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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

thout anemia (hemoglobin did not decrease to less than 10 g/dL). Anemia is a known adverse event with combination therapy for hepatitis C and this association with higher SVR has been seen in other clinical studies with peginterferon and ribavirin, including the IDEAL study.(4) Boceprevir is associated with about a 1 g/dL incremental decrease in hemoglobin. In the HCV SPRINT-1 study, anemia occurred in approximately half of the patients in the boceprevir arms and over a third of patients in the control arm. Erythropoietin (EPO) supplementation was allowed in the study at the discretion of the investigator and was used by 26 percent of patients in the control arm and 39-51 percent of patients in the boceprevir arms with standard-dose REBETOL.

Safety data from the study showed that the most common adverse events reported in the boceprevir arms were fatigue, anemia, nausea and headache. The incidence of skin adverse events (rash or pruritus) observed in the boceprevir arms was similar to that seen in the PEGINTRON and REBETOL control arm.

Treatment discontinuations due to adverse events in Part I of the study were between 9 and 19 percent for patients in the boceprevir arms, compared to 8 percent for the control arm. Treatment discontinuations for boceprevir patients due to viral breakthrough were fewer in the 28- and 48-week lead-in arms (4 and 5 percent, respectively) compared to the no lead-in arms (7 and 12 percent, respectively).

SCH 900518 (Next-Generation HCV Protease Inhibitor) Data at EASL

Researchers at EASL also presented early phase clinical data for SCH 900518, Schering-Plough's investigational next-generation HCV protease inhibitor.(5) This proof-of-concept study explored the safety and antiviral activity of two different dosing regimens for SCH 900518 administered as monotherapy and in combination therapy with PEGINTRON with or without ritonavir in treatment-naive and treatmen
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SOURCE Schering-Plough Corporation
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