Hepatitis C and its preventions

For details
http://www.studyandjobs.com/Hepatitis.html

or visit
http://www.studyandjobs.com

Regards
StudyAndJobs

L.O.L.A. Presents the
2nd New York City
Hepatitis C March

Together we will continue to raise awareness on the
seriousness of the Hepatitis C Virus (HCV). With more
education, prevention and testing methods we can help stop the
spread of HCV within our communities.

Come Join Us and Bring Your Family and Friends Too!

R  E  M  E  M  B  E  R

C-ING IS BELIEVING!

Date: Thursday, May 18, 2006
Place: From Battery Park to City Hall Park
Registration: 9:30 am to 10:30 am
March: 12:00 Noon

Free Admission — Free T-Shirts for the first 1,000 people.

To Register or Volunteer, Please Call 718 892 8697.
To Register for HCV March click link and print the form
http://www.lola-national.org/


http://www.StatusCUnknown.com is a proud member of LOLA's
2nd Hepatitis C March Planning Committee

I met my future wife      here! hehe. And thought I should share it with any
other men who are worried about ending up alone like I was. Check it out if you
like http://www.alwaysopenforyou.info/bbcb

FOR IMMEDIATE RELEASE:
HMA MOVEMENT TO SPONSOR "MARCH ACROSS AMERICA"
      Monday, March 6, 2006
Contact:        HMA Press Office, 540-248-7324

From DC's Capital Hill to NY's City Hall Park, Liver Organizations,
Activist, Families & Support Groups Are Making Plans for May 2006,
National Hepatitis C Awareness Month.
      WASHINGTON, DC– Hepatitis C Movement for Awareness (HMA) is once
again hosting the Fifth Annual, "Weekend for Awareness," with a new
twist this year. Joining HMA, the Latino Organization for Liver
<http://www.lola-national.org/>  Awareness, LOLA, and other
organizations will "March Across America," promoting the need for a
General Awareness Campaign.
In recognition of "Hepatitis C Awareness Month," individuals and groups
that can't make the DC event, are scheduling a march in their own
hometown.  Most will rally on local government to inform about the risk
to communities. Groups interested in participating can visit this link
to sign up. The Movement provides pamphlets that volunteers can print
out, which include a voucher for a free in home test kit.
http://www.march-on-dc.com/National/News/2006/LocalMarch.asp
<http://www.march-on-dc.com/National/News/2006/LocalMarch.asp>

Dubbed "The National Event," held in DC, begins Wednesday, May 24. The
first two days, local State teams will unite on Capital Hill, with
scheduled appointments. This is followed by a "Kick Off" Rally and
Silent Auction, Thursday evening. The March begins Friday, 10 AM, with
plans to step off at 11:30. Participants will gather at Lafayette Park,
across from the White House. There will be guest speakers from the
Hepatitis C community. More information will follow.    Saturday is
"National Testing Day"; a free day for enjoying the National Memorial
activities. Services including parades and entertainment, Many
volunteers will converge on t <http://www.march-on-dc.com/> he National
Mall, distributing HMA's pamphlets and vouchers. Events will end with a
candlelight vigil that evening in memory of the 10,000 former Military
Veterans that died last year because of Hepatitis C.   HEPATITIS C is
viral infection of the blood, with almost 6 million Americans infected.
It can lead to permanent problems, cirrhosis and organ failure. Only 20%
know they have the infection. The only means to prevent it is through
awareness, testing, and a "General Education Campaign."  There is no
vaccine.    As the leading epidemic in the world and the number one
cause of liver transplants in the United States, organizers want the
message clear; "Our primary mission is to alert the public to the many
ways the virus is spread while encouraging people to get tested."
Especially minorities and those with military backgrounds, most
affected. Please come out and support a true effort for federal and
state responses to this epidemic.
Register online at
http://www.march-on-dc.com/National/Events/2006/WelPKG.asp
<http://www.march-on-dc.com/National/Events/2006/registration/WelPkg/sig\
nup.asp>
Special room rates expire on April 21.
For more information and get a copy of the "Are You At Risk" pamphlet
with a test kit voucher visit: www.March-on-DC.com
<http://www.march-on-dc.com/>


[Non-text portions of this message have been removed]

Most people haven't heard of it it has only been known here for the
past 3 years. I started drinking it in December 2005 after reading
about a man that lowered his viral load counts using this juice. Not
trying to sell it, just trying to see if anybody else is using it if
has worked for them or not

