Lima, Peru — New data from the PURPOSE 2 study of twice-yearly lenacapavir for HIV prevention are among the scientific highlights at HIVR4P 2024, the 5th HIV Research for Prevention Conference, taking place in Lima, Peru, and virtually from 6 to 10 October.
At the official HIVR4P 2024 press conference today, PURPOSE 2 principal investigator Colleen Kelley of Emory University announced new efficacy, safety and demographic data from the trial, in which only two HIV acquisitions occurred among 2,184 trial participants who were randomized to receive subcutaneous lenacapavir every six months (for details, see the press release issued today by Gilead Sciences, which developed lenacapavir). Kelley will formally present these data at HIVR4P 2024 on 8 October at a session starting at 11:00 Peru time (PET).
PURPOSE 2 enrolled HIV-negative cisgender gay, bisexual and other men, trans women, trans men and gender non-binary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States who have sex with partners assigned male at birth. Last month, topline results from an interim analysis indicated that lenacapavir reduced HIV acquisitions by 96% compared to background HIV incidence and demonstrated superiority to daily F/TDF for HIV prevention. Prior to that, the PURPOSE 1 study demonstrated that lenacapavir reduced HIV acquisitions by 100% and demonstrated superiority to daily F/TDF among cisgender women in Africa. Gilead Sciences has said it will begin a series of global regulatory filings by the end of 2024.
“These findings confirm that lenacapavir for PrEP has the potential to transform the global HIV prevention landscape for people of all genders,” Beatriz Grinsztejn, the President of IAS – the International AIDS Society – said. “All stakeholders must work together now, ahead of regulatory approvals, to plan for a rapid, equitable global rollout of this important new prevention tool.”
“The IAS commends Gilead for signing voluntary licensing agreements with generic manufacturers to increase access to lenacapavir in high-incidence, resource-limited countries,” Grinsztejn added . “However, we’re highly concerned that these agreements do not cover large parts of the world, including the majority of countries in Latin America.”
Grinsztejn is also a member of the PURPOSE 2 study team, an HIVR4P 2024 Organizing Committee member and the Director of the HIV/AIDS Clinical Research Unit at the Evandro Chagas National Institute of Infectious Diseases – FIOCRUZ in Brazil.
Other scientific highlights at HIVR4P 2024 include:
• Evidence that the three-month dapivirine vaginal ring is pharmacokinetically superior to the monthly ring
• A PrEP choice study finding moderate uptake of the dapivirine vaginal ring among women in Africa
• A study finding no pharmacologic interactions between long-acting cabotegravir for HIV prevention and hormonal contraceptives
• A drug-agnostic transcutaneously refillable subdermal implant that provides ultra-long-acting delivery of antiretrovirals for HIV prevention
• Data showing that an innovative dosing strategy improves early immune responses to an experimental germline-targeting HIV vaccine
Hosted by the IAS, HIVR4P is the only global scientific conference focused exclusively on the rapidly evolving field of HIV prevention research. It brings together the global scientific community to address the biggest challenges and opportunities in HIV prevention, including vaccines, microbicides, PrEP, treatment as prevention, and biomedical interventions, as well as the social and behavioural implications of these advances.
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This year, the conference is being held in Latin America for the first time, creating an opportunity to highlight HIV prevention needs in the region.
"We hope that by holding the conference in Lima, we can help draw attention to the urgent need to scale up HIV prevention efforts across Latin America,” Grinsztejn said. “Ours is one of the only regions in the world where HIV is on the rise. It’s alarming that new HIV acquisitions in Latin America increased by 9% between 2010 and 2023 despite broadly expanded access to antiretroviral therapy. Unfortunately, the scale of powerful new prevention tools like PrEP remains significantly limited."
