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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Biological: Pegylated interferon alfa-2b (PegIFN-2b)

Study type: Observational

Funder types: Industry

Identifiers

NCT00725751

P05255

Details and patient eligibility

About

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).

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with hepatitis C

Exclusion criteria

• According to the products' European labeling

Trial design

353 participants in 2 patient groups

PegIFN-2b/ribavirin with substitution therapy

Description:

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

Treatment:

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

Drug: Ribavirin

PegIFN-2b/ribavirin without substitution therapy

Description:

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

Treatment:

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

Drug: Ribavirin