This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
1000 mg orally bid, 24 weeks
100 mg orally bid, 24 weeks
180 mcg weekly, 24 weeks
1000-1200 mg/kg/day orally in two divided doses, 24 weeks
100 mg orally bid, 24 weeks
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Coronado, California, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
DeLand, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Atlanta, Georgia, United States
...and 17 more locations
Safety: Incidence of adverse events
Time frame: 48 weeks
Pharmacokinetics (PK): Area under the concentration-time curve (AUC)
Time frame: Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24
Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test
Time frame: 48 weeks
Emergence of viral resistance: HCV RNA gene sequence variations
Time frame: From baseline to Week 48
Virologic response: HCV RNA levels
Time frame: approximately 1 year
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