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Durability of Pegasys in previous nonresponders - 2/3 yr follow up

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  • claudine intexas
    NATAP - www.natap.org ... AASLD Dallas, Nov 9-13 Reported by Jules Levin Abstract 633. LONG-LASTING SUSTAINED VIROLOGICAL RESPONSE IN CHRONIC HEPATITIS C
    Message 1 of 2 , Dec 1, 2001
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      NATAP - www.natap.org
      ----------------------

      AASLD
      Dallas, Nov 9-13
      Reported by Jules Levin

      Abstract 633. LONG-LASTING SUSTAINED VIROLOGICAL
      RESPONSE IN CHRONIC HEPATITIS C PATIENTS PREVIOUSLY
      TREATED WITH 40 KDA PEGINTERFERON ALFA-2A (PEGASYS)

      Mark Swain, Univ of Calgary, Calgary, AB Canada; E J
      Heathcote, Toronto Western Hosp, Toronto, ON Canada;
      Ming-Yang Lai, National Taiwan Univ Hosp, Taipei
      Taiwan; Vincent Bain, Univ of Alberta Hosp, Edmonton,
      AB Canada; Victor Feinman, Univ of Toronto, Toronto,
      ON Canada; Morris Sherman, Toronto Gen Hosp, Toronto,
      ON Canada; Kelly D Kaita, Univ of Manitoba, Winnipeg,
      MB Canada; Edward Gane, Auckland Hosp, Auckland New
      Zealand; Kevork Peltekian, Queen Elizabeth Hosp,
      Halifax, NS Canada; Karen Lindsay, Univ of Southern
      CA, Los Angeles, CA; Joseph Hoffman, Michael Brunda,
      Hoffmann-La Roche, Nutley, NJ

      Background: Treatment of chronic hepatitis C (CHC)
      patients with 40 kDa peginterferon alfa-2a (PEGASYS)
      results in superior antiviral efficacy compared to
      patients treated with interferon alfa-2a (IFN a-2a) in
      both a general CHC population and in a population of
      CHC patients with cirrhosis (Zeuzem S et al. N Engl J
      Med. 2000;343:1666-1672; Heathcote EJ et al. N Engl J
      Med. 2000;343:1673-1680; Pockros PJ et al. Hepatology.
      2000;32(suppl):442A). In these studies, the sustained
      virological response was determined at the end of a
      24-week treatment-free follow-up period. With other
      anti-HCV therapies, long-term virological responses
      have been reported at time points beyond 24 weeks of
      follow-up. To date there has been no long-term
      follow-up on patients who were treated in studies
      evaluating the effects of 40 kDa peginterferon
      alfa-2a.

      Objective: To investigate the long-term virological
      effects of treatment with 40 kDa peginterferon alfa-2a
      in patients with CHC.

      Methods: CHC patients who previously participated in
      one of 3 phase III studies comparing the safety and
      efficacy of 40 kDa peginterferon alfa-2a and IFN a-2a
      were included in this study if they had completed the
      24 week follow-up period in the original study.
      Patients could not be on any anti-HCV therapy
      subsequent to their original treatment and were tested
      yearly for HCV RNA. All patients were off original
      therapy for 2 to 3 years. HCV RNA was measured using
      AMPLICOR HCV��� Test v 2.0, with a lower limit of
      detection of 50 IU/mL.

      Results: To date, over 300 patients have been enrolled
      into the study. Study enrollment and data collection
      are ongoing. Approximately two-thirds of the patients
      were originally infected with HCV genotype 1 and 25%
      were cirrhotic. Seventy percent of patients entering
      this trial were treated with 40 kDa peginterferon
      alfa-2a. Patients were evenly divided, with
      approximately 50% of patients being HCV RNA negative
      and 50% HCV RNA positive at the last assessment in the
      original protocol.

      --Of the patients who were originally HCV RNA
      negative, > 99% remained HCV RNA negative 2 to 3 years
      after the end of their original therapy.

      --In this population, all patients who were of HCV
      genotype 1 or cirrhotic remained HCV RNA negative.

      In the patient population that was HCV RNA positive at
      the end of follow-up of the original study, all but
      one patient remained HCV RNA positive. Interestingly,
      the one patient who became HCV RNA negative was a
      virological responder until week 24 of follow-up in
      the original trial. No HCV RNA could be quantified in
      this patient, consistent with the possibility of a
      false positive HCV RNA test at the last evaluation in
      the original study.

      Conclusions: The sustained virological response
      achieved with 40 kDa peginterferon alfa-2a results in
      a durable response in all patients, including those
      with more difficult-to-treat disease (genotype 1 and
      patients with cirrhosis). The data demonstrate that
      CHC patients originally treated with 40 kDa
      peginterferon alfa-2a and were HCV RNA negative at the
      end of 24 weeks of treatment-free follow-up remain HCV
      RNA negative 2 to 3 years after the end of treatment.
      Future evaluations of this patient population will
      determine the long-term effects of 40 kDa
      peginterferon alfa-2a on virological response.



