A twice-yearly injectable drug for HIV prevention, lenacapavir, is a breakthrough advancement in public health. On Wednesday at AIDS 2024, the 25th International AIDS Conference, Linda-Gail Bekker presented the full results from the ‘PURPOSE 1’ trial of twice-yearly injectable lenacapavir for HIV prevention.
The new data provides details on the efficacy, safety and tolerability of twice a year lenacapavir injections and were presented at a special late-breaking session at the conference. The data has also been published today in The New England Journal of Medicine.
”The results confirm that lenacapavir demonstrated 100% efficacy for HIV prevention in cisgender women,” Linda-Gail Bekker, Chief Executive Officer at Desmond Tutu Health Foundation. Deputy Director, Prof of Medicine, The Desmond Tutu HIV Centre. “We believe these results are sustainable for women around the world,” she said.
“Funded by Gilead Sciences, a top pharmaceutical firm, the results of Phase 3 PURPOSE 1 trial sets a new standard for person-centred HIV prevention trials, demonstrating what can happen when a thoughtful scientific and community-focused trial design, a promising drug candidate and an inclusive trial implementation plan come together,” she added.
Data from the Phase 3, double-blind, active-controlled, multicenter, randomised trial were collected from 5,345 HIV-negative, cisgender adolescent girls and young women aged 16-26 at 25 sites in South Africa and three sites in Uganda.
Overall, lenacapavir was highly effective among trial participants, with zero HIV infections observed in the lenacapavir group (compared to background HIV incidence), translating to a 100% reduction in HIV infections.
Gilead expects results in late 2024/early 2025 from the programme’s s other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PreP (Pre-Exposure Prophylaxis) among cisgender men, transgender men, transgender women 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.
“The results confirm that lenacapavir demonstrated 100% efficacy for HIV prevention in cisgender women. These are stand out results but we need to turn to serious conversations around accessibility of the drug and reduction in prices,” Winnie Byaniyima, Executive Director, UNAIDS. She quoted a study where experts have calculated the minimum price for mass production of a generic version and estimated it at $40 a year.
“If this price is offered then there is a fighting chance we can talk to our governments to be able to procure the drugs,” she said, Gilead Sciences working towards strategy to enable access globally.
Jared Baeten, Vice President, Clinical Development, Gilead Science, who was present at the roundtable meet said Gilead was committed to HIV prevention and treatment for more than three decades and are working towards a strategy to enable broad, sustainable access globally. “We are awaiting the results of the PURPOSE 2 trial in other populations by the end of the year and are prioritising swift access and enabling efficient paths for regulatory approval of Lenacapavir for PrEP in high-incidence, resource-limited countries,” he said.
Sharon Lewin, President of IAS – the International AIDS Society, AIDS 2024 International Co-Chair and Director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne in Australia further added ,“ If approved and delivered – rapidly, affordably, and equitably – to those who need or want it, this long-acting tool could help accelerate global progress in HIV prevention. We all owe a debt of gratitude to the thousands of young women in South Africa and Uganda who volunteered to be part of this study.
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