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Hepatitis B surface antigen level identifies patients with inactive chronic hepatitis B from Asia with HCC risk below
Tai-Chung Tseng1,2,3, Shang-Chin Huang1,2,4,5, Mei-Hung Pan6
1Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Insights
Hepatitis B surface antigen (HBsAg) levels below 100 IU/mL in inactive chronic hepatitis B (CHB) patients indicate a negligible risk of liver cancer (HCC). This finding aids in optimizing surveillance and defining a partial hepatitis B virus (HBV) cure.
Area of Science:
- Hepatology
- Virology
- Oncology
Background:
- Chronic hepatitis B (CHB) poses a significant global health risk, predominantly due to its association with hepatocellular carcinoma (HCC).
- Identifying patients with inactive CHB and minimal HCC risk is crucial for effective management and treatment strategies.
- Defining criteria for a partial hepatitis B virus (HBV) cure requires accurate assessment of viral activity and cancer risk.
Purpose of the Study:
- To identify patients with inactive CHB who have a negligible risk of developing HCC.
- To utilize hepatitis B surface antigen (HBsAg) levels as a key marker for assessing HCC risk and defining partial HBV cure.
- To validate the use of HBsAg levels in conjunction with alanine transaminase (ALT) for risk stratification without requiring HBV DNA testing.
Main Methods:
- Analysis of data from 2674 inactive CHB patients across the ERADICATE-B and REVEAL-HBV cohorts.
- Primary endpoint was HCC development, with HBsAg levels used to identify patients with an annual HCC risk below 0.2%.
- Validation of findings using the NTUH-iMD cohort, correlating HBsAg levels (<100 IU/mL) and normal ALT with HCC risk.
Main Results:
- Over a median follow-up of 26.3 years, 76 patients developed HCC.
- Inactive CHB patients with HBsAg <100 IU/mL exhibited an annual HCC incidence of 0.08%, significantly lower than those with HBsAg ≥100 IU/mL.
- HBsAg levels <100 IU/mL, combined with normal ALT, effectively identified patients with negligible HCC risk, comparable to the general population and below surveillance thresholds.
Conclusions:
- Serum HBsAg levels <100 IU/mL are a reliable indicator for identifying inactive CHB patients with negligible HCC risk.
- This marker signifies limited viral activity and is instrumental in optimizing surveillance strategies for CHB.
- These findings contribute to the definition of a partial HBV cure by pinpointing patients with minimal risk and viral load.
Background:
Chronic hepatitis B (CHB) is a major global health concern primarily due to hepatocellular carcinoma (HCC) development.
Objective:
This study aimed to identify patients with inactive CHB with negligible HCC risk using hepatitis B surface antigen (HBsAg) levels, which is the key to define partial HBV cure.
Design:
Data from 2674 patients with inactive CHB (non-cirrhotic, hepatitis B e antigen negative, normal alanine transaminase (ALT), HBV DNA <2000 IU/mL) in the ERADICATE-B and REVEAL-HBV cohorts were analysed. The primary endpoint was HCC development, with HBsAg levels used to identify patients with annual HCC risk <0.2%. Results were validated using the NTUH-iMD cohort.
Results:
Over a median follow-up of 26.3 years, 76 patients developed HCC. Among 989 patients with inactive CHB with HBsAg<100 IU/mL, the annual HCC incidence was 0.08% (95% CI 0.05% to 0.13%), lower than those with HBsAg≥100 IU/mL (adjusted HR 0.35, 95% CI 0.21 to 0.61). Their HCC risk was lower than the recommended threshold for HCC surveillance and was close to the risk of the general population. Even for older patients recommended for HCC surveillance, those with HBsAg levels <100 IU/mL were associated with HCC risk lower than the surveillance threshold. Moreover, patients with inactive CHB with negligible HCC risk could be identified by combining HBsAg <100 IU/mL and normal ALT levels, without the need for HBV DNA testing, as validated in the NTUH-iMD cohort.
Conclusion:
Serum HBsAg levels <100 IU/mL effectively identify patients with inactive CHB with negligible HCC risk and limited viral activity, which is important in optimising surveillance strategies and defining partial HBV cure.
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