The Global Fund to Fight AIDS, Tuberculosis and Malaria has signed an access agreement with Gilead Sciences to procure lenacapavir, a groundbreaking long-acting injectable for HIV prevention, for low- and middle-income countries (LMICs). This agreement marks a historic milestone: it is the first time an HIV prevention product will be made available in LMICs concurrently with high-income countries, representing a major step forward for global health equity.
This development follows the U.S. Food and Drug Administration’s recent approval of lenacapavir for pre-exposure prophylaxis (PrEP) in June. Lenacapavir, administered twice yearly, is the first long-acting injectable of its kind for HIV prevention. Its extended dosing schedule offers a critical option for individuals who face challenges with existing PrEP methods, such as adherence issues or social stigma, thereby broadening the spectrum of HIV prevention tools.
Under the new agreement, Global Fund-supported countries will be able to access lenacapavir for PrEP, with early access prioritized based on HIV burden, prevention strategies, and resource availability. Countries with high HIV incidence, particularly in sub-Saharan Africa, have expressed strong interest in adopting lenacapavir at scale. The Global Fund aims to deliver the first shipments to at least one African country by the end of 2025, signaling a transformative shift in HIV prevention delivery.
In nations like South Africa, where adolescent girls and young women are disproportionately affected by HIV, lenacapavir is being recognized as a potential game changer. South Africa’s Minister of Health emphasized the need for scientific advances to be backed by political will, community leadership, and long-term investment, ensuring equitable access to this new prevention method.
Lenacapavir is part of a broader HIV prevention strategy that includes tools such as condoms, oral PrEP, voluntary medical male circumcision, and other proven methods. While no single tool can end the HIV epidemic, the introduction of lenacapavir adds a powerful new option to the prevention arsenal. The Global Fund remains committed to supporting countries in implementing long-acting PrEP solutions in ways that are community-driven, culturally sensitive, and sustainable.
To make lenacapavir more affordable and accelerate its introduction, the Global Fund is utilizing private-sector donor contributions and catalytic funding. The Children’s Investment Fund Foundation (CIFF) is a key supporter, helping lower financial barriers and ensuring that those most at risk, particularly adolescent girls and young women, can benefit from this innovation.
This effort is backed by a coalition of global partners, including the World Health Organization, UNAIDS, the Gates Foundation, Unitaid, AVAC, the Elton John AIDS Foundation, and CIFF. These organizations will provide technical support, help streamline regulatory approval, drive community awareness, and facilitate early implementation.
The Global Fund has emphasized that achieving the goal of reaching 2 million people with long-acting PrEP will require urgent and sustained financial investment. The initiative represents a significant opportunity to shift the trajectory of the HIV epidemic and bring life-saving innovations to those who need them most — without delay.
