Posted: 21-May-2007 << BACK
19 May 2007 medilexicon.com
A total of 20 oral and poster presentations on clinical studies with Schering-Plough's hepatitis products, including PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy for chronic hepatitis C virus (HCV) infection, as well as boceprevir (SCH 503034), the company's investigational oral HCV protease inhibitor currently in Phase II clinical development, will be presented by leading researchers at the 38th annual Digestive Disease Week (DDW) meeting to be held at the Washington Convention Center in Washington, D.C., May 20-23.
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.
PEGINTRON
Clinical investigators will present findings at DDW from numerous PEGINTRON studies evaluating patient response to therapy at certain treatment milestones, an approach that is aimed at individualizing treatment for patients. Schering-Plough also is exploring novel therapeutic approaches with PEGINTRON in combination with investigational antiviral agents to optimize treatment for patients with more difficult-to-treat forms of the disease, such as patients who were nonresponders to previous therapy.
Boceprevir (SCH 503034)
Schering-Plough is undertaking a large, fully integrated clinical development program for its oral HCV protease inhibitor boceprevir, with the goal of developing new strategies for improving treatment outcomes for patients with hepatitis C.
At DDW, Schering-Plough will present results of in vitro studies conducted in collaboration with Wyeth/ViroPharma of boceprevir in combination with their investigational non-nucleoside HCV polymerase inhibitor HCV-796.
In Addition, Schering-Plough has initiated the HCV SPRINT-1 study (HCV Serine Protease Inhibitor Therapy-1), a large Phase II study with boceprevir ongoing at sites across the U.S., Canada and Europe. The primary objective of the study is to evaluate the safety and efficacy of boceprevir (800 mg TID) in combination with PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily) in the HCV genotype 1 treatment-naive patient population. The first part of the study (screening cohort 1) has completed enrollment and involves more than 500 patients in five treatment arms. A second part to the study (screening cohort 2) recently opened for patient enrollment and adds two additional treatment arms. This second cohort will evaluate the safety and efficacy of boceprevir in combination with PEGINTRON and a lower dose of REBETOL (400-1000 mg daily). In total, approximately 550-600 patients will be enrolled in the HCV SPRINT-1 study.
Schering-Plough also is conducting a large Phase II study evaluating the safety and efficacy of boceprevir in combination with PEGINTRON and REBETOL in patients chronically infected with HCV genotype 1 who were null responders to previous peginterferon and ribavirin combination therapy (i.e., patients who did not achieve undetectable HCV-RNA or a 2 log decline in viral load with a minimum of 12 weeks of peginterferon and ribavirin combination therapy). This represents a very difficult-to-treat patient population for which there is a great unmet medical need. The study involves approximately 350 patients and is ongoing at centers in the United States and Europe. All study participants have completed treatment with boceprevir in combination with PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily) and are in the follow-up phase of the study. Data from this study will be available later in 2007, and will help guide future clinical development of boceprevir.
Key Oral Presentations at DDW
Favorable Cross-Resistance Profile of HCV-796 and Boceprevir (SCH-503034) and Enhanced Anti-Replicon Activity Mediated By Combination Treatment; R. Ralston, Monday, May 21, 11:15 a.m., Room 206
Pharmacodynamic Analysis of the Antiviral Activity of the Non-Nucleoside Polymerase Inhibitor, HCV-796, in Combination With Peginterferon Alfa-2b in Treatment-Naive Patients With Chronic HCV; E.S. Maller, Monday, May 21, 2:15 p.m., Room 206
Phase II Study of celgosivir in combination with Peginterferon alfa-2b and ribavirin in chronic hepatitis C genotype 1 nonresponder patients; K.D. Kaita, Monday, May 21, 2:45 p.m., Room 206
Schering-Plough Sponsored CME Symposium
"HCV Treatment Decisions: Challenging Issues"
Monday, May 21, 6:30-8:30 pm, Grand Hyatt Washington,
Independence Ballroom A, 1000 H Street, NW, Washington, D.C.
This case-based symposium is designed to outline effective management strategies for patients with hepatitis C virus infection. Optimizing HCV patient outcome requires a thorough understanding of the underlying patient and disease factors that influence treatment. Clinical scenarios will be presented, and through the use of case studies, the distinguished faculty will review and discuss current data to illustrate their respective treatment decisions.
