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. |
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Interventions |
Experimental group:
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. |
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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 |