Circular 17 June 2021: Dolutegravir in Pregnant Women and Women of Child-bearing Potential (WOCP)
The risk of neural tube defects in infants exposed to dolutegravir in early pregnancy that was first identified in the Tsepamo observational study in Botswana has diminished over time, with the accumulation of further data. The risk difference between dolutegravir and efavirenz is no longer significant. Dolutegravir (especially when combined with tenofovir alafenamide) is associated with more wei
The risk of neural tube defects in infants exposed to dolutegravir in early pregnancy that was first identified in the Tsepamo observational study in Botswana has diminished over time, with the accumulation of further data. The risk difference between dolutegravir and efavirenz is no longer significant.
Dolutegravir (especially when combined with tenofovir alafenamide) is associated with more weight gain during pregnancy than efavirenz, but the difference is unlikely to be clinically relevant.
Randomised controlled trials have shown non-inferiority in terms of maternal viral suppression rates at 48 weeks. Dolutegravir causes more rapid viral suppression than efavirenz, resulting in increased viral suppression rates by time of delivery in randomised controlled trials of ART initiation in the second and third trimester of pregnancy. This has not yet translated into a demonstrable difference in mother-to-child transmission risk, but event rates are very low with both regimens.