Loading ...
Sorry, an error occurred while loading the content.

Pegasys in previous nonresponders to Interferon Alfa-2A

Expand Messages
  • claudine intexas
    NATAP - www.natap.org ... AASLD Dallas, Nov 9-13 Reported by Jules Levin ENHANCED VIROLOGICAL RESPONSE TO TREATMENT WITH 40 KDA PEGINTERFERON ALFA-2A (PEGASYS)
    Message 1 of 1 , Dec 1, 2001
    • 0 Attachment
      NATAP - www.natap.org
      ----------------------

      AASLD
      Dallas, Nov 9-13
      Reported by Jules Levin

      ENHANCED VIROLOGICAL RESPONSE TO TREATMENT WITH 40 KDA
      PEGINTERFERON ALFA-2A (PEGASYS) IN PATIENTS PREVIOUSLY
      UNRESPONSIVE TO TREATMENT WITH INTERFERON ALFA-2A

      editorial note from Jules Levin: there have been
      several studies showing mostly relatively preliminary
      data that shows patients who previously failed IFN+RBV
      (Rebetron) could respond to Pegaylated IGN + RBV. This
      study reports encouringing data that patients
      previously not responding to IFN monotherapy can
      respond to Pegasys alone. See resulrs below. See NATAP
      website for ongoing coverage of the AASLD liver
      meeting.

      Gerald Y Minuk, Univ of Manitoba, Winnipeg, MB Canada;
      K. Rajender Reddy, Univ of Miami Sch of Medicine,
      Miami, FL; Samuel S Lee, Univ of Calgary, Calgary, AB
      Canada; E. Jenny Heathcote, Toronto Western Hosp,
      Toronto, ON Canada; John O'Grady, King's Coll Sch of
      Medicine, London Uk; Paul J Pockros, The Scripps
      Clinic, La Jolla, CA; Mitchell L Shiffman, Med Coll of
      Virginia, Richmond, VA; Nikolai V Naoumov, Univ Coll
      London, London Uk; Farhad Sedarati, Jean Depamphilis,
      Hoffmann-La Roche, Nutley, NJ

      Background: Initial treatment with interferon (IFN) in
      patients with chronic hepatitis C (CHC) results in
      sustained virological response (SVR) in only about
      8-20% of patients. Retreatment of IFN nonresponders
      with a second, more intensive IFN course has yielded
      disappointing results. 40 kDa peginterferon alfa-2a
      (PEGASYS) is a modified form of IFN a-2a with an
      optimized pharmacokinetic profile. In previous studies
      treatment of IFN-na�ve CHC patients with 40 kDa
      peginterferon alfa-2a results in SVRs of 30% to 39%
      (Zeuzem S et al. N Engl J Med. 2000; 343:1666-1672).
      The efficacy of 40 kDa peginterferon alfa-2a in
      patients unresponsive to previous IFN therapy has not
      yet been reported.

      Objectives: To evaluate the efficacy of therapy with
      40 kDa peginterferon alfa-2a in patients previously
      unresponsive to IFN a-2a therapy.

      Methods: All eligible patients had received 24-48
      weeks of IFN a-2a tiw (3-6 MIU for the first 12 weeks
      followed by 3 MIU for the remainder of treatment) for
      the treatment of CHC, and had failed to achieve an SVR
      (defined as undetectable HCV RNA using AMPLICOR HCV�
      Test, v 2.0, lower limit of sensitivity 100 copies/mL,
      24 weeks post-treatment). Patients who had not
      tolerated IFN therapy were ineligible for retreatment.
      Participating patients received 40 kDa peginterferon
      alfa-2a 180 mg sc qw for up to 48 weeks and were
      subsequently followed for 24 weeks. Patients failing
      to show a 2 log10 decrease in HCV RNA between baseline
      and week 12, and patients demonstrating detectable HCV
      RNA despite 24 weeks of treatment, were considered
      nonresponders and were prematurely discontinued from
      therapy.

      Results. A total of 101 patients participated in this
      study, including 92 end-of-treatment nonresponders
      (EoT-NR) and 9 responder-relapse patients (RR).
      Patients were predominantly male (73%) with a mean
      weight of 78.3 kg and baseline viral load ranging from
      0.04 x 10(6) to 40.9 x 10(6) copies/mL (54 patients
      [54%] 2.0 x 10(6) copies/mL). Seventy-one patients
      (71%) were infected with HCV genotype 1, and 29
      patients (29%) had cirrhosis or bridging fibrosis.

      --Among previously-treated EoT-NR, end-of-treatment
      response (EoTR) and SVR were achieved by 33% and 19%
      of patients, respectively.

      --EoTR and SVR for RR patients were 89% and 33%,
      respectively.

      --Importantly, among patients who did achieve
      undetectable HCV RNA during the initial IFN treatment
      regimen (ie, breakthrough and RR, n=31), EoTR and SVR
      were found in 24 (77%) and 14 (45%) patients.

      --Only 17 patients (24%) and 8 patients (11%) achieved
      EoTR and SVR, respectively, among the 70 patients who
      had never completely responded.

      Conclusions: These results provide further evidence
      that 40 kDa peginterferon alfa-2a is an optimized form
      of IFN with improved efficacy over the parent
      compound, particularly in traditionally
      difficult-to-treat patient groups. Moreover, these
      data suggest that retreatment with the combination of
      40 kDa peginterferon alfa-2a and ribavirin may result
      in even higher SVR in IFN nonresponders, especially
      those who had achieved undetectable HCV RNA at some
      point during the initial treatment period.


      __________________________________________________
      Do You Yahoo!?
      Buy the perfect holiday gifts at Yahoo! Shopping.
      http://shopping.yahoo.com
    Your message has been successfully submitted and would be delivered to recipients shortly.