Treatment with Bulevirtide Improves Patient-reported Outcomes in Patients with Chronic Hepatitis Delta: An Exploratory Analysis of a Phase 3 Trial at 48 Weeks

Bulevirtide (BLV), a novel NTCP entry inhibitor, is conditionally approved in the European Union for the treatment of chronic hepatitis delta (CHD). We report an exploratory analysis of quality-of-life (QoL) outcomes in patients with CHD after 48 weeks of treatment with BLV 2 mg in an ongoing Phase 3 trial.

MYR301 (NCT03852719; EudraCT 2019-001213-17) is a randomised, open-label, parallel-group, multicentre trial that assigned 150 CHD patients (1:1:1) to 3 exploratory arms (BLV 2 or 10 mg or control) for up to 3 years. Control patients received no active anti-HDV treatment until Week (W)48. Patients completed the Hepatitis Quality of Life Questionnaire (HQLQ) at study baseline (BL), W24, and W48. Higher scores on the HQLQ (range 0−100) indicate better health. Interim W24 results were reported previously.

BL characteristics were well balanced between BLV 2 mg (n=49) and controls (n=51). From BL–W48, BLV 2 mg was associated with improvements in all HQLQ domains;>5-point improvements were observed for 10 of 14 items. Treatment differences vs controls in least-squares mean changes from BL–W48 were statistically significant (P<.05) for role–physical, hepatitis-specific (HS) limitations, and HS health distress. Improvements with BLV 2 mg seen at W24 were largely maintained or increased at W48.

CHD patients receiving BLV 2 mg showed improvements at W48 in all HQLQ domains, while patients in the control group remained largely unchanged, apart from improvements in health distress and HS health distress.

Publication History

Article published online:
18 January 2023