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. 2017 Jun 6;2017(6):CD012143. doi: 10.1002/14651858.CD012143.pub2
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.