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The Global Fund to Fight AIDS, Tuberculosis and Malaria has announced a landmark agreement with pharmaceutical company Gilead Sciences to deliver lenacapavir, a revolutionary long-acting injectable for HIV prevention, to low- and middle-income countries (LMICs).
This marks the first time an HIV prevention product will be introduced simultaneously in LMICs and high-income countries—a major step toward advancing global health equity.
Lenacapavir received approval from the U.S. Food and Drug Administration (FDA) in June and has been hailed as one of the most significant advances in HIV prevention in decades.
Unlike daily oral pills, lenacapavir requires just two injections per year, offering a discreet and convenient option for millions, particularly for those who face stigma, struggle with adherence, or have limited access to health services.
“This is not just a scientific breakthrough—it’s a turning point for HIV/AIDS. 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,” said Peter Sands, Executive Director of the Global Fund.
“However, we can only do that if the world provides the necessary resources. 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—whatever they are, and wherever they live.”
Addressing the HIV Burden Among Women and Girls
Sub-Saharan Africa continues to bear the highest burden of new HIV infections globally.
Adolescent girls and young women remain disproportionately affected, often due to structural barriers, stigma, and entrenched gender inequalities.
“This is a game changer for South Africa. Lenacapavir offers young women and everyone at risk a discreet, long-acting option to stay HIV-free,” said Dr. Aaron Motsoaledi, Minister of Health of South Africa and co-host of the Global Fund’s upcoming Eighth Replenishment.
“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.”
The Global Fund plans to deliver the first shipment of lenacapavir to at least one African country before the end of 2025.
This marks the beginning of a transformational shift in how HIV prevention tools are delivered at scale in communities with the highest new infections.
A Broad Coalition Driving Access and Implementation
The Global Fund’s agreement with Gilead Sciences is supported by a broad coalition of partners working to accelerate access, streamline regulatory pathways, and ensure community-led implementation.
These include the World Health Organization (WHO), UNAIDS, the Bill & Melinda Gates Foundation, Unitaid, the Elton John AIDS Foundation (EJAF), AVAC, and the Children’s Investment Fund Foundation (CIFF).
To reduce financial barriers, the Global Fund is leveraging private-sector donor funding, including catalytic investments from CIFF.
“CIFF remains committed to accelerating access to lifesaving innovations that will break the cycle of HIV infection. Our support of the Global Fund’s efforts to introduce lenacapavir is about ensuring that no one is left behind and that communities who need it the most can access it,” said Kate Hampton, CEO of CIFF.
“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.”
These partnerships are essential not only for financing procurement but also for generating demand, providing technical assistance, and guiding culturally relevant and sustainable delivery models from the outset.
Equity in Access: A Central Principle
“This agreement is about putting equity into action. Our goal is to ensure that people in the highest-burden countries are not waiting years to access the latest prevention tools,” said Hui Yang, Head of Supply Operations at the Global Fund.
“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.”
Lenacapavir is envisioned as a critical complement to existing prevention strategies, which include condoms, oral PrEP, voluntary medical male circumcision, and behavioral interventions.
No single tool can end HIV, but a combination approach can significantly bend the epidemic curve.
Funding Cuts Pose a Threat to Progress
While the lenacapavir rollout offers hope, it comes amid growing concerns about the sustainability of HIV prevention efforts due to recent international aid reductions.
In 2025, the United States—the largest donor for global HIV programs—slashed over 80% of USAID’s global health funding and froze parts of the President’s Emergency Plan for AIDS Relief (PEPFAR) programming.
These cuts have already led to disruptions in antiretroviral (ARV) drug supply chains, closures of clinics, and interruptions in community outreach in several high-burden countries, including Kenya, Uganda, and Eswatini.
UNAIDS and WHO have warned that, without urgent restoration of these funds, millions more people could be infected with HIV or die from AIDS-related causes by 2030.
The situation jeopardizes years of progress and risks widening health inequities.
In this challenging landscape, the Global Fund’s lenacapavir deal is more than a technological advance—it is a vital intervention to sustain momentum toward ending AIDS.
The Road Ahead
Successfully reaching the Global Fund’s goal of 2 million people on long-acting PrEP will require coordinated efforts and substantial investments from governments, donors, and communities.
Early demonstration of impact is key to accelerating broader uptake.
With strong political will, community leadership, and continued funding, lenacapavir could reshape HIV prevention by offering a highly effective, discreet, and user-friendly option, especially for populations who struggle with existing prevention methods.
Peter Sands emphasized the stakes:
“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—whatever they are, and wherever they live.”
