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Schering-Plough Addresses Major Milestones and Challenges in,Treatment of Patients With Chronic Hepatitis C

es with PEGINTRON will be presented at EASL evaluating patient response to therapy at certain treatment milestones, an approach that is aimed at individualising treatment for patients.

Schering-Plough also is exploring novel therapeutic approaches with PEGINTRON in combination with investigational antiviral agents to optimize treatment for patients with more difficult-to-treat forms of the disease, such as those with HCV genotype 1 and nonresponders to previous therapy.

Schering-Plough is undertaking a large, fully integrated clinical development program for its oral HCV protease inhibitor boceprevir (SCH 503034), with the goal of developing new strategies for improving treatment outcomes for patients with hepatitis C.

As part of this effort, Schering-Plough has collaborated with Wyeth/ViroPharma and Idenix/Novartis to conduct separate in vitro studies of boceprevir in combination with their respective investigational HCV polymerase inhibitors, HCV-796, a non-nucleoside polymerase inhibitor, and NM107 (the active moiety of NM283, valopicitabine), a nucleoside polymerase inhibitor. These in vitro experiments suggest that the combination of boceprevir and either one of these polymerase inhibitors achieves additive antiviral activity and a complementary resistance profile; the combination of two agents increases the barrier for developing resistance to either drug alone.

In addition, Schering-Plough has initiated the HCV SPRINT-1 study (HCV Serine Protease Inhibitor Therapy-1), a large Phase II study that is currently enrolling 400 HCV genotype 1, treatment-naïve patients in sites across the United States, Canada and Europe. The primary objective of the study is to evaluate the safety and efficacy of boceprevir 800 mg TID in combination with PEGINTRON and REBETOL in the treatment-naïve patient population.

Schering-Plough also is conducting a large Phase II study evaluating the safety and efficacy of boceprevi
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