my name is kevin. I was diagnosed in 2002 i was
wondering if anyone has been taking milk thistle and
vitamin e. If so has anyone noticed any difference? I
dont know anything more than in 2002 my alt levels
were 80. I cannot afford the treatments either
--- lonestarheppers@yahoogroups.com
<no_reply@yahoogroups.com> wrote:
>
> "Phase I/II Dose Escalation Trial Assessing
Tolerance,
> Pharmacokinetics and Antiviral Activity of NM283, a
novel Antiviral
> Treatment for Hepatitis C"
>
> Reported by Jules Levin
>
> E Godofsky reported on NM283, a new HCV drug
(polymerase inhibitor),
> and the initial clinical study results at the final
hepatitis oral
> session on May 18 at DDW May 2004 in New Orleans.
>
> Summary: NM283 is orally administered new HCV drug.
This is the
> first study conducted in HCV-infected patients.
About 80 patients
> were studied with various doses. Using the highest
dose regimen HCV
> viral load was reduced by a mean 1.1 log after 15
days of dosing.
> Patients were all genotype 1 and interferon
failures. Overall the
> drug appeared safe and tolerable. GI side effects
were seen but were
> transient. The next planned study is a 4 week
combination study with
> peginterferon.
>
> Godofsky said in his talk that >800,000 cases of
end-stage hepatitis
> C are expected in the USA in the coming decade;
similar trend in
> Europe. We need high SVR rates with limited
treatment duration,
> particularly in genotype 1 with >70% in the USA
being genotype 1 and
> 60% in Europe. We need oral, safe and well-tolerated
medicines with
> treatment for patients with decompensated cirrhosis.

>
> NM283, a novel candidate HCV RNA polymerase
inhibitor, has anti-
> flavivirus activity that is highly synergistic with
interferon-_ in
> vitro, and suppresses viremia in chimpanzees
chronically infected
> with human-derived HCV-1 (Standring, EASL2003). Here
we report the
> first clinical data for NM283 in humans.
>
> NM283 has EC50 vs BVDV=0.67 ± 0.22 uM; 2'-methyl
substituent key to
> anti-HCV activity; inhibits virus encoded RNA
polymerase- probable
> mechanism of action- viral RNA chain-terminator; no
activity against
> HIV or DNA viruses; valyl ester prodrug provides
high oral
> bioavailability.
>
> NM107 is the precursor to NM283 and is active in a
surrogate mouse
> virus model and is synergistic in combination with
IFN-a in a cell
> based persistent BVDV infection model. In this model
BVDV titer log
> units/mL was reduced about 1 log by IFN 200
units/mL, about 4 logs
> by NM107 8uM, and by 8 logs with IFN 200 units/mL
plus NM107 8uM in
> 12 day experiment (Standring et al EASL 2003).
>
> NM283 inhibited HCV-1 replication in chronically
infected
> chimpamzees by mean 1.05 log. 5 chimpanzees who were
chronically
> infected with HCV-1 received oral treatment for 7
days once daily, 3
> treatment arms: placebo (1 animal); NM283 8.3
mg/kg/day (7 animals);
> higher dose NM283 16.6 mg/kg/day (2 animals). Serum
HCV RNA was
> quantified by Roche Amplicor PCR.HCV RNA was reduced
by 0.83 log
> (low dose) and 1.05 log (high dose); no change in
placebo chimp
> (Standring et al EASL 2003).
>
> NM283 for Hepatitis C: Dose Escalation Trial
>
> --first in man dose escalation trial
> --objective is to evaluate safety, antiviral
activity and PK during
> 15 day treatment and 2 week post-treatment
follow-up. The patients
> were adults with chronic HCV; HCV genotype 1; IFN
failures &
> treatment-naïve. Serum HCV RNA >5 log IU/mL; ALT <5
x ULN; no IFN in
> preceding 6 months; compensated liver disease, no
cirrhosis.
>
> Dosing levels: 50-800 mg/day. Each dosing cohort of
12 eligible
> patients randomized 10:2 to NM283 vs placebo. The
study was held at
> 6 US sites. All patienys confirmed non-cirrhotic by
liver biopsy.
>
> Characteristics of patients: age 47-52; 60-70% men;
90% Caucasian;
> 90% IFN failures; serum HCV RNA -- 6.6 mean log
IU/mL; serum ALT --
> 64 mean units/mL; cohrt 6 was dose escalated from
100 to 800 mg;
> cohort 7 was escalated from 400 to 800 mg +
antiematic.
>
> VIRAL LOAD REDUCTIONS AT DAY 15
>
> The placebo group had no reduction.
>
> The dose escalation group 400 to 800 mg + antiematic
had mean viral
> load reduction of 1.1 log.
>
=== Message Truncated ===




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