Millions at High Risk of HIV to Benefit from a Biannual Injectable Drug

Summary:

• Over 2 million high-risk individuals, including many in Uganda, are set to benefit from lenacapavir, a biannual injectable drug for HIV prevention. Backed by global donors like PEPFAR, the Global Fund, CIFF, and BMGF, this initiative aims to provide affordable and equitable access to the drug over three years. Tested successfully in Uganda and South Africa, lenacapavir has shown promising results in reducing HIV infections and could significantly advance global efforts to end the epidemic by 2030.

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Over two million individuals at high risk of HIV infection, including many in Uganda, are set to gain access to a groundbreaking injectable drug under a new initiative spearheaded by global donors. The drug, lenacapavir, is administered biannually and has demonstrated significant efficacy in preventing HIV.

The Global Fund and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), in collaboration with the Children’s Investment Fund Foundation (CIFF) and the Bill & Melinda Gates Foundation (BMGF), have committed to providing access to lenacapavir for at least two million people over three years. This ambitious initiative will benefit nations supported by PEPFAR and the Global Fund.

Despite multiple prevention strategies, including condom distribution and oral PrEP, Uganda continues to register about 38,000 new HIV infections annually, according to government data. Lenacapavir, tested in Uganda and South Africa, showed promising results in protecting participants at elevated risk of HIV infection.

PEPFAR’s statement from the U.S. Mission in Uganda highlights a coordinated effort to make lenacapavir affordable and accessible following regulatory approvals from the U.S. Food and Drug Administration (FDA), national pharmaceutical regulators, and a World Health Organization (WHO) recommendation.

Lenacapavir, developed by Gilead Sciences, is already approved in various countries to treat multidrug-resistant HIV when combined with other antiretroviral drugs. In October 2024, Gilead signed agreements with six manufacturers to produce low-cost versions for distribution in 120 low- and middle-income countries.

Peter Sands, Executive Director of the Global Fund, emphasized the potential of lenacapavir to significantly reduce new infections among high-risk populations. “We are excited to work with partners to ensure equitable and affordable access to this powerful innovation,” Sands stated.

U.S. Global AIDS Coordinator Dr. John Nkengasong echoed this sentiment, highlighting lenacapavir’s potential to transform HIV prevention efforts and support global goals to end the epidemic as a public health threat by 2030.

CIFF Founder Sir Chris Hohn stressed the urgency of breaking the cycle of HIV transmission and ensuring those most in need can access lenacapavir. Hui Yang, Head of Supply Operations at the Global Fund, added that scalable implementation of affordable lenacapavir, alongside other HIV prevention measures, could significantly improve the sustainability of global HIV responses.

Trevor Mundel, President of Global Health at BMGF, underscored the importance of partnerships in ensuring access to innovative treatments. “Far too many people at high risk of HIV infection lack lifesaving options. Game-changing products like lenacapavir offer an opportunity to transform the fight against HIV,” he said.

The collaborative effort among the Global Fund, PEPFAR, CIFF, BMGF, and other global health partners aims to scale up national and sub-national long-acting PrEP programs, ensuring that innovative solutions reach those most at risk and catalyze sustainable progress in the global fight against HIV/AIDS.