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Hepatitis C Community
This forum is for questions about medical issues and research aspects of Hepatitis C such as, questions about being newly diagnosed, questions about current treatments, information and participation in discussions about research studies and clinical trials related to Hepatitis. If you would like to communicate with other people who have been touched by Hepatitis, please visit our new Hepatitis Social/Living with Hepatitis forum
Aniexty, Nausea, Liver Related?
by AcheyinWashington, Nov 02, 2004 12:00AM
I used to be a very, active, energetic person. Exercising regularly, etc. At least until last month. I woke u p one night to what felt like internal spasms in my back - right side. I had had some tingling sensations in my right side, beneath my ribs, and my left side as well and likened them to a liver problem (my own assessment). At any rate, I've been driving myself MAD - with anxiety and stress about this entire situation. Nausea, dizziness, and increased urination followed. I rushed to emergency about a week after - but the doctor decided that it was only an anxiety attack I was having. He ordered a CBC - which came back normal. Nothing elevated, nothing decreased. An herbalist put me on some liver chelate medicine which appeared to make matters worse by constipating me severly whereby I was unable to have a good bowel movement for 2-3 weeks. Then I decided it was time for me to make an appointment with a doctor. My doctor said it was epigastric pain which emanated to the back and prescribed me some Pepcid. Since then, I feel like things have been getting worse. Severe back pain (I can't tell if it is muscle related or not), pain emanating all throughout (internally) my abdomen - right side, then left. Sometimes a stabbing pain, other times a burning one. My doctor also ran liver enzyme, thyroid, and calcium tests which showed no abnormalities and an ultrasound which revealed nothing abnormal with my gall bladder, liver or bile ducts. Today I feel a tightness in my stomach area and really need some advice to help ease my worries and mind. Any ideas.
To all folks battling HBV the folks from HCV Advocate Organization have started a site just for hep B sufferers it is at www.hbvadvocate.org Good stuff here, info and support.
Idenix Pharmaceuticals, Inc. (IDIX) Presents New
Data For NM 283 For The Treatment Of Hepatitis C
CAMBRIDGE, MA, Nov. 1 /PRNewswire-FirstCall/ --
Idenix Pharmaceuticals, Inc. , a biopharmaceutical
company engaged in the discovery and development of
drugs for the treatment of human viral and other
infectious diseases, is today presenting new data
for its drug candidate, NM 283, an antiviral agent
for the treatment of hepatitis C virus (HCV), which
is currently in a phase IIa clinical trial.
New data for NM 283 are being presented at AASLD's
55th Annual Meeting in Boston by Dr. Nezam Afdhal of
Harvard Medical School. In this late-breaker oral
presentation today at 5:15 p.m., Dr. Afdhal will
discuss final data from the NM 283 phase I clinical
trial including the 800 mg/day monotherapy cohort
that demonstrated a 1.2 log10, or 94 percent, mean
viral load (HCV RNA) reduction from baseline in
patients with chronic hepatitis C after 15 days of
treatment.
Dr. Afdhal will also review interim 28-day data for
19 patients enrolled in an ongoing phase IIa
clinical trial evaluating the combination of NM 283
and pegylated-interferon. These interim results
demonstrate that the 12 patients receiving the
combination therapy achieved a mean viral load
reduction of 2.7 log10, or 99.8 percent, after 28
days of treatment. These preliminary HCV RNA
responses from the phase IIa clinical trial appear
more consistent across the treated patient
population and greater than results from other
studies that reported data for 4 weeks of treatment
with current standard therapy (pegylated-interferons
and ribavirin) in HCV-1 patients. To date, NM 283
has demonstrated a satisfactory safety profile with
no treatment- related discontinuations in either
clinical trial. Both clinical trials include
patients infected with chronic hepatitis C genotype
1, a difficult to treat strain of the virus, which
is the predominant HCV strain in the U.S., Europe
and Japan.
"Although we have seen improvements in hepatitis C
therapy during the past few years, there is still a
tremendous need for further treatment advances in
efficacy, safety and tolerability particularly for
patients who have HCV genotype 1 and for patients who have failed interferon-based therapies," said
Nezam Afdhal, M.D., a principal investigator in both
NM 283 trials, Chief of Hepatology at Beth Israel
Deaconess Medical Center in Boston and Associate
Professor at Harvard Medical School. Dr. Afdhal
continued, "Data from these clinical trials are
encouraging and suggest that NM 283 may prove to be
a potentially new treatment option for these
patients."
NM 283 - Phase I
The double-blind, randomized phase I dose escalation
clinical trial was designed to evaluate the safety,
pharmacokinetics and antiviral activity of NM 283
during 15 days of treatment with a 2-week follow-up
period. All patients were chronically infected with
the genotype 1 strain of HCV (HCV-1) and either had
previously failed various interferon-based therapies
(87%) or were previously untreated (13%).
The design of the phase I clinical trial included
five once-daily dosing cohorts, 50, 100, 200, 400
and 800 mg, and one twice-daily dosing cohort of 200
mg. Two additional cohorts explored dose-titration
methods to optimize gastrointestinal tolerance of
higher daily doses. Each cohort included 12
patients, randomized so that 10 patients received NM
283 and 2 patients received placebo. Final data
included 95 patients comprising eight dose groups of
which 79 patients received assigned doses of NM 283
and 16 received placebo.
