Dapivirine Ring: Key Results
Overview of Phase III trial results: Two large clinical trials — The Ring Study and ASPIRE — showed in 2016 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. Participants who used the ring at least some of the time saw their HIV infection risk cut by 45 percent across both studies.
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. This finding is 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. Final results are expected in 2019.
Next steps for the ring: IPM, the ring's developer, is pursuing approvals from global and national regulatory authorities to license the product in countries where women face the highest risk.
Two open-label extension studies, DREAM and HOPE, are providing the ring to former Ring Study and ASPIRE participants, respectively. Both studies were launched in July 2016 and are expected to be completed by December 2018.
Impact: Modeling studies show that microbicides would be cost-effective and have a significant public health impact as part of a rights-based HIV prevention toolkit that could avert tens of millions of HIV infections over time.
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 Phase III dapivirine ring studies:
- Primary Phase III trial results (Feb. 2016):
- Additional Phase III trial data analyses (July 2016): Press releases from IPM and MTN
- Interim open-label study results (March 2018):
- Fact sheet: A Long-Acting Ring to Protect Women Against HIV
- Fact sheet: IPM: Pioneering HIV prevention options for women