CBR: Dapivirine Ring Offering Women in Sub-Saharan Africa First Long-Acting HIV Prevention Option
Product: dapivirine vaginal ring (DVR)
Product Type: Device
Disease: HIV/AIDS
Every day, nearly 1,400 women in Sub-Saharan Africa acquire HIV. Existing HIV prevention tools like condoms and the daily oral antiretroviral (ARV) pill known as PrEP (or pre-exposure prophylaxis) are highly effective, but not all women are able to use them. In a milestone development for women’s HIV prevention, the dapivirine vaginal ring, developed by the nonprofit International Partnership for Microbicides (IPM)*, received a positive opinion from the European Medicines Agency, prequalification and a recommendation from the WHO, which have paved the way for national regulatory approvals, currently in 7 African countries.
The monthly ring is the first long-acting HIV prevention product and is designed to help address women’s unmet need for new methods given the persistently high rates of HIV they face, especially in Sub-Saharan Africa. Made of a flexible silicone, the ring slowly releases an ARV called dapivirine locally in the vagina with minimal systemic absorption elsewhere in the body, which could help minimize side effects. Women would insert the ring themselves and replace it each month.
The dapivirine ring reduced women’s HIV risk by 35% in one Phase III trial[i] and 27% in a second Phase III trial[ii], with no safety concerns. Subsequent open-label extension (OLE) studies saw higher product use and suggested greater HIV risk reduction.[iii] The ring has shown a strong safety profile in all clinical trials to date.
“Empowering women with new HIV prevention options is critical not only to controlling the HIV/AIDS epidemic but also to protecting women’s sexual and reproductive health. We are grateful to our many partners across sectors who helped make a long-acting woman-controlled product a reality. We look forward to building on these and new partnerships to get the dapivirine ring into the hands of women where the need is urgent.”
—ZEDA ROSENBERG, CEO AND FOUNDER, IPM
The development of the dapivirine ring is a result of global partnerships with researchers; trial communities in Africa, Europe, and the United States; civil society; governments; industry; and donors spanning 16 years of research. To shorten the time to product introduction, IPM forged collaborations with entities such as Johnson & Johnson (which granted IPM the rights to dapivirine), the USAID-funded OPTIONS, PROMISE and now MOSAIC projects, and a range of stakeholders across sectors. With this strong political will and funding, the dapivirine ring is now available through demonstration projects and implementation programs around the world.
Additional research on the ring’s efficacy among young women, who are among the highest risk for HIV, is also being collected through ongoing and planned demonstration projects and implementation programs. Collaboration with the Microbicide Trials Network (MTN) are also ongoing to complete studies of the monthly ring’s safety and use among other key populations, including adolescent girls, pregnant women, and breastfeeding women, results from which will inform next steps on potentially expanding the indication for the monthly ring to those groups in the future.
Next steps include the development of dapivirine ring line-extension products including a longer-acting three-month dapivirine ring and three-month multipurpose technology that could simultaneously reduce the risk of HIV and unintended pregnancy.
i. European Medicines Agency review, unpublished data, 2020; Nel A. et al., Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention for Women, NEJM
ii. Baeten J. et al., Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention for Women, NEJM, Feb. 2016.
iii. Nel A. et al., Safety, Adherence and HIV-1 Seroconversion in DREAM—An Open-Label Dapivirine Vaginal Ring Trial, 9th South Africa AIDS Conference, June 2019