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Serum Biomarkers Predictive of Significant Fibrosis and Cirrhosis in Chronic Hepatitis B. GOALS/BACKGROUND: Aspartate aminotransferase to platelet ratio index (APRI) and FIB-4 index are noninvasive biomarkers to evaluate hepatic fibrosis. However, their usefulness in chronic hepatitis B (CHB) patients remains unclear. METHODS: A total of 631 CHB patients were enrolled and randomly divided into a training set (n=420) and a validation set (n=211). Areas under receiver operating characteristic (AUROC) curves for FIB-4 index and APRI were compared to evaluate their diagnostic values in identifying significant fibrosis and cirrhosis. RESULTS: The AUROC of FIB-4 index for the diagnosis of significant fibrosis and cirrhosis in the entire cohort was higher than that of APRI (0.769 vs. 0.704, P=0.0003 and 0.869 vs. 0.706, P<0.0001). By using cutoff APRI of 0.38 and 4.04 in the validation set, the diagnostic accuracy for absence of significant fibrosis and presence of cirrhosis was 67.7% and 76.8%. At cutoff FIB-4 index of 0.87 and 3.40 in the validation set, the diagnostic accuracy for absence of significant fibrosis and presence of cirrhosis was 69.2% and 84.4%. Compared with patients with concordance, patients with overestimated score by FIB-4 index had a significantly higher serum alanine aminotransferase (ALT) level (299±245 vs. 168±196 U/L, P=0.001) as well as a higher ratio of hepatitis flare (ALT>400 U/L) (25% vs. 7.9%, P=0.008). CONCLUSIONS: FIB-4 index proves to be more reliable than APRI in predicting significant fibrosis and cirrhosis in CHB patients. By using FIB-4 index, a substantial proportion of patients could be identified correctly as significant fibrosis and cirrhosis without further invasive liver biopsy.