Development of a Simple Noninvasive Model to Predict Significant Fibrosis in Patients with Chronic Hepatitis B: Combination of Ultrasound Elastography, Serum Biomarkers, and Individual Characteristics

Abstract

Objectives:The accurate assessment of liver fibrosis is clinically important in patients with chronic hepatitis B (CHB). Blood tests and elastography are now widely used for the noninvasive diagnosis of liver fibrosis in CHB patients. The aim of this study was to develop a new and more accurate predictive model, which combines elastography data, serum biomarkers, and individual characteristics, to discriminate between CHB patients with and without significant liver fibrosis.Methods:Two noninvasive methods, specifically, an ultrasound elastography technique termed acoustic radiation force impulse imaging (ARFI) and a blood test, were used to assess a cohort of 345 patients (estimation group, 218 patients; validation group, 127 patients) with CHB. Multivariate logistic regression analysis revealed that ARFI, the aspartate aminotransferase (AST) to platelet ratio, and age were significantly associated with fibrosis. Based on these results, we constructed and validated a model for the diagnosis of significant hepatic fibrosis.Results:The area under the receiver operating characteristic (ROC) curve was 0.921 for the estimation group and 0.929 for the validation group, significantly higher than those for ARFI (0.887, 0.893) and for the AST-to-platelet ratio index (APRI; 0.811, 0.859). Using an optimal cutoff of 3.05 in the validation group, all the indices of the proposed model, including accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic odds ratio, were better than those for ARFI or APRI.Conclusions:We developed a simple noninvasive model that used ultrasound elastography, routine serum biomarkers, and individual characteristics to accurately differentiate significant fibrosis in patients with CHB. Compared with elastography or the biomarker index alone, this model was significantly more accurate and robust.

Performance of common imaging techniques vs serum biomarkers in assessing fibrosis in patients with chronic hepatitis B: A systematic review and meta-analysis

“…A total of 2831 studies were searched by the described search strategies, of which 2627 were excluded following title and abstract screening. Of those, 81 papers were included in the review following full-text screening (Text S5); 47 studies were related to the APRI[24-70], 11 to the ARFI[29,42,69-77], 32 to the FIB-4[24,25,27,30,35,36,39,40,43-46,48-55,57,58,60,62,63,65-69,78-79], 29 to the FibroScan[28,38,42,52,53,58,60,61,71,73,80-98], and 6 to the MRE[99-104].…”

The non-invasive serum biomarker soluble Axl accurately detects advanced liver fibrosis and cirrhosis

“…The results of our study correspond well with previous reports on the diagnostic accuracy of ELF™ test and TE. 2 , 6 , 8 However, both tests bear the disadvantage of high costs. 19 Additionally, TE shows limitations in applicability since reliable results cannot be generated in up to 15.8% of patients mainly attributable to obesity, presence of ascites, or less operator experience.…”

“… 4 , 5 A variety of serum-based biomarker panels, frequently combined with clinical parameters, such as body mass index (BMI), age, or the presence of diabetes, have been investigated in comparison to liver biopsy as a non-invasive, lower-cost alternative. All of these markers, like APR Index (APRI), 6 , 7 Enhanced Liver Fibrosis (ELF) test, 8 , 9 Fibrosis 4 (FIB4)-Index, 10 Non-alcoholic fatty liver disease (NAFLD) fibrosis score, 11 Cirrhosis Probability in Hepatitis C (Lok) index 12 or FibroTest, 13 , 14 were analysed in various liver diseases, mostly associated with non-alcoholic fatty liver disease (NAFLD) and viral hepatitis showing areas under the receiver operating curve (AUROC) of 0.67 to 0.94 for the detection of significant fibrosis (F) (F≥2), or advanced fibrosis (F≥3), respectively. 3 Furthermore, transient elastography (TE) has been extensively studied for its applicability in routine clinical use.…”

Changes of liver stiffness measured by magnetic resonance elastography during direct‐acting antivirals treatment in patients with chronic hepatitis C

“…While histologic diagnosis following liver biopsy still remains the gold standard method for diagnosing hepatic fibrosis, 8 it presents with challenges including accompanying procedural complications, under‐or over‐sized biopsy sampling tissue areas, 9‐11 and its invasive nature which makes repeat procedures difficult. Nowadays, elastography, a noninvasive imaging modality to evaluate hepatic fibrosis, is widely used to measure the elasticity and stiffness of the liver 12‐14 . Magnetic resonance elastography (MRE) is used as a noninvasive tool for estimating liver fibrosis and MRE demonstrates higher diagnostic accuracy rather than ultrasound‐based elastography or serum test 15,16 .…”

“…Nowadays, elastography, a noninvasive imaging modality to evaluate hepatic fibrosis, is widely used to measure the elasticity and stiffness of the liver. [12][13][14] Magnetic resonance elastography (MRE) is used as a noninvasive tool for estimating liver fibrosis and MRE demonstrates higher diagnostic accuracy rather than ultrasound-based elastography or serum test. 15,16 MRE is also used as a standard for evaluating efficacy in clinical trials.…”