Clinical noninvasive markers for antiviral therapy decision in chronic hepatitis B with alanine aminotransferase less than two times upper limit of normal.

Liver biopsy is the reference method for antiviral therapy decision making in chronic hepatitis B (CHB) when alanine aminotransferase (ALT) is less than two times of upper limit of normal (<2ULN). Our aim was to explore noninvasive markers for antiviral therapy decision in CHB with ALT <2ULN. 452 treatment naïve CHB patients with ALT<2ULN who had undergone liver biopsy were analyzed in this prospective multi-center study. If liver biopsy showed moderate or severe inflammation (Histology activity index≥5) or significant fibrosis (Ishak fibrosis score≥3), antiviral treatment was recommended. We analyzed data using univariate and multivariate analysis and receiver operating characteristic curves (ROC). 269(59.5%) of 452 cases with ALT<2ULN had moderate, severe or significant inflammation. Aspartate aminotransferase (AST)(P=0.03), anti-hepatitis B virus core antibody (anti-HBc)(P=0.003) and liver stiffness measurement (LSM) (P=0.000) were independent variables for antiviral therapy decision making, with area under ROC curve (AUROC) of 0.718, 0.703 and 0.819 respectively. Our novel AAF index, which combined AST, anti-HBc and LSM, showed better performance with AUROC of 0.876, 0.877 and 0.876 in estimation, validation and total set. Finally, 247(54.6%) of 452 patients could avoid liver biopsy based on AAF index. Furthermore, performances of 23 noninvasive models were unsatisfactory for antiviral therapy decision with AUROC less than 0.800, which were inferior to AAF index. In conclusion, AST, anti-HBc and LSM were related to antiviral therapy decision making among CHB patients with ALT<2ULN. Thus the novel AAF index was a more reliable noninvasive model for antiviral therapy decision making. This article is protected by copyright. All rights reserved.