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Performance of noninvasive tests of fibrosis among Asians, Hispanic and non-Hispanic Whites in the STELLAR trials

Background & aims: The effect of race on routinely available noninvasive tests of fibrosis is incompletely understood. This study evaluated the performance of noninvasive tests among White and Asian patients in the STELLAR trials (NCT03053050 and NCT03053063), which evaluated selonsertib in patients with advanced (F3-F4) fibrosis due to nonalcoholic steatohepatitis (NASH).

Methods: Baseline liver biopsies were centrally read using the NASH Clinical Research Network system, and four noninvasive tests (Nonalcoholic fatty liver disease fibrosis score [NFS], Fibrosis-4 index [FIB-4], Enhanced Liver Fibrosis test [ELF] and liver stiffness [LS] by vibration-controlled transient elastography) were measured. The performance of these tests to discriminate advanced fibrosis was evaluated using areas under the receiver operating characteristics curves (AUROCs) with 5-fold cross-validation repeated 100 times.

Results: Among 3207 patients screened with evaluable liver histology, 2281 were Whites and 762 were Asians. 72% of Whites and 67% of Asians had advanced fibrosis. The AUROCs of the noninvasive tests for advanced fibrosis were similar in Whites and Asians: 0.73 and 0.75 for NFS, 0.78 and 0.80 for FIB-4, 0.79 and 0.81 for ELF, and 0.80 and 0.83 for LS, respectively. At the published cutoffs, the tests had similar sensitivities and specificities in the two groups. However, the sensitivities of NFS, FIB-4 and ELF were low in both White and Asian patients younger than 40 years.

Conclusions: In the global phase 3 STELLAR trials, the diagnostic performance of routinely available noninvasive tests for the detection of advanced fibrosis due to NASH was acceptable and similar between White and Asian patients.

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S8292 Selonsertib (GS-4997) Selonsertib (GS-4997) is a highly selective and potent once-daily oral ASK1 inhibitor with potential anti-inflammatory, antineoplastic and anti-fibrotic activities.

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