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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-03-31

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).

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PegIFN-2b/ribavirin with substitution therapy

Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)

Pegylated interferon alfa-2b (PegIFN-2b)

Intervention Type BIOLOGICAL

PegIFN-2b administered according to European labeling.

Ribavirin

Intervention Type DRUG

Ribavirin administered according to European labeling.

PegIFN-2b/ribavirin without substitution therapy

Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine)