This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
180 mcg sc weekly
1'000/1'200 mg daily orally, 24 - 72 weeks
800 mg daily orally, 16 - 48 weeks
Safety of individualized Copegus treatment in combination with Pegasys: Adverse events
Time frame: up to 96 weeks
Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)
Time frame: up to 96 weeks
Virological response/sustained virological response (serum HCV RNA levels)
Time frame: 24 weeks after treatment completion
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