– Latest Outcomes From HIV Prevention and Treatment Clinical Research, Including Data From Pivotal Phase 3 PURPOSE 1 & 2 Trials –

– Real World Evidence in COVID-19 Reinforce Veklury (remdesivir) as the Antiviral Standard of Care for the Treatment of People Hospitalized for COVID-19 –

– Investigational Obeldesivir Safety and Tolerability Data From BIRCH and OAKTREE Trials Support Continued Evaluation as a Potential Treatment Option for RSV –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new findings from its antiviral research and development programs at IDWeek 2024, taking place from October 16-19. The data from 31 presentations across HIV treatment and prevention, COVID-19 and viral hepatitis include one late breaker abstract and six oral presentations, reflecting Gilead's commitment to helping address the evolving needs of a diverse range of people and communities affected by some of the world's most challenging viruses.

"We look forward to sharing new research that highlights the breadth of our antiviral portfolio and expanding pipeline as we strive to treat, prevent, cure and help eradicate viral diseases worldwide," said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head at Gilead Sciences. "The data reflect our unwavering commitment to advance scientific innovations in virology, aimed at addressing urgent global needs."

HIV Research

Continuous scientific discovery in HIV is a pillar of Gilead's commitment to help end the HIV epidemic. Presented studies' results and analyses will include further evaluation of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a long-term treatment option for a broad range of people with HIV (PWH). Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including new data on GS-1720, a novel once-weekly integrase strand transfer inhibitor (INSTI), and a late-breaker oral presentation of Week 48 data from the Phase 2 study evaluating an investigational once-weekly oral combination regimen of islatravir and lenacapavir will also be presented.

Gilead will present an overview of results from its pivotal Phase 3 PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials, which studied the efficacy and safety of lenacapavir, the company's injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention in a broad, diverse range of people globally. The trials were unblinded in June and September, respectively.

Additionally, Gilead will present five-year outcomes in new subgroup analyses from Studies 1489 (NCT02607930) and 1490 (NCT02607956), which assessed the safety and efficacy of Biktarvy compared to Triumeq (ABC/DTG/3TC) and dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, DTG+F/TDF. The first analysis evaluated the safety and efficacy of Biktarvy in treatment naïve PWH aged 50 or older, providing data to inform treatment decisions in this increasing proportion of PWH with a greater burden of age-related comorbidities. The second analysis evaluated the safety and efficacy of Biktarvy in treatment-naïve Black adults, a population that has historically been underrepresented in clinical studies despite the disproportionate impact of HIV on Black communities.

Gilead will also present three-year outcomes from the CAPELLA study (NCT04150068), which evaluated twice-yearly subcutaneous dosing of Sunlenca (lenacapavir) in combination with an optimized background regimen in people with multi-drug resistant HIV.

HIV prevention data will include an analysis of newly initiated pre-exposure prophylaxis (PrEP) use in priority populations with unmet needs for PrEP in the U.S.

Additional HIV research findings include a presentation of survey data reporting current real-world trends for PWH with ART resistance mutations and utilization of healthcare resources in addition to the impact on efficacy, safety and clinical outcomes.

COVID-19 Research

Across Gilead's 14 presentations in COVID-19, key data will highlight the dynamic nature of the SARS-CoV-2 virus and address the needs of those most susceptible to severe outcomes from COVID-19. A real-world evidence analysis will feature outcomes following treatment with Veklury (remdesivir, 100mg for injection), for people hospitalized with COVID-19 who have leukemia, lymphoma and multiple myeloma. Additionally, a presentation of in vitro data will demonstrate the ongoing antiviral activity of Veklury against recent Omicron subvariants.

An oral presentation will discuss how investigational obeldesivir reduced SARS-CoV-2 infectious viral titers in people with COVID-19. Gilead will also present full data results from the obeldesivir BIRCH (NCT05603143) and OAKTREE (NCT05715528) clinical trials. Previously, Gilead announced the early termination of the BIRCH trial due to lower-than-expected COVID-19 incidence rates and related hospitalizations or all-cause death by Day 29, which were primary endpoints in the study. The decision did not reflect any safety or efficacy concerns. Gilead also previously announced top-line results from the OAKTREE trial which found that while the study did not meet its primary endpoint in people without risk factors, obeldesivir was found to have a generally well tolerated safety profile. The detailed data add to the breadth of safety data on obeldesivir.

Based on results from BIRCH and OAKTREE, as well as results from preclinical studies in Respiratory Syncytial Virus (RSV), Gilead has launched a Phase 2 trial to study obeldesivir as a potential treatment for non-hospitalized adults with acute RSV. The study will evaluate if obeldesivir can help participants' symptoms improve faster.

Overview of Scientific Presentations

For more information about Gilead at IDWeek 2024, including a complete list of abstracts and their corresponding oral and poster sessions, please visit .

GS-1720 is an investigational compound and not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. The use of the compound alone or in combination with other antiretrovirals is investigational. Its safety and efficacy are unknown.

Lenacapavir is presently marketed as Sunlenca and approved for the treatment of adults with multi-drug resistant HIV in combination with an optimized background regimen. Lenacapavir 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 PWH and individuals who need or want PrEP. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.

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 and Veklury.

There is currently no cure for HIV or AIDS.

All uses of obeldesivir are investigational and have not been determined to be safe or efficacious and is not approved by the FDA.

Bulevirtide 2 mg remains the only approved treatment for adults with chronic HDV and compensated liver disease in the European Economic Area (EEA), Great Britain and Switzerland and is not approved in the U.S. Bulevirtide 10 mg is an investigational product and is not approved anywhere.

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 (lenacapavir), 300 mg tablet and 463.5 mg/1.5 mL injection, 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.

About Veklury

Veklury (remdesivir) is a nucleotide analog prodrug invented by Gilead, building on more than a decade of the company's antiviral research. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury is the only antiviral studied in hospitalized COVID-19 patients in clinical trials and large real-world analyses that has demonstrated reduced time to recovery, as well as disease progression, mortality and readmission.

Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against recent Omicron subvariants of concern, including XBF, XBB.1.16, FL.22, E.G.5.1 and BA.2.86. Veklury continues to be evaluated against emerging variants of interest and concern.

Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to approximately 14.5 million patients around the world, including more than 8.1 million people in middle- and low-income countries through Gilead's voluntary licensing program.

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. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population.
• 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.

Meaghan Smith, Media
public_affairs@gilead.com

Jacquie Ross, Investors
investor_relations@gilead.com