Based on new evidence assessing benefits and risks, the World Health Organization (WHO) is recommending dolutegravir (DTG) as preferred first- and second-line HIV treatment for all populations, including pregnant women and women of childbearing potential.
Initial studies had highlighted a possible link between DTG and neural tube defects in infants born to women using the drug at the time of conception. Based on these preliminary findings (May 2018), many countries advised pregnant women and women of childbearing potential to take efavirenz (EFV) instead.
New data from two large clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now expanded the evidence base, with risks of neural tube defects significantly lower than what the initial studies may have suggested, said the WHO.
The WHO guidelines group also considered a number of other factors, including DTG is more effective, easier to take and has fewer side effects than alternative drugs.
DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to EFV and nevirapine-based regimens. In 2019, 12 of 18 countries surveyed by the WHO reported pre-treatment drug resistance levels exceeding the recommended threshold of 10 per cent.