Guidelines for Management of Hepatitis B Virus Infections

Management of Hepatitis B Virus Infection: 2018 Guidelines from the Canadian Association for the Study of Liver Disease and Association of Medical Microbiology and Infectious Disease Canada. Clinical Practise Guidelines Committee (Co-Chairs: Coffin CS, Fung SK; Committee Authors: Alvarez F, Cooper CL, Doucette KE, Fournier C, Kelly E, Ko HH, Ma MM, Martin SR, Osiowy C*, Ramji A, Tam E, Villeneuve JP. Canadian Liver Journal Fall 2018; 1(4):156-217. doi:

This science story describes the NML’s role in helping develop and shape the content of the new Canadian guidelines on the management of Hepatitis B virus (HBV), specifically with regards to recommendations for HBV laboratory testing. HBV remains an important public health concern in Canada and the NML continues to provide reference services and research to contribute to the understanding of this pathogen.

What was known about this area prior to your work, and why was the research done?

Hepatitis B (HBV) is a viral infection that attacks the liver and can cause both acute and chronic disease. It is a global public health issue, and the most common type of viral hepatitis. It is estimated that about 780,000 people die each year due to complications from HBV, including liver cirrhosis and liver cancer. A recent prevalence assessment by the Canadian Liver Foundation estimated that there are 250,000 to 460,000 individuals with chronic hepatitis B (CHB) infection in Canada. Although advances in HBV diagnostic tests, non-invasive tests for assessment of liver disease, and antiviral therapy have led to improved prognosis for many patients diagnosed with HBV, issues with HBV management in Canada remain. The main issues/gaps include: prevention (vaccination programs are not standardized), diagnosis (identifying those at risk for end-stage liver cancer and need for therapy), and access (to effective therapy). In order to address some of these gaps, the Canadian Association for the Study of the Liver and the Association of Medical Microbiology and Infectious Disease Canada develop guidelines to inform and guide healthcare providers in the management of HBV. New guidelines were recently published, and the Section of Viral Hepatitis and Bloodborne Pathogens (VHBP) played a key role in the development of recommendations in the guidelines.

What are your most significant findings from this work?

The HBV guidelines address all aspects of HBV infection, including best practices for laboratory diagnostic testing. Due to their work on HBV, VHBP was called upon to lead development of the guidelines in the HBV laboratory assessment section. This section includes areas such as best practices for diagnostics (screening/testing), and molecular analysis of the HBV genome for information on the viral genotype and the presence of mutations associated with drug resistance, immune escape, and altered expression. These areas all have implications for transmission, epidemiology, clinical outcome, and patient management. The recommendations for HBV laboratory testing provide a comprehensive guide to current testing, as well as an overview of novel HBV diagnostic tests being considered for practice.

What are the implications or impact of the research?

The guidelines with respect to HBV diagnostic testing provide key information and recommendations to guide physicians and laboratorians in appropriate testing of HBV for best practices in infection management. The goal of the HBV guidelines, as a whole, was to summarize best-practice management but also to highlight the need for increased resources for treatment and research on HBV pathogenesis and epidemiology in Canada. The NML was able to play an important role in the development of these guidelines that are now being employed throughout the country and consulted worldwide.

Additional References of Significance:

  • Lau KCK, Osiowy C*, Coffin CS. Hepatitis B virus (HBV) genome detection and genotyping in virally suppressed patients using nested polymerase chain reaction based Sanger sequencing. Diagn Microbiol Infect Dis 2019 Apr; 93 (4): 318-324. doi:
  • Osiowy C*, Coffin, C., Andonov A*. Review of laboratory tests used in monitoring hepatitis B response to pegylated interferon and nucleos(t)ide analog therapy. Curr Treat Options Infect Dis 2016; 8:177-93. doi:
  • Osiowy C*, Kowalec K, Giles E*. Discordant diagnostic results due to a hepatitis B virus T123A HBsAg mutant. Diagn Microbiol Infect Dis 2016 Jul; 85(3):328-33. doi:

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