KENILWORTH, N.J., May 15 Schering-PloughCorporation (NYSE: SGP), a leader in advancing the science and treatment ofchronic hepatitis C virus (HCV) infection, announced today that data fromseveral clinical studies with PEGINTRON(TM) (peginterferon alfa-2b) andREBETOL(R) (ribavirin, USP) combination therapy, as well as boceprevir, thecompany's investigational oral HCV protease inhibitor, will be presented atthe 39th annual Digestive Disease Week (DDW) meeting to be held at the SanDiego Convention Center, May 17-22.
Hepatitis C is the most common blood-borne infection in America and themost common form of liver disease, affecting nearly 5 million people in theUnited States and 200 million people worldwide. It is the leading cause ofcirrhosis and liver cancer, and the number one reason for liver transplants inthe United States.
Clinical investigators will present findings from several PEGINTRONstudies evaluating patient response to therapy at important treatmentmilestones, an approach that is aimed at individualizing treatment forpatients to help improve outcomes. In particular, Schering-Plough isexploring unique treatment strategies for patients with moredifficult-to-treat forms of the disease, such as patients who werenonresponders to previous therapy.
Schering-Plough also is exploring novel therapeutic approaches to treatinghepatitis C with boceprevir, its investigational oral HCV protease inhibitorcurrently in Phase II clinical development. The final results of a Phase IIdose-finding study of boceprevir with or without ribavirin in patients whowere "null" responders to previous peginterferon and ribavirin combinationtherapy will be presented.
Key Data Presentations at DDW
Results from the EPIC3 Program: Platelet Counts Are Strong Predictors ofSustained Viral Response (SVR) in the Retreatment of PreviousInterferon/Ribavirin Non-Responders (NR). Poynard, T. et al. Poster S1000,Abstract No. 442673, Sunday, May 18, 8:00 a.m. - 5:00 p.m., Sails Pavilion.
Clearance of HCV at 5 Year Follow-Up for Peginterferon Alfa-2b with orwithout Ribavirin Is Predicted by Sustained Virologic Response at 24 WeeksPost-Treatment. Lindsay, K. et al. Poster S1001, Abstract No. 443097, Sunday,May 18, 8:00 a.m. - 5:00 p.m., Sails Pavilion.
Sustained Virologic Response and Relapse Rates with Peginterferon Alfa-2bPlus Ribavirin in Clinical Trials Are Comparable to Those in Community-BasedStudies. Manns, M. et al. Poster W1004, Abstract No. 441859, Wednesday, May21, 8:00 a.m. - 5:00 p.m., Sails Pavilion.
Rapid Virologic Response to Peginterferon Alfa and Ribavirin Treatment ofChronic Hepatitis C Predicts Sustained Virologic Response and Relapse.Poordad, F. et al. Poster W1007, Abstract No. 439219, Wednesday, May 21, 8:00a.m. - 5:00 p.m., Sails Pavilion.
Role of Interferon Response During Re-Treatment of Null Responders withBoceprevir Combination Therapy: Results of Phase II Trial. Schiff, E. et al.Oral Presentation 162, Abstract No. 442360, Sunday, May 18, 4:30 p.m., Room6DE.
Schering-Plough Supported CME Symposium
Defining the Course in the Management of HCV: A Case Based ApproachSunday, May 18, 6:30-9:30 p.m., San Diego Marriott Hotel and Marina, Hall 3-6.A world-renowned faculty will present and discuss recent data and how thisinformation may impact clinical management decisions. Among the educationalobjectives of this program is to define the role of viral clearance as apredictor of HCV treatment response.
In the United States, PEGINTRON is indicated for use alone or withribavirin for the treatment of chronic hepatitis C in patients withcompensated liver disease who have not been previously treated with interferonalpha and who are at least 18 years of age.
Important Safety Information Regarding U.S. Labeling f