Lee 2005.

Methods	Randomised clinical trial with two parallel‐group design. Sample size calculation: performed, 70 participants estimated for each group. Intention‐to‐treat analysis: used (14 and five participants discontinued treatment in peginterferon plus ribavirin and interferon plus ribavirin groups).
Participants	Country: Taiwan. Number of participants randomly assigned: 153; 105 men and 48 women. All participants were treatment‐naive. Genotype: one, two, three, four. Inclusion criteria. HCV RNA detectable in serum by PCR assay. Had undergone a liver biopsy within one year before entry that was consistent with chronic hepatitis. Elevated serum ALT defined as two (upper limit of normal) for at least two measurements within six months preceding trial entry. Exclusion criteria. Positive HBsAg. Previous liver transplantation. Neutropenia (fewer than 1500/mm3). Thrombocytopenia (fewer than 100,000/mm3). Anaemia (less than 13 g/dL for men and less than 12 g/dL for women). HIV infection. Decompensated liver disease. Other causes of liver disease. Abnormal serum creatinine or alpha‐fetoprotein level. Abnormal thyroid function test. Preexisting psychiatric disorders. Haemoglobinopathies. Autoimmune‐type disease. Poorly controlled coexisting medical conditions. Unable to use contraception.
Interventions	Participants were randomly assigned to two arms. Group 1: peginterferon alpha‐2b 1.5 µg/kg plus ribavirin 1000 mg to 1200 mg (n = 76). Group 2: interferon alpha‐2b 3 MU plus ribavirin 1000 mg to 1200 mg (n = 77). The dose of ribavirin was based on body weight (1000 mg for weight 75 kg, and 1200 mg for weight greater than 75 kg). Participants were treated for 24 weeks and were followed for another 24 weeks after the end of treatment.
Outcomes	Primary outcomes were biochemical response, virological response, which was defined as the persistent disappearance of serum HCV RNA, and degree of histological improvement. Other outcomes reported are adverse events. Limit for hepatitis C virus RNA detection was 50 IU/mL.
Notes	The trial was supported by research grants from Schering‐Plough Limited, Taiwan. Additional data were obtained through personal communication with the study author.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comments: Sequence generation was performed by a computer programme.
Allocation concealment (selection bias)	Low risk	Comments: Central allocation concealment.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: It is mentioned only that the liver histology was analysed by a single pathologist, who was unaware of the participant's identity, treatment regimen, response or timing of the biopsy relative to treatment.
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	Unclear risk	Comment: The trial was supported by research grants from Schering‐Plough Limited, Taiwan. The study may have conflict of interest bias.