European Medicines Agency (EMA) approval of the dapivirine ring for HIV prevention for women in high HIV burden settings

The European Medicines Agency (EMA) announced today that its human medicines committee (CHMP) provided a positive benefit-risk opinion on the use of the Dapivirine Vaginal Ring (DPV-VR) for HIV prevention.The DPV-VR is intended to be used to reduce the risk of acquiring HIV during vaginal sex for women aged 18 years and over, who are at higher HIV risk, in combination with safer sex practices when oral pre-exposure prophylaxis (PrEP) is not used, cannot be used or is not available.The antiretroviral drug dapivirine is released from the ring into the vagina slowly over one month. The ring is made of silicone and is easy to bend and place in the vagina.The vaginal ring was developed as a female-initiated option to reduce the risk of HIV infection. The ring should be continuously worn in the vagina for a period of 28 days, after which it should be replaced by a new ring.The DPV-VR is intended for use by women as a complementary prevention approach in addition to safer sex practices when women cannot use or do not have access to oral PrEP. While contraceptive vaginal rings have been available for several years, the DPV-VR is the first vaginal HIV prevention product. Research is underway to develop a vaginal ring that includes both contraception and HIV prevention. This CHMP scientific opinion is part of EMA’s cooperation with WHO, named EU-Medicines 4 All (EU-M4all) under article 58 of Regulation (EC) No 726/2004; EMA provides scientific opinions on high priority medicines intended for markets outside of the European Union, specifically to facilitate access in low- and middle-income countries to products that prevent or treat diseases of major public health importance, including HIV. An EMA positive opinion paves the way for regulatory approvals for the ring in countries where women could benefit from additional HIV prevention options. The CHMP has indicated that it is looking for further safety and efficacy data in younger women (18 to 25 years old) and on resistance testing in women who become HIV positive (seroconverters). WHO will review scientific evidence related to DPV-VR and the values and preferences of women as part of its ongoing ARV guideline process but does not yet have a recommendation for its use. “This decision opens doors to PrEP access for women. The Dapivirine Vaginal Ring safety profile is a real winner, making an over-the-counter, easily accessible PrEP product, with true end user control, available to women a real possibility. The future of multi-purpose intravaginal products with the addition of contraceptives is something we can now eagerly look forward to. We thank the EMA for their thorough and considerable review and celebrate these results for our daughters and their children.” said Dr Nelly Mugo, Chief Research Officer and Head, Sexual, Reproductive, and Adolescent Child Health Research Program (SRACH-RP) at the Kenya Medical Research Institute (KEMRI).“We have learned from the example of oral PrEP that women will use products when they have been researched and found to work. Women need choices and we hope that the ring may add to these options in the future.” said Definate Nhamo, community representative, Zimbabwe.Adolescent girls and young women in many parts of East and southern Africa continue to experience unacceptably high HIV incidence. Women want and need more HIV prevention choices. The DPV ring adds to the options available. “The ring is unique in a way that I do not have to get agreement from or disclose to anyone because it is discreet. It gives me power that I can protect myself without seeking consent from anyone” said Cleopatra Makura, young woman advocate, Zimbabwe.WHO stresses that when providing HIV prevention for women it is always critical to provide these alongside other services including STI diagnosis and treatment, HIV testing and links to antiretroviral therapy for all women who test positive and a range of contraception options. Services must also be provided for women who experience intimate partner violence and health care workers need training to provide services that are respectful and inclusive of women in all their diversity. “The monthly dapivirine ring provides women with the first discreet, long-acting HIV prevention choice. Although the efficacy of the DPV ring is probably less than that for oral daily PrEP, it could offer an option for women who are unable to take oral PrEP as part of comprehensive HIV and SRH services.” said Dr Sinead Delany-Moretlwe, HPTN 084 protocol chair, Wits RHI, South Africa.