The Issue
HIV remains a major global public health concern with a disproportionate burden on women. Oral pre-exposure prophylaxis (PrEP) has been an important HIV prevention product, but uptake and adherence has remained low. Long-acting injectable prevention methods are starting to be available but supply to low- and middle-income countries will be limited for several years. To achieve the Sustainable Development Goal of ending the HIV epidemic by 2030, women must be able to choose among a range of HIV prevention options that address their different needs and preferences, as recognized in the UNAIDs Choice Manifesto.
The Product
The monthly dapivirine vaginal ring (DapiRing™) is a user-controlled method that can reduce the risk of HIV transmission during vaginal sex. Once the woman inserts the ring, it sits inside the vagina near the cervix where it slowly releases the antiretroviral drug dapivirine at the site of potential infection. Dapivirine works by blocking HIV’s ability to make copies of itself inside healthy cells. The DapiRing received a positive scientific opinion in July 2020 from the European Medicines Agency for use among women ages 18 and older. The ring has also received prequalification and a recommendation from the World Health Organization. DapiRing now has regulatory approval in 11 countries in Sub-Saharan Africa with additional registrations under review.
The Population Council is currently developing a three-month dapivirine vaginal ring as a line-extension of the monthly dapivirine vaginal ring, with plans to submit for European Medicines Agency (EMA) review in the near future. The three-month dapivirine ring is the same size and shape as the monthly dapivirine ring and is expected to significantly reduce the annual cost of HIV prevention as women would use four rings a year versus 12. Pending a positive review from the EMA, regulatory approval would be sought in Sub-Saharan Africa while exploring options for access in additional regions.
The Progress
A Phase I trial (IPM-054, NCT05416021) to investigate the relative bioavailability of the monthly ring compared to the three-month ring has been completed and data analysis is underway. Data from this study will support the line-extension filing for the three-month ring to the EMA, which is expected to be submitted in 2025. Acceptability data collected in IPM-054 indicate that most women would be willing to use the three-monthly ring, supporting the case for convenience in addition to cost-efficiency of the longer-acting line extension product.
The Population Council is engaged in scaling and optimizing the three-month ring manufacturing process to further improve the cost of goods and reduce production costs. The Population Council has signed a memorandum of understanding with Kiara Health, a 100% Black-owned African-based pharmaceutical manufacturing and health care solutions company, for commercial distribution and manufacturing of the three-month ring. Once a license is in place, this would shift the leadership of the dapivirine vaginal rings to Sub-Saharan Africa, the geography that is most impacted by HIV.
As announced in July 2024, the Children’s Investment Fund Foundation (CIFF), in partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund), will launch an initiative of up to $2 million USD over the 2024-2025 period for the purchase of approximately 150,000 monthly dapivirine vaginal rings in countries that implement Global Fund grants to fight HIV and AIDS. In collaboration with other partners, including Unitaid, the initiative also aims to bridge the gap to the lower-cost, three-month dapivirine ring which will lead to lower prices over the long-term.
The Impact
The three-month dapivirine vaginal ring could represent a nearly 60 percent price reduction to the one-month ring, with further price reduction opportunities still being explored. This price reduction will enable broader access by reducing the annual cost of HIV prevention. By increasing convenience to women, the three-month ring may also increase acceptability and adherence, and may lead to fewer gaps in between ring usage. The three-month dapivirine vaginal ring will expand options and choice for women to protect their health and accelerate global efforts to end the HIV epidemic.
