Racial Difference in HCV/Host Interactions

Exclusion Criteria

• •Hypersensitivity to interferon or ribavirin.
• •Any cause for chronic liver disease other than chronic hepatitis C.
• •Active hemolytic anemia.
• •Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy.
• •Any known preexisting medical condition that could interfere with the patient's participation in the protocol including: (Central Nervous System) CNS trauma or uncontrolled seizure disorders; poorly controlled diabetes mellitus; serious pulmonary disease; immunologically-mediated diseases; gout' or any medical condition requiring, or likely to require during the course of the study, chronic administration of steroids.
• •Patients with evidence of ischemia or stress testing, Electrocardiogram (ECG) evidence of ischemia, a significant arrhythmia, cardiac failure, recent coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months. Pretreatment stress test will be required for all participants greater than 50 years of age or 45 years of age if diabetic.
• •Patients with clinically significant retinal abnormalities.
• •Substance abuse, such as alcohol (greater than 80 gm/day), intravenous (IV) drugs and inhaled drugs. If the patient has a history of substance abuse, to be considered for inclusion into the protocol, the patient must have abstained from using the abused substance for at least 3 months.
• •Patients with a history of organ transplantation will be excluded.
• •Patients infected with human immunodeficiency virus.
• •Preexisting psychiatric conditions; especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, active suicidal ideation and/or suicidal attempt are excluded. Patients with a history of mild depression may enter the protocol if they meet the following eligibility criterion and are monitored more intensively. Mild depression includes either situational depression for a limited period or depressive symptoms, which do not significantly interfere with the patient's work or daily functions. All patients will complete the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report scale designed to measure depressive symptomatology experienced during the week prior to the interview. The items are scored on a four-point scale (0-3), with the total score ranging from zero to 60. CES-D scores of 16-20 suggest minor depression, and scores greater than 20 suggest major depression. The score can be determined in real time. A score of 16 or higher should prompt further questioning and consideration of treatment or referral to psychiatry. Detailed follow-up of each patient may be individualized according to his/her need; this would usually include predetermined visits.