Diagnostic Accuracy of PIVKA-II, Alpha-Fetoprotein and a Combination of both in Diagnosis of Hepatocellular Carcinoma in Patients Affected by Chronic HCV Infection.

Background/aim: Patients affected by liver cirrhosis are at high risk for developing hepatocellular carcinoma (HCC). The aim of this study was to evaluate the feasibility of PIVKA-II (protein induced by vitamin K absence or antagonist-II) alone or in combination with α-1 fetoprotein (AFP), as a screening marker for development of HCC.

Materials And Methods: A case-control study was conducted in 2 hospital wards in Naples. All anti-HCV-positive patients affected by HCC were considered as cases, while consecutive anti-HCV-positive patients without HCC were considered as controls.

Results: Overall, 160 patients were enrolled, 56 cases and 104 controls. At the set cut-off of 36 mAU/ml, PIVKA-II was more sensitive (78.6% vs. 60%), but less specific than AFP at the set cut-off of 12 ng/ml (66.3% vs. 77.2%). The negative predictive value of PIVKA in combination with AFP was 93.2%.

Conclusion: PIVKA II, when combined with AFP, may be considered as a screening test for HCC due to its high negative predictive value.