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    Chronic Hepatitis B (CHB)

    KNOW IT BY THE NUMBERS

    Start comprehensive biomarker testing, including quantitative and qualitative HBsAg, for more informed clinical decisions1-4

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    Comprehensive biomarker testing in CHB starts with quantitative and qualitative HBsAg.1-4

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    Comprehensive biomarker testing may offer more clinical insights5,6

    Real-world monitoring practices may diverge from the guideline recommendations for chronic hepatitis B (CHB).

    MONITORING OF PATIENTS NOT ON TREATMENT

    ~50%

    did not receive ALT and either HBV DNA or HBeAg testing within 12 months of CHB diagnosis7

    MONITORING OF PATIENTS ON TREATMENT

    >60%

    did not receive ALT + HBV DNA testing after antiviral treatment initiation8

    ONLY

    40%–53%

    of Asian American patients with CHB adhered to monitoring and follow-up care, which is notable because despite only making up 6% of the US population, Asian Americans account for 58% of Americans living with CHB9

    Insufficient biomarker testing and delayed treatment initiation can increase the risk of disease progression and serious liver-related outcomes.10-14

    CHB may lead to cirrhosis, liver failure, or HCC in 15%–40% of patients.10,15

    Persistent viremia due to inadequate monitoring and lack of treatment adjustment contributes to ongoing liver injury and fibrosis progression.12-14

    In 2022, HBV-related cirrhosis or HCC caused an estimated 1.1 million deaths globally.11

    • ALT=alanine aminotransferase; DNA=deoxyribonucleic acid; HBeAg=hepatitis B e-antigen; HBsAg=hepatitis B surface antigen; HBV=hepatitis B virus; HCC=hepatocellular carcinoma.

    Emerging biomarkers may reveal clinical insights that complement the AASLD guidelines13

    AASLD recommendations are based on HBeAg, HBV DNA, and ALT levels.13

    Grey zone of Hepatitis B virus

    Figure used with permission. © 2024 Wolters Kluwer Medknow Publications. Lim YS. Gray zone of hepatitis B virus infection. Saudi J Gastroenterol. 2024;30(2):76-82. https://journals.lww.com/sjga/fulltext/2024/30020/gray_zone_of_hepatitis_b_virus_infection.2.aspx

    28%–55% of patients with CHB are viremic, but fall into a grey zone without clear guidance on optimal management and treatment. HBeAg-negative patients are in the “grey zone,” in which HBV DNA or ALT levels are borderline between inactive CHB and immune-active, HBeAg-negative CHB.13,17

    • Quantitative HBsAg testing is an emerging biomarker gaining traction in international guidelines (EASL, CASL) due to its predictive and prognostic value, but it remains underutilized in US practice18-20

    Quantitative HBsAg testing can help guide management of “grey zone” patients.13

    • AASLD=American Association for the Study of Liver Diseases; CASL=Canadian Association for the Study of the Liver; EASL=European Association for the Study of the Liver.

    In chronic hepatitis B (CHB):

    Comprehensive testing of key biomarkers allows for more clarity when characterizing disease phase and severity, assessing patient prognosis, and evaluating treatment response13,18,19:

    HBV DNA

    Quantitative HBsAg

    Qualitative HBsAg

    HBeAg

    Anti-HBe antibodies

    Full hepatic function panel:

    ALT, AST, total bilirubin, +/– direct bilirubin, alkaline phosphatase, and albumin1

    Noninvasive tests of fibrosis:

    Serum APRI or FIB-4, and elastography, FibroScan, ultrasound, or MRI1

    For both cirrhotic and noncirrhotic patients, include HCC surveillance with ultrasound and alpha-fetoprotein.13,18

    Chronic hepatitis B phases21

    Chronic hepatitis B phases

    Figure used with permission. © 2018 Springer Nature. Yuen MF, et al. Hepatitis B virus infection. Nat Rev Dis Primers. 2018;4:18035. https://www.nature.com/articles/nrdp201835

    • Anti-HBe=anti–hepatitis B e-antigen; APRI=aspartate aminotransferase to platelet ratio index; AST=aspartate aminotransferase; FIB-4=fibrosis-4; MRI=magnetic resonance imaging.

    AASLD* and EASL biomarker testing recommendations

    Recent EASL updates acknowledge the value of, and recommend, quantitative HBsAg testing, whereas it is not recommended by AASLD13

      Review AASLD Guidelines for additional considerations regarding coinfection screening, HCC surveillance, and special populations, including pregnant women and immunosuppressed individuals.

      • *AASLD guidance does not seek to dictate a “one size fits all" approach for the management of CHB; clinical considerations may justify a course of action that differs from this guidance.
      •  
      • AFP=alpha-fetoprotein; anti-HCV=anti-hepatitis C virus; anti-HDV=anti–hepatitis D virus; anti-HIV=anti-human immunodeficiency virus; HBsAg+=hepatitis B surface antigen–positive; peg-IFN=pegylated interferon; qHBsAg=quantitative hepatitis B surface antigen.

      KEY BIOMARKER: Quantitative and qualitative HBsAg testing

      HBsAg testing in CHB management

      • HBsAg is a viral surface protein and an important marker of active chronic HBV infection2
      • It is a measure of the total transcriptional activity of both covalently closed circular DNA (cccDNA) and integrated HBV DNA in liver cells23
      • HBsAg is believed to promote immune evasion and disease chronicity23

      HBsAg tests for CHB:

      Qualitative and quantitative HBsAg tests for CHB
      • †

        “Functional” but not sterilizing cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment.25

      • CLIA=chemiluminescence immunoassay; ELISA=enzyme-linked immunosorbent assay.

      Quantitative HBsAg and its interpretation

      Quantitative HBsAg and its interpretation table

      HBsAg loss (below detection threshold of <0.05 IU/mL) serves as a reliable indicator of reduced viral DNA expression, which is associated with improved clinical outcomes.18

      Quantitative HBsAg is an important biomarker in assessing clinical response and functional cure.13,18

      HR=hazard ratio.

      Clinical utility of quantitative HBsAg

      Prognostic Value

      • Predicts risk of liver fibrosis and development of HCC13

      Identify True Inactive HBV DNA Carriers

      • Helps guide treatment approach for patients in an indeterminate stage or “grey zone” (HBeAg-negative with borderline levels of HBV DNA or ALT)13

      Monitor Response

      • Predictor of on-treatment virologic control—helps identify potential candidates to withdraw from therapy (in combination with HBV DNA)27

      Determine Probability of HBsAg Loss

      • Higher probability of spontaneous HBsAg clearance if <1,000 IU/mL13,28

      KEY BIOMARKER: HBeAg testing

      HBeAg indicates immune activity, helps define disease phase, and differentiates between active‡ and inactive CHB3,13,29

      BEFORE TREATMENT

      Who to Treat

      All newly diagnosed CHB patients:
      To determine immune-tolerant vs immune-active phase of infection13

      Pregnant women who are HBsAg+:
      To assess risk of vertical transmission13,18

      HBeAg testing before treatment table

      DURING TREATMENT

      Who to Treat

      All patients: To monitor HBeAg seroconversion13

      HBeAg testing during treatment table

      AFTER TREATMENT

      Who to Treat

      Patients with suspected reactivation or liver flares13

      HBeAg testing after treatment table
      • ‡

        Per AASLD guidelines, immune-active chronic hepatitis B is defined by ALT ≥2X ULN or significant histologic disease with HBV DNA >2,000 IU/mL (HBeAg-negative) or >20,000 IU/mL (HBeAg-positive).13

      • HBeAg+=hepatitis B e-antigen–positive; HBeAg-=hepatitis B e-antigen–negative; ULN=upper limit of normal. 

      KEY BIOMARKER: HBV DNA testing

      HBV DNA testing in Chronic Hepatitis B (CHB) management

      HBV DNA is a measure of viral replication and guides treatment decisions, but levels can fluctuate13:

      • Serial monitoring is more reliable than cutoff values13
      • Levels should be interpreted alongside other clinical variables13

      WHO TO TEST

      Before Treatment

      At baseline:

      • At diagnosis to determine phase of infection and eligibility for treatment1,18
      • All patients with CHB to assess viral replication13
      • Individuals with abnormal liver enzymes or signs of liver disease13
      • Pregnant woman who are HBsAg+ to assess risk of vertical transmission13

      Annually or biannually after the first year:

      • For untreated patients to monitor disease activity and progression13

      During Treatment

      Please see Prescribing Information for any treatment-specific monitoring requirements.

      Every 3–6 months:

      Patients undergoing immunosuppressive therapy or chemotherapy (at risk of HBV reactivation)13

      • Individuals with HBeAg-negative CHB to detect occult viral replication13

      Before therapy cessation:

      To confirm sustained viral suppression13

      INTERPRETING RESULTS AND NEXT STEPS

      Interpreting CHB testing results and next steps table
      • §

        Conditional recommendation based on very low evidence.13

      • NAFLD=nonalcoholic fatty liver disease.

      KNOW THE NUMBERS. Know the complete picture.

      Routine testing of all chronic hepatitis B biomarkers, including quantitative and qualitative HBsAg may provide a fuller picture of patients’ disease and better inform treatment decisions.3,24,30

      • Quantitative and qualitative HBsAg, HBeAg, and HBV DNA tests are commercially available24

      For the management of Chronic Hepatitis B (CHB)

      Explore comprehensive biomarker testing resources

      View the CHB Biomarker Guide

      Know CHB testing by the numbers and take it with you in PDF form.

