Gilead Finalizes Agreement With the Global Fund to Accelerate Access to Twice-Yearly Lenacapavir for HIV Prevention for up to Two Million People in Primarily Low- and Lower-Middle-Income Countries

Business Wire

09-07-2025

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to supply lenacapavir—Gilead's twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP). Through the agreement, Gilead will supply enough doses to reach up to two million people over three years in countries supported by the Global Fund, at no profit to Gilead.
In October 2024, Gilead signed non-exclusive, royalty-free voluntary licensing agreements to manufacture and supply high-quality generic versions of lenacapavir in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries (LLMICs). Until licensed generic versions are available and can fully meet demand in LLMICs, Gilead also committed to providing Gilead-supplied lenacapavir for PrEP at no profit. Under this strategic partnership agreement with the Global Fund, countries supported by the Global Fund that are among the 120 high-incidence, resource-limited countries can access lenacapavir for PrEP. The Global Fund will prioritize early-access countries based on HIV epidemiology, national prevention strategies, and available resources. Gilead looks forward to partnering with other global aid organizations to further accelerate access to lenacapavir for PrEP in LLMICs.
'The agreement between Gilead Sciences and the Global Fund is based on our shared intention to benefit as many people as possible, as quickly as possible with this breakthrough in HIV prevention,' said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. 'We are providing the medicine at no profit to Gilead, and in enough supply to reach up to two million people in low- and lower-middle-income countries ahead of generic lenacapavir becoming available. This is all part of our unprecedented approach to access for a medicine that could help end the HIV epidemic.'
'This is not just a scientific breakthrough — it's a game-changer 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 HIV, but for the fundamental principle that lifesaving innovations must reach those who need them most — whoever they are, and wherever they live.'
This collaboration is one of several actions Gilead is taking to help ensure supply until licensed generic versions of lenacapavir are available in countries covered by its voluntary licensing program, which is the earliest and most geographically expansive ever developed for an anti-HIV agent. Gilead's voluntary licensing agreements were finalized well before any regulatory filing or decision, to enable these countries to quickly introduce generic versions of lenacapavir for PrEP, if approved. Gilead hopes to secure approvals in key high-incidence, resource-limited countries as quickly as possible following the recent U.S. and potential EU approvals. To that end, in February 2025, the European Medicines Agency (EMA) validated Gilead's EU-Medicines for all (EU-M4all) application for lenacapavir for PrEP. Through the EU-M4all procedure, national regulatory authorities in LLMICs can leverage the EMA opinion to expedite their review processes, potentially accelerating access to lenacapavir for PrEP. Gilead is actively consulting with global aid organizations, including the Global Fund, to understand product demand and collaborate on distribution. Gilead has contracted at-risk manufacturing capacity to produce vials of lenacapavir for PrEP and corresponding oral initiation doses for up to two million people in the countries covered by the licensing agreements until generics fully meet demand, with the ability to produce additional supply to fulfill the needs of countries and global procurers.
Extending Access Across More Countries
In other middle-income countries, including many in Latin America with a high burden of HIV that are not covered by this agreement and the voluntary licensing program, Gilead is pursuing multiple strategies to support access to lenacapavir for PrEP, including tiered pricing and potential public-private partnerships, and is working with payers to establish fast, efficient pathways to help reach those who need or want PrEP.
Gilead will continue to provide updates on regulatory filings and other steps aimed at expanding access to lenacapavir for HIV prevention. The company remains deeply engaged with stakeholders around the world, including community-based organizations, governments and multilateral organizations, to help ensure that its access efforts address the needs and preferences of the people and communities that stand to benefit from PrEP.
Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the United States.
There is currently no cure for HIV or AIDS.
Gilead's U.S. Access Strategy
In the U.S., where lenacapavir for HIV prevention is approved as Yeztugo ®, Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage. Additionally, for eligible commercially insured individuals, Gilead's Advancing Access ® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars for many.
Gilead is also committed to helping to ensure that people without insurance in the U.S. will be able to benefit from Yeztugo. For those who are eligible, Gilead's Advancing Access medication assistance program will provide Yeztugo free of charge.
About Lenacapavir
Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition. Please see below for the U.S. Indication and Important Safety Information for Yeztugo ® (lenacapavir), including Boxed Warning.
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. 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.'
U.S. Indication for Yeztugo
Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.
U.S. Important Safety Information for Yeztugo
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen.
Contraindications
Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status.
Warnings and precautions
Comprehensive risk management:
Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk.
Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate.
Potential risk of resistance:
There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment.
To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen.
Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection.
Long-acting properties and potential associated risks:
Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection.
Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance.
Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously.
Adverse reactions
Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea.
Drug interactions
Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers.
It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors.
Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo.
Dosage and administration
HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection.
Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food.
Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally.
Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks.
Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose.
Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate.
Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations.
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 13 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 for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.
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. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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 realize the anticipated benefits from the collaboration; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead's earnings; 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 Yeztugo (lenacapavir) (such as PURPOSE 1 and 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; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary 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 March 31, 2025, 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.
U.S. full Prescribing Information for Yeztugo, including Boxed Warning, is available at www.gilead.com.
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