Gilead and PAHO Partner to Expand Twice-Yearly Lenacapavir PrEP Access Across Latin America and the Caribbean
Key Insights
Gilead Sciences and the Pan American Health Organization (search) signed an agreement to accelerate access to twice-yearly lenacapavir for HIV (search) pre-exposure prophylaxis across all PAHO Member States.
The deal uses PAHO's Regional Revolving Funds to create a coordinated regional procurement pathway, adding 14 countries outside Gilead's existing voluntary licensing agreements.
PAHO estimates roughly 140,000 new HIV (search) infections occur annually in Latin America and the Caribbean, where new infections rose 13% between 2010 and 2024.
Gilead Sciences and the Pan American Health Organization (search) have signed an agreement to accelerate access to twice-yearly lenacapavir for HIV (search) prevention as pre-exposure prophylaxis (PrEP) across all PAHO Member States in Latin America and the Caribbean. The arrangement routes the medicine through PAHO's Regional Revolving Funds, which pool demand among member states to help countries secure medicines and health technologies more efficiently and on favourable terms.
The immediate access pathway covers 14 countries that sit outside Gilead's lenacapavir voluntary licensing agreements: Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay and Venezuela. The framework itself applies to all PAHO Member States.
"The agreement between Gilead and PAHO reflects our shared commitment to help countries move as quickly as possible from scientific innovation to real-world access to HIV (search) prevention and public health impact," said Johanna Mercier, chief commercial and corporate affairs officer at Gilead Sciences. "These strategic partnerships are essential to our ambition to help end the HIV epidemic."
Regional Burden and Access Gaps
PAHO estimates that about 140,000 new HIV (search) infections occur annually in Latin America and the Caribbean. Gilead reports that new infections in the region increased by 13% between 2010 and 2024, alongside gaps in PrEP utilisation.
"The Americas today have increasingly effective tools to prevent HIV (search), but these innovations will have an impact only if they reach the people who need them," said PAHO Director Dr Jarbas Barbosa. "This initiative is an important step toward reducing gaps in access to lenacapavir, expanding the prevention options available to countries and advancing toward HIV elimination."
The agreement complements, rather than replaces, Gilead's existing generic-access strategy. Voluntary licensing agreements already cover 24 countries in Latin America and the Caribbean as part of a framework spanning 120 countries worldwide. Gilead's broader access strategy combines voluntary licensing, technology transfer, no-profit supply and regional access pathways.
Mechanism and Dosing
Lenacapavir is a first-in-class HIV (search) capsid inhibitor. Its multi-stage mechanism of action is distinguishable from other currently approved classes of antiviral agents: while most antivirals act on a single stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle. Gilead states that the drug has no known cross-resistance exhibited in vitro to other existing drug classes.
For prevention, the long-acting injectable formulation is administered twice a year. In 2025, the World Health Organization recommended lenacapavir as an additional HIV (search) prevention option after clinical trials showed almost 100% efficacy in preventing infection. The six-month dosing schedule offers an alternative for people who struggle to adhere to more frequent regimens.
Lenacapavir is approved in multiple countries as PrEP to reduce the risk of sexually acquired HIV (search) in adults and adolescents at risk of acquisition. It is also approved in multiple countries for treatment of multidrug-resistant HIV in adults, in combination with other antiretrovirals. It is marketed as Sunlenca in the United States and the EU for treatment of multidrug-resistant HIV-1 in heavily treatment-experienced adults, and for prevention as Yeztugo (search) in the United States and Yeytuo in the EU for PrEP in adults and adolescents weighing at least 35 kilograms who are at increased risk of HIV-1 acquisition.
Pipeline and Broader Rollout
Gilead continues to develop lenacapavir across prevention and treatment programmes. In prevention, the registrational phase III PURPOSE 365 study is evaluating once-yearly lenacapavir and has completed enrolment. The phase III PURPOSE 2 trial evaluated the efficacy and safety of twice-yearly lenacapavir for PrEP and forms part of the company's access efforts in the region. Additional mid-stage studies are evaluating twice-yearly dosing for PrEP in different populations and geographies.
In treatment, Gilead recently received FDA approval for Bixlenvo (search), a once-daily oral combination of bictegravir and lenacapavir, for virologically suppressed adults with HIV (search). The phase III ISLEND-1 and ISLEND-2 studies are evaluating once-weekly oral islatravir/lenacapavir in virologically suppressed adults with HIV-1.
Beyond the PAHO agreement, Gilead expanded its partnership commitments with the U.S. State Department through PEPFAR (search) and the Global Fund (search), increasing the planned reach of its no-profit supply programme by 50%, from 2 million people to up to 3 million people through 2028. Lenacapavir is now available in 10 countries across sub-Saharan Africa. Gilead is also exploring opportunities with the Brazilian Ministry of Health to enable local production of lenacapavir in Brazil.
Implementation Requirements
PAHO said the introduction of lenacapavir into national HIV (search) programmes would be gradual, depending on regulatory approvals, clinical protocols, health-worker training and programme planning. Participating countries will be able to procure the drug through the Regional Revolving Funds, subject to national regulatory approvals and programme requirements.
The agency is providing technical support to help countries assess demand, develop guidelines, strengthen monitoring systems and prepare health services for rollout. The agreement aligns with the Alliance for the Elimination of HIV (search), a regional platform established under PAHO's Disease Elimination Initiative.
PAHO noted that lenacapavir joins a growing range of HIV (search) prevention options, including daily and event-driven oral PrEP, long-acting cabotegravir and condoms, alongside early diagnosis and prompt access to antiretroviral treatment. Offering a broader menu of prevention tools, the agency said, can better address differing needs and preferences while supporting more person-centred approaches to care.
"Expanding access to effective prevention, diagnostic and treatment tools, and ensuring they reach everyone who needs them, will remain essential to reducing new HIV (search) infections and advancing toward the goal of ending HIV as a public health problem by 2030," PAHO said.