Fibrosis Assessed by Non-Invasive Tests is Similar to Liver Biopsy for Predicting Clinical Outcomes: A TARGET-NASH Study

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.

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.

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.

NIT-vs-biopsy outcome prediction equivalence evidence for NASH endpoint strategy, FIB-4-based cirrhosis classification validation against clinical outcomes, Real-world surrogate endpoint validation for non-invasive NAFLD staging