Lenacapavir is an innovative long-acting injectable for HIV pre-exposure prophylaxis (PrEP) that offers an unprecedented six months of protection from HIV acquisition and has been hailed as the scientific breakthrough of the year.
A milestone towards access to new prevention options
Yesterday, the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) in collaboration with the Children’s Investment Fund Foundation (CIFF) and the Bill and Melinda Gates Foundation (BMGF) announced a coordinated effort to ensure that two million people have equitable access to affordable lenacapavir in Global Fund and PEPFAR supported countries for three years.
This effort to rapidly provide lenacapavir to countries is contingent upon regulatory approval from the United States Food and Drug Administration, relevant national pharmaceutical regulators, and a World Health Organization (WHO) recommendation.
The trial results from recent studies show lenacapavir’s potential in preventing new HIV infections in populations at substantial risk of HIV. At scale implementation of the lenacapavir as a part of the HIV prevention “options kit” including other forms of PrEP, PEP, condoms and lubricants, voluntary medical male circumcision, and harm reduction among others has the potential to not only address some persistent gaps like reducing experiences of stigma and discrimination but also to accelerate progress towards ending HIV as a public health threat.
“The urgency to accelerate HIV prevention has never been greater than today. We have a moment of opportunity with lenacapavir to ensure that prevention choices are available and equitably accessible to all populations at risk, especially in countries with high-incidence settings.” says Angeli Achrekar, Deputy Executive Director of Programmes at UNAIDS. “Together with our partners Global Fund and PEPFAR, we will ensure that the right people in the right places will have access to lenacapavir at the right cost and enabling policy environment.”
In October this year, Gilead announced that it had signed a non-exclusive, royalty-free voluntary licensing with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for HIV prevention in 120 primarily low-and-lower-middle-income countries.
“A coordinated, multisectoral response including governments, donors, civil society, programme implementers, and the private sector among others is required to ensure accelerated implementation, equitable access, and sustainable impact,” says Mitchell Warren, Executive Director, AVAC and co-chair, Global HIV Prevention Coalition. “The best practices and lessons learned from previous PrEP implementation efforts must be leveraged to ensure we don’t repeat past mistakes. All stakeholders must act decisively to seize this opportunity, ensuring alignment of financing mechanisms, prioritization of underrepresented regions and communities, and an enabling environment to maximize the public health potential of this innovative prevention option.”
Affordable access will also be required in additional countries, including middle income countries not covered by current licensing agreements.
According to the 2024 World AIDS Day report, an estimated 1.3 million people acquired HIV in 2023 – three times more than the 2025 global target. The Global HIV prevention Coalition is co-convened by UNAIDS and UNFPA, together with its partners works towards ensuring that new long-acting technologies including lenacapavir, alongside proven, effective HIV prevention options are not only effective, but widely accessible.
A major 2030 prevention access push is required
Despite the remarkable first milestones in access to new prevention options, much remains to be done. UNAIDS and partners through the Global HIV Prevention Coalition are preparing a major push for HIV prevention access. The world needs a more ambitious 2030 target for access to new prevention technologies, in addition to, and not instead of, access to existing prevention options and high HIV treatment coverage. Only if more people in need of prevention use an effective HIV prevention option, do we have a chance of achieving the target to reduce new HIV infections by 90% by 2030. Never have the investments in scaled prevention access been more promising, or more urgent, than in the short window between 2025 and 2030.
Additional resources:
- From Clinical Trial Efficacy to Public Health Impact: A Plan for Accelerating Access to Injectable Lenacapavir for PrEP
- Gears of Lenacapavir for PrEP Rollout
- https://www.who.int/news/item/26-09-2024-long-acting-injectable-lenacapavir-continues-to-show-promising-results-for-hiv-prevention
- https://www.who.int/news/item/06-12-2024-who-announces-the-development-of-updated-guidance-on-managing-advanced-hiv-disease