The European Medicine Agency (EMA) announced today that its Committee on Human Medicines (CHMP) has provided a positive benefit-risk opinion on the use of the dapivirine vaginal ring (DPV-VR) for HIV prevention.
DPV-VR is used to reduce the risk of acquiring HIV during vaginal sex for women over the age of 18 who are at greater HIV risk, in combination with safe sex practices when oral pre- Proliferation prophylaxis (PrEP) is not used, cannot be used, or is not available.
The antiretroviral drug Depivirin is released slowly from the ring into the vagina over a month. The ring is made of silicone and is easy to bend and place in the vagina.
The vaginal ring was developed as a woman-initiated option to reduce the risk of HIV infection. The ring should be worn vaginally for 28 consecutive days, after which it should be replaced with a new ring.
DPV-VR may not be used by women other than safe sex practices or access to oral PrEP as a complementary prevention approach for use by women. While contraceptive vaginal rings have been available for many years, 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 collaboration with the WHO, named EU-Medicines 4 All (EU-M4all), under Article 58 of Regulation (EC) No 726/2004; The EMA provides scientific opinion on high-priority medicines for markets outside the European Union, particularly facilitating access to low and middle-income countries for products that prevent or treat diseases of major public health importance, including HIV. For making.
An EMA positive opinion paves the way for regulatory approval for RING in countries where women can benefit from additional HIV prevention options. The CHMP has indicated that it is looking for further safety and efficacy data in young women (ages 18 to 25) and on resistance testing in 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 its ongoing ARV guideline process, but not yet recommended for its use.
“This decision opens the doors for prep access for women. The Dapivirin Vaginal Ring Safety Profile is a real winner, making over-the-counter, easily accessible SAP products with real end-user control available for women a real possibility. The future of multi-purpose intraveginal products other than contraception is something we can now look forward to. We thank the EMA for their thorough and considerable review and celebrate these results for our daughters and their children. ”Chief Research Officer at Kenya Medical Research Institute (KEMRI) and head of the Sexual, Reproductive and Adolescent Child Health Research Program (SRACH-RP). Nelly Mugo said.
“We learned from the example of oral PrEP that women would use the products when they were researched and got to work. Women need options and we hope that Ring can join these options in the future. ”Said Nemo, community representative, Zimbabwe.
In many parts of eastern and southern Africa, adolescent girls and young women experience unacceptably high HIV incidence. Women want more HIV prevention options. The DPV ring adds to the available options.
“The ring is unique in such a way that I do not have to compromise or confront anyone because it is thoughtful. It empowers me that I can protect myself without seeking consent from anyone ”Cleopatra Makura, young female lawyer, Zimbabwe.
The WHO emphasized that while providing HIV prevention for women, linking to STI diagnosis and treatment, HIV testing and antiretroviral therapy, it is always important to provide other services including positive testing for all women and a range of contraceptive options. Services should also be provided for women who experience intimate partner violence and health care workers need training to provide services that honor women and are inclusive in all their diversity.
“The monthly dapivirin ring provides women with the first thoughtful, long-acting HIV prevention choice. Although the efficacy of the DPV ring is probably lower than that for oral daily PrEP, it may offer an option for women who are unable to take oral PrEP as part of comprehensive HIV and SRH services. "Dr. Sinead Delany-Moretlwe, HPTN 084 Protocol Chair, Wits RHI, South Africa.