吉利德预告AASLD 2026将公布Livdelzi IDEAL III期与Hepcludex长期数据，但新闻稿未披露任何结果

- Late-Breaking Phase 3 Data from the IDEAL Study Highlight the Impact of Livdelzi
®
on Composite Alkaline Phosphatase (ALP) Normalization and Other Markers of Disease Progression in Primary Biliary Cholangitis (PBC) -
- New Long-Term and Real-World Evidence in Hepatitis Delta Virus (HDV) Examine Combined Virologic and Biochemical Response with Hepcludex
®
-
FOSTER CITY, Calif.--(BUSINESS WIRE)--
Gilead 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
®
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.
Key Highlights
Gilead’s scientific program includes 21 accepted abstracts, including late-breaking Phase 3 research from the Livdelzi
®
(seladelpar) 10 mg development program and new long-term and real-world evidence for Hepcludex
®
(bulevirtide-gmod) 2 mg and 8.5 mg in chronic HDV.
The portfolio of research reflects Gilead's continued focus on generating evidence that helps broaden understanding of treatment response, patient experience, and long-term management considerations.
By combining long-term clinical data, real-world insights, and research in patient-centred outcomes, Gilead continues to drive innovation and progress scientific advancements to inform treatment decisions and enhance understanding of rare liver diseases.
Improving Care Across the PBC Journey
Gilead 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.
Additional 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.
“As treatment options evolve, our ambitions for people living with rare liver diseases should evolve as well,” said Swati Tole, Senior Vice President, Clinical Development, Inflammation at Gilead. “At 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.”
Advancing Long-Term Disease Outcomes in Chronic HDV
Gilead 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).
U.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.
Gilead’s Commitment to Improving Outcomes for People with Liver Diseases
For 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.
For more information, including a complete list of abstract titles being presented at the meeting, please visit the
AASLD website
.
Key Abstracts at AASLD 2026:
ID
Abstract Title
PBC
Abstract #5007
Oral Presentation
November 8, 2026
5:00–5:15 PM
Seladelpar for Alkaline Phosphatase Normalization in Primary Biliary Cholangitis: Results from the IDEAL Phase III Randomized-Controlled Trial
Abstract #5040
Poster Presentation
November 8, 2026
1:00–2:00 PM
Clinically Meaningful Fatigue Improvement with Seladelpar in Patients with Primary Biliary Cholangitis: Data from the Open-label ASSURE Study
Abstract #1170
Poster Session
November 5, 2026
12:00-1:00 PM
Sustained 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
Abstract #1137 Poster Session
November 5, 2026
12:00-1:00 PM
Seladelpar is Associated with Stable Renal Function Over 5 Years of Treatment: Interim Results from the ASSURE Study
Abstract #1164 Poster Session
November 5, 2026
12:00-1:00 PM
Seladelpar Downregulates Inflammatory and Fibrotic Pathways: Insights from Serum Proteomic Analysis
Abstract #1157
Poster Session
November 5, 2026
12:00-1:00 PM
Seladelpar Leads to Rapid and Sustained Alkaline Phosphatase Reduction, Regardless of Baseline Levels, Over 5 Years of Treatment in Patients with Primary Biliary Cholangitis
Abstract #1160
Poster Session
November 5, 2026
12:00-1:00 PM
Seladelpar Leads to Long-Term Efficacy and Safety in Patients with Prior OCA and/or Fibrate Exposure
Abstract #1233
Poster Session
November 5, 2026
12:00-1:00 PM
Seladelpar Leads to Durable and Significant Decrease in the Pruritogenic Cytokine IL-31, Associated with Pruritus Improvement: Long-Term Data from the ASSURE Study
Abstract #1221
Poster Session
November 5, 2026
12:00-1:00 PM
Risk Factors for Progression in Patients with Primary Biliary Cholangitis who are Eligible for Second-line Treatment: Evidence from a Real-world Study
Abstract #1171
Poster Session
November 5, 2026
12:00-1:00 PM
Health-related Quality of Life Among Patients with PBC by Response Status: Analysis of a Real-world Dataset
Abstract #1182
Poster Session
November 5, 2026
12:00-1:00 PM
Healthcare Resource Utilization and Costs in Patients with Primary Biliary Cholangitis in the United States
Abstract #1313
Poster Session
November 5, 2026
12:00-1:00 PM
Association Between Treatment Adherence and Healthcare Utilization Among Individuals with Primary Biliary Cholangitis in the United States
Hepatitis Delta
Abstract #3200
Poster Session
November 7, 2026
1:00–2:00 PM
Characteristics and Outcomes of On-Treatment ALT Flares in Patients with Hepatitis Delta Virus Receiving Bulevirtide and Pegylated Interferon
Abstract #3203
Poster Session
November 7, 2026
1:00–2:00 PM
Integrated Efficacy Analysis of Bulevirtide 10 mg Monotherapy in Patients with Chronic Hepatitis Delta
Abstract #3243
Poster Session
November 7, 2026
1:00–2:00 PM
Clinically 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
Abstract #4080
Poster Session
November 8, 2026
1:00–2:00 PM
Hepatitis Delta Testing Rates Remain Low Among Individuals with Chronic Hepatitis B: a US Administrative Claims Analysis
Abstract #3216
Poster Session
November 7, 2026
1:00–2:00 PM
Disease Progression Among a Nationally Representative Cohort of Commercially Insured Patients with Hepatitis Delta Virus in the United States
Abstract #3215
Poster Session
November 7, 2026
1:00–2:00 PM
On-Treatment and Posttreatment Patterns of Non-Invasive Tests of Fibrosis with Long-Term Bulevirtide Treatment for Chronic Hepatitis Delta: An Integrated Analysis
Abstract #3236
Poster Session
November 7, 2026
1:00–2:00 PM
Diagnostic Performance of Noninvasive Tests for Hepatic Fibrosis in Patients with Chronic Hepatitis Delta Receiving Bulevirtide
Abstract #3202
Poster Session
November 7, 2026
1:00–2:00 PM
A 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
Hepatitis B
Abstract #4089
Poster Session
November 8, 2026
1:00–2:00 PM
Combining PAGE-B Score with Fibrotest Improves HCC Risk Stratification in Patients Treated with Tenofovir-based Treatment
About Livdelzi
Livdelzi (seladelpar) is an oral PPAR‑delta agonist, or delpar, for the treatment of primary biliary cholangitis (PBC). PPAR‑delta is known to regulate key metabolic and liver disease pathways. Preclinical and clinical data indicate that Livdelzi has anticholestatic, anti‑inflammatory, antipruritic, and antifibrotic effects.
