Phase 3 Results of Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection - PubMed
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- #Clinical Trial
- #Hepatitis B
- #Antisense Oligonucleotide
- Bepirovirsen significantly increased functional cure rates compared to placebo in two phase 3 trials for chronic HBV infection, with 19-20% achieving sustained HBsAg loss and HBV DNA below detection at week 72.
- Both trials (B-Well 1 and B-Well 2) involved adults on stable nucleoside analogue therapy, administering weekly subcutaneous bepirovirsen 300 mg or placebo for 24 weeks, with NA therapy discontinued at week 48.
- Adverse events were more common with bepirovirsen (91% vs. 73%), including higher rates of serious events (7% vs. 4%) and grade 3+ events (16% vs. 3%), most notably alanine aminotransferase increases in 6%.