Gilead to Present Latest Research Across Key Liver Disease Indications at the European Association for the Study of the Liver Congress 2024
– Key Findings from PBC, HDV, HCV, HBV and MASH/Fibrosis Studies Affirm Commitment to Drive Life-changing Science in Liver Disease –
- Interim results for two years from the ASSURE study which evaluate the long-term efficacy and safety profile of investigational seladelpar for the treatment of primary biliary cholangitis (PBC);
- Results of a pooled analysis, showcasing the effects of tenofovir-based antiviral therapy in reducing long-term incidence of primary liver cancer in people living with chronic hepatitis B (HBV);
-
Final results of the Phase 2b
MYR204 study evaluating the efficacy and safety of Hepcludex® (bulevirtide) in combination with pegylated interferon alfa-2a (PegIFN) in patients with compensated chronic hepatitis delta virus (HDV); and -
A late breaker presentation on the final results from the pivotal
MYR301 Phase 3 study evaluating the efficacy and safety of bulevirtide as monotherapy.
“These data underline Gilead’s commitment to drive life-changing science and create healthier futures for people living with liver disease. We look forward to presenting our latest research at EASL, as we strive to deliver novel medicines to populations with high unmet medical need,” said
To drive efforts in supporting the World Health Organization’s (
Advancing Treatment options in PBC
New data demonstrating the long-term efficacy and safety profile of investigational seladelpar for the treatment of primary biliary cholangitis (PBC) will be presented at EASL. These include the first interim data from the Phase 3 open-label ASSURE study that includes people
Key Findings in HDV
At the
Further highlighting Gilead as a leader in HDV research, a sub-analysis of the
Key Abstracts at EASL 2024:
ID |
Abstract Title |
PBC |
|
OS-019 |
Efficacy and safety of seladelpar in patients with primary biliary cholangitis and compensated liver cirrhosis in the open-label, long-term ASSURE safety study: interim results |
THU-098 |
Appraising gain of an extended 2-year placebo-controlled trial in primary biliary cholangitis: challenges for evaluating clinical outcomes |
SAT-175 |
PPAR-delta activation with seladelpar regulates cholangiocyte inflammation |
THU-119 |
Seladelpar treatment increases fatty acid beta-oxidation and serum carnitine levels in patients with primary biliary cholangitis consistent with increased expression of the carnitine transporter OCTN2 and the mitochondrial carnitine shuttle |
SAT-177 |
Assessment of PPAR-delta target engagement in mouse liver assessed by single nuclei sequencing following a single oral dose of seladelpar |
LB-283 |
Long-term efficacy and safety of open-label seladelpar treatment in patients with primary biliary cholangitis (PBC): interim results for 2 years from the ASSURE study |
HDV |
|
GS-002 |
48-week off-therapy efficacy and safety of bulevirtide in combination with pegylated interferon alfa-2a in patients with chronic hepatitis delta: Final results from |
LB-309 |
Efficacy and safety of 144 weeks of bulevirtide 2 mg or 10 mg monotherapy from the ongoing Phase 3 study, |
TOP-400 |
Impact of bulevirtide given with or without nucleos(t)ide analogues on 48-week virologic outcomes in patients with chronic hepatitis delta virus infection |
WED-395 |
Undetectable hepatitis delta virus RNA at the end of treatment with bulevirtide and pegylated interferon alpha-2a is an important predictor of 48 weeks sustained virologic response in chronic hepatitis delta |
OS-122 |
Bulevirtide in combination with pegylated interferon alfa-2a shows a sustained off-treatment response in the liver |
FRI-435 |
Serological and nucleic acid testing laboratory screening rates for hepatitis delta virus among adult patients in |
HCV |
|
THU-374 |
Description of age, sex, and characteristics of hepatitis C patients in the SVR10K study: a real-world SOF/VEL analysis performed across five global regions |
WED-498 |
Impact of direct acting antiviral market access policy barriers and restrictions for Hepatitis C patients: a database analysis of claims from states with and without Medicaid restrictions |
WED-447 |
Age at incident cirrhosis in individuals with hepatitis C virus infection: a US administrative claims analysis |
HBV |
|
WED-397 |
Tenofovir-based antiviral therapy reduces long-term incidence of hepatocellular carcinoma in chronic hepatitis B patients |
FRI-390 |
Off-treatment outcomes after discontinuing tenofovir-based treatment in hepatitis B e antigen-positive and hepatitis B e antigen-negative patients with chronic hepatitis B virus |
MASH/Fibrosis |
|
TOP-264 |
Paired assessment of Enhanced Liver Fibrosis (ELF) and Fibrosis-4 (FIB-4) scores is associated with an elevated risk of liver-related clinical events in patients with advanced fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH) |
For more information, including a complete list of abstract titles being presented at the meeting, please visit the EASL website.
In
Seladelpar is an investigational compound and is not approved by the
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 US). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of ALP, ALT, and GGT, enzymes found primarily in the liver, as well as total bilirubin. The most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality.
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 hepatitis B (HBV). On average, HDV progresses to cirrhosis within 5 years and to liver cancer within 10 years. Nearly 5% of people
About
For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped 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 primary biliary cirrhosis (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
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 Hepcludex (bulevirtide) and seladelpar; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the FDA and other regulatory authorities may not approve bulevirtide for the treatment of HDV and/or seladelpar for the treatment of PBC, and the risk that any such approvals, if granted, may be subject to significant limitations on use; 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
Hepcludex, Gilead and the Gilead logo are registered trademarks of
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/20240522704668/en/
public_affairs@gilead.com
investor_relations@gilead.com
Source: