Positive Opinion on Monthly Vaginal Ring to Reduce HIV Risk
On July 24, 2020, International Partnership for Microbicides (IPM) announced that the European Medicines Agency (EMA) has rendered a “positive opinion” regarding use of the dapivirine vaginal ring by cisgender women ages eighteen and older in developing countries to reduce their risk of HIV-1 infection. The positive scientific opinion from EMA reflects its assessment of the quality, safety, efficacy, and benefit-risk balance of the dapivirine ring, the first step in seeking approvals for the ring in the countries where it is most needed, especially sub-Saharan Africa.
In June 2017, IPM submitted to the EMA data collected from several studies, including the Ring Study led by IPM, and ASPIRE, conducted by IPM’s clinical trial partner Microbicide Trials Network (MTN) (funded by the National Institutes of Health), two subsequent OLE studies, and a number of smaller safety studies spanning sixteen years of research and development. At the suggestion of the EMA, IPM will conduct further research among cisgender women ages eighteen to twenty-five to better understand the ring’s efficacy and to collect additional data on safety and potential ARV resistance. IPM is also working with MTN to study the efficacy and safety of the monthly ring among adolescent girls, pregnant women, and breastfeeding women, who are at elevated HIV risk. IPM is also accelerating development of other rings, including a longer-acting three-month dapivirine ring and a dual-purpose prevention ring designed for both HIV prevention and contraception.
New HIV infections are declining overall worldwide; however, in many parts of the world, gender inequities make women more susceptible to infection than men. For instance, nearly 1,400 women in sub-Saharan Africa acquire HIV every day. “Even as HIV/AIDS has increasingly become an epidemic borne by women and girls, the response to it has not kept pace,” Dr. Peter Piot, director of the London School of Hygiene & Tropical Medicine and founding executive director of UNAIDS, said in a press release. “As the first long-acting tool for HIV prevention, the dapivirine ring could help change the course of the epidemic for women.”
Before it can be rolled out for worldwide use, the dapivirine vaginal ring must be submitted to other agencies such as the World Health Organization, regulatory reviewers in Africa, and the U.S. Food and Drug Administration.
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—Reporting by Hank Trout
Hank Trout, Senior Editor, edited Drummer, Malebox, and Folsom magazines in the early 1980s. A long-term survivor of HIV/AIDS (diagnosed in 1989), he is a forty-year resident of San Francisco, where he lives with his husband Rick. Follow him on Twitter @HankTroutWriter.