Development and Validation of a PIVKA-II-Based Model for HCC Risk Stratification in Patients With HCV-Related Cirrhosis Successfully Treated With DAA.

Autor: Caviglia GP; Department of Medical Sciences, Liver Unit, University of Turin, Turin, Italy., Fariselli P; Department of Medical Sciences, Computational Biomedicine, University of Turin, Turin, Italy., D'Ambrosio R; Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Colombatto P; Hepatology Unit and Laboratory of Molecular Genetics and Pathology of Hepatitis Viruses, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, University Hospital of Pisa, Pisa, Italy., Degasperi E; Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Ricco G; Hepatology Unit and Laboratory of Molecular Genetics and Pathology of Hepatitis Viruses, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, University Hospital of Pisa, Pisa, Italy., Abate ML; Department of Medical Sciences, Liver Unit, University of Turin, Turin, Italy., Birolo G; Department of Medical Sciences, Computational Biomedicine, University of Turin, Turin, Italy., Troshina G; Department of Medical Sciences, Liver Unit, University of Turin, Turin, Italy., Damone F; Hepatology Unit and Laboratory of Molecular Genetics and Pathology of Hepatitis Viruses, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, University Hospital of Pisa, Pisa, Italy., Coco B; Hepatology Unit and Laboratory of Molecular Genetics and Pathology of Hepatitis Viruses, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, University Hospital of Pisa, Pisa, Italy., Cavallone D; Hepatology Unit and Laboratory of Molecular Genetics and Pathology of Hepatitis Viruses, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, University Hospital of Pisa, Pisa, Italy., Perbellini R; Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Monico S; Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Saracco GM; Department of Medical Sciences, Liver Unit, University of Turin, Turin, Italy.; Gastroenterology Unit, Città della Salute e della Scienza di Torino-Molinette Hospital, Turin, Italy., Brunetto MR; Hepatology Unit and Laboratory of Molecular Genetics and Pathology of Hepatitis Viruses, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, University Hospital of Pisa, Pisa, Italy.; Institute of Biostructure and Bioimaging, National Research Council, Naples, Italy., Lampertico P; Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.; CRC 'A. M. and A. Migliavacca' Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy., Ciancio A; Department of Medical Sciences, Liver Unit, University of Turin, Turin, Italy.; Gastroenterology Unit, Città della Salute e della Scienza di Torino-Molinette Hospital, Turin, Italy.
Jazyk: angličtina
Zdroj: Alimentary pharmacology & therapeutics [Aliment Pharmacol Ther] 2024 Nov 21. Date of Electronic Publication: 2024 Nov 21.
DOI: 10.1111/apt.18409
Abstrakt: Background and Aims: Patients with hepatitis C virus (HCV)-related cirrhosis with sustained virological response (SVR) to direct-acting antivirals (DAA) remain at risk of developing hepatocellular carcinoma (HCC). Recently, serum protein induced by vitamin K absence or antagonist-II (PIVKA-II) has shown promising results as an HCC-predictive biomarker. We aimed to develop and validate a PIVKA-II-based model for HCC risk stratification in cirrhotic patients with SVR to DAA.
Methods: A total of 1220 consecutive patients (Turin, n = 531; Pisa, n = 335; Milan, n = 354) with HCV-related cirrhosis treated with DAA were included in the study. Patients were retrospectively allocated to the training cohort (Turin+Pisa; median follow-up [FU] 39, 22-55 months; incident HCC: 93 [10.7%]) and validation cohort (Milan; median FU 49.0, 35.0-52.0 months; incident HCC: 19 [5.4%]). Serum PIVKA-II levels were measured using the LumipulseG system (Fujirebio, Japan) at SVR12 (Turin and Pisa cohorts) or the end of treatment (Milan cohort).
Results: Using Cox regression analysis, a model including PIVKA-II combined with age, sex, ALT, AST, γGT, platelet count, albumin and total bilirubin was derived from the training cohort (C-index = 0.72). In the validation cohort, the model showed a C-index of 0.71 with an area under the curve of 0.84 for identifying patients who developed HCC during the first 12 months of FU. When patients were grouped into three risk categories, the cumulative incidence of HCC was 2.7%, 4.0% and 14.3% in the low-, medium- and high-risk groups, respectively (p < 0.001). Notably, no HCC occurred within 3 years of FU in the low-risk group.
Conclusions: Our PIVKA-II-based model showed satisfactory accuracy for HCC risk stratification and may represent a valuable tool for implementing risk-based surveillance protocols in patients with HCV-related cirrhosis with SVR to DAA.
(© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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