{"id":50326,"date":"2022-11-01T14:02:22","date_gmt":"2022-11-01T13:02:22","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/gilead-to-present-data-across-viral-hepatitis-and-liver-fibrosis-at-the-liver-meeting-2022-reinforcing-gilead-as-a-leader-in-addressing-treatment-needs-for-people-living-with-liver-disease\/"},"modified":"2022-11-01T14:02:22","modified_gmt":"2022-11-01T13:02:22","slug":"gilead-to-present-data-across-viral-hepatitis-and-liver-fibrosis-at-the-liver-meeting-2022-reinforcing-gilead-as-a-leader-in-addressing-treatment-needs-for-people-living-with-liver-disease","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/gilead-to-present-data-across-viral-hepatitis-and-liver-fibrosis-at-the-liver-meeting-2022-reinforcing-gilead-as-a-leader-in-addressing-treatment-needs-for-people-living-with-liver-disease\/","title":{"rendered":"Gilead to Present Data Across Viral Hepatitis and Liver Fibrosis at The Liver Meeting\u00ae 2022, Reinforcing Gilead as a Leader in Addressing Treatment Needs for People Living With Liver Disease"},"content":{"rendered":"
\n

\n\u2013<\/i> More than 70 Clinical and Real-World Abstracts Address Key Treatment Needs in Liver Disease <\/i>\u2013<\/i><\/b>\n<\/p>\n

\n\u2013 <\/i>Integrated Analyses from Three Studies Underscore the Efficacy and Safety Profile of Hepcludex<\/i>\u00ae<\/sup><\/i>, <\/i>for the Treatment of Chronic Hepatitis Delta Virus <\/i>\u2013<\/i><\/b>\n<\/p>\n

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that clinical and real-world data from more than 70 abstracts will be presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting\u00ae<\/sup>, taking place from Nov. 4-8, 2022. Key presentations include Week 48 integrated efficacy and safety analyses from Phase 2 and Phase 3 studies of Hepcludex\u00ae<\/sup> (bulevirtide), Gilead\u2019s first-in-class investigational treatment for chronic hepatitis delta virus (HDV), and preclinical data on hepatitis B virus (HBV), which was selected to be included in AASLD\u2019s \u201cBest of the Liver Meeting\u201d meeting highlights. The oral presentation will share preclinical research on an investigational HBV therapeutic vaccine as a potential component for an HBV cure regimen. New data will also be presented on the efficacy and safety of Vemlidy\u00ae<\/sup> (tenofovir alafenamide) chronic treatment in HBV, and Epclusa\u00ae<\/sup> (sofosbuvir\/velpatasvir) curative treatment in chronic hepatitis C (HCV) across specific populations.\n<\/p>\n

<\/a><\/p>\n

\n\u201cAt this year\u2019s The Liver Meeting, our latest research helps to address some of the most significant needs of people living with liver diseases globally. It includes analyses from our clinical program on bulevirtide for the treatment of chronic hepatitis delta virus and preclinical data demonstrating the progress Gilead is making on the journey towards a potential cure for hepatitis B,\u201d said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead. \u201cThrough our ongoing research programs, we continue our longstanding commitment to address the unmet needs of people impacted by liver diseases.\u201d\n<\/p>\n

\nSafety and Efficacy Profile of Bulevirtide Further Demonstrated in Integrated Analyses
\n
<\/span><\/b>Gilead will present data from several clinical studies on bulevirtide, underscoring the clinical utility of bulevirtide as a potential treatment option for people living with chronic HDV. Data will be presented from two integrated analyses of Week 48 data from three studies evaluating the safety (MYR204) and efficacy (MYR203 and MYR301) of bulevirtide for the treatment of chronic HDV (PO-1016 and PO-1024).\n<\/p>\n

\nAnalyses of healthcare data will also be presented, highlighting the substantial economic cost, resource utilization and quality-of-life burden associated with HDV (PO-3469). An analysis of MYR301 using self-completed ratings of patients\u2019 health evaluates the impact of bulevirtide across several quality-of-life markers (PO-1019).\n<\/p>\n

