The relatively uncommon neural tube defects (NTDs) are among the most severe birth defects that affect an estimated 300 000 births annually.
Although the causes of NTDs are multifactorial and difficult to study, folate supplementation is well established in their prevention. In this context, the 2018 announcement that preconception use of dolutegravir was associated with four NTDs in a population-based surveillance study in Botswana generated immediate and massive concern.
Dolutegravir was at that time poised to become the preferred first-line antiretroviral agent throughout international guidelines; the announcement sent shockwaves through the HIV world, as regulators, scientists, policy makers and people living with HIV sought to grapple with this possible association.