A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis

Roche

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]; Drug: danoprevir + ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01749150

YV28218

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients of East Asian or Southeast Asian origin, >/= 18 years of age
• Presence of chronic genotype 1 hepatitis C infection
• Treatment-naïve

Exclusion criteria

• History or presence of decompensated liver disease
• Presence or history of non-hepatitis C chronic liver disease
• Positive for hepatitis B or HIV infection

Trial design

61 participants in 2 patient groups

with cirrhosis

Experimental group

Treatment:

Drug: danoprevir + ritonavir

Drug: ribavirin [Copegus]

Drug: ribavirin [Copegus]

Drug: danoprevir + ritonavir

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

without cirrhosis

Experimental group

Treatment:

Drug: danoprevir + ritonavir

Drug: ribavirin [Copegus]

Drug: ribavirin [Copegus]

Drug: danoprevir + ritonavir

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]