The final data from the phase I clinical trial
indicate a dose-related, consistent viral load
reduction after 15 days treatment with NM 283.
Patients receiving 800 mg/day of NM 283 throughout
the 15-day treatment period, the highest overall
dose exposure, achieved a mean viral load reduction
of 94 percent, or 1.2 log10. Transient, generally
mild gastrointestinal side effects, consisting of
nausea and, occasionally, vomiting, were observed in
some patients. However, these side effects were
never treatment limiting and all affected patients
completed treatment uninterrupted. No serious
adverse events, pattern of lab abnormalities, or
dose-limiting toxicities were observed.
NM 283 - Phase IIa
A phase IIa clinical trial for NM 283 is currently ongoing, and is designed to assess the safety,
antiviral activity and pharmacokinetics of the
combination of NM 283 and pegylated interferon
compared to NM 283 alone. This clinical trial,
evaluating 30 previously untreated patients, was
originally designed to include a 28-day treatment
period. By protocol amendment, the treatment period
has been extended to 3 months. Key entry criteria
for this clinical trial include patients with HCV
genotype 1, baseline viral load greater than 5 log10
copies/ml and alanine aminotransferase (ALT) levels
less than 5 times the upper limit of normal. In this
phase IIa clinical trial, patients are being
randomized to one of two treatment arms so that 12
patients will receive NM 283 monotherapy and 18
patients will receive NM 283 plus pegylated
interferon. In the combination treatment arm,
patients receive a once-daily titrating dose of NM
283 beginning with 400 mg/day, then reaching 800
mg/day at day 8 and continuing with the 800 mg/day
dose through the end of the treatment period. A 1.0
mug/kg dose of pegylated-interferon is administered
on day 8 and every 7th day thereafter throughout the
treatment period.
To date, 19 patients have been enrolled in the
ongoing phase IIa study, with 7 patients randomized
to the NM 283 monotherapy arm and 12 patients to the
combination treatment arm. The interim data
demonstrate marked, consistent, and rapid reductions
in serum virus levels (HCV RNA levels) among the 12
patients receiving the combination treatment (NM 283
plus pegylated- interferon). Patients receiving the
combination treatment achieved a mean viral load
(HCV RNA) reduction of 2.7 log10 copies/mL through
week 4, representing a 99.8 percent reduction in
virus load in the first 4 weeks of treatment.
Results for the combination regimen also show an
enhanced antiviral effect compared to the NM 283
monotherapy arm. This result is consistent with data
from preclinical laboratory studies, which suggested
a synergistic antiviral effect for the combination
of NM 283 plus interferon- alpha.
Of the 12 patients receiving combination treatment
evaluated to date, 9 patients, or 75 percent,
experienced early virologic response (EVR) at 28
days. In this therapeutic field, EVR is defined as a
decrease in serum HCV RNA of greater than or equal
to 2 log10 copies/mL. EVR is also demonstrated by a
reduction of HCV RNA to levels undetectable by a highly sensitive polymerase chain reaction (PCR)
assay. Scientists studying antiviral treatments,
including treatments consisting of interferon plus
ribavirin, have reported that the achievement of EVR
by week 12 of treatment correlates with an improved
chance of sustained viral clearance.
"The consistent antiviral effects observed with NM
283 in the completed phase I trial, in a population
of patients comprised of both previously untreated
patients and interferon non-responders, together
with the early data from the phase IIa clinical
trial, support continued and expanded clinical
testing of NM 283 in combination with pegylated
interferon," said Dr. Nathaniel A. Brown, executive
vice president, clinical research, and chief medical
officer of Idenix Pharmaceuticals. "While these
results are promising, we look forward to evaluating
the combination of NM 283 and pegylated-interferon
for longer treatment durations in the extended phase
IIa trial as well as a phase IIb trial."
Next Steps
Idenix plans to begin a phase IIb clinical trial for
NM 283 by year-end 2004. This 6-month trial is
expected to enroll approximately 165 HCV genotype 1
patients who have previously failed at least 3
months' treatment with current standard therapy
(pegylated interferon plus ribavirin). This phase
IIb trial is designed as a head-to-head study of the
combination of NM 283 and pegylated interferon
compared to the standard treatment regimen of
pegylated interferon plus ribavirin. This phase IIb
clinical trial will also include a monotherapy arm
of NM 283. Idenix expects to complete the phase IIa
and phase IIb trials for NM 283 in 2005.
About NM 283
NM 283 is an oral, novel, nucleoside analog that was
co-discovered by Idenix and the University of
Cagliari through a cooperative laboratory agreement
under the direction of Dr. Paolo LaColla, Director
of the Department of Biomedical Sciences and
Technologies of the university. After absorption, NM
283 is metabolized to a form that inhibits the HCV
RNA polymerase. NM 283 has also demonstrated
inhibition...
Magnum......... still infected after 3 treatments.