Improvement in liver histology is observed in most patients with chronic hepatitis delta after 48 weeks of bulevirtide monotherapy

Aims: Patients with chronic HDV treated with bulevirtide (BLV) in study MYR301 showed superior responses at week48 vs controls based on virological and biochemical response. We now explore the relationship between virologic, biochemical, and histologic change through 48W.

Method: Patients were randomized to 144W of BLV 2mg or 10mg or control with additional 96W of follow-up after end of treatment. Liver biopsy was performed at Baseline and W48. Analysis focused on patients with paired biopsies. Viral response categories at W48 included VR, partial response or non-response. Histologic parameters included histologic activity index and Ishak fibrosis score.

Results: Of 150 patients 55% had paired biopsy data. At BL: mean age 42 years, 52% males, 33% with compensated cirrhosis and 61% on concomitant NUC-therapy. Mean HDV RNA and median ALT, HAI, and Ishak fibrosis score was 5.1 log10 IU/mL, 92 U/L, 9, and 2. At W48, 80%, 11% and 9% of patients treated with BLV achieved VR, PR, and NR while no control achieved VR. Similar median change in ALT was observed across viral response group. Decrease in ALT was observed in 89% of BLV treated patients of those 80% had HAI improvement. Higher likelihood of improvement in HAI category and greater decrease in median HAI from BL was observed with VR: 69% and PR: 83%. ALT normalization didn’t have correlation with degree of HAI improvement. Improvement in fibrosis occurred in VR: 58%, PR: 33%, NR: 25% and control: 30%. Histological improvement occurred in VR: 69%, PR: 83%, NR: 25%, controls: 33%

Publication History

Article published online:
20 January 2025