HEP4Di: Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy
Study Details
Study Description
Brief Summary
Spontaneous, pharmacological observational, no-profit, retrospective, multi-center.
This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected retrospectively/longitudinally.
The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ <6 IU/ml) at month 12 of therapy.
All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated treatment with 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 met the inclusion criteria and none of the exclusion criteria.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hepatis Delta Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
Drug: Bulevirtide
dose of 2 mg/day subcutaneously
|
Outcome Measures
Primary Outcome Measures
- Describe the virological response to BLV in all patients starting BLV therapy [Month 12]
percentage of patients with undetectable HDV RNA.
- Describe the virological response to BLV in all patients starting BLV therapy [Month 12]
percentage of patients with ≥ 2 log IU/ml decline of HDV RNA at month 12 of BLV therapy, compared to baseline.
Secondary Outcome Measures
- Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment [Month 12]
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
- Evaluation of the percentage of patients with normal ALT, at the twelfth month of treatment [Month 12]
Percentage of patients with normal ALT at 12 months of BLV treatment
- 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 the end of the first year of treatment [Month 12]
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
- Evaluation of treatment safety [Month 12]
Occurrence change in serum bile acid levels (µmol/L)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age or older
-
Chronic hepatitis delta
-
Compensated cirrhosis HDV related
-
Bulevertide 2 mg/day within December 15, 2020, to December 31, 2022
Exclusion Criteria:
- HDV-related decompensated cirrhosis (CPT ≥7)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. | Milan | MI | Italy | 20122 |
Sponsors and Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IN-IT-589-6246