– Late-Breaking Phase 3 Data from the IDEAL Study Highlight the Impact of Livdelzi\u00ae<\/sup> on Composite Alkaline Phosphatase (ALP) Normalization and Other Markers of Disease Progression in Primary Biliary Cholangitis (PBC) –<\/i><\/b><\/p>\n – New Long-Term and Real-World Evidence in Hepatitis Delta Virus (HDV) Examine Combined Virologic and Biochemical Response with Hepcludex\u00ae<\/sup> –<\/i><\/b><\/p>\n FOSTER CITY, Calif.–(BUSINESS WIRE<\/a>)– Key Highlights<\/b><\/p>\n Improving Care Across the PBC Journey<\/span><\/b><\/p>\n \nGilead will present analyses from the Livdelzi clinical development program and real-world studies, including late-breaking Phase 3 presentation of the IDEAL study results which evaluate the impact of seladelpar on composite alkaline phosphatase (ALP) normalization in a historically understudied population of adults living with PBC with lower levels of ALP elevation (1-1.67x ULN) who were on or intolerant to ursodeoxycholic acid (UCDA). (LB#5007). ALP normalization is an increasingly recognized treatment goal that continues to be studied in relation to long-term outcomes in PBC. Additional data on safety and efficacy of seladelpar up to five years (#1170) and late-breaking data on fatigue (LB#5040) will also be presented.<\/p>\n \nAdditional real-world studies will examine persistent gaps in care, including factors affecting eligibility for, and escalation to, second-line treatment (#1170 and #1221). Together, the analyses provide a broader understanding of the diverse experiences, unmet needs and challenges faced by people living with PBC, including those at high risk of disease progression.<\/p>\n \n\u201cAs treatment options evolve, our ambitions for people living with rare liver diseases should evolve as well,\u201d said Swati Tole, Senior Vice President, Clinical Development, Inflammation at Gilead. \u201cAt The Liver Meeting, we will present late-breaking results from the Phase 3 IDEAL study highlighting composite alkaline phosphatase (ALP) normalization, an important marker of disease activity in people with PBC. We will also share data that look beyond biochemical measures of disease activity to explore durability of response, symptoms and the realities of long-term disease management. Together, these insights can help broaden our understanding of important aspects of care for people living with PBC.\u201d<\/p>\n Advancing Long-Term Disease Outcomes in Chronic HDV<\/span><\/b><\/p>\n \nGilead will also present new long-term and real-world data that deepens the understanding of Hepcludex for the treatment of chronic HDV. Highlights include 96-week efficacy findings on the combined virologic and biochemical response (#3203) and a 48-week analysis of clinically significant portal hypertension prevalence and impact of Hepcludex in people living with chronic HDV (#3243).<\/p>\n \nU.S. real-world studies will also spotlight low testing rates (#4080) and the burden of advanced liver disease (#3216), underscoring the need for earlier detection and stronger long-term management for people living with HDV.<\/p>\n Gilead\u2019s Commitment to Improving Outcomes for People with Liver Diseases<\/span><\/b><\/p>\n \nFor people living with PBC and HDV, delayed diagnosis and treatment can mean more time living with burdensome symptoms or progressive liver damage. Gilead’s new data highlight these persistent gaps and showcase opportunities for earlier diagnosis, timely treatment escalation, more patient-centered research, and a better understanding of long-term disease management. Collectively, the data emphasizes the importance of identifying people at risk of progression, optimizing treatment decisions and advancing understanding of long-term outcomes across PBC and HDV.<\/p>\n \nFor more information, including a complete list of abstract titles being presented at the meeting, please visit the AASLD website<\/a>.