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Summary: Background: The composite histological endpoint comprising nonalcoholic steatohepatitis (NASH) and NAFLD activity score ≥4 and advanced fibrosis (F ≥ 2) (“fibrotic NASH”) is becoming an important diagnostic target in NAFLD: it is currently used to select patients for inclusion in phase III therapeutic trials and will ultimately be used to indicate treatment in clinical practice once the new drugs are approved. Aim: To develop a new blood test specifically dedicated for this new diagnostic target of interest. Methods: Eight Hundred and forty‐six biopsy‐proven NAFLD patients from three centres (Angers, Nice, Antwerp) were randomised into derivation and validation sets. Results: The blood fibrosis tests BARD, NFS and FIB4 had poor accuracy for fibrotic NASH with respective AUROC: 0.566 ± 0.023, 0.654 ± 0.023, 0.732 ± 0.021. In the derivation set, fibrotic NASH was independently predicted by AST, HOMA and CK18; all three were combined in the new blood test MACK‐3 (hoMa, Ast, CK18) for which 90% sensitivity and 95% specificity cut‐offs were calculated. In the validation set, MACK‐3 had a significantly higher AUROC (0.847 ± 0.030, P ≤ 0.002) than blood fibrosis tests. Using liver biopsy in the grey zone between the two cut‐offs (36.0% of the patients), MACK‐3 provided excellent accuracy for the diagnosis of fibrotic NASH with 93.3% well‐classified patients, sensitivity: 90.0%, specificity: 94.2%, positive predictive value: 81.8% and negative predictive value: 97.0%. Conclusion: The new blood test MACK‐3 accurately diagnoses fibrotic NASH. This new test will facilitate patient screening and inclusion in NAFLD therapeutic trials and will enable the identification of patients who will benefit from the treatments once approved. [ABSTRACT FROM AUTHOR]

Recently, concerns were raised of high rates of HCC recurrence in patients treated with direct-acting antivirals ( DAA) for hepatitis C infection. We investigated the HCC occurrence and recurrence rates within 6 months after treatment with DAA with or without pegylated interferon ( PEG- IFN) in real life. This is a retrospective, multicenter cohort trial, executed in 15 hospitals distributed across Belgium. Populations were matched based on fibrosis score (Metavir F3-F4). Patients with a Child-Pugh score ≥ B were excluded. In total, 567 patients were included, of whom 77 were treated with PEG- IFN+ DAA between 2008 and 2013 and 490 with DAA without PEG- IFN between 2013 and 2015. Patients treated with PEG- IFN+ DAA (53±9y) were younger than patients treated with DAA without PEG- IFN (59±12y) ( P=.001). 47% of patients treated with PEG- IFN+ DAA were in the F4 stage vs 67% of patients treated with DAA without PEG- IFN ( P=.001). Screening was inadequate in 20% of both patient groups ( P=.664). The early occurrence rate of HCC was 1.7% and 1.1% in patients treated with DAA with and without PEG- IFN, respectively ( P=.540). The early recurrence rate was 0% in patients treated with PEG- IFN+ DAA and 15.0% in patients treated with DAA without PEG- IFN ( P=.857). There is no difference in early occurrence of new HCC between patients treated with DAA with and without PEG- IFN. We did observe a high early recurrence rate of HCC in patients treated with DAA without PEG- IFN. However, these patients were at baseline more at risk for HCC. Finally, in 20%, screening for HCC was inadequate. [ABSTRACT FROM AUTHOR]