\nBulevirtide was granted Breakthrough Therapy and Orphan Drug designations by the FDA. Bulevirtide is not approved by the U.S. FDA and is conditionally authorized under the tradename Hepcludex\u00ae<\/sup> in the European Economic Area and the United Kingdom.\n<\/p>\n

\nEarly Research Exploring Potential HBV Cure Approach Selected for \u201cBest of the Liver Meeting\u201d
\n
<\/span><\/b>Gilead will present preclinical HBV research selected for the \u201cBest of the Liver Meeting\u201d. The preclinical data demonstrates that an alternating-vector immunization strategy, utilizing a combination of Pichinde virus (PICV) (GS-2829) and lymphocytic choriomeningitis virus (LCMV) vectors (GS-6779), could serve as a potential backbone component of an HBV cure combination regimen based on the magnitude and consistency of HBV-specific T cell responses (PO-23). This important research adds to the progress in Gilead\u2019s cure research program for HBV.\n<\/p>\n

\nGilead will also present safety and efficacy data for Vemlidy\u00ae<\/sup> (tenofovir alafenamide 25 mg, TAF) in children and adolescents (age 6 to less than 18 years of age and weighing 25 kg or more) with chronic HBV. The data showed that the efficacy and safety observed at Week 24 was maintained through Week 48, while continued treatment with TAF for 48 weeks resulted in increased rates of virologic and biochemical responses (HBV DNA <20 IU\/mL). No resistance was observed in this population at Week 48 (PO-1184).\n<\/p>\n

\nVemlidy is indicated for the treatment of chronic HBV in adults and pediatric patients 12 years of age and older with compensated liver disease. The use of Vemlidy for other patient populations is investigational, and the safety and efficacy for these uses have not been established. The U.S. full Prescribing Information for Vemlidy contains a BOXED WARNING for post-treatment severe acute exacerbation of hepatitis B. See below for U.S. Important Safety Information.\n<\/p>\n

\nNew Treatment Approaches for HCV Explored
\n
<\/span><\/b>To achieve the World Health Organization (WHO) goal of elimination of viral hepatitis as a public health threat by 2030, innovative care delivery models and rapidly effective treatment are needed to continue progress.\n<\/p>\n

\nGilead will present an interim analysis of a real-world study that found utilizing a test and treat strategy implemented by non-specialists with Epclusa\u00ae<\/sup> (400 mg sofosbuvir\/100 mg velpatasvir tablets) treatment achieved similar sustained virologic response rates at 12 weeks as those patients treated by specialists; SVR12 was 100% in the non-specialist group and 97.6% among those managed by specialists (OS-1296). Another study of nearly 1,400 participants found undetectable HCV RNA was achieved in >90% of patients at only 4 weeks of treatment and in 99.9% at 12 weeks (PO-1245). Finally, an analysis of Gilead\u2019s ReLink initiatives, which are designed to identify and engage people living with HCV into care, demonstrate that active case-finding, patient navigation and care coordination increased patient engagement and treatment success rates among people living with HCV (OS-25).\n<\/p>\n

\nNew Approaches to NASH Treatment and PSC Monitoring
\n
<\/span><\/b>Gilead continues to pursue scientific advances across the broader liver disease research and development program, including new approaches for potential treatment and monitoring in nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).\n<\/p>\n

\nGilead will present data from the Phase 2b ATLAS Study utilizing SomaScan\u00ae<\/sup> plasma proteome analysis in people with NASH with advanced fibrosis, demonstrating specific activity of combination therapy with investigational compounds, cilofexor and firsocostat, compared to monotherapies (OS-75). Non-invasive tests to determine stage of fibrosis in PSC remain an unmet medical need for this patient population, where increased fibrosis is associated with a higher risk of liver-related morbidity. Gilead will present research indicating that blood-based and imaging-based non-invasive tests are useful in identifying significant fibrosis (Ludwig F2-F4) in patients with PSC (PO-4743).\n<\/p>\n

\nThe safety and efficacy of cilofexor and firsocostat have not been established. Cilofexor and firsocostat are investigational compounds and are not approved by the U.S. FDA or any other regulatory authority.\n<\/p>\n

\nSelect accepted abstracts being presented at AASLD 2022 include:<\/b>\n<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\nAbstract<\/b>\n<\/p>\n<\/td>\n

