In utero exposure to ART posed little to no risk for congenital anomalies
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Recent data indicate antiretroviral exposure in utero posed a small increased risk for infants, suggesting the benefits of recommended ART during pregnancy outweighs risks.
On behalf of the Pediatric HIV/AIDS Cohort Study, Paige L. Williams, PhD, of Harvard School of Public Health in Boston, and colleagues investigated associations between in utero exposure to ART and congenital anomalies among HIV-exposed children without HIV (n=2,580). The study was conducted at 22 US medical centers.
Overall, 175 infants had confirmed congenital anomalies, indicating a prevalence of 6.78% (95% CI, 5.85%-7.82%).
Prevalence of congenital anomalies significantly increased with each successive birth cohort; children born before 2002 had a prevalence rate of 3.8% and children born from 2008 to 2010 had a rate of 8.3% (P=.03).
Besides birth cohort, demographic and socioeconomic characteristics did not influence differences in distribution of congenital anomalies.
Children with congenital anomalies were more likely to be delivered by cesarean section and to be born preterm compared with children without anomalies.
Higher maternal viral load, defined as HIV RNA concentration greater than 1,000 copies/mL, was not associated with congenital anomalies. Similarly, maternal tobacco or drug use was not associated with congenital anomalies.
Children exposed to ART (8.1%) or protease inhibitors (8.5%) in the first trimester had a significantly higher prevalence of congenital anomalies compared with unexposed children (5.8%).
Regarding protease inhibitors, children exposed to atazanavir, lopinavir and ritonavir booster had significantly higher rates of congenital anomalies. Combinations of atazanavir with ritonavir, tenofovir or emtricitabine were associated with increased risk for congenital anomalies. Children exposed to atazanavir during the first trimester were more likely to develop musculoskeletal and skin anomalies.
Exposure to combinations of didanosine plus stavudine or zidovudine plus lamivudine at any time during pregnancy was associated with a significantly higher risk for congenital anomalies.
“Our study was reassuring in confirming the lack of an increased risk of congenital anomalies among children exposed to antiretrovirals during the first trimester of pregnancy,” the researchers wrote. “As WHO 2013 antiretroviral guidelines are implemented globally, an increasing percentage of women with HIV will be expected to enter pregnancy already receiving antiretrovirals. Therefore, risks associated with in utero antiretroviral exposure must be considered to identify optimal regimens based on their safety profiles.”
Disclosure: Tulane University receives financial support from Gilead Sciences for partial support of the Pediatric HIV/AIDS Cohort Study.