Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bulevirtide.
- Who it may be relevant to
- Registry conditions: Hepatitis D. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)
Overview
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.
Interventions
- Drug Bulevirtide
dose of 2 mg/day subcutaneously
Primary outcome measures
- Investigate the virological response rate to BLV [Time frame: Week 96]
- Investigate the virological response rate to BLV [Time frame: Week 96]
Secondary outcome measures (7)
- 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) [Time frame: Week 96]
- Evaluation of the percentage of patients with normal ALT [Time frame: Week 96]
- Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA [Time frame: Week 96]
- 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. [Time frame: Week 96]
- Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response [Time frame: Week 96]
- Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available) [Time frame: Year 5]
- Evaluation of bile acids levels over time and correlation of bile levels with virological response rates [Time frame: Week 96]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Chronic hepatitis without any evidence of cirrhosis
- Decompensated cirrhosis
- PegIFN alpha therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology an — Milan
Identifiers
NCT: NCT06397859 · IN-IT-589-7118