FDA approves Hibsago (bepirovirsen) for chronic hepatitis B

The U.S. Food and Drug Administration approved Hibsago (bepirovirsen) injection, according to fda.gov, for use in combination with existing antiviral therapy to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis fda.gov. It is the first FDA-approved antisense oligonucleotide for chronic hepatitis B. The approval was granted to GSK plc fda.gov.

Indication and mechanism

The drug is approved for adults without cirrhosis who have taken HBV antiviral therapy for at least six months, have suppressed HBV levels in the blood and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test fda.gov. Chronic hepatitis B is a long-term liver infection that can lead to cirrhosis and raises the risk of liver cancer. Hibsago targets the genetic instructions the virus uses to copy itself and make viral proteins, which reduces the amount of virus and HBsAg in the body fda.gov.

The FDA also authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic. It is intended to help select patients for antiviral therapy and to monitor them during treatment fda.gov.

Trial results and safety

Hibsago was studied in two clinical trials against a placebo. It is injected under the skin for up to 24 weeks alongside the patient's existing hepatitis B medicine, which continues for at least 24 weeks after the last injection fda.gov. Across the two trials, 24% of patients who received Hibsago met the requirements to stop their existing medicine, compared with none on placebo fda.gov. Twenty-four weeks after stopping all hepatitis B treatment, 19% of Hibsago patients still had the virus under control, with no detectable HBsAg in the blood fda.gov.

According to the results published in the New England Journal of Medicine, this corresponded to 233 of 1,220 participants on bepirovirsen and 0 of 614 on placebo. GSK describes the drug as a functional cure; whether the effect lasts for years after treatment has not yet been shown.

Hibsago carries a boxed warning for serious liver reactions and for low platelet counts, which can increase the risk of potentially life-threatening bleeding fda.gov. It also has warnings for worsening kidney function, serious inflammatory reactions such as vasculitis, and risks if the injection is not administered properly. Patients need regular blood tests and follow-up before and during treatment. The most common side effects, excluding laboratory abnormalities, are injection site reactions, fever, fatigue and headache fda.gov.

The FDA granted the drug Fast Track status, a second expedited-development designation and Priority Review fda.gov.

FDA approves GSK's Hibsago (bepirovirsen) for chronic hepatitis B in adults on antiviral therapy

Indication and mechanism

Trial results and safety

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