title: A 24-week course of high-dose interferon-alpha plus ribavirin for Taiwanese chronic hepatitis C patients with persistently normal or near-normal alanine aminotransferase levels.
abstract: OBJECTIVE
  We aimed to evaluate the efficacy, advantage, and safety of a 24-week regimen with high-dose interferon-alpha (INF-alpha; 6 million units thrice weekly) plus ribavirin (1000-1200 mg/day) combination therapy for 46 Taiwanese chronic hepatitis C (CHC) patients with persistently normal or near-normal alanine aminotransferase (PNALT) levels.
  
  
  METHODS
  Ninety-two age- and sex-matched CHC patients with elevated ALT levels (> 2 times the upper limit of normal range) with a ratio of 1:2, treated with the same regimen, served as a control.
  
  
  RESULTS
  The sustained virologic response (SVR) rate was comparable between PNALT (67.4%) and elevated ALT (65.2%) groups (intention-to-treat analysis). The two groups had similar rates of discontinuation and incidence of adverse effects. Viral genotype 1b, baseline viral loads, body mass index, and age were significant factors negatively associated with SVR. Further decline of ALT levels throughout the follow-up period was observed in sustained responders of the PNALT group. None of the eight patients with ALT flares developed icteric hepatitis. The virologic efficacy was sustained in a 3-year extended follow-up period.
  
  
  CONCLUSIONS
  high-dose INF-alpha with ribavirin combination therapy is effective, safe, and well tolerated in CHC patients with PNALT levels. The ALT assay might not be used as a single biochemical marker for determination of treatment consideration.
authors.affiliation: Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
authors.forename: Ming-Lung
authors.initials: ML
authors.lastname: Yu
authors.forename: Chia-Yen
authors.initials: CY
authors.lastname: Dai
authors.forename: Li-Po
authors.initials: LP
authors.lastname: Lee
authors.forename: Nei-Jen
authors.initials: NJ
authors.lastname: Hou
authors.forename: Ming-Yen
authors.initials: MY
authors.lastname: Hsieh
authors.forename: Jee-Fu
authors.initials: JF
authors.lastname: Huang
authors.forename: Zu-Yau
authors.initials: ZY
authors.lastname: Lin
authors.forename: Shinn-Cherng
authors.initials: SC
authors.lastname: Chen
authors.forename: Ming-Yuh
authors.initials: MY
authors.lastname: Hsieh
authors.forename: Liang-Yen
authors.initials: LY
authors.lastname: Wang
authors.forename: Wen-Yu
authors.initials: WY
authors.lastname: Chang
authors.forename: Wan-Long
authors.initials: WL
authors.lastname: Chuang
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood*; D000998:Antiviral Agents / Q000008:administration & dosage*; D016022:Case-Control Studies; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin; D000410:Alanine Transaminase