Dapivirine Ring: Key Results
Overview of Phase III trial results: In 2016, two large clinical trials — The Ring Study and ASPIRE — found that IPM's monthly vaginal ring containing the antiretroviral drug dapivirine reduced women's HIV-1 risk by approximately 30 percent overall and was well-tolerated with long-term use. HIV risk was cut by 45 percent among participants who used the ring at least some of the time.
Interim open-label study results suggest greater adherence and risk reduction can be achieved: In March 2018, interim analyses of two open-label studies of the ring, DREAM and HOPE, found increased product use over the Phase III trials, with over 90 percent of women using the ring at least some of the time. In addition, the interim data suggest that the HIV incidence observed in the open-label studies was approximately 50 percent lower than would be expected without use of the dapivirine ring based on statistical modeling. More recent data from DREAM suggest a 59 percent reduction in HIV risk. These findings are limited by the lack of placebo comparison groups in the open-label studies, which are ongoing. Together, these results suggest that when women know the ring helped reduce HIV risk in large clinical trials, they are more likely to use it and see greater protection. HOPE completed in October 2018 and DREAM completed in January 2019, with final results expected in 2019.
Next steps for the ring: IPM, the ring's developer, is submitting applications to regulators to potentially license the product in countries where women face the highest risk.
Impact: Modeling studies show that microbicides like the dapivirine ring would have a meaningful public health impact as part of a comprehensive HIV prevention approach.
If approved, the dapivirine ring would be the first long-acting HIV prevention method and could be an important new self-initiated option for women, who bear the greatest burden of the global HIV/AIDS epidemic.
Learn more about the results from the dapivirine ring studies:
- Interim open-label study results (March 2018):
- Additional Phase III trial results (July 2017): IAS 2017 abstract and
- Primary Phase III trial results (Feb. 2016):
- Fact sheet: A Long-Acting Ring to Protect Women Against HIV
- Fact sheet: IPM: Pioneering HIV prevention options for women