Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181) (FAST-4)
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.
Hepatitis C, Chronic
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Rate and Predictors of Relapse in the Treatment of Hepatitis C in Real-life Clinical Practice in Spanish Hospitals (FAST-4)|
- Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) [ Time Frame: From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment ] [ Designated as safety issue: No ]
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
- Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) [ Time Frame: From 24 weeks post-treatment to 72 weeks post-treatment ] [ Designated as safety issue: No ]
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.
|Study Start Date:||April 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
PEG IFN alfa-2b + RBV
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.