Methods | Randomised clinical trial | |
Participants | 351 participants Countries: France, Germany, Poland, and USA Inclusion criteria: treatment‐naive non‐cirrhotic genotype 1 infected HCV participants Exclusion criteria: not described |
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Interventions |
Experimental group: GS‐9451 (200 mg) once daily (those who achieved an extended very rapid virological response (defined as HCV RNA < LLOQ at Weeks 2 and 4 that remained undetectable through week 8) were randomised to stop treatment at either Week 12 or Week 24) Control group: no intervention Co‐intervention: GS‐5885 (30mg once a day) + peg (180 mg/week) + RBV (1000 mg–1200 mg/day) |
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Outcomes | Adverse events, SVR | |
Notes | We emailed Marcellin and colleagues on 27 April 2016 for additional information 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 | 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 | Safety assessment was not properly described (NCT01356160) |
Vested‐interest bias | Unclear risk | Not described |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias |