Hibsago (bepirovirsen) Approved in the US for the Treatment of Chronic Hepatitis B (CHB)
The FDA approved GSK's Hibsago (bepirovirsen), a first-in-class antisense oligonucleotide for chronic hepatitis B, granted under Priority Review and Breakthrough Therapy Designation. Pooled B-Well Phase 3 data showed a 19% functional cure rate versus 0% on placebo in patients with HBsAg ≤3000 IU/ml, rising to 26% in the ≤1000 IU/ml subgroup — far above the <1% typical of standard of care. The label carries a Boxed Warning for on-treatment hepatic flares and thrombocytopenia, which may shape uptake.
Key figures
- Drug Name
- Hibsago (bepirovirsen)
- Phase Of Trial
- Phase 3
- Us chb patient population
- approximately 1.7 million
- Functional cure rate overall
- 19% (233/1220 vs 0/614 placebo)
- Functional cure rate hbsag le 1000
- 26% (200/768 vs 0/393 placebo)
AI analysis
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