- The FDA approved Hibsago (bepirovirsen) injection with existing antiviral therapy for certain adults with chronic hepatitis B virus infection and without cirrhosis, effective October 20, 2026.
- Eligible patients have taken HBV antiviral therapy for at least six months, have suppressed HBV levels, and have HBsAg levels of 3,000 IU/mL or less as determined by an FDA-authorized test.
- Across two placebo-controlled trials, 24% of Hibsago patients met the requirements to stop their existing medicine, compared with none on placebo.
- At 24 weeks after stopping all hepatitis B treatment, 19% of Hibsago patients still had the virus under control and no detectable HBsAg in their blood.
- Hibsago carries a boxed warning for serious liver reactions and low platelet counts, along with warnings for worsening kidney function and serious inflammatory reactions such as vasculitis.
- The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic for patient selection and treatment monitoring.
- Hibsago received Fast Track, Breakthrough Therapy designations and Priority Review.
Quotes
“Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.”