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Data Supporting Boceprevir Response Guided Therapy Presented at American Association for the Study of Liver Diseases (AASLD) Annual Meeting
Date:11/1/2009

ribavirin therapy (defined as <1 log decrease in HCV viral load) after the 4-week lead-in period. Overall, 38 percent of null responders achieved SVR (19/50), with 25 percent (7/28) of patients who received 28 weeks of therapy and 55 percent (12/22) of patients who received 48 weeks of therapy achieving SVR. Patients with null response to peginterferon and ribavirin are considered to be among the most difficult to treat successfully and historically achieve a low rate of SVR.

"Although the numbers are small, this analysis of the HCV SPRINT-1 study data showed that it was possible to achieve SVR in a proportion of null responders to peginterferon and ribavirin when boceprevir was added to their backbone regimen," 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. "However, the risk of developing viral resistance to protease inhibitors in patients who do not achieve SVR must be carefully weighed against the potential benefits of treatment with this new class of direct antiviral agents. With the lead-in strategy, initial peginterferon and ribavirin responsiveness is determined prior to the addition of a protease inhibitor, thus allowing the physician to take into account the potential for the development of resistance."

The ongoing Phase III boceprevir registration studies employ the lead-in strategy for all patients and will provide greater insight into the relationship between peginterferon and ribavirin responsiveness and the likelihood of achieving SVR in a diverse patient population. These Phase III studies, in treatment-naïve patients (HCV SPRINT-2) and patients who failed prior treatment (HCV RESPOND-2), prospectively evaluate the use of rapid viral response (RVR) to determine which boceprevir patients can stop all treatment at
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SOURCE Schering-Plough Corporation
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