--- In lonestarheppers@yahoogroups.com, "Arnold Coley" <arnman@...>
wrote:
>
> Actually, I never heard of it. Tell me this is not someone trying
to sell
> the group something!
>
> Arnie
>
> -----Original Message-----
> From: lonestarheppers@yahoogroups.com
> [mailto:lonestarheppers@yahoogroups.com] On Behalf Of lhanas
> Sent: Tuesday, February 07, 2006 7:57 PM
> To: lonestarheppers@yahoogroups.com
> Subject: [Lone Star Heppers] Mangosteen Juice
>
> Hi, I am new to the group. Was wondering if anybody is drinking
> mangosteen juice to help with Hepatitis C?
>
>
>
>
>
>
> Yahoo! Groups Links
>

I have had HepC since 1994 and have gone through two treatments.
still carrying a load and will try new regimen this fall.  This is
new because I have never really talked or shared with others.  Hi.
There, that's a beginning.

Richard

Actually, I never heard of it. Tell me this is not someone trying to sell
the group something!

Arnie

-----Original Message-----
From: lonestarheppers@yahoogroups.com
[mailto:lonestarheppers@yahoogroups.com] On Behalf Of lhanas
Sent: Tuesday, February 07, 2006 7:57 PM
To: lonestarheppers@yahoogroups.com
Subject: [Lone Star Heppers] Mangosteen Juice

Hi, I am new to the group. Was wondering if anybody is drinking
mangosteen juice to help with Hepatitis C?






Yahoo! Groups Links

Hi, I am new to the group. Was wondering if anybody is drinking
mangosteen juice to help with Hepatitis C?

The following is an excerpt from www.healthyhepper.com ebook
  IMMUNE SYSTEM POWER:  Fight and Win Against the Dragon


THYMIC PROTEIN A - THYMUS EXTRACTS
What is Thymic Protein A?

It is a nutritional supplement designed to effect the same biological activity
as the protein
from the human thymus. It is made from cultured cells, not from actual thymus
glands.
The isolated and purified protein is derived from bovine thymus cells.
Bio Pro Thymic Protein A is packaged in single dose packets, each containing 12
trillion
biologically active molecules of protein in a base of maltodextrin powder.
Dr. Tery Beardsley, an immunologist, discovered and patented the way to preserve
an
intact activated protein in the same complete form as would be produced by the
human
thymus.

How does it work?

The human thymus is part of the body's endocrine and lymphatic systems. It
reaches its
maximum size at puberty and then begins to gradually shrink as we age.

It is Dr. Beardsley's belief that age related decreased immunity is due to a
lack of properly
programmed T-cells and the shrinking of the thymus gland. It is said that by age
40, the
thymus gland is drastically smaller and has very reduced function.

The thymus gland plays a very important role in cell-mediated immunity. The
thymus
gland produces proteins which "program" T-cells. T-cells (T-lymphocytes) are
made by
the bone marrow and they are white blood cells. T-cells find and kill foreign
invaders.
Without the thymic proteins produced by the thymus, the T-cells are "naive",
immature,
and they will not function.

Insufficient production of thymic proteins to program the T-cells could allow
chronic
infections and degenerative diseases to develop. If a T-4 (helper) cell is
programmed by
the proper thymic protein it can identify any invader in the bloodstream, and
secrete
proteins called interleukins and interferons which tell the T-8 (killer) cells
where to find
the invader and how to destroy it.

As explained by Dr. Beardsley, of all the cells in the immune system the t-4
helper cell is
the most important, it regulates the delicate balance of the immune system by
secreting
certain lympokines and cytokines, among them interleukin-2 and interferon, which
act as
"messengers" to tell specific cells to attack and destroy invading pathogens.

Essentially, the T-4 cells guide the "killer" cells (T-8, cytotoxic) to attack
and destroy
certain invadig cells such as viruses and cancer cells. Thymic Protein A is
designed to be
the precise thymus protein which is the key to the cell-mediated immune system
which
programs the T-4 lymphocyte (T-4 helper cell).

A relatively new product (about 5 years old), clinical research does not appear
to be
published yet. Dr. Beardsley is quoted as saying that clinical research is
"already
underway". And that a study is underway on hepatitis C.

Who else takes Thymic Protein A?

Naomi Judd! The world-famous celebrity and country singer has recovered from her
own
battle with hepatitis C. AlternativeMedicine.com, in one of their website<
articles,
describes Naomi's health regimen/protocol, "Perhaps one of the most significant
therapies
(for its effect on Naomi's liver) was thymus glandular extract from calves...
Naomi's liver
enzyme levels, which had gone up again after the interferon cycle ended, dropped
to
within the normal range after she added the thymus glandulars to her program."

