Abstract: Objective To evaluate the efficacies of serum HBsAg levels and HBV DNA loads in prediction of hepatic histological activity grading and fibrosis staging in patients with chronic hepatitis B. Methods 740 patients with CHB were randomly divided into training set and validation set. 281 were HBeAg-positive,and 169 HBeAg-negative in training set,and 170 were HBeAg-positive,and 120 HBeAg-negative in validation set. Liver biopsies were performed,and histological activity grading and fibrosis staging ≥G₂ and ≥S₂,≥G₃ and ≥S₃, and ≥G₄ and ≥S₄ were respectively defined as significant inflammation and significant fibrosis, severe inflammation and severe fibrosis,and advanced inflammation and advanced fibrosis. Serum HBsAg was measured by Abbott Architect I2000,and serum HBV DNA was assayed by real-time PCR. Results In HBeAg-positive patients,the efficiencies of serum HBsAg levels for prediction of severe fibrosis and advanced fibrosis achieved moderate levels in training set,and the areas under ROC curves were 0.707 and 0.726, respectively; the optimal cut-off-value of serum HBsAg levels as determined by Youden indexes for prediction of severe fibrosis and advanced fibrosis were ≤6.683×10³ IU/mL and ≤6.427×10³ IU/mL,and the corresponding sensitivities and specificities in training set were 0.682 and 0.754,and 0.673 and 0.634,respectively,and those in validation set were 0.667 and 0.806,and 0.644 and 0.619,respectively;In HBeAg-negative patients,the efficiencies of serum HBV DNA loads for prediction of significant inflammation and significant fibrosis were significant,and the areas under ROC curves were 0.629 and 0.671,respectively;the optimal cut-off-value of serum HBV DNA levels as determined by Youden indexes for prediction of significant inflammation and significant fibrosis were ≥4.315×10⁴ IU/mL and ≥2.748×10³ IU/mL,respectively,and the corresponding sensitivities and specificities in training set were 0.444 and 0.606,and 0.795 and 0.717,respectively,and those in validation set were 0.446 and 0.613,and 0.797 and 0.622,respectively. Conclusions Serum HBsAg levels in HBeAg-positive patients with CHB have significant values for prediction of severe fibrosis and advanced fibrosis,and serum HBV DNA loads in HBeAg-negative patients have some hints of significant inflammation and significant fibrosis in liver tissues.

Key words: Hepatitis B, Hepatitis B viral surface antigen, Hepatitis B virus DNA, Quantitative measurement, Liver fibrosis, Noninvasive diagnosis