GSK reported Phase 3 functional-cure results for bepirovirsen (an antisense oligonucleotide targeting hepatitis B viral transcripts) across two trials in chronic HBV, with company data showing about one-fifth of patients reaching functional cure after treatment discontinuation. In the pooled reporting, the functional cure rate was 19% with bepirovirsen versus none in placebo arms. The NEJM-published analysis described the primary endpoint at week 72 after patients stopped background nucleos(t)ide therapy at week 48. Adverse events were common in both arms, but grade 3+ events were higher with bepirovirsen, driven mainly by alanine aminotransferase elevations. GSK framed the results as a potential pivot point for a disease affecting roughly 240 million people globally that can progress to cirrhosis and liver cancer. The company’s next steps are tied to ongoing regulatory reviews in multiple markets.
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