Benhamou 2013a1

Methods	Randomised clinical trial
Participants	24 participants Sex: 15 men, 9 women Median age: 45.5 years Country: France Inclusion criteria: chronic G4 HCV infection. HCV‐infected treatment‐naive participants aged 18–65 years and in good health (except for chronic G4 HCV infection) were eligible if they had a plasma HCV RNA load of > 10,000 IU/mL, an absolute neutrophil count of ≥ 1500 neutrophils/mm3, and a platelet count of ≥ 100,000 platelets/mm3. Exclusion criteria: contraindications to IFN (peg‐IFN in particular) or RBV treatment; history or evidence of cirrhosis, end‐stage liver disease, or decompensated liver disease (as shown by screening laboratory results); HIV or HBV co‐infection; history of alcohol or illicit drug use; and pregnancy/current breast‐feeding
Interventions	Experimental group 1: oral 750 mg of telaprevir 3 times daily for 2 weeks Experimental group 2: oral 750 mg of telaprevir 3 times daily for 2 weeks + peg‐IFN α‐2a 180 μg once weekly, and RBV 1000–1200 mg/day (weight‐based) Control group: placebo + peg‐IFN α‐2a 180 μg once weekly, and RBV 1000–1200 mg/day (weight‐based) for 2 weeks Co‐intervention: after the 2 weeks of treatment, all participants received peg‐IFN α‐2a 180 μg once weekly, and RBV 1000–1200 mg/day (weight based) (48 weeks for experimental group 1, and 46 weeks for experimental group 2 and control group)
Outcomes	Efficacy assessment, virology assessment, safety and pharmacokinetic assessment
Notes	NCT00580801
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described adequately (computer‐based)
Allocation concealment (selection bias)	Unclear risk	Not described adequately (computer‐based)
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	The trial was only partially blinded. The participants in the telaprevir group without peg‐IFN and RBV were not blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The trial was only partially blinded. The participants in the telaprevir group without peg‐IFN and RBV were not blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	< 5% dropped out (1 person)
Selective reporting (reporting bias)	Unclear risk	No predefined outcomes were stated in the protocol (NCT00580801)
Vested‐interest bias	High 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