Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)

Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C

This is a non-interventional study designed to evaluate the efficacy and safety of combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were enrolled into study.

Participants with positive genotype-1 HCV RNA received 48 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants who were non-genotype-1 HCV RNA positive received 24 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants were asked to complete a questionnaire to measure the satisfaction and the use of training materials of PegIntron pen using a 1-5 score system provided in the questionnaire. The questionnaire was completed once at first follow-up visit. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 of treatment and at week-24 of follow-up in positive Non-genotype-1 HCV RNA participants. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 and at week-48 of treatment, and at week-24 of follow-up, for positive Genotype-1 HCV RNA participants.

Inclusion Criteria:

• Demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Equal to or greater than 18 years.
• Confirmed chronic hepatitis C with hepatitis C virus (HCV) RNA positive in plasma.
• No previous use of PegIntron Pen.

Exclusion Criteria:

• Hypersensitivity to the active substance or to any interferon or to any of the excipients.
• Pregnant women.
• Women who are breastfeeding.
• Existence of or a history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
• A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months.
• Severe debilitating medical condition, including patients with chronic renal failure or creatinine clearance < 50 ml/minute.
• Auto immune hepatitis or a history of autoimmune disease.
• Severe hepatic dysfunction or decompensated cirrhosis of the liver.
• Pre-existing thyroid disease unless it can be controlled with conventional treatment.
• Epilepsy and/or compromised central nervous system (CNS) function.