INTRODUCTION
NTDs, NTD
MAY, TERATOGENIC EFFECT
Dolutegravir‐based antiretroviral therapy (ART) has become the preferred treatment option for children living with HIV due to superior efficacy and similar safety compared to non‐dolutegravir‐based ART [A number of studies explored the teratogenic effects of dolutegravir. Pre‐clinical animal studies conducted as part of the dolutegravir development programme showed no effect on embryonic or foetal development [One of the mechanisms by which drugs may contribute to neural tube defects (NTDs) and other teratogenic defects is through interference with folate transport or its metabolism [The largest surveillance study on the use of dolutegravir in pregnancy was conducted in Botswana. The first report from the Tsepamo study in May 2018 suggested an increased risk of NTD among infants of women who conceived on dolutegravir compared to non‐dolutegravir regimens (4/426 [0.9%] vs. 14/11,300 [0.12%]; prevalence difference 0.82%, 95% confidence interval (CI) 0.24, 2.3) [Before the concerns regarding the possible association of pre‐conception dolutegravir with NTDs had been resolved, and considering that a substantial proportion of ODYSSEY participants would be older than 17 years by the end of the randomized phase, with pregnancies already reported in the trial [