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. 2017 Jun 6;2017(6):CD012143. doi: 10.1002/14651858.CD012143.pub2
Methods Randomised clinical trial
Participants 18 participants
Sex: 10 men, 8 women
Mean age: 44 years
Inclusion criteria: participants chronically infected with hepatitis C virus genotype 1, treatment‐naive or treatment non‐responders or treatment intolerant; and not co‐infected with HIV or HBV, HCV‐RNA viral load of ≥ 10*5* IU/mL and had a BMI 18‐35 kg/m²
Exclusion criteria: any significant acute or chronic medical illness which was not stable or not controlled with medication and not consistent with HCV infection and major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
Interventions Experimental group:
  1. daclatasvir 1 mg

  2. daclatasvir 10 mg

  3. daclatasvir 100 mg


Control group: placebo
Outcomes Pharmacokinetics, antiviral activity, safety.
Notes We contacted trial authors for additional information on allocation sequence generation and concealment, how was blinding maintained, whether HIV participants included.
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 double‐blinded but the placebo was not described in detail
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) All outcomes Unclear risk More than 5% of participants dropped out and it was unclear how the trial handled missing data
Selective reporting (reporting bias) Low risk All the outcomes stated in the protocol were reported on NCT00546715
Vested‐interest bias Unclear risk The trial was funded by a company that might have an interest in a given result (Bristol‐Myers Squibb)
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias