title: Pegylated interferon-α2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 1 receiving hemodialysis: a randomized trial.
abstract: BACKGROUND
  Data are limited on the efficacy and safety of pegylated interferon plus ribavirin for patients with hepatitis C virus genotype 1 (HCV-1) receiving hemodialysis.
  
  
  OBJECTIVE
  To compare the efficacy and safety of combination therapy with pegylated interferon plus low-dose ribavirin and pegylated interferon monotherapy for treatment-naive patients with HCV-1 receiving hemodialysis.
  
  
  METHODS
  Open-label, randomized, controlled trial. (ClinicalTrials.gov: NCT00491244).
  
  
  METHODS
  8 centers in Taiwan.
  
  
  METHODS
  205 treatment-naive patients with HCV-1 receiving hemodialysis.
  
  
  METHODS
  48 weeks of pegylated interferon-α2a, 135 µg weekly, plus ribavirin, 200 mg daily (n = 103), or pegylated interferon-α2a, 135 µg weekly (n = 102).
  
  
  METHODS
  Sustained virologic response rate and adverse event-related withdrawal rate.
  
  
  RESULTS
  Compared with monotherapy, combination therapy had a greater sustained virologic response rate (64% vs. 33%; relative risk, 1.92 [95% CI, 1.41 to 2.62]; P < 0.001). More patients receiving combination therapy had hemoglobin levels less than 8.5 g/dL than those receiving monotherapy (72% vs. 6%; risk difference, 66% [CI, 56% to 76%]; P < 0.001). Patients receiving combination therapy required a higher dosage (mean, 13 946 IU per week [SD, 6449] vs. 5833 IU per week [SD, 1169]; P = 0.006) and longer duration (mean, 29 weeks [SD, 9] vs. 18 weeks [SD, 7]; P = 0.004) of epoetin-β than patients receiving monotherapy. The adverse event-related withdrawal rates were 7% in the combination therapy group and 4% in the monotherapy group (risk difference, 3% [CI, -3% to 9%]).
  
  
  CONCLUSIONS
  Open-label trial; results may not be generalizable to patients on peritoneal dialysis.
  
  
  CONCLUSIONS
  In treatment-naive patients with HCV-1 receiving hemodialysis, combination therapy with pegylated interferon plus low-dose ribavirin achieved a greater sustained virologic response rate than pegylated interferon monotherapy.
  
  
  BACKGROUND
  National Center of Excellence for Clinical Trial and Research.
authors.forename: Chen-Hua
authors.initials: CH
authors.lastname: Liu
authors.forename: Chung-Feng
authors.initials: CF
authors.lastname: Huang
authors.forename: Chun-Jen
authors.initials: CJ
authors.lastname: Liu
authors.forename: Chia-Yen
authors.initials: CY
authors.lastname: Dai
authors.forename: Cheng-Chao
authors.initials: CC
authors.lastname: Liang
authors.forename: Jee-Fu
authors.initials: JF
authors.lastname: Huang
authors.forename: Peir-Haur
authors.initials: PH
authors.lastname: Hung
authors.forename: Hung-Bin
authors.initials: HB
authors.lastname: Tsai
authors.forename: Meng-Kun
authors.initials: MK
authors.lastname: Tsai
authors.forename: Shih-I
authors.initials: SI
authors.lastname: Chen
authors.forename: Jou-Wei
authors.initials: JW
authors.lastname: Lin
authors.forename: Sheng-Shun
authors.initials: SS
authors.lastname: Yang
authors.forename: Tung-Hung
authors.initials: TH
authors.lastname: Su
authors.forename: Hung-Chih
authors.initials: HC
authors.lastname: Yang
authors.forename: Pei-Jer
authors.initials: PJ
authors.lastname: Chen
authors.forename: Ding-Shinn
authors.initials: DS
authors.lastname: Chen
authors.forename: Wan-Long
authors.initials: WL
authors.lastname: Chuang
authors.forename: Ming-Lung
authors.initials: ML
authors.lastname: Yu
authors.forename: Jia-Horng
authors.initials: JH
authors.lastname: Kao
mesh_terms: D000740:Anemia / Q000139:chemically induced; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D006454:Hemoglobins / Q000378:metabolism; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006435:Renal Dialysis; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D006454:Hemoglobins; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a