Dolutegravir – Risk of neural tube defects

ViiV Healthcare would like to inform you of a potential safety issue which has been brought to our attention by the Principal Investigator of the above study conducted in Botswana. The potential safety issue is related to Neural Tube Defect (NTD) cases in infants born to women with exposure to dolutegravir-containing regimens at the time of conception identified from a preliminary unscheduled analysis of the Tsepamo study (4 NTD cases out of 426 pregnancies on dolutegravir). This represents an incidence of about 0.9% with an expected background rate of about 0.1%.

2019 Apr