Gilead Statement on Access Planning for Lenacapavir for HIV Prevention in Low- and Middle-Income Countries

Foster City, Calif., June 18, 2025 – Gilead Sciences, Inc. today announced that the U.S. Food and Drug and Administration (FDA) approved lenacapavir—the first and only twice-yearly injectable HIV-1 capsid inhibitor—under the trade name Yeztugo^® as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition in the United States. Long-acting HIV PrEP options are a critical component of Gilead’s commitment to ending the HIV epidemic for everyone, everywhere.

While lenacapavir for PrEP is currently only approved in the U.S., Gilead is executing an unprecedented access strategy—informed by extensive input from global health advocates, governments and organizations, as previously communicated—to enable broad, sustainable access in low- and middle-income countries.

Gilead understands the importance of access for lenacapavir for PrEP: we’ve developed the earliest and geographically broadest voluntary licensing strategy for an anti-HIV agent to date to enable access globally, particularly in countries where the need is greatest. Gilead’s strategy prioritizes speed and enables the most efficient paths for the regulatory review, approval of and access to lenacapavir for PrEP around the world. In 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries, Gilead is pursuing a two-part strategy: establishing a robust voluntary licensing program, and planning to provide Gilead-supplied product at no profit to Gilead until generic manufacturers are able to fully support demand in voluntary licensing countries. In other middle-income countries, including many in Latin America, Gilead is actively engaging with an array of stakeholders to help achieve the broadest access possible and is supporting advocacy efforts for HIV prevention options and policies. We are pursuing multiple strategies to support access to lenacapavir for PrEP, including tiered pricing and potential public-private partnerships, and are working with payors to establish fast, efficient pathways to help reach those who need or want PrEP.

Gilead is moving intentionally and with urgency to implement its access strategy on multiple fronts:

• Completed voluntary licensing agreements: In October 2024, Gilead announced it signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for 120 primarily low- and lower-middle-income countries. These 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.
• Completed technology transfer: In December 2024, tech transfers to these six manufacturers were completed within three months of the signing of the licensing agreements, so that manufacturers are able to ramp up production as quickly as possible, if lenacapavir for PrEP is approved. 
• Pursuing accelerated global regulatory pathways: Gilead hopes to secure approvals in key high-incidence, resource-limited countries as quickly as possible in relation to 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 low- and lower-middle-income countries can leverage the EU opinion to expedite their review processes, potentially accelerating access to lenacapavir for PrEP. Additionally, on May 19, 2025, the World Health Organization (WHO) Director-General announced that WHO expects to conclude both the guideline and prequalification processes for lenacapavir for PrEP this year.
• Prioritizing timely national regulatory submissions: In March 2025, Gilead submitted a new medicine application for lenacapavir for PrEP in South Africa and submitted a new drug registration application in Brazil. The applications will be reviewed under each country's regulatory framework for medicines registration. Additionally, now that lenacapavir for PrEP has received FDA approval, Gilead is preparing additional filings in countries that rely on FDA approval for regulatory submission, including Argentina, Mexico and Peru. Lastly, if lenacapavir for PrEP is approved through the EU-M4all pathway, Gilead anticipates moving swiftly to pursue expedited submissions in other countries.
• Ensuring supply for low- and lower-middle-income countries: We are taking concrete actions to meet our commitment to provide Gilead-branded product to countries covered by the voluntary licenses at no profit to Gilead, until our voluntary licensing partners are able to fully support demand. We are actively consulting with key procurement agencies to understand product demand; collaborating on plans for procurement and distribution; and have contracted at-risk manufacturing capacity to produce vials of lenacapavir for PrEP and corresponding oral initiation doses. Together, these steps will ensure supply of lenacapavir for PrEP to approximately 2 million people in the countries covered by the licensing agreements.

Gilead will continue to provide regular updates on regulatory filings and other steps to enable access. As we have since the beginning, we continue to work closely with stakeholders around the world—including community organizations, governments and multilateral organizations—to ensure our efforts help address the needs and preferences of the people and communities that could 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.

Please see below for the U.S. Indication and Important Safety Information for Yeztugo, including Boxed Warning.

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.

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.

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 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); 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 may not see the benefits of prescribing Yeztugo for PrEP; 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, are available at www.gilead.com .

Yeztugo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).