Methods | Randomised clinical trial | |
Participants | 54 participants Country: USA Inclusion criteria: Adult treatment‐naive participants in genotype 1 HCV participants. |
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Interventions |
Experimental group: oral 25 mg, 75 mg, or 200 mg of GS‐9256 twice daily, or 300 mg of GS‐9256 once daily for 3 days. Control group: placebo. |
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Outcomes | Safesty assessment, HCV RNA level, pharmacokinetics. | |
Notes | We emailed Lawitz and colleagues on 26 April 2016 for additional information on random, blinding, missing data, protocol, data, participants characteristics, funding, number of participants in placebo/exp group 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 it was not described how blinding was performed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Described as double‐blinded, but it was not described how blinding was performed |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not described |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained |
Vested‐interest bias | High risk | Several authors worked for Gilead Sciences |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias |