Gilead to Highlight Landmark Progress in Research Across HIV Prevention, Treatment and Cure Programs at AIDS 2024

- Late-Breaking Full Results from HIV Prevention Research of Twice-Yearly Injectable Lenacapavir -

- Progress and Person-Centered Approaches Across HIV Treatment, Cure Research and Development Programs -

- Key Initiatives Demonstrate Commitment to Collaboration to Help End the HIV Epidemic Worldwide -

Gilead Sciences, Inc. (Nasdaq: GILD) today announced its program for the upcoming 25th International AIDS Conference (AIDS 2024), taking place in Munich, Germany, and virtually, from July 22-26. As the leading innovator in HIV, Gilead will share new data from its research and development programs and Gilead-supported collaborations that unite leading scientific innovation and partnership aimed at ending the HIV epidemic.

"The AIDS 2024 conference convenes the global HIV community – scientists, advocates, and partners from the public and private sectors," said Jared Baeten, MD, PhD, Senior Vice President, Virology Clinical Development, Gilead Sciences. "Our contributions to this year's meeting demonstrate Gilead's leadership in person-centered innovations across HIV prevention, treatment, and cure. Our scientific advancements are grounded in collaboration with community and research partners around the world. I look to a future where every person has options to help obtain their own HIV prevention or treatment success and where we've come together to end the HIV epidemic."

Gilead’s AIDS 2024 program highlights include:

Late-breaking: Full data from pivotal PURPOSE 1 trial: Data evaluating lenacapavir, an investigational, twice-yearly medicine for HIV prevention, will be presented at the Co-Chairs’ Choice session on July 24, 10:30 a.m.-noon, CEST. Developed in partnership with communities affected by HIV around the world, the PURPOSE clinical trials comprise the most comprehensive and diverse HIV prevention trial program ever conducted. PURPOSE 1 is the first HIV prevention trial to intentionally include pregnant and lactating women. In June, the topline results from an interim analysis of the Phase 1 trial were announced, demonstrating 100% efficacy for the investigational use of HIV prevention in cisgender women.

Oral presentation: Week 48 outcomes from ARTISTRY-1: The latest data from an ongoing Phase 2/3 study (NCT05502341) designed to evaluate an investigational once-daily single-tablet regimen of bictegravir and lenacapavir in virologically suppressed people with HIV who are on a complex regimen.

Two-year outcomes from BICSTaR: The latest findings from an ongoing global, observational study evaluating the effectiveness, safety and tolerability of Biktarvy^® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities.

Additional research studies evaluating Biktarvy include five-year outcomes from the pivotal trials evaluating Biktarvy as a long-term treatment option in older adults with a high burden of comorbidities and the Hispanic/Latine community, respectively.

HIV treatment research pipeline findings will also include new data on GS-1720 and GS-4182. Both investigational agents are being clinically evaluated as part of potential future once-weekly oral HIV treatment options. Additionally, resistance analyses from a study evaluating the investigational combination of lenacapavir + teropavimab (GS-5423, TAB) + zinlirvimab (GS-2872, ZAB) will be presented to support previously presented data demonstrating the potential of this combination as a novel, long-acting, twice-yearly treatment option.

Symposia focused on addressing barriers to HIV care and prevention: Two symposia to discuss the latest progress in policies and practical solutions from around the world to help achieve more equitable access to HIV care and services.

1. What’s Preventing Us From Preventing? Pushing Together Towards the UNAIDS 2030 HIV Prevention Goals (July 24, 7-8 a.m., CEST) will convene experts and community members to strategize about working to achieve UNAIDS 2030 goals. Topics include forward-thinking policies, person-centered care and innovative solutions for health equity.
2. How Treatment Selection Can Support Long-Term Success (July 25, 12-1 p.m., CEST) will bring together providers and the HIV community to explore ways to help achieve long-term success in HIV management. Discussions will focus on the importance of treatment selection from the outset, aiming for long-term, durable viral suppression.

Gilead-supported initiatives highlighting collaboration to advance health equity: To help end the HIV epidemic, it is essential to extend beyond science. Gilead will highlight two initiatives that aim to bridge gaps in HIV awareness and improve linkage to and retention in care:

1. The Person-Centered Care (PCC) Program with the International AIDS Society (IAS) is a multidisciplinary, integrated and long-term, focused approach to care for people with and affected by HIV that is responsive to their evolving needs, priorities and preferences.
2. RADIAN^® – a groundbreaking partnership between Gilead and the Elton John AIDS Foundation (EJAF) – will host a community exchange event, led by community leaders from Eastern Europe and Central Asia (EECA), to discuss how RADIAN-supported innovation and services are elevating efforts to end the HIV crisis in EECA.

