Hepatitis D
Conditions
Brief summary
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
DRUGBulevirtide
dose of 2 mg/day subcutaneously
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigate the virological response rate to BLV | Week 96 | Percentage of patients with \>2 Log decline in HDV-RNA (IU/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the percentage of patients with normal ALT | Week 96 | Percentage of patients with normal ALT |
| Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA | Week 96 | 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. | Week 96 | Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96; |
| 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) | Week 96 | Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT (combined response) |
| Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available) | Year 5 | Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5 |
| Evaluation of bile acids levels over time and correlation of bile levels with virological response rates | Week 96 | Correlation between bile acids levels and virological response over time |
| Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response | Week 96 | Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV |
Countries
Italy
Outcome results
None listed