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Fit-for-purpose: The Evolving Role of Liver Biopsies in MASH Clinical Trials and Patient management Post Drug-approval

Date: 30 May 204

About the Webcast

The recent FDA approval of Rezdiffra™ (resmetirom) for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH) has marked a significant milestone in the management of this complex liver disease. In light of this development, a panel of distinguished experts convened for a webcast titled “‘Fit for Purpose’: The Evolving Role of Liver Biopsies in MASH Clinical Trials and Patient Management Post-drug Approval.” The webcast, moderated by Professor Nikolai Naoumov, brought together Dr. Arun Sanyal, Dr. David Kleiner, and Dr. Timothy Kendall to discuss the implications of Rezdiffra’s approval on clinical practice and future drug development in MASH.

Topics covered:

  1. The role of liver biopsy in MASH diagnosis and assessing treatment response in clinical practice
  2. The use of non-invasive tests (NITs) in MASH patient diagnosis and monitoring
  3. The role of liver biopsy in analyzing the efficacy of combination trials and addressing the heterogeneity in MASH
  4. The importance of pairing liver biopsies with molecular pathology to guide personalized treatment strategies
  5. The potential of digital pathology and artificial intelligence in MASH assessment
Key takeaways: 
 
  1. Liver biopsies remain crucial in MASH diagnosis and management, especially when non-invasive tests (NITs) provide discrepant or inconclusive results.
  2. NITs are becoming increasingly important, but they have limitations in precision and sometimes give mixed messages. A combination of NITs is often needed for a comprehensive assessment.
  3. The AASLD guidance recommends liver biopsy as a tiebreaker when there’s diagnostic confusion or discrepant NIT results.
  4. Digital pathology and AI show promise in extracting more detailed information from liver biopsies, potentially predicting treatment responses and clinical outcomes.
  5. The heterogeneity of MASH suggests that combination therapies may be more effective, and liver biopsies could play a role in analyzing the efficacy of individual components.
  6. Experts suggest combining machine learning approaches with molecular pathology to better understand disease mechanisms and guide personalized treatment strategies.
  7. The approval of Rezdiffra will impact clinical trial design, affecting patient recruitment, retention, and potentially requiring adjustments to inclusion/exclusion criteria.
  8. There’s a need for longer-term biopsies (e.g., at 96 weeks) in clinical trials to properly assess drug efficacy and disease progression.
  9. The importance of paired biopsies (before and after treatment) was emphasized for studying treatment response kinetics and fibrosis progression.
  10. The ultimate goal is to match the right patient to the right drug, moving towards precision medicine in MASH treatment.