1. Non-invasive tests accurately stratify patients with NAFLD based on their risk of liver-related events
- Author
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Intercept Pharmaceuticals, Ekstedt, Mattias [0000-0002-5590-8601], Bonacci, Martin [0000-0002-4528-8066], Cure, Sandrine [0000-0002-8296-0771], Kechagias, Stergios [0000-0001-7614-739X], Boursier, Jerome, Hagström, Hannes, Ekstedt, Mattias, Moreau, Clemence, Bonacci, Martin, Cure, Sandrine, Ampuero, Javier, Nasr, Patrik, Tallab, Lilian, Canivet, Clémence M., Kechagias, Stergios, Sánchez-Torrijos, Yolanda, Dincuff, Eloise, Lucena-Valera, Ana, Roux, Marine, Riou, Jeremie, Trylesinski, Aldo, Romero-Gómez, Manuel, Intercept Pharmaceuticals, Ekstedt, Mattias [0000-0002-5590-8601], Bonacci, Martin [0000-0002-4528-8066], Cure, Sandrine [0000-0002-8296-0771], Kechagias, Stergios [0000-0001-7614-739X], Boursier, Jerome, Hagström, Hannes, Ekstedt, Mattias, Moreau, Clemence, Bonacci, Martin, Cure, Sandrine, Ampuero, Javier, Nasr, Patrik, Tallab, Lilian, Canivet, Clémence M., Kechagias, Stergios, Sánchez-Torrijos, Yolanda, Dincuff, Eloise, Lucena-Valera, Ana, Roux, Marine, Riou, Jeremie, Trylesinski, Aldo, and Romero-Gómez, Manuel
- Abstract
[Background & Aims] Previous studies on the prognostic significance of non-invasive liver fibrosis tests in non-alcoholic fatty liver disease (NAFLD) lack direct comparison to liver biopsy. We aimed to evaluate the prognostic accuracy of fibrosis-4 (FIB4) and vibration-controlled transient elastography (VCTE), compared to liver biopsy, for the prediction of liver-related events (LREs) in NAFLD., [Methods] A total of 1,057 patients with NAFLD and baseline FIB4 and VCTE were included in a multicenter cohort. Of these patients, 594 also had a baseline liver biopsy. The main study outcome during follow-up was occurrence of LREs, a composite endpoint combining cirrhosis complications and/or hepatocellular carcinoma. Discriminative ability was evaluated using Harrell’s C-index., [Results] FIB4 and VCTE showed good accuracy for the prediction of LREs, with Harrell’s C-indexes >0.80 (0.817 [0.768-0.866] vs. 0.878 [0.835-0.921], respectively, p = 0.059). In the biopsy subgroup, Harrell’s C-indexes of histological fibrosis staging and VCTE were not significantly different (0.932 [0.910-0.955] vs. 0.881 [0.832-0.931], respectively, p = 0.164), while both significantly outperformed FIB4 for the prediction of LREs. FIB4 and VCTE were independent predictors of LREs in the whole study cohort. The stepwise FIB4-VCTE algorithm accurately stratified the risk of LREs: compared to patients with “FIB4 <1.30”, those with “FIB4 ≥1.30 then VCTE <8.0 kPa” had similar risk of LREs (adjusted hazard ratio [aHR] 1.3; 95% CI 0.3–6.8), whereas the risk of LREs significantly increased in patients with “FIB4 ≥1.30 then VCTE 8.0-12.0 kPa” (aHR 3.8; 95% CI 1.3–10.9), and even more for those with “FIB4 ≥1.30 then VCTE >12.0 kPa” (aHR 12.4; 95% CI 5.1–30.2)., [Conclusion] VCTE and FIB4 accurately stratify patients with NAFLD based on their risk of LREs. These non-invasive tests are alternatives to liver biopsy for the identification of patients in need of specialized management.
- Published
- 2022