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The IDEAL (Individualized Dosing Efficacy vs. flat dosing to AssessoptimaL pegylated interferon therapy) study is the first large, randomized,clinical study comparing the leading therapies for chronic hepatitis C:PEGINTRON and REBETOL combination therapy vs. Pegasys (peginterferon alfa-2a)and Copegus (ribavirin, USP) combination therapy,(1) as well as a lower doseof PEGINTRON plus REBETOL in an investigational combination regimen. Pegasysand Copegus were dosed in accordance with their approved U.S. labeling in thisstudy of more than 3,000 U.S. genotype 1 patients. Results showed thatsustained virologic response (SVR), the primary endpoint of the study, wassimilar for all three treatment regimens. The study also showed in asecondary endpoint that fewer patients treated with both PEGINTRON regimensrelapsed after the end of treatment compared to those receiving Pegasys andCopegus.
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Final results will be presented for the EPIC3 study, in which more than2,000 hepatitis C patients with moderate to severe fibrosis or cirrhosis whofailed prior treatment with interferon alpha (pegylated or non-pegylated) andribavirin combination therapy were retreated with PEGINTRON combinationtherapy. PEGINTRON combination therapy is the first and only pegylatedinterferon combination therapy approved in the European Union (EU) forretreating both hepatitis C relapsers and nonresponders.
Researchers also will present the final results of the COPILOT study,which evaluated the investigational use of low-dose PEGINTRON as maintenancetherapy in chronic hepatitis C nonresponder patients with fibrosis orcirrhosis. The goal of maintenance therapy in this very hard-to-treat patientpopulation is to prevent or delay the progression of liver disease, livercancer or death.
Schering-Plough also is exploring novel therapeutic approaches to treatinghepatitis C with boceprevir, its investigational oral HCV protease inhibitorcurrently in Phase II clinical development. Oral presentations of boceprevirdata will include interim results from the HCV SPRINT-1 study intreatment-naive hepatitis C patients and final results of the HCV RESPOND-1study in patients who were "null" responders to previous peginterferon andribavirin combination therapy.
Key Data Presentations at EASL
PEGINTRON Oral Presentations
Final results of the IDEAL (Individualized Dosing Efficacy versus flatdosing to Assess optimaL pegylated interferon therapy) Phase IIIb study.Sulkowski, M. et al. Late-Breaker Parallel Session 16, Saturday, April 26,4:45 p.m. Hall A.
Sustained viral response (SVR) is dependent on baseline characteristics inthe retreatment of previous alfa interferon/ribavirin (I/R) nonresponders(NR): final results from the EPIC3 program. Poynard, T. et al. Late-BreakerParallel Session 16, Saturday, April 26, 4:00 p.m. Hall A.
Colchicine versus peginterferon alfa 2b long term therapy: results of the4 year COPILOT trial. Afdhal, N.H. et al. General Session 1, Thursday, April24, 3:10 p.m., Hall A.
PEGINTRON Poster Presentations
Sustained virologic response after peginterferon alfa-2b and ribavirintreatment predicts l
