About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Chronic hepatitis without any evidence of cirrhosis
Decompensated cirrhosis
PegIFN alpha therapy
Trial design
Treatments tested in this trial
- Bulevirtide