Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1
Brief 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.


Options:
A: 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
B: Inclusion Criteria:

* Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
* Have been infected with Hepatitis C virus for greater than (\>) 6 months
* Seronegative for hepatitis B surface antigen and human immunodeficiency virus 1 and 2
* Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
* Female subjects must have a negative pregnancy test at all visits before the first dose.

Exclusion Criteria:

* Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
* Any medical contraindications to Peg-IFN-alfa-2a or Ribavirin therapy
* Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis.
* Diagnosed or suspected hepatocellular carcinoma.
* Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before Study start.
* Alcohol/drug abuse or excessive use in the last 12 months.
* Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
C: Inclusion Criteria:

* Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
* Have been infected with hepatitis C virus for greater than (\>) 6 months
* Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2
* Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
* Female subjects must have a negative pregnancy test at all visits before the first dose

Exclusion Criteria:

* Received any approved or investigational drug or drug regimen for the treatment of hepatitis C
* Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy
* Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis
* Diagnosed or suspected hepatocellular carcinoma
* Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
* Alcohol abuse or excessive use in the last 12 months
* Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
D: Inclusion Criteria:

* evidence of CHC;
* evidence of hepatitis C non-genotype 2 or 3;
* compensated liver disease.

Exclusion Criteria:

* infection with HCV genotype 2 or 3;
* history of having received systemic antiviral therapy with activity against CHC \<=3 months prior to start of study;
* hepatitis A, hepatitis B or human immunodeficiency virus (HIV) infection;
* history or evidence of a medical condition associated with chronic liver disease other than CHC.

Answer: A