HIV prevention drug backed by RTI International research takes step toward federal regulation

A technology for HIV prevention that’s been studied for years by researchers in the Triangle has taken a big leap forward on its path to regulatory approval.

The European Medicines Agency on Friday announced a favorable scientific opinion about the monthly DPV – dapivirine vaginal ring – for HIV prevention.

The device would be the first long-acting, safe and effective HIV prevention product of its kind for women.

Research Triangle Park-based RTI International has been studying the ring for more than a decade through a collaborative effort with both the International Partnership for Microbicides and the Microbicide Trial Network. And it was among the organizations providing information to the EMA.

In a prepared statement about the technology, Ariane van der Straten, the director of the Women’s Global Health Imperative Program at RTI, called it a “big step forward toward HIV prevention in low- and middle-income countries.”

“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.”

Data that showed a 35 percent reduction rate in HIV through the use of the DPV ring was described a “conservative estimate,” according to RTI.

Now that the opinion has been released, DPV could soon move into a multiple regulatory process across Africa as well as a submission to the U.S. Food and Drug Administration.

RTI is among those pledging to continue to study the impact of the DPV ring on adolescent girls, pregnant women and breastfeeding women. The goal is to make the DPV ring widely available in 2021, RTI said.

Originele artikelbron: Driehoek zakelijk dagboek