Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis ... (o a contemporaneous control of PEGINTRON...)

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Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

Date:4/23/2009

o a contemporaneous control of PEGINTRON, full-dose REBETOL and boceprevir for 48 weeks. The primary endpoint of the study was SVR after 24 weeks of follow up. In the study, the 28-week and 48-week boceprevir no lead-in arms had SVR rates of 54 percent (n=58/107) and 67 percent (n=69/103), 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 represented 16 percent of the patients enrolled and 7 percent of the patients in the study were cirrhotic.

Rationale for Lead-In Regimen

The use of the P/R lead-in prior to the addition of boceprevir was shown in the HCV SPRINT-1 study to reduce the incidence of viral breakthrough regardless of treatment duration. The rationale for the lead-in treatment regimen is based on the fact that both PEGINTRON and REBETOL reach steady-state concentrations by week 4, therefore patients have the protease inhibitor added at a time when the backbone drug levels have been optimized and viral load (HCV RNA) has been reduced. In addition, the patient's immune system will have been activated and primed by PEGINTRON at the time that boceprevir is added to the regimen. This approach may minimize the period of time when there is a "functional monotherapy" with a direct antiviral agent, potentially reducing the likelihood for the development of resistance.

About Ongoing Boceprevir Phase III Registration Studies

Patient enrollment has been completed in two ongoing randomized, double-blind, placebo-controlled registration studies evaluating boceprevir in combination with PEGINTRON and REBETOL compared to standard of care with PEGINTRON and REBETOL alone. More than 1,500 patients were enrolled in these studies at U.S. and international sites.

The HCV SPRINT-2 study evaluates the effi
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SOURCE Schering-Plough Corporation
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Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis ...(o a contemporaneous control of PEGINTRON...),Health