Retrospective and prospective, pharmacological, multicentre, non-profit observational study.
Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be enrolled in the study.
Aim of this study is to investigate virological and clinical effectiveness of Bulevirtide 2 mg/day in patients with HDV-related compensated cirrhosis in the real-life setting.
Primary endpoint of the study is the rate of virological response, defined as at least 2 Log decline or undetectable HDV RNA compared to baseline, at week 96 of treatment.
Age≥18 years
HDV-related compensated cirrhosis defined by positivity of HDV RNA for at least 6 months and clinical or laboratory or histological diagnosis of cirrhosis
Started treatment with BLV monotherapy between September 1st 2019 and 2025
Chronic hepatitis without any evidence of cirrhosis
Decompensated cirrhosis
PegIFN alpha therapy
The study will enrol patients with chronic HDV infection (defined by HDV RNA positivity for at least 6 months) who started or will start BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who meet the inclusion criteria and do not present any of the exclusion criteria. The decision to treat patients with BLV is determined based on the clinical judgment of the treating physicians prior to study enrolment.
Cohort
Other
Bulevirtide
Drugdose of 2 mg/day subcutaneously
Investigate the virological response rate to BLV
Percentage of patients with \>2 Log decline in HDV-RNA (IU/mL)
Investigate the virological response rate to BLV
Percentage of patients with undetectable HDV-RNA (IU/mL)
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA (IU/mL) or undetectable HDV-RNA (IU/mL) along with normalization of ALT (combined response)
Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT (combined response)
Evaluation of the percentage of patients with normal ALT
Percentage of patients with normal ALT
Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA
Percentage of patients with \< 1 log decline HDV RNA levels
Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at week 96 of treatment.
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96;
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