title: Efficacy of pegylated interferon plus ribavirin combination therapy for hepatitis C patients with normal ALT levels: a matched case-control study.
abstract: BACKGROUND
  The antiviral effect of pegylated interferon (Peg-IFN) plus ribavirin combination therapy in chronic hepatitis C (CHC) patients with normal alanine aminotransferase (ALT) levels (N-ALT) has been reported to be equivalent to that for patients with elevated ALT levels (E-ALT). However, the actual antiviral effect in N-ALT patients remains obscure because efficacy can be overestimated in patients with an advantageous background.
  
  
  METHODS
  In this study, 386 patients were extracted, for a matched case-control study, from 1320 CHC patients treated with Peg-IFN alpha-2b plus ribavirin combination therapy; 193 N-ALT patients [116 with hepatitis C virus genotype 1 (HCV-1), 77 with HCV genotype 2 (HCV-2)] were matched with 193 E-ALT patients by a propensity score method using the variables of age, sex, IFN treatment history, body mass index, and platelet counts.
  
  
  RESULTS
  On multivariate analysis for sustained virological response (SVR) in N-ALT patients, younger age, low HCV RNA level at baseline, and HCV-2 were significant factors. The matched case-control study showed that the SVR rates of N-ALT patients were equivalent to those of E-ALT patients; at 49 and 40% in the HCV-1 group (P = 0.146), and 78 and 81% in the HCV-2 group (P = 0.691). However, in N-ALT patients with non-SVR, approximately 40% showed ALT elevation at 24 weeks post-treatment.
  
  
  CONCLUSIONS
  Our findings indicate that the antiviral effect of Peg-IFN plus ribavirin therapy in N-ALT patients is comparable to that for E-ALT patients irrespective of their advantageous background; however, the application of this therapy for N-ALT patients, especially for those with HCV-1, should be considered carefully.
authors.affiliation: Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan. hiramatsu@gh.med.osaka-u.ac.jp
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiramatsu
authors.forename: Yuko
authors.initials: Y
authors.lastname: Inoue
authors.forename: Tsugiko
authors.initials: T
authors.lastname: Oze
authors.forename: Nao
authors.initials: N
authors.lastname: Kurashige
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yakushijin
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Mochizuki
authors.forename: Takuya
authors.initials: T
authors.lastname: Miyagi
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tatsumi
authors.forename: Shinichi
authors.initials: S
authors.lastname: Kiso
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Kanto
authors.forename: Akinori
authors.initials: A
authors.lastname: Kasahara
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Takehara
authors.forename: Masahide
authors.initials: M
authors.lastname: Oshita
authors.forename: Eiji
authors.initials: E
authors.lastname: Mita
authors.forename: Hideki
authors.initials: H
authors.lastname: Hagiwara
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Inui
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Katayama
authors.forename: Shinji
authors.initials: S
authors.lastname: Tamura
authors.forename: Harumasa
authors.initials: H
authors.lastname: Yoshihara
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Imai
authors.forename: Norio
authors.initials: N
authors.lastname: Hayashi
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood* / Q000187:drug effects; D000998:Antiviral Agents / Q000008:administration & dosage*; D016022:Case-Control Studies; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011379:Prognosis; D057216:Propensity Score; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D000410:Alanine Transaminase; C417083:peginterferon alfa-2b