Rwanda will evaluate the effectiveness of Dolutegravir (DTG), an Anti-retro viral drug which the World Health Organisation has recently approved and cleared.
Initial studies had highlighted a possible link between DTG and birth neural tube defects (defects of the brain and spinal cord in infants born to women using the drug at the time of conception.
However, based on new evidence assessing benefits and risks, the WHO has recommended the use of the HIV drug as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential.
According to information from the Rwanda Biomedical Centre, Rwanda will host a scientific meeting next month on the use of the drug, and recommendations concerning it will be made.
Potential safety concern about the drug was reported in May 2018 from a study in Botswana that found 4 cases of neural tube defects (defects of the brain and spinal cord) out of 426 women who became pregnant while taking DTG.
Based on these preliminary findings, many countries advised pregnant women and women of childbearing potential to take efavirenz (another type of ARVs) instead.
However, new data from two large clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now expanded the evidence base. The risks of neural tube defects are significantly lower than what the initial studies may have suggested.
The study conducted by a Johannesburg-based research group from the University of the Witwatersrand, will only be completed next year. But early results show that dolutegravir is an effective and well-tolerated antiretroviral drug.
The scientists considered mathematical models of the benefits and dangers associated with the drug; the values and preferences of people living with HIV, as well as factors related to implementation of HIV programmes in different countries, and cost.
“DTG is a drug that is more effective, easier to take and has fewer side effects than alternative drugs that are currently used,” read a statement from WHO website after the drug was recommended.
“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 (both ARV drugs),” it went on.
In 2019, 12 out of 18 countries surveyed by WHO reported pre-treatment drug resistance levels exceeding the recommended threshold of 10%.
However, WHO urged that for any medications, informed choice is important.
“Every treatment decision needs to be based on an informed discussion with the health provider weighing the benefits and potential risks,” read a statement from WHO.
The HIV prevalence in Rwanda has been at 3 per cent in the general population (15-49 years) over the last decade.