This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
421
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Danoprevir 50 mg BID
Danoprevir 100 mg BID
Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time frame: 24 weeks after end of treatment
Safety: Incidence of adverse events
Time frame: from baseline up to 72 weeks
Evaluation of relapse rate
Time frame: up to 24 weeks after end of treatment
Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses)
Time frame: from baseline up to 72 weeks
Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time frame: From baseline up to 72 weeks
Evaluation of virological breakthrough (viral load rebound) rate
Time frame: up to 72 weeks
Evaluation of pharmacokinetics (serum concentrations assessed by validated methods)
Time frame: up to 72 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Danoprevir 200 mg BID
Pegasys 180 microgram sc qw
Ritonavir 100 mg
Unnamed facility
La Jolla, California, United States
Unnamed facility
Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Orlando, Florida, United States
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Orlando, Florida, United States
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South Miami, Florida, United States
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Decatur, Georgia, United States
Unnamed facility
Honolulu, Hawaii, United States
...and 58 more locations