---
title: >-
  Fibrosis Assessed by Non-Invasive Tests is Similar to Liver Biopsy for
  Predicting Clinical Outcomes: A TARGET-NASH Study.
description: >-
  Explore this publication on real-world evidence: Fibrosis Assessed by
  Non-Invasive Tests is Similar to Liver Biopsy for Predicting Clinical
  Outcomes: A…
date: '2020-01-01'
category: Publications
tags:
  - AASLD
  - Poster Presentation
  - R&D
  - Care
  - Hepatology
  - MASH/MASLD
  - Health System Partner
canonical_url: >-
  https://www.pedestalhealth.com/resources/publications/aasld/fibrosis-assessed-by-non-invasive-tests-is-similar-to-liver/
source: Pedestal Health
license: © 2026 Pedestal Health. All rights reserved.
slug: fibrosis-assessed-by-non-invasive-tests-is-similar-to-liver
id: yArKacSConsOwDIGFKRn0
contentType: article
---

## Challenge

It was unknown whether non-invasive FIB-4-based cirrhosis diagnosis could substitute for liver biopsy in predicting clinical outcomes—decompensation, HCC, liver transplant, death—in NAFLD patients, a question with direct implications for the design of NIT-based endpoints in NASH trials.

## Solution

The TARGET-NASH cohort was used to compare time-to-event curves and hazard ratios for clinical outcomes across patients diagnosed with cirrhosis by biopsy, FIB-4, VCTE, or clinical criteria, with non-cirrhotic patients as the reference group.

## Impact

Demonstrating that FIB-4-defined cirrhosis predicts clinical outcomes with hazard ratios comparable to biopsy-defined cirrhosis directly supports the regulatory acceptability of FIB-4-based cirrhosis classification in NAFLD trials and real-world outcome studies.

### [Andrea R. Mospan](/people/andrea-mospan/)

![Andrea R. Mospan, PhD, RAC — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/4w6bkwPHPqrXKYs4tHZPkK/1d21763b54ecc3466764986693b7072f/andrea-mospan.jpg)