A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

Roche

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Pegasys; Drug: Ritonavir; Drug: Copegus; Drug: Danoprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01220947

2010-019584-10

NV22776

Details and patient eligibility

About

This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

Enrollment: 421 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults patients, >/=18 years of age
• Chronic Hepatitis C, Genotype 1 and 4
• HCV RNA >/=50,000 IU/mL
• treatment-naive

Exclusion criteria

• Patients with cirrhosis or incomplete/transition to cirrhosis
• Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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421 participants in 5 patient groups

Group A

Experimental group

Description:

Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks

Treatment:

Drug: Danoprevir

Drug: Copegus

Drug: Ritonavir

Drug: Pegasys

Drug: Danoprevir

Drug: Danoprevir

Group B

Experimental group

Description:

Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks

Treatment:

Drug: Danoprevir

Drug: Copegus

Drug: Ritonavir

Drug: Pegasys

Drug: Danoprevir

Drug: Danoprevir

Group C

Experimental group

Description:

Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks

Treatment:

Drug: Danoprevir

Drug: Copegus

Drug: Ritonavir

Drug: Pegasys

Drug: Danoprevir

Drug: Danoprevir

Group D

Experimental group

Description:

Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks

Treatment:

Drug: Danoprevir

Drug: Copegus

Drug: Ritonavir

Drug: Pegasys

Drug: Danoprevir

Drug: Danoprevir

Group E

Active Comparator group

Description:

Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks

Treatment:

Drug: Copegus

Drug: Pegasys