2020/07/29: In a milestone for women’s HIV Prevention, the European Medicines Agency (EMA) adopted a positive opinion on the International Partnership for Microbicides (IPM) Dapivirine Vaginal Ring to reduce HIV risk.
DF/Net Research welcomes this EMA action which moves a much-needed, woman-initiated HIV prevention option one step closer to reaching women who urgently need it.
The monthly ring is the first long-acting HIV prevention product and is designed to help address women’s unmet need for new methods given the persistently high rates of HIV they face, especially in sub-Saharan Africa. It will be an important option for women who choose not to or are unable to use the daily oral antiretroviral (ARV) pill known as PrEP (or pre-exposure prophylaxis), now becoming more widely available in Africa. Oral PrEP is highly effective, but not all women are able to use it.
Efficacy data, including additional data provided during the EMA’s review, showed that IPM’s dapivirine ring reduced women's HIV risk by 35% with no safety concerns with long-term use. More recent data from open-label extension (OLE) studies of the product suggest even greater HIV risk reduction.
Congratulations to our IPM friends and global partners in clinical research for this long-awaited excellent news. “It has been a pleasure and great honor to work with IPM’s team of dedicated research professionals over the past 14 years,” says Lisa Ondrejcek, President and co-founder of DF/Net Research. DF/Net has managed and analyzed data for the dapivirine ring studies, among other HIV prevention drug trials. We look forward to continuing to collaborate and contribute to IPM’s impactful work in developing follow-on HIV prevention options, addressing the needs of women globally.