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European Union's CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
Date:9/24/2007

nts with clinically stable HIV coinfection. Upon approval, this new retreatment indication will result in Marketing Authorization with unified labeling that will be valid in the current EU 27 member states as well as in Iceland and Norway.

The CHMP positive opinion is based on results from an ongoing non-comparative clinical study (EPIC3)(1) in which 1,336 patients with moderate to severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin therapy were retreated with PEGINTRON combination therapy.

In this study, virological response at week 12 of treatment was shown to be an important predictor for achieving a sustained virological response (SVR), with 57 percent (282/499) of patients who had undetectable virus (HCV-RNA) at week 12 going on to achieve SVR with a 48-week course of therapy. Within this subgroup, the SVR rates were 59 percent and 47 percent for patients who failed prior therapy with non-pegylated or pegylated interferon, respectively. Approximately 37 percent of patients in the study overall had undetectable virus at week 12. Importantly, patients who achieved a significant reduction in virus (greater than 2 log decreased) but did not have undetectable virus at week 12, had little chance of achieving SVR (6 percent). Overall, 23 percent of patients in the study achieved SVR. SVR is defined as undetectable HCV-RNA at 24 weeks post-treatment.

"The ability with PEGINTRON to help predict efficacy of retreatment early in the course of therapy would assist physicians in managing this hard-to- treat patient population," said Thierry Poynard, M.D., professor of medicine, University of Paris VI, Hopital Pitie-Salpetriere, Paris, and a lead investigator of the clinical trial. "Patients with undetectable virus at week 12 have an even chance of success regardless of whether they failed previous therapy with pegylated or non-pegylated interferon and are motivated to continue treatment, and those patients
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SOURCE Schering-Plough Corporation
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