Antiretrovirals and Pregnancy: New Warnings Demand Close Attention

Antiretroviral therapy should be taken during pregnancy to prevent vertical transmission of HIV; thus, understanding the safety and efficacy of antiretroviral medications in pregnancy is of paramount importance. Now, new data have raised concerns about two medications — dolutegravir when taken around the time of conception and cobicistat-boosted darunavir when used during pregnancy.

In May 2018, authors of the Tsepamo observational study in Botswana reported preliminary findings of neural tube defects (NTD) in four infants born among 426 women who conceived while on dolutegravir (a rate higher than in offspring of women receiving other antiretroviral medications). As a result, the FDA and Department of Health and Human Services (DHHS) Guidel…