Overview of Scientific Presentations

For more information, including a complete list of abstracts and their corresponding oral and poster session titles, please visit: https://programme.aids2024.org/

Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established.

GS-5423, GS-2872, GS-1720, GS-4182 and GS-8588 are investigational compounds, and alone or in combination with lenacapavir, are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown.

Lenacapavir, marketed as Sunlenca^®, is being studied in multiple ongoing early and late-stage development programs and has the potential to offer a diverse set of person-centric options for treatment and prevention that could uniquely fit into the lives of people with HIV and individuals who need or want pre-exposure prophylaxis (PrEP).

The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. 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.

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

There is currently no cure for HIV or AIDS.

About Biktarvy

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy^® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.

About Sunlenca

Sunlenca (300 mg tablet and 463.5 mg/1.5 mL injection) [(lenacapavir)] is a first-in-class, long-acting HIV capsid inhibitor approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom, and the United States for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is the only HIV treatment option administered twice-yearly. Sunlenca tablets are approved for oral loading during initiation of Sunlenca treatment, prior to or at the time of the first long-acting lenacapavir injection depending on initiation option.

The multi-stage mechanism of action of Sunlenca’s active pharmaceutical agent, lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, Sunlenca 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 for HIV prevention is investigational, and its safety and efficacy for this use have not been established. 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.

U.S. Indication for Biktarvy

Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

U.S. Important Safety Information for Biktarvy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

• Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

• Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

Warnings and precautions

• Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
• Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
• New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
  
  Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
• Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

• Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

• Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
• Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
• Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration

• Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
• Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.
• Hepatic impairment: Not recommended in patients with severe hepatic impairment.
• Prior to or when initiating: Test patients for HBV infection.
• Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

Pregnancy and lactation

• Pregnancy: BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy.
• Lactation: Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding.

U.S. Indication for Sunlenca

Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

U.S. Important Safety Information for Sunlenca

Contraindications

• Coadministration: Concomitant administration of Sunlenca is contraindicated with strong CYP3A inducers.

Warnings and precautions

• Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported in patients treated with combination antiretroviral (ARV) therapy.
• Long-acting properties and potential associated risks with Sunlenca: Residual concentrations of Sunlenca may remain in the systemic circulation of patients for up to 12 months or longer. Sunlenca may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing Sunlenca, begin alternate suppressive ARV regimen within 28 weeks from last injection.
• Injection site reactions may occur, and nodules and indurations may be persistent.

Adverse reactions

• Most common adverse reactions (incidence ≥3%, all grades) are injection site reactions (65%) and nausea (4%).

Drug interactions

• Prescribing information: Consult the full prescribing information for Sunlenca for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
• Enzymes/transporters: Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentration of Sunlenca. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1 together may significantly increase the concentration of Sunlenca. Sunlenca may increase the exposure of drugs primarily metabolized by CYP3A, when initiated within 9 months after the last injection of Sunlenca, which may increase the potential risk of adverse reactions.

Dosage and administration

• Dosage: Initiation with 1 of 2 options, followed by maintenance dosing once every 6 months. Tablets may be taken with or without food.
  • Initiation Option 1: Day 1: 927 mg by subcutaneous injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets).
  • Initiation Option 2: Day 1: 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous injection.
  • Maintenance: 927 mg by subcutaneous injection every 26 weeks +/- 2 weeks from date of last injection.
• Missed Dose: During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue Sunlenca treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2.

Pregnancy and lactation

• Pregnancy: There is insufficient human data on the use of Sunlenca during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established.
• Lactation: Individuals infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

About Gilead Sciences in HIV

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, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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 12 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 is recognized as one of the leading funders of HIV-related programs in a report released by Funders Concerned About AIDS.

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

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 or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Biktarvy, lenacapavir, teropavimab, zinlirvimab, GS-1720, GS-4182 and GS-8588; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; 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, 2024, 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. Prescribing Information for Biktarvy, including BOXED WARNING, and U.S. full Prescribing Information for Sunlenca are available at www.gilead.com

Biktarvy, Descovy, Sunlenca, RADIAN, 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 (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs at public_affairs@gilead.com, 1-800-GILEAD-5 or 1-650-574-3000.

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