Based on new evidence of benefits and risks, the World Health Organization recommends the preferred use of dolutegravir (DTG) as a first- and second-line HIV treatment for all populations, including pregnant women and women of childbearing age.
Initial studies had identified a possible link between DTG and neural tube defects (birth defects of the brain and spinal cord that cause conditions such as spina bifida) in infants born to mothers who took the drug at the time of conception. This potential safety issue was reported in May 2018 in a study in Botswana that found 4 cases of neural tube defects in 426 women who became pregnant while taking DTG. Based on these preliminary results, many countries have advised pregnant women and women of childbearing age to take efavirenz (EFV) instead of DTG.
New data from two large clinical trials comparing the efficacy and safety of DTG and VFE in Africa have now added to the evidence base. The risks of neural tube defects are significantly lower than the original studies suggested.
The guideline development group also examined mathematical models of the benefits and harms associated with the two drugs, the values and preferences of people living with HIV, and factors related to the implementation of HIV programmes in different countries and cost.
DTG is a more effective drug, easier to take and with fewer side effects than other drugs currently in use. It also has a high genetic barrier to the development of drug resistance, which is important as resistance to VTE and nevirapine-based regimens tends to increase. In 2019, 12 of the 18 countries included in a WHO survey reported pre-treatment drug resistance levels exceeding the recommended 10% threshold.
All of the above findings led to the decision to update the 2019 guidelines. In 2019, 82 low- and middle-income countries reported that they had begun transitioning to DTG-based HIV regimens. These new updated guidelines aim to help more countries improve their HIV policies.
As with any medication, informed choice is important. Each treatment decision should be based on an informed discussion with the health care provider to assess the potential benefits and risks.
WHO also stresses the importance of providing information and options to help women make an informed choice. To this end, WHO has convened an advisory group of women living with HIV from diverse backgrounds to seek their views on policy issues related to their health, including sexual and reproductive health. WHO stresses the need for continued monitoring of the risk of neural tube defects associated with GTT.