Lawitz 2013c

Methods	Randomised phase IIb clinical trial
Participants	211 participants Sex: 131 men, 80 women Mean age: 49.5 years Countries: Australia, Austria, Belgium, Canada, Chile, Czech Republic, France, Germany, Israel, Korea, Lithuania, New Zealand, Poland, South Korea, Sweden, Taiwan, Thailand, UK, and USA Inclusion criteria: treatment‐experienced non‐cirrhotic adults chronic genotype 1 HCV‐infected participants whose previous treatments with P/R had failed, a minimum of 25% of participants prior null responders, men and women 18–65 years of age, and baseline HCV RNA > 4 x 105 IU/mL. Exclusion criteria: non‐HCV‐related chronic hepatitis, HIV co‐infection, evidence of cirrhosis on liver biopsy or approved non‐invasive imaging, or any other condition contraindicated for treatment with P/R
Interventions	4 different experimental arms Experimental group 1: oral MK‐7009 600 mg twice daily for 24 weeks. Experimental group 2: oral MK‐7009 600 mg twice daily for 24 weeks and 24 weeks of placebo for 24 weeks. Experimental group 3: oral MK‐7009 300 mg twice daily for 48 weeks. Experimental group 4: oral MK‐7009 600 mg twice daily for 48 weeks. Control group: placebo for 48 weeks. Co‐intervention: peg‐IFN 180 μg weekly and RBV 1000–1200 mg/day for 24–48 weeks.
Outcomes	Safety assessment, SVR.
Notes	We emailed Lawitz and colleagues on 26 April 2016 for additional information on randomisation, blinding, dealing with missing data, baseline characteristics for IL28B genotype 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	Unclear risk	The trial was described as being double‐blinded but it was unclear how the blinding was performed
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The trial was described as being double‐blinded but it was unclear how the blinding was performed
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Above 5% dropouts, and it was unclear how the trial handled missing data
Selective reporting (reporting bias)	Low risk	All outcomes in the protocol were reported on. NCT00704405
Vested‐interest bias	High risk	The trial was funded by Merck, Sharp & Dohme Corp
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias