The combination of PIVKA‐II and AFP improves the detection accuracy for HCC in HBV caucasian cirrhotics on long‐term oral therapy

Abstract

Background & Aims Protein Induced by Vitamin K Absence or Antagonist‐II (PIVKA‐II) has been suggested as a serum biomarker for hepatocellular carcinoma (HCC) in Asian HBV‐treated subjects but no studies tested it in Caucasian cirrhotics long‐term nucleos(t)ide analogs (NUCs)‐treated. We assessed the detection accuracy of PIVKA‐II alone or in combination with alpha‐fetoprotein (AFP) in patients under surveillance. Methods This cross‐sectional, single center case‐control study was conducted in 212 NUC‐treated cirrhotics: 64 HCC and 148 HCC‐free controls for 84 (60‐107) months. PIVKA‐II was determined by a CMIA Immunoassay (Abbott; limit of quantification: 8.2 mAU/mL). Results PIVKA‐II and AFP levels were significantly higher in HCC patients [BCLC‐stage 0/A in 91%, diameter 20 (6‐50) mm] compared to controls: 109 (17‐12,157) vs 31 (13‐82) mAU/mL and 5 (1‐1,163) vs 2 (1‐7) ng/mL (p20 mm or neoplastic thrombosis. Conclusions Combination of PIVKA‐II and AFP increases the detection rate for HCC in NUC‐treated HBV Caucasian cirrhotics, a potential new approach for surveillance.