Abstract: Objective The aim of this study was to investigate the predictive value of histological activity index and fibrosis by liver stiffness measurement (LSM) and indocyanine green retention at 15 minutes (ICGR15) in patients with chronic hepatitis B (CHB) and normal or minimally elevated serum ALT levels.Methods A total of 309 patients with CHB with normal or minimally elevated serum ALT were recruited in this study, and all of them underwent liver biopsies. LSM and ICGR15 were detected. The area under receiver operating characteristic curve(AUC) was applied to estimate the efficacy of diagnosis.Results Out the 309 patients with CHB, the stable disease was found in 113 patients, and the progressive disease defined as histological activity index being grading 2 or more or fibrosis being staging 2 or more in 196 patients; there were no significant differenceswith respect to age, gender, platelet counts, serum HBeAg positive and serum ALT levels(P>0.05), while there were significant differences as for serum HBV DNA loads, albumin, LSM and ICGR15 comparison between the two groups (P<0.05); the LSM, ICGR15 or LSM/ICGR15 combination was positively correlated to hepatic METAVIR score(P<0.05); the ROC analysis showed that the AUC of LSM, ICGR15 or LSM/ICGR15 combiantion in predicting progressive liver disease were 0.655, 0.617 and 0.686, e.g., when the LSM equal to 7.35 kPa as the cut-off-value, the diagnosic sencitivity was 55.4%, and the specificity was 68.1%, when the ICGR15 equal to 4.15% as the cut-off-value, they were 34.4% and 90.3%, and when the LSM/ICGR15 combined, they were 59.5% and 78.8%.Conclusion The application of LSM and ICGR15 might have a predictive value for prediction of hepatic grading and staging in patients with CHB, especially in those with normal serum ALT levels or mild liver injury, which needs further investigation.

Key words: Hepatitis B, Alanine aminotransaminase, Liver stiffness measurement, Indocyanine green retention, METAVIR score, Diagnosis