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. 2017 Jun 6;2017(6):CD012143. doi: 10.1002/14651858.CD012143.pub2
Methods Randomised clinical trial
Participants 244 participants
Mean age: 50 years
Inclusion criteria: treatment‐naive or prior non‐responders.
Exclusion criteria: women who were pregnant or breastfeeding, ALT >/ or = 5 x the ULN, AST >/ or = 5 x the ULN.
Interventions Experimental group:
  1. HCV 796 capsules, 500 mg, every 12 h. daily, 48 weeks (treatment‐naive).

  2. HCV 796 capsules, 500 mg, every 12 h daily, 48 weeks (non‐responders).


Control group: placebo.
Co‐intervention: Peg‐Intron subcutaneous injection, weight‐based dosing, weekly and Rebetol capsules, weight‐based dosing, every 12 h daily for 48 weeks.
Outcomes Primary outcome complete early virologic response. Secondary outcome rapid virological response.
Notes We contacted trial authors for addition information on whether HIV participants included, allocation sequence generation and concealment, how was blinding maintained, who was blinded, maximum follow‐up, how many participants dropped out, how was missing data handled, SAE, death, SVR24 but reply not received.
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 The trial is 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 The number of dropouts was not described
Selective reporting (reporting bias) Unclear risk The outcome called upon in the protocol was reported (NCT00367887)
Vested‐interest bias High risk The trial was funded by a company that might have an interest in a given result (PfizerViroPharma)
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias