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EASL: Independent Study Evaluates Virologic Response of Two Approved Forms of Pegylated Interferon In Combination with Ribavirin BERLIN, GERMANY -- April 19, 2004 -- Schering-Plough Europe reported on an independent investigator-initiated study1 evaluating the two approved forms of pegylated interferon therapy for chronic hepatitis C virus (HCV) infection: PegIntron® (peginterferon alfa-2b/Schering Corporation) and Pegasys (peginterferon alfa-2a/Hoffmann-La Roche, Inc.), both used in combination with the same dose of ribavirin. Interim results from this study showed that individualized weight-based dosing with PegIntron achieved an earlier and greater virological response2 compared to Pegasys, which is administered as a flat dose regardless of individual body weight, in previously untreated patients chronically infected with hepatitis C, genotype 1. Genotype 1 virus is the most common worldwide, the most difficult to treat successfully and accounts for about 70 percent of HCV infections among European patients overall. In the study (Kinetic of Virological Response During PEG-IFN Therapy in Chronic Hepatitis C, Poster #490), researchers at the University of Padova, Italy, reported that weight-based PegIntron (1.5 mcg/kg/once weekly) plus ribavirin (15 mg/kg/daily) achieved a greater virological response in patients with hepatitis C, genotype 1, at weeks 4, 12, 24 during therapy and at end of treatment (EOT), than Pegasys (180 mcg/once weekly) plus the same dose of ribavirin. The EOT virological response for the PegIntron regimen was 76 percent versus 55 percent for the Pegasys regimen in patients with genotype 1 virus. Results of this independent study and other investigator-initiated clinical studies with PegIntron were presented at the 39th annual meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany. In all, clinical investigators made 17 presentations on PegIntron data. "For treating physicians, this data continues to underscore the impact of viral factors, such as genotype, and host factors, such as body weight, in predicting a virologic response to treatment for patients infected with hepatitis C," said Liliana Chemello, M.D., University of Padova, Italy, and a lead investigator of the study. "A careful evaluation of critical factors such as these prior to treatment will help enable physicians to select an approach they believe will be most likely to achieve a successful outcome." In this study, researchers consecutively treated, in a non-randomized set, 75 treatment-naïve patients with either PegIntron (n=52) or Pegasys (n=23). Both groups received peginterferon in combination with weight-based dosed ribavirin. Baseline characteristics between the two groups were comparable. Viral levels were tested in all patients at weeks 4, 12 and 24 during therapy and at EOT. The following results were noted: · At week 4, the time to viral response in patients was earlier with PegIntron than with Pegasys (32 percent vs. 9 percent in genotype 1 and 67 percent vs. 58 percent in genotypes 2 or 3); · At week 12, patients with genotype 1 showed a greater early virological response (EVR)3 when treated with PegIntron than with Pegasys (60 percent vs. 36 percent); · At week 24, patients with genotype 1 continued to show a greater virological response when treated with PegIntron than with Pegasys (80 percent vs. 64 percent); · At EOT, more patients with genotype 1 had achieved a virological response when treated with PegIntron than with Pegasys (76 percent vs. 55 percent); · As expected, viral clearance rates for patients with genotype 2 or 3 virus were similar and uniformly high (>90 percent) at weeks 12, 24 and 48 in both treatment groups. In the study, no new side effects were observed. However, patients in the Pegasys group had higher drop-out rates than patients in the PegIntron group (17 percent vs. 8 percent). "The results of this study, as well as numerous other reports being presented at EASL, continue to demonstrate the efficacy of individualized, weight-based PegIntron and Rebetol combination therapy and the value of using early predictors of response," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "In particular, the early virological response achieved with PegIntron combination therapy in difficult-to-treat genotype 1 patients provides physicians the flexibility to monitor response and identify non-responders quickly, an important consideration in making therapy decisions." While Schering-Plough has made unrestricted grants to the University of Padova, it did not support this study. IDEAL Trial Evaluates Efficacy and Safety of Leading Hepatitis C Treatments To further illustrate the efficacy of individualized, weight-based PegIntron combination therapy, Schering-Plough Research Institute is conducting comparative studies with the two approved forms of pegylated interferon. Foremost among these is the IDEAL study (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy), a major randomized clinical study involving 2,880 patients that will directly compare the efficacy and safety of individualized weight-based dosing with PegIntron and Rebetol versus Pegasys, which is administered as a flat dose to all patients regardless of individual body weight, and Copegus (ribavirin) dosed either at 1,000 mg or 1,200 mg, in U.S. patients with chronic hepatitis C, genotype 1. Additional Comparative Studies The PegIntron and Pegasys interferon molecules differ significantly, both in the structure of their protein and in the size, shape and site of their PEG (polyethylene glycol) attachment. Alpha interferons exert their antiviral effects through physical interaction with the alpha/beta interferon receptor on the host cell. To understand the in vivo consequence of differing peg molecule sizes and to explore the relationship between the pharmacokinetics (PK) and pharmacodynamics (PD) of pegylated alfa interferons, Schering-Plough Research Institute has conducted a randomized, third-party blind, parallel group study in 36 previously untreated patients chronically infected with hepatitis C, genotype 1. Results of this study are expected to be reported this year. About PegIntron and Rebetol Combination Therapy PegIntron and RebetolÒ (ribavirin) combination therapy for chronic hepatitis C was approved in the European Union (EU) in March 2001. PegIntron had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C. PegIntron is the only peginterferon approved for dosing according to patient body weight. It is a longer-acting form of Intron® A (interferon alfa-2b, recombinant) Injection that uses proprietary PEG technology developed by Enzon, Inc. (NASDAQ: ENZN) of Bridgewater, N.J. PegIntron, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy that is designed to achieve an effective balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PegIntron. Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity. It is approved worldwide for use in combination with PegIntron or Intron A for the treatment of adult patients with chronic hepatitis C. Schering-Plough has rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with Valeant Pharmaceuticals International (NYSE: VRX), formerly ICN Pharmaceuticals Inc., of Costa Mesa, Calif., USA. PegIntron and Rebetol are licensed to Aesca in Austria, Essex Pharma in Germany and Essex Chemie in Switzerland. Pegasys is a trademark of Hoffmann-La Roche Inc. See Pegasys product insert for information on this product. References: 1 Luise, S., E. Bernardinello, L. Cavalletto, L. Chemello, S. De Carlo, K. Mattiello, A. Gottardo, I. Mezzocollli, A. Gatta. Early and Late Kinetic of Virological Response During PEG-IFN Therapy in Chronic Hepatitis C. Dept. of Clinical and Experimental Medicine, Clinica Medica 5 - University of Padova, Italy 2 Virological response is defined as achieving undetectable virus (HCV-RNA) levels in the blood. 3 EVR is defined as achieving either undetectable virus (HCV-RNA) levels or a significant (greater than 2 log10) drop in viral load at week 12 of therapy. SOURCE: Chandler Chicco Agency E-mail this page to a friend or colleague! To print, use this version