September 9 -13, 2019 – Representatives from Westat South Africa, visited selected health facilities in Kenya to monitor the progress and analyse the process of an ongoing study on the effects of Dolutegravir (DTG) on women of childbearing age. DTG is a first-line antiretroviral (ARV) drug used for the treatment of HIV infection in combination with other ARVs.
With support from the United States President’s Emergency Plan for AIDS Relief (PEPFAR) through Centers for Disease Control and Prevention (CDC); Centre for Health Solutions – Kenya (CHS); and National AIDS and STI Control Programme (NASCOP) are currently conducting a study, Assessment of Periconceptional Dolutegravir Use and Risk of Adverse Pregnancy Outcomes in Kenya. The aim of the study is to investigate the relationship between maternal periconceptional use of DTG and the risk of Neural Tube Defects (NTDs) and other adverse pregnancy outcomes among women of childbearing age.
A preliminary analysis from a birth outcomes surveillance study in Botswana, The Tsepamo Study, presented a need to further investigate and analyse the birth outcomes among women on ARVs after four cases of NTDs were identified among infants of 596 women living with HIV, who became pregnant while taking DTG. The results indicated an NTD prevalence of 0.7% in the DTG-exposed group (4/596), which is approximately seven times greater than that found among women living with HIV on a non-DTG-based regimen (0.1%; 14 of 11,300).
The study is being conducted in nine counties (Nairobi, Siaya, Machakos, Mombasa, Trans Nzoia, Bungoma, Uasin Gishu, Nyeri, and Kisumu) across 24 facilities.
