Dapivirine Vaginal Ring

dapivirine 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, are ongoing and will provide additional data on the ring. Both were launched in July 2016 and are expected to be completed by December 2018. 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.
  • 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, rings for pregnant and lactating women, and rings for menopausal women. See a full list of trials here.

Status

  • 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. A decision is expected late-2018. For the latest information, visit IPM's website here.
Dapivirine ring regulatory pathway

Dapivirine ring regulatory timeline

  • IPM has chosen to focus their initial introduction planning in Malawi, South Africa, Uganda, Zimbabwe, Kenya, Rwanda and Tanzania. Once the EMA provides a decision, and the product secures WHO pre-qualification, any country can decide to introduce the dapivirine ring.

Resources

The Basics

Study Results, Literature Reviews and Summaries


Blogs

  • "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 and Podcasts

  • 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 11, 2018.

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