Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) Patients in Italy: a National Real Life Data Study

Conditions
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Hepatitis D

Intervention / Treatment
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* Drug: Bulevirtide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatis Delta<br>Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously | Drug: Bulevirtide<br>* dose of 2 mg/day subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the virological response to BLV in all patients starting BLV therapy | percentage of patients with undetectable HDV RNA. | Month 12 | 
| Describe the virological response to BLV in all patients starting BLV therapy | percentage of patients with ≥ 2 log IU/ml decline of HDV RNA at month 12 of BLV therapy, compared to baseline. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment | Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT | Month 12 | 
| Evaluation of the percentage of patients with normal ALT, at the twelfth month of treatment | Percentage of patients with normal ALT at 12 months of BLV treatment | Month 12 | 
| 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 | Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) | Month 12 | 
| Evaluation of treatment safety | Occurrence change in serum bile acid levels (µmol/L) | Month 12 |