– Interim Phase 3 Data Evaluating Hepcludex®, a First-in-Class Entry Inhibitor, Conditionally Approved in the EU, for the Treatment of Chronic Hepatitis Delta Virus will be Presented in Official Press Program –
– One Late-Breaking, Six Oral Presentations and Posters across HDV, HCV, HBV, NASH and PSC Demonstrate the Breadth of Gilead’s Commitment to People with Liver Disease –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that more than 70 abstracts from the company’s liver disease programs will be presented at The International Liver Congress™ 2021 (ILC) taking place from June 23-26. The breadth of data reflects Gilead’s continued commitment to liver disease, including the recent expansion into chronic hepatitis delta virus (HDV), with Hepcludex® (bulevertide) as the first-in-class treatment for people with HDV conditionally approved in Europe. Gilead will also present clinical and real-world data on global efforts to support the World Health Organization’s goal of hepatitis C (HCV) elimination, the impact of treatment in chronic hepatitis B infection (HBV) and ongoing research in nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
“We’re excited to join the liver community at this year’s International Liver Congress and in particular to share these Phase 3 data which reinforce the potential of Hepcludex for the treatment of HDV, the most severe form of chronic viral hepatitis,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We continue to strive to address some of the most substantial challenges in liver diseases, and we look forward to leveraging our expertise to transform the trajectory for people living with HDV.”
Gilead will present interim data on Hepcludex for the treatment of HDV from Phase 3 and Phase 2b clinical trials, which reinforce the safety and efficacy data that was used for the European Medicines Agency (EMA) conditional approval in 2020.
Interim results from the Phase 3 study (MYR301) evaluating the efficacy of Hepcludex monotherapy at low and high doses will be presented as a late-breaking poster presentation (LBP-2730) and broadcast live as part of the ILC’s Official Press Program on June 24 at 9:00 am EDT/15:00 pm CET. Additionally, interim findings from the Phase 2b study (MYR204) will be presented, evaluating the safety and efficacy of Hepcludex monotherapy and in combination with peginterferon alfa-2a. Hepcludex is not approved by the U.S. Food and Drug Administration (FDA).
“HDV only occurs in people co-infected with HBV and leads to more serious liver disease than HBV alone, complicating the diagnosis and treatment journey for this patient population,” said Tarik Asselah, Professor of Hepatology at Hôpital Beaujon, Clichy, and at the University Paris, and Head of Viral Hepatitis Team at INSERM UMR1149, France. “The data on bulevertide to be presented at ILC provide significant progress and promise for people living with chronic HDV, who have previously had very limited treatment options and a poor prognosis.”
HCV Elimination Efforts
Gilead will present real-world data from HCV screening and linkage to care initiatives which underscore the company’s dedication to global HCV elimination efforts. Additional results will be presented showcasing the potential of Epclusa® (400 mg sofosbuvir/100 mg velpatasvir) in the test-and-treat strategy for HCV management based on a simplified monitoring algorithm for appropriate patients.
HBV Treatment and Functional Cure
Data on HBV will highlight the long-term results of switching to Vemlidy® (tenofovir alafenamide 25 mg, TAF). Data will also be presented on Gilead’s ongoing pursuit toward HBV functional cure.
