Sjögren 2007.

Methods	Randomised clinical trial with two parallel‐group design. Intention‐to‐treat analysis: used.
Participants	Country: USA. Number of participants randomly assigned: 59. All participants are treatment‐naive. All participants are infected with HCV genotype one. Inclusion criteria: HCV RNA positive patients with liver biopsy compatible with chronic HCV infection Exclusion criteria: minimum haemoglobin 12g/L for women and 13g/L for men, WBC < 3x103/mm3, Neutrophil count < 1,5x103/mm3, platelet count < 75x103/mm3, prothrombin time > 2 sec above the upper limit of normal, severe psychiatric conditions, other causes of liver disease than HCV infection
Interventions	Participants are randomly assigned to two groups. Group 1: peginterferon 1.5 µg/kg and ribavirin 1000 mg or 1200 mg (n = 29). Group 2: non‐pegylated consensus interferon 15 µg and ribavirin 1000 mg or 1200 mg (n = 30). Treatment is planned for 48 weeks if serum HCV RNA is undetectable at week 24; otherwise, drugs are to be discontinued.
Outcomes	Primary outcome is sustained virological response, which will be determined at week 72. Other outcomes reported include end of treatment virological response and adverse events.
Notes	An ongoing study with interim results. No new publications regarding this data. Study author contacted for additional information, but no reply obtained.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomised using a computerized system".
Allocation concealment (selection bias)	Low risk	Comments: central allocation concealment.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Quote: "HCV RNA and HCV genotype were tested at a central laboratory". However, it is not clear whether adverse event outcome assessors were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comments: Incomplete outcome data were addressed adequately.
Selective reporting (reporting bias)	Low risk	Comment: All clinically relevant and reasonably expected outcomes were reported.
Other bias	Low risk	Comment: The trial seems to be free of other sources of bias.