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Hepatology
Article . 2019 . Peer-reviewed
License: Wiley Online Library User Agreement
Data sources: Crossref
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Hepatology
Article . 2020
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Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials

Authors: Quentin M. Anstee; Eric J. Lawitz; Naim Alkhouri; Vincent Wai‐Sun Wong; Manuel Romero‐Gomez; Takeshi Okanoue; Michael Trauner; +18 Authors

Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials

Abstract

Accurate noninvasive tests (NITs) are needed to replace liver biopsy for identifying advanced fibrosis caused by nonalcoholic steatohepatitis (NASH). We analyzed screening data from two phase 3 trials of selonsertib to assess the ability of NITs to discriminate advanced fibrosis. Centrally read biopsies from the STELLAR studies, which enrolled patients with bridging fibrosis and compensated cirrhosis, were staged according to the NASH Clinical Research Network classification. We explored associations between fibrosis stage and NITs, including the nonalcoholic fatty liver disease fibrosis score (NFS), fibrosis‐4 (FIB‐4) index, Enhanced Liver Fibrosis (ELF) test, and liver stiffness by vibration‐controlled transient elastography (LS by VCTE). The performance of these tests to discriminate advanced fibrosis, either alone or in combinations, was evaluated using areas under the receiver operating characteristic curve (AUROCs) with 5‐fold cross‐validation repeated 100 times. Of the 4,404 patients screened for these trials, 3,202 had evaluable biopsy data: 940 with F0‐F2 fibrosis and 2,262 with F3‐F4 fibrosis. Significant differences between median values of NITs for patients with F0‐F2 versus F3‐F4 fibrosis were observed: −0.972 versus 0.318 for NFS, 1.18 versus 2.20 for FIB‐4, 9.22 versus 10.39 for ELF, and 8.8 versus 16.5 kPa for LS by VCTE (all P < 0.001). AUROCs ranged from 0.75 to 0.80 to discriminate advanced fibrosis. FIB‐4 followed by an LS by VCTE or ELF test in those with indeterminate values (FIB‐4 between 1.3 and 2.67) maintained an acceptable performance while reducing the rate of indeterminate results. Conclusion: Among patients being considered for enrollment into clinical trials, NITs alone or in combination can reduce the need for liver biopsy to discriminate advanced fibrosis caused by NASH. The predictive value of these tests for general screening will require confirmation in a real‐world population.

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United Kingdom
Keywords

Liver Cirrhosis, Male, Biopsy, Reproducibility of Results, Middle Aged, Severity of Illness Index, Clinical Trials, Phase III as Topic, Non-alcoholic Fatty Liver Disease, Elasticity Imaging Techniques, Humans, Female, Diagnostic Techniques and Procedures, Aged

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
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