Harare (Zimbabwe), Dec. 8, GNA – Dolutegravir (DTG) is safe to use in pregnancy, Dr. Vincent Ganu, a Principal Medical Officer at the Korle Bu Teaching Hospital in Ghana has stated.
Dr. Ganu explained that dolutegravir is a new class of HIV medications that has less side effects, decreases the amount of HIV in the blood in a shorter time and has less resistance compared to the existing HIV medications.
He was speaking on “Dolutegravir safety in pregnancy: Outcomes from an observational cohort study in Ghana, 2022,” during a panel discussion at the ongoing 22nd edition of the International Conference on Aids and Sexually Transmitted Infections in Africa (ICASA) in Harare, Zimbabwe.
Dr Ganu said Ghana rolled out DTG for the first time in 2019, adopting WHO caution in its guidelines at the time of avoiding giving DTG to pregnant women especially in the first 2 months of pregnancy.
He said dolutegravir had been widely available since 2017, following the signal that infants born to women with dolutegravir exposure at conception in Botswana had a higher risk of neural tube defects (NTDs).
He said public health leaders initiated a national investigation to evaluate periconception dolutegravir exposure among all pregnant women.
Dr. Ganu noted that research on DTG was commissioned from August 2020 to September 2022 to assess treatment outcomes in a cohort of patients living with HIV initiated on DTG.
The study also assessed neural tube defects in children born to pregnant women in that cohort in Ghana, a country with folic acid fortification of food.
In this prospective, observational, national cohort study, non-pregnant women in the cohort initiated on DTG were eligible and were counselled to notify clinicians of their desire to get pregnant for DTG to be changed to Efavirenz (EFV) (an already existing HIV medication) as per national HIV treatment guidelines in 2019.
All women identified with pregnancies and possible dolutegravir exposure within 8 weeks of the estimated date of conception, Dr. Ganu stressed that all non-pregnant women in the cohort who were identified to be 8 weeks or more pregnant whilst on DTG without pre-notification of clinicians were included in the study and followed up.
He noted that the primary outcome was the presence of neural tube defects (NTDs) in babies at birth, explaining that neural tube defects are a group of birth defects in which an opening in the spine or cranium remains from early in human development.
He said 2097 women were initiated on the DTG programme. 2039 were not pregnant, 58 pregnancies were recorded during the period out of which 22 notified clinicians and were switched to EFV.
But 36 were pregnant ≥8 weeks and still on DTG and did not notify clinicians so were followed up till they delivered, and their children examined for NTDs.
Dr. Ganu noted that, based on empirical evidence gathered during the study period, the research team concluded that there were no NTDs in children born to women with dolutegravir exposure within eight weeks of conception in our study.
“Despite the small sample size being a limitation, we can report that dolutegravir is safe to use in pregnancy,” the Principal Medical Officer at the Korle Bu Teaching Hospital stated.
