An open-label, randomized, controlled study of peginterferon alpha-2a/ribavirin plus meloxicam treatment for the patients with genotype 1 chronic hepatitis C (COMET study)

INTERVENTION: PEG‐IFN alfa‐2a 180 microgram weekly plus ribavirin (600‐1000 mg/day) for 48 weeks PEG‐IFN alfa‐2a 180 microgram weekly plus ribavirin (600‐1000 mg/day) for 48 weeks plus meloxicam (10 mg/day) for 8 weeks CONDITION: chronic hepatitis C PRIMARY OUTCOME: rate of patients who require dose reduction SECONDARY OUTCOME: SVR; virological response; change in counts of neutrophil and platelet INCLUSION CRITERIA: (1) genotype 1 (2) TaqMan: 5 logIU/ml or greater (2) neutrophil counts; 1500/microL or greater (3) platelet counts; 90000/microL or greater (4) hemoglobin concentration; 12 g/dl or greater