Protocol Number: 02-DK-0065
Patients 18 years of age and older with hepatitis C, genotype 1, with or without kidney disease may be eligible for this study. Candidates will be screened with a medical history and physical evaluation, blood tests, symptom questionnaires, 24-hour urine collection, chest X-ray, electrocardiogram, and liver ultrasound. A liver biopsy (removal of a small piece of liver tissue) will be done in patients who have not had one within the last year. Additional procedures, such as eye examination, treadmill stress test, hearing test, or others may be required depending on the individual's medical condition. Patients without kidney disease will be randomly assigned to one of two treatment groups: Group A will take both peginterferon (by injection under the skin once a week) and ribavirin (capsules by mouth) from the start of therapy; Group B will start treatment with peginterferon alone and add ribavirin after 4 weeks. Patients with kidney disease (Group C) will start with peginterferon alone and add ribavirin 4 weeks later. All patients will be admitted to the NIH Clinical Center for a few days when treatment starts in order to draw blood at precise intervals (6, 12, 24, 48, and 72 hours after the first peginterferon injection) for measurements of viral levels. Blood will then be drawn once a week for 4 weeks (just before each injection) to determine how rapidly viral levels decrease with treatment and to measure blood levels of interferon and ribavirin. After 4 weeks of therapy, patients will have a blood test and check of symptoms and side effects every 4 weeks for 24 weeks (every 2 weeks for Group C patients until the optimum ribavirin dose is found) and then every 8 weeks for the remainder of the study. They will have a physical examination and urine test every 12 weeks. Patients will be tested for hepatitis virus RNA after 24 weeks of therapy to determine if they are a responder or non-responder. Responders will be advised to continue therapy for a full 48 weeks to ensure a continued response when treatment stops. Non-responders-whose chances for a lasting response are estimated at only 2%-will be offered the option to continue treatment, to stop treatment and continue being followed without treatment, or to enroll in other studies of non-responders. At the end of the 72-week treatment and follow-up, patients will have the same blood and urine tests as were done at the beginning of the study and a repeat liver ultrasound.
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