Global Fund and PEPFAR Announce Coordinated Action to Reach 2 Million People with Lenacapavir under PrEP to Significantly Reduce Global HIV Infections – Press Releases

Global Fund, PEPFAR Announce Coordinated Effort to Reach 2 Million People with Lenacapavir on PrEP to Significantly Reduce Global HIV Infections

December 17, 2024

– The Global Fund to Fight AIDS, Tuberculosis and Malaria (the “Global Fund”) and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) have joined forces with the Children’s Investment Fund Foundation (CIFF) and the Bill & Melinda Gates Foundation ( BMGF) to announce today a coordinated effort that can rapidly ensure inexpensive and equitable access to twice-yearly lenacapavir in injections for HIV pre-exposure prophylaxis (PrEP) after regulatory approval from the U.S. Food and Drug Administration, relevant national pharmaceutical regulatory authorities, and suggestion from the World Health Organization (WHO).

The Global Fund and PEPFAR aim to offer countries with sustainable solutions to access this latest, potentially game-changing HIV prevention innovation – supported by significant commitment from CIFF and support from BMGF – that will enable access to lenacapavir for at the least 2 years. million people over three years in countries supported by PEPFAR and the Global Fund.

Gilead Sciences’ lenacapavir is already approved in multiple countries for the treatment of adult patients with multidrug-resistant HIV together with other antiretroviral drugs. The latest and really promising clinical trial results have also demonstrated its potential in stopping latest HIV infections. If implemented at scale alongside other HIV prevention tools, including each day oral antiretrovirals already approved to be used in PrEP, lenacapavir has the potential to speed up progress towards 2030 Sustainable Development Goal 3. HIV goal to finish HIV /AIDS as a threat to public health, and to make sure a sustainable response to HIV beyond 2030.

In October 2024 Gilead announced that it has signed a non-exclusive, royalty-free, voluntary license with six pharmaceutical firms to provide and provide high-quality, low-cost versions of lenacapavir for the prevention of HIV infection to 120 mainly low- and lower-middle-income countries.

“At the Global Fund, we are extremely excited about the promise of lenacapavir and its potential to help us achieve further significant reductions in new infections among people at high risk of HIV infection,” said Peter Sands, executive director of the Global Fund. “As part of this coordinated effort, the Global Fund, PEPFAR, CIFF and BMGF will work with Gilead and voluntary licensing manufacturers to accelerate affordable and equitable access so more people can benefit from this powerful innovation from day one.”

“We cannot achieve a sustainable response to HIV without rapidly reducing the 1.3 million new HIV infections that occur around the world each year,” said Ambassador Dr. John Nkengasong, U.S. global AIDS coordinator and senior official of the Office of Global Affairs Health Security and Diplomacy on the US Department of State Affairs. “Lenacapavir offers a potentially huge opportunity to transform the impact of HIV treatment programs to ensure that adolescent girls and young women, key populations and others who could benefit from them have access to highly effective HIV prevention, testing and treatment services and end HIV /AIDS as a public health threat by 2030.”

Sir Chris Hohn, founder and chairman of CIFF, said: “We must urgently break the cycle of HIV transmission and get back heading in the right direction to meeting the 2030 targets. Testing and prevention are essential because innovations like lenacapavir have the potential to significantly impact the lives of thousands and thousands of individuals. It could be a travesty if the communities that needed it most did not have access. That’s why this collaboration is so essential to be certain that lenacapavir is on the market as quickly as possible to those that need it most.”

“Large-scale implementation of low-cost lenacapavir, alongside other HIV prevention interventions, can catalyze improvements within the sustainability of the HIV response, with countries and communities having alternative and access to quality-assuring and lower-cost HIV treatment and prevention tools to sustain over the long run by stopping HIV infections,” said Hui Yang, director of procurement operations on the Global Fund.

The Global Fund and PEPFAR will work closely with CIFF and BMGF to support countries and communities in implementing national and native PrEP programs with long-acting injectable anti-HIV drugs, along with WHO, Unitaid, UNAIDS and others.

“Far too many people at high risk of HIV infection do not have access to lifesaving treatments,” said Trevor Mundel, president of Global Health at BMGF. “Our mission is to work with communities and partners to change this by providing access to breakthrough products like lenacapavir that can protect individuals against HIV infection and help end the disease.”

The Global Fund plays a proactive, thoughtful and strategic role in shaping markets to enhance access to products and improve health outcomes for people living with HIV, TB and malaria. Through its NextGen Market Shaping approach, the Global Fund contributes to improving health outcomes by leveraging its position to facilitate healthier global health markets, today and in the longer term. This vision reiterates the importance of a proactive approach and highlights the link between the Global Fund’s market shaping efforts and its deal with health outcomes.