News Details

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced a new agreement with the Pan American Health Organization (PAHO) to accelerate access to twice-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP) across all PAHO Member States in Latin America and the Caribbean. Through PAHO’s Regional Revolving Funds, the agreement establishes a coordinated regional pathway to expand access to long-acting HIV prevention and support country-led efforts toward adoption and implementation, as part of the broader efforts to end the epidemic across the region.

Key Highlights

• Marks a major milestone within Gilead’s broader global lenacapavir access strategy.
• Establishes a regional pathway across all PAHO Member States in Latin America and the Caribbean to support broader country-led efforts toward adoption and implementation.
• Combines PAHO’s regional coordination and procurement capabilities with Gilead’s access strategy to enable sustainable scale-up.

The agreement with PAHO builds on Gilead’s longstanding scientific and access efforts to address HIV incidence in Latin America and the Caribbean, where new infections increased by 13% between 2010 and 2024 and gaps in PrEP utilization exist. Those efforts include the PURPOSE 2 trial, which evaluated the efficacy and safety of twice-yearly lenacapavir for PrEP and form part of Gilead's broader commitment to expanding prevention access across the region.

Today’s announcement provides a new access pathway for 14 countries outside of Gilead’s lenacapavir voluntary licensing agreements, complementing existing generic access pathways across the region. Together, these tailored approaches help broaden access to lenacapavir for PrEP across Latin America and the Caribbean. These countries are Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay and Venezuela.

“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 prevention and public health impact,” said Johanna Mercier, Chief Commercial & Corporate Affairs Officer, Gilead Sciences. “For decades, Gilead has worked alongside governments, public health organizations and communities to expand access to HIV innovation around the world. These strategic partnerships are essential to our ambition to help end the HIV epidemic. This agreement demonstrates how collaboration can help accelerate access, support country-led implementation and create the conditions for sustainable scale.”

Beyond the agreement, Gilead intends to continue exploring opportunities to work with PAHO to support country readiness and scale-up of long-acting HIV prevention access, consistent with country priorities and PAHO’s regional public health leadership through the Alliance for the Elimination of HIV in the Americas. The Alliance brings governments, partners and communities together to help accelerate and sustain progress toward ending HIV as a public health issue, including by reaching populations facing the greatest barriers to effective prevention.

“The Americas today have increasingly effective tools to prevent HIV, 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,” he added.

In addition to this agreement, Gilead continues to explore opportunities with the Brazilian Ministry of Health to advance the Ministry’s goal of enabling local production of lenacapavir in Brazil and support long-term regional access objectives through its partnership with PAHO.

The agreement with PAHO forms part of Gilead’s broader global access strategy for lenacapavir, which combines voluntary licensing, technology transfer, no-profit supply, regional access pathways, and partnerships to accelerate access to HIV prevention around the world. Together, these complementary approaches are designed to move countries from planning toward implementation while laying the foundation for sustainable access at scale. These efforts reflect Gilead’s commitment to expanding prevention choice and helping more people benefit from scientific advances in HIV prevention.

Building Toward Broad, Sustainable Access to Lenacapavir for HIV Prevention

Gilead continues to make progress on its strategy to expand access to twice-yearly lenacapavir for HIV prevention as PrEP. The company recently expanded its partnership commitments with the U.S. State Department through PEPFAR and the Global Fund, increasing the planned reach of its no-profit supply program 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.

At the same time, governments and other partners are actively preparing for upcoming generic availability, reflecting continued momentum toward making twice-yearly HIV prevention medicine, if approved, available to more people in the regions with the greatest unmet need.

About Lenacapavir

Twice-yearly lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.

Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program, including a once-yearly injection for HIV prevention. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

About Gilead HIV

For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 14 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.

Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to effectively manage, execute or realize the anticipated benefits from its global strategy to expand access to lenacapavir for HIV prevention, including twice-yearly lenacapavir, including its partnerships with PAHO, the Global Fund, the U.S. State Department through PEPFAR, and other partners; difficulties or unanticipated challenges in executing the global strategy; Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; the risk that physicians and patients may not see the advantages of lenacapavir for PrEP, subject to applicable regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

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