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Antiviral therapy for chronic hepatitis delta: new insights from clinical trials and real-life studies.
Gut
December 2024
D-SOLVE consortium, an EU Horizon Europe funded project (No 101057917), Hannover, Germany.
Chronic hepatitis D (CHD) is the most severe form of viral hepatitis, carrying a greater risk of developing cirrhosis and its complications. For decades, pegylated interferon alpha (PegIFN-α) has represented the only therapeutic option, with limited virological response rates and poor tolerability. In 2020, the European Medicines Agency approved bulevirtide (BLV) at 2 mg/day, an entry inhibitor of hepatitis B virus (HBV)/hepatitis delta virus (HDV), which proved to be safe and effective as a monotherapy for up to 144 weeks in clinical trials and real-life studies, including patients with cirrhosis.
View Article and Find Full Text PDFBulevirtide Monotherapy Is Safe and Well Tolerated in Chronic Hepatitis Delta: An Integrated Safety Analysis of Bulevirtide Clinical Trials at Week 48.
Liver Int
December 2024
Clinic for Gastroenterology, Hepatology, Infectious Diseases, and Endocrinology, Hannover Medical School, Hannover, Germany.
Article Synopsis
- The study assessed the safety and tolerability of bulevirtide (BLV), a new treatment for chronic hepatitis delta (CHD), by analyzing data from three clinical trials involving 269 patients.
- The findings indicated that certain adverse events, such as increased bile acid levels and injection-site reactions, were more common with BLV compared to a control group, but serious side effects were minimal and did not lead to treatment discontinuation.
- Overall, BLV was deemed safe and well tolerated over 48 weeks of therapy in patients with CHD, showing promise as an effective treatment option.
Dynamics of Virological and Clinical Response Parameters of Bulevirtide Treatment for Hepatitis D: Real-World Data.
Gastro Hep Adv
January 2024
Department for Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Background And Aims: The entry inhibitor bulevirtide represents the first specific treatment for hepatitis-D virus (HDV)-infected patients. In clinical trials, around 80% of patients achieve normalization of alanine aminotransferase (ALT) with about 60% virological response after 1 year, but little is known about the dynamics of responses and clinical predictors of treatment outcomes. We report our single-center data from 15 patients and describe response dynamics, clinical outcomes, and predictive factors for treatment response.
View Article and Find Full Text PDFBulevirtide monotherapy in patients with chronic HDV needs further evaluation.
J Hepatol
July 2024
First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China. Electronic address:
Patient-reported outcomes in chronic hepatitis delta: An exploratory analysis of the phase III MYR301 trial of bulevirtide.
J Hepatol
January 2025
Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; CRC "A. M. and A. Migliavacca" Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Background & Aims: Once-daily treatment of chronic hepatitis delta (CHD) with bulevirtide is well tolerated and associated with significant reductions in HDV RNA in the blood and in biochemical liver disease activity. This study explored the effects of 48-week bulevirtide treatment on health-related quality of life (HRQoL) in patients with CHD.
Methods: In an open-label, randomised, phase III trial, 150 patients with CHD and compensated liver disease were stratified by cirrhosis status and randomised 1:1:1 to no treatment (control), bulevirtide 2 mg/day, or bulevirtide 10 mg/day for 48 weeks.
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