Gilead Presents Real-World and Long-Term Data From HIV Research Programs at HIV Glasgow 2022

– New Clinical and Patient-Reported Outcomes in People with HIV on Biktarvy^® in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting –

– Long-Term Switch Data Further Establish the Robust and Durable Efficacy Profile of Biktarvy –

– Clinical Data Reinforces the Sustained Efficacy of Twice-Yearly Lenacapavir in People with Multi-Drug Resistant HIV –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company’s upcoming new data from its HIV research and development programs to be presented at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022) in Glasgow, Scotland and virtually from October 23-26, 2022. Gilead will present data supporting its current and pipeline innovations in HIV treatment and the latest research from its ongoing cure development program, reflecting the company’s innovative approach to continuous scientific discovery.

“Continued scientific innovation and inclusive approaches are essential in the discovery and development of person-centred options that address the evolving needs of a broad range of individuals and communities affected by HIV,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “The data presented at HIV Glasgow reflect the latest progress in our research and development programs and underscore Gilead’s commitment to driving transformational innovation in HIV research. Our goal, together with the broader HIV community, is to end the HIV epidemic for everyone, everywhere. We look forward to connecting in person in Scotland at this year’s meeting and sharing these data with the scientific community as we work towards this important goal.”

Driving Transformational Innovation in HIV Research

Gilead will present new data on Biktarvy^® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) evaluating the safety, efficacy and resistance profile of the once-daily single-tablet regimen in a broad range of people with HIV. The latest findings from the BICSTaR study, a global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV with a high burden of co-morbidities, will be presented. As the average age of persons living with HIV increases, the evaluation and management of comorbid conditions that may occur in an individual’s life takes on a larger role in HIV clinical care. These latest findings may help inform the future of coordinated, person-centred HIV care and the role of Biktarvy in long-term treatment.

Gilead will also present long-term safety and efficacy data from two Phase 3 studies (Study 1489 and Study 1490) evaluating outcomes in adults with HIV who switched to treatment with Biktarvy following 144 weeks of initial treatment with a dolutegravir-based regimen. Following previous presentation of the primary endpoint findings at Week 48, at HIV Glasgow 2022 results of the open-label extension phase through a maximum of Week 240 will be presented. These data provide additional long-term evidence of the safety and efficacy of Biktarvy in those who switch from a DTG-containing regimen. Long-term clinical outcomes following a regimen switch are often lacking for modern antiretroviral therapy.

Additionally, Gilead will share new findings on long-acting HIV treatment strategies. Data will include a subgroup analysis from the ongoing Phase 3 CAPELLA trial evaluating lenacapavir, recently approved in the EU and UK and marketed as Sunlenca^®, in people with HIV who are heavily-treatment experienced with poor outcome measures at baseline, including high HIV-1 RNA, low CD4+ T cell counts and resistance to some or all the active agents in their optimized background regimen.

Summary of Presentations

Accepted abstracts at HIV Glasgow 2022 include:

For more information about Gilead at HIV Glasgow 2022, including a complete list of abstracts, please visit: https://www.hivglasgow.org/scientific-programme-2022

Please see below for U.S. Indications and Important Safety Information, including Boxed Warnings, for Biktarvy^®.

The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

Lenacapavir is a first-in-class, long-acting HIV capsid inhibitor approved in the EU and UK for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. Lenacapavir, alone or in combination, is not approved by any regulatory authority outside of the EU or the UK for any use. The European Marketing Authorization applies to all 27 member states of the European Union, as well as Norway, Iceland and Liechtenstein.

For important safety information for lenacapavir, including dosing and method of administration, special warnings, drug interactions and adverse drug reactions, please see the Summary of Product Characteristics (SmPC) for lenacapavir, available from the European Medicines Agency website at www.ema.europa.eu.

There is currently no cure for HIV or AIDS.

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.

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 is a first-in-class, long-acting HIV capsid inhibitor approved in the European Union 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’s multi-stage mechanism of action is distinguishable from other currently approved classes of antiviral agents and is designed to provide a new avenue for the development of a long-acting treatment option for individuals with multi-drug resistant HIV whose virus was no longer effectively responding to therapy. 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 to other existing drug classes. Sunlenca is the only HIV treatment option administered twice-yearly.

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 and cancer.

For 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 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.

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 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 Biktarvy and Sunlenca (lenacapavir); uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that additional regulatory authorities may not approve lenacapavir for the treatment of HIV in a timely manner or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the risk that physicians in the EU and UK may not see the benefits of prescribing Sunlenca; 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, 2022, 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.

Full Summary of Product Characteristics for Sunlenca are available from the EMA website at www.ema.europa.eu.

U.S. full Prescribing Information for Biktarvy, including BOXED WARNINGS, are available at www.gilead.com.

Biktarvy, Sunlenca, 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 Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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