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Move On Down the Road: The vaginal dapivirine ring will enter open-label extension trial

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AVAC
Monday, March 14, 2016

Over the weekend, the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), announced that it would move forward with an open-label extension (OLE) study of a vaginal ring for HIV prevention. This welcome development is the latest step in the journey of a unique, woman-controlled prevention option.

It’s been almost exactly three weeks since the world got its first look at data from the ASPIRE trial and The Ring Study, both of which found that a vaginal ring containing the antiretroviral dapivirine provided women in the trial with a modest level of protection against HIV. Both trials had similar results: among all women in the ASPIRE study, the ring reduced the risk of transmission by 27 percent; in the Ring Study, the overall reduction was 31 percent; and effectiveness varied by age—with higher levels of protection seen in older women, possibly because of more consistent use in this age group.

The trial data caused celebration and immediate conversation about what would happen next given that the trial showed both that the ring works and that there may be real challenges with adherence, particularly in younger women. These are the kinds of questions that open-label trials are meant to answer (for a description of the types of studies that follow efficacy results, click here). By definition, in an open-label extension (OLE) study, everyone knows that they are receiving the product, and they receive information learned from the previous clinical trials of the product. Women participants in the open-label extension study of ASPIRE, known as HOPE, will be told that the product reduces risk of HIV if it is used correctly and consistently—worn in the vagina for roughly a month at a time. This type of information may lead more women to use the product versus the trial, where they are told at every study visit that they may have received the placebo, and that there is no evidence that the experimental product provides protection.

NIAID reached its decision to move forward after last week’s consultation with a panel of outside experts that included physicians, scientists, advocates, ethicists and statisticians – including two AVAC Advocacy Fellows from Malawi and Zimbabwe.

NIAID announced that they will also fund additional studies to help answer additional questions that the OLE is not designed to answer. One of these is a study with adolescents and young women (ages 16-21) to look at safety, adherence and acceptability of the dapivirine ring and oral PrEP. This is an important development, and one that will help ensure that the world has the information it needs about the ring should it receive regulatory approval. This regulatory approval process, which is being pursued in tandem with the open-label extensions, involves preparation and submission of an extensive dossier of information on the product from the clinical trials. The International Partnership for Microbicides (IPM), the ring’s developer, is expected to submit for approval in about one year’s time.

Now that NIAID has agreed to fund HOPE, the extension of ASPIRE, it is essential that IPM’s donors similarly support the Ring Study’s proposed open-label extension, DREAM. AVAC and our advocacy partners will be working with urgency in the coming weeks to amplify demand for this study, as well as additional research needed to understand the potential role of the ring in women’s lives. At the same time, we continue to emphasize the urgent need to roll out daily oral PrEP as a tool that can be used right now to reduce risk for women and men and to maintain a robust prevention research pipeline of additional options that will, over time, provide a wider range of options from which women and men can choose.