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Real-Time Polymerase Chain Reaction-Based Detection and Quantification of Hepatitis B Virus DNA
Published on: December 15, 2023
Chronic hepatitis B prognostic markers other than pre-treatment viral load predicted composite treatment outcome
Myo Nyein Aung1, Wattana Leowattana, Khine Nwe Win
1Department of Public Health, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Insights
Predictors of chronic hepatitis B (CHB) treatment success were identified. HBeAg negativity and early ALT normalization predict better outcomes on nucleos(t)ide analogue therapy, not initial viral load.
Area of Science:
- Hepatology
- Virology
- Clinical Medicine
Background:
- Chronic hepatitis B (CHB) is a prevalent global infectious disease with complex clinical progression.
- Nucleos(t)ide analogues (NA) are standard treatments for CHB, particularly in Southeast Asia.
- Composite treatment outcomes are crucial but rarely predicted epidemiologically in CHB management.
Purpose of the Study:
- To compare composite treatment outcomes in CHB patients with low versus high baseline viral loads.
- To identify predictors of composite treatment outcomes in CHB patients receiving NA therapy.
Main Methods:
- A retrospective cohort study involving 95 CHB patients treated with NA for one year.
- Composite outcome: undetectable HBV DNA, normalized ALT, and HBeAg clearance (if applicable).
- Multinomial logistic regression analyzed predictors of treatment response.
Main Results:
- Complete composite outcome achieved by 52% of patients with viral load < 6.5 log10 copies/mL vs. 31% with viral load ≥ 6.5 log10 copies/mL.
- HBeAg negativity (aRRR=11.1) and ALT normalization within 6 months (aRRR=6.7) predicted successful outcomes.
- ALT elevation >1.5x normal (40 IU/mL) predicted incomplete response (aRRR=6.2).
Conclusions:
- Routine clinical markers, excluding pre-treatment viral load, effectively predict composite CHB outcomes.
- HBeAg status and early ALT normalization are key indicators for NA therapy success in CHB.
Introduction:
Chronic hepatitis B (CHB) is a globally common infectious disease. Its clinical course is complicated. In Southeast Asia, nucleos(t)ide analogues (NA) are commonly used drugs for CHB treatment. Composite treatment outcome has often been used in CHB clinical practice, but rarely predicted epidemiologically. This study aimed to compare the composite treatment outcome between CHB patients with low and high treatment-naïve viral load, and to identify its predictors
Methodology:
This retrospective cohort study followed up 95 CHB patients on NA treatment for a year. Composite treatment outcome was defined as undetectable HBV DNA level, ALT normalization and, HBeAg clearance in the case of HBeAg-positive patients. Multinomial logistic regression analysis was applied to analyze the significant treatment response predictors.
Results:
Complete composite treatment outcome was achieved by 52% of CHB patients with an initial viral load < 6.5 log 10 copies /ml, but 31% of those had an initial viral load ≥ log 6.5 log 10 copies /ml. Outcome was predicted by HBeAg negativity (adjusted relative risk ratio, aRRR = 11.1, 95 % confidence interval, CI 3-41.3) and ALT normalization within the sixth month of therapy (aRRR = 6.7, CI 1.8-24.9). An elevation of ALT to more than 1.5 times the normal value (40 IU/ml) can lead to an incomplete response on NA therapy (aRRR = 6.2, CI 1.5-26.6.)
Conclusion:
Routine clinical markers other than pre-treatment viral load predicted composite CHB outcome on NA Therapy.
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