A Two-Step Algorithm for the Noninvasive Identification of Candidates for Nonalcoholic Steatohepatitis Clinical Trials: The APRI-FAST

Clinical trials enrolling patients with nonalcoholic steatohepatitis (NASH) are typically designed to show improvement in histologic inflammation without worsening fibrosis. Ideally, NASH therapies will also improve the fibrosis stage. Most trial participants therefore have evidence of histologic NASH with fibrosis stages 2–3. The need for liver biopsy to identify this stage and grade, however, can limit enrollment. Data regarding the optimal strategy to screen and select potential candidates using noninvasive testing are limited.