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Largest study comparing leading hepatitis C treatments

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  • claudine intexas
    Largest study comparing leading hepatitis C treatments Medical centers, hospitals, clinics and other treatment sites across the country are actively enrolling
    Message 1 of 1 , May 15, 2004
      Largest study comparing leading hepatitis C treatments

      Medical centers, hospitals, clinics and other treatment sites
      across the country are actively enrolling Americans with the
      hepatitis C virus (HCV) in a nationwide study that will for the
      first time determine which of the two FDA-approved pegylated
      interferon therapy regimens offers patients the best chance to
      eliminate the virus. The regimens being compared are PEG-INTRON(R)
      (peginterferon alfa- 2b/Schering Corporation) versus PEGASYS
      (peginterferon alfa-2a/ Hoffmann-La Roche, Inc.), both used in
      combination with ribavirin.

      Hepatitis C, a potentially fatal virus that infects the liver,
      blood and other tissues, is the most common blood-borne infection
      in America, and is the leading cause of liver transplantation in
      the United States, according to the National Institutes of Health.
      Approximately 4 million Americans, or about one in every 50 adults,
      are now infected with HCV,(1) compared to 900,000 Americans with

      A total of 2,880 patients at up to 100 U.S. sites will join the
      IDEAL study, which stands for Individualized Dosing Efficacy vs.
      flat dosing to Assess optimaL pegylated interferon therapy. The
      study is led by co-principal investigators John G. McHutchison,
      M.D., FRACP, Medical Director, Liver Research, Duke University
      Medical Center, and Mark S. Sulkowski, M.D., assistant professor of
      medicine in the Division of Infectious Diseases, Johns Hopkins
      University School of Medicine.

      IDEAL study sites currently open to patient enrollment can be
      identified via zip code search on the study's Web site:
      www.idealstudy.com. Patients are encouraged to check the Web site
      on an ongoing basis as additional study sites will be opening
      enrollment in the coming weeks and will be added to the Web site at
      that time.

      Unlike some clinical studies, where patients receive either active
      drug or placebo, all participates in the IDEAL study will receive
      active treatment at no cost.

      "The IDEAL Study offers an excellent opportunity to collect more
      data on hepatitis C treatment," said Alan Brownstein, president and
      chief executive officer of the American Liver Foundation. "Treating
      HCV is a long and arduous process. To give people the best chance
      for success in the future, we need more information."

      The IDEAL study will compare the efficacy and safety of
      individualized weight-based dosing with PEG-INTRON and REBETOL(R)
      (ribavirin, USP) to PEGASYS, which is administered as a flat dose
      to all patients regardless of individual body weight, and COPEGUS
      (ribavirin, USP) dosed either at 1,000 mg or 1,200 mg daily, in
      U.S. patients chronically infected with hepatitis C, genotype 1.
      Genotype 1 is the most common worldwide, the most difficult to
      treat successfully and accounts for about 70 percent of HCV
      infection among Americans. PEG-INTRON is a form of interferon
      alfa-2b that has been chemically "pegylated" so it is retained in
      the body longer than standard interferon, thereby providing for
      once weekly administration. PEGASYS is a pegylated form of
      interferon alfa-2a.

      IDEAL is sponsored by Schering-Plough Research Institute (SPRI) and
      is being conducted to respond to questions raised by the hepatitis
      C medical and patient communities.

      "These two treatment regimens have never before been directly
      compared in a study of this magnitude," said Robert J. Spiegel,
      M.D., senior vice president of medical affairs and chief medical
      officer, Schering-Plough Research Institute. "We are confident that
      the results of this large head-to- head study between PEG-INTRON
      and PEGASYS will help doctors and patients determine the therapy
      that offers them the best chance for achieving a sustained
      virologic response." http://www.schering-plough.com

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