Health Canada Approves Bepirovirsen, the First 'Functional Cure' for Chronic Hepatitis B
Health Canada has approved GSK's bepirovirsen, described as the first functional cure for chronic hepatitis B, with a Canadian rollout expected in early 2027. While clinical trials showed lasting viral control in about one-fifth of patients, experts caution that high costs and eligibility restrictions may limit access for the estimated 260,000 Canadians living with the virus.
In early November, Health Canada approved bepirovirsen, a new drug developed by GSK that offers the first "functional cure" for a portion of patients living with chronic hepatitis B. The pharmaceutical company expects to roll out the treatment in Canada in early 2027.
An estimated 260,000 Canadians are currently living with hepatitis B, a chronic infection that can lead to cancer or sudden liver failure. Roughly half of those infected are unaware of their condition. Bepirovirsen provides hope for eligible patients to discontinue long-term antiviral therapies, though its reach is limited to a minority of cases.
Clinical trial data showed that around one-fifth of patients maintained viral control, with undetectable levels of the virus in their blood, 24 weeks after stopping all other hepatitis B treatments. The latest figures indicate the drug has a lasting impact of at least 96 weeks, although its long-term durability remains uncertain. Individuals with a history of cirrhosis do not qualify for the bepirovirsen treatment.
Cost and access present significant challenges. In Japan, where the drug was approved earlier, a single course of therapy costs roughly $84,000 Cdn. Experts warn that such high costs and access barriers may limit the drug's availability for average Canadian patients.
Alongside the drug approval, prevention strategies remain a focus. In November, Canada's vaccine advisors issued a recommendation for all Canadian infants to receive the hepatitis B shot, viewing universal infant vaccination as a key strategy to eliminate the virus globally. This approach contrasts with recent policy shifts in the United States, where the Centers for Disease Control and Prevention (CDC) removed its longstanding universal hepatitis B vaccination recommendation for newborns in late 2025.
The global burden of the disease remains severe. In 2024, 75 per cent of all global hepatitis B-related deaths occurred across Africa and the Western Pacific.