AI Article Synopsis

  • * Researchers analyzed data from 1,220 patients with HCV-related cirrhosis, creating a risk model using factors like PIVKA-II levels, age, sex, and liver function markers.
  • * The model demonstrated good accuracy in distinguishing HCC risk, with low, medium, and high-risk groups showing cumulative incidence rates of 2.7%, 4.0%, and 14.3%

Article Abstract

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.

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Source
http://dx.doi.org/10.1111/apt.18409DOI Listing

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