KENILWORTH, N.J., May 15 /PRNewswire-FirstCall/ — Schering-Plough Corporation , a leader in advancing the science and treatment of chronic hepatitis C virus (HCV) infection, announced today that data from several clinical studies with PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy, as well as boceprevir, the company’s investigational oral HCV protease inhibitor, will be presented at the 39th annual Digestive Disease Week (DDW) meeting to be held at the San Diego Convention Center, May 17-22.
Hepatitis C is the most common blood-borne infection in America and the most common form of liver disease, affecting nearly 5 million people in the United States and 200 million people worldwide. It is the leading cause of cirrhosis and liver cancer, and the number one reason for liver transplants in the United States.
Clinical investigators will present findings from several PEGINTRON studies evaluating patient response to therapy at important treatment milestones, an approach that is aimed at individualizing treatment for patients to help improve outcomes. In particular, Schering-Plough is exploring unique treatment strategies for patients with more difficult-to-treat forms of the disease, such as patients who were nonresponders to previous therapy.
Schering-Plough also is exploring novel therapeutic approaches to treating hepatitis C with boceprevir, its investigational oral HCV protease inhibitor currently in Phase II clinical development. The final results of a Phase II dose-finding study of boceprevir with or without ribavirin in patients who were "null" responders to previous peginterferon and ribavirin combination therapy will be presented.
Key Data Presentations at DDW
PEGINTRON
Results from the EPIC3 Program: Platelet Counts Are Strong Predictors of Sustained Viral Response (SVR) in the Retreatment of Previous Interferon/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 or without Ribavirin Is Predicted by Sustained Virologic Response at 24 Weeks Post-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-2b Plus Ribavirin in Clinical Trials Are Comparable to Those in Community-Based Studies. Manns, M. et al. Poster W1004, Abstract No. 441859, Wednesday, May 21, 8:00 a.m. - 5:00 p.m., Sails Pavilion.
Rapid Virologic Response to Peginterferon Alfa and Ribavirin Treatment of Chronic Hepatitis C Predicts Sustained Virologic Response and Relapse. Poordad, F. et al. Poster W1007, Abstract No. 439219, Wednesday, May 21, 8:00 a.m. - 5:00 p.m., Sails Pavilion.
Boceprevir
Role of Interferon Response During Re-Treatment of Null Responders with Boceprevir Combination Therapy: Results of Phase II Trial. Schiff, E. et al. Oral Presentation 162, Abstract No. 442360, Sunday, May 18, 4:30 p.m., Room 6DE.
Schering-Plough Supported CME Symposium
Defining the Course in the Management of HCV: A Case Based Approach Sunday, 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 this information may impact clinical management decisions. Among the educational objectives of this program is to define the role of viral clearance as a predictor of HCV treatment response.
About PEGINTRON
In the United States, PEGINTRON is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.
Important Safety Information Regarding U.S. Labeling for PEGINTRON and REBETOL
Alpha interferons, including PEGINTRON and INTRON(R) A, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON and/or INTRON A therapy.
Use with Ribavirin: Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen
Contraindications
PEGINTRON is contraindicated in patients with hypersensitivity to PEGINTRON or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. INTRON A (Interferon alfa-2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON A or any component of the product, autoimmune hepatitis, and decompensated liver disease. PEGINTRON or INTRON A in combination with REBETOL therapy is additionally contraindicated in patients with hypersensitivity to ribavirin or any other component of the product, women who are pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL/min.
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