Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy
|ClinicalTrials.gov Identifier: NCT01045278|
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : October 7, 2013
Hepatitis C is the leading cause of chronic liver disease in industrialized countries, and is the most common indication for liver transplantation. In the Western world, the absolute majority of cases of Hepatitis C Virus (HCV) infection are related to the use of injectable narcotic drugs. Most injecting drug users contract HCV infection within the first years after starting injecting drug use. The aim of this study is to study hepatitis C in a cohort of patients registered in clinics providing maintenance therapy for opiate dependence in three metropolitan areas of Sweden. The cohort is defined as all patients registered in these three clinics at the date of study initiation. The study contains four parts:
Part I: the first part of the study aims to evaluate the prevalence of HCV exposure in the cohort and the proportion of anti-HCV positive participants with chronic infection.
Part II: Patients with chronic HCV infection will be offered further investigation of chronic liver disease, including liver biopsy, for selection of candidates for antiviral therapy and identification of risk factors for development of severe liver disease.
Part III: Based on the results of these investigations, patients will be considered for antiviral therapy. Indications for such therapy will mainly be clinical and/or histological signs of chronic liver disease with fibrosis. All patients will receive weight-based doses of pegylated interferon-alfa-2b and ribavirin.
Part IV: Study of pharmacokinetic interactions between ribavirin and opiate substitution molecule (methadone or buprenorphine) in patients receiving antiviral therapy according to part III.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Pegylated interferon-alfa-2b and ribavirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||277 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
- Drug: Pegylated interferon-alfa-2b and ribavirin
Pegylated interferon-alfa-2b 1.5 microg/kg subcutaneously once weekly plus weight based ribavirin 800-1200 mg PO for a variable period depending on their HCV genotype and response to treatment.
- To determine the completion rates of HCV treatment with pegylated interferon-alfa-2b and ribavirin in patients who are under opiate maintenance treatment and eligible for HCV therapy. [ Time Frame: 14-72 weeks ]
- Prevalence of chronic HCV infection in the patient population eligible for part I in the study. [ Time Frame: Screening visit (first visit of the study). ]
- Clinical and histological characteristics of chronic hepatitis C. [ Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol. ]
- Prevalence of hepatic decompensation and cirrhosis/advanced liver disease. [ Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol. ]
- Risk factors for advanced liver disease. [ Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol. ]
- Proportion of sustained virological responders, defined as a plasma HVC RNA level below Lower Level of Quantification at 24 week post-treatment. [ Time Frame: 24 weeks post-treatment. ]
- Rates of relapse in opiate drug abuse. [ Time Frame: Treatment period (14-72 weeks) and up till 24 weeks post-treatment. ]
- Prevalence of depressive symptoms and assessment of quality of life before, under and after HCV treatment. [ Time Frame: Treatment period (14-72 weeks) and up to 24 weeks post-treatment. ]
- Potential pharmacokinetic interactions between ribavirin and methadone or buprenorphine. [ Time Frame: Measured after 4 weeks treatment. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045278
|Skåne university hospital|
|Study Director:||Anna Jerkeman, MD||Skane University Hospital|