Objective: To evaluate the safety of in-utero antiretroviral
exposure in children born to mothers with HIV, using a trigger-based design.
Design: The Surveillance Monitoring of ART Toxicities Study
is a prospective cohort study conducted at 22 US sites to evaluate safety of
in-utero antiretroviral drug exposure in HIV-uninfected children born to
HIV-infected mothers. Children meeting predefined clinical or laboratory
thresholds have more intensive evaluations to determine whether they meet
criteria for adverse events.
Methods: Adverse event “cases” were defined for the
following domains: growth, hearing, language, neurology, neurodevelopment,
metabolic, hematologic/clinical chemistry and blood lactate. We used adjusted
log-binomial models to calculate relative risks (RR) of case status overall and
within individual domains for various antiretroviral exposures during
pregnancy.
Results: Among 2680 youth enrolled between 2007 and 2012
(48% female, 66% black, 33% Hispanic), 48% met a trigger and 25% were defined
as a case in at least one domain. Language (13.2%) and metabolic (11.4%) cases
were most common. After adjustment for birth cohort and other factors, there
was no association of any antiretroviral regimen, drug class, or individual
drug with meeting overall case criteria (case in any domain). Within individual
domains, zidovudine (74% exposed) was associated with increased risk of
metabolic case [RR = 1.69, 95%confidence interval (CI) 1.08–2.64] and
didanosine plus stavudine (<1% exposed) with increased risk of both
neurodevelopmental (RR = 12.40, 95%CI 5.29–29.08) and language (RR = 4.84,
95%CI 1.14–20.51) cases.
Conclusion: Our findings support current recommendations for
combination antiretroviral therapy during pregnancy, although higher risk of
metabolic disorder with zidovudine exposure warrants further study.
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