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Roche and InterMune Initiate Phase 2b Clinical Trial of RG7227/ ITMN-191 in Patients With Chronic Hepatitis C
Date:8/19/2009

improved RG7227/ ITMN-191 AUC and plasma concentrations at later times. There were no remarkable safety findings.

The Phase 1 study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of once-daily and twice-daily ritonavir-boosted RG7227/ ITMN-191 regimens administered with PEGASYS and ribavirin for 14 days.

Dr. Duff commented, "Combining RG7227/ ITMN-191 with low dose ritonavir has the potential to deliver additional benefits to patients, including the requirement for less frequent dosing and fewer tablets per day. Data generated from this Phase 1 trial may pave the way for larger studies investigating this treatment combination."

RG7227/ ITMN-191 is also being investigated in combination with the NS5B polymerase inhibitor RG7128 in the INFORM-1 study. This innovative study has recently been expanded to examine regimens in which both RG7227/ ITMN-191 and RG7128 are dosed twice daily in treatment-experienced patients. Results from all cohorts of this study will be presented in an oral presentation in Presidential Plenary Session III on the morning of November 3 at the 2009 AASLD meeting. Additional abstracts regarding pharmacokinetic/pharmacodynamics and resistance have been accepted for poster presentation.

Notes to Editors

* Patients who achieve RVR, defined as undetectable viral levels (less than 15 IU/mL) by the end of week 4, will stop all treatment at week 24 and will be followed post treatment to evaluate whether they achieve SVR. Patients in the treatment arms who do not achieve RVR will continue with PEGASYS and COPEGUS treatment for a total duration of 48 weeks.

** As in Part 1, patients who achieve RVR by the end of week 4 will stop all treatment at week 24 and will be followed post treatment to evaluate whether they achieve SVR. Patients who do not achieve RVR will continue with PEGASYS and COPEGUS
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SOURCE InterMune, Inc.
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