Incidence of hepatocellular carcinoma in HCV-infected patients with normal alanine aminotransferase levels categorized by Japanese treatment guidelines

Abstract

This study was conducted to evaluate Japanese treatment guidelines for patients with chronic hepatitis C virus (HCV) infection and normal alanine aminotransferase (N-ALT) levels from the viewpoint of the incidence of hepatocellular carcinoma (HCC). Four groups of patients with chronic HCV infection treated with pegylated interferon (Peg-IFN) plus ribavirin, and classified according to the N-ALT guidelines, were examined for HCC incidence: group A (n=353), ALT ≤30IU/L and platelet (PLT) ≥15×10(4)/mm(3); group B (n=123), ALT ≤30IU/L and PLT <15×10(4)/mm(3); group C (n=233), 30<ALT≤40IU/L and PLT ≥15×10(4)/mm(3); and group D (n=100), 30<ALT≤40IU/L and PLT <15×10(4)/mm(3). The mean observation period was 36.2±16.5months In groups A and C, the HCC incidence was low even in patients with non-response (NR) (cumulative rates at 3years, 0.0 and 2.9%, respectively). In groups B and D, 14.5 and 5.3% of NR patients had developed HCC at 3years, but none of the patients with sustained virologic response (SVR) or relapse had developed HCC. In group B, no patients with mild fibrosis developed HCC irrespective of the antiviral effect of the treatment. Among patients with PLT <15×10(4)/mm(3) (group B plus group D), the HCC incidence was significantly lower in patients with SVR and relapse than in NR patients (p<0.001, p=0.021, respectively). These results suggest that N-ALT patients with PLT <15×10(4)/mm(3) could be candidates for early antiviral therapy.