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16122Fw: NATAP: Retreat w/Pegasys for PegIntron Failures

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  • Alley Pat
    May 2, 2006
      NATAP http://natap.org/


      Retreatment with peginterferon alfa-2a plus ribavirin in patients in whom peginterferon alfa-2b plus ribavirin has failed

      Interim efficacy analysis of the REPEAT study

      Patrick Marcellin,1 Donald Jensen and the REPEAT Study Group
      1Hôpital Beaujon, Clichy,
      University of Paris, France

      NATAP- The most original, real-time, comprehensive, independent conference reporting.
      Reported by Jules Levin
      EASL, April 26-30, Vienna, Austria

      REPEAT study: primary objective
      To investigate the efficacy and safety of peginterferon alfa-2a plus ribavirin in patients whose previous pegylated interferon alfa-2b plus ribavirin combination therapy had failed

      To compare:
      - Fixed-dose induction during the first 12 weeks
      (360 ug/week) vs standard dose (180 ug/week)
      - Extended duration of treatment
      (72 weeks) vs standard duration (48 weeks)

      In a difficult-to-treat population (patients in whom prior pegylated interferon alfa-2b plus ribavirin has failed), high rates of EVR were achieved following 12 weeks' retreatment with peginterferon alfa-2a (PEGASYS®) plus ribavirin (COPEGUS)--

      -- 45% with standard dose (180 ug/week)
      -- 62% with fixed-dose induction (360 ug/week)

      Patients with advanced liver disease also achieved high EVR rates at week 12:

      -- 38% with standard dose
      -- 50% with fixed-dose induction

      In patients with poor prognostic factors, stratified analyses documented high EVR rates with standard-dose peginterferon alfa-2a:
      -- EVR rates were even higher in those patients receiving the fixed-dose induction (360 ug/ml)

      In addition to treatment regimen, bodyweight, baseline HCV RNA level and cirrhosis/bridging fibrosis were significant predictors of an EVR in multivariate analysis
      -- HCV genotype was not a significant predictor of an EVR

      Fixed-dose induction peginterferon alfa-2a plus ribavirin was as well tolerated as the standard dose

      REPEAT study design
      950 patients randomised 2:1:1:2

      RBV dose: 1000/1200 mg/day

      Protocol-planned week-12 interim analysis

      Planned interim efficacy
      and safety analysis
      -- Prospectively-defined, protocol-planned analysis of efficacy and safety
      -- All randomised and treated patients
      -- Comparison of peginterferon alfa-2a:
      -- 360 ºg/week vs 180 ºg/week
      -- At the end of the induction period (week 12)

      o Non-responders to â?¥12 weeks of treatment with standard doses of pegylated interferon alfa-2b plus ribavirin
      o Pegylated interferon alfa-2b plus ribavirin discontinued
      >12 weeks prior to enrolment
      o Age â?¥18 years
      o Detectable HCV RNA (>600 IU/mL) in serum
      o Liver biopsy consistent with chronic hepatitis C
      o Compensated liver disease
      o Recruited between September 2003 and March 2005

      Baseline characteristics

      Week 12 efficacy analysis
      -Early virological response (EVR) assessed at week 12

      Defined as:
      -- HCV RNA undetectable (<50 IU/mL)â?¡
      -- HCV RNA below quantitation (<600 IU/mL)â?
      -- >2-log10 drop of HCV RNAâ?

      â?¡COBAS AMPLICOR HCV Test, v2.0

      Virological response at week 12

      EVRâ? by baseline histological status

      â? >2-log10 drop in HCV RNA or unquantifiable HCV RNA or undetectable HCV RNA

      EVRâ? in patients with poor prognostic factors

      â? >2-log10 drop in HCV RNA or unquantifiable HCV RNA or undetectable HCV RNA

      Final multivariate logistic regression model:
      Factors associated with an EVRâ?

      â? >2-log10 drop in HCV RNA or unquantifiable HCV RNA or undetectable HCV RNA
      â?¡HCV genotype, bridging fibrosis/cirrhosis and region were included in the model as these were stratification factors
      ALT quotient was not included as the Wald chi-square statistic was not significant at the 0.2 level

      Key safety data

      Effect of treatment on platelet count

      Effect of treatment on neutrophil count


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