HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

• To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able to accomplish 14 weeks treatment with Peginterferon alfa-2a (PEG-INF) and ribavirin to the same extent than non-opioid dependents.

• To determine the efficacy of this anti-HCV treatment

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sorlandet Hospital HF
• Treatments: Interferons; Methadone; Ribavirin

Criteria

Inclusion Criteria:

• Serologic evidence of hepatitis C infection, genotype 2 and 3

• Normal or elevated serum ALT activity

• In MMT-programme and with at least 6 months with satisfactory drug abuse control. That means no iv injections and no or minimal use of drugs.

• Male and female patients

Exclusion Criteria:

• Women with ongoing pregnancy or breast feeding

• Untreated serious psychiatric disorders, particularly depression.

• Serious drug abuse or alcohol abuse last 6 months

• Intravenous drug abuse last 6 months

• Hepatitis A, B or HIV infection

• HCV genotype 1, 4, 5 and 6

• Leucocytes < 3000 cells/mm3 at screening (neutrophil count <1500 cells/mm3)

• Platelet count < 80 000 cells/mm3 at screening

• Hb <11 g/dL in women or <12 g/dL in men at screening

• Documented or presumed coronary artery disease or cerebrovascular disease

• Thyroid dysfunction not adequately controlled

• Epilepsy

• Malignant disease