Effectiveness of Six International Guidelines Using Fibrosis-4 and FibroScan for Risk Stratification of Metabolic...

Screening of patients with type 2 diabetes (T2D) and metabolic dysfunction-associated steatotic liver disease (MASLD), who are at high risk for significant (F2F4) or advanced fibrosis (F3F4), is an unmet need. Recently, several pathways have been proposed to screen patients at risk for MASLD and fibrosis. We aimed to compare their performance in a large cohort of outpatients with T2D.

A total of 1572 participants with T2D (60% male; median age, 61 years) attending a diabetes clinic were prospectively screened for MASLD (steatosis and/or elevated alanine aminotransferase) of whom 163 underwent liver biopsy. The European Association for the Study of the Liver (EASL) 2021, 2024, American Association for the Study of Liver Diseases (AASLD), American Gastroenterological Association (AGA), American Association of Clinical Endocrinology (AACE), and American Diabetes Association (ADA) pathways were applied using Fibrosis-4 followed by vibration-controlled transient elastography (VCTE). Outcomes were the percent requiring hepatology referral and the false negative and positive rates in patients according to liver biopsy (F3F4 for EASL, AGA and AASLD and F2F4 for AACE and ADA).

In the 1572 patients, the 6 pathways performed similarly, identifying 12% of patients requiring hepatology referral. In the 163 patients, the false positive rates (36%-39%) were higher than the false negative rates (15%-18%) for F3F4 (EASL, AGA, and AASLD), whereas the opposite was true for F2F4 (AACE and ADA) (17% and 44%, respectively). Using VCTE as the first line, resulted in a higher percentage of hepatology referrals (19%) and a low false negative rate (3%) for F3F4.

The percentage of patients with T2D in diabetes clinics requiring referral to hepatology (12%) was similar across the 6 pathways, but higher (19%) when VCTE was used as the first line, with a low false negative rate (3%) for advanced fibrosis.