- Canadian hepatitis B guidelines have been updated, covering screening, vaccination and treatment
- This update includes new algorithms to create personalized treatment plans for patients
- Hepatitis B is vaccine-preventable and treatable, but there is no cure for chronic infection
Hepatitis B virus (HBV) is spread through similar routes as hepatitis C virus (HCV) and HIV. Rates of new HBV infections continue to increase in Canada. There are approximately 262,000 people living with chronic HBV in Canada—and scientists estimate that nearly 50% of these people are not aware that they have chronic HBV. If left undiagnosed and untreated, chronic HBV can cause serious complications, including liver cancer. HBV can be detected with blood tests and treatment is available.
Canada has endorsed the World Health Organization strategy to eliminate hepatitis B virus (HBV) as a public health issue by 2030. The Public Health Agency of Canada has also developed an action plan to help reduce the spread of sexually transmitted and blood borne infections (STBBIs), and this includes HBV.
A team of leading healthcare providers and scientists from the Canadian Association for the Study of the Liver (CASL) and the Association of Medical Microbiology and Infectious Disease Canada (AMMI) comprised a panel that updated the HBV guidelines.
The updated guidelines are rich in detail and are designed for an array of healthcare providers, including the following:
- hepatologists
- infectious disease specialists
- primary care providers
- nurse practitioners
- public health practitioners
- laboratory specialists
The guidelines have many helpful tables and algorithms to shape clinical and laboratory decision making. The full guidelines are available here.
In this CATIE News bulletin, we highlight some key parts of the guidelines.
Screening and long-term monitoring of people with HBV
The guidelines recommend that all adults in Canada get one-time HBV screening. The guidelines state: “In consultation with the patient, evidence of a new activity or persistent risk for HBV infection should prompt periodic re-testing if the patient is not immune.” Long-term monitoring of the health of people with HBV is critical and the guidelines encourage this and provide useful information about the different tests that are used as well as cancer screening.
Vaccination for HBV
The HBV vaccine is highly safe and effective. The guidelines recommend HBV vaccination for all infants (“ideally at birth”). They also recommend universal “catch-up” vaccination for adults who did not receive a full series of HBV inoculations or who are not sure about their vaccination history.
Treatment
The guidelines recommend standard therapy for chronic HBV. Treatment is comprised of one of the following daily oral medications: TDF (tenofovir disoproxil fumarate), TAF (tenofovir alafenamide) or entecavir. In some cases, a long-lasting form of interferon-alpha called PEG-interferon (injected once weekly) may also be used.
Special populations
The HBV guidelines draw attention to special populations and/or situations, such as pregnancy and coinfection of HBV and other viruses, particularly hepatitis D virus (HDV).
Pregnancy
The guidelines recommend HBV screening during pregnancy and outline certain conditions under which treatment should be offered. Pregnant people should also be offered assessment for active hepatitis and non-invasive screening of the liver (using specialized ultrasound scans early in pregnancy).
The guidelines state that “all pregnant [people] found to have advanced liver disease or meet criteria for treatment, regardless of mother-to-child transmission risk, should be immediately offered therapy with nucleo(t)side analogues (TDF).” The guidelines note that TDF and TAF are safe for use in pregnancy. They also note that people who were on this treatment prior to pregnancy should continue with treatment during pregnancy.
Entecavir is not recommended during pregnancy because of “the lack of robust safety data.” PEG-interferon is unsafe during pregnancy; therefore, it is not recommended for use in pregnant people.
The guidelines state that “breast-feeding is safe and should be encouraged; there is minimal excretion of nucleo(t)side analogues in breast milk and no reports of HBV transmission via human breast milk.”
There are many additional recommendations for the care and treatment of HBV during and after pregnancy. Please see the guidelines for full details.
Children
According to the guidelines, cases of HBV in children are “relatively low” and decreasing “thanks to preventive measures against vertical transmission and vaccination.” The guidelines have extensive information on the course of HBV in children, as well as options for monitoring and treating HBV in this population.
Coinfections
HBV and hepatitis C virus coinfection
Due to shared routes of infection, some people are coinfected with HBV and hepatitis C virus (HCV). Coinfection increases the risk for chronic liver injury and liver cancer. The guidelines recommend that people who are screened for HBV also be screened for HCV, and vice versa. Treatment is available for HCV that can cure the infection in more than 95% of people. The guidelines provide information about treatment considerations for HBV in people coinfected with HCV. They also provide information on monitoring HBV.