Clinical 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‑term follow‑up in multiple studies. These findings are supported by clinical studies evaluating Livdelzi in participants treated for up to 5 years.
Livdelzi 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.
U.S. Indication for Livdelzi
Livdelzi 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).
Limitations of Use:
Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
U.S. Important Safety Information for LIVDELZI
Warnings and Precautions
Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care.
Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI.
Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated.
Adverse Reactions
The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%).
Drug Interactions
Potential Increased Exposure of LIVDELZI with:
Probenecid:
Avoid coadministration with LIVDELZI.
Strong CYP2C9 Inhibitors:
Monitor for adverse effects during concomitant use.
Dual Moderate CYP2C9 and Moderate or Strong CYP3A4 Inhibitors (eg, fluconazole):
Monitor for adverse effects during concomitant use.
CYP2C9 Poor Metabolizers Using Moderate or Strong CYP3A4 Inhibitors:
Monitor for adverse effects during concomitant use of a moderate or strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers.
Dual or Multiple Clinical Inhibitors of Drug Transporters OATP1B1, OATP1B3, and BCRP (eg, cyclosporine):
Monitor for adverse effects during concomitant use.
Potential Reduction in LIVDELZI Exposure with:
Rifampin:
Concomitant use of LIVDELZI with rifampin, an inducer of metabolizing enzymes, may result in delayed or suboptimal LIVDELZI biochemical response. Monitor biochemical response (eg, ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment.
Bile Acid Sequestrants:
Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible.
Pregnancy and Lactation
Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235.
Lactation: There are no data on the presence of LIVDELZI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI.
About Hepcludex (bulevirtide-gmod) 8.5 mg in the U.S.
Hepcludex (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.
Hepcludex works by blocking the entry of both HDV and HBV into liver cells, addressing a key step in the viral lifecycle. The FDA’s 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.
Hepcludex 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.
For more information, please visit Hepcludex.com
U.S. Access and Hepcludex Approval Across Markets
The Gilead Support Path
®
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.
Bulevirtide 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.
Please see below for U.S. Indication and Important Safety Information for Hepcludex.
U.S. Indication for Hepcludex
Hepcludex (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.
This 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).
U.S. Important Safety Information for HEPCLUDEX
IMPORTANT SAFETY INFORMATION
BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B
Severe acute exacerbations of hepatitis D and
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.
Warnings and Precautions
Hypersensitivity reactions including anaphylaxis:
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.
Adverse Reactions
Most common adverse reactions (incidence ≥10%; all grades) in HEPCLUDEX clinical trials were injection site reactions, headache, abdominal pain, fatigue and pruritus.
Dosage and Administration
Dosage in adults: 8.5 mg once daily administered by subcutaneous injection
HEPCLUDEX should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown.
In all patients, manage the underlying HBV infection as clinically appropriate.
Pregnancy and Lactation
Pregnancy:
There are insufficient data from human pregnancies exposed to HEPCLUDEX to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Lactation:
There are no data on the presence of HEPCLUDEX in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPCLUDEX and any potential adverse effects on the breastfed child from HEPCLUDEX or from the underlying maternal condition.
About Gilead Sciences in Liver Disease
For 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’s research will turn into tomorrow’s cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. But our commitment doesn’t 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.
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, cancer and inflammation.
In 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 – 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.
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 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’s 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.
Hepcludex, Livdelzi, Lyvdelzi, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
U.S. full Prescribing Information for Livdelzi
®
and Hepcludex
®
is available at
www.gilead.com
.
For more information about Gilead, please visit the company’s website at
www.gilead.com
, follow Gilead on X/Twitter(@Gilead Sciences) and LinkedIn(@Gilead-Sciences)
Priscilla White, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
Source: Gilead Sciences, Inc.