Brazilian Cohort: No Neural Tube Defects Detected in Children of Women on Dolutegravir

A handful of new studies weighing the risks and benefits of antiretroviral therapy (ART) regimens containing dolutegravir have triggered new recommendations from the World Health Organization (WHO), advising the use of the medication for all populations, including women of childbearing potential.

One of the studies contributing to the conversation on dolutegravir use in pregnancy was carried out by a team of investigators evaluating a cohort of 382 women in Brazil. The results were presented at the 10th IAS Conference on HIV Science (IAS 2019).

No neural tube defects (NTDs) were detected in infants born to HIV-positive women exposed to dolutegravir at conception in the study.

“DTG-exposure was not associated with NTD in our cohort; the incidence of NTD is likely well under 1% among DTG-exposed HIV-positive women in Brazil,” the investigators reported.

The research team, comprising investigators with Brazilian public health, as well as Vanderbilt University, combed the Brazilian ART database to identify women who became pregnant while taking ART containing dolutegravir, efavirenz, or raltegravir within +/- 8 weeks from estimated date of conception between January 2015 and May 2018. The primary outcome was occurrence of a NTD.

Of the 1468 women included in the study, 382 were dolutegravir-exposed, compared with 1086 efavirenz- and/or raltegravir-exposed. At conception, in general, dolutegravir-exposed women were younger, more recently diagnosed with HIV, had lower CD4 counts, and were less likely to have achieved virological suppression. Of the dolutegravir-exposed women, 48% received folic acid supplements during pregnancy.

In infants born to women included in the study, no NTDs were detected in either exposure group—dolutegravir-exposed [0; 95% CI 0, 0.0099] or unexposed [0; 95% CI 0, 0.003].

“Ongoing pharmacovigilance of pregnancy outcomes from diverse settings is necessary for clarification of NTD risk associated with DTG,” the investigators concluded.

Based on this study and others presented at IAS 2019 weighing the benefits and risks of ART regimens containing dolutegravir, the WHO announced it is updating its recommendations on first- and second-line ART including dolutegravir.

“Based on new evidence assessing benefits and risks, the WHO recommends the use of the HIV drug dolutegravir as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential,” a WHO press release reported Monday.

The study, “No occurrences of neural tube defects among 382 women on dolutegravir at pregnancy conception in Brazil,” was presented Monday, July 22 2019, at IAS 2019 in Mexico City, Mexico.