HIV treatment in sub-Saharan Africa: delays in transition to dolutegravir

BACKGROUND: In July 2018, WHO assumed a regulatory role and issued a 'safety signal' regarding dolutegravir (DTG) based on preliminary Botswana Tsepamo neural tube defects study data. Regulatory evaluations of rare neonatal adverse reactions are complex and require considerable subject area expertise. In July 2019, WHO reversed itself and recommended DTG as part of the preferred first-line HIV treatment for all adults. The year delay, mixed messaging, and confusion regarding DTG safety may have impacted national level adoption.
METHODS: We collected 35 HIV guidelines published after 2015 for 20 countries in the sub-Saharan Africa (94% regional HIV burden in 2019, 24 million people living with HIV). We abstracted publication date and DTG-specific recommendations. Months delay to revised national guidelines after the WHO 2019 DTG recommendation were calculated.
RESULTS:

As of February 2021, only eight countries (55% regional burden) recommend DTG for all adults per WHO 2019 guidelines. Five countries (15% regional burden) recommend DTG with exception of pregnant women and/or women of childbearing age (WHO 2018 recommendations) and two countries (9% regional burden) recommend it as an alternate regimen (WHO 2015 recommendations). DTG is still not recommended in five countries (15% regional burden). The average time lag of WHO 2019 guidelines adoption was 5 months (range 3'7 months). Assuming that the remaining 12 countries adopt DTG for all adults by February 2021, the average time lag will increase to 12 months.
CONCLUSIONS: Adoption of DTG in sub-Saharan Africa is delayed. The 2018 false alarm and ensuing confused messaging about safety may be contributing to the delay. Monitoring uptake of WHO guidelines provides an opportunity to learn lessons and take corrective actions. Millions of lives depend on establishing a critical pathway for the rapid translation of science to service delivery while holding people and agencies accountable for accelerating or delaying proposed national policy changes.