Pegylated interferon α-2b plus ribavirin for Japanese chronic hepatitis C patients with normal alanine aminotransferase

Aim: To investigate the efficacy and safety of a pegylated interferon (PEG-IFN) α-2b plus ribavirin (RBV) combination treatment for patients with chronic hepatitis C virus (HCV) infection who have persistently normal alanine aminotransferase (NALT). Methods: This multicenter study included 989 patients with HCV genotype 1 (114 with NALT and 875 with elevated ALT) who received weight-based doses of PEG-IFN α-2b plus RBV for 48weeks. We compared the sustained viral response (SVR) rates of patients with NALT and elevated ALT who received at least 80% or more of the target dosage of PEG-IFN α-2b and 60% or more of the target RBV (minimum acceptable dosage). Results: No significant difference was found in the overall SVR rate between the NALT (42.1%) and elevated ALT groups (37.3%). No significant difference in the SVR rates was found between NALT (63.3%) and elevated ALT group (61.6%) patients who received minimum acceptable dosage. Multivariate analysis showed that age (<65years old) and total cholesterol (≧220mg/dL) were significantly independent positive factors associated with an SVR in the NALT group. Twenty-four weeks after treatment, an ALT increase above the normal range was observed for 34.0% (18 of 53) of the non-responsive group of NALT patients. Conclusions: The efficacy and safety of PEG-IFN α-2b plus RBV combination therapy for patients with chronic HCV infection are similar for patients with NALT and those with elevated ALT levels. These results indicate that patients with NALT should be considered for treatment with PEG-IFN α-2b plus RBV.