Lawitz 2013e

Methods	Randomised clinical trial
Participants	40 participants Sex: 33 men, 7 women Mean age: 46 years Country: USA Inclusion criteria: participants aged 18–55 years with a BMI 18.5 to 636 kg/m2 and chronic, compensated, genotype1 HCV infection. All participants had a baseline HCV RNA > 106 IU/mL and no evidence of cirrhosis or bridging fibrosis (according to biopsy within 3 years of screening). Participants also had laboratory values within pre‐specified criteria at study entry. Exclusion criteria: participants previously treated with approved HCV therapy or with a DAA for HCV, or with chronic HBV or HIV infection were excluded.
Interventions	Experimental group: received different doses of vaniprevir orally, for 8 days twice daily (25 mg, 75 mg, 250 mg, 500 mg, 700 mg) or 8 days once daily (125 mg, 600 mg). Control group: matching placebo.
Outcomes	Safety, tolerability and efficacy, pharmacokinetics, medication adherence.
Notes	We emailed Lawitz and colleagues on 26 April 2016 for additional information on allocation concealment, blinding of outcome assessors, sample size and protocol for trial 1 and 2 but reply not received yet.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated centralised randomisation
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Matching placebo delivered in equal amounts
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Only on person dropped out
Selective reporting (reporting bias)	Low risk	All outcomes stated in the protocol were assessed
Vested‐interest bias	High risk	This study was funded by Merck Sharp & Dohme Corp
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias