Clinical trial NCT00147784: HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.
Official title: HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a Methadone Maintenance Treated (MMT) Opioid Addicted Group.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opiate Dependence
Hepatitis
Keywords: Chronical Hepatitis C treatment
Methadone Maintenance Treatment
Pegylated Interferon and Ribavirin
14 weeks treatment
Genotype 2 and 3
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2005-09-07
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: - Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment
timeFrame: 24 weeks after end of treatment
Secondary outcomes:
measure: Retention in treatment, compliance, psychological distress, measures of quality of life, perceived drug use control and urine toxicology
timeFrame: 2, 4, 8, 14 and 24 weeks after study start
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Soerlandet Hospital HF
state: Vest-Agder
city: Kristiansand
country: Norway
facility: Addiction Unit, Sorlandet Hospital
state: Vest-Agder
Study officials:
affiliation: Soerlandet Hospital HF
name: Oistein Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Addiction Unit, SSHF
name: Oistein Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kristensen O, Sundoy A, Skeie K, Vederhus JK, Oye I, Opsal A, Rysstad O, Gallefoss F. [Short-term treatment of Hepatitis C in heroin-dependent patients]. Tidsskr Nor Laegeforen. 2009 Aug 27;129(16):1639-42. doi: 10.4045/tidsskr.09.33690. Norwegian.