Select accepted abstracts being presented at the ILC include:
Abstract | Abstract Title |
HDV |
|
OS-2717
| Safety and efficacy of bulevirtide monotherapy and in combination with Peginterferon alfa-2a in patients with chronic hepatitis delta: 24 weeks interim data of MYR204 Phase 2b study |
LBP-2730
| Bulevirtide monotherapy at low and high dose in patients with chronic hepatitis delta: 24 weeks interim data of the Phase 3 MYR301 study |
PO-665
| Transcriptomic analyses reveal variation of liver inflammation across phases of chronic hepatitis B infection |
HCV |
|
PO-377
| Risk of multiple drug-drug interactions (DDIs) in HCV patients receiving pangenotypic DAAs (pDAAs): A complex drug interaction scenario first time evaluated in German patients |
PO-1431
| Value assessment of sofosbuvir-based regimens for (chronic) hepatitis C in Spain |
PO-1426
| A discrete choice experiment about patients' and clinicians' preferences for the meet-test-treat approach to HCV management |
OS-199
| Get Tested LeEDs: Clinical impact and cost-effectiveness of opt-out emergency department testing for bloodborne viruses (BBVs) |
PO-1341
| Active search to retrieve lost-to follow-up HCV patients (RELINK-C strategy): health and economic value |
PO-2020
| Good practice hepatitis C screening and linkage to care initiatives at the SLTC Summit 2020: three out of four diagnosed patients able to start direct-acting antiviral treatment |
HBV | |
PO-2338
| Switching from TDF and/or other oral antivirals to TAF in virally suppressed chronic hepatitis B patients with hepatic impairment: 2 year data efficacy & safety results from a Phase 2 study |
PO-2395
| Switching from TDF and/or other oral antivirals to TAF in virally suppressed CHB patients with moderate or severe renal impairment or ESRD on HD: 96 week efficacy & safety results from a Phase 2 study |
OS-2283
| Long-term efficacy and safety of tenofovir disoproxil fumarate (TDF) in children with chronic hepatitis B (CHB): final results from a placebo-controlled trial |
PO-2429
| Safety and efficacy of oral TLR8 agonist, selgantolimod, in viremic adult patients with chronic hepatitis B |
PO-2422
| Safety, efficacy, & pharmacodynamic (PD) activity of 12 weeks treatment with oral RIG-I agonist, inarigivir (IRIG), plus 48 weeks of tenofovir alafenamide in adult patients with chronic hepatitis B: a Phase 2 collaboration study |
PO-1309
| Alanine aminotransferase flares and seroclearance in chronic hepatitis B virus patients |
OS-2225
| Predictive immune biomarkers of persistent HBV DNA suppression and low replicative state after treatment discontinuation in CHB patients |
NASH | |
OS-1611
| AI-based histologic measurement of NASH (AIM-NASH): A drug development tool for assessing clinical trial endpoints |
OS-1746
| Cilofexor and firsocostat treatment is associated with widespread changes in the hepatic transcriptome in NASH patients with advanced fibrosis |
PO-757
| Fenofibrate is safe and mitigates increases in serum triglycerides in NASH patients treated with the combination of the ACC inhibitor firsocostat and the FXR agonist cilofexor: A randomized trial |
PO-756
| Combination treatments including semaglutide, cilofexor, and/or firsocostat lead to greater improvements in the FibroScan-AST (FAST) score compared to semaglutide alone in patients with non-alcoholic steatohepatitis |
PO-1714
| Liver stiffness by vibration-controlled transient elastography predicts disease progression in patients with advanced fibrosis due to NASH |
PO-1568
| Longitudinal variability of noninvasive tests of fibrosis: Implications for treatment response monitoring in patients with NASH |
PO-756
| Combination treatments including semaglutide, cilofexor, and/or firsocostat lead to greater improvements in the FibroScan-AST (FAST) score compared to semaglutide alone in patients with non-alcoholic steatohepatitis |
PO-1831
| Combinations of an acetyl CoA carboxylase inhibitor, FXR agonist and GLP-1R agonist inhibits fibrosis progression in the rat choline-deficient, L-amino acid defined, high-fat diet model of advanced fibrosis |
PO-866
| Comparing traditional machine learning and deep learning models to Fibrosis-4 index in the prediction of non-alcoholic fatty liver disease-associated liver fibrosis |
PSC | |
PO-1644
| A deep learning approach to analysis of MRCP images predicts clinical events and progression to cirrhosis in patients with primary sclerosing cholangitis |
For more information, including a complete list of abstract titles being presented at the meeting, please visit: https://easl.eu/event/the-international-liver-congress-2021/scientific-programme/.
Hepcludex has been granted PRIority MEdicines (PRIME) scheme eligibility by EMA for the treatment of HDV infection and Breakthrough Therapy designation by the U.S. FDA. Bulevirtide is an investigational agent in the U.S. and outside of the European Economic Area; in these regions the safety and efficacy have not been established.
Cilofexor, firsocostat, inarigivir 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 U.S. Indications and Important Safety Information, including BOXED WARNINGS, for Epclusa and Vemlidy.
U.S. Important Safety Information for Epclusa
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
Adverse Reactions
Drug Interactions
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.
U.S. Important Safety Information and Indication for Vemlidy
BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Warnings and Precautions
Adverse Reactions
Drug Interactions
Dosage and Administration