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    • claudine intexas
      The CORRECT title should have been Durability of Pegasys - 2/3 year follow-up of those previously treated with Pegasys - NOT non-responders! A big difference!
      Message 2 of 2 , Dec 1, 2001
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        The CORRECT title should have been Durability of
        Pegasys - 2/3 year follow-up of those previously
        treated with Pegasys - NOT non-responders! A big
        difference!
        C
        --- claudine intexas <claudineintexas@...>
        wrote:
        > NATAP - www.natap.org
        > ----------------------
        >
        > AASLD
        > Dallas, Nov 9-13
        > Reported by Jules Levin
        >
        > Abstract 633. LONG-LASTING SUSTAINED VIROLOGICAL
        > RESPONSE IN CHRONIC HEPATITIS C PATIENTS PREVIOUSLY
        > TREATED WITH 40 KDA PEGINTERFERON ALFA-2A (PEGASYS)
        >
        > Mark Swain, Univ of Calgary, Calgary, AB Canada; E J
        > Heathcote, Toronto Western Hosp, Toronto, ON Canada;
        > Ming-Yang Lai, National Taiwan Univ Hosp, Taipei
        > Taiwan; Vincent Bain, Univ of Alberta Hosp,
        > Edmonton,
        > AB Canada; Victor Feinman, Univ of Toronto, Toronto,
        > ON Canada; Morris Sherman, Toronto Gen Hosp,
        > Toronto,
        > ON Canada; Kelly D Kaita, Univ of Manitoba,
        > Winnipeg,
        > MB Canada; Edward Gane, Auckland Hosp, Auckland New
        > Zealand; Kevork Peltekian, Queen Elizabeth Hosp,
        > Halifax, NS Canada; Karen Lindsay, Univ of Southern
        > CA, Los Angeles, CA; Joseph Hoffman, Michael Brunda,
        > Hoffmann-La Roche, Nutley, NJ
        >
        > Background: Treatment of chronic hepatitis C (CHC)
        > patients with 40 kDa peginterferon alfa-2a (PEGASYS)
        > results in superior antiviral efficacy compared to
        > patients treated with interferon alfa-2a (IFN a-2a)
        > in
        > both a general CHC population and in a population of
        > CHC patients with cirrhosis (Zeuzem S et al. N Engl
        > J
        > Med. 2000;343:1666-1672; Heathcote EJ et al. N Engl
        > J
        > Med. 2000;343:1673-1680; Pockros PJ et al.
        > Hepatology.
        > 2000;32(suppl):442A). In these studies, the
        > sustained
        > virological response was determined at the end of a
        > 24-week treatment-free follow-up period. With other
        > anti-HCV therapies, long-term virological responses
        > have been reported at time points beyond 24 weeks of
        > follow-up. To date there has been no long-term
        > follow-up on patients who were treated in studies
        > evaluating the effects of 40 kDa peginterferon
        > alfa-2a.
        >
        > Objective: To investigate the long-term virological
        > effects of treatment with 40 kDa peginterferon
        > alfa-2a
        > in patients with CHC.
        >
        > Methods: CHC patients who previously participated in
        > one of 3 phase III studies comparing the safety and
        > efficacy of 40 kDa peginterferon alfa-2a and IFN
        > a-2a
        > were included in this study if they had completed
        > the
        > 24 week follow-up period in the original study.
        > Patients could not be on any anti-HCV therapy
        > subsequent to their original treatment and were
        > tested
        > yearly for HCV RNA. All patients were off original
        > therapy for 2 to 3 years. HCV RNA was measured using
        > AMPLICOR HCV��� Test v 2.0, with a lower limit of
        > detection of 50 IU/mL.
        >
        > Results: To date, over 300 patients have been
        > enrolled
        > into the study. Study enrollment and data collection
        > are ongoing. Approximately two-thirds of the
        > patients
        > were originally infected with HCV genotype 1 and 25%
        > were cirrhotic. Seventy percent of patients entering
        > this trial were treated with 40 kDa peginterferon
        > alfa-2a. Patients were evenly divided, with
        > approximately 50% of patients being HCV RNA negative
        > and 50% HCV RNA positive at the last assessment in
        > the
        > original protocol.
        >
        > --Of the patients who were originally HCV RNA
        > negative, > 99% remained HCV RNA negative 2 to 3
        > years
        > after the end of their original therapy.
        >
        > --In this population, all patients who were of HCV
        > genotype 1 or cirrhotic remained HCV RNA negative.
        >
        > In the patient population that was HCV RNA positive
        > at
        > the end of follow-up of the original study, all but
        > one patient remained HCV RNA positive.
        > Interestingly,
        > the one patient who became HCV RNA negative was a
        > virological responder until week 24 of follow-up in
        > the original trial. No HCV RNA could be quantified
        > in
        > this patient, consistent with the possibility of a
        > false positive HCV RNA test at the last evaluation
        > in
        > the original study.
        >
        > Conclusions: The sustained virological response
        > achieved with 40 kDa peginterferon alfa-2a results
        > in
        > a durable response in all patients, including those
        > with more difficult-to-treat disease (genotype 1 and
        > patients with cirrhosis). The data demonstrate that
        > CHC patients originally treated with 40 kDa
        > peginterferon alfa-2a and were HCV RNA negative at
        > the
        > end of 24 weeks of treatment-free follow-up remain
        > HCV
        > RNA negative 2 to 3 years after the end of
        > treatment.
        > Future evaluations of this patient population will
        > determine the long-term effects of 40 kDa
        > peginterferon alfa-2a on virological response.
        >
        >
        >
        > __________________________________________________
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        > Buy the perfect holiday gifts at Yahoo! Shopping.
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