No association between maternal antiretrovirals in pregnancy and congenital anomalies

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.”


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.

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