peginterferon dose evaluations for previously untreated subjects with chronic hepatitis c infected with genotype 1 (study p03471)

Conditions: Hepatitis C, Chronic

Summary: the objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis c infected with genotype 1: (1) pegintron 1.5 µg/kg/wk in combination with weight based rebetol (800-1400 mg/day); (2) pegintron 1µg/kg/wk in combination with weight based rebetol (800-1400 mg/day); and (3) pegasys 180 µg/wk plus copegus 1000-1200 mg/day.

pegintron dose will be administered once weekly subcutaneously on the same day of the week: screening 2 weight 40-50 kg volume to inject (ml) 0.22; screening 2 weight 51-60 kg volume to inject (ml) 0.28; screening 2 weight 61-75 kg volume to inject (ml) 0.33; screening 2 weight 76-85 kg volume to inject (ml) 0.41; screening 2 weight 86-104 kg volume to inject (ml) 0.48; screening 2 weight 105-125 kg volume to inject (ml) 0.58 from two vials rebetol dosage (for use with pegintron): screening 2 weight 40-65 kg daily dose 800 mg; screening 2 weight \>65-85 kg daily dose 1000 mg; screening 2 weight \>85-105 kg daily dose 1200 mg; screening 2 weight \>105-125 kg daily dose 1400 mg the pegasys dose of 1 ml (180 µg) will be administered once weekly subcutaneously on the same day of the week copegus dosage (for use with pegasys): screening 2 weight \ or = 75 kg daily dose 1200mg note: double blind for pegintron; open label for rebetol, pegasys and copegus note: rebetol is the schering-plough brand name for ribavirin. copegus is the hoffman-la roche brand name for ribavirin.

Eligibility criteria:
inclusion criteria: * previously untreated adults with chronic hepatitis c (hepatitis c virus ribonucleic acid \[hcv rna\] quantitative polymerase chain reaction \[qpcr\] plasma positive) * individuals with hcv genotype 1 (mixed 1a/1b is acceptable) * compensated liver disease * pretreatment liver biopsy slides available * adults aged 18-70 * individuals weighing 88-275 pounds (40-125 kg) * free from substance abuse for past 2 years * those suffering from diabetes and/or hypertension must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis c treatment is given) * patients and partners of patients willing to use adequate contraception during the course of the study * hematology laboratory results of: * hemoglobin (hgb) ≥ 12 g/dl for females or ≥ 13g/dl for males * white blood cell count (wbc) ≥ 3,000/mm\^3 * neutrophils ≥ 1,500/mm\^3 * platelets ≥ 80,000/mm\^3 * chemistry laboratory results of: * normal thyroid stimulating hormone (tsh), albumin, creatinine, and direct bilirubin * antinuclear antibody (ana) ≤ 1:320 * fasting glucose 70-140 mg/dl note: if glucose levels are between 116-140 mg/dl or an individual has diabetes, glycosylated hemoglobin \[hba1c\] must be ≤ 8.5% exclusion criteria: * previous hepatitis c treatment * pregnant women or partners of pregnant women * patients or partners of patients who intend to become pregnant any time during the 48 weeks * women who are breastfeeding * individuals with liver disease not caused by hepatitis c * individuals infected with the hepatitis b virus and/or human immunodeficiency virus (hiv) * patients with a history of liver cancer (hepatocellular carcinoma) * known blood disorders such as hemoglobinopathy, coagulopathy, or glucose-6-phosphate dehydrogenase \[g6pd\] deficiency * body organ transplant * any known or suspected cancer within the past 5 years * individuals who currently use epoetin \[epo\], granulocyte colony stimulating factor \[g-csf\] and/or granulocyte monocyte colony stimulating factor \[gm-csf\] * those having a history of or active clinical gout * individuals who have chronic pulmonary disease * individuals who have a medical condition that would likely require systemic steroids * those with a history of central nervous system (cns trauma) or seizure disorders * current or previous use of lithium or antipsychotic drugs * individuals who currently have or show signs of moderate to severe depression or history of significant psychiatric disorders * patients with clinically significant electrocardiogram (ecg) abnormalities * individuals with serious heart problems such as those who have had a heart attack, uncontrolled high blood pressure, or other heart problems * patients that weigh \> 231-275 pounds (105-125 kg) and have a body mass index (bmi) \> 30 and have 3 or more of the risk factors below: (a) strong family history of coronary heart disease (chd) which includes 2 or more first-degree relatives with chd or family history of early chd at age \< 55 for male relatives or \< 65 for female relatives (b) individuals with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) diabetes (d) hypertension (e) smoking