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.
Study Type
OBSERVATIONAL
Enrollment
100
dose of 2 mg/day subcutaneously
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Milan, MI, Italy
RECRUITINGDescribe the virological response to BLV in all patients starting BLV therapy for CHD
Percentage of patients with undetectable HDV RNA
Time frame: Month 6
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
Time frame: Month 12
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
Time frame: Month 6
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
Time frame: Month 12
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
Time frame: Month 6
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
Time frame: Month 12
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT
Time frame: Month 6
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT
Time frame: Month 12
Evaluation of the percentage of patients with normal ALT
Percentage of patients with normal ALT
Time frame: Month 6
Evaluation of the percentage of patients with normal ALT
Percentage of patients with normal ALT
Time frame: 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
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
Time frame: Month 6
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
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
Time frame: Month 12
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Change in serum levels of HBsAg- by medians and ranges
Time frame: Month 6
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Change in serum levels of HBsAg- by medians and ranges
Time frame: Month 12
Investigation of changes over time in serum levels of albumin (g/dL)
Change in serum levels albumin- by medians and ranges
Time frame: Month 6
Investigation of changes over time in serum levels of albumin (g/dL)
Change in serum levels albumin- by medians and ranges
Time frame: Month 12
Investigation of changes over time in serum levels of platelets (10e9/L)
Change in serum levels of platelets - by medians and ranges
Time frame: Month 6
Investigation of changes over time in serum levels of platelets (10e9/L)
Change in serum levels of platelets - by medians and ranges
Time frame: Month 12
Investigation of changes over time in serum levels of AFP (µg/L)
Change in serum levels of AFP - by medians and ranges
Time frame: Month 6
Investigation of changes over time in serum levels of AFP (µg/L)
Change in serum levels of AFP - by medians and ranges
Time frame: Month 12
Evaluation of treatment safety
Occurrence of change in serum bile acid levels (µmol/L)
Time frame: Month 6
Evaluation of treatment safety
Occurrence of adverse events
Time frame: Month 6
Evaluation of treatment safety
Occurrence of change in serum bile acid levels (µmol/L)
Time frame: Month 12
Evaluation of treatment safety
Occurrence of adverse events
Time frame: Month 12
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