Abstract
Evaluating liver fibrosis is crucial for disease severity assessment, treatment decisions, and hepatocarcinogenic risk prediction among patients with chronic hepatitis C. In this retrospective multicenter study, we aimed to construct a novel model formula to predict cirrhosis. A total of 749 patients were randomly allocated to training and validation sets at a ratio of 2:1. Liver stiffness measurement (LSM) was made via transient elastography using FibroScan. Patients with LSM ≥12.5 kPa were regarded as having cirrhosis. The best model formula for predicting cirrhosis was constructed based on factors significantly and independently associated with LSM (≥12.5 kPa) using multivariate regression analysis. Among the 749 patients, 198 (26.4%) had LSM ≥12.5 kPa. In the training set, multivariate analysis identified logarithm natural (ln) type IV collagen 7S, ln hyaluronic acid, and ln Wisteria floribunda agglutinin positive Mac-2-binding protein (WFA+-Mac-2 BP) as the factors that were significantly and independently associated with LSM ≥12.5 kPa. Thus, the formula was constructed as follows: score = −6.154 + 1.166 × ln type IV collagen 7S + 0.526 × ln hyaluronic acid + 1.069 × WFA+-Mac-2 BP. The novel formula yielded the highest area under the curve (0.882; optimal cutoff, −0.381), specificity (81.5%), positive predictive values (62.6%), and predictive accuracy (81.6%) for predicting LSM ≥12.5 kPa among fibrosis markers and indices. These results were almost similar to those in the validated set, indicating the reproducibility and validity of the novel formula. The novel formula scores were significantly, strongly, and positively correlated with LSM values in both the training and validation data sets (correlation coefficient, 0.721 and 0.762; p = 2.67 × 10−81 and 1.88 × 10−48, respectively). In conclusion, the novel formula was highly capable of diagnosing cirrhosis in patients with chronic hepatitis C and exhibited better diagnostic performance compared to conventional fibrosis markers and indices.
Highlights
Liver fibrosis evaluation is crucial for determining liver disease severity, planning treatment strategies, and predicting hepatocarcinogenic risk among patients with chronic hepatitis C
A total of 749 consecutive patients who were diagnosed with chronic hepatitis C and underwent transient elastography (FibroScan, Echosens, Paris, France) at Nippon Medical School Chiba Hokusoh Hospital, Nippon Medical School, Tokyo Women’s Medical University Yachiyo Medical Center, Mie University School of Medicine, Yamaguchi University Graduate School of Medicine, Yokohama City University Medical Center, Shinmatsudo Central General Hospital, Nagoya City University, Kagawa Prefectural Central Hospital, and Osaka City University Medical School from April 2014 to June 2020 were included in this retrospective study
The inclusion criteria were as follows: (1) persistent presence of serum hepatitis C virus (HCV) RNA; (2) chronic liver disease diagnosed based on laboratory, histology, and/or imaging tests, including ultrasonography and computed tomography; and (3) available data on serologic fibrosis markers and transient elastography
Summary
Liver fibrosis evaluation is crucial for determining liver disease severity, planning treatment strategies, and predicting hepatocarcinogenic risk among patients with chronic hepatitis C. WFA+-M2BP has been found to be useful for diagnosing patients with advanced fibrosis due to chronic hepatitis B and non-alcoholic fatty liver disease, as well as chronic hepatitis C [9, 11, 12], and is superior to other conventional fibrosis markers [10]. Apart from these single serologic markers, several scoring systems comprising a combination of multiple laboratory tests, such as aspartate aminotransferase to platelet ratio index (APRI) [13], fibrosis-4 (FIB-4) index [14], and FibroTest [15], have been proposed for estimating liver fibrosis
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