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. 2017 Jun 6;2017(6):CD012143. doi: 10.1002/14651858.CD012143.pub2
Methods Randomised clinical trial
Participants 100 participants
Sex: 65 men, 35 women
Country: USA
Inclusion criteria: compensated cirrhotic adults with chronic HCV genotype 1 infection.
Exclusion criteria: not described.
Interventions Experimenatal group: oral 250 mg of GS‐9669 once daily for 8 weeks or oral 500 mg of GS‐9669 once daily for 8 weeks.
Control group: RBV. Co‐intervention: ledipasvir and sofosbuvir.
Outcomes Adverse events, HCV RNA SVR12
Notes We emailed Lawitz and colleagues on 26 April 2016 for additional information on random, blinding, missing data, protocol, data separate from the groups, participants characteristics, funding, IL28b‐databut 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 Not described
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described
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 several pharmaceutical companies
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias