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 (PEGHOPE)

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01416610

ML25159

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

88 participants in 1 patient group

All Participants

Description:

Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy