The European Medicines Agency (EMA) has approved the dapivirine HIV prevention ring for women with a high HIV burden

The European Medicines Agency (EMA) announced today that the Committee for Medicinal Products for Human Use (CHMP) has given a favorable opinion on the benefits and risks of using Dapivirine Vaginal Ring (DPV-VR) for HIV prevention.

DPV-VR is used to reduce the risk of HIV infection during vaginal sex for women aged 18 and over, who are at higher risk of HIV, combined with safer sexual practices when oral pre-exposure is prophylaxis ( PrEP) is not used, cannot be used or is not available.

The antiretroviral drug dapivirin is released from the ring into the vagina slowly over one month. The ring is made of silicone and is easily bent and placed in the vagina.

The vaginal ring was developed as a female option initiated to reduce the risk of HIV infection. The ring should be worn continuously in the vagina for 28 days, after which it should be replaced with a new ring.

DPV-VR is intended for use by women as a complementary approach to prevention, with safer sex practices when women cannot use or do not have access to oral PrEP. Although vaginal contraceptive rings have been available for several years, DPV-VR is the first vaginal product to prevent HIV. Research is underway to develop a vaginal ring that includes both contraception and HIV prevention.

This scientific opinion of the CHMP is part of the EMA’s cooperation with the WHO, entitled EU-medicines 4 All (EU-M4all) in accordance with Article 58 of Regulation (EC) No 1907/2006. 726/2004; The EMA provides scientific advice on high-priority medicines for markets outside the European Union, in particular to facilitate access in low- and middle-income countries to products that prevent or treat diseases of major public importance, including HIV.

The EMA’s positive opinion paves the way for regulatory approvals for countries in countries where women could benefit from additional HIV prevention options. The CHMP announced that it would seek further data on safety and efficacy in younger women (18 to 25 years of age) and on resistance testing for women who become HIV positive (seroconverters). The WHO will review the scientific evidence related to DPV-VR and the values ​​and preferences of women as part of the ongoing ARV guidance process, but there is still no recommendation for its use.

“This decision opens the door to PrEP for women. The safety profile of the Dapivirine vaginal ring is a real winner, making it a real, easily accessible PrEP product, with true end-user control, available to women. The future of multi-purpose intravaginal products with the addition of contraceptives is now something we can look forward to. We thank the EMA for a thorough and meaningful review and celebrate these results on our daughters and their children. said Dr. Nelly Mugo, principal investigator and head of the Child Sexual, Reproductive and Reproductive Health Research Program (SRACH-RP) at the Kenya Medical Research Institute (KEMRI).

“On the example of oral PrEP, we learned that women will use products when they are researched and found to work. Women need choices and hopefully the ring may contribute to these options in the future. said Definate Nhamo, a community representative, Zimbabwe.

Girls and young women in many parts of East and South Africa continue to experience unacceptably high rates of HIV. Women want and need more choices for HIV prevention. The DPV ring adds options that are available.

“The ring is unique in a way that I don’t have to lie or reveal to anyone because it’s discreet. It gives me the strength to protect myself without asking anyone’s consent,” said Cleopatra Makura, a proponent of the young woman, Zimbabwe.

The WHO emphasizes that to provide HIV prevention to women, it is always critical to provide them along with other services, including diagnosis and treatment of STIs, HIV testing and links to antiretroviral therapy for all women testing positive options and a range of contraceptive options. Services must also be provided to women who experience intimate partner violence, and health professionals need training to provide services that respect and include women in all their diversity.

“A monthly ring with dapivirine provides women with the first discreet, long-lasting choice of HIV prevention. Although the effectiveness of the DPV ring is likely to be lower than that for oral daily PrEP, it could offer the option to women who are unable to take oral PrEP as part of comprehensive HIV and SRH services. said Dr. Sinead Delany-Moretlwe, Chair for the HPTN 084 Protocol, Wits RHI, South Africa.