Effectiveness and Safety of Bulevirtide Therapy in Patients With Chronic Hepatitis Delta A Multicenter Prospective Real-Life Data Study in Italy

What this Trial Is About

This research investigates the effectiveness and safety of Bulevirtide (BLV) therapy in patients with chronic Hepatitis Delta (CHD) across multiple hepatology centers in Italy. The study aims to provide a real-life overview of treatment outcomes by following patients according to standardized EASL 2017 guidelines for antiviral therapy management. The primary goal is to describe how well patients respond to BLV in reducing the hepatitis D virus load over a 12-month period. Participants receive Bulevirtide administered as a 2 mg dose once daily by subcutaneous injection. The study enrolls patients starting this BLV treatment from May 2023, following official guidelines. Patient data is collected at regular intervals including months 0, 1, 2, 4, 6, and 12, allowing detailed monitoring of antiviral effects and safety. Throughout the study, clinical and biochemical data are gathered from medical records and ongoing assessments to track virological response, defined as a significant decline or undetectable levels of HDV-RNA at 6 and 12 months. Researchers monitor safety and treatment adherence during these visits, with the overall study designed to capture comprehensive real-world evidence over the course of one year.

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