A review and economic analysis of the dapivirine vaginal ring as HIV pre-exposure prophylaxis for women, to inform South African public-sector guidelines.

BACKGROUND:South Africa has a high HIV incidence and oral pre-exposure prophylaxis (PrEP) is available as public-sector standard of care. Access to alternative prevention methods for women may further reduce HIV acquisition. SETTING:South African public-sector. METHODS:We performed a systematic search for high-quality up-to-date guidelines recommending dapivirine ring as PrEP using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE)-Adolopment process. We appraised the systematic review and randomised controlled trial (RCT) evidence underpinning the selected guideline's recommendations and conducted a cost-effectiveness analysis. The GRADE Evidence-to-Decision framework guided the adaptation of source guideline recommendations, according to our local context. RESULTS:We identified the 2021 World Health Organization PrEP Guidelines, informed by two placebo-controlled RCTs, which were included in a contemporaneous systematic review. There were 23 fewer HIV acquisitions per 1000 clients with dapivirine ring versus placebo (95% confidence interval 10-34), with no increase in adverse events (moderate certainty evidence). We found no RCTs comparing dapivirine to oral PrEP, or amongst adolescent/pregnant/breastfeeding clients. Dapivirine is less cost-effective than oral PrEP at $14.59/ring, at the current price. CONCLUSION:The source guideline recommendation was adapted for the local context. Dapivirine ring appears to be less efficacious than oral PrEP, although comparative studies are lacking. Data in adolescents and pregnancy are also lacking, currently limiting the use of dapivirine as an alternative for women unable to take oral PrEP. At the current price, dapivirine is not cost-effective and unaffordable for inclusion in the South African Essential Medicines List.