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Results Indicate New Drug Therapy Improves Adherence and Cure Rate

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    North Shore-LIJ Physician Is Lead Author of Hepatitis C Study; Results Indicate New Drug Therapy Improves Adherence and Cure Rate The Next New Epidemic?
    Message 1 of 1 , Mar 6, 2002
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      North Shore-LIJ Physician Is Lead Author of Hepatitis C Study;
      Results Indicate New Drug Therapy Improves Adherence and Cure Rate

      The Next New Epidemic?

      MANHASSET, N.Y., March 5 /PRNewswire/ -- If you have a serious
      that is curable by medication, you take the medication. That should
      without saying, but it often is not the case with hepatitis C, a
      blood-borne virus that affects the liver. The side effects with the
      therapy (interferon in combination with ribavirin) are so unpleasant
      that patients frequently abandon treatment, even though when left
      untreated hepatitis C is a life-threatening illness.

      An investigational drug, PEGASYS(R), promises improved quality of
      over the standard therapy, which could increase the likelihood that
      patients adhere to the one-year course of therapy necessary for
      success, according to a study published this month in Hepatology. The

      study's lead author is David Bernstein, MD, of North Shore University

      Hospital (NSUH) in Manhasset, New York.

      The study is significant because hepatitis C is viewed by many as
      new epidemic"; unless it can be controlled, it threatens to overwhelm

      the U.S. healthcare system.

      PEGASYS is a pegylated interferon. To define this term simply, there
      a strand of an inert, synthetic polymer called polyethylene glycol
      (PEG) attached to the interferon molecule. This PEG strand sweeps
      like a tail and keeps the medication from being broken down too
      That means it can be administered once a week as compared with three
      times. And, most important, the PEG seems to help keep the drug at a
      fairly constant level in the patient's bloodstream, preventing "peaks
      valleys" which have been linked to negative side effects.

      In Dr. Bernstein's study, entitled "Relationship of Health-Related
      Quality of Life to Treatment Adherence and Sustained Response in
      Hepatitis C Patients," PEGASYS was compared to standard interferon in

      over 1,400 patients from 11 countries, including the United States.
      on health surveys and fatigue severity scales administered to these
      patients at five points during their treatment, they had more energy,
      fatigue, less bodily pain and fewer problems doing their job than
      patients taking standard interferon. In addition to being better
      PEGASYS has the highest overall efficacy of any hepatitis C
      and provides an early indication (at three months) of whether the
      patient might or might not succeed on therapy. Of patients on PEGASYS
      ribavirin for whom success was projected based on early response, 75
      percent who adhered to the full course of therapy had virus below the

      limits of detection after finishing their course of therapy.

      Background on Hepatitis C

      It is estimated that 2.7 million people are infected with hepatitis
      many of them still undiagnosed, according to Dr. Bernstein, who is
      director of hepatology of the Division of Gastroenterology and
      at NSUH in Manhasset, one of the cornerstone hospitals of the North
      Shore-Long Island Jewish Health System. He starts seeing patients at
      a.m. in his hospital office to get through his caseload--92 percent
      diagnosed with hepatitis C.

      "The practices of most hepatologists I know are bursting at the
      he said. "Cirrhosis may occur in 20 to 30 percent of cases within 20
      years. Hepatitis C is the leading predisposing factor for liver
      and liver transplant. It's already overburdening our transplant
      facilities. And we're seeing just the leading edge. There's no way
      our medical
      system can handle this epidemic."

      Hepatitis C patients represent all socioeconomic classes and have
      infected in a variety of ways, including intravenous or intranasal
      use, blood transfusion prior to 1992, when procedures were put in
      to safeguard the U.S. blood supply, and other less risky-seeming
      procedures such as manicures, tattooing and body piercing. Patients
      can be
      symptom free for decades, while the disease progresses, which is part
      the adherence problem.

      "Maybe they're diagnosed as a result of a blood test performed by an
      insurance company, but they feel fine," said Dr. Bernstein. "Then
      start on the medication and they feel terrible. I find that 80 to 90
      percent of my patients suffer some side effects: flu-like symptoms,
      irritability, depression, thyroid problems. They find it hard to do
      their jobs
      or take care of their children. It affects their relationships --
      know that the therapy can cure them, but their quality of life is so
      seriously diminished that they quit, even though it's their only
      for a cure." Studies show that between 4 and 27 percent of patients
      discontinue conventional therapy within 24 weeks.

      "Hepatitis C is the only virus known that can be cured by medication,

      and interferon is the only medication known that can cure it," Dr.
      Bernstein said. "PEGASYS is likely to be our mainstay for quite some
      because of its effect on adherence, although I expect it to be used
      combination with other antiviral agents as they are developed. And as
      number of cures increases, the spread decreases. I view PEGASYS as a
      significant advance on the hepatitis C front."

      PEGASYS has been approved for use in 13 countries to date. Approval
      use in additional countries, including the United States, is expected

      to be granted in the coming months.



      SOURCE North Shore University Hospital

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