Larrey 2013

Methods	Randomised clinical trial
Participants	60 participants Sex: 48 men, 12 women Mean age: 50.2 years Inclusion criteria: treatment‐naive or treatment‐experienced participants without cirrhosis or treatment‐experienced participants with compensated cirrhosis female, aged 18‐70 years, with confirmed chronic HCV genotype 1 infection. Deleobuvir had shown activity against HCV genotype 1a and 1b in vitro; therefore, participants with either subgenotype were eligible. All participants had an HCV RNA level > 100,000 IU/mL at screening. The treatment‐experienced group included previous null responders, partial responders, and relapsers. The presence or absence of cirrhosis was confirmed by liver biopsy or transient elastography (Fibroscan 12.5 kPa). Exclusion criteria: hepatitis B or HIV co‐infection, concurrent liver disease other than HCV, past treatment with any experimental polymerase inhibitor, planned or concurrent use of any other approved or investigational pharmacological therapy, or current drug or alcohol abuse. Participants were also excluded if they had hyperbilirubinaemia, abnormal hematologic or laboratory values at screening, or concurrent disease considered clinically significant by the investigator.
Interventions	Experimental group: rising doses of 100 mg, 200 mg, 400 mg, 800 mg, and 1200 mg every 8 h of deleobuvir (BI 207127). Control group: placebo.
Outcomes	N25B variants, safety assessment, pharmacokinetics.
Notes	We emailed Larrey and colleagues on 26 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	Described as double‐blinded but method was not described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Described as double‐blinded but method was not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not described (it was described that 3 participants dropped out due to AEs)
Selective reporting (reporting bias)	Low risk	All outcomes stated in the protocol were assessed
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