The FDA approved GSK’s Hibsago (bepirovirsen) on October 20, 2026, for certain adults with chronic hepatitis B. It is the first antisense oligonucleotide approved in the U.S. for the disease.
Hibsago is used alongside existing antiviral pills. The approval covers adults without cirrhosis who have taken antiviral therapy for at least six months, have suppressed HBV DNA, and meet a specified hepatitis B surface antigen (HBsAg) threshold.
In Phase 3 trials, 19% of eligible patients had undetectable HBV DNA and HBsAg 24 weeks after stopping all treatment; no placebo patients met that outcome. This is called a functional cure:
the virus remains controlled without medication, not that the infection is eradicated.
Treatment involves injections for up to 24 weeks. Patients continue their existing antiviral medicine for at least 24 weeks after the final injection; stopping it afterward depends on clinical and laboratory criteria.
The FDA granted Priority Review and Breakthrough Therapy designation. The result offers a new finite-course option, but most trial participants did not achieve a functional cure, and the approval is limited to a defined patient group.
Sources:
Hibsago (bepirovirsen) approved in the US for the treatment of chronic hepatitis B (CHB) | GSK US
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