buprenorphine versus methadone maintenance in hepatitis c patients receiving peg-intron and rebetol (study p04279)(terminated)

Conditions: Hepatitis C, Chronic

Summary: this randomized, single-center, controlled study is designed to evaluate the safety, tolerability, and efficacy of treatment with peg-intron with rebetol in methadone or buprenorphine maintenance patients with hepatitis c.


Eligibility criteria:
inclusion criteria: * male and female patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution. * patients with newly diagnosed chronic hepatitis c. * age 18-65. * hepatitis c virus (hcv)-ribonucleic acid (rna) positive in serum as measured by polymerase chain reaction (pcr) within the last 4 weeks. * genotype 2 or 3. * elevated alanine aminotransferase (alt) levels. * in women of child-bearing age, pregnancy must be excluded prior to entry into the study, and the use of a safe contraceptive device (intrauterine device, oral contraceptive, diaphragm + spermicide, condom + spermicide, tubal ligation) must be documented. * lab parameters: * hemoglobin: \>=12 g/dl (women) or \>=13 g/dl (men) * leukocytes \>=3,000/µl * thrombocytes \>=100,000/µl * prothrombin time (pt)/partial thromboplastin time (ptt)/coagulation within the normal range * albumin: not more than 10% deviation from lower normal value * thyroid-stimulating hormone (tsh) normal * creatinine normal * uric acid normal * antinuclear antibodies \<=1:160 * signed informed consent. exclusion criteria: * refusal by women of child-bearing age or by sexually active patients to use a safe contraceptive. * breast-feeding women. * cirrhosis stage b and c according to child-pugh. * signs of decompensated liver disease (ascites, bleeding varices and spontaneous encephalopathy). * confirmed co-infection with human immunodeficiency virus (hiv) or hepatitis b virus (hbv). * existing psychiatric comorbidity. * alcohol abuse. * active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma). * existing psoriasis or other dermatological disorder (relative exclusion criterion: due to great differences with regard to the severity of the disorder and the individual therapy compatibility, the therapy decision is at the discretion of the physician). * treatment with a study drug within the last 30 days. * any uncontrolled underlying medical conditions (e.g. diabetes). * clinically significant electrocardiogram (ecg) abnormalities and / or significant cardiovascular dysfunction within the last 6 months (angina, heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia) is an exclusion criterion. in case of other suspected heart disease, a cardiologic examination is required prior to inclusion of the patient. * any liver disorder of other genesis than the study indication (with regard to elevated iron levels, only patients with manifest hemochromatosis are excluded). * autoimmune disorder (except lkm-positive patients: these patients may be included in the study). * misuse of buprenorphine or methadone.

Keywords: buprenorphine methadone peg-intron rebetol