FOR IMMEDIATE RELEASE
October 7th, 2024
Media Contact: Joe Shaffner, Director of Communications,
Population Council, jshaffner@popcouncil.org
Lima, Peru – The Population Council, an international nonprofit research organization, announced today at HIVR4P 2024, the 5th HIV Research for Prevention Conference, the results of a phase I open-label randomized crossover relative bioavailability trial (IPM 054).
The trial found that a 3-month dapivirine vaginal ring delivers the active antiretroviral drug, dapivirine, at higher levels than the 1-month dapivirine vaginal ring. The trial, conducted among 124 women in South Africa, suggests that the longer-acting ring will be as effective as the 1-month ring, offering a more cost effective and convenient option to women who continue to seek options to prevent HIV infection during sex.
“Not only do these results suggest that the 3-month ring will be as effective as the 1-month ring, we expect it to reduce the cost per user by 60%,” said Dr. Brid Devlin, Chief Scientific Officer at the Population Council’s Center for Biomedical Research. “Accessibility and affordability are top of mind for us, as we want to make sure we get these rings in the hands of those who would like to use this method of HIV prevention.”
The 1-month dapivirine ring received a positive scientific opinion from the European Medicines Agency’s Medicines-4-All procedure; it also received prequalification and recommendation from the World Health Organization. The 1-month ring is currently approved for use in 11 African countries. In this trial, the 3-month ring was also shown to be acceptable and well-tolerated for the women in the trial, who used both the 1- and 3-month rings. Depending on country clinical guideline recommendations, the 3-month ring has the potential to reduce the number of clinic visits by users of biomedical HIV prevention.
In July, the Children’s Investment Fund Foundation (CIFF) and Global Fund announced the creation of an Early Market Access Vehicle to accelerate distribution of the 1-month ring where it is approved for use.
“The results of this trial are an exciting step forward as we consider the desire for additional non-systemic options for HIV prevention,” said Professor Thesla Palanee-Phillips, Principal Investigator on Phase III Dapivirine Ring trial (ASPIRE) and Adolescent PrEP study (REACH) and Director of Clinical Trials at Wits Reproductive Health Unit, South Africa. “Ongoing investment in acceptable, affordable, scalable and deliverable longer-acting interventions like the 3-month DPV ring shows responsiveness to end-users’ needs, especially in regions most affected by the HIV epidemic. Any intervention that reduces the burden associated with refill and persistence of use on end-users, healthcare facilities and healthcare providers is a winning trifecta.”
“I participated in the Phase III monthly dapivirine ring clinical trials and used it successfully,” said Akhona Gxarhisa a ring user in Cape Town, South Africa. “Now that my circumstances have changed, I’m older and working full-time – I’m excited about the 3-month ring. It means I won’t have to stress about inserting a new ring every month. With just four rings needed for the entire year, it makes things so much easier for me.”
Choice is essential in the HIV prevention movement, as emphasized in The HIV Prevention Choice Manifesto for Women and Girls in Africa. Despite the availability of other HIV prevention methods, the dapivirine vaginal rings offers a user-controlled, long-acting option to women like Akhona and helps to offer a constellation of options to women and girls.
“We are thrilled by this advancement in dapivirine ring technology,” said Dr. Rana Hajjeh, President of the Population Council. “The 3-month ring has the potential to expand options for women worldwide, protecting their health while accelerating global efforts to end the HIV epidemic.”
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