Schering-Plough (NYSE: SGP) announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3. Researchers will present sustained virologic response (SVR) data on boceprevir triple combination therapy in treatment-naive HCV genotype 1 patients who had a null response to peginterferon and ribavirin (defined as <1 log decrease in HCV viral load) in the 4-week lead-in arms of the Phase II SPRINT-1 study. Patients with null response to peginterferon and ribavirin are considered to be among the most difficult to treat successfully.
Phase III registration studies with boceprevir in treatment-naive HCV patients and those who failed prior treatment have been fully enrolled and are expected to be completed in mid-2010.
In addition, a late-breaker oral presentation on narlaprevir (SCH 900518), a next-generation once-daily HCV protease inhibitor, will report week-4 rapid virologic response (RVR) and week-12 early virologic response (EVR) data in treatment-naive HCV genotype 1 patients from the ongoing NEXT-1 study. Narlaprevir is currently in Phase II clinical development.
Several presentations will report results with PEGINTRON(R) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy, an approved treatment regimen for chronic hepatitis C. These include a late-breaker oral presentation on a genome-wide analysis of patients from the IDEAL study that identified the first genetic marker that may predict a patient's response to peginterferon and ribavirin combination therapy for hepatitis C. Peginterferon and ribavirin are expected to remain the backbone of HCV treatment regimens for the next several years. Schering-Plough is in the process of analyzing options for the development of a genetic test based on this marker and for making it widely accessible to providers, patients and diagnostic companies for the advancement of science and for helping physicians and patients make more informed treatment decisions.