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

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 (p 20 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.