Psychoeducation Reaches HCV-Infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment (Permit)

Inclusion Criteria:

• Women and men at the age of 18 to 70 years
• Opiate dependence according to ICD-10
• Stable substitution (i.e. either keeping the last 5 dates or fulfilling criteria for the Take Home assignment)
• Proof of HCV by means of PCR
• Patient must be therapy naive regarding the hepatitis C (no preceding treatment attempts with interferon and/or Ribavirin)
• Ability to comprehend und follow the study protocol

• Compensated liver disease with the following haematological and biochemical minimum criteria:

  1. Leukocytes ≥ 3.000/mm3
  2. Neutrophile granulocytes ≥ 1.500/mm3
  3. Thrombocytes ≥ 90.000/mm3
  4. Direct and indirect bilirubin within the standard range (if not factors, which are not hepatitis-conditioned, as M. Meulengracht, represent an explanation for the increase of the indirect bilirubin; in these cases the indirect bilirubin must be less than 3.0 mg/dl or 51.3 µmol/l)
  5. Albumin within the standard range
  6. Creatinine within the standard range
• TSH (Thyreotropine) within the standard range of the test laboratory
• Normal blood sugar value for non-diabetics or haemoglobin A1c max. 8.5% for diabetics (induced by pharmacotherapy and/or diet controls). An eye examination is required in diabetics.
• Haemoglobin values ≥ 12 mg/dl for women and/or ≥ 13 mg/dl for men
• ANA ≤ 1:160
• In patients with cirrhosis or transition to cirrhosis: exclusion of hepatocellular carcinoma
• Readiness to abstain from alcohol during interferon treatment.
• Negative pregnancy test in female patients within 24 hours before the first dose
• Regular confirmation that sexual active women at the age capable of child-bearing and/or sexual active men use two reliable methods of contraception during interferon / ribavirin treatment and six months thereafter, one contraception method with barrier effect (e.g. condom, diaphragm)
• Female patients may not breastfeed during interferon / ribavirin treatment.

Exclusion Criteria:

• Decompensated liver cirrhosis (Child-Pugh B or C)
• Haemochromatosis
• Lack of Alfa-1-Antitrypsin (homozygote - PIZZ)
• Morbus-Wilson
• positive proof of HBsAg, anti- HIV or anti- HAV IgM antibodies
• Autoimmune diseases (e.g. autoimmune hepatitis, autoimmune thyroid disease, rheumatoid arthritis)
• Kidney failure (Creatinine > 1,5 mg/dl)
• Liver- or kidney-transplantation
• Hyperlipidemia (Cholesterol > 1,5-times above the upper standard value)
• Clinically manifested gout
• Severe heart insufficiency
• Severe coronary heart disease
• Patients with cardiac pacemaker
• Severe chronic pulmonary diseases (e.g. COPD)
• Serious psychological illness, in particular severe depression
• Epilepsy
• Oesophagus varicose in the prehistory
• Patient with high anaemia risk (e.g. Thalassaemia)
• Retinopathy
• Severe other illness
• Patients, who cannot follow the study conditions
• Male partners of pregnant women
• Current desire to have children / no safe contraception under therapy and until including 6 months after study end
• Participation in a clinical study within the last 6 months