Health Canada has approved bepirovirsen as a functional cure for a portion of chronic hepatitis B patients, offering a short-term injection course that can clear viral markers from the blood. The drug is expected to roll out in early 2027, though experts warn it will only help a minority of patients and may be expensive or difficult to access.
Approval of Bepirovirsen
Health Canada approved the breakthrough drug in early November, according to [CBC]. Drugmaker GSK expects to roll out the treatment in early 2027.
“This new treatment, it completely clears all of the viral markers for hepatitis B out of the blood,” Dr. Curtis Cooper, who leads the Ottawa Hospital’s viral hepatitis program, told CBC.
He noted the therapy offers “quite a bit of hope” for patients aiming to stop other treatments.
The medication consists of a short-term course of injections that can lead to undetectable levels of virus DNA. Clinical trials compared the drug to a placebo and showed roughly one-fifth of patients maintained virus control 24 weeks after stopping all other treatments.
Clinicians Must Select Eligible Patients Carefully
The treatment works only for a minority of patients, according to Dr. Carla Coffin, a hepatologist and professor at the University of Calgary’s Cumming School of Medicine. Coffin told CBC that clinicians must carefully select eligible patients who will benefit.
Individuals with a history of cirrhosis do not qualify for the treatment.
Patients may also experience side effects such as rashes from the injections, which exceed the side-effect profile of daily antiviral medications.
Data from clinical trials shows the drug has a lasting impact of at least 96 weeks. “Our expectation is that it will last,” Coffin told CBC, adding that long-term follow-up is still required.
Cost and Access Could Present Major Barriers
Dr. Eric Yoshida, a professor of medicine in the division of gastroenterology at the University of British Columbia, questioned how the drug will fit into current treatments. Yoshida told CBC that access and cost could present major barriers to uptake in Canada.
In Japan, where regulators approved the drug earlier, a course of therapy costs roughly $84,000 Cdn, according to Yoshida.
He questioned whether provinces and private drug plans will cover the expense.
“Looking into the future, well, this is the first generation,” Yoshida told CBC. “The next generation is probably going to be even better and even less expensive, so I think the future is looking bright.”
Canada Recommends Hepatitis B Shots for All Infants
An estimated 260,000 Canadians live with hepatitis B, and roughly half remain unaware of their infection. The virus spreads through infected bodily fluids, including blood, semen, and vaginal fluids, and can pass from mother to child or through contaminated injection equipment.
Canada’s vaccine advisors issued a new recommendation in November for all Canadian infants to receive the hepatitis B shot.
This contrasts with the United States, where the Centers for Disease Control and Prevention removed its longstanding universal newborn vaccination recommendation in late 2025.
Global immunization efforts continue to face challenges. According to [World Health Organization data], 75 per cent of all global hepatitis B-related deaths occurred across Africa and the Western Pacific in 2024.
“We still have a long way to go,” Coffin told CBC.
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