Background: To optimize management strategies and predict the long-term clinical course in patients with chronic hepatitis B (CHB), non-invasive tests to determine the degree of hepatic fibrosis have been developed. Aims: We aimed to conduct a large-scale external validation of a simple, non-invasive test called P2/MS using CHB patients and to compare it to other non-invasive tests for the prediction of histological cirrhosis. Methods: From 2006 to 2009, we enrolled a total of 521 consecutive CHB patients who underwent liver biopsy. Fibrosis stage was assessed according to the Metavir scoring system by a single pathologist who was unaware of the patients' histories. Results: For predictions of significant (p ≥ 2) and severe (p ≥ 3) fibrosis and cirrhosis (p = 4), the areas under the receiver operating characteristic curves were 0.801, 0.856, and 0.906, respectively. In predicting cirrhosis, we found that diagnostic values were comparable to age-spleen platelet ratio index (0.931, p = 0.063), spleen-platelet ratio index (0.923, p = 0.145), age-platelet index (0.914, p = 0.670), and FIB-4 (0.898. p = 0.597) and had better outcomes than the aspartate aminotransferase (AST)-platelet ratio index (0.780, p < 0.001), and AST-alanine aminotransferase ratio index (0.729, p < 0.001). The cut-off points of P2/MS >83 and P2/MS <30 provided 91.1% of negative predictive value and 91.3% of positive predictive value, respectively. Based on these results, liver biopsies could be avoided in 67.0% of the population. These cut-offs were validated internally using bootstrap resampling methods, which showed good agreement. Conclusions: P2/MS is a simple, accurate, and inexpensive method with comparable outcomes to other non-invasive tests and may reduce the need for liver biopsy in the majority of CHB patients.
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Acknowledgments The author thanks Eun Hee Choi, PhD (Department of Biostatistics, Yonsei University College of Medicine, Seoul, Republic of Korea) and Hae Ryoung Song, PhD (Department of Research Affairs, Yonsei University College of Medicine, Seoul, Republic of Korea) for critical comments on statistics. This study was supported by the Liver Cirrhosis Clinical Research Center, in part by a grant from the Brain Korea 21 Project for Medical Science, and by a grant from Ministry for Health, Welfare and Family Affairs, Republic of Korea (no. A050021).
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