Dolutegravir in pregnancy-effects on HIV-positive women and their infants

The development of new drugs for treatment of HIV has increased the efficacy and the quality of life together with decreased unwanted side-effect for people living with HIV. The integrase inhibitor dolutegravir has in short time become part of the first-line treatment in many countries, but is not a recommended first-line drug in pregnancy. As there are few publications of dolutegravir use during pregnancy, we found it valuable to analyze the Stockholm pregnancy cohort. A retrospective analysis of all pregnant women and their infants exposed to dolutegravir at Karolinska University Hospital, 2014-August 2017. Information about maternal health, treatment, pregnancy, and child outcome were collected. Thirty-six women with singleton pregnancies were included. Four early spontaneous abortions occurred. One late termination was performed and one was lost to follow-up. Fourteen were on dolutegravir before and 22 started during pregnancy. Eighteen delivered by caesarean section, three of them because of HIV RNA > 50 copies/mL. The preeclampsia rate and the maternal liver function were normal. One infant was delivered in GW 34 on maternal indication and the rest in full term. No gross malformations were noted. All infants received antiretroviral prophylaxis and have tested negative on follow-up. No increased maternal or infant morbidity was detected in this retrospective study of dolutegravir during pregnancy. This is so far one of the largest observational studies of dolutegravir treatment during pregnancy, but the number is indeed small, and further studies are needed to evaluate the safety and efficacy.