Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)

Study Overview
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Brief Summary
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This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.

Official Title
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Rate and Predictors of Relapse in the Treatment of Hepatitis C in Real-life Clinical Practice in Spanish Hospitals (FAST-4)

Conditions
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Hepatitis C, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with chronic hepatitis C virus (HCV)[any genotype] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis C. Negative HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible. Exclusion Criteria: Women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. Appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner. Completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry. Positive HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate). Participants treated for a period shorter than the enrollment period. Co-infection with Human Immumodeficiency Virus (HIV). Co-infected with Hepatitis B Virus (HBV).

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 |
| --- | --- |
| PEG IFN alfa-2b + RBV<br>Adult participants with chronic hepatitis C who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment during this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) | Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid | From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) | Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72. SVR was defined as negative for HCV RNA at Week 24 of follow-up. | From 24 weeks post-treatment to 72 weeks post-treatment |