title: Cancer preventive effect of pegylated interferon α-2b plus ribavirin in a real-life clinical setting in Japan: PERFECT interim analysis.
abstract: OBJECTIVE
  This study was conducted to clarify the incidence of hepatocellular carcinoma (HCC) and the factors contributing to its occurrence by following chronic hepatitis C patients who received pegylated interferon (PEG-IFN) α-2b plus ribavirin (RBV) combination therapy.
  
  
  METHODS
  Patients who received PEG-IFN α-2b and RBV combination therapy with no history of HCC or HCC within 3 months after the start of treatment were observed for the onset of HCC at 67 centers.
  
  
  RESULTS
  Sustained virological response (SVR) was observed in 999 (53.5%) of 1865 patients eligible for analysis. During the observation period (median duration: 4 years and 3 months), HCC developed in 59 patients (3.1%). A significant difference was observed in the 5-year cumulative incidence of HCC between SVR and non-SVR patients (1.1% vs. 7.1%). Factors contributing to HCC selected in multivariate analysis were therapeutic efficacy, sex, age, alanine aminotransferase (ALT) level at 24 weeks after the end of treatment, and platelet count. Non-SVR patients with ALT improvement after the end of treatment had a significantly lower 5-year cumulative incidence of HCC than those without (3.4% vs. 11.0%). HCC developed in 10 patients who achieved SVR, and multivariate analysis indicated that ALT level at 24 weeks after the end of treatment was the only significant factor contributing to HCC.
  
  
  CONCLUSIONS
  Several known risk factors for HCC contributed to HCC in patients who received PEG-IFN α-2b and RBV combination therapy, and ALT abnormality after the end of treatment contributes to the onset of HCC in both non-SVR and SVR patients.
authors.affiliation: Department of Gastroenterology, Juntendo University School of Medicine, Tokyo             First Department of Internal Medicine, Faculty of Medicine, University of Yamanashi, Yamanash             Department of Gastroenterology, Graduate School of Medicine, the University of Tokyo, Tokyo             Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo             Department of Medicine, Teikyo University School of Medicine, Tokyo             Department of Medicine and Gastroenterology, Tokyo Women's Medical University, Tokyo             Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo             Department of Hepatology, Toranomon Hospital, Tokyo             Department of Gastroenterology, Showa University School of Medicine, Tokyo, Japan.
authors.forename: Sumio
authors.initials: S
authors.lastname: Watanabe
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Enomoto
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
authors.forename: Namiki
authors.initials: N
authors.lastname: Izumi
authors.forename: Hajime
authors.initials: H
authors.lastname: Takikawa
authors.forename: Etsuko
authors.initials: E
authors.lastname: Hashimoto
authors.forename: Fuminori
authors.initials: F
authors.lastname: Moriyasu
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kumada
authors.forename: Michio
authors.initials: M
authors.lastname: Imawari