One step closer to first long-acting HIV prevention option for women in sub-Saharan Africa

the Seke South clinical research site, one of 3 sites that participated in the ASPIRE Phase III trial

the Seke South clinical research site, one of 3 sites that participated in the ASPIRE Phase III trial 

A woman-controlled, long-acting HIV prevention tool is one step closer to helping stop the spread of HIV. The European Medicines Agency issued a positive opinion supporting the use of the dapirivine ring, developed by the International Partnership for Microbicides, for HIV prevention by cisgender women 18 and older in sub-Saharan African countries. The review was done in cooperation with the World Health Organization using the same rigorous standards for products intended for use in the European Union. The positive opinion is a step along the way to making this essential technology available in some of the areas hardest hit by the HIV epidemic.

The easy-to-use ring works for a month at a time, and users insert and remove it themselves every month. It slowly releases an HIV-prevention drug called dapirivine. Having a longer-acting option is essential for women who don’t want to or are unable to take a daily pill to prevent HIV. The discreet nature of the ring also offers protection to women who may not be able to negotiate condom use with their partners.

Three sites of the Bixby Center’s University of Zimbabwe College of Health Sciences Clinical Trials Unit (UZCHS-CTU) were among 15 international sites that conducted the ASPIRE and HOPE trials in collaboration with Microbicide Trials Network. These trials showed that the ring reduced the risk of HIV by around 30%, with reduction higher in women who used the ring regularly. “This major milestone is a long-awaited achievement for women’s HIV prevention that will provide options for women at risk of HIV”, noted Dr. Mike Chirenje, UZCHS-CTU Principal Investigator, and Site Investigator for both trials.

The EMA opinion opens the door to continuing the work to make the ring available in the areas with the most urgent need. The next steps include review by the World Health Organization, the US FDA and regulatory agencies in individual countries in sub-Saharan Africa. With a concerted push, they may be able to make the ring available by spring of 2021. At the same time, the University of Zimbabwe team and colleagues in other countries will conduct trials for use of the ring with adolescents and pregnant and breastfeeding women. Just like with birth control, no one option will be right for everyone. Introducing new technologies like the dapivirine ring so everyone can find the option that is right for them is a critical step toward a future without HIV.