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Daily high-dose interferon for the treatment of chronic hepatitis C

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  • claudine intexas
    Am J Gastroenterol 2000 Nov;95(11):3225-9 A multicenter, randomized trial of daily high-dose interferon-alfa 2b for the treatment of chronic hepatitis c:
    Message 1 of 1 , Dec 3, 2000
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      Am J Gastroenterol 2000 Nov;95(11):3225-9


      A multicenter, randomized trial of daily high-dose
      interferon-alfa 2b
      for
      the treatment of chronic hepatitis c: pretreatment
      stratification by
      viral
      burden and genotype.


      Fried MW, Shiffman M, Sterling RK, Weinstein J,
      Crippin J, Garcia G,
      Wright
      TL, Conjeevaram H, Reddy KR, Peter J, Cotsonis GA,
      Nolte FS

      Emory University School of Medicine, Atlanta, Georgia,
      USA.
      [Medline record in process]

      OBJECTIVES: The aim of this study was to determine
      prospectively
      whether an
      intensive regimen of daily, high-dose interferon would
      improve the
      response
      rate for the treatment of chronic hepatitis C in
      patients with
      unfavorable
      virological characteristics. METHODS: A total of 104
      patients with
      chronic
      hepatitis C were randomized at eight centers to
      receive interferon
      alfa-2b
      at a dose of 5 million units (MU) daily or 3 MU t.i.w.
      for a period of
      24
      wk. Patients were prospectively randomized by low or
      high viral burden
      and
      stratified by genotype. HCV RNA was measured by
      quantitative polymerase
      chain reaction, and response rates were compared
      between the dosage
      regimens. RESULTS: HCV RNA levels dropped more rapidly
      to lower levels
      in
      the group treated with 5 MU daily. In this group, the
      initial
      virological
      response (IR) at wk 12 and the end-of-treatment
      response (ETR) at wk 24
      were
      double that of patients treated with standard
      interferon (66% vs 33%
      and 48%
      vs 24%, p < 0.01). Sustained response rates were low
      for both dose
      groups
      (14% vs 4%, p = 0.08). Genotype-related differences in
      initial response
      rates were present in the standard dose group (63%
      non-1 genotype vs
      24%
      genotype 1; p = 0.005) but not in those treated with 5
      MU daily (66% vs
      67%,
      p = NS). Using multivariate analysis, only the
      interferon dose was
      associated with IR and ETR (p = 0.002). CONCLUSIONS:
      Daily, high dose
      interferon rapidly dropped HCV RNA and increased
      initial and
      end-of-treatment response rates when compared to
      t.i.w. regimens. This
      effect, independent of viral burden and genotype,
      suggests that
      patients
      with unfavorable viral characteristics might benefit
      from an intensive
      regimen that promotes rapid viral clearance. These
      data support further
      study of the use of high-dose induction regimens.
      However, improvements
      in
      sustained response rates will require additional
      therapeutic maneuvers
      such
      as prolonged therapy or the adjunctive use of
      ribavirin.
      PMID: 11095346, UI: 20544455



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