A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
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.
Inclusion Criteria:

 -  Adult patients, 18 to 65 years of age inclusive

 -  Chronic hepatitis C, genotype 1 or 4

 -  Cohort 1: Treatment-naïve for hepatitis C

 -  Cohort 2: Prior null responder to treatment with approved doses of pegylated
 interferon plus ribavirin

 -  Liver biopsy confirming cirrhosis

 -  Compensated cirrhosis (Child-Pugh A)

 Exclusion Criteria:

 -  Pregnant or lactating women or male partners of women who are pregnant

 -  History or presence of decompensated liver disease (ascites, hepatic encephalopathy,
 hepatocellular carcinoma, or bleeding esophageal varices)

 -  Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin
 treatment due to reasons other than null response

 -  History of clinically significant cardiovascular or cerebrovascular disease