CONCERTO‐1 2015

Methods	Randomised phase III clinical trial
Participants	188 participants Inclusion criteria: HCV genotype 1 infection, treatment‐naive male and female participants aged 20–70 years with documented chronic genotype 1 HCV infection and plasma HCV RNA P5.0 log10 IU/mL at screening. Exclusion criteria: liver cirrhosis, hepatic failure, any other liver disease of non‐HCV etiology and co‐infection with HIV‐1, HIV‐2, hepatitis B, or non‐genotype 1 HCV.
Interventions	Experimental group: simeprevir 100 mg once a day plus peg‐IFNa‐2a/RBV for 12 weeks followed by response‐guided therapy with peg‐IFNa‐2a/RBV alone for 12 or 36 weeks. Control group: placebo with peg‐IFNa‐2a/RBV for 12 weeks followed by peg‐IFNa‐2a/RBV for 36 weeks. Peg‐IFNα‐2a (Pegasys®, Chugai, Japan) was administered as a subcutaneous injection (180 μg once weekly) and RBV (Copegus®, Chugai) as oral tablets (600‐1000 mg total daily dose, depending on body weight). Co‐intervention: peg‐IFN (subcutaneously at 180 µg/week) and RBV orally twice daily dosed according to body weight.
Outcomes	HCV RNA, safety assessment, ALT/AST elevations.
Notes	We emailedWe emailed Hayashi and colleagues on 21 April 2016 for additional information but reply not received yet.
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	The trial was described as double‐blinded but it was unclear how the blinding was performed
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The trial was described as double‐blinded but it was unclear how the blinding was performed
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	More than 5% dropped out
Selective reporting (reporting bias)	Low risk	All outcomes stated in the protocol were assessed (NCT01292239)
Vested‐interest bias	High risk	The trial was funded by Bristol‐Myers Squibb
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias