title: Incidence of hepatocellular carcinoma in HCV-infected patients with normal alanine aminotransferase levels categorized by Japanese treatment guidelines.
abstract: BACKGROUND
  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).
  
  
  METHODS
  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 ≤30 IU/L and platelet (PLT) ≥15 × 10(4)/mm(3); group B (n = 123), ALT ≤30 IU/L and PLT <15 × 10(4)/mm(3); group C (n = 233), 30 < ALT ≤ 40 IU/L and PLT ≥15 × 10(4)/mm(3); and group D (n = 100), 30 < ALT ≤ 40 IU/L and PLT <15 × 10(4)/mm(3). The mean observation period was 36.2 ± 16.5 months
  
  
  RESULTS
  In groups A and C, the HCC incidence was low even in patients with non-response (NR) (cumulative rates at 3 years, 0.0 and 2.9 %, respectively). In groups B and D, 14.5 and 5.3 % of NR patients had developed HCC at 3 years, 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).
  
  
  CONCLUSIONS
  These results suggest that N-ALT patients with PLT <15 × 10(4)/mm(3) could be candidates for early antiviral therapy.
authors.affiliation: Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, 565-0871, Suita, Osaka, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Harada
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiramatsu
authors.forename: Tsugiko
authors.initials: T
authors.lastname: Oze
authors.forename: Ryoko
authors.initials: R
authors.lastname: Yamada
authors.forename: Mika
authors.initials: M
authors.lastname: Kurokawa
authors.forename: Masanori
authors.initials: M
authors.lastname: Miyazaki
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yakushijin
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: 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: Atsuo
authors.initials: A
authors.lastname: Inoue
authors.forename: Norio
authors.initials: N
authors.lastname: Hayashi
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Takehara
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood*; D000998:Antiviral Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D006528:Carcinoma, Hepatocellular / Q000453:epidemiology / Q000821:virology*; D004796:Clinical Enzyme Tests / Q000379:methods / Q000592:standards; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000097:blood / Q000150:complications* / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D007564:Japan / Q000453:epidemiology; D008113:Liver Neoplasms / Q000453:epidemiology / Q000821:virology*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010976:Platelet Count; D011092:Polyethylene Glycols / Q000627:therapeutic use; D017410:Practice Guidelines as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D000410:Alanine Transaminase; C417083:peginterferon alfa-2b