Please select the eligibility criteria that correspond to the clinical trial below.
Title: Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)
Brief Summary: The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.

Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.

The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.

The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.


Options:
A: Inclusion Criteria:

* adult patients at least 18 years of age
* CHC infection, genotype 1
* use of 2 forms of contraception during study in both men and women

Exclusion Criteria:

* previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents
* medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
* decompensated liver disease
* women who are pregnant or breastfeeding
B: 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
C: Inclusion Criteria:

* Age at entry at least 18 years.
* Positive for Hepatitis C.
* Previous treatment with any interferon or interferon and ribavirin for at least 3 months.
* Documented non-response to treatment with interferon.
* A liver biopsy demonstrating significant liver scarring.

Exclusion Criteria:

* No other liver disease.
* No unstable major medical diseases or conditions.
* No major complications of cirrhosis.
* No recent abuse of alcohol or illicit drugs.
D: Inclusion Criteria:

1. Adult men and women
2. Age: 25 to 55 years with documented chronic hepatitis
3. Elevated serum alanine aminotransferase at least 2 times the upper limit of normal (40 U/L) on 2 occasions during the preceding 6 months
4. Detectable anti-HCV antibody status assessed by second-generation enzyme-linked immunosorbent assay (Roche Diagnostics, Branchburg, New Jersey); 5. Detectable HCV RNA by polymerase chain reaction (Cobas Amplicor HCV Monitor v2.0 \[Roche Diagnostics, Branchburg, New Jersey\]; lower limit of quantitation \[50 IU/mL\])
5. Infection with HCV genotype 4
6. Histologic evidence of chronic hepatitis C in a liver biopsy specimen obtained within the preceding year.

Exclusion Criteria:

1. Hepatitis A, hepatitis B, autoimmune hepatitis, alcoholic liver disease, drug-induced hepatitis.
2. Decompensated liver disease with a history of variceal hemorrhage, ascites, or hepatic encephalopathy.
3. Patients coinfected with schistosomiasis or human immunodeficiency virus
4. leukocyte count lower than 3000 /mm3, neutropenia (\<1500 cells/mm3), a hemoglobin level lower than 12 g/dL for women and lower than 13 g/dL for men, thrombocytopenia (\<90,000 cells/mm3), creatinine concentration 1.5 times the upper limit of normal
5. Organ transplantation
6. Neoplastic disease
7. Severe cardiac or pulmonary disease
8. Unstable thyroid dysfunction
9. Psychiatric disorder
10. Current pregnancy or breast feeding.
11. Therapy with immunomodulatory agents within the last 6 months

Answer: C