January 2nd 2025
The December month in review spotlights hepatic FDA news as well as the latest research in viral hepatitis and MASH.
December 31st 2024
To celebrate the close of 2024, we're recapping the 10 most popular approval articles across the HCPLive Network of brands.
December 27th 2024
2024 was a historic year in hepatology, characterized by notable hepatic FDA approvals, pipeline developments, new WHO HBV guidelines, and more.
Resmetirom made history when it became the first and only FDA-approved MASH drug in 2024, but the pipeline continues to show promise heading into 2025.
December 23rd 2024
Patients with PSC had worse death, transplant, liver-related mortality, and liver-related decompensation outcomes than PBC and autoimmune hepatitis.
Machine Learning Model Accurately Predicts Long-Term HCC Risk in Patients with HBV
The ML model exhibited better predictive performance than previous traditional HCC models in patients with chronic HBV on long-term antiviral therapy.
Belapectin Misses Primary Endpoint in Phase 3 MASH Cirrhosis, Portal Hypertension Trial
The phase 2b/3 NAVIGATE trial missed its primary endpoint for the prevention of varices in patients with MASH cirrhosis and portal hypertension.
New Data Supports Liver Retransplantation for Patients with PSC Recurrence
Retransplantation outcomes were similar or better in patients with PSC compared with patients with other liver disease etiologies.
FDA Adds Boxed Warning to Fezolinetant (Veozah) for Liver Injury Risk
The Boxed Warning is based on the FDA’s review of a postmarketing case of serious liver injury with fezolinetant reported to the FAERS database.
Study Highlights Real-World Mortality Rates, Factors Increasing Mortality Risk in MASH
Real-world data from 18,710 MASH patients highlight the impact of comorbidities, biomarkers, and region on mortality, with 70% of deaths CVD-related.
Machine-Learning Models Could Help ID MASH Patients Considered Candidates for Resmetirom
Machine learning models improve accuracy in detecting MASH with F2-F3 fibrosis, surpassing noninvasive tests in sensitivity, specificity, and predictive value.
Immunodeficiency, Injection Drug Use Linked to Failed HCV Treatment in People with HIV
Lower CD4+ cell counts, HCV genotype 4, and recent injection drug use were linked to unsuccessful DAA treatment in people with HCV and HIV.
Tobevibart, Elebsiran Receive FDA Breakthrough Therapy Designation for Chronic HDV
The FDA awarded Breakthrough Therapy Designation to Vir Biotechnology’s tobevibart and elebsiran for the treatment of chronic hepatitis delta.
FDA Finds Obeticholic Acid (Ocaliva) Linked to Serious Liver Injury in Noncirrhotic PBC
An FDA review of postmarket clinical trial data revealed an increased risk of liver injury with obeticholic acid in patients with PBC without cirrhosis.
Bulevirtide Monotherapy Well-Tolerated, Safe for Chronic Hepatitis Delta at Week 48
In this study, investigators described the safety and tolerability of BLV therapy following 48 weeks of therapy among those with CHD.
Novel Model Performs Well in Identifying Liver Fibrosis Risk in Patients with Diabetes
Investigators developed and validated a novel model to identify liver fibrosis in patients with diabetes which performed better than existing models.
COVID-19 Vaccine Efficacy Reduced With Immunosuppressive, Antiviral HBV Drug Use
Patients taking immunosuppressive and hepatitis B antiviral drugs after living donor liver transplant had lower antibody response to COVID-19 vaccination.
Study Highlights Traits of Patients with Alcohol-Associated Cirrhosis Seeking Treatment
This analysis involved assessing rates of lifetime as well as prior 12-month treatment use for AUD, in addition to demographic and clinical characteristics linked to AUD treatment.
Study Finds Sex Differences in MASLD Adverse Events: Cirrhosis Greater Risk in Women
A new study identifies sex differences in MASLD adverse events, such as females having a greater risk of developing cirrhosis and males having a greater risk of non-liver cancers.
Inflammation-Based Score Predicts Long-Term Prognosis of HBV-Related ACLF
The inflammation-based scoring system provides the first tool for predicting long-term mortality in hepatitis B-related acute on chronic liver failure.
PRICE-2: Hypovolaemic Phlebotomy Reduces Blood Transfusions After Liver Resection
Hypovolaemic phlebotomy reduced perioperative blood transfusion and improved operative conditions versus usual care in patients undergoing liver resection.
HepB-CpG Offers Superior Seroprotection in People with HIV, Prior HBV Vaccine Nonresponse
HepB-CpG achieved superior seroprotection response versus conventional HepB-alum in patients with HIV and nonresponse to prior hepatitis B vaccination.
Study Suggests Fragmented Nocturnal Sleep May Play a Role in MASLD Development
A new study showed patients with MASLD have fragmented nocturnal sleep with frequent awakenings per night and a session on healthy sleep habits did not improve sleep parameters.
The Clinical Impact of Seladelpar in PBC Care
Trivedi and Lawitz discuss the clinical impact of having seladelpar as a second-line treatment option for patients with PBC.
Understanding Seladelpar as a Second-Line Treatment for PBC
Trivedi and Lawitz discuss seladelpar’s mechanism of action and its use as a second-line therapy in PBC.
Bemnifosbuvir, Ruzasvir Regimen Meets Safety, SVR Primary Endpoints in Phase 2 HCV Trial
The phase 2 study of a bemnifosbuvir and ruzasvir regimen for the treatment of HCV met both primary endpoints for safety and SVR 12 weeks post-treatment.
Hepatology Month in Review: November 2024
This month in review spotlights FDA news, new clinical trial data, and HCPLive’s coverage of the NASPGHAN 2024 annual meeting and AASLD The Liver Meeting.
This Year in Medicine 2024: Stories that Defined Healthcare
An overview and landing page for future installments from HCPLive's 8th annual This Year in Medicine Series.
Clinical Quiz: AASLD Guidelines for Noninvasive Testing in Chronic Liver Disease
Test your knowledge of the 2024 AASLD Practice Guidelines on blood- and imaging-based noninvasive liver disease assessment with this clinical quiz!
Clinical Quiz: Impact of New MASLD Nomenclature on 2023 AASLD NAFLD Guidance
Test your knowledge of the AASLD NAFLD Practice Guidance and its clinical application in light of the new MASLD nomenclature.
Malin Fromme, MD: Lung, Liver Risk Stratification in Alpha-1 Antitrypsin Deficiency
Fromme describes the importance of risk stratification in AATD and explains the potential utility of noninvasive fibrosis measures for predicting outcomes.
Pavel Strnad, MD: The Underlying Molecular Mechanisms of PI*ZZ AATD Liver Disease
Strnad reviews findings from a proteomic analysis about AATD-associated liver disease and how they may aid future disease monitoring and drug development.
Gideon Hirshfield, FRCP, PhD: Developing Therapies to Address Pruritus in PBC
Hirschfield describes the need for therapies that address itch in PBC and explains what linerixibat, an IBAT inhibitor, may offer for pruritus.
Country-Level Socioeconomic Status, Healthcare Impact AKI Outcomes in Cirrhosis
Kavish Patidar, DO, explains how socioeconomic status and healthcare delivery impact outcomes in patients with acute kidney injury and cirrhosis.
Marcelo Kugelmas, MD: Elafibranor (Iqirvo) Does Not Impact Renal Function in PBC
Kugelmas reviews findings from a secondary analysis of the phase 3 ELATIVE trial suggesting elafibranor is associated with stable kidney function.