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Breakthrough Hepatitis B Drug Offers 'Functional Cure' for First Time
The first antisense therapy for chronic hepatitis B could help some patients reach a functional cure after six months, with 19% responding in late-stage trials.
On Tuesday, October 20, 2026, the FDA approved Hibsago as an add-on injection for adults with chronic hepatitis B who do not have cirrhosis.
Chronic hepatitis B affects up to 2.4 million people in the U.S., with patients typically requiring lifelong antiviral therapy to suppress the virus.
In B-WELL trials, 19% of patients achieved a functional cure with undetectable viral levels 24 weeks after stopping treatment, compared to 0% for placebo.
The drug carries a boxed warning for serious liver reactions and low platelet counts requiring regular blood monitoring. GSK Chief Scientific Officer Tony Wood emphasized it is not a complete cure.
Analysts project around $3 billion in peak annual sales, while clinicians must use a Roche Elecsys HBsAg companion diagnostic to identify eligible patients and monitor treatment progress.