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Semin Liver Dis 2020; 40(04): 339-345
DOI: 10.1055/s-0040-1709491
Review Article

Histological Endpoints for Nonalcoholic Steatohepatitis Trials: Lights and Shadows

Ian A. Rowe
1   Leeds Institute for Medical Research, University of Leeds, United Kingdom
2   Leeds Institute for Data Analytics, University of Leeds, United Kingdom
3   Leeds Liver Unit, St James's University Hospital, Leeds, United Kingdom
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Abstract

Nonalcoholic steatohepatitis (NASH) with liver fibrosis is an increasingly important cause of liver-related morbidity and mortality. A diagnosis of NASH can only be made using liver biopsy. Liver histology also forms the endpoint for the expedited licensing strategies that have been approved by regulators to allow patients with NASH access to treatment before the impact of these on clinical outcomes is known. Validation of these histological surrogate endpoints is critical for the ongoing development of new therapies for NASH. The use of liver biopsy to define both trial entry and endpoints raises questions about the use of treatments for NASH in practice when the effectiveness of treatment will likely depend, at least in part, on the use of histology for patient selection in the real world.

Keywords

NASH - NAFLD - surrogate - validity


Publication History

Article published online:
09 September 2020

© 2020. Thieme. All rights reserved.

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