Maximine Update from AASLD
This new HCV treatment in development was updated at
AASLD. It will be
studied in combination with Pegasys. It's limited by
the fact that it
administered by subcutaneous injection.
Maximine is an immune based therapy with application
is supposed to inhibit oxidative stress which can
to lymphocytes which are essential for viral killing.
48 week results of a 72 week study on 129
individuals receiving interferon+Maxima. Maxima was
given at various
regimens and is
administered by subcutaneous injections. This was an
international study. At baseline mean age was young
(30), Viral load
at 6.7 million, and 53% with >2 million copies/ml. 47%
had genotype 1,
about 49% had genotype 2. Patients were randomized to
1 of 4 dosing
A limitation of this study is that all patients
received Maximine and
its difficult to tell how much benefit Maximine is
viral response is defined as <1000 copies/ml. In
brief, after 48 weeks-
--58% of all patients (57-69% across all 4 dose
response AND virologic response is defined as >1000
--58% with genotype 1b (range 36-88%) had viral
--70% with genotypes 2/3 (58-80%) had viral
--48% with high viral load (33-57%) had viral
--Drug administration resulted in mild
transient side effects.
induced short lasting flush in most patients and a
--headache, hypotension, and lachycardia in
some patients. They
overall it was well tolerated. 5% discontinued study
by week 48.
Another unusual aspect of results is that genotype 1
genotype 2/3. They reported drug has an acceptable
reported preliminary 12 week data from small ongoing
who did not respond to previous therapy (nonresponders
are genotype 1. After 8 weeks patients can increase
IFN dose ftom 3 MIU
times per week to 3-6 MIU daily. Maxima dose was 1 mg
injection with option to escalate to 1 mg bid, once
weekly. After 12
4/13 were serum HCV RNA negative. Obviously too soon
to tell anything.
8/13 had 2 or more log decrease in viral load. 5/18
There were no unexpected and/or irreversible adverse
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