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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

8- and 48-week lead-in arms (4 and 5 percent, respectively) compared to the no lead-in arms (7 and 11 percent, respectively).

About the HCV SPRINT-1 Study

In this Phase II study, known as HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir (800 mg TID) was evaluated in three treatment regimens: 4 weeks of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) therapy followed by the addition of boceprevir to the combination for 24 or 44 weeks (totaling 28 or 48 weeks of treatment), boceprevir in combination with PEGINTRON and REBETOL at the doses described above for 28 or 48 weeks, and, in Part II of the study, boceprevir in combination with PEGINTRON and low-dose REBETOL (400-1000 mg daily based on patient weight) for 48 weeks, compared to a control of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) alone for 48 weeks (an approved treatment regimen). The primary endpoint of the study is SVR after 24 weeks of follow up (SVR 24). This is an ongoing study and SVR 24 rates are not yet available for patients in the 48-week boceprevir arms or the 48-week control arm of the study. In addition, SVR rates are not yet available and consequently results are not being reported for the boceprevir arm with low-dose REBETOL (n=59) compared to contemporaneous control (n=16) as described above.

Sustained Virologic Response (ITT)*

Treatment Arm All patients

No P/R Lead-in 28 Weeks 55% (59/107)

P/R Lead-in 28 Weeks 56% (58/103)

No P/R Lead-in 48 Weeks 66% (68/103)

P/R Lead-in 48 Weeks 74% (76/103)

P/R Control 48 Weeks 38% (39/104)

P/R Lead-in = PEGINTRON and REBETOL for 4 weeks prior to the addition of boceprevir

P/R Control = PEGINTRON and REBETOL alone f
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SOURCE Schering-Plough Corporation
Copyright©2008 PR Newswire.
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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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