The following doctors use it regularly in their practices (or for themselves):

Drs. Robert Atkins, Abram Ber, Jonathan Wright, Lee Cowden and Serafina
Corsello.

Lloyd Wright, the author of Triumph Over Hepatitis C, who has been "cured" and
now tests
negative for HCV, has tried it. However, he stresses that the "frozen thymus" is
far superior
in many ways and attributes most of his success getting rid of the virus to
"live cell frozen
thymus extract," which is available on his website, hepatitiscfree.com.


Frozen Thymus Extract


Lloyd Wright has provided a a statement from the manufacturer of the frozen
thymus
extract, which explains how it is different from Thymic Protein A : "The thymus
provided
by Author and researcher Lloyd Wright is manufactured using our state-of-the-art
extraction and ultra-filtration process to preserve the integrity of the active
thymic
molecules and peptides. The thymus extract sold by Lloyd Wright provides broad-
spectrum thymic peptides of 50,000 Daltons or less. Some thymus products have
only one
known peptide (thymic protein A). Moreover, our propritary ultra-filtration
technology is a
chemical solvent free process that eliminates unwanted compounds such as fat and
fibrous tissues typically found in powders. The live cell thymus provides the
molecules in
the most natural state possible and it is the highest quality peptide complex
available.
Kept frozen to preserve integrity of all peptides.You can read more about this
and find out
how to get it at hepatitiscfree.com.



When asked to compare Thymic Protein A with thymus extracts, Dr. Beardsley,
comments,
" Extracts of the thymus generally consist of whole thymus gland which is ground
and
dried or strained into liquid and administered in capsules or in sublingual
drops. By the
very nature of how these extracts are processed the resultant product is a
conglomeration
of thymus tissue, cell debris, fragments of thymus proteins and thymus
by-products.
These extracts are only slightly effective because they are mere fragments. To
attain full
effectiveness a protein must have a specific shape with extract transmitter and
receptor
sites."


Bovine Thymus Extracts

The Encyclopedia of Natural Medicine, lists thymus extracts as a treatment for
hepatitis C.
It states that there is good clinical data to support the effectiveness of
orally administered
bovine thymus extracts in treating acute and chronic viral hepatitis. It
reports, " The
effectiveness of the thymus extract in treating viral hepatitis is reflective of
broad-
spectrum immune-system enhancement, presumably mediated by improved thymus gland
activity."

Summary

Dr. Julian Whitaker's Health & Healing Newsletter summarizes,
"What the single thymic protein that has been isolated by Dr. Beardsley does is
take over
the work that your thymus used to perform - it stimulates the immune system by
programming T-4 lymphocytes, increasing both their numbers and activity. Since
the
primary function of Thymic Protein A is to program T-4 cells, it is interesting
to consider
the importance of T-4 cells as described by hepatitis C expert Matthew Dolan in
The
Hepatitis C Handbook, "It is the behavior of these cells (T helper cells/CD4)
that are
thought to be the primary indicator of who is likely to clear the virus upon
infection and
who is not.

Researchers have shown that a strong and multispecific CD4+lymphocyte response
to HCV
proteins is only present in HCV infected patients who successfully clear the
virus..."

The question is does Bio Pro activate a T-cell response to HCV proteins?

If cell-mediated immunity and the T-cell initiated immune response is important
to the
management or even elimination of HCV (as the most current research reported in
Matthew Dolan's book seems to suggest) and if Thymic Protein A truly stimulates
these
aspects of the immune system, it would appear to be an attractive product to
use.

Matthew Dolan classifies thymic extracts as an alternative therapy, " It is a
branch of cell
therapy, a treatment approach that is popular for cancer in Germany and involves
the
injection of live cells from (calf) thymus. The general idea is to reinvigorate
the immune
system. There is no accurate reports on its efficacy for hepatitis C yet."

Method of Use

The extract should be slowly dissolved under the tongue (where is is absorbed
directly
into the bloodstream), as stomach acids will destroy fragile structure of the
protein,
according to John Anderson, author of the article Resetting The Immune System's
Thermostat With Thymus Protein on AlternativeMedicine.com.


MAD COW DISEASE & THYMUS SUPPLEMENTS


Bovine spongiform encephalopathy (BSE) is a fatal brain disease of cattle. The
disease is
believed to be caused by a "self-replicating" protein (a prion) rather than a
bacterium or
virus. Meat and milk have not been shown to carry the infective agent and
measures have
been taken to exclude those parts shown to carry the infective agent (primarily
brain and
nervous tissue) from the food supply.


