Methods | Randomised clinical trial | |
Participants | 252 participants Sex: 151 men, 101 women Countries: USA and Europe. Inclusion criteria: non cirrhotic treatment‐naive adult participants with chronic hepatitis C genotype 1. Exclusion criteria: not described. |
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Interventions |
Experimental group 1: oral tegobuvir 40 mg twice daily for 48 weeks. Experimental group 2: oral tegobuvir 40 mg response‐guided for 24‐48 weeks. Control group: placebo. Co‐intervention: peg/RBV. |
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Outcomes | Safety assessment, pharmacokinetics, HCV RNA. | |
Notes | We emailed Lawitz and colleagues on 26 April 2016 for additional information on randomisation, blinding, missing data, protocol, complete trial, data, funding 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 placebo‐controlled, but it was not described how blinding was performed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Described as placebo‐controlled, but it was not described how blinding was performed |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | More than 5% percent dropped out |
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 |