Continuous Pump Infusion of Consensus Interferon in Non-responders
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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
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
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