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