Lenacapavir Sodium

iStock, Sundry Photography In coordination with the United States President’s Emergency Plan for AIDS Relief, Gilead will make its twice-yearly HIV prophylactic Yeztugo available to resource-limited countries “at no profit.” Gilead is partnering with the U.S. State Department to make its newly approved, twice-yearly HIV pre-exposure prophylactic Yeztugo accessible to patients in resource-limited countries. In collaboration with the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the pharma aims to “accelerate access” to Yeztugo in primarily low- and lower-middle-income countries, Gilead CEO Daniel O’Day said in a prepared statement on Thursday. It is not clear what the exact commitments of each party are under this partnership, though O’Day revealed that his company will provide Yeztugo “at no profit” under the agreement. Gilead is currently working with PEPFAR and other global groups to gauge demand for Yeztugo in these target countries. Gilead did not specify which countries the partnership was targeting, though in its statement the company said it was preparing regulatory submissions for a series of countries with heavy HIV burdens, including Botswana, Mozambique and the Philippines. This accessibility push follows the FDA’s June approval of Yeztugo, a long-acting preventive therapy that can provide protection against HIV for up to six months. In Phase III studies, twice-yearly Yeztugo hit efficacy as high as 100%. In July, Gilead teamed up with the international non-profit the Global Fund to Fight AIDS, Tuberculosis and Malaria, with the similar goal of making Yeztugo broadly available to low- and middle-income countries. At the time, the partners said their effort would mark “the first time in history” that an HIV prophylactic will be made available in lower-income countries “at the same time as in high-income countries.” In announcing the new U.S. government partnership, Gilead said it has also entered into royalty-free agreements with six generic drugmakers covering 120 lower-income countries with high HIV incidence rates. Thursday’s agreement with Gilead comes after Health Secretary Robert F. Kennedy Jr. in June pulled U.S. funding from the global vaccine alliance Gavi , alleging that the group ignored safety concerns linked to vaccines.

– PEPFAR, Coordinated by the U.S. State Department, will Support Delivery of Lenacapavir for PrEP in High-Incidence, Resource-Limited Countries as Key Part of Strategic Efforts with Global Fund to Accelerate Access – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced a partnership with the U.S. State Department and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) to deliver lenacapavir—Gilead's twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP). This is a key component of Gilead’s larger coordinated efforts, now bringing together the resources and expertise of both PEPFAR and the Global Fund, to further advance access to lenacapavir for PrEP for up to two million people over three years in countries supported by both organizations. “The support of the U.S. State Department through PEPFAR will accelerate access to lenacapavir and move us closer to ending the HIV epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Lenacapavir is one of the most important scientific breakthroughs of our time and the result of nearly two decades of work by Gilead scientists. We are providing the medicine at no profit in this partnership so we can support the U.S. government in delivering life-saving programs where the need is most urgent.” “This U.S. commitment exemplifies Secretary Rubio’s America First life-saving assistance agenda: it champions American innovation, advances the Administration’s goal of ending mother-to-child transmission of HIV during President Trump’s second term, and will serve as an important catalyst for greater global and private sector investment in access to this groundbreaking medication,” said Jeremy Lewin, Senior Official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom. “Accelerating access to innovations like lenacapavir is imperative if we are to turn the tide against HIV,” said Peter Sands, Executive Director of the Global Fund. “In a severely resource-constrained environment, we must ensure that breakthrough tools are deployed rapidly, affordably, and in the most impactful way possible. By targeting where lenacapavir can have the greatest effect, and working with the U.S. and Gilead, we can help countries integrate it efficiently into their HIV prevention programs—reducing new infections and enabling them to move more quickly along the pathway toward transition and self-reliance.” This milestone marks Gilead’s latest progress in executing its ambitious access strategy to enable broad, sustainable access to lenacapavir for PrEP in primarily low- and lower-middle-income countries (LLMICs), if approved. Gilead has secured royalty-free agreements with six generic manufacturers to cover 120 high-incidence, resource-limited countries that account for a large share of the global HIV burden. These agreements allow for the generic manufacturers to seek regulatory approvals for lenacapavir for PrEP, and provide access in sufficient volumes to meet demand and generate competition to drive down costs. By the end of 2025, Gilead intends to complete regulatory submissions for lenacapavir for PrEP in 18 countries that represent approximately 70% of the HIV burden in the region covered by the voluntary license. The company will provide Gilead-supplied product at no profit until generic manufacturers are able to fully support demand in those countries—including through its strategic partnership agreements with PEPFAR and the Global Fund to supply lenacapavir for PrEP for up to two million people. In middle-income countries with a high burden of HIV that are not covered by Gilead’s voluntary licensing program and the agreement with the Global Fund, Gilead is pursuing multiple strategies to support access, including tiered pricing and public-private partnerships, and is working with payers to establish fast, efficient pathways to access. Gilead continues to advance its access strategy with urgency, including: Pursuing accelerated global regulatory pathways: Gilead is working to secure approvals in key high-incidence, resource-limited countries as quickly as possible in relation to the recent U.S. approval, European Commission marketing authorization and a positive EU-Medicines for all (EU-M4all) opinion. Gilead is following a strategic, phased approach designed to facilitate the fastest possible registration for all priority countries: EU-M4all: In July 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive EU-M4all opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in high-incidence, resource-limited countries. WHO Prequalification: Gilead submitted lenacapavir for PrEP for WHO prequalification in August 2025. WHO has announced that it expects to conclude the prequalification process by the end of 2025. WHO Stringent Regulatory Authority Collaborative Registration Procedure (WHO SRA CRP): Gilead will leverage the WHO SRA CRP, which uses the regulatory expertise of stringent regulatory authorities to simplify the product evaluation and approval processes for other, national regulatory authorities, helping to accelerate access to lenacapavir for PrEP. Prioritizing timely national regulatory submissions: Now that Gilead has received a positive EU-M4all opinion for lenacapavir for PrEP, the company can pursue swift submissions to the National Regulatory Authorities in high-incidence, resource-limited countries, utilizing the EU-M4all opinion to facilitate an accelerated review timeline. The company plans to use the EU-M4all opinion as a supporting reference when submitting lenacapavir for PrEP registrations by the end of 2025 covering Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe. Gilead has already submitted a regulatory filing in South Africa. Ensuring supply for low- and lower-middle-income countries: Gilead is actively consulting with PEPFAR and the Global Fund to understand product demand and has 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 up to two million people in the countries covered by the voluntary 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: Gilead is exploring options with partners, including the Pan American Health Organization (PAHO), to support countries outside the voluntary license scope. Gilead will continue to provide updates on regulatory filings and other steps aimed at expanding access to lenacapavir for PrEP. We remain deeply engaged with stakeholders around the world, including community-based organizations, governments and multilateral organizations, to ensure that our access efforts help address the needs and preferences of the people and communities that could benefit from PrEP. Gilead is grateful to these stakeholders for their engagement and expertise, as we continue making progress toward enabling access to lenacapavir for PrEP in LMICs soon after U.S. and EU approvals. 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. Gilead’s U.S. Access Strategy In the U.S., where lenacapavir for PrEP 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. can 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 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. 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. 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. 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. 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. 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 with PEPFAR; 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 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. Advancing Access, 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 (@GileadSciences) and LinkedIn (@Gilead-Sciences). Ashleigh Koss, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com