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

Continuous Pump Infusion of Consensus Interferon in Non-responders

Expand Messages
  • claudine intexas
    NATAP - www.natap.org Continuous Pump Infusion of Consensus Interferon in Non-responders to HCV Therapy: pilot study Myron Tong, Huntington Memorial Hospital
    Message 1 of 1 , Nov 15, 2003
    • 0 Attachment
      NATAP - www.natap.org

      Continuous Pump Infusion of Consensus Interferon in Non-responders to
      HCV Therapy: pilot study

      Myron Tong, Huntington Memorial Hospital Liver Center, Pasadena, CA
      and colleagues and InterMune, Inc., Brisbane, CA. 54th AASLD, Oct
      25-29, 2003, Boston, MA

      ABSTRACT
      Pegylation of interferon-alfa results in an improved pharmacokinetic
      profile by maintaining constant blood levels, resulting in higher
      sustained response rates (SVR). However, modification of
      interferon-alfa by pegylation also reduces biologic potency. Delivery
      of a bio-optimized alpha interferon in an unmodified form (consensus
      interferon, Infergen(r)) by continuous infusion can be expected to
      provide sustained and constant levels of a fully potent protein.

      We hypothesize that such an approach may potentially result in
      greater antiviral activity and improved tolerability by avoiding wide
      swings in interferon levels.

      We conducted a phase 2 pilot study to assess the safety, tolerability
      and viral kinetics of Infergen (12 ug/day) by continuous infusion
      using a subcutaneous infusion device (Medtronic MiniMed(r) pump) in
      combination with ribavirin (1000 mg or 1200 mg daily). The MiniMed
      model 508 micro infusion pump is cleared for use in the treatment of
      diabetes. HCV RNA viral levels were measured at days 1, 3, 7, 10, 14,
      21, 28 and then at weeks 6 and 12.

      Among 10 nonresponders treated to date with Infergen by continuous
      infusion with available early viral kinetics data, 7 showed a
      substantial reduction in HCV viral levels (at least 1 log10 reduction
      in 4, and 2 log10 reduction in 3). All 7 of these patients were
      genotype 1 and 6 had less than 1.0 log10 decrease with prior
      treatment while 1 had a 1.5 log10 decrease at similar time-points
      with other combination therapy [either pegylated interferon/RBV (4
      pts) or interferon-alfa/RBV (3 pts)].

      No serious adverse events were reported and 3 patients discontinued
      (2 due to moderate interferon-related side effects and 1 due to
      inability to acclimate to the pump). Other patients continuing on
      study experienced mild adverse events that have been tolerable.

      The authors concluded that consensus interferon administered by
      continuous delivery via the Medtronic MiniMed pump shows early
      substantial reduction of HCV RNA levels among nonresponder patients
      and shows a good safety and tolerability profile. Updated data on a
      total of 22 patients (including 10 na�ve genotype 1 patients) will be
      presented.


      __________________________________
      Do you Yahoo!?
      Protect your identity with Yahoo! Mail AddressGuard
      http://antispam.yahoo.com/whatsnewfree
    Your message has been successfully submitted and would be delivered to recipients shortly.