EMA adopts first-ever vaginal ring for HIV prevention

EMA adopts first-ever vaginal ring for HIV prevention

The European Medicines Agency has given a positive scientific opinion on the monthly dapivirine ring. The ring adapts a medical technology commonly used to deliver hormones to women, a milestone for women's HIV prevention. The opinion paves way for WHO and National Regulatory reviews. It is developed by the nonprofit International Partnership for Microbicides (IPM).

What is the dapivirine ring’s potential impact?

Dapivirine ring could give women in Sub-Saharan Africa first long-acting HIV prevention option. Existing prevention methods have not done enough to stop the spread of HIV among women, who bear a disproportionate burden of the epidemic, particularly in sub-Saharan Africa. The monthly dapivirine ring brings women in control by providing them with the first discreet, long-acting HIV prevention option. The ring can be used without a partner’s involvement with no daily action needed.

Girl holding the ring in both hands
Photo: courtesy of IPM

How does it work?

The flexible silicone vaginal ring contains the ARV dapivirine which is slowly released over the course of a month. Extensive trial studies in Malawi, South Africa, Uganda and Zimbabwe showed that HIV risk was reduced by more than half in women who used the dapivirine ring.

Georgina Caswell, Head of Programmes GNP+: "This is really a big deal. You don’t have to get permission from somebody else to be able to use it. This is not only a health thing. It’s a rights thing. This is about women’s rights to be able to take care of our own health and wellbeing. As women we continue to be most affected by HIV so it is really important that there are more choices out there. Already 15 years I’ve been an advocate for microbicides which are women-initiated, self-initiated. I cannot express how excited I am."

For more information, access IPM's press release, a dapivirine ring fact sheet and frequently asked questions.

Aidsfonds welcomes EMA positive scientific opinion

Aidsfonds congratulates IPM with this big step towards zero new HIV infections. New tools are urgently needed to bring down the persistently high infection rates among women. In particular adolescent girls and young women are often not in the position to negotiate condom use, or face challenges in accessing HIV prevention commodities. The dapivirine ring is a highly welcomed additional method for young women to take the lead in their own health, their right to protect themselves, their right to choose.

Next steps

There are still next steps to take before the ring is accessible to women. IPM will collaborate with the WHO to ensure the ring will be included as a prevention method in the WHO HIV prevention guidelines. Countries will need to officially approve the ring, funding need to be found and women and health providers need to be made aware of this new and exciting additional HIV prevention option. To reduce time to market, Aidsfonds is keen to advocate for political and financial support and buy-in.

About IPM

The International Partnership for Microbicides (IPM) is a non-profit enterprise dedicated to develop HIV prevention products for women they can use to protect their health, and to make these products available and accessible where they are urgently needed. Founded in 2002 as a product development partnership, IPM has become an important partner in the microbicide field.

 

Young women and HIV

Every week, over 6000 adolescent girls and young women (aged 15–24 years) become newly infected with HIV, accounting for 60% of new infections in that age group. Among 15-19 years old in Eastern and Southern Africa the gender disparity is worse, with 83% of new infections being among girls.

Aidsfonds releases a bi-annual e-news dedicated to young people. Subscribe to the Young People and HIV newsletter.

Header photo Andrew Loxley, courtesy of IPM

 

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