Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy

Inclusion criteria

• Patients that meet all of the following inclusion criteria are eligible for part I of the study:

• Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
• Written informed consent for part I of the study.
• Patients that meet all of the following inclusion criteria are eligible for part II of the study:

• Fulfilled part I
• Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
• HCV-PCR positive.
• Written informed consent for part II of the study.
• Patients that meet all of the following inclusion criteria are eligible for part III of the study:

• Fulfilled part II
• Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
• HCV-PCR positive.
• Written informed consent for part III of the study and able to adhere to dosing and visiting schedules.
• At least 6 months of uninterrupted maintenance therapy for opiate dependence.
• Treatment indication with at least one of the following:

• Fibrosis/cirrhosis
• Other HCV related disease/symptoms
• Psychological indication
• For patients with cirrhosis, an ultrasound investigation should be performed within six months before study initiation, part III, (not showing signs of HCC).
• Use of adequate contraception during the treatment period and for six months after the completion of therapy (for all participants regardless of gender).

Exclusion criteria

• The presence of any of the following criteria will exclude the patient from participating in part III of the study:

• Pregnant women, women who plan to become pregnant, male patients whose partner wants to become pregnant, and breastfeeding women.
• Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with an interferon or ribavirin product, whether alone or in combination.
• Participation in another clinical drug trial.
• Coinfection with HBV or HIV
• Hemoglobin <120 g/L for females and <130 g/L for males.
• LPK <3,0 x 109/L
• Platelets <80 x 109/L
• Creatinin clearance <50mL/min
• Any of the following diseases considered to be a dominant cause of the patients chronic liver disease:

• Hemochromatosis
• Alpha-1 antitrypsin deficiency
• Wilson's disease
• Autoimmune hepatitis
• Alcoholic liver disease
• Non-alcoholic steatohepatitis (NASH)
• Drug-related liver disease
• Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
• Patients with organ transplants, except for corneal or hair transplant.
• Poorly controlled diabetes mellitus.
• Evidence of severe retinopathy or clinically relevant ophthalmological disorder in patients with diabetes mellitus or hypertension.
• Poorly controlled epilepsy.
• Thyroid dysfunction not adequately controlled
• Decompensated cirrhosis (Child-Pugh B-C).
• Treatment with immunomodulatory drugs (chronic systemic corticosteroids (equivalent to >10 mg prednisone/day), immunosuppressive drugs, chemotherapy) and/or treatment with herbal drugs for chronic hepatitis.
• Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.