The objective of this study is to investigate if patients with Chronic Hepatitis C virus who were unable to tolerate or did not respond to 12 weeks of PEG-Intron plus Rebetol/Ribavirin therapy can be safely initiated on Pegasys plus Copegus therapy and tolerate and complete a full course (36 to 60 weeks) of treatment.
Eligibility & Criteria
Inclusion Criteria:- Age >= 18 years – Infected with Hepatitis C virus Genotype 1 – Unable to tolerate PEG-Intron plus Rebetol/Ribavirin therapy after 12 weeks of treatment, documented Hepatitis C infection prior to initiation of PEG-Intron plus Rebetol/Ribavirin therapy, and whose physician has decided to initiate treatment with Pegasys plus Copegus due to one or more of the following reasons: depression, fatigue, injection site reaction, flu-like symptoms OR if the patient has no virological response to PEG-Intron plus Rebetol/Ribavirin after 12 weeks of treatment. Exclusion Criteria :- Pregnant, breast-feeding or male partners of those who are pregnant – Chronic Hepatitis C virus other than Genotype 1 – Previously treated with any systemic antiviral therapy or investigational drug (other than PEG-Intron plus Rebetol/Ribavirin) within 24 weeks prior to first dose of study drug. Exception: Patients with a limited (<= 7 day) course of acyclovir for herpes more than 1 month prior to first dose of study drug are not excluded.
Please reference Study ID Number: RLI-ML16965 973-235-5000 or 800-526-6367 (FOR US ONLY) Hoffmann-La Roche