Gilead to Present Latest Research Across Key Liver Disease Indication at the American Association for the Study of Liver Disease (AASLD) Meeting 2024
Gilead Sciences is set to present over 40 abstracts at The Liver Meeting® 2024, hosted by the American Association for the Study of Liver Diseases (AASLD) from November 15-19 in San Diego. Key highlights include:
1. Primary Biliary Cholangitis (PBC): 11 abstracts, including data from the RESPONSE trial on Livdelzi® (seladelpar) efficacy and safety.
2. Hepatitis Delta Virus (HDV): Interim analysis of the Phase 3 MYR301 study on bulevirtide monotherapy.
3. Hepatitis C Virus (HCV): Safety and tolerability outcomes for Epclusa® in pregnant individuals (STORC study).
4. Hepatitis B Virus (HBV): Late-breaking data from a Phase 2a study on novel combination therapies.
5. Nonalcoholic Steatohepatitis (NASH)/Fibrosis: Validation of the Mediterranean Diet Adherence Screener for diet quality assessment.
The research spans viral and inflammatory liver diseases, reflecting Gilead's commitment to advancing liver disease treatment and care.
Gilead Sciences presenterà oltre 40 abstract al The Liver Meeting® 2024, organizzato dall'American Association for the Study of Liver Diseases (AASLD) dal 15 al 19 novembre a San Diego. I punti salienti includono:
1. Colangite biliare primitiva (PBC): 11 abstract, compresi i dati del trial RESPONSE sull'efficacia e la sicurezza di Livdelzi® (seladelpar).
2. Virus dell'epatite delta (HDV): Analisi intermedia dello studio di Fase 3 MYR301 sul trattamento monoterapico con bulevirtide.
3. Virus dell'epatite C (HCV): Risultati di sicurezza e tollerabilità per Epclusa® in individui in gravidanza (studio STORC).
4. Virus dell'epatite B (HBV): Dati recenti da uno studio di Fase 2a su nuove terapie combinate.
5. Steatoepatite non alcolica (NASH)/Fibrosi: Validazione dello strumento di screening per l'aderenza alla dieta mediterranea per la valutazione della qualità alimentare.
La ricerca copre malattie epatiche virali e infiammatorie, riflettendo l'impegno di Gilead per il progresso nel trattamento e nella cura delle malattie epatiche.
Gilead Sciences presentará más de 40 resúmenes en The Liver Meeting® 2024, organizado por la American Association for the Study of Liver Diseases (AASLD) del 15 al 19 de noviembre en San Diego. Los puntos destacados incluyen:
1. Colangitis Biliar Primaria (PBC): 11 resúmenes, incluyendo datos del ensayo RESPONSE sobre la eficacia y seguridad de Livdelzi® (seladelpar).
2. Virus de la Hepatitis Delta (HDV): Análisis intermedio del estudio de Fase 3 MYR301 sobre la monoterapia con bulevirtida.
3. Virus de la Hepatitis C (HCV): Resultados de seguridad y tolerabilidad para Epclusa® en personas embarazadas (estudio STORC).
4. Virus de la Hepatitis B (HBV): Datos de última hora de un estudio de Fase 2a sobre nuevas terapias combinadas.
5. Esteatosis Hepática No Alcohólica (NASH)/Fibrosis: Validación del Cuestionario de Adherencia a la Dieta Mediterránea para la evaluación de la calidad de la dieta.
La investigación abarca enfermedades hepáticas virales e inflamatorias, reflejando el compromiso de Gilead por avanzar en el tratamiento y cuidado de las enfermedades hepáticas.
길리어드 사이언스는 2024년 간 질환 회의(The Liver Meeting®)에서 40개 이상의 초록을 발표할 예정입니다. 이 회의는 11월 15일부터 19일 사이 샌디에고에서 미국 간 질환 연구 협회(AASLD)에 의해 개최됩니다. 주요 하이라이트는 다음과 같습니다:
1. 원발성 담즙성 담관염 (PBC): 리브델지® (셀라델파르)의 효능과 안전성에 대한 RESPONSE 시험 데이터를 포함한 11개의 초록.
2. 델타간염바이러스 (HDV): 부레비르타이드 단독 요법에 관한 3상 MYR301 연구의 중간 분석.
3. 간염 C 바이러스 (HCV): 임신 중인 개인을 위한 Epclusa®의 안전성 및 허용성 결과 (STORC 연구).
4. 간염 B 바이러스 (HBV): 새로운 조합 요법에 대한 2a상 연구의 최신 데이터.
5. 비알콜성 지방간염 (NASH)/섬유증: 식단 품질 평가를 위한 지중해식 식단 준수 스크리너의 검증.
이 연구는 바이러스성 및 염증성 간 질환을 포괄하며, 길리어드가 간 질환 치료와 관리 발전에 대한 헌신을 반영합니다.
