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. 2017 Jun 6;2017(6):CD012143. doi: 10.1002/14651858.CD012143.pub2
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.
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.
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