HBV and hepatitis D virus coinfection
Hepatitis D virus (HDV) is spread in similar ways as HBV, and some people who have HBV also have HDV. According to the guidelines, HDV “causes the most aggressive form of viral hepatitis in [people].” HDV requires HBV to survive and help it complete its life cycle. People can get HDV if they already have HBV or can become infected simultaneously with HBV and HDV.
HDV is relatively uncommon in Canada, but it is estimated that there are between 10,000 and 15,000 people living with this virus.
After the updated HBV guidelines were published, a new HDV treatment called bulevirtide (Hepcludex) was approved for use in Canada for people with chronic HDV who do not have symptoms arising from extensive scarring of the liver. This drug is given via daily subcutaneous injection and is generally well tolerated. The manufacturer, Gilead Sciences, is in discussion with private insurance companies about securing their coverage for the drug. It is also possible that at some point in the future ministries of health may subsidize the drug. In the meantime, physicians who have patients with HDV with an urgent need for treatment can discuss this with their Gilead Sciences medical science liaison. The company may make the drug available on a limited basis if eligibility criteria are met.
Although PEG-interferon is not approved for the treatment of chronic HDV, some doctors prescribe weekly injections of PEG-interferon for 48 consecutive weeks. This can sometimes be effective.
The nucleo(t)side analogues used against HBV have no direct impact on HDV. However, the guidelines state: “In theory, the aggressive suppression of HBV replication and prevention of HBV flares in HDV coinfection may help reduce the risk of liver disease progression.”
The guidelines make recommendations for screening people with HBV for HDV.
The guidelines have extensive information about managing HDV in the setting of HBV coinfection.
HBV and HIV coinfection
Scientists estimate that there are more than 65,000 people living with HIV in Canada, of whom between 6% and 8% have both HIV and HBV. HIV can accelerate liver injury and the risk of liver cancer in coinfected people.
The guidelines recommend that all people with HIV be screened for HBV and immunized if they are negative for HBV.
There are several drugs that have activity against both HIV and HBV: TDF, TAF and 3TC. These are often used as part of HIV combination treatment and the guidelines recommend that they be included as part of HIV treatment in coinfected people.
Increasingly, dual-drug combinations for people with HIV are becoming available. One commonly used dual treatment is cabotegravir + rilpivirine (given ultimately as injections every two months). Neither of these drugs has activity against HBV. The guidelines recommend that people coinfected with HBV and HIV who are using these dual regimens (or other combinations that do not have an anti-HBV component) also take an HBV drug to help suppress this virus.
Bear in mind
The updated guidelines have many details relevant to the screening, care and management of people with HBV and coinfections such as HDV, HCV and HIV. Universal adult screening for HBV is strongly recommended. The guidelines have information on the management of HBV during pregnancy and in pediatrics. They recommend that Canada’s provinces and territories invest in “enhanced HBV surveillance, improved access to recommended HBV/HDV lab tests and implementation of point of care diagnostics, within a patient-centred approached aimed at reducing inequities in access to care and treatment.”
—Sean R. Hosein
Resources
Hepatitis B Basics – CATIE
Hepatitis B and C in Canada: Why testing matters – CATIE
REFERENCES:
- Clinical Practice Guidelines Committee Chair; Osiowy C; Panel Members; Alvarez F, Coffin CS, Cooper CL, et al. The Management of Chronic Hepatitis B: 2025 Guidelines Update from the Canadian Association for the Study of the Liver and Association of Medical Microbiology and Infectious Disease Canada. Canadian Liver Journal. 2025 May 26;8(2):368-440.
- Wedemeyer H, Schöneweis K, Bogomolov P, et al. Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection (MYR202): a multicentre, randomised, parallel-group, open-label, phase 2 trial. Lancet Infectious Diseases. 2023 Jan;23(1):117-129.
- Degasperi E, Anolli MP, Jachs M, et al. Real-world effectiveness and safety of bulevirtide monotherapy for up to 96 weeks in patients with HDV-related cirrhosis. Journal of Hepatology. 2025 Jun;82(6):1012-1022.