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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

Retrospective and prospective, pharmacological, multicentre, non-profit observational study.

Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be enrolled in the study.

Aim of this study is to investigate virological and clinical effectiveness of Bulevirtide 2 mg/day in patients with HDV-related compensated cirrhosis in the real-life setting.

Primary endpoint of the study is the rate of virological response, defined as at least 2 Log decline or undetectable HDV RNA compared to baseline, at week 96 of treatment.

Eligibility

Inclusion Criteria:

  • Age≄18 years
  • HDV-related compensated cirrhosis defined by positivity of HDV RNA for at least 6 months and clinical or laboratory or histological diagnosis of cirrhosis
  • Started treatment with BLV monotherapy between September 1st 2019 and 2025

Exclusion Criteria:

  • Chronic hepatitis without any evidence of cirrhosis
  • Decompensated cirrhosis
  • PegIFN alpha therapy

Study details
    Hepatitis D

NCT06397859

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

22 June 2024

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