Is a cure on the horizon for hepatitis B? New drug offers hope, but there's a 'long way to go'

This is an excerpt from Second Opinion, a weekly analysis of health and medical science news emailed to subscribers Saturday mornings. If you haven't subscribed yet, you can do that by clicking here.

Despite decades of efforts to wipe out hepatitis B, the viral liver infection remains a quiet threat — and one that's long lacked a cure.

While rates have dropped dramatically since the rise of childhood vaccination programs, an estimated 260,000 Canadians are still living with the virus, including roughly half who don't know they're infected. Over time, many of those silently carrying the virus go on to develop a range of life-threatening issues, including cancer or sudden liver failure. 

Could a long-awaited cure finally be in sight?

In early November, Health Canada approved a breakthrough drug offering the first "functional cure" for a portion of chronic hepatitis B patients, which drugmaker GSK expect to roll out in early 2027.

Dr. Carla Coffin, a hepatologist and professor at the University of Calgary's Cumming School of Medicine, calls it a "major step forward."

At the same time, she warned it's only effective in a relatively small proportion of people with hepatitis B — and questions remain around cost, access and just how long the impacts of the powerful new treatment last.

Virus can lead to chronic liver infection

The hepatitis B virus spreads through infected bodily fluids, including blood, semen and vaginal fluids, making it both a sexually-transmitted infection and one that passes from mother-to-child, or via contaminated drug-injection equipment like needles.

Most healthy adults who contract the virus clear it on their own and develop lifelong immunity. 

But when someone contracts hepatitis B as an infant or during childhood, it can become a chronic infection that causes long-term damage and inflammation to the liver, leading to serious complications or death. 

• All infants should be vaccinated against hep B, says Canadian vaccine advisory committee

• Audio

  Health Canada approves first "functional cure" for Chronic Hepatitis B

The burden of these infections is disproportionately carried by certain populations. There are higher rates among Indigenous communities, illicit drug users, individuals engaging in high-risk sexual activity and immigrants from countries where hepatitis B is more common.

Up until now, patients have required long-term antiviral therapy to surpress the virus, explained Dr. Curtis Cooper, who leads the Ottawa Hospital's viral hepatitis program.

"This new treatment, it completely clears all of the viral markers for hepatitis B out of the blood," he said, noting it offers "quite a bit of hope" for patients aiming to discontinue other treatments.

LISTEN | Health Canada approves first 'functional cure' for hepatitis B:

Ottawa Morning7:02Health Canada approves first "functional cure" for Chronic Hepatitis B

Drug may replace long-term antiviral treatment

The drug, called bepirovirsen, is a short-term course of injections which can lead to undetectable levels of virus DNA in some patients.

"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 Coffin, from the University of Calgary.

The data is based on clinical trials comparing the drug to a placebo, which showed around one-fifth of patients still had the virus under control 24 weeks after stopping all other hepatitis B treatments, with undetectable levels in their blood. 

• Doctors, liver specialist team up to better fight hepatitis in Alberta

• 1 in 8 cancer cases worldwide is caused by infections, study suggests

The drug works only for a minority of patients, Coffin stressed, and "clinicians have to very carefully decide on which patients would be eligible and which would benefit from the treatment."

For instance, individuals with a history of cirrhosis — where healthy liver tissue is permanently scarred, blocking normal blood flow — don't qualify, Coffin noted. She added there can be more side effects from the shot, including a rash, compared to taking a daily anti-viral medication.

It's also not clear just how durable the treatment will be. Coffin says data is still emerging as more time passes since the clinical trials, with the latest figures showing the drug has a lasting impact of at least 96 weeks. 

"Our expectation is that it will last," Coffin said. "But of course, we won't know that until we do the long-term follow-up in these patients."

WATCH | CDC panel vote to stop universal hep B shot for babies called 'irresponsible':

CDC panel vote to stop hep B vaccine for babies called 'irresponsible'

December 5, 2025|

Duration

2:05

Questions around cost, access

Dr. Eric Yoshida, a professor of medicine in the division of gastroenterology at the University of British Columbia, is skeptical of where the drug fits into the broader landscape for hepatitis B treatments. 

While he agreed bepirovirsen offers a major scientific leap forward, he says access and cost could be barriers to uptake — meaning the drug may not reach many Canadians.

• Trump signs executive order calling for fewer childhood vaccinations

• New HIV infections in Canada are rising. Advocates say years of progress are at risk

In Japan, where the drug was approved earlier, Yoshida says a course of therapy costs roughly $84,000 Cdn. Though actual pricing for Canada isn't yet clear, he questioned whether private drug plans and the provinces will end up covering it. 

"Looking into the future, well, this is the first generation. The next generation is probably going to be even better and even less expensive, so I think the future is looking bright," Yoshida said. 

"But I think for the average Canadian patient with hepatitis B, it's probably not going to mean a heck of a lot."

WATCH | N.W.T. dentist's patients possibly exposed to HIV, hepatitis:

N.W.T. dental patients possibly exposed to HIV and hepatitis want to see improved care

October 15, 2024|

Duration

1:45

Canada calls for universal infant vaccination

Treatment possibilities aside, both Coffin and Yoshida stressed the need for more awareness of hepatitis B vaccination as a way to stamp out the virus for good. Yet global immunization programs for this virus remain fraught.

In November, Canada's vaccine advisors issued a new recommendation for all Canadian infants to receive the hepatitis B shot, which may — in time — align provinces that offer the shot at a mix of ages, from infancy to children in grades six or seven.

"If every country in the world vaccinated their newborns," said Yoshida, "I think hepatitis B would be basically on the way out."

But Canada's recent move is a stark contrast from the U.S., where the Centers for Disease Control and Prevention (CDC) removed its longstanding universal hepatitis B vaccination recommendation for newborns in late 2025.

Many countries also struggle with hepatitis B immunization, leading to significantly higher rates of chronic infection in certain regions. In 2024, 75 per cent of all global hepatitis B-related deaths were across Africa and the Western Pacific, World Health Organization data shows.