By Bunmi Yekini
In a groundbreaking move to combat HIV/AIDS, the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) have teamed up with the Children’s Investment Fund Foundation (CIFF) and the Bill & Melinda Gates Foundation (BMGF) to ensure equitable access to lenacapavir, a twice-yearly injectable HIV pre-exposure prophylaxis (PrEP), once regulatory approvals are secured. This coordinated effort aims to provide this potentially transformative treatment to at least 2 million people in countries supported by PEPFAR and the Global Fund over the next three years.
Lenacapavir, developed by Gilead Sciences, has already been approved in multiple countries for the treatment of multidrug-resistant HIV. Recent promising clinical trials suggest its potential in preventing new HIV infections as well. If widely adopted, lenacapavir could accelerate progress toward the 2030 goal of ending HIV/AIDS as a public health threat.
Peter Sands, Executive Director of the Global Fund, expressed his enthusiasm for the new treatment, saying, “At the Global Fund, we are incredibly excited by the promise of lenacapavir and its potential to help us achieve a further significant reduction in new infections among individuals at high risk of acquiring HIV. As part of this coordinated effort, the Global Fund, PEPFAR, CIFF, and BMGF will work with Gilead and the voluntary licensing manufacturers to accelerate affordable and equitable access, so that more people can benefit from this powerful innovation from day one.”
In October 2024, Gilead entered into a voluntary licensing agreement with six pharmaceutical companies to manufacture and supply low-cost versions of lenacapavir for HIV prevention in 120 low- and middle-income countries. Ambassador Dr. John Nkengasong, U.S. Global AIDS Coordinator, emphasized the need for rapid action, stating, “We cannot reach a sustainable HIV response without rapidly reducing the 1.3 million new HIV infections that occur worldwide every year. Lenacapavir offers a potentially tremendous opportunity to transform the impact of HIV programs to ensure adolescent girls and young women, key populations, and others who could benefit have access to highly effective HIV prevention, testing, and treatment services.”
CIFF Founder and Chair Sir Chris Hohn highlighted the urgency of tackling HIV transmission, stating, “We must urgently break the cycle of HIV transmission and get back on track to achieve the 2030 goals. Testing and prevention are vital, where innovations like lenacapavir can profoundly impact the lives of millions. It will be a travesty if the communities who need it most don’t have access. That is why this collaboration is so essential to ensure that lenacapavir is available as soon as possible for those who need it the most.”
Hui Yang, Head of Supply Operations at the Global Fund, explained the broader impact of the initiative, saying, “Implementation of affordable lenacapavir at scale, alongside other HIV prevention interventions, has the potential to catalyze improved sustainability of the HIV response, with countries and communities having choices and access to quality-assured and lower-cost HIV treatment and prevention tools to sustain over the long-term, owing to HIV infections averted.”
The Global Fund and PEPFAR will work closely with CIFF, BMGF, and other global organizations such as WHO, Unitaid, and UNAIDS to roll out national and sub-national HIV prevention programs utilizing long-acting injectable PrEP.
Trevor Mundel, President of Global Health at BMGF, emphasized the importance of increasing access to life-saving treatments, stating, “Far too many people at high risk of HIV infection lack access to lifesaving treatments. Our mission is to work alongside communities and partners to change that by ensuring access to game-changing products like lenacapavir that can protect individuals from HIV infection and help to end the disease.”