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Boceprevir Phase II Study Showed High Rate of Sustained Response With 28- and 48-Week Regimens in Genotype 1 Treatment-Naive Hepatitis C Patients
Date:11/1/2008

or 48 weeks

* SVR 12 for 48 week arms; SVR 24 for 28 week arms(2-4)

In the study, predictability of attaining SVR (12 or 24) based on rapid virologic response (RVR) following 28 or 48 weeks of the boceprevir regimen was greater for patients in the lead-in arms (82 and 92 percent respectively) compared to the no lead-in arms (74 and 82 percent, respectively).

The HCV SPRINT-1 study was conducted at sites across the United States, Canada and Europe. Overall, 77 percent of the 595 patients in the study were enrolled in the United States. African-Americans represent 16 percent of the patients enrolled and 7 percent of patients in the study are cirrhotic.

Update on Boceprevir Phase III Studies

Schering-Plough is conducting two large ongoing pivotal Phase III studies of boceprevir in patients chronically infected with HCV genotype 1. One study is in treatment-naive patients and the other in patients who failed prior treatment (relapsers and nonresponders). The two randomized, double-blind, placebo-controlled studies evaluate the efficacy of boceprevir in combination with PEGINTRON and REBETOL compared to standard of care with PEGINTRON and REBETOL alone.

The study in treatment-naive patients is known as HCV SPRINT-2 and the study in patients who failed prior treatment is known as HCV RESPOND-2. The two studies are expected to enroll a total of more than 1,400 patients at U.S. and international sites.

For more information about these ongoing Phase III studies, please visit http://www.clinicaltrials.gov, search term boceprevir.

About Hepatitis C

Hepatitis C is a serious and potentially life-threatening disease. It is the most common blood-borne infection in America and Europe, and the most common form of liver disease, affecting nearly 5 million people in the United States, 5 million in Europe and some 200 million people worldwide. It is the leading cau
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SOURCE Schering-Plough Corporation
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1. Initial Results of Phase II Study with HCV Protease Inhibitor Boceprevir in Treatment-Naive Hepatitis C Patients Show a High Rate of Early Virologic Response
2. Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting
3. Interim Results from Boceprevir Phase II Study in Genotype 1 Treatment-Naive Hepatitis C Patients Presented At EASL
4. Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Hepatitis C Data Presentations at Digestive Disease Week (DDW) Annual Meeting
5. Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior Treatment
6. Top-Line Results of Boceprevir Phase II Study Showed High Rate of Sustained Response (SVR) in Genotype 1 Treatment-Naive Hepatitis C Patients
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