This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731, RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further treatment-naïve patients will receive a successful regimen from Part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Unnamed facility
La Jolla, California, United States
Unnamed facility
Englewood, Colorado, United States
Unnamed facility
South Miami, Florida, United States
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Honolulu, Hawaii, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Kansas City, Kansas, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Saint Louise, Missouri, United States
Unnamed facility
Asheville, North Carolina, United States
...and 21 more locations
Sustained virological response (defined as undetectable serum HCV RNA) 12 weeks after end of treatment
Time frame: approximately 20 months
Safety: Incidence of adverse events
Time frame: approximately 20 months
Antiviral activity: Change in serum HCV RNA levels
Time frame: from baseline to 24 weeks after end of treatment
Pharmacokinetics in coadministration: Area under the concentration-time curve (AUC)
Time frame: Pre-dose Weeks 1, 2, 3, 4, 6, 10, and 12 and up to 12 hours post-dose Weeks 1, and 4 or 3 and 6
HCV drug resistance
Time frame: approximately 20 months
Quality of life: Short-Form 36v2/Brief Fatigue Inventory questionnaires
Time frame: approximately 20 months
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