This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
59
oral doses
180 mcg sc once weekly
oral doses
1000-1200mg/day po
oral doses
Unnamed facility
Montpellier, France
Unnamed facility
Christchurch, New Zealand
Unnamed facility
Grafton, New Zealand
Unnamed facility
Warsaw, Poland
Safety and tolerability: Adverse events, ECG, laboratory parameters
Time frame: approximately 3 years
Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2
Time frame: Days 3-9
Antiviral activity: HCV RNA (COBAS Taqman HCV Test)
Time frame: from baseline to Day 28
Viral resistance development
Time frame: from baseline to Day 17
Effects on cytochrome P450(CYP)2C9 and 3A isozymes
Time frame: from baseline to Day 17
Virological response in prior null-responders
Time frame: from baseline to week 72
Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment
Time frame: approximately 3 years
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