Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

Study Overview
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Brief Summary
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Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).

Official Title
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Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Biological: Pegylated interferon alfa-2b (PegIFN-2b)
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with hepatitis C Exclusion Criteria: According to the products' European labeling

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 |
| --- | --- |
| PegIFN-2b/ribavirin with substitution therapy<br>Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) | Biological: Pegylated interferon alfa-2b (PegIFN-2b)<br>* PegIFN-2b administered according to European labeling.<br>* Other names: SCH 54031;Drug: Ribavirin<br>* Ribavirin administered according to European labeling.<br>* Other names: SCH 18908;|
| PegIFN-2b/ribavirin without substitution therapy<br>Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) | Biological: Pegylated interferon alfa-2b (PegIFN-2b)<br>* PegIFN-2b administered according to European labeling.<br>* Other names: SCH 54031;Drug: Ribavirin<br>* Ribavirin administered according to European labeling.<br>* Other names: SCH 18908;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin | For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. | 24 to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Sustained Virologic Response (SVR) | SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. | 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype) | 
| Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy | This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy. | Day 1 |