Non-Invasive Tests and Liver Medications

by | Sep 10, 2025 | Uncategorized | 0 comments

“Defining non-invasive criteria for indicating drug therapy in metabolic-associated liver disease,” published in Clinical Gastroenterology and Hepatology has these provocative lines–

“Thirty-eight percent of patients (486/1281) were diagnosed with MASLD fibrosis stages 2-3 based on biopsy. However, only 39% and 56% of them met treatment eligibility criteria according to the Expert Panel Criteria and the AASLD Practice Guidance, respectively.”

-and-

“The diagnostic performance and reliability of the proposed non-invasive criteria for initiating Resmetirom treatment were suboptimal. About the half of patients with indication would not receive treatment under these criteria. A new strategy, using FIB-4, the presence of diabetes and overweight, and liver stiffness improved the identification of MASLD patients with fibrosis stage 2-3.”

Background & Aims

Resmetirom is the first FDA-approved medication for treating metabolic-associated steatotic liver disease (MASLD) in patients with moderate liver fibrosis—specifically, those at stages F2 or F3 with steatohepatitis. However, the non-invasive criteria currently proposed to determine who should start resmetirom have not yet been validated in clinical practice, raising concerns about their practical reliability.

Study Findings & Implications

  • The research evaluated the diagnostic performance and reliability of these non-invasive criteria.

  • It concluded that these criteria were suboptimal, meaning that nearly half of the patients who should qualify for treatment according to guideline indications would not be identified using them.

  • To address this gap, the authors proposed a new strategy: a two-step non-invasive algorithm combining:
    1. FIB-4 score >1.30, or, for patients with diabetes and overweight whose FIB-4 is <1.30,
    2. A liver stiffness measurement between 8 and 25 kPa.
  • This approach significantly improved the identification of eligible patients for resmetirom therapy.

The Net Net

  • Problem: Current non-invasive criteria miss about 50% of patients who are eligible for resmetirom.
  • Solution Proposed: A refined, two-step approach using FIB-4 in combination with diabetes/overweight status and elastography-based liver stiffness measurements.
  • Benefit: Enhanced accuracy in identifying MASLD patients (F2–F3) who would benefit from treatment.