<\/p>\n Key Abstracts at AASLD 2026:<\/b><\/p>\n ID<\/b><\/p>\n<\/td>\n Abstract Title<\/b><\/p>\n<\/td>\n<\/tr>\n PBC<\/b><\/p>\n<\/td>\n<\/tr>\n \nAbstract #5007<\/p>\n \nOral Presentation<\/p>\n \nNovember 8, 2026<\/p>\n \n5:00\u20135:15 PM<\/p>\n<\/td>\n \nSeladelpar for Alkaline Phosphatase Normalization in Primary Biliary Cholangitis: Results from the IDEAL Phase III Randomized-Controlled Trial<\/p>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nAbstract #5040<\/p>\n \nPoster Presentation<\/p>\n \nNovember 8, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nClinically Meaningful Fatigue Improvement with Seladelpar in Patients with Primary Biliary Cholangitis: Data from the Open-label ASSURE Study<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1170<\/p>\n \nPoster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nSustained Biochemical Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis, Including Those at High Risk for Progression, up to 5 years of Treatment from ASSURE<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1137 Poster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nSeladelpar is Associated with Stable Renal Function Over 5 Years of Treatment: Interim Results from the ASSURE Study<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1164 Poster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nSeladelpar Downregulates Inflammatory and Fibrotic Pathways: Insights from Serum Proteomic Analysis<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1157<\/p>\n \nPoster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nSeladelpar Leads to Rapid and Sustained Alkaline Phosphatase Reduction, Regardless of Baseline Levels, Over 5 Years of Treatment in Patients with Primary Biliary Cholangitis<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1160<\/p>\n \nPoster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nSeladelpar Leads to Long-Term Efficacy and Safety in Patients with Prior OCA and\/or Fibrate Exposure<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1233<\/p>\n \nPoster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nSeladelpar Leads to Durable and Significant Decrease in the Pruritogenic Cytokine IL-31, Associated with Pruritus Improvement: Long-Term Data from the ASSURE Study<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1221<\/p>\n \nPoster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nRisk Factors for Progression in Patients with Primary Biliary Cholangitis who are Eligible for Second-line Treatment: Evidence from a Real-world Study<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1171<\/p>\n \nPoster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nHealth-related Quality of Life Among Patients with PBC by Response Status: Analysis of a Real-world Dataset<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1182<\/p>\n \nPoster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nHealthcare Resource Utilization and Costs in Patients with Primary Biliary Cholangitis in the United States<\/p>\n<\/td>\n<\/tr>\n \nAbstract #1313<\/p>\n \nPoster Session<\/p>\n \nNovember 5, 2026<\/p>\n \n12:00-1:00 PM<\/p>\n<\/td>\n \nAssociation Between Treatment Adherence and Healthcare Utilization Among Individuals with Primary Biliary Cholangitis in the United States<\/p>\n<\/td>\n<\/tr>\n Hepatitis Delta<\/b><\/p>\n<\/td>\n<\/tr>\n \nAbstract #3200<\/p>\n \nPoster Session<\/p>\n \nNovember 7, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nCharacteristics and Outcomes of On-Treatment ALT Flares in Patients with Hepatitis Delta Virus Receiving Bulevirtide and Pegylated Interferon<\/p>\n<\/td>\n<\/tr>\n \nAbstract #3203<\/p>\n \nPoster Session<\/p>\n \nNovember 7, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nIntegrated Efficacy Analysis of Bulevirtide 10 mg Monotherapy in Patients with Chronic Hepatitis Delta<\/p>\n<\/td>\n<\/tr>\n \nAbstract #3243<\/p>\n \nPoster Session<\/p>\n \nNovember 7, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nClinically Significant Portal Hypertension may Improve in Some Patients with Chronic Hepatitis Delta After 48 Weeks of Bulevirtide Treatment – a Pooled Analysis of Phase II\/III Clinical Trials<\/p>\n<\/td>\n<\/tr>\n \nAbstract #4080<\/p>\n \nPoster Session<\/p>\n \nNovember 8, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nHepatitis Delta Testing Rates Remain Low Among Individuals with Chronic Hepatitis B: a US Administrative Claims Analysis<\/p>\n<\/td>\n<\/tr>\n \nAbstract #3216<\/p>\n \nPoster Session<\/p>\n \nNovember 7, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nDisease Progression Among a Nationally Representative Cohort of Commercially Insured Patients with Hepatitis Delta Virus in the United States<\/p>\n<\/td>\n<\/tr>\n \nAbstract #3215<\/p>\n \nPoster Session<\/p>\n \nNovember 7, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nOn-Treatment