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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

egimen achieved SVR. RVR is defined as undetectable virus (HCV RNA) in plasma at 4 weeks after the addition of boceprevir. In the lead-in arms, 64 percent of patients achieved RVR. Fewer patients in the lead-in arms discontinued treatment due to viral breakthrough.

"These results are very exciting and provide important insights to help further define response guided therapy using a P/R lead-in boceprevir regimen with peginterferon and ribavirin backbone treatment," said Paul Kwo, M.D., associate professor of medicine and medical director, liver transplantation, Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, and lead investigator of the study. "Building on these results, the boceprevir Phase III clinical program individualizes treatment based on response, utilizing RVR criteria at week 4 of boceprevir treatment to determine overall duration of therapy. Based on the RVR rate seen in this Phase II study, we are hopeful that the majority of patients can be treated with 28 weeks of therapy."

Part II of the HCV SPRINT-1 study explored a low-dose ribavirin strategy in which boceprevir was given in combination with PEGINTRON and low-dose REBETOL for 48 weeks. SVR for the low-dose REBETOL arm was 36 percent (n=21/59) compared to 50 percent for a 48-week control arm with PEGINTRON and standard-dose REBETOL plus boceprevir (n=8/16). In contrast to the results seen in Part I, the low-dose REBETOL regimen was associated with increased viral breakthrough during treatment, higher relapse rates after the end of treatment and lower SVR, strongly indicating that standard-dose ribavirin is required to optimize response.

Another key finding of the HCV SPRINT-1 study is that treatment-emergent anemia appeared to be associated with higher SVR, with anemic patients (hemoglobin decreasing to less than 10 g/dL) having higher SVR rates than those wi
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SOURCE Schering-Plough Corporation
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