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Hibsago (bepirovirsen) Approved in the US for the Treatment of Chronic Hepatitis B (CHB)

Business Wire

  • Approval based on phase III data showing unprecedented functional cure rates compared to standard of care

  • Six-month treatment with option of self-administration after first dose

  • CHB affects approximately 1.7 million people in the US1

PHILADELPHIA, October 20, 2026--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B virus (HBV) surface antigen (HBsAg) levels ≤3000 IU/ml, as determined by an FDA-authorised test.2 Bepirovirsen is a first-in-class antisense oligonucleotide (ASO) and offers unprecedented functional cure rates compared to current standard of care. The approval was granted under FDA Priority Review and Breakthrough Therapy Designation, recognizing significant improvement of bepirovirsen and nucleos(t)ide analog therapy over existing standard of care.3

Tony Wood, Chief Scientific Officer, GSK, said: "Despite current therapies, many people living with chronic hepatitis B remain on treatment indefinitely and continue to face the risk of serious liver complications.4,5 For the first time, with Hibsago, US patients have the potential to achieve functional cure after a six-month treatment course, with the added convenience of the option of self-administration after the first dose."

The approval was supported by results from the B-Well phase III trials showing functional cure rates of 19% in adults with ≤3000 IU/ml HBsAg, compared to current standard of care alone, which typically achieves less than 1% functional cure rate after one year of treatment.6,7 Functional cure occurs when HBV DNA and viral protein – HBsAg – are undetectable for at least 24 weeks after stopping all treatment, indicating the disease is controlled by the immune system without medication.8

Dr. Norah Terrault, Chief of Gastroenterology & Hepatology, USC Keck Medical Center, said: "This is the start of a new era in treating people living with CHB. Bepirovirsen offers patients the potential to achieve functional cure after a short period of treatment, a long-standing goal for patients and physicians alike."

Dr. Chari Cohen, President of Hepatitis B Foundation, said: "CHB is a major public health challenge, affecting millions of people in the US and accounting for approximately 56% of all global liver cancer cases.1,9 Today marks significant progress towards our aim of transforming the way CHB is managed with improvements in screening, diagnosis, and the availability of innovative treatment options for our community."

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