and Posttreatment Patterns of Non-Invasive Tests of Fibrosis with Long-Term Bulevirtide Treatment for Chronic Hepatitis Delta: An Integrated Analysis<\/p>\n<\/td>\n<\/tr>\n \nAbstract #3236<\/p>\n \nPoster Session<\/p>\n \nNovember 7, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nDiagnostic Performance of Noninvasive Tests for Hepatic Fibrosis in Patients with Chronic Hepatitis Delta Receiving Bulevirtide<\/p>\n<\/td>\n<\/tr>\n \nAbstract #3202<\/p>\n \nPoster Session<\/p>\n \nNovember 7, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nA Systematic Literature Review and Meta-Analysis Evaluating Post-Treatment HDV RNA-Based Surrogate Endpoints for Predicting Long-Term Clinical Outcomes in Hepatitis Delta Virus Infection<\/p>\n<\/td>\n<\/tr>\n Hepatitis B<\/b><\/p>\n<\/td>\n<\/tr>\n \nAbstract #4089<\/p>\n \nPoster Session<\/p>\n \nNovember 8, 2026<\/p>\n \n1:00\u20132:00 PM<\/p>\n<\/td>\n \nCombining PAGE-B Score with Fibrotest Improves HCC Risk Stratification in Patients Treated with Tenofovir-based Treatment<\/p>\n<\/td>\n<\/tr>\n<\/table>\n About Livdelzi<\/span><\/b><\/p>\n \nLivdelzi (seladelpar) is an oral PPAR\u2011delta agonist, or delpar, for the treatment of primary biliary cholangitis (PBC). PPAR\u2011delta is known to regulate key metabolic and liver disease pathways. Preclinical and clinical data indicate that Livdelzi has anticholestatic, anti\u2011inflammatory, antipruritic, and antifibrotic effects.<\/p>\n \nClinical trial data demonstrate that Livdelzi supports meaningful improvements in key markers of disease activity, including biochemical response and alkaline phosphatase (ALP) normalization, with sustained effects observed over long\u2011term follow\u2011up in multiple studies. These findings are supported by clinical studies evaluating Livdelzi in participants treated for up to 5 years.<\/p>\n \nLivdelzi has the potential to help address ongoing unmet needs for people living with PBC, including those who remain inadequately controlled on existing therapies. Pruritus is one of the most common and debilitating symptoms of PBC that can significantly impair quality of life. Clinical trial data have demonstrated improvements in pruritus with Livdelzi compared with placebo.<\/p>\n U.S. Indication for Livdelzi<\/span><\/b><\/p>\n \nLivdelzi is indicated for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).<\/p>\n Limitations of Use:<\/span><\/b><\/p>\n \nUse of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).<\/p>\n U.S. Important Safety Information for LIVDELZI<\/span><\/b><\/p>\n Warnings and Precautions<\/span><\/b><\/p>\n Adverse Reactions<\/span><\/b><\/p>\n Drug Interactions<\/span><\/b><\/p>\n Potential Increased Exposure of LIVDELZI with:<\/b><\/p>\n Potential Reduction in LIVDELZI Exposure with:<\/b><\/p>\n Pregnancy and Lactation<\/span><\/b><\/p>\n About Hepcludex (bulevirtide-gmod) 8.5 mg in the U.S.<\/span><\/b><\/p>\n \nHepcludex (bulevirtide-gmod) is a first-in-class entry inhibitor for the treatment of adults living with chronic hepatitis delta virus (HDV) infection. Chronic HDV infection is a serious liver disease that occurs only as a co-infection in individuals with chronic HBV and is associated with rapid disease progression, liver failure, and increased mortality. Hepcludex is supplied as a vial for once-daily subcutaneous injection. Each vial contains an 8.5 mg dose when prepared according to the Instructions for Use within FDA-approved labeling.<\/p>\n \nHepcludex works by blocking the entry of both HDV and HBV into liver cells, addressing a key step in the viral lifecycle. The FDA\u2019s accelerated approval of Hepcludex is supported by data from the Phase 3 MYR301 study demonstrating that Hepcludex was an effective and generally well-tolerated treatment option, with efficacy and safety observed at week 48 through long-term treatment of up to 144 weeks.<\/p>\n \nHepcludex is supplied as a once-daily injectable therapy and represents the first and only treatment option for people living with chronic HDV that received FDA accelerated approval in the United States, addressing a long-standing unmet medical need for this historically underserved patient community.