Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis

Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA (IU/mL) or undetectable HDV-RNA (IU/mL) along with normalization of ALT (combined response)

Percentage of patients with \>2 Log decrease in HDV-RNA along with normalization of ALT (combined response)

Time frame: Week 96

Evaluation of the percentage of patients with normal ALT

Percentage of patients with normal ALT

Time frame: Week 96

Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA

Percentage of patients with \< 1 log decline HDV RNA levels

Time frame: Week 96

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 week 96 of treatment.

Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96;

Time frame: Week 96

Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response

Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV

Time frame: Week 96

Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)

Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5

Time frame: Year 5

Evaluation of bile acids levels over time and correlation of bile levels with virological response rates

Correlation between bile acids levels and virological response over time

Time frame: Week 96