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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
Date:10/18/2007

feron and ribavirin combination therapy. In these boceprevir studies, the most common adverse events have been fatigue, headache, nausea and anemia. No increase in skin adverse events (rash) beyond what was seen in the PEGINTRON and REBETOL control was observed. Gastrointestinal events were the most common adverse events leading to discontinuation in the boceprevir arms.

In the treatment-naive study, known as HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir (800 mg TID) is being evaluated in three treatment regimens: in combination with PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily) for 28 or 48 weeks; 4 weeks of PEGINTRON and REBETOL combination therapy at the doses described above followed by adding boceprevir to the combination for 24 or 44 weeks; and boceprevir in combination with PEGINTRON and low-dose REBETOL (400-1000 mg daily) for 48 weeks, compared to a control of PEGINTRON and REBETOL alone for 48 weeks (a standard of care). The primary endpoint of this study is sustained virologic response. Patients receiving these boceprevir regimens achieved a high rate of early virologic response, with 70, 79 and 54 percent of patients, respectively, having undetectable virus (HCV-RNA) at week 12 of boceprevir therapy compared to 34 percent of patients in the control arm (Roche Cobas Taqman 1.0 assay; lower limit of detection is 15 IU/mL). Treatment discontinuations due to adverse events were 12, 9, and 8 percent for patients in the boceprevir regimens, respectively, compared to 5 percent for the control arm.

A total of 595 patients have been treated in the HCV SPRINT-1 study at sites across the United States, Canada and Europe, including 491 patients treated with boceprevir. Overall, 77 percent of patients in the study were enrolled in the United States. African-Americans represent 16 percent of the patients enrolled in the study and 7 percent of patients in the study are cirrhotic.

Boceprevir in "Null" Nonrespon
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SOURCE Schering-Plough Corporation
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