Long-Acting HIV Prevention Drug Takes a Step Toward Federal Regulation – a Milestone in HIV Prevention

Researchers at RTI International studied the impact of the dapivirine vaginal ring for over a decade

RESEARCH TRIANGLE PARK, N.C. – The European Medicines Agency (EMA) announced today a favorable scientific opinion about the monthly dapivirine vaginal ring (DPV) for HIV prevention. This is the first long-acting, safe and effective, HIV prevention product of its kind for women and further secures the DPV ring on a trajectory towards regulatory approval, globally. Researchers at RTI International, a nonprofit research institute, have studied the ring for over a decade through a collaborative effort with the International Partnership for Microbicides (IPM) and the Microbicide Trial Network (MTN).

“The DPV ring is a big step forward towards HIV prevention in low- and middle-income countries,” said Ariane van der Straten, PhD, the Director of the Women’s Global Health Imperative Program at RTI.  “The success of the ring shows hope and optimism for the future of HIV prevention as we continue to work toward a more diverse portfolio of prevention methods.”

At the end of 2019, the WHO reported that there were nearly 38 million people living with HIV across the globe. Data, including that thereof provided by the EMA during the review process, reports a 35 percent reduction rate in HIV with use of the DPV ring. This is likely a conservative estimate as more recent data from open-label extension studies show that the reduction rate could be even higher. Because the ring is also well liked and accepted by users, these protection levels are a significant milestone towards reducing global HIV rates.

Researchers from many organizations, including RTI, have published several studies in the past decade on the DPV ring. Most notably, the effectiveness found from multiple different phase III trials of the DPV ring have culminated an overall positive opinion of the ring – a milestone step on the path toward regulatory approval.

“This work cannot end with today’s exciting news,” said van der Straten. “Now that we’ve demonstrated that a topical, monthly product is safe and effective in preventing HIV, we need to make sure it is accessible in communities and take into account the intended user’s desires, needs and preferences.”

After today’s favorable opinion, researchers are hopeful the DPV ring will move into a multiple regulatory process across Africa and a FDA submission. IPM and MTN alongside RTI researchers, aim to study the impact of monthly DPV rings on adolescent girls, pregnant women and breastfeeding women.

The organizations aim to make the DPV ring widely available in 2021, though there are several next steps in the approval process.

RTI's Women's Global Health Imperative research informs the design, implementation and scale-up of new programs, monitoring and evaluation systems, and health policies around the globe.

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