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WHO HBV Guideline
New WHO HBV Treatment Guidelines: A Public Health Approach

Released: September 06, 2024

Expiration: September 05, 2025

Maria Buti
Maria Buti, MD
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Key Takeaways
  • The new 2024 World Health Organization hepatitis B virus guidelines now include guidance on hepatitis delta virus testing and, in pregnancy, universal hepatitis B virus testing and treatment.
  • They also include clearer treatment pathways, including expansion to use noninvasive tests like APRI to assess fibrosis.

Data from 2019 show that hepatitis B virus (HBV) is responsible for almost 300 million infections and 820,000 deaths worldwide annually, yet only 10% of patients are properly diagnosed and only 3% receive treatment. This is likely due to the complexity of most guidelines (particularly American and European ones), their lack of focus on viral hepatitis elimination, and the high HBV prevalence in low-income countries with limited access to diagnosis, viremia testing, and treatment.

The recent updates to the World Health Organization (WHO) guidelines for the prevention, diagnosis, care, and treatment for people with HBV infection recommend scaling up testing and antiviral treatment for HBV and provide insight on the best approaches from a public health perspective.

2024 HBV Guideline Updates—From Diagnosis to Treatment
The 2024 WHO HBV guidelines include 5 novel, impactful recommendations (2 for diagnosis, 2 for treatment, and 1 that encompasses both). The first novel recommendation for diagnosis is to use antigen testing to test all patients with HBV for hepatitis delta. This marks the first time the WHO-produced guidelines discuss hepatitis delta. The second novel recommendation for diagnosis is to introduce point-of-care testing, which is currently underutilized.

The first new treatment recommendation provides guidance for treating patients with coinfections—including HIV, hepatitis delta, metabolic dysfunction–associated liver disease, extrahepatic manifestations, or a family history of liver cancer, diabetes, or metabolic dysfunction—who have a higher risk of disease progression. The second novel treatment recommendation is about expanding treatment for patients with stage 2 or greater fibrosis or those who have cirrhosis (the former is a new addition, the latter being carried over from the previous recommendations). The guideline recommends diagnosing fibrosis by an aspartate aminotransferase (AST)-to-platelet ratio index (APRI) greater than 0.5 or a transient elastography value greater than 7 KPa, regardless of alanine transaminase (ALT) levels or HBV DNA. This recommendation is applicable for both adult and adolescent patients, marking a shift from other guidelines that typically do not focus as much on adolescents.

Lastly, the guidelines provide instructions for preventing mother-to-child transmission of HBV—the most common form of transmission and one that poses a very high risk to the child (especially infants). This includes a diagnostic recommendation to test ALL pregnant women for HBV using HBV antigen testing and/or HBV DNA testing, and a treatment recommendation to initiate antiviral prophylaxis therapy in HBV-positive women starting in their second trimester of pregnancy.

The guidelines provide critical updates to treatment candidacy recommendations from previous guidelines. While the updated guidelines maintain a recommendation for using the classical criteria from the 2017 European Association for the Study of the Liver guidelines to determine treatment candidacy (an HBV DNA level >2000 IU/mL and elevated ALT level), the WHO 2024 guidelines add a specific recommendation for low-income countries that do not have access to HBV DNA testing. In these cases, the WHO recommends using hepatitis B antigen testing and elevated ALT levels for indicating when treatment should be started. 

For HBV treatment, the new guidelines maintain their recommendation of using entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF), with 2 key changes noted. First, antiviral prophylaxis to prevent mother-to-child transmission should be done with TDF or TAF only, as ETV is associated with teratogenicity. Second, TAF should be reserved for patients with renal or bone disease due to cost.

How Will This Impact Your Clinical Practice?
Taken together, the updated WHO guidelines improve the accessibility and application of HBV disease control. They provide recommendations that can be used by clinicians, policymakers, and national HBV program managers for prevention, diagnosis, and treatment.

The recommendations to use point-of-care testing with noninvasive markers such as APRI makes them more accessible across high-, mid-, and low-income countries. This will be particularly impactful for vulnerable populations in these countries, including those who do not have access to primary healthcare or hospitals due to financial, geographic, or legal reasons. These updated recommendations are increasingly aligned with those used for HIV and hepatitis C—two diseases that use the same mechanism of transmission and thus could be tested for simultaneously alongside HBV.

For countries whose public health systems use these guidelines to shape their reimbursement and insurance company policies, complex guidelines typically result in less reimbursement for treatment, which negatively impacts accessibility and implementation of HBV patient care. These new guidelines seek to remedy this by providing recommendations that clearly outline different options and treatment pathways, which should improve adoption of the guideline internationally, reduce insurance-associated costs, and increase rates of patient reimbursement. Ultimately, the updated 2024 WHO HBV guidelines are expected to stimulate development of new, comprehensive HBV programs that will improve disease control both from a public health and patient perspective.

Your Thoughts?
What impact will the new 2024 WHO guidelines for prevention, diagnosis, care, and treatment of people with hepatitis B have for HBV patient care? You can get involved in the discussion by posting a comment below.