Abstract
Background and AimsLiver stiffness measurement (LSM) and FibroTest (FT) are frequently used as non-invasive alternatives for fibrosis staging to liver biopsy. However, to date, diagnostic performances of Enhanced Liver Fibrosis (ELF) test, which consists of hyaluronic acid, aminoterminal propeptide of procollagen type-III, and tissue inhibitor of matrix metalloproteinases-1, have not been compared to those of LSM and FT in Asian chronic hepatitis B (CHB) patients.MethodsBetween June 2010 and November 2011, we prospectively enrolled 170 CHB patients who underwent liver biopsies along with LSM, FT, and ELF. The Batts system was used to assess fibrosis stages.ResultsAreas under receiver operating characteristic curves (AUROCs) to predict significant fibrosis (F≥2), advanced fibrosis (F≥3), and cirrhosis (F = 4) were 0.901, 0.860, and 0.862 for ELF, respectively; 0.937, 0.956, and 0.963 for LSM; and 0.896, 0.921, and 0.881 for FT. AUROCs to predict F≥2 were similar between each other, whereas LSM and FT had better AUROCs than ELF for predicting F≥3 (both p<0.05), and LSM predicted F4 more accurately than ELF (p<0.05). Optimized cutoffs of ELF to maximize sum of sensitivity and specificity were 8.5, 9.4, and 10.1 for F≥2, F≥3, and F = 4, respectively. Using suggested ELF, LSM and FT cutoffs to diagnose F1, F2, F3, and F4, 91 (53.5%), 117 (68.8%), and 110 (64.7%) patients, respectively, were correctly classified according to histological results.ConclusionsELF demonstrated considerable diagnostic value in fibrosis staging in Asian CHB patients, especially in predicting F≥2. However, LSM consistently provided better performance for predicting F≥3 and F4.
Highlights
Accurate assessment of the severity of liver fibrosis in patients with chronic hepatitis B (CHB) is necessary for prediction of the long-term clinical course, and determination of whether and when to begin antiviral therapy
The most recent guidelines on the management of CHB proposed that the presence of significant fibrosis with detectable serum hepatitis B virus (HBV) DNA indicates antiviral therapy, since viral suppression can reduce liver-related complications in patients with CHB who have significant fibrosis to cirrhosis [1,2]
Since patients with cirrhosis should be entered into the active surveillance program for early detection of hepatocellular carcinoma (HCC) and other complications associated with hepatic decompensation, including gastroesophageal varices, assessment of fibrosis in patients with CHB has become an important clinical issue for physicians [3]
Summary
Accurate assessment of the severity of liver fibrosis in patients with chronic hepatitis B (CHB) is necessary for prediction of the long-term clinical course, and determination of whether and when to begin antiviral therapy. To-date, liver biopsy has been the gold standard to assess liver fibrosis It is often limited, by its invasiveness, cost, risk of complications, poor acceptance by patients, lack of availability of expert practitioners, and intra/inter-observer variability [4]. By its invasiveness, cost, risk of complications, poor acceptance by patients, lack of availability of expert practitioners, and intra/inter-observer variability [4] These drawbacks have made sequential liver biopsies unfeasible, especially when repeated examinations are required to monitor the response to antiviral or anti-fibrosis treatment. Liver stiffness measurement (LSM) using transient elastography (TE; FibroScanH; Echosens, Paris, France), which calculates liver elasticity using a low frequency elastic wave transmitted through the liver, has been introduced recently and proven useful for non-invasive assessment of liver fibrosis among subjects with chronic liver diseases (CLDs) due to various etiologies [14,15,16]. To date, diagnostic performances of Enhanced Liver Fibrosis (ELF) test, which consists of hyaluronic acid, aminoterminal propeptide of procollagen type-III, and tissue inhibitor of matrix metalloproteinases-1, have not been compared to those of LSM and FT in Asian chronic hepatitis B (CHB) patients
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