Erhardt 2009

Methods	Randomised clinical trial
Participants	96 adult men Sex: 96 men Mean age: 44.6 years Country: Germany, Spain, and France Inclusion criteria: chronic HCV genotype 1 with minimal to mild liver fibrosis (Ishak score or Metavir grade < 2, confirmed by liver biopsy within the past 24 months) and HCV RNA viral load > 100.000 IU/mL at screening. No restriction was on the basis of prior IFN treatment experience. Exclusion criteria: laboratory measurements, HIV, HBV, any other additional cause for chronic liver disease, concurrent disease requiring treatment, any use of co‐medication, treatment with IFN and/or RBV within 6 months prior to screening and use of any investigational drug 30 days prior to screening or 5 periods of drug plasma half life.
Interventions	Trial was divided into 8 cohorts and randomised in these cohorts. Experimental group: oral 10, 20, 40, 60, 80, 100, 150, 200, 300, 450 mg BILB‐1941 three times a day for 4 days, plus a morning dose on 5th day. Control group: placebo.
Outcomes	Antiviral response, pharmacokinetics, safety assessment.
Notes	We emailed Erhardt and colleagues on 20 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 being 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 being 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)	Unclear risk	No protocol could be obtained
Vested‐interest bias	High risk	The trial was funded by Boehringer‐Ingelheim
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias