Net sensitivity of sequential testing driver#
Net sensitivity of sequential testing trial#

8,9 These studies identified progression in approximately 40% of patients, no change in 40%, and regression in 20%. This observation is supported by data from dual biopsy studies showing that the severity of fatty liver disease fluctuates. The natural history of fatty liver disease is dynamic, with disease severity вЂњwaxing and waningвЂќ under the influence of environmental factors that act on a polygenic background of varying susceptibility. 6 Increased severity of diabetes, obesity, hypertension, and dyslipidemia correlate with more fat in the liver 7 and a higher likelihood of progression to steatohepatitis and fibrosis. The more features of the metabolic syndrome an individual exhibits, the greater the risk of steatohepatitis and progressive fibrosis. Several studies have provided insight into the factors that drive progression. Histologically, fibrosis is categorized on a scale from F0, which is essentially no fibrosis, to F4, which indicates cirrhosis. 5 Patients progress from steatosis (nonalcoholic fatty liver ) to nonalcoholic steatohepatitis (NASH), which is the inflammatory form of the disease, and fibrosis. It is known that fatty liver progresses to cirrhosis and/or hepatocellular carcinoma in a significant minority of cases. 3,4 The rate may be even higher in South America and the Middle East, although there are relatively few studies in these populations on which to base estimates. NAFLD affects approximately a quarter of the adult population in most Western countries, particularly those in Europe and North America.

Net sensitivity of sequential testing driver#

1 Obesity, a primary driver of NAFLD, is increasing 2 the majority of the modern general population weighs more than in previous generations. Nonalcoholic fatty liver disease (NAFLD) is an extremely common condition, and its prevalence is predicted to increase. Translational & Clinical Research Institute, Faculty of Medical Sciences Professor of Experimental Hepatology & Consultant Hepatologist Anstee, BSc(Hons), MB BS, PhD, MRCP(UK), FRCP Staging of Fibrosis in Nonalcoholic Steatohepatitis (NASH): Implications for Prognosis Data from these and other trials will provide evidence regarding the utility of newer agents for the treatment of NASH and NASH-related fibrosis. The REVERSE study is evaluating obeticholic acid in patients with NASH and cirrhosis.

Net sensitivity of sequential testing trial#

The MAESTRO-NASH trial is comparing resmetirom, a thyroid hormone beta receptor agonist, vs placebo. Results from the recent phase 3 REGENERATE trial suggest that obeticholic acid may improve hepatic fibrosis in patients with NASH-associated fibrosis. Diet and lifestyle modifications are important across the spectrum of disease. Current management strategies reflect the disease stage. Accuracy and positive predictive value are improved when the tests are used in combination or sequentially, by decreasing the proportion of patients with indeterminate values. These tests work best in excluding the presence of advanced disease. Imaging tests include vibration-controlled transient elastography (VCTE), magnetic resonance elastography (MRE), and multiparametric magnetic resonance imaging, such as corrected T1 (cT1). There are also proprietary biochemical biomarkers. Biochemical biomarker tests include the NAFLD fibrosis score (NFS), the FIB-4 score, and the aspartate transaminase to platelet ratio (APRI) test. There are 2 broad categories of noninvasive tests: biochemical biomarkers (or so-called вЂњwet biomarkersвЂќ) and imaging biomarkers. The challenges associated with biopsy led to the development of noninvasive testing strategies in NASH. The classic approach to assessing disease severity in this setting is with liver biopsy. Among patients with NASH, fibrosis predicts long-term outcomes, including liver-related sequelae, cardiovascular disease, and all-cause morbidity and mortality. Patients may progress from isolated steatosis through nonalcoholic steatohepatitis (NASH) to fibrosis. Abstract: Nonalcoholic fatty liver disease (NAFLD) affects approximately a quarter of the adult population in most Western countries, particularly those in Europe and North America.