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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatis Delta | Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulevirtide | Drug | dose of 2 mg/day subcutaneously |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- HDV-related decompensated cirrhosis (CPT ≥7)
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. | Milan | MI | 20122 | Italy |
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| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000718249 | bulevirtide |
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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 |
| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |