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

Sorlandet Hospital HF10 enrolled

Overview

* 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

Chronic infection with the hepatitis C virus (HCV) is a health problem worldwide. In Norway, there are about 3000 patients participating in Methadone Maintenance Treatment(MMT) programs. A prevalence study at the MMT treatment unit in Kristiansand, showed that more than 90 % of 177 patients have been infected with hepatitis C. A major problem with anti-HCV treatment for this group is the lack of compliance and retention in treatment. Further, due to the high incidence of psychological disorders in opioid dependent patients, this may also complicate anti-HCV treatment. Drug addicted in MMT treatments programs may find themselves excluded from Hepatitis C treatment. Due to better treatment efficacy with the new PEG-INF's and encouraging reports from 14 weeks studies, it may be easier to motivate opioid dependents to fulfill treatment. Weekly psychological follow-up of these patients will further increase the possibility of opioid dependents in MMT to be able to complete anti-HCV treatment. The aim of this study is to focus on this patients situation, and strengthen their possibility to have a real opportunity to get treatment. We therefore wish to make a pilot study to investigate the feasibility, efficacy and psycological side-effects of the treatment.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opiate Dependence Hepatitis

Interventions

RibavirinDRUG

800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks

Pegylated InterferonDRUG

180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks

Eligibility

Sex: ALLMin age: 25 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (2)

Soerlandet Hospital HF

Kristiansand, Vest-Agder, Norway

Addiction Unit, Sorlandet Hospital

Kristiansand, Vest-Agder, Norway

Outcomes

Primary Outcomes

- Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment

Time frame: 24 weeks after end of treatment

Secondary Outcomes

Retention in treatment, compliance, psychological distress, measures of quality of life, perceived drug use control and urine toxicology

Time frame: 2, 4, 8, 14 and 24 weeks after study start

Data from ClinicalTrials.gov

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