N/A
Completed N=88
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
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01416610 ↗
Enrolled (actual)
88
Serious AEs
16.3%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) — 83.0 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) |
83.0 | — |
| SECONDARY Percentage of Participants With SVR 12 |
81.8 | — |
| SECONDARY Percentage of Participants With End of Treatment Response |
87.5 | — |
| SECONDARY Percentage of Participants With Virological Relapse |
10.6 | — |
| SECONDARY Short Form Health Survey (SF-36) Scores by Visit |
77.9; 63.5; 62.7; 76.1; 60.6; 32.4 | — |
| SECONDARY Fatigue Severity Scale (FSS) Score by Visit |
4.0; 5.0; 5.0; 3.8 | — |
| SECONDARY Beschwerdeliste (BL) Score by Visit |
3.1; 2.8; 2.7; 3.1 | — |
| SECONDARY Beck Depression Inventory (BDI) Score by Visit |
13.7; 18.4; 16.9; 11.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01416610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.