Reesink 2006

Methods	Randomised phase I clinical trial
Participants	37 adult participants Sex: 22 men, 12 women (analysed) Mean age: 47 years Countries: Germany, the Netherlands. Inclusion criteria: men or women between the ages of 18 and 65 years, with BMI between 18.5 and 29.0 kg/m2 (men) or 18.5 and 32.5 (women). Entry criteria included an HCV RNA level 1 105 IU/mL as measured using the Roche COBAS TaqMan HCV assay (Roche Molecular Diagnostics, Pleasanton, CA) (confirmed by repeat measure of 2 separate samples taken during the screening period), HCV genotype 1 (any subtype), and an ALT concentration 4 times the ULN. Exclusion criteria: decompensated liver disease, cirrhosis, and positive screening for hepatitis B surface antigen or anti‐HIV 1/2.
Interventions	Experimental group: oral 450 mg or 750 mg of VX‐950 3 times daily, or 1250 mg twice daily for 14 days. Control group: placebo.
Outcomes	Pharmacokinetics, safety assessment, antiviral assessment.
Notes	We emailed Reesink 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)	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 double‐blinded with matching placebo, but it was unclear if the participants and investigators were blinded to results (except HCV RNA)
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The trial was described as double‐blinded with matching placebo, but it was unclear if the participants and investigators were blinded to results (except HCV RNA)
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	More than 5% did not complete the trial (3 participants were not included in the analyses)
Selective reporting (reporting bias)	Unclear risk	No protocol could be obtained
Vested‐interest bias	High risk	The trial was funded by Vertex Pharmaceuticals Incorporated
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias