Bulevirtide vs receiving SOC
Research type
Research Study
Full title
Clinical Benefit of Bulevirtide Therapy in Adult Patients With Chronic Hepatitis Delta Compared to a Historical Control Group Receiving Standard of Care
IRAS ID
353047
Contact name
Sergio Leva
Contact email
Sponsor organisation
Gilead Sciences Srl
Duration of Study in the UK
8 years, 5 months, 20 days
Research summary
Hepatitis delta virus (HDV) infection is the most severe form of viral hepatitis affecting between 10 million and 20 million people worldwide. The therapeutic options for patients with HDV infection are severely limited. The purpose of this study is to compare the risk of liver-related events (ie, development of cirrhosis, hepatic decompensation, hepatocellular carcinoma (HCC), liver transplantation, and liver-related death) in adult patients with Chronic Hepatitis Delta (CHD) treated with the study drug Bulevirtide (BLV) (to demonstrate the long-term clinical benefit of BLV) against patients receiving standard of care and were not treated with BLV during up to 5 years of follow-up time.
This is a retrospective data collection study and data will be extracted from medical records from participating sites and countries. A total of 500 patients treated with BLV and 350 patients from a historical control group data will be used for this study. The study population is adult patients with CHD without evidence of decompensated liver disease in the 2 years prior to study entry and without a history of HCC or solid organ transplantation.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0078
Date of REC Opinion
5 Mar 2025
REC opinion
Favourable Opinion