Health Canada approves GSK's Hibsago (bepirovirsen) as first functional-cure therapy for chronic hepatitis B
What's the deal? Health Canada has approved GSK's Hibsago (bepirovirsen) as a finite course of treatment intended to achieve functional cure of chronic hepatitis B virus (HBV) infection — a long-term viral infection of the liver — in non-cirrhotic adults who have been on standard antiviral therapy for at least six months. Announced on 3 November 2026 under Health Canada's Priority Review pathway, the approval makes Hibsago the first and only therapy approved in Canada with an indication to achieve functional cure in chronic hepatitis B. Functional cure means the virus's genetic material (HBV DNA) and its surface antigen (HBsAg) are undetectable for at least 24 weeks after stopping all hepatitis B treatment, indicating the immune system controls the disease without medication.
Why it matters: Bepirovirsen is an antisense oligonucleotide — a short synthetic strand of genetic material designed to bind to the virus's RNA and stop it producing viral proteins — licensed by GSK from Ionis Pharmaceuticals, which collaborated on its development. The approval is supported by the Phase 3 B-Well trials, which showed functional cure rates of 19% in patients with baseline HBsAg at or below 3,000 IU/mL and 26% in those at or below 1,000 IU/mL, versus 0% in the placebo group. Chronic hepatitis B affects around 262,000 people in Canada and is a leading cause of liver cancer; until now, standard treatment meant lifelong viral suppression rather than the prospect of stopping therapy. The Canadian authorisation follows approvals in Japan and the United States, where the FDA cleared Hibsago in October 2026. GSK expects Canadian supply from early 2027.
