Abstract
Diagnosis of liver cirrhosis is essential in the management of chronic hepatitis C virus (HCV) infection. Liver biopsy is invasive and thus entails a risk of complications as well as a potential risk of sampling error. Therefore, non-invasive diagnostic tools are preferential. The aim of the present study was to create a model for accurate prediction of liver cirrhosis based on patient characteristics and biomarkers of liver fibrosis, including a panel of non-cholesterol sterols reflecting cholesterol synthesis and absorption and secretion. We evaluated variables with potential predictive significance for liver fibrosis in 278 patients originally included in a multicenter phase III treatment trial for chronic HCV infection. A stepwise multivariate logistic model selection was performed with liver cirrhosis, defined as Ishak fibrosis stage 5–6, as the outcome variable. A new index, referred to as Nordic Liver Index (NoLI) in the paper, was based on the model: Log-odds (predicting cirrhosis) = −12.17+ (age×0.11) + (BMI (kg/m2)×0.23) + (D7-lathosterol (μg/100 mg cholesterol)×(−0.013)) + (Platelet count (x109/L)×(−0.018)) + (Prothrombin-INR×3.69). The area under the ROC curve (AUROC) for prediction of cirrhosis was 0.91 (95% CI 0.86–0.96). The index was validated in a separate cohort of 83 patients and the AUROC for this cohort was similar (0.90; 95% CI: 0.82–0.98). In conclusion, the new index may complement other methods in diagnosing cirrhosis in patients with chronic HCV infection.
Highlights
Morbidity and mortality in Hepatitis C virus (HCV) infection results mainly from the development of complications of cirrhosis, or hepatocellular carcinoma (HCC) [1]
The primary aim of this study was to develop a reliable model for predicting HCV-related liver cirrhosis
The new index combines age, BMI, platelet count and prothrombin index, i.e. factors that previously have been consistently associated with fibrosis [6,9,10,11,35], along with D7lathosterol which, to our knowledge, has not previously been evaluated in this setting
Summary
Morbidity and mortality in Hepatitis C virus (HCV) infection results mainly from the development of complications of cirrhosis, or hepatocellular carcinoma (HCC) [1]. Due to the potential risk of complications [3] as well as other limitations, e.g. the risk of sampling error and inter-observer variability [4,5] associated with liver biopsy, several non-invasive methods for fibrosis assessment previously have been proposed. Transient elastography has been thoroughly evaluated among HCV infected patients [17,18,19,20] with a high diagnostic accuracy for cirrhosis [21] but it may often be difficult to obtain a valid examination, especially in obese patients. In recent years algorithms combining different non-invasive methods has improved the diagnostic accuracy for staging of fibrosis [22,23]. Transient elastography appears to be the most accurate method when compared with currently available biomarkers [14,21], but a freely available biochemical index that could complement to liver elastography measurement for the diagnosis of cirrhosis is desirable
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