Expert Interview
Assessing the Two-Year Data from the MAESTRO-NAFLD-1 Trial of Rezdiffra (Resmetirom) in Compensated MASH Cirrhosis from Madrigal Pharmaceuticals
Ticker(s): MDGLInstitution: Virginia Commonwealth University School of Medicine
Director of Alcohol Sciences at Stravitz-Sanyal Institute for Liver Disease and Associate Professor of Medicine in Gastroenterology, Hepatology, and Nutrition, at Virginia Commonwealth University School of Medicine
Treats 1000 patients per year with MASH
Research interest in clinical/translational research and epidemiology in alcohol-related liver disease (ALD) and metabolic dysfunction-associated steatotic liver disease (MASLD).
Rezdiffra treatment led to a mean 6.7 kPa reduction in liver stiffness, the largest reported reduction in a compensated MASH cirrhosis population. How significant is this improvement in terms of delaying disease progression and reducing the risk of complications?
Added By: slingshot_insightsRecent studies suggest that VCTE is a strong predictor of clinical outcomes and may even outperform biopsy-based assessments in some cases. How reliable is liver stiffness measurement as a surrogate endpoint for therapeutic efficacy in MASH cirrhosis?
Added By: slingshot_insightsOver half of the patients (51%) achieved at least a 25% reduction in liver stiffness, which has been associated with a lower risk of progression to end-stage liver disease. In clinical practice, how would this translate into real-world benefits for patients?
Added By: slingshot_insightsCurrently, there are no approved therapies for MASH cirrhosis. How does Rezdiffra compare to standard-of-care interventions such as lifestyle modifications, weight loss, or off-label treatments in terms of efficacy and patient adherence?
Added By: slingshot_insightsGiven Rezdiffra's safety profile in the MAESTRO-NAFLD-1 trial, with a low rate of discontinuations due to adverse events, and given that cirrhotic patients often have compromised liver function, what additional safety considerations need to be addressed in future trials?
Added By: slingshot_insightsMadrigal has emphasized that Rezdiffra should not be used for compensated MASH cirrhosis until further evidence from the ongoing MAESTRO-NASH OUTCOMES trial. What key regulatory hurdles must be overcome before this drug can receive approval for this population?
Added By: slingshot_insightsIf Rezdiffra demonstrates positive outcomes in the MAESTRO-NASH OUTCOMES study, how do you foresee its role expanding beyond its current indication in F2-F3 MASH? Could it eventually become a front-line therapy for earlier-stage liver disease?
Added By: slingshot_insightsWith MASH expected to become the leading cause of liver transplantation in the U.S., what role do you see Rezdiffra playing in reshaping treatment paradigms, and how does it compare to other emerging therapies in the space?
Added By: slingshot_insightsAre You Interested In These Questions?
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