Pol 2012

Methods	Randomised clinical trial
Participants	48 participants Sex: 32 men, 16 women Mean age: 51.3 years Countries: USA and France. Inclusion criteria: chronic HCV genotype 1 infection and were treatment‐naive or had < 4 weeks of exposure to RBV or IFN‐based therapy. Participants needed to have an HCV RNA concentration of ≥ 105 IU/mL and be aged 18‐70 years. Exclusion criteria: cirrhosis, by liver biopsy within 24 months of baseline, clinically significant comorbidities, and HIV or hepatitis B co‐infection.
Interventions	Experimental group: oral 3 mg, 10 mg, 60 mg once daily for 48 weeks. Control group: placebo. Co‐intervention: peg‐IFN α‐2a (180 μg per week) and RBV (1000 mg–1200 mg daily).
Outcomes	HCV RNA, safety assessment, virological response.
Notes	We emailed Pol and colleagues on 27 April 2016 for additional information but reply not received yet.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random allocation sequence
Allocation concealment (selection bias)	Low risk	Interactive voice‐response system
Blinding of participants and personnel (performance bias) All outcomes	High risk	The participants and personnel were only blinded until week 12
Blinding of outcome assessment (detection bias) All outcomes	High risk	The sponsors, who performed the analyses, were only blinded until week 12
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	More than 5% dropped out
Selective reporting (reporting bias)	High risk	The trial changed outcomes from the protocol
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