A Novel Noninvasive Program for Staging Liver Fibrosis in Untreated Patients With Chronic Hepatitis B

Chronic hepatitis B (CHB) causes liver fibrosis and then liver cirrhosis and hepatocellular carcinoma, which can result in life-threatening complications, such as gastrointestinal bleeding and liver failure (1,2). In the algorithm for management of CHB, early and accurate diagnosis of liver fibrosis/cirrhosis is particularly important to guide the preventive strategy of their related complications (3). Currently, liver biopsy remains the gold standard approach for staging liver fibrosis, but is often limited by its invasiveness, poor acceptance, sampling variability, and complications (4,5). In addition, repeated biopsy is often unacceptable for dynamic assessment of progression and regression of liver fibrosis. In this setting, the physicians have paid more and more attention to noninvasive assessment of liver fibrosis by physical examinations, routine biochemical and hematological tests, and surrogate serum fibrosis markers (6,7). Several noninvasive models have been developed, such as the FibroTest (8), aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio (AAR) (9), AST to platelet index (APRI) (10), and Hepascore (11), etc. However, their diagnostic accuracy is not satisfactory. For example, the evidence from meta-analyses of 37 articles suggested that the APRI had moderate diagnostic performance for significant fibrosis, advanced fibrosis, and cirrhosis in patients with CHB with summary areas under the receiver operating characteristic curve of less than 0.8 (12). Some components included in these models, such as haptoglobin, α2-macroglobulin, and apolipoprotein A1, are not routinely available in clinical practice. It has been reported that liver stiffness measurement (LSM) may have a higher diagnostic accuracy for assessment of advanced liver fibrosis and cirrhosis than serum biomarkers in patients with CHB (13,14), but its usefulness is often questioned in some specific population (i.e., obesity and ascites) (15). In addition, the performance of noninvasive markers for diagnosing middle stages of fibrosis is reduced (16). We have conducted a Chinese multicenter cross-sectional study involving 1,200 patients with CHB to develop and validate a noninvasive program (i.e., Chin-CHB score) for accurately differentiating liver fibrosis stage by stage based on 30 routinely available parameters.