Gilead Sciences Update on Access Strategy for Lenacapavir for HIV Prevention in High-Incidence, Resource-Limited Countries

Foster City, Calif., Sept. 24, 2025 – As global leaders convene during the United Nations General Assembly to advance global health access, Gilead Sciences is sharing the significant progress the company has made in its global access strategy for lenacapavir for pre-exposure prophylaxis (PrEP). This twice-yearly injectable represents a major scientific advancement in the fight against HIV, and Gilead is committed to ensuring it reaches people in high-incidence, resource-limited countries as quickly as possible, if approved.

ACCELERATING ACCESS: Within months of signing royalty-free licensing agreements with six manufacturers to cover 120 primarily low- and lower-middle-income countries (LLMICs) that collectively bear a substantial share of the global HIV burden, Gilead rapidly completed the technology transfers to these voluntary licensing partners, enabling them to begin scaling up manufacturing and supply immediately. Consistent with this strategy put in place well before Phase 3 data were available, Gilead welcomes generic entry into the 120 voluntary license countries as soon as possible, with the support of donor organizations.

PARTNERSHIPS: Newly announced agreements between the Gates Foundation and Gilead’s voluntary license partner Hetero, and between the Clinton Health Access Initiative, Unitaid, Wits RHI, and Gilead’s voluntary license partner Dr. Reddy’s, advance Gilead’s commitment to enabling supply of high-quality, low-cost versions of lenacapavir for PrEP in LLMICs at unprecedented speed. Additionally, Gilead recently announced agreements with the U.S. State Department, through PEPFAR, and the Global Fund to rapidly expand access to lenacapavir for PrEP for up to two million people over three years in countries supported by both organizations. Gilead will supply lenacapavir to the organizations at no profit to the company until generics are able to meet demand.

UNPRECEDENTED SPEED: By the end of 2025, Gilead aims to complete regulatory submissions for lenacapavir for PrEP in 18 countries that together represent 70% of the HIV burden across the voluntary license region. Gilead-supplied lenacapavir is expected to reach the first LLMIC before the end of the year, with broader access in 2026. This is the first time a country supported by PEPFAR and the Global Fund is expected to receive access to an innovator company-supplied HIV medicine in the same year it receives regulatory approval in the U.S. and EU.

LOOKING AHEAD: We continue to expand our network of partners and work closely with national programs to support regulatory submissions, health system readiness, and community engagement. We are also investing in implementation science and real-world evidence to help lenacapavir reach those who need it most, in ways that are sustainable and scalable. Our commitment is long-term, and our focus remains on driving meaningful impact in the global HIV response. Updates on our access strategy can be found at www.gilead.com.

Lenacapavir for HIV prevention is not approved by any regulatory authority outside of U.S. or EU. 

There is currently no cure for HIV or AIDS. 

About Lenacapavir

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. 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. 

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 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; Gilead’s ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; Gilead’s ability to realize the anticipated benefits from the voluntary licensing arrangements and external partnerships relating to lenacapavir; difficulties or unanticipated expenses in connection with such arrangements and partnerships and the potential effects on Gilead’s earnings; 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, 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.

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

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