Efficacy and Safety at 96 weeks of Bulevirtide 2 mg or 10 mg Monotherapy for Chronic Hepatitis Delta: Results From an Interim Analysis of a Phase 3 Randomized Study

Bulevirtide (BLV) is a first-in-class inhibitor for chronic hepatitis delta (CHD). Week (W) 48 primary endpoint analysis for MYR301 (NCT03852719), a Phase 3 randomized study, showed monotherapy with subcutaneous BLV at 2 or 10mg/d was superior to no active anti–hepatitis delta virus (HDV) treatment and generally well tolerated. We present findings from the predefined W96 interim analysis.

Patients with CHD were randomized (1:1:1) and stratified based on the presence/absence of compensated cirrhosis as follows: Arm A, no active anti-HDV treatment for 48 weeks followed by BLV 10mg/d for 96 weeks (n=51); Arms B and C, immediate treatment for 144 weeks with BLV at 2mg/d (n=49) or 10mg/d (n=50), respectively, with 96 weeks of follow-up after end of treatment. Combined response was defined as undetectable HDV RNA or decrease by≥2 log10 IU/mL from baseline and alanine aminotransferase (ALT) normalization; other endpoints included viral response, ALT normalization, log10 change in HDV RNA, and change in liver stiffness by transient elastography.

Of 150 patients, 143 (95%) completed 96 weeks of treatment. W96 efficacy responses were improved vs W48. At W96, similar combined, virologic, and biochemical responses were seen in arms B and C. BLV was well tolerated; there were no drug discontinuations, serious adverse events or deaths attributed to BLV. Increases in bile acids without a correlation to pruritus or other symptoms were noted with BLV treatment. More injection site reactions occurred in patients receiving 10mg/d dosing.

BLV continues to be safe and well tolerated as monotherapy for CHD through W96.

Publication History

Article published online:
23 January 2024