Foster 2011a1

Methods	Multicenter randomised clinical trial
Participants	52 participants Sex: 35 men, 17 women Mean age: 44 years Countries: France, UK, Italy, and Sweden Inclusion criteria: 18–65 years; chronic infection with either genotype 2 or genotype 3 HCV (serum HCV RNA > 10,000 IU/mL); absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3; no prior treatment for HCV Exclusion criteria: relevant concomitant medical condition; decompensated liver disease or cirrhosis, or other significant liver disease; HIV or HBV co‐infection; peg‐IFN or RBV contraindication; a history of alcohol or illicit drug use; pregnancy/breast feeding
Interventions	The participants were randomised according to genotype 2 and 3 Experimental group 1: oral 750 mg telaprevir every 8th hour for 2 weeks Experimental group 2: oral 750 mg telaprevir every 8th hour + peg‐IFN‐α‐2a 180 µg once weekly plus RBV 400 mg twice daily for 2 weeks Control group: telaprevir placebo (every 8 h) plus peg‐IFN‐α‐2a 180 µg once weekly plus RBV 400 mg twice daily for 2 weeks Co‐intervention: The peg‐IFN‐α‐2a and RBV were a co‐intervention between control group and experimental group 2 during treatment period, and all participants received peg‐IFN‐α‐2a 180 g once weekly plus RBV 400 mg twice daily for 24 weeks after treatment.
Outcomes	Viral kinetics, efficacy and safety assessment
Notes	We emailed Foster and colleagues on 21 April 2016 for additional information (randomisation, blinding, death, missing data) but reply not received yet.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described (central randomisation system)
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	The monotherapy group was not blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	More than 5% percent dropped out (7 participants)
Selective reporting (reporting bias)	Low risk	All outcomes stated in the protocol were assessed
Vested‐interest bias	Unclear risk	The trial was funded by Janssen Pharmaceuticals and Vertex Pharmaceuticals)
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias