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