The World Health Organisation (WHO) announced that it has updated the 2019 guidelines regarding the treatment of all HIV populations, including pregnant women and those of childbearing potential.
ViiV Healthcare’s dolutegravir (DTG) is an integrase strand transfer inhibitor and the most recent antiretroviral approved for treatment of HIV-1 infection.
However, there has previously been controversy over its use. A study conducted in May 2018, in Botswana, had found a possible link between DTG and neural tube defects in infants born to women using the drug at the time of conception.
Four cases were reported of neural tube defects out of 426 women who became pregnant while taking DTG. Following these results, many countries advised pregnant women and women of childbearing potential to switch use to efavirenz (EFV), an alternative HIV treatment.
However, according to WHO, new data from two large clinical trials in Africa have now expanded the evidence base and found that the risks of neural tube defects are ‘significantly lower’ than the initial studies suggested.
The guidelines group also considered the benefits and harms associated with the two drugs, the values and preferences of people living with HIV, as well as the implementation and cost of HIV programmes in different countries.
“DTG is more effective, easier to take and with fewer side effects than alternative drugs,” the WHO suggested and added that the drug also has a high genetic barrier to developing drug resistance.
According to the organisation, this is important given the rising trend of resistance to EFV and nevirapine-based regimens. In 2019, 12 out of 18 countries reported pre-treatment drug resistance levels exceeding the recommended threshold of 10%.
WHO concluded that “Every treatment decision needs to be based on an informed discussion with the health provider weighing the benefits and potential risks.”