<\/p>\n \nFor more information, please visit Hepcludex.com<\/p>\n U.S. Access and Hepcludex Approval Across Markets<\/span><\/b><\/p>\n \nThe Gilead Support Path\u00ae<\/sup> Program offers information and resources to help patients diagnosed with chronic HBV, HDV and hepatitis C virus (HCV) and primary biliary cholangitis (PBC), as well as healthcare professionals, understand coverage and financial options for prescribed Gilead treatments.<\/p>\n \nBulevirtide 2 mg is also approved for use in the European Economic Area (EEA), Canada the United Kingdom and other countries globally to treat people living with chronic HDV.<\/p>\n \nPlease see below for U.S. Indication and Important Safety Information for Hepcludex.<\/p>\n U.S. Indication for Hepcludex<\/span><\/b><\/p>\n \nHepcludex (bulevirtide-gmod) 8.5 mg for injection is indicated for the treatment of chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis.<\/p>\n \nThis indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).<\/p>\n U.S. Important Safety Information for HEPCLUDEX<\/span><\/b><\/p>\n IMPORTANT SAFETY INFORMATION<\/b><\/p>\n BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B<\/b><\/p>\n Severe acute exacerbations of hepatitis D and<\/b>hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted.<\/b><\/p>\n Warnings and Precautions<\/b><\/p>\n Hypersensitivity reactions including anaphylaxis: <\/b>Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment.<\/p>\n Adverse Reactions<\/b><\/p>\n \nMost common adverse reactions (incidence \u226510%; all grades) in HEPCLUDEX clinical trials were injection site reactions, headache, abdominal pain, fatigue and pruritus.<\/p>\n Dosage and Administration<\/b><\/p>\n Pregnancy and Lactation<\/b><\/p>\n About Gilead Sciences in Liver Disease<\/span><\/b><\/p>\n \nFor decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For individuals living with hepatitis B or D, Gilead’s focus on advancing medicines drives hope that today\u2019s research will turn into tomorrow\u2019s cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. But our commitment doesn\u2019t stop there. Through ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. Gilead remains committed to a future without liver disease.<\/p>\n About Gilead Sciences<\/span><\/b><\/p>\n \nGilead 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.<\/p>\n \nIn 2025, Gilead announced a $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness \u2013 while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.<\/p>\n Forward-Looking Statements<\/span><\/b><\/p>\n \nThis 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\u2019s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Livdelzi\/Lyvdelzi (seladelpar) and Hepcludex (bulevirtide) (such as IDEAL); uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for seladelpar and bulevirtide; 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; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead\u2019s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, 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.<\/p>\n Hepcludex, Livdelzi, Lyvdelzi, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.<\/i><\/p>\n U.S. full Prescribing Information for Livdelzi\u00ae<\/sup> and Hepcludex\u00ae<\/sup> is available at www.gilead.com<\/a>.<\/i><\/p>\n For more information about Gilead, please visit the company\u2019s website at <\/i>www.gilead.com<\/i><\/a>, follow Gilead on X\/Twitter(@Gilead Sciences) and LinkedIn(@Gilead-Sciences)<\/i><\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20261021867668\/en\/<\/a><\/span><\/p>\n \nPriscilla White, Media \nJacquie Ross, Investors KEYWORDS:<\/b> California Colorado United States North America<\/p>\n INDUSTRY KEYWORDS:<\/b> Health Hospitals Clinical Trials Research Science Pharmaceutical Biotechnology<\/p>\n
\nGilead Sciences, Inc. (Nasdaq: GILD) will present new clinical and real-world evidence across primary biliary cholangitis (PBC) and chronic hepatitis delta virus (HDV) infection at The Liver Meeting\u00ae<\/sup> 2026, hosted by the American Association for the Study of Liver Diseases (AASLD), November 5-9 in Denver, Colorado. The data will examine durability of response, patient-relevant symptoms, and opportunities to better understand long-term disease management across these two rare and serious liver diseases.<\/p>\n\n
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public_affairs@gilead.com<\/a><\/p>\n
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investor_relations@gilead.com<\/a><\/p>\n
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