Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)
Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)
The objective of this study is to determine the relapse rate in the French patient population
 with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN
 alfa-2b) plus Ribavirin according to standard clinical practice. Treatment was to be
 completed prior to the enrollment in the current study. The study will also aim to identify
 factors that are predictive of relapse. Relapse rate is defined as the percentage of patients
 with negative viral load at end of treatment who again have positive viral load at 6 months
 after the end of treatment.
Non-probability sampling: The study population consists of adult patients over the age of 18
 affected by CHC who were previously treated for the first time with Peg-IFN alfa-2b plus
 ribavirin and achieved end-of-treatment response. Five hundred ninety patients must be
 recruited in order to evaluate the objectives of the study. The patients must meet all
 inclusion criteria and not meet any of the exclusion criteria in order to be included in the
 study.
Inclusion Criteria:

 -  The patient must demonstrate his/her continued willingness to participate in the
 study.

 -  The patient must be at least 18 years of age, of either gender.

 -  Patients with chronic hepatitis C (any genotype) who received Peg-IFN alfa-2b +
 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:

 -  Patients who completed treatment with PegInterferon Alfa-2b plus Ribavirin more than 4
 weeks before study entry.

 -  Patients with positive HCV-RNA at the end of treatment (24 or 48 weeks according to
 the product labeling as appropriate).

 -  Patients treated for a period shorter than the enrollment period.

 -  Patients co-infected with human immunodeficiency virus (HIV).

 -  Patients co-infected with hepatitis B virus (HBV).

 -  Patients who do not use appropriate effective method of birth control after the end of
 treatment (according to legal recommendations).