An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy

Study Overview
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Brief Summary
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This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.

Official Title
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A Prospective, Observational, Multicenter Non-interventional Trial Examining Efficacy of Combination Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD) Plus COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing an Opioid Maintenance-Therapy With Special Focus on Patient Compliance and Quality of Life

Conditions
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Hepatitis C, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants, >/= 18 years of age Participants undergoing an opioid maintenance therapy Serologic evidence of CHC prior to therapy CHC genotype 2, 3, 1 or 4 Quantifiable serum hepatitis C (HCV) ribonucleic acid (RNA) All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment Exclusion Criteria: Harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator Pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study Co-infection with hepatitis A, hepatitis B or Human Immunodeficiency Virus (HIV) Current diagnosis of a major depression or any psychotic disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) | SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total). | 24 weeks after completing treatment, within 3 years, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With SVR 12 | SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total). | 12 weeks after completing treatment, within 3 years, 6 months | 
| Percentage of Participants With End of Treatment Response | A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total). | at end of treatment, within 3 years, 6 months | 
| Percentage of Participants With Virological Relapse | Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total). | by end of follow-up, within 3 years, 6 months | 
| Short Form Health Survey (SF-36) Scores by Visit | The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit. | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months | 
| Fatigue Severity Scale (FSS) Score by Visit | The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit. | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months | 
| Beschwerdeliste (BL) Score by Visit | The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit. | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months | 
| Beck Depression Inventory (BDI) Score by Visit | The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit. | at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months |