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A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C

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  • claudine intexas
    Hepatology 2000 Sep;32(3):647-53 Related Articles, Books, LinkOut A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C.
    Message 1 of 2 , Sep 3, 2000
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      Hepatology 2000 Sep;32(3):647-53 Related Articles,
      Books, LinkOut


      A dose-ranging study of pegylated interferon alfa-2b
      and ribavirin in
      chronic hepatitis C.

      Glue P, Rouzier-Panis R, Raffanel C, Sabo R, Gupta SK,
      Salfi M, Jacobs
      S,
      Clement RP

      Schering-Plough Research Institute, Kenilworth, NJ.

      [Medline record in process]

      The objectives of this study were to assess the
      safety,
      pharmacokinetics,
      and efficacy of pegylated interferon alfa-2b
      (PEG-Intron) plus
      ribavirin in
      patients with chronic hepatitis C. A total of 72
      patients (35 men/37
      women,
      age range 20-68 years) with clinically compensated
      chronic hepatitis C
      virus (HCV) were enrolled into this open-label,
      randomized, active
      controlled study. Patients received either PEG-Intron
      0.35, 0.7, or 1.4
      &mgr;g/kg subcutaneously weekly for 24 weeks alone, or
      in combination
      with
      ribavirin 600, 800, or 1,000 to 1,200 mg orally daily.
      Patients were
      evaluated during treatment and after a 24-week
      follow-up period for
      safety
      and efficacy. Detailed pharmacokinetic assessments
      were performed at
      weeks
      1 and 4. PEG-Intron alone produced expected
      dose-related reductions in
      white cells, neutrophils and platelets. Addition of
      ribavirin reduced
      hemoglobin levels in a dose-related manner, did not
      further reduce
      PEG-Intron-induced decreases in neutrophil or white
      cell count, and
      increased platelet counts. Neutrophil function tests
      (C5a and FMLP
      migration, killing curves) were unaltered. Reported
      adverse events
      (flu-like symptoms, asthenia) were qualitatively
      similar in all dose
      groups. Anti-HCV activity, as measured by loss of
      detectable serum HCV
      RNA
      (i.e. <100 copies/mL) at the end of treatment (week
      24) and after 24
      weeks
      of follow-up (week 48) showed dose-response trends for
      PEG-Intron. At
      each
      PEG-Intron dose level, anti-HCV activity was higher in
      patients
      coadministered ribavirin than in patients treated with
      PEG-Intron
      monotherapy. There was no evidence of pharmacokinetic
      interactions with
      either drug. We conclude that the safety and
      tolerability of combined
      PEG-Intron/ribavirin and PEG-Intron alone were
      comparable. Combined
      PEG-Intron/ribavirin showed dose-related synergistic
      anti-HCV effects,
      which were numerically superior to those obtained with
      PEG-Intron
      monotherapy.

      PMID: 10960463, UI: 20417957


      =====
      Claudine
      claudinecrews@...

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    • claudine intexas
      Hepatology 2000 Sep;32(3):647-53 A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C. Glue P, Rouzier-Panis R, Raffanel
      Message 2 of 2 , Sep 16, 2000
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        Hepatology 2000 Sep;32(3):647-53

        A dose-ranging study of pegylated interferon alfa-2b
        and ribavirin in
        chronic hepatitis C.

        Glue P, Rouzier-Panis R, Raffanel C, Sabo R, Gupta SK,
        Salfi M, Jacobs
        S,
        Clement RP

        Schering-Plough Research Institute, Kenilworth, NJ.

        The objectives of this study were to assess the
        safety,
        pharmacokinetics,
        and efficacy of pegylated interferon alfa-2b
        (PEG-Intron) plus
        ribavirin in
        patients with chronic hepatitis C. A total of 72
        patients (35 men/37
        women,
        age range 20-68 years) with clinically compensated
        chronic hepatitis C
        virus
        (HCV) were enrolled into this open-label, randomized,
        active controlled
        study. Patients received either PEG-Intron 0.35, 0.7,
        or 1.4 &mgr;g/kg
        subcutaneously weekly for 24 weeks alone, or in
        combination with
        ribavirin
        600, 800, or 1,000 to 1,200 mg orally daily. Patients
        were evaluated
        during
        treatment and after a 24-week follow-up period for
        safety and efficacy.
        Detailed pharmacokinetic assessments were performed at
        weeks 1 and 4.
        PEG-Intron alone produced expected dose-related
        reductions in white
        cells,
        neutrophils and platelets. Addition of ribavirin
        reduced hemoglobin
        levels
        in a dose-related manner, did not further reduce
        PEG-Intron-induced
        decreases in neutrophil or white cell count, and
        increased platelet
        counts.
        Neutrophil function tests (C5a and FMLP migration,
        killing curves) were
        unaltered. Reported adverse events (flu-like symptoms,
        asthenia) were
        qualitatively similar in all dose groups. Anti-HCV
        activity, as
        measured by
        loss of detectable serum HCV RNA (i.e. <100 copies/mL)
        at the end of
        treatment (week 24) and after 24 weeks of follow-up
        (week 48) showed
        dose-response trends for PEG-Intron. At each
        PEG-Intron dose level,
        anti-HCV
        activity was higher in patients coadministered
        ribavirin than in
        patients
        treated with PEG-Intron monotherapy. There was no
        evidence of
        pharmacokinetic interactions with either drug. We
        conclude that the
        safety
        and tolerability of combined PEG-Intron/ribavirin and
        PEG-Intron alone
        were
        comparable. Combined PEG-Intron/ribavirin showed
        dose-related
        synergistic
        anti-HCV effects, which were numerically superior to
        those obtained
        with
        PEG-Intron monotherapy.

        PMID: 10960463, UI: 20417957


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