This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
61
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks
180 mcg sc weekly, 12 weeks
180 mcg sc weekly, 24 weeks
1000-1200 mg orally daily in divided doses, 12 weeks
1000-1200 mg orally daily in divided doses, 24 weeks
Unnamed facility
Busan, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Chiayi County, Taiwan
Unnamed facility
Kaohsiung City, Taiwan
Unnamed facility
Taichung, Taiwan
Unnamed facility
Taipei, Taiwan
Unnamed facility
Taoyuan District, Taiwan
Unnamed facility
Yunlin County, Taiwan
...and 3 more locations
Safety: Incidence of adverse events
Time frame: approximately 1.5 years
Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir
Time frame: up to 14 days
Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System
Time frame: from baseline to Week 36/48
Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study
Time frame: approximately 1.5 years
Incidence of viral resistance to danoprevir
Time frame: approximately 1.5 years
Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4
Time frame: approximately 1.5 years
Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12
Time frame: approximately 1.5 years
Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration
Time frame: approximately 1.5 years
Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration
Time frame: approximately 1.5 years
SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12
Time frame: approximately 1.5 years
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