Health Canada Approves First Functional Cure for Chronic Hepatitis B

Health Canada approved a breakthrough drug offering the first functional cure for a portion of chronic hepatitis B patients on November 3, CBC reported, with drugmaker GSK expecting a commercial rollout in early 2027.

Key Clinical Takeaways:

• Health Canada cleared bepirovirsen as the first functional cure for chronic hepatitis B, clearing viral markers from the blood.
• Clinical trial data shows roughly one-fifth of treated patients maintained viral control 24 weeks after stopping standard therapies.

Despite decades of public health efforts, an estimated 260,000 Canadians live with the viral liver infection, according to CBC reporting, with roughly half unaware of their status. Untreated chronic carriers risk developing liver cancer or sudden liver failure. While childhood vaccination programs have driven down overall incidence, marginalized populations—including Indigenous communities, individuals using illicit drugs, and immigrants from endemic regions—continue to bear a disproportionate burden of disease.

The newly approved regimen utilizes bepirovirsen, a short-term series of injections designed to reduce viral DNA to undetectable levels. Clinical trials comparing the drug to a placebo demonstrated that approximately one-fifth of participants maintained viral suppression 24 weeks after discontinuing all other treatments, CBC reported.

“From the data that we have now, if it works, then we can reassure [patients] that they have a functional cure and they won’t need to take any further hepatitis B treatments in the future,” said Carla Coffin, a hepatologist and professor at the University of Calgary’s Cumming School of Medicine, told CBC.

However, clinicians must carefully select eligible candidates. Patients with a history of cirrhosis—marked by permanent scarring that restricts blood flow—do not qualify for the treatment, and recipients experience higher rates of side effects like skin rashes compared to conventional daily antivirals.

The long-term durability of the drug is under observation. Coffin said that current trial follow-ups confirm a lasting impact of at least 96 weeks, though extended monitoring is required to establish permanent efficacy.

Previous management relied on lifelong antiviral suppression. “This new treatment, it completely clears all of the viral markers for hepatitis B out of the blood,” said Curtis Cooper, who leads the Ottawa Hospital’s viral hepatitis program, told CBC, adding that it provides meaningful hope for patients seeking to exit long-term medication regimens.

Eric Yoshida, a professor of medicine in the division of gastroenterology at the University of British Columbia, told CBC that a course of therapy costs roughly $84,000 Canadian in Japan, where regulators approved the drug earlier. Yoshida questioned whether provincial health plans and private insurers will subsidize the treatment locally.

In 2024, 75 per cent of all global hepatitis B-related deaths occurred across Africa and the Western Pacific, according to World Health Organization data. “We still have a long way to go,” Coffin told CBC.

Disclaimer: The information provided in this article is for educational and scientific communication purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding any medical condition, diagnosis, or treatment plan.