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Top-Line Results of Boceprevir Phase II Study Showed High Rate of Sustained Response (SVR) in Genotype 1 Treatment-Naive Hepatitis C Patients
Date:8/4/2008

ned 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 equals PEGINTRON and REBETOL for 4 weeks prior to the addition of boceprevir

P/R Control equals PEGINTRON and REBETOL alone for 48 weeks

* SVR 12 for 48 week arms; SVR 24 for 28 week arms(1-3)

"These top-line results further validate this novel treatment paradigm and the design of our pivotal Phase III studies of boceprevir, one in treatment-naive patients and one in patients who had failed prior treatment, in which all patients will receive 4 weeks of PEGINTRON and REBETOL prior to the addition of boceprevir," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "Additionally, this strategy has the potential to reduce the likelihood of the development of resistance by identifying patients who are responders to interferon and ribavirin prior to their receiving a protease inhibitor."

The rationale for this novel treatment regimen is based on the fact that both PEGINTRON and REBETOL reach steady-state concentrations by week 4, so patients have the protease inhibitor added at a time when the backbone drug levels have been optimized. 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, potentially reducing the likelihood for the development of resistance.

The HCV SPRINT-1 study was conducted at sites across the United States, Canada and Europe. Overall, 77
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SOURCE Schering-Plough Corporation
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