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

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 266

Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Location: Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. Milan

Summary

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 Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06397859). StuddyBuddy aggregates publicly available trial information.