Two studies investigating the safety of dolutegravir-based antiretroviral therapy (ART) during pregnancy found that higher rates of adverse pregnancy outcomes did not occur in women who initiated dolutegravir-based ART before conception, and in a cohort of women from Brazil, exposure to dolutegravir at pregnancy conception was not associated with neural tube defects (NTD). Results were presented at the 10th IAS Conference on HIV Science, held July 21 to 24, in Mexico City, Mexico.
Results from the ADVANCE trial showed that of 65 pregnancies, 43.1% were live births, 12.3% were spontaneous abortions, 24.6% were elective terminations, and 16.9% pregnancies were ongoing. Of note, 43 of these 65 pregnancies occurred while the women were receiving treatment with dolutegravir. In addition, the cohort experienced 1 stillbirth and 1 neonatal death. Median birth weights were similar across all treatment groups, although 7.1% of births were premature and 17.2% of births were small for gestational age. Two infants had minor birth defects. No HIV transmission was reported.
In the second study, which specifically investigated dolutegravir and NTD in Brazil, a total of 1468 women were included, of whom 382 were receiving dolutegravir and 1086 were receiving efavirenz and/or raltegravir. Among infants who were exposed to dolutegravir, stillbirths/abortions occurred in 6.5%, whereas this occurred in 4.3% of infants who were not exposed to dolutegravir (P =.09). There were no NTDs in either group.
Both studies add to the limited evidence on the safety of dolutegravir in pregnancy. Investigators reported that ongoing work is needed to clarify the risks for NTDs as a result of dolutegravir exposure in diverse settings and that data from all similar trials need to be pooled to provide regular updates.
1. Chandiwana N, Akpomiemie G, Hill A, et al. Pregnancy outcomes among HIV-positive women on dolutegravir versus efavirenz-based antiretroviral therapy: Week 48 analysis of the ADVANCE trial. Presented at 10th IAS Conference on HIV Science; July 21-24, 2019; Mexico City, MX. Abstract 3269.2.
2. Pereira G, Kim A, Jalil E, et al. No occurrences of neural tube defects among 382 women on dolutegravir at pregnancy conception in Brazil. Presented at 10th IAS Conference on HIV Science; July 21-24, 2019; Mexico City, MX. Abstract 4991.