Backgrounds:: To optimize management and predict long-term clinical courses in patients with chronic hepatitis B (CHB), noninvasive tests to determine the degree of hepatic fibrosis have been developed. Aims:: This study aimed to validate a simple, noninvasive FIB-4 index, which was first derived from an HCV-HIV-co-infected population, in patients with CHB and to compare it with other noninvasive tests for predicting cirrhosis. Methods:: From 2006-2008, a total of 668 consecutive CHB patients who underwent liver biopsies were enrolled. The fibrosis stage was assessed according to the Batts and Ludwig system by a single pathologist blinded to patients' data. Results:: For prediction of significant (F≥2) and severe (F≥3) fibrosis, and cirrhosis (F=4), the area under the receiver-operating characteristic curves were 0.865, 0.910 and 0.926 respectively. In predicting cirrhosis, it demonstrated diagnostic values comparable to the age-spleen platelet ratio index (0.937, P=0.414) and age-platelet index (0.928, P=0.888), and better outcomes than spleen-platelet ratio index (0.882, P=0.007), aspartate aminotransferase (AST)-platelet ratio index (0.731, P<0.001) and AST-alanine aminotransferase ratio index (0.730, P<0.001). FIB-4 cut-offs of 1.6 and 3.6 provided 93.2% negative predictive value and 90.8% positive predictive value for detection of cirrhosis respectively. Based on these results, liver biopsy could be avoided in 70.5% of the study population. These cut-offs were validated internally using bootstrap resampling methods, showing good agreement. Conclusions:: FIB-4 is a simple, accurate and inexpensive method of predicting cirrhosis, with outcomes comparable to other noninvasive tests and may reduce the need for liver biopsy in the majority of CHB patients.
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