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. |
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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. |
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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 |