Additional research from Botswana has found that the risk of neural tube defects (NTDs) is less than posted last year.
The development comes after Tsepamo study presented the 22nd International AIDS Conference (AIDS 2018) last year, suggested that the use of dolutegravir (DTG) in early pregnancy may be linked to neural tube defects (NTDs), serious birth defects of the brain and spine.
According to a press release from Botswana Harvard AIDS Institute Partnership (BOHAIP) Communications Coordinator Tapela Morapedi, the safety of the HIV treatment drug, dolutegravir (DTG), during pregnancy has been one of the most urgent questions in global health for the past year. “The Tsepamo study resulted in some countries stopping their plans to make DTG-based regimes their preferred first-line therapy. The World Health Organisation (WHO) issued a note of caution about the use of DTG by women of childbearing age as part of its interim guidelines. It also recommended DTG as the preferred first- and second-line antiretroviral therapy for people living with HIV,” Morapedi notes.
To help clinicians and health ministries act on these new findings, WHO issued updated recommendations on antiretroviral therapy and DTG use. Morapedi indicates that to inform those recommendations, a number of community and scientific fora were held to discuss the issue directly with women of reproductive age who have the least access to obtaining DTG.
WHO updated the recommendations based on new evidence. Botswana’s Tsepamo study analysed more than 119,000 deliveries from August 2014 to April 2019, including nearly 1,700 amongst women who were taking DTG-based therapy around conception.
“A second analysis from Botswana surveyed health facilities that were not included in the Tsepamo study. Examining data from 22 facilities from October 2018 to March 2019, researchers confirmed one case of NTDs in pregnancies of 152 mothers who had been taking DTG-based therapy at conception. By comparison, two cases of NTDs occurred among of more than 2,300 HIV-negative mothers,” he states.
With more data, the researchers have found the risk in the prevalence of NTDs among women taking DTG is less than originally signalled. Specifically, NTDs occurred in three per 1,000 deliveries among women on DTG from conception – compared with one per 1,000 deliveries among women taking other ARV regimens.
“Community engagement, including input from women living with HIV, has played a key role in updating these recommendations and will be critical to rolling them out,” Jacque Wambui, African Community Advisory Board (AFROCAB) member, Kenya, said.
“Ultimately, what is most important is offering women the choice to make informed decisions,” Anton Pozniak, International AIDS Society (IAS) President and IAS 2019 International Scientific Chair, said.
Dolutegravir (DTG)-based first-line ART was recommended as an alternative regimen due to evidence gaps for its use in pregnancy, preconception and with rifampicin (RIF)-based tuberculosis (TB) treatment and lack of generic formulations at that time.