\n

\nAbstract Title<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHBV<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nOral 23\n<\/p>\n<\/td>\n

\n

\nGS-2829 \/ GS-6779 HBV Therapeutic Vaccine Generates Robust, Polyfunctional, Genotype Cross-Reactive CD8 T Cell Responses Accompanied by High Titers of Anti-HBsAg Antibodies\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPoster 1184\n<\/p>\n<\/td>\n

\n

\nSafety and Efficacy at 1 Year in Children and Adolescents with Chronic Hepatitis B (CHB) Receiving Tenofovir Alafenamide (TAF)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHDV<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPoster 1016\n<\/p>\n<\/td>\n

\n

\nBulevirtide Monotherapy is Safe and Well Tolerated in Patients with Chronic Hepatitis D (CHD): An Integrated Safety Analysis of 48-Week Data\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPoster 1024\n<\/p>\n<\/td>\n

\n

\nEfficacy of Bulevirtide as Monotherapy for Chronic Hepatitis D (CHD): Week-48 Results from an Integrated Analysis\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPoster 3430\n<\/p>\n<\/td>\n

\n

\nHDV Patient Perspective: The Impact of Disease and Current Unmet Needs\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPoster 3469\n<\/p>\n<\/td>\n

\n

\nUnderstanding the Economic and Quality of Life Burden of Chronic Hepatitis Delta: A Systematic Literature Review\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPoster 1019\n<\/p>\n<\/td>\n

\n

\nBulevirtide Improves Health Related Quality Life Measured by EQ-5D VAS in Patients with Chronic Hepatitis Delta: An Exploratory Analysis of a Phase 3 Trial at 48 Weeks\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nHCV<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nOral 1296\n<\/p>\n<\/td>\n

\n

\nPatients with Chronic Hepatitis C Could Be Treated with Sofosbuvir\/Velpatasvir for 12 Weeks by Non-Specialists: 2nd Interim Analysis of Prospective Study Helios-3\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nOral 52\n<\/p>\n<\/td>\n

\n

\nEffectiveness of Relink Initiatives to Re-engage Diagnosed-but-Untreated HCV-Positive Patients with Direct-Acting Antiviral Treatment\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPoster 1245\n<\/p>\n<\/td>\n

\n

\nCuring HCV with Direct-Acting Antiviral (DAA) Treatment: Adherence and Rapid Onset of HCV RNA Undetectability After 4 Weeks of Treatment with Sofosbuvir\/Velpatasvir\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nNASH<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nOral 75\n<\/p>\n<\/td>\n

\n

\nCombination Therapy with Cilofexor and Firsocostat Improves Plasma Fibrosis Biomarkers in Patients with Advanced Fibrosis Due to Non-Alcoholic Steatohepatitis\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nOral 76\n<\/p>\n<\/td>\n

\n

\nExploratory Analyses of NASH Histology Using CRN Scores Derived From a Multi-Stain Machine Learning Method\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPoster 2324\n<\/p>\n<\/td>\n

\n

\nHsd17b13 Ablation Ameliorates NASH Fibrosis in Mice Through Regulation of Interferon Signaling and Hepatic Stellate Cell Activation\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPSC<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPoster 4743\n<\/p>\n<\/td>\n

\n

\nAssociations of AST to Platelet Ratio Index (APRI), Enhanced Liver Fibrosis (ELF) Score, Fibrosis-4 (FIB-4) and Liver Stiffness Measurement (LSM) with Fibrosis Stages in Patients with Primary Sclerosing Cholangitis (PSC)\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nFor more information, including a complete list of abstract titles being presented at the meeting, please visit https:\/\/aasldpubs.onlinelibrary.wiley.com\/doi\/abs\/10.1002\/hep.32697<\/a>.\n<\/p>\n

\nPlease see below for the U.S. Indications and Important Safety Information, including BOXED WARNINGS, for Epclusa and Vemlidy.\n<\/p>\n

\nU.S. Important Safety Information And Indication for Epclusa<\/span><\/b>\n<\/p>\n

\nBOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV\/HBV COINFECTED PATIENTS<\/b>\n<\/p>\n

\nTest 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.<\/b>\n<\/p>\n

\nContraindications<\/b>\n<\/p>\n