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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

Endnotes:

(1) SVR, the protocol specified primary efficacy endpoint, is defined as

achievement of undetectable HCV-RNA at 24 weeks after the end of

treatment. Per protocol, if a patient does not have a 24-week

post-treatment assessment, the patient's 12-week post-treatment

assessment will be utilized.

(2) Kwo et al., EASL 2008, p. 372; Oral Presentation.

(3) SVR 12 is defined as undetectable HCV-RNA in plasma at 12 weeks after

the end of treatment. The protocol specified primary efficacy

endpoint of the HCV SPRINT-1 study is SVR as defined above.

(4) Intention-To-Treat (ITT) analysis includes any patient who has taken

at least one dose of any study drug.

(5) Roche Cobas Taqman 1.0 assay; lower limit of detection is 15 IU/mL.


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