News Releases

Global Fund Secures Access to Breakthrough HIV Prevention Drug Lenacapavir for Low- and Middle-Income Countries

A pivotal moment in the fight to end AIDS — ensuring lifesaving innovation reaches those who need it most, wherever they live

09 July 2025

GENEVA - The Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) today announced it has signed an access agreement with Gilead Sciences to procure lenacapavir, a long-acting injectable for HIV prevention, for low- and middle-income countries (LMICs). This marks the first time in history that an HIV prevention product will be introduced in LMICs at the same time as in high-income countries — a significant milestone for global health equity.

The agreement follows the U.S. Food and Drug Administration’s approval of lenacapavir for HIV prevention in June and represents one of the most significant advances in HIV prevention in decades. As the first twice-yearly, long-acting injectable for pre-exposure prophylaxis (PrEP), lenacapavir expands the HIV prevention choice basket — offering a powerful new option for people who experience stigma, adherence challenges with existing PrEP tools, or other barriers in their daily lives

“This is not just a scientific breakthrough — it’s a turning point for HIV/AIDS,” said Peter Sands, Executive Director of the Global Fund. “For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic — but only if we get it to the people who need it most. Our ambition is to reach 2 million people with long-acting PrEP. But we can only do that if the world steps up with the resources required. This is a pivotal moment — not just for the fight against AIDS, but for the fundamental principle that lifesaving innovations must reach those who need them most — whoever they are, and wherever they live.”

Under this agreement, countries supported by the Global Fund can access lenacapavir for PrEP. Early access will be prioritized based on HIV epidemiology, national prevention strategies, and available resources. Countries — particularly those with high HIV incidence, mostly in sub-Saharan Africa — have expressed strong interest in introducing lenacapavir for PrEP early and at scale. Our ambition is to have the first shipment and delivery of the products reaching at least one African country by the end of 2025, to mark the beginning of a transformational shift in how HIV prevention is delivered to communities with the highest burden of new infections.

The urgency is particularly acute in countries like South Africa, where adolescent girls and young women remain disproportionately affected by HIV. “This is a game changer for South Africa,” said Dr. Aaron Motsoaledi, Minister of Health of South Africa and co-host of the Global Fund’s upcoming Eighth Replenishment. “Lenacapavir offers young women, and everyone at risk, a discreet, long-acting option to stay HIV-free. For far too long, women and girls in our country have carried the greatest burden of this epidemic. But scientific breakthroughs must be backed by political will, community leadership, and sustained investment. We are determined to ensure no one is left behind.”

Lenacapavir for PrEP is one of several essential tools in a comprehensive HIV prevention strategy — alongside condoms, oral PrEP, voluntary medical male circumcision, and other proven methods. No single tool will end HIV on its own, but together, these tools can help bend the curve toward ending the epidemic. As the public health landscape evolves, the Global Fund remains fully committed to helping countries drive forward HIV prevention with long-acting PrEP. This includes focusing on successful country implementation, ensuring that delivery is community-led, culturally relevant, and sustainable, and demonstrating rapid early gains to catalyze further adoption and scale.

To help accelerate access, the Global Fund is leveraging private-sector donor funding to make the introduction and scale-up of lenacapavir more affordable for the countries and communities it supports. This financing approach is further strengthened by catalytic investments, including the generous support from the Children’s Investment Fund Foundation (CIFF). These efforts ensure that the financial barriers to scaling this new tool are lowered as much as possible, supporting countries to act quickly.

“CIFF remains committed to accelerate access to lifesaving innovations that will break the cycle of HIV infection,” said Kate Hampton, CEO of the Children’s Investment Fund Foundation (CIFF). “Our support of the Global Fund’s efforts to introduce lenacapavir is about ensuring that no one is left behind and communities who need it the most can access it. We are proud to stand alongside governments, communities, and the Global Fund to help turn this breakthrough into impact — especially for adolescent girls and young women, who continue to bear the brunt of this epidemic.”

Achieving this ambition is made possible through a unique coalition of partners providing vital technical assistance, policy guidance, demand generation, and community mobilization. Key partners include the World Health Organization (WHO), UNAIDS, the Gates Foundation, Unitaid, the Elton John AIDS Foundation (EJAF), AVAC, and CIFF, each playing a critical role in helping countries navigate introduction, accelerate regulatory pathways, generate demand, and ensure community-led implementation from day one.

“This agreement is about putting equity into action,” said Hui Yang, Head of Supply Operations at the Global Fund. “Our goal is to make sure that people in the highest-burden countries — are not waiting years to access the latest prevention tools. Lenacapavir is one of several tools in the prevention toolkit, but its unique, long-acting profile could be transformational for millions of people who face barriers to daily or oral PrEP. Implementation will require coordination and commitment, but the potential for impact is enormous.”

Without urgent and sustained investments, the ambition to reach 2 million people with long-acting PrEP risks falling short — just as the world stands at the brink of a decisive step toward ending AIDS for good.