Multicenter pharmacological observational prospective, no-profit, study.
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 longitudinally.
The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, 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.
HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled.
18 years of age or older
Chronic hepatitis delta
Compensated cirrhosis HDV related
Patients who will start therapy with BLV 2 mg/day from May 2023
HDV-related decompensated cirrhosis (CPT ≥7)
All patients with CHD (quantifiable HDV-RNA) who will start 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.
Cohort
Prospective
Bulevirtide
Drugdose of 2 mg/day subcutaneously
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Percentage of patients with undetectable HDV RNA
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Proportion of patients with virological response, defined as a \>2 Log decline in HDV-RNA
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Proportion of patients with virological response, defined as a \>2 Log decline in HDV-RNA
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Proportion of patients with virological response, defined as undetectable HDV-RNA
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Proportion of patients with virological response, defined as undetectable HDV-RNA
Click on the lead sponsor to view all of their trials.