Gilead Sciences est sur le point de présenter plus de 40 résumés lors du The Liver Meeting® 2024, organisé par l'American Association for the Study of Liver Diseases (AASLD) du 15 au 19 novembre à San Diego. Les points forts incluent :
1. Cholangite biliaire primitive (PBC): 11 résumés, y compris des données de l'essai RESPONSE sur l'efficacité et la sécurité de Livdelzi® (seladelpar).
2. Virus de l'hépatite delta (HDV): Analyse intermédiaire de l'étude de phase 3 MYR301 sur la monothérapie bulevirtide.
3. Virus de l'hépatite C (HCV): Résultats de sécurité et de tolérabilité pour Epclusa® chez les personnes enceintes (étude STORC).
4. Virus de l'hépatite B (HBV): Données de dernière minute d'une étude de phase 2a sur les nouvelles thérapies combinées.
5. Stéatohépatite non alcoolique (NASH)/Fibrose: Validation de l'outil de dépistage de l'adhésion au régime méditerranéen pour évaluer la qualité du régime alimentaire.
La recherche couvre les maladies hépatiques virales et inflammatoires, reflétant l'engagement de Gilead à faire progresser le traitement et les soins des maladies du foie.
Gilead Sciences wird auf dem The Liver Meeting® 2024 mehr als 40 Abstracts präsentieren, der von der American Association for the Study of Liver Diseases (AASLD) vom 15. bis 19. November in San Diego ausgerichtet wird. Die wichtigsten Highlights umfassen:
1. Primäre biliäre Cholangitis (PBC): 11 Abstracts, einschließlich Daten aus der RESPONSE-Studie zur Wirksamkeit und Sicherheit von Livdelzi® (Seladelpar).
2. Hepatitis-Deltavirus (HDV): Zwischenanalyse der Phase-3-Studie MYR301 zur Monotherapie mit Bulevirtid.
3. Hepatitis-C-Virus (HCV): Sicherheits- und Verträglichkeitsdaten für Epclusa® bei schwangeren Personen (STORC-Studie).
4. Hepatitis-B-Virus (HBV): Aktuelle Daten aus einer Phase-2a-Studie zu neuartigen Kombinationstherapien.
5. Nicht-alcoholische Fettleberentzündung (NASH)/Fibrose: Validierung des Mediterranean Diet Adherence Screener zur Bewertung der Ernährungsqualität.
Die Forschung umfasst virale und entzündliche Lebererkrankungen und spiegelt das Engagement von Gilead wider, die Behandlung und Pflege von Lebererkrankungen voranzutreiben.
- None.
- None.
- Key Insights from Viral Hepatitis, PBC, and MASH/Fibrosis Studies Highlight Gilead's Ongoing Commitment to Advancing Life-Changing Liver Disease Research -
Beyond PBC, Gilead will be presenting an interim analysis of the Phase 3
“We’re excited to share our latest research at The Liver Meeting, as we push the boundaries of what’s possible in liver disease treatment. The breadth of this research reflects Gilead’s unwavering dedication to advancing life-changing science and shaping healthier futures for people living with liver disease,” said Anu Osinusi, Vice President of Clinical Development for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences. “The depth and range of our data, spanning both viral and inflammatory liver diseases, underscores our commitment to making a meaningful impact at every stage of a person’s journey in liver disease. Our goals go far beyond treatment alone—our work spans awareness, education, screening, diagnosis, and long-term care, all intending to address unmet needs and enhance treatment outcomes.”
Gilead will also present hepatitis C virus (HCV) data which will include safety and tolerability outcomes for Epclusa® (velpatasvir/sofosbuvir) in pregnant individuals with chronic HCV (the STORC study). As a special population that is often excluded from clinical research, these results may help clinicians better support pregnant people living with HCV, which in turn may reduce the risk of transmission to infants. Furthermore, real-world findings from the SVR10K study on HCV will be showcased, demonstrating the effects of direct-acting antivirals against all HCV genotypes across diverse regions. Late-breaking data from a Phase 2a open-label study assessing the safety and efficacy of novel combination therapies for chronic hepatitis B virus (HBV) will also be presented by Gilead.
Key Abstracts at AASLD 2024:
ID |
Abstract Title |
PBC |
|
164 |
Efficacy and Safety of Seladelpar in Patients with PBC and Compensated Cirrhosis in the Phase 3 Placebo-controlled RESPONSE Trial |
167 |
Attenuation, Near Resolution, and Prevention of Pruritis in Patients with PBC Treated with Seladelpar: A Secondary Analysis of Patterns of Pruritis Change in the RESPONSE Trial |
4339 |
Alkaline Phosphatase Changes with Seladelpar Across Subgroups of Primary Biliary Cholangitis Patients in the RESPONSE Trial |
4342 |
Seladelpar and Reductions in Lipids in Patients with Primary Biliary Cholangitis with and without Statin use in the Phase 3 Placebo-controlled RESPONSE Study |
4341 |
Long-term Safety of Seladelpar 10 mg with up to 5 Years of Treatment in Patients with Primary Biliary Cholangitis |
Primary sclerosing cholangitis (PSC) |
|
151 |
Associations Between Biomarkers and Magnetic Resonance Imaging-derived ANALI Score in Patients with Primary Sclerosing Cholangitis: Analysis from the Phase 3 PRIMIS Study |
HDV |
|
1147 |
Efficacy and Safety of BLV Monotherapy for Chronic Hepatitis Delta: Post Treatment Results through 48 Weeks after the End of Treatment from an Interim Analysis of a Randomized Phase 3 Study |
1193 |
Patient-reported Outcomes among Patients with Chronic Hepatitis Delta Treated with Bulevirtide 2 mg: A Long-term Analysis of the Phase 3 |
139 |
Long-term Bulevirtide Monotherapy in Patients with HDV-related Compensated Cirrhosis: Effectiveness, Safety and Clinical Outcomes from the Retrospective Multicenter European Study (SAVE-D) |
HCV |
|
222 |
Safety, Tolerability, and Outcomes of Velpatasvir/Sofosbuvir in Treatment of Chronic Hepatitis C Virus during Pregnancy (STORC) |
1455 |
The SVR10K Study: A Real-world Data with Pangenotypic Direct-acting Antivirals across Multiple Diverse Regions |
1476 |
Hepatitis C Treatment Uptake Differs by Gender among a Commercially Insured Population in |
HBV |
|
1380 |
Results from a Phase 2a, Open-label Study to Evaluate the Safety and Efficacy of Novel Combination Therapies Containing VIR-2218, Selgantolimod, and Nivolumab for the Treatment of Chronic Hepatitis B |
1252 |
Effectiveness and Safety of Tenofovir Alafenamide in Chronic Hepatitis B Patients with Suboptimal Response to Antiviral Therapy |
1337 |
Characterization of Changes in Noninvasive Fibrosis Markers over 8 Years of Tenofovir-based Treatment in Chronic Hepatitis B Patients Enrolled in Two Phase 3 Trials |
Nonalcoholic steatohepatitis (NASH)/Fibrosis |
|
1520 |
Prospective Validation of the Mediterranean Diet Adherence Screener (MEDAS) for Point-of-care Assessment of Diet Quality in Patients with Metabolic Dysfunction-associated Steatotic Liver Disease |
For more information, including a complete list of abstract titles being presented at the meeting, please visit the AASLD website.
In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for bulevirtide 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide’s conditional MA license in
Cilofexor and selgantolimod are investigational compounds and are not approved by the FDA or any other regulatory authority; their safety and efficacy have not been established.
Please see below for the
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Contraindications
- If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.
Warnings and Precautions
- Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
- Risk of Reduced Therapeutic Effect Due to Use with P-gp Inducers and/or Moderate to Strong Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John’s wort and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.
Adverse Reactions
-
The most common adverse reactions (≥
10% , all grades) with EPCLUSA in adults and pediatric patients 6 years of age and older were headache and fatigue; and when used with RBV in adults with decompensated cirrhosis were fatigue, anemia, nausea, headache, insomnia and diarrhea. The most common adverse reactions (≥10% , grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting up the drug.
Drug Interactions
- Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan.
- Coadministration of EPCLUSA is not recommended with proton-pump inhibitors, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.
Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments.
Indication
EPCLUSA is indicated for the treatment of adult and pediatric patients 3 years of age and older with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.
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 (eg, 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
- OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid coadministration with LIVDELZI due to increased LIVDELZI exposure.
- Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment. Coadministration may result in delayed or suboptimal biochemical response of LIVDELZI.
- Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (eg, cyclosporine): Monitor closely for adverse effects. Concomitant administration with LIVDELZI may increase LIVDELZI exposure.
- CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase LIVDELZI exposure and risk of LIVDELZI adverse reactions.
- 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.
Indication
LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have 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 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).
About HDV
HDV is considered the most aggressive or severe form of viral hepatitis, associated with more rapid progression towards liver-related death and liver cancer in people with HBV. On average, HDV progresses to cirrhosis within 5 years and to liver cancer within 10 years. Nearly
About PBC
PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the
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 people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with PBC. But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are 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. Gilead operates in more than 35 countries worldwide, with headquarters in
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 or additional clinical trials or studies, including those involving Epclusa, Hepcludex (bulevirtide), Livdelzi (seladelpar), cilofexor and selgantolimod (such as the ASSURE, RESPONSE,
Epclusa, Hepcludex, Livdelzi, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241022654506/en/
Meaghan Smith, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
Source: Gilead Sciences, Inc.
FAQ
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