Methods |
Randomised clinical trial |
Participants |
Treatment‐naive and treatment‐ experienced participants (prior treatment with PR for ≥ 12 weeks had failed) with chronic HCV genotype 1 infection. |
Interventions |
All participants initially received PR for 4 weeks. Participants randomised to control treatment then received PR for an additional 44 weeks. Treatment‐naive participants randomised to triple therapy received boceprevir (800 mg 3 times daily) plus PR for 24 weeks and then further therapy according to treatment week 8 HCV RNA levels. Treatment‐experienced participants received boceprevir plus PR for 32 wk and then further therapy according to treatment week 8 HCV RNA levels. |
Outcomes |
SVR defined as undetectable HCV RNA 24 weeks after completing all study therapy. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not described |
Allocation concealment (selection bias) |
Unclear risk |
Not described |
Blinding of participants and personnel (performance bias) All outcomes |
Unclear risk |
Not described |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Not described |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
< 5% missing data |
Selective reporting (reporting bias) |
Unclear risk |
No protocol |
Vested‐interest bias |
High risk |
"Supported by Merck and Co., Inc. Kenilworth, NJ, US."; "Medical writing and editorial assistance were provided by Tim Ibbotson, Ph.D. of ApotheCom, Yardley,PA, United States." |
Other bias |
Unclear risk |
Unclear. |