Jacobson 2010

Methods	Randomised clinical trial
Participants	35 adult participants Sex: 18 men, 17 women Mean age: not reported Country: USA and Puerto Rico. Inclusion criteria: 18‐65 years of age treatment‐naive (no prior treatment with IFN‐a +/‐ RBV regimens, discontinued IFN‐a containing regimens after < 2 weeks of therapy due to tolerability issues were considered treatment‐naive, HCV RNA > 100,000 IU/mL at screening, genotype 1, a diagnosis of chronic HCV infection for at least 6 months. Exclusion criteria: evidence of acute or chronic infection with HIV or HBV, exposure within the previous 3 months to an investigational anti‐HCV agent, evidence of severe or decompensated liver disease, participants with liver disease unrelated to HCV infection.
Interventions	Experimental group: oral 200 mg, 300 mg, 500 mg twice daily for 4 weeks. Control group: placebo. Co‐intervention: standard care as per investigator's discretion up to Week 48, then off‐treatment up to Week 72 in open‐label period. Standard of care included peg‐IFN α‐2a 180 μg subcutaneously once weekly starting from day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing ≤ 75 kg; 1200 mg/day orally in 2 divided doses for participants weighing > 75 kg.
Outcomes	Plasma HCV, pharmacokinetics, ALT levels, safety assessment.
Notes	NCT00720434 We emailed Jacobson and colleagues on 21 April 2016 for additional information 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	Open‐label after week 4
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label after week 4
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	More than 5% dropped out (Jacobson 2010, described 2 dropping out)
Selective reporting (reporting bias)	Low risk	All outcomes stated in the protocol were assessed
Vested‐interest bias	High risk	The trial was funded by Pfizer
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias