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Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior Treatment
Date:5/21/2008

of 48 weeks. Patients in any arm of this study with detectable virus at week 24 will be considered treatment failures and will discontinue treatment.

The primary efficacy endpoint of the study is sustained virologic response (SVR).(1) Secondary efficacy endpoints include early virologic response in patients who achieve SVR. The study will be stratified by HCV genotype 1 subtype 1a versus 1b, and baseline viral load.

Professor Jean-Pierre Bronowicki, M.D., Ph.D., department of hepato-gastroenterology, University Hospital of Nancy, France, and Jonathan McCone, M.D., director, Mount Vernon Endoscopy Center, Alexandria, Va., are the other co-principal investigators of this study.

Pivotal Study in Patients Who Failed Prior Treatment

The primary objective of this pivotal study, known as HCV RESPOND-2 (Retreatment with HCV Serine Protease Inhibitor Boceprevir and PEGINTRON/REBETOL) is to evaluate the efficacy of 36- and 48-week regimens of boceprevir (800 mg TID) in combination with PEGINTRON (1.5 mcg/kg/week) and REBETOL (600-1400 mg/day) compared to a control of PEGINTRON and REBETOL alone for 48 weeks in adult patients with chronic HCV genotype 1 who failed prior treatment with peginterferon and ribavirin combination therapy. The study is projected to enroll a total of 375 patients.

This study will enroll treatment-failure patients who have documented previous interferon responsiveness by achieving at least a 2 log decrease in viral load by week 12 of peginterferon and ribavirin therapy (nonresponders) or who were viral negative at end of peginterferon and ribavirin therapy, but did not obtain a sustained virologic response (relapsers). 'Null' responders -- those patients who do not meet the aforementioned criteria -- will not be enrolled in this study.

In this study, in the 36-week treatment arm, RVR criteria at 4 weeks of boceprevir treatment (treatment week 8) will be used to determine which boceprevir patients can stop all
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