Polly Clayden, HIV i-Base

Data from the NISDI Perinatal Study conducted in Argentina and Brazil suggest no association between in utero antiretroviral (ARV) exposure and congenital anomalies (CAs).

The NISDI Perinatal Study is a prospective cohort study of HIV-positive women and their infants.

In this analysis all singleton pregnancy outcomes ≥20 weeks gestation were included. CAs were evaluated according to the Antiretroviral Pregnancy Registry criteria. Maternal ARV regimens were categorised according to the most complex regimen received for ≥28 days of pregnancy.

Of the women enrolled in this study 995/1229 pregnancy outcomes met the inclusion criteria. The investigators reported that, of these, 60/974 liveborn infants and 1 stillborn infant had at least one CA. They found the overall incidence of CAs in this study was 6.26 defects/100 live births (95% CI: 4.74 -7.78).

They reported no statistically significant differences in the proportion of pregnancy outcomes with CAs according to: whether maternal ART was initiated before conception (p=0.86); the most complex ARV regimen received during pregnancy (p=0.45) or during the 1st trimester (p=0.06).

They wrote: “In this study population, preliminary results suggest CAs were not associated with exposure to ARVs at conception or most complex regimen received during the first trimester or during pregnancy overall.”

Ref: Joao E, Calvert GA, Krauss M et al. Maternal antiretrovirals during pregnancy and infant congenital anomalies: The NISDI Perinatal Study. 48th ICAAC, 25-28 October 2008. Washington. Abstract H-457.