Correction: Re: Durability of Pegasys in previous nonresponders - 2/3 yr follow up
- 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
--- claudine intexas <claudineintexas@...>
> NATAP - www.natap.org__________________________________________________
> 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,
> AB Canada; Victor Feinman, Univ of Toronto, Toronto,
> ON Canada; Morris Sherman, Toronto Gen Hosp,
> ON Canada; Kelly D Kaita, Univ of Manitoba,
> 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)
> both a general CHC population and in a population of
> CHC patients with cirrhosis (Zeuzem S et al. N Engl
> Med. 2000;343:1666-1672; Heathcote EJ et al. N Engl
> Med. 2000;343:1673-1680; Pockros PJ et al.
> 2000;32(suppl):442A). In these studies, the
> 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
> Objective: To investigate the long-term virological
> effects of treatment with 40 kDa peginterferon
> 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
> were included in this study if they had completed
> 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
> 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
> into the study. Study enrollment and data collection
> are ongoing. Approximately two-thirds of the
> 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
> original protocol.
> --Of the patients who were originally HCV RNA
> negative, > 99% remained HCV RNA negative 2 to 3
> 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
> the end of follow-up of the original study, all but
> one patient remained HCV RNA positive.
> 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
> this patient, consistent with the possibility of a
> false positive HCV RNA test at the last evaluation
> the original study.
> Conclusions: The sustained virological response
> achieved with 40 kDa peginterferon alfa-2a results
> 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
> end of 24 weeks of treatment-free follow-up remain
> RNA negative 2 to 3 years after the end of
> 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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