Methods | Randomised clinical trial | |
Participants | 60 adult participants Sex: not described Mean age: not described Inclusion criteria: chronic hepatitis C and with a psychiatric disorder (n = 60, schizophrenia 20/60 (33.3%)), major depression 15/60 (25%), bipolar disorder 20/60 (33.3%), and prior suicidal attempts with depression 5/60 (8.3%). Exclusion criteria: Renal failure with CrCl < 30, sickle cell, thalassaemic syndromes, haemolytic syndrome, co‐infections (HBV, HIV), or CHF NYHA Stage IV. |
|
Interventions |
Experimental group: Group 1: simeprevir 150 mg and RBV 1000 mg daily Group 3: simeprevir 150 mg and vitamin D 5000 mg daily. Control group: placebo and RBV 1000 mg daily Co‐intervention: Sofosbuvir 400 mg |
|
Outcomes | Antiviral effect | |
Notes | Email was sent to Basu and colleagues on 06 June 2016 for additional information on allocation sequence generation and concealment, blinding, incomplete outcome data, protocol, full publication, study sponsor, death, SAE, SVR 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 | High risk | The trial is described as open‐label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The trial is described as open‐label |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is unclear how many participants dropped out |
Selective reporting (reporting bias) | Unclear risk | No protocol could be found |
Vested‐interest bias | Unclear risk | It was unclear how the trial was funded |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias |