Dolutegravir in pregnancy and neural tube defects
Preliminary data from an observational study of pregnant women with HIV in Botswana previously suggested a potential association between maternal dolutegravir use at the time of conception and neural tube defects in the infants. However, in the final results of the study, which included a larger number of dolutegravir exposures, an elevated risk remained but was substantially lower than previously reported. The overall incidence of neural tube defects was 0.3 percent with exposure to dolutegravir-based antiretroviral therapy (ART) at conception versus 0.1 percent with non-dolutegravir-based ART. Based on these results, the World Health Organization concluded that the benefits of dolutegravir outweighed this risk and confirmed dolutegravir-based ART as the preferred first-line regimen for people with HIV, including pregnant women and those of child-bearing potential.