      DOWNLOAD YOUR GUIDE

      View the AASLD GuidelinesII

      View the official recommendations of the American Association for the Study of Liver Diseases for biomarker testing and the treatment of chronic hepatitis B.

      IIThis external link is provided for reference; content is owned by AASLD and published in the journal Hepatology. GSK has no role in guideline development.

      VIEW THE GUIDELINES

      View the EASL Guidelines

      View the official recommendations of the European Association for the Study of the Liver for biomarker testing and the treatment of chronic hepatitis B.

      The link to the EASL Clinical Practice Guidelines on the management of chronic hepatitis B is provided for educational purposes only and does not constitute an endorsement by EASL of the content presented on this website.

      VIEW THE GUIDELINES

      View the CASL Guidelines**

      View the official recommendations of the Canadian Association for the Study of the Liver for biomarker testing and the treatment of chronic hepatitis B.

      **The link to the CASL Management of Hepatitis B Virus Infection Guidelines is provided for educational purposes only and does not constitute an endorsement by CASL of the content presented on this website.

      VIEW THE GUIDELINES

      References

      1. Screening and testing for hepatitis B virus infection: CDC recommendations – United States, 2023. Centers for Disease Control and Prevention. March 10, 2023. Accessed September 5, 2025. https://www.cdc.gov/mmwr/volumes/72/rr/rr7201a1.htm

      2. Clinical testing and diagnosis for hepatitis B. Centers for Disease Control and Prevention. January 31, 2025. Accessed September 5, 2025. https://www.cdc.gov/hepatitis-b/hcp/diagnosis-testing/index.html

      3. Additional hepatitis B blood tests. Hepatitis B Foundation. Accessed September 24, 2025. https://www.hepb.org/prevention-and-diagnosis/diagnosis/hepatitis-b-blood-tests/

      4. Understanding your test results. Hepatitis B Foundation. Accessed August 8, 2025. https://www.hepb.org/prevention-and-diagnosis/diagnosis/understanding-your-test-results/#:~:text=Understanding

      5. Wong G, Lemoine M. J Hepatol. 2025;82(5):918-925.

      6. Wong RJ. Gastroenterol Rep (Oxf). 2025;13:goaf016.

      7. Pham T, et al. Med Care. 2023;61(4):247-253.

      8. Zhou Y, et al. J Viral Hepat. 2022;29(3):189-195.

      9. Ma GX, et al. Healthcare (Basel). 2022;10(10):1944.

      10. Fattovich G. J Hepatol. 2003;39 Suppl 1:S50-S58.

      11. Hepatitis B. World Health Organization. July 23, 2025. Accessed September 6, 2025. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

      12. Zhang Q, et al. J Clin Transl Hepatol. 2021;9(6)850-859.

      13. Terrault NA, et al. Hepatology. 2018;67(4):1560-1599.

      14. Sun Y, et al. Clin Gastroenterol Hepatol. 2020;18(11):2582-2591.

      15. Lavenchy D, Kane M. Global epidemiology of hepatitis B virus infection. In: Liaw YF, Zoulim F, eds. Hepatitis B Virus in Human Diseases. Humana Press; 2016:187-203.

      16. Lim YS. Saudi J Gastroenterol. 2024;30(2):76-82.

      17. You H, et al. Infect Dis Immun. 2023;3(4):145-162.

      18. European Association for the Study of the Liver. J Hepatol. 2025;83(2):502-583.

      19. Coffin CS, et al. Can Liver J. 2018;1(4):156-217.

      20. Mahajan A, et al. J Viral Hepat. 2024;31(11):746-759.

      21. Yuen MF, et al. Nat Rev Dis Primers. 2018;4:18035.

      22. Terrault NA, et al. Hepatology. 2016;63(1):261-283.

      23. Lin CL, Kao JH. Clin Mol Hepatol. 2016;22(4):423-431.

      24. Ghany MG, et al; 2022 AASLD-EASL HBV-HDV Treatment Endpoints Conference Faculty. J Hepatol. 2023;79(5):1254-1269.

      25. Cornberg M, et al. 2019 EASL-AASLD HBV Treatment Endpoints Conference Faculty. J Hepatol. 2020;72(3):539-557.

      26. Yang HC. Clin Liver Dis (Hoboken). 2024;23(1):e0195.

      27. Hirode G, et al; RETRACT-B Study Group. Gastroenterology. 2022;162(3):757-771.e4.

      28. Tseng T, et al. Aliment Pharmacol Ther. 2015;41(10):949-960.

      29. World Health Organization. Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. World Health Organization; March 2024.

      30. Vachon A, Osiowy C. Viruses. 2021;13(6):951.