Gilead Showcases Latest HIV Pipeline Progress and the Impact of Global Collaboration on Health Equity Efforts at IAS 2023

– Key Initiatives Highlight the Role of Catalytic Collaboration to Help Advance Health Equity –

– Latest HIV Research and Development Data Drive the Next Wave of Person-Centric Scientific Discovery in Treatment, Prevention and Novel Research Strategies in HIV Cure –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming contributions to the 12th International AIDS Society Conference on HIV Science (IAS 2023), taking place in Brisbane, Australia, and virtually, from July 23-26, 2023. As the leader in HIV innovation, Gilead will provide updates on its signature initiatives and key collaborations while sharing new scientific data from its research and development programs. The breadth of data presented at the meeting, along with Gilead-led symposia, reflect its innovative approach to advancing HIV prevention, treatment and cure strategies and underscore Gilead’s focus on forming partnerships with communities worldwide as part of its unequivocal commitment to help end the HIV epidemic for everyone, everywhere.

“HIV will remain a global epidemic so long as people and communities do not have access to HIV care, services and innovative and life-saving medicines due to structural and social inequalities,” said Alex Kalomparis, Senior Vice President, Public Affairs, Gilead Sciences. “At Gilead, our efforts at the global, national and local levels aim to reduce these disparities, with an emphasis on eliminating stigma and discrimination, ensuring equitable access to people-centered HIV care and services, and forging industry-leading partnerships that expand global access to our innovative and life-saving medicines. During IAS 2023, we look forward to sharing the latest from our ongoing health equity efforts and launching a new community-based initiative that seeks to change the future of the HIV epidemic.”

Advancing Efforts to Address Barriers to HIV Care and Prevention

At IAS 2023, Gilead will convene 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.

Ignite change: Championing HIV status-neutral care together (July 23, 3:00pm AEST), will feature an international multidisciplinary expert panel exploring how a status-neutral approach can improve care and help eliminate structural stigma; discuss steps to close the gaps in the care continuum; and consider what long-term success means for people living with HIV.

A second symposium, titled The Fire Within Us: Driven by Our Collective Passion to End the HIV Epidemic (July 24, 8:00am AEST), will highlight ongoing programs working to integrate patient-centered approaches across the HIV care continuum to improve access and care. The discussion will feature insights from a diverse panel on practical, person-centered solutions, which aim to enhance healthcare for everyone affected by HIV.

RADIAN^®, a collaboration between Gilead and the Elton John AIDS Foundation, is hosting the forum; Eastern Europe and Central Asia in Crisis: Community-led strategies to leave no one behind and end the rapidly growing HIV epidemic taking place on July 24 at 6:30 p.m. AEST.

To learn more about Gilead’s unique collaborations around the world and the work to help end the HIV epidemic for everyone, everywhere, visit: https://www.gileadhivtogether.com.

Driving Transformational Innovation in HIV Research

Gilead is committed to continuous scientific discovery to meet the evolving needs of people affected by HIV. At IAS 2023, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company’s continued pursuit of an HIV cure.

“At Gilead, our person-centered approach to developing novel medicines aims to generate findings that are meaningful and beneficial to the people and communities confronting the day-to-day realities of HIV,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Collaboration with researchers and community stakeholders, particularly those living with HIV or those who could benefit from PrEP, is integral to all aspects of Gilead’s scientific discovery process and is essential to realizing the transformative potential impact of our innovations. IAS 2023 is an invaluable opportunity to interact directly with the broad HIV community and help further our HIV research and development efforts.”

As part of the company’s ongoing effort to advance treatment research in communities with diverse health needs, Gilead will present results from studies evaluating Biktarvy^® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in women with HIV who are pregnant and virologically suppressed and TAF-containing regimens in virologically suppressed children with HIV. Additional presentations from Gilead’s HIV treatment research program will include new 96-week findings from ALLIANCE, an ongoing Phase III trial evaluating the efficacy and safety profile of Biktarvy versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV/HBV co-infection initiating treatment.

Additionally, outcomes from multiple studies evaluating lenacapavir, Gilead’s first-in-class, long-acting HIV-1 capsid inhibitor will be presented. The latest findings will highlight patient-reported outcomes from CAPELLA, which is an ongoing Phase 2/3 registrational study designed to evaluate the antiviral activity of twice-yearly lenacapavir administered as a subcutaneous injection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. Research will also be presented on the efficacy and safety profile of temporary oral bridging with lenacapavir when the administration of subcutaneous lenacapavir was interrupted.

Insights from Gilead’s cure research program include new data evaluating broadly neutralizing antibodies and the maintenance of virologic control in the absence of antiretroviral therapy.

Gilead scientists will also contribute to three IAS-hosted satellite sessions to further advance scientific dialogue on key issues including:

• Advancing HIV care for mothers and newborns: Exploring long-acting solutions, (July 23, 9:30am AEST)
• Estimating HIV incidence in the era of long-acting PrEP, (July 24 at 2:45pm AEST)
• bNAbs: From prevention to cure, (July 25 at 6:30pm AEST)

Summary of Presentations

Key abstracts will include:

For more information about Gilead at IAS 2023, including a complete list of abstracts and their corresponding oral and poster sessions, please visit: https://www.iasociety.org/conferences/ias2023.

The use of Biktarvy in individuals with HIV-1/HBV coinfection is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

Teropavimab and zinlirvimab are investigational compounds and 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.

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, Switzerland, the United Arab Emirates the United Kingdom and the United States for the treatment of HIV infection, in combination with other antiretroviral(s), in people 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 prevention and treatment research program. Lenacapavir is being developed as a foundation for 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 patient needs and preferences.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

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: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
• Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

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

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 reduce the risk of acquiring HIV infection, 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 and collaborations, 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 the number one philanthropic funder 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 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 and zinlirvimab; uncertainties relating to regulatory applications and related filing and approval timelines; Gilead’s ability to receive regulatory approvals in a timely manner or at all, and the risk that any such approvals, if granted, may have significant limitations on its use; and any assumptions underlying any of the foregoing.

Jacquie Ross, Investors
investor_relations@gilead.com

Meaghan Smith, Media
public_affairs@gilead.com