psychoeducation reaches hcv-infected methadone/buprenorphine substituted patients in standard antiviral treatment

Conditions: Intravenous Drug Abuse; Chronic Hepatitis C

Summary: study objective: feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients

primary objective: * retention in antiviral treatment (feasibility) secondary objectives: * mental health mental health is monitored by means of the symptom checklist 90-r (scl-90-r). its sum score, the global severity index (gsi), serves as indicator. mental health will be regarded as stable in case of a change of less than 6 gsi-points, otherwise mental health will be regarded as improved (gsi - 6 points) or decreased (gsi + 6 points). * course of addiction course of addiction under antiviral treatment will be monitored according to retention in substitution treatment, compliance with scheduled visits, and co-consumption of illicit drugs (patients record, urinalysis). * sustained viral response (svr) svr as measured by polymerase chain reaction 6 months after per protocol antiviral treatment (itt-analysis).

Eligibility criteria:
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

Keywords: opiate dependence chronic hepatitis c