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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Hepatitis D

Treatments: Drug: Bulevirtide

Study type: Observational

Funder types: Other

Identifiers

NCT06397859

IN-IT-589-7118

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

266 participants in 1 patient group

Hepatis Delta

Description:

Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously

Treatment:

Drug: Bulevirtide