Dapivirine Vaginal Ring
The first microbicide to be submitted for regulatory approval is an intravaginal silicone ring, developed by the International Partnership for Microbicides (IPM). It looks like the contraceptive ring but instead releases dapivirine, an antiretroviral drug, slowly over the course of one month. It is user-controlled (the woman can remove the ring herself if she wants to) and its effect is localized (limited to the vagina) rather than systemic (affecting the whole body).
Evidence and Research
- Between 2012 and 2016, IPM and the Microbicide Trials Network (MTN) conducted two Phase III "sister studies" (called The Ring Study and ASPIRE) to test the ring's effectiveness. With the help of over 4,500 women participants in Malawi, South Africa, Uganda and Zimbabwe, they found that ring use reduced the rate of new HIV infections by 56 percent among the women who used it as instructed. Interestingly, women over 21 were more likely than younger women to leave the ring in place. Research is now underway to learn more about how younger women perceive the ring and what might increase their interest in using it.
- Two open-label extension studies, DREAM and HOPE launched in July 2016 to collect additional data on the ring. DREAM completed in January 2019 and HOPE completed in October 2018, with results for both studies expect in 2019. At CROI 2018, researchers presented data from HOPE showing 90 percent of women participating in the study used the ring at least some of the time. In addition, the rate of HIV infection among participants in the open-label study, which has no placebo arm for comparison, is half of what might be expected in the absence of the ring, according to mathematical modeling that has significant limitations. DREAM was also presented at CROI 2018: Interim Results of Open-Label Study of IPM’s Dapivirine Vaginal Ring Find Increased Product Use and Suggest Greater HIV Risk Reduction
- The REACH study will evaluate how adolescent girls and young women use the monthly dapivirine ring and daily oral PrEP, and their preferences for either or both approaches.
- IPM and the MTN (Microbicides Trial Network) are also conducting trials on 3-month rings and rings for pregnant and lactating women. See a full list of trials of IPM’s ring here. Other rings are also in development. See here.
- IPM, the ring's developer, applied to the European Medicines Agency (EMA) for review of the ring under Article 58. This procedure allows the EMA, in cooperation with the World Health Organization (WHO), to provide a scientific opinion on the safety, efficacy and quality of medicines that would be marketed exclusively outside of the European Union—specifically in low- and middle-income countries—for diseases of major public health interest. An opinion is expected by mid-2019. For the latest information, visit IPM's website here.
- IPM has chosen to focus their initial introduction planning in Kenya, Malawi, Rwanda, South Africa, Tanzania, Uganda and Zimbabwe. For many countries, the EMA opinion will advance national-level regulatory decision-making, as would WHO pre-qualification.
- Ring Backgrounder (IPM, Dec 2017) a two-page overview of the dapivirine ring, including trial results, next steps, and potential impact of the product.
- Microbicides Fact Sheet (AVAC, Nov 2017) provides an overview of microbicides, why they are needed, and the current status of microbicide products.
- Dapivirine Ring: The Case for Action (OPTIONS, Sep 2017) lays out next steps for the ring as it nears a regulatory decision and the field prepares for product introduction.
- The Dapivirine Ring Design Guide: Human-centered Design Research to Increase Uptake and Use (USAID, 2017). Design concepts and tools to increase the adoption and sustained use of the DPV ring.
- Video: The promise of the ring for women's HIV prevention (IPM, Dec 2016) provides an overview of the dapivirine ring and next steps for IPM to bring the product to life.
- Video: Microbicides for Women's HIV Prevention (IPM, Oct 2015) provides additional information on the dapivirine ring and is available in Luganda, Sepedi, Tswana, Xhosa and Zulu.
Study Results, Literature Reviews and Summaries
- Results from the Ring Study published in the New England Journal of Medicine (Dec 2016).
- Results from ASPIRE published in the New England Journal of Medicine (Dec 2016).
- Dapivirine Ring Social Behavioral Literature Review and Bibliography (OPTIONS, 2017). A summay of social and behavioral factors influencing dapivirine ring use.
- Dapivirine Ring Modeling Literature Review and Bibliography (OPTIONS, 2017). A review of cost and impact modeling on the dapivirine ring.
- Dapivirine Ring Early Introduction Considerations (OPTIONS, 2018). The OPTIONS Consortium conducted secondary research and interviews with key stakeholders in several countries to understand questions about the ring that could inform demonstration and processes for introducing new biomedical HIV prevention products.
- "What Young Women Want" (AVAC Partners, Dec 2017) — This letter comes from a group of young African women and reflects their HIV prevention research priorities. It was submitted to the National Institutes of Health's (NIH) Division of AIDS (DAIDS) during the open-comment period concerning the structure and agenda for its next funding cycle (2021-2027).
- Inside My Purse (IPM) is a blog by and for adolescent girls and young women across Africa. With sexual and reproductive health as its primary focus, the platform encourages visits and contributions from everyone who cares about promoting health, wellness and empowerment among young women.
Webinars, Podcasts and Presentations
- Lessons Learned from PrEP Rollout for the Dapivirine Ring — presented by AVAC's Elizabeth Gardiner at a HOPE Protocol Team Meeting in September 2018
- Planning for Success: Next steps for the dapivirine ring — In this satellite session from HIV R4P, presenters shared the latest on dapivirine ring research and talked about needed steps to help prepare for the ring's introduction. Click here for the flyer with agenda. And view the webcast here.
- The Latest on the Dapivirine Vaginal Ring — In this webinar, Zeda Rosenberg from International Partnership for Microbicides (IPM) and Jared Baeten of the Microbicide Trials Network (MTN) presented on and discussed the latest data on the dapivirine vaginal ring for HIV prevention. Initial data from the HOPE and DREAM open-label extension ring trials were presented at CROI 2018 and showed that the use of the ring cut HIV risk by 50 percent. Learn more about what these initial data show us, what additional data are expected and plans for the ring in the coming year. And, as always, what can advocates do to advance the agenda?
- What's Next for the Dapivirine Ring — In this episode of Px Pulse, Zeda Rosenberg of the International Partnerships for Microbicides explains the latest findings and spells out how, when, where and if the ring might become an available tool. A trial participant and community leader in Uganda pulls back the curtain on the ups and downs of using the ring, and a Ugandan investigator with the REACH study, Carolyne Akello of the Makere University-Johns Hopkins University Research Collaboration, explains the importance of this trial, the next step in testing the potential of this monthly vaginal ring for young women.
Last updated April 8, 2018.