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Peginterferon Alfa-2a in Patients with Chronic Hepatitis C and Cirrhosis

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    The New England Journal of Medicine -- December 7, 2000 -- Vol. 343, No. 23 Peginterferon Alfa-2a in Patients with Chronic Hepatitis C and Cirrhosis E. Jenny
    Message 1 of 1 , Dec 7, 2000
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      The New England Journal of Medicine -- December 7,
      2000 -- Vol. 343, No. 23


      Peginterferon Alfa-2a in Patients with Chronic
      Hepatitis C and Cirrhosis
      E. Jenny Heathcote, Mitchell L. Shiffman, W. Graham E.
      Cooksley, Geoffrey M.
      Dusheiko, Samuel S. Lee, Luis Balart, Robert
      Reindollar, Rajender K. Reddy,
      Teresa L. Wright, Amy Lin, Joseph Hoffman, Jean De
      Pamphilis
      ------------------------------------------------------------------------------

      --

      Abstract
      Background. Chronic hepatitis C virus (HCV) infection
      in patients with
      cirrhosis is difficult to treat. In patients with
      chronic hepatitis C but
      without cirrhosis, once-weekly administration of
      interferon modified by the
      attachment of a 40-kd branched-chain polyethylene
      glycol moiety
      (peginterferon alfa-2a) is more efficacious than a
      regimen of unmodified
      interferon. We examined the efficacy and safety of
      peginterferon alfa-2a in
      patients with HCV-related cirrhosis or bridging
      fibrosis.

      Methods. We randomly assigned 271 patients with
      cirrhosis or bridging
      fibrosis to receive subcutaneous treatment with 3
      million units of interferon
      alfa-2a three times weekly (88 patients), 90 �g of
      peginterferon alfa-2a once
      weekly (96), or 180 �g of peginterferon alfa-2a once
      weekly (87). Treatment
      lasted 48 weeks and was followed by a 24-week
      follow-up period. We assessed
      efficacy by measuring HCV RNA and alanine
      aminotransferase and by reviewuating
      liver-biopsy specimens. A histologic response was
      defined as a decrease of at
      least 2 points on the 22-point Histological Activity
      Index.

      Results. In an intention-to-treat analysis, HCV RNA
      was undetectable at week
      72 in 8 percent, 15 percent, and 30 percent of the
      patients treated with
      interferon alfa-2a and with 90 �g and 180 �g of
      peginterferon alfa-2a,
      respectively (P=0.001 for the comparison between 180
      �g of peginterferon
      alfa-2a and interferon alfa-2a). At week 72, alanine
      aminotransferase
      concentrations had normalized in 15 percent, 20
      percent, and 34 percent of
      patients, respectively (P=0.004 for the comparison
      between 180 �g of
      peginterferon alfa-2a and interferon alfa-2a). In the
      subgroup of 184
      patients with paired liver-biopsy specimens, the rates
      of histologic response
      at week 72 were 31 percent, 44 percent, and 54
      percent, respectively (P=0.02
      for the comparison between 180 �g of peginterferon
      alfa-2a and interferon
      alfa-2a). All three treatments were similarly
      tolerated.

      Conclusions. In patients with chronic hepatitis C and
      cirrhosis or bridging
      fibrosis, 180 �g of peginterferon alfa-2a administered
      once weekly is
      significantly more effective than 3 million units of
      standard interferon
      alfa-2a administered three times weekly. (N Engl J Med
      2000;343:1673-80.)


      Source Information
      From the Department of Medicine, University Health
      Network, Toronto Western
      Hospital, Toronto (E.J.H.); the Hepatology Section,
      Department of Medicine,
      Medical College of Virginia, Richmond (M.L.S.); the
      Department of Medicine,
      Royal Brisbane Hospital, Brisbane, Australia
      (W.G.E.C.); the Clinical
      Research Department, Department of Medicine, Royal
      Free Hospital, London
      (G.M.D.); the Department of Medicine, Heritage Medical
      Research Clinic,
      Calgary, Alta., Canada (S.S.L.); the Department of
      Medicine, Louisiana State
      University Health Sciences Center, New Orleans (L.B.);
      Carolinas Center for
      Liver Disease, Department of Medicine, Charlotte, N.C.
      (R.R.); the Center for
      Liver Diseases, Department of Medicine, University of
      Miami School of
      Medicine, Miami (R.K.R.); the Gastroenterology Unit,
      Department of Medicine,
      Veterans Affairs Medical Center, San Francisco
      (T.L.W.); and
      Hoffmann-LaRoche, Nutley, N.J. (A.L., J.H., J.D.).
      Address reprint requests
      to Dr. Heathcote at the University Health Network,
      Toronto Western Hospital,
      399 Bathurst St., Toronto, ON M5T 2S8, Canada.

      The other members of the study group are listed in the
      Appendix.


      Appendix
      In addition to the authors, members of the study group
      who participated in
      this study were V. Bain, University of Alberta,
      Edmonton, Canada; M.F.
      Bassendine, Freeman Hospital, Newcastle upon Tyne,
      United Kingdom; C.L. Berg,
      University of Virginia Health System, Charlottesville;
      T.D. Boyer, Emory
      University School of Medicine, Atlanta; M. DeMicco,
      Associated
      Gastroenterology Medical Group Clinical Research,
      Anaheim, Calif.; P.
      Desmond, St. Vincent's Hospital, Melbourne, Victoria,
      Australia; G. Farrell,
      Westmead Hospital, Westmead, Australia; M. Fried,
      University of North
      Carolina, Chapel Hill; K. Lindsay, Ambulatory Health
      Center, University of
      Southern California, Los Angeles; P.F. Malet,
      University of Texas
      Southwestern Medical Center, Dallas; P. Martin, UCLA
      School of Medicine, Los
      Angeles; G.Y. Minuk, Health Sciences Centre, Winnipeg,
      Man., Canada; D.K.
      Moonka, Henry Ford Hospital, Detroit; N.V. Naoumov,
      University College London
      Medical School, London; J. O'Grady, King's College
      School of Medicine and
      Dentistry, London; S. Pedder and B.P. Rae,
      Hoffmann-LaRoche, Nutley, N.J.;
      P.J. Pockros, Scripps Clinic, La Jolla, Calif.; W.
      Rosenberg, University of
      Southampton School of Medicine, Southampton, United
      Kingdom; S. Ryder,
      Queen's Medical Center, Nottingham, United Kingdom; M.
      Sherman, Toronto
      General Hospital, Toronto; C. Smith, Minnesota
      Clinical Research Center, St.
      Paul; H.C. Thomas, St. Mary's Hospital, London; and S.
      Whalley, Royal Free
      Hospital, London. Members of the Safety Review Board
      were C. Ghent,
      University of Western Ontario, London, Ont., Canada;
      E. Krawitt, University
      of Vermont Medical Center, Burlington; and J. Rakela,
      Mayo Clinic Scottsdale,
      Scottsdale, Ariz.

      <A
      HREF="http://www.nejm.org/content/2000/0343/0023/1673.asp">
      http://www.nejm.org/content/2000/0343/0023/1673.asp</A>

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