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

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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 1 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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