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Two Phase 3 trials showed GSK's bepirovirsen produced functional cures in nearly one-fifth of chronic hepatitis B patients. Current nucleoside analogue treatments reach functional cures in only 1-3% of cases. The company has submitted the drug for regulatory approval.
StatAn experimental GSK medicine produced functional cures of chronic hepatitis B in 19% and 20% of patients across two late-stage trials, according to data released Thursday. The results far exceed the 1% to 3% functional cure rate seen with existing nucleoside analogue treatments. No patients on placebo reached functional cure in either study.
Some 250 million to 300 million people worldwide live with chronic hepatitis B. The infection can progress to cirrhosis and liver cancer and causes about 1 million deaths annually. The two Phase 3 trials tested bepirovirsen, referred to internally as "bepi." The medicine was given to adults with chronic hepatitis B infection.
GSK has submitted bepirovirsen for regulatory approval to the FDA and other agencies. The company described the outcomes in a statement accompanying the data release. Patients typically require lifelong treatment. Bepirovirsen works through a different mechanism that targets the viral RNA, offering the possibility of shorter treatment courses. The data were presented on May 28, 2026.
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