further research may be warranted to fully understand the long-term implications of prenatal atazanavir exposure.
Abstract

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