Bepirovirsen Delivers 17.5-Point HBV Cure Gain in Phase 3 Trials
Updated
Updated · Medscape · Jan 7
Bepirovirsen Delivers 17.5-Point HBV Cure Gain in Phase 3 Trials
3 articles · Updated · Medscape · Jan 7
Summary
Two phase 3 trials found bepirovirsen produced significantly more functional cures than placebo at week 72, with risk differences of 17.5 percentage points in B-Well 1 and 13.3 points in B-Well 2.
The 24-week antisense treatment was tested in 1,834 chronic HBV patients across 29 countries who were already on nucleoside or nucleotide analog therapy and later stopped treatment if they met strict response criteria.
At week 72 after discontinuation, 23% of bepirovirsen-treated patients maintained HBV DNA below the quantification limit versus 0% on placebo in both trials.
Patients starting with lower HBsAg levels of 1,000 IU/mL or less showed larger functional-cure gains—24.6 points in B-Well 1 and 27.8 points in B-Well 2.
Safety signals were higher with bepirovirsen: serious adverse events occurred in 4% versus 1% on placebo, and grade 3 or higher events in 16% versus 3%, most commonly ALT elevations.
Why did the new 'breakthrough' Hepatitis B drug fail to cure four out of five patients in its pivotal trials?
With an FDA decision months away, can the world actually afford this new 24-week Hepatitis B treatment?
Bepirovirsen Achieves 24% Functional Cure Rate in Phase 3 Trials: A New Era for Chronic Hepatitis B Treatment and Global Elimination Efforts
Overview
Bepirovirsen’s global Phase 3 trials, B-Well 1 and B-Well 2, have been successfully completed, generating excitement in the medical community. The trials achieved unprecedented functional cure rates for chronic hepatitis B, which is the main reason for this enthusiasm. These remarkable results mark a major step toward a functional cure for HBV infection and position Bepirovirsen as an attractive option for selected patients. With this success, the focus now shifts to imminent regulatory decisions, expected in late 2026, which could bring a groundbreaking new treatment to millions of people worldwide.