Anderson 2014a1

Methods	Randomised clinical trial
Participants	74 participants were randomised Sex: 58 men, 16 women Mean age: 50.2 Inclusion criteria: treatment‐naive adults 18‐65 years of age with chronic HCV genotype 1 infection for > 6 months before study enrolment, with a BMI > 18 and < 35 kg/m2. Chronic HCV infection was defined as 1 of the following: detectable HCV RNA or reactive HCV antibody > 6 months before enrolment; reactive antibody for HCV before screening and a liver biopsy > 6 months before enrolment demonstrating pathology consistent with HCV infection; and reactive HCV antibody or detectable HCV RNA before screening with an HCV risk factor (e.g. unsafe injection practices, blood transfusion before June 1992, receipt of clotting factor before 1987) that had emerged > 6 months before enrolment. In addition, participants had a liver biopsy result with histology consistent with HCV‐induced liver damage and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV within the 3‐year period before study enrolment and participants had plasma HCV RNA level > 100.000 IU/mL at screening. Exclusion criteria: participants with METAVIR fibrosis score of 3 or 4 on liver biopsy, a positive test result for hepatitis B surface antigen or anti‐HIV antibodies, a history of major depression within the 2 years before enrolment, or unresolved clinically significant diseases other than HCV were excluded from participation.
Interventions	Experimental group: ABT‐450/r 50/100 mg once a day + peg‐IFN/RBV ABT‐450/r 100/100 mg once a day + peg‐IFN/RBV ABT‐450/r 200/100 mg once a day + peg‐IFN/RBV ABT‐072 100 mg once a day + peg‐IFN/RBV ABT‐072 300 mg once a day + peg‐IFN/RBV ABT‐072 600 mg once a day + peg‐IFN/RBV ABT‐333 400 mg twice a day + peg‐IFN/RBV ABT‐333 800 mg twice a day + peg‐IFN/RBV Control group: placebo + peg‐IFN/RBV Co‐intervention: peg‐IFN and RBV Participants were treated with ABT‐450/r, ABT‐333, or ABT‐072 monotherapy for 3 days, followed by 81 days (12 weeks minus 3 days of monotherapy) of ABT‐450/r, ABT‐333, or ABT‐072 combined with pegylated IFN/RBV (peg‐IFN/RBV), followed by 36 weeks of peg‐IFN/RBV alone.
Outcomes	Primary outcomes: maximal change from baseline in HCV RNA levels, maximum plasma concentration (Cmax) of ABT‐450, time to maximum plasma concentration (Tmax) of ABT‐450, area under the plasma concentration‐time curve from 0‐24 h (AUC24) post‐dose of ABT‐450, maximum plasma concentration (Cmax) of ritonavir, time to maximum plasma concentration (Tmax) of ritonavir, area under the plasma concentration‐time curve from 0‐24 h (AUC24) post‐dose of ritonavir, maximum plasma concentration (Cmax) of ABT‐072, time to maximum plasma concentration (Tmax) of ABT‐072, area under the plasma concentration‐time curve from 0‐24 h (AUC24) post‐dose of ABT‐072, maximum plasma concentration (Cmax) of ABT‐333, time to maximum plasma concentration (Tmax) of ABT‐333, area under the plasma concentration‐time curve from 0‐12 h (AUC12) post‐dose of abt‐333. Secondary outcomes: percentage of participants with rapid virologic response (RVR) at week 4, percentage of participants with partial early virologic response (EVR) at week 12, Ppercentage of participants with complete early virologic response (cEVR) at week 12.
Notes	We emailed Anderson and colleagues on 20 April 2016 for unpublished data and additional information regarding allocation concealment, random sequence generation, and blinding of outcome 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	Investigators and participants were blinded to the study drug treatment regimen, but it was not stated how the blinding was maintained.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	More than 5% of participants did not complete the study (19%), according to study protocol
Selective reporting (reporting bias)	Low risk	A protocol was found (NCT01074008)
Vested‐interest bias	High risk	This study was funded by AbbVie
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias