News / 21 October 2026
FDA approves Hibsago, first antisense oligonucleotide for chronic hepatitis B
The FDA approved Hibsago (bepirovirsen) injection, used with existing antiviral therapy, to treat chronic hepatitis B virus infection in certain adults without cirrhosis.[1] It is the first FDA-approved antisense oligonucleotide for chronic hepatitis B, and the approval was granted to GSK plc.[1]
Hibsago is approved for certain adults without cirrhosis who have taken HBV antiviral therapy for at least six months, have suppressed levels of HBV in their blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test.[1] The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic device to aid in selecting patients for treatment and to assist in monitoring them during treatment.[1]
Researchers studied Hibsago in two clinical trials that compared it with a placebo, an inactive treatment.[1] Hibsago is injected under the skin for up to 24 weeks, alongside patients' existing hepatitis B medicine, which they continue for at least 24 weeks after their last Hibsago injection.[1] Some patients may then be able to stop their existing medicine if they meet certain health and lab test requirements.[1]
Across the two trials, 24% of patients who received Hibsago met the requirements to stop their existing medicine, compared with none who received placebo.[1] Twenty-four weeks after stopping all hepatitis B treatment, 19% of patients who received Hibsago still had the virus under control, and HBsAg could not be detected in their blood.[1]
Hibsago has a boxed warning for serious liver reactions as well as low platelet counts, which can increase the risk of potentially life-threatening bleeding.[1] It also carries warnings for worsening kidney function, serious inflammatory adverse reactions like vasculitis, and serious risks if the injection is not administered properly.[1] The most common side effects, excluding laboratory abnormalities, are injection site reactions, fever, fatigue and headache.[1] The FDA granted Hibsago Fast Track and Breakthrough Therapy designations as well as Priority Review.[1]
Background
Wendy Carter, DO, Acting Director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research, said treatment can mean taking antiviral medication for years to keep the virus suppressed, and that Hibsago gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended.[1] Chronic hepatitis B is a long-term liver infection that can lead to serious liver disease, including cirrhosis, and increase the risk of liver cancer.[1]
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Sources
- U.S. Food and Drug Administration. FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment. Published 2026-10-20. Read the source
Checked 21 October 2026. How we check sources