NAFLD: Reporting Histologic Findings in Clinical Practice.

Area of Science:

• Hepatology
• Pathology
• Gastroenterology

Background:

• Nonalcoholic steatohepatitis (NASH) is a significant liver disease with growing unmet medical needs.
• Drug development and clinical trials for NASH are expanding, alongside noninvasive diagnostic tests.
• Accurate diagnosis and patient stratification are crucial for effective NASH management and research.

Purpose of the Study:

• To provide a focused review of liver biopsy evaluation in nonalcoholic fatty liver disease (NAFLD) and NASH.
• To offer succinct reporting guidelines for histopathologic elements of NASH.
• To distinguish NASH from nonalcoholic fatty liver and alcohol-associated steatohepatitis.

Main Methods:

• Review of current literature and expert consensus on liver biopsy interpretation in NASH.
• Discussion of histopathologic features, including steatosis, inflammation, and hepatocyte injury.
• Inclusion of special populations (pediatrics, advanced fibrosis/cirrhosis) and semiquantitative scoring methods.

Main Results:

• Liver biopsy remains the gold standard for NASH diagnosis and patient selection in clinical trials.
• Standardized reporting aids in distinguishing NASH from other liver conditions.
• Semiquantitative scoring aids in assessing disease activity and fibrosis progression.

Conclusions:

• Standardized liver biopsy evaluation is critical for advancing NASH drug development and clinical practice.
• This white paper provides practical guidance for hepatologists and pathologists.
• Accurate histopathologic assessment ensures appropriate patient intervention and research stratification.