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  • Mark Middle Mountain
    New Treatment for Hepatitis C Mark B. McClellan, MD, PhD The FDA has approved peg-interferon alfa-2a (Pegasys; Hoffmann-La Roche Ltd, Nutley, NJ) for the
    Message 1 of 1 , Dec 9, 2002
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      New Treatment for Hepatitis C

      Mark B. McClellan, MD, PhD



      The FDA has approved peg-interferon alfa-2a (Pegasys; Hoffmann-La Roche Ltd,
      Nutley, NJ) for the treatment of adults with chronic hepatitis C who have
      compensated liver disease and have not been previously treated with
      interferon alfa. The product was approved on the basis of the results of
      three randomized, open-label, active-controlled clinical studies with
      approximately 1500 adult patients whose condition is described in the
      indication. All patients received therapy by subcutaneous injection for 48
      weeks and were followed up for an additional 24 weeks. One of the studies
      was designed to enroll only patients with cirrhosis or transition to
      cirrhosis, and such patients were included also in the other two trials.

      In study 1, patients received 3 mIU of interferon alfa-2a (Roferon-A;
      Hoffmann-La Roche Ltd) three times per week, 135 µg of Pegasys once per
      week, or 180 µg of Pegasys once per week. In study 2, patients received 6
      mIU of Roferon-A three times per week for 12 weeks followed by 3 mIU of
      Roferon-A three times per week for 36 weeks or 180 µg of Pegasys once per
      week. In study 3, patients received 3 mIU of Roferon-A 3 times per week, 90
      µg of Pegasys once per week, or 180 µg of Pegasys once per week for 48
      weeks. In study 1, combined virological and biological sustained response at
      week 72 was 20% for Pegasys vs 9% for Roferon-A; in study 2, 28% vs 15%; and
      in study 3, 20% vs 3%.

      One or more serious adverse reactions (including among others hepatic
      dysfunction, fatty liver, cholangitis, arrhythmia, and suicide) added up to
      a frequency of 9% of all patients receiving Pegasys. The most commonly
      reported adverse reactions included headache (54%), fatigue (50%), myalgia
      (37%), pyrexia (36%), rigors (32%), depression (18%), and irritability
      (13%).

      Alfa interferons, including Pegasys, may cause or aggravate fatal or
      life-threatening neuropsychiatric, autoimmune, ischemic, and infectious
      disorders. Patients should be closely monitored and physicians should
      consider withdrawing the medication from those with persistently severe or
      worsening signs of these conditions.





      AUTHOR INFORMATION


      Mark B. McClellan, MD, PhD
      Commissioner of Food and Drugs
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