February 22, 2016
Big news from two trials of HIV prevention for women was released today at the 2016 Conference on Retroviruses and Opportunistic Infections. Two trials of a vaginal ring containing the antiretroviral drug dapivirine announced their results. Both ASPIRE and The Ring Study found evidence of modest protection. The data were described at a CROI press conference and will be officially presented on Wednesday, February 24.
This update contains links to resources from the trials, AVAC’s press release, and a brief summary of key facts about, and AVAC’s take on, these important data. We will be updating our website in the coming days and working with partners to prepare a fuller analysis of the advocacy agenda for the ways forward. Please join the conversation—starting with our webinar on March to discuss the latest with researchers and advocates from around the globe. (Update: Recording now available.
At a glance:
- Should I be excited about this? Yes. The two trials, which were independently conducted, had very similar results. This is good news for the field—in the past microbicide trials of the same product have had different findings. The data are clear that the dapivirine vaginal ring can work, and this should trigger regulatory action (see below).
- What’s the bottom line? The data show that, as with daily oral PrEP and condoms, the product works when it is used correctly and consistently. But the trials also show that in a research setting, when women are told that they might be getting a placebo and that the product might or might not protect them, some participants—especially younger women—did not use the ring as prescribed.
- When can I get the ring? The dapivirine ring is different from daily oral PrEP in that it is an experimental product (tenofovir-based oral PrEP used an existing, widely-used drug for HIV treatment). This means quantities are limited, and that the product can only be made available through research settings until it is approved. There is no opportunity for off-label use.
- Well, then what do we do in the meantime? Younger women in both trials had lower rates of product use and lower rates of protection than older women. This, along with incidence rates of over 4 percent, is a reminder of the urgent need to deliver tools and programs that truly address young women and adolescent girls’ prevention needs now, while developing additional methods for the future.
AVAC’s priorities for action:
Demonstrate the ring’s role in prevention
- The trials show that the dapivirine ring can be an effective prevention option for some women. The International Partnership for Microbicides should immediately proceed to submit a regulatory dossier for product licensure. If licensed, the ring could be piloted in “real world” settings, where approaches to improve consistent use can be explored.
- Open-label extension trials for HIV-negative participants in the trials should be launched. Funders should not turn away from the evidence. The dapivirine ring works for some women and, now that safety and effectiveness has been established, it may work for more women—including those assigned to the placebo arms in the original trials. All participants should have access to open-label extension trials as originally planned by both trial sponsors.
Deliver daily oral PrEP
- Even if the steps above are taken, it will be years before the dapivirine ring is available in public health programs designed to meet the needs of women in all their diversities. Daily oral PrEP is available today and must be explored via ambitious and innovative programs that provide safe, sustainable and community-supported access. This can include offering daily oral PrEP in open-label extension studies for the dapivirine ring.
Develop additional tools
- Vaginal rings are already used to deliver contraception. They are a valuable platform for potential “multipurpose prevention technologies” (MPTs) that would provide both contraception and HIV prevention in a single product. MPT research must continue—for many women, including those at substantial risk of HIV, pregnancy prevention is a top priority. A combination tool is a critical goal for the field.
- Additional prevention options remain necessary. Funders, researchers and civil society must remain resolute in sustaining the search for prevention options that women and men will want and use, including other long-acting ARV-based prevention options, vaccines and antibody-mediated prevention.
Please join us in congratulating both trial teams, the site staff and most especially the women who participated in the trials, whose contributions of time, information and trust have once again advanced the field.
We look forward to working with all stakeholders to understand and act on these results.