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. 2014 Feb 28;2014(2):CD005441. doi: 10.1002/14651858.CD005441.pub3

Horsmans 2008.

Methods Study design: multi‐centre, controlled randomised trial comparing three groups.
ITT analysis: performed.
Participants Country: Belgium.
Total number (sample size): 258 (initially 336, but 78 had not commenced treatment).
Age, years (STD) : 45, 46, and 45.
Sex (male, number): 63, 62, and 36.
Genotype: one, two, and three.
Previous HCV treatment: naive.
Inclusion criteria: chronic hepatitis C diagnosed by the following.
  • Elevated alanine aminotransferase (ALT) activity.

  • Presence of HCV RNA in serum.


Exclusion criteria.
  • Patients with decompensated liver cirrhosis.

  • Patients with other chronic liver disease (e.g., HBV).

  • Patients coinfected with HIV.

  • Active alcohol abuse and intravenous drug abuse.

  • Patients with contraindication to RBV.

Interventions Group 1 (n = 101).
  • Drug: interferon alpha‐2b (daily) 4 MIU sc for participants > 65 kg or 0.06 MIU/kg ≤ 65 kg.


Group 2 (n = 98).
  • Drug:  peginterferon alpha‐2b 100 µg/wk for participants > 65 kg or 1.5 µg/kg/d for participants ≤ 65 kg.


Group 3 (n = 59).
  • Drug: IFN‐2b.

    • Dosage: 3 MIU three times a week.

  • Ribavirin.

    • Dose: 1000 mg/d for participants weighing less than 75 kg or 1200 mg/d for participants weighing more than 75 kg.

Outcomes End of treatment response; sustained virological response; adverse events.
Notes Inconsistency in the figures across the study report is evident: total number (sample size): 258 (initially 336, but 78 had not commenced treatment).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comments: Method of sequence generation is not mentioned. Randomisation process is not well described.
Allocation concealment (selection bias) Unclear risk Comments: The allocation concealment process is not mentioned.
Blinding (performance bias and detection bias) 
 All outcomes High risk Coments: open‐label trial.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: 78 participants had not commenced treatment; it is not clear whether the trial adhered to the intention‐to‐treat analysis.
Selective reporting (reporting bias) Low risk Comment: All clinically relevant and reasonably expected outcomes were reported.
Other bias Unclear risk All medication was provided by Schering‐Plough.