Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Hepatitis D

Treatments: Drug: Bulevirtide

Study type: Observational

Funder types: Other

Identifiers

NCT06122285

184853

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Chronic hepatitis delta
• Compensated cirrhosis HDV related
• Patients who will start therapy with BLV 2 mg/day from May 2023

Exclusion criteria

• HDV-related decompensated cirrhosis (CPT ≥7)

Trial design

100 participants in 1 patient group

Hepatis Delta

Description:

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

Treatment:

Drug: Bulevirtide