title: Pegylated interferon α-2b plus ribavirin for Japanese chronic hepatitis C patients with normal alanine aminotransferase.
abstract: OBJECTIVE
  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 48 weeks. 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 (<65 years old) and total cholesterol (≧220 mg/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.
authors: Department of General Internal Medicine, Kyushu University HospitalDepartments of Medicine and Clinical Science             Medicine and Bioregulatory Science             Medicine and Biosystemic Science, Graduate School of Medical Science, Kyushu University             Department of Medicine, Hamanomachi Hospital             The Center for Liver Disease, Shin-Kokura Hospital             Department of Medicine, Fukuoka City Hospital             Department of Gastroenterology, Kyushu Medical Center, National Hospital Organization, Fukuoka             Department of Internal Medicine, Nippon Steel Yawata Memorial Hospital Harunomachi             Center for Liver Disease, National Hospital Organization Kokura Medical Center Harugaoka             Department of Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
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