The Search Continues for a Noninvasive Test for Nonalcoholic Steatohepatitis that Works in the Real World

Nonalcoholic steatohepatitis, or NASH, is a serious progression of nonalcoholic fatty liver disease. Percutaneous liver biopsy is currently the gold standard for diagnosing and staging nonalcoholic steatohepatitis, but it is frequently avoided due to the high cost, potential risk to the patient and lack of approved treatments once diagnosis is confirmed. According to Fernando Bril, M.D., an assistant professor in the University of Florida College of Medicine’s Division of Endocrinology, Diabetes and Metabolism, “This is a bidirectional problem. We need better diagnostic tools to identify nonalcoholic steatohepatitis, but we also need a better way to treat it once we find it. That’s why UF Health is committed to meeting both challenges.”

Bril works alongside a team of several researchers led by Kenneth Cusi, M.D., who are searching for an effective noninvasive diagnostic test for nonalcoholic steatohepatitis at UF Health. They have investigated several methods in the past, including the use of biomarkers such as plasma cytokeratin-18 and the One Way Liver Metabolomics test, and the use of ultrasound. Most recently, they investigated the use of a commercially available blood test that is a combination of four different noninvasive biomarker panels, including one for diagnosing steatosis, two for diagnosing necrosis and inflammation, and one for diagnosing fibrosis. All four panels were developed and validated originally in nondiabetic cohorts. Cusi’s team assessed them in combination to see how they would perform in a large cohort of patients with Type 2 diabetes, reflecting a more real-world setting for diagnosing nonalcoholic steatohepatitis.

The study, which was conducted in 220 patients, found that many of the panels may underperform in patients with Type 2 diabetes. The results suggest that patients with Type 2 diabetes may require different panels specifically developed for this patient population to diagnose nonalcoholic steatohepatitis.

Bril and his colleagues at UF Health will continue their search for an effective diagnostic test for nonalcoholic steatohepatitis while they also continue working on effective treatments.

References

Bril F, Ortiz-Lopez C, Lomonaco R, et al. Clinical value of liver ultrasound for the diagnosis of nonalcoholic fatty liver disease in overweight and obese patients. Liver Internat. 2015;35:2139-2146.

Bril F, Millán L, Kalavalapali S, et al. Use of a metabolomics approach to non-invasively diagnose non-alcoholic fatty liver disease in patients with type 2 diabetes mellitus. Diab Obes Metab. 2018;20:1702-1709.

Bril F, McPhaul MJ, Caulfield MP, et al. Performance of the SteatoTest, ActiTest, NashTest, and FibroTest in a multiethnic cohort of patients with type 2 diabetes mellitus. J Invest Med. 2018;0:1-9: doi:10.1136/jim-2018-000864

Cusi K, Chang Z, Harrison S, et al. Limited value of plasma cytokeratin-18 as a biomarker for NASH and fibrosis in patients with non-alcoholic fatty liver disease. J Hepatol. 2014;60: 167-174.