Napoli 2005.

Methods	Randomised clinical trial with two‐group design. Sample size calculation: unclear, not described. Intention‐to‐treat analysis: used.
Participants	Country: Italy. Number of participants randomly assigned: 64; 45 men and 19 women. All participants were treatment‐naive. Inclusion criteria. Positive for HCV RNA by PCR. Serum levels of ALT above the upper limit of normal values for at least six months before treatment. Histopathological confirmation of chronic hepatitis. Exclusion criteria. Decompensated liver cirrhosis. Haematological abnormalities (haemoglobin level less than 12 g/dL in women and less than 13 g/dL in men; neutrophil count fewer than 1.5 × 1000 cells/mL; platelet count fewer than 90 × 1.000 cells/mL). Preexisting severe psychiatric conditions. Severe cardiac disease. Haemoglobinopathies. Haemophilia. Autoimmune diseases. HIV coinfection. Previous liver transplantation. Other causes of liver disease. Women unable or unwilling to practice contraception.
Interventions	Participants were randomly assigned to two arms: Group 1: peginterferon alpha‐2b 1.5 µg/kg plus ribavirin 800 mg to 1200 mg (n = 32). Group 2: non‐pegylated leucocyte interferon alpha 6 MU plus ribavirin 800 mg to 1200 mg (n = 32). Dose of ribavirin depended on pretreatment body weight: 800 mg for weight less than 60 kg; 1000 mg for weight greater than and equal to 60 kg and less than 75 kg; 1200 mg for weight greater than and equal to 75 kg. Duration of treatment was 48 weeks for participants infected with HCV genotype one and 24 weeks for participants infected with genotypes two and three.
Outcomes	Primary outcomes were end of treatment and sustained virological responses, defined as the absence of detectable HCV‐RNA in the serum at the end of treatment and at week 24 of post‐treatment follow‐up. Other outcomes reported are adverse events and dose reductions. Limit for hepatitis C virus RNA detection was 3200 copies/mL.
Notes	The study was supported by grants from Ministero dell Universita e della Ricerca Scientifica e Tecnologica, Rome, Italy. 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	Comments: Blinding is not mentioned.
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 study seems to be free of other sources of bias.