According to an article by Amy Norton entitled "Herbal supplements Can Contain
Animal
Parts" (Source: Reuters Health, July 26, 2000), thymus products may contain "raw
animal
parts". Some people are of the persuasion that there is a theoretic possibility
of a risk of
transmitting "mad cow" disease by consuming thymus products.


Dr. Scott A. Norton, in an interview with Reuters Health, stated, "I would
advise all of my
patients not to take supplements that contain central nervous system tissue from
animals." The reference to this article comes from HEPCBC.org and it states that
the article
warned readers that not all supplements list their full ingredients, or some
people may not
realize that the word "hypothalamus" means brain tissue, and "orchis" means bull
testicles.
It says that regulatory institutions have little or no power over dietary and
herbal
supplements.


My opinion is that we should investigate our thymus products mindfully, but that
we
shouldn't jump to irrational and paranoid conclusions. I asked Lloyd Wright
about this
issue and here's what he had to say:


"There is no evidence of mad cow disease on the north American continent. I hope
they
keep it this way. 1. The thymus is thymus, live cell, no central nervous system
in it. 2.
Again, Natcell thymus is Thymus, nothing else."


"There are approximately 2000 boxes of natcell thymus sold a week in the US and
a whole
lot more world wide. It is safe. The Natcell thymus is taken from live calves.
Most thymus
products are made from dead cows. There is a huge difference."

The following is an excerpt from the e-book:
SAVE YOUR LIVER:
Vital Nutrients Your Liver MUST Have
www.healthyhepper.ccom

ANTIOXIDANTS, FREE RADICALS
& YOUR LIVER



WHAT ARE FREE RADICALS?


Free radicals are explained in the book "Prescription for Natural Healing", by
James Balch
as follows: "A free radical is an atom or group of atoms that contains at least
one unpaired
electron. Electrons are negatively charged particles that usually occur in
pairs, forming a
chemically stable arrangement. If an electron is unpaired, another atom or
molecule can
easily bond with it, causing a chemical reaction. Because they join so readily
with other
compounds, free radicals can effect dramatic changes within the body, and they
can cause
a lot of damage...
The presence of a dangerous number of free radicals can alter the way in which
the cells
code genetic material. Changes in protein structure can occur as a result of
errors in
protein synthesis. The body's immune system may then see this altered protein as
a
foreign substance and then destroy it. The formation of mutated proteins can
eventually
damage the immune system and then lead to cancer and other diseases.
In addition to damaging genetic material, free radicals can destroy the
protective cell
membranes.


WHAT ARE ANTIOXIDANTS?
By destroying free radicals, antioxidants help to detoxify and protect the body.
We can
minimize free radical damage by taking supplements of key nutrients. There is a
group of
vitamins, minerals and enzymes that are classified as antioxidants.
Antioxidants can be obtained from food sources such as fresh fruits and
vegetables, it is
difficult to get enough of them to be effective in protecting against the
cellular damage
caused by a virus such as hepatitis.

Since antioxidants protect against cellular damage it is no wonder they are used
in health
regimens prescribed for hepatitis, since hepatitis can do massive free radical
damage to
the liver!



WHAT ROLE DO ANTIOXIDANTS PLAY IN THE TREATMENT OF HCV?

A US study confirmed that oxidative stress (from free radical damage) occurs in
patients
with chronic hepatitis and that the levels of the free radicals correlated with
the activity of
the hepatitis.

There are clinical studies from Italy that suggest that glutathione, a very
important liver
antioxidant, influences hepatitis C in the following ways:
* impairs the replication of HCV
* improvement in liver enzyme levels
* improve liver cell damage
* make interferon anti-viral therapy more
effective
(To see a more detailed description of these clinical studies please see
www.thione.com)
The information provided by some clinical studies done in Spain and Italy
suggest that
there is an important relationship between antioxidants and chronic liver
disease,
specifically hepatitis C.

Many sources believe that antioxidants are important in the management of
patients with
viral hepatitis, particularly hepatitis C.

Taking a look at the treatment programs used by "survivors" of HCV (Naomi Judd,
among
many others) one will see that antioxidants were invariably used in their health
regimens.
Antioxidant supplements are believed by many to protect against the free
radicals
generated by the hepatitis C virus.

OUR REPORTS

The reports we offer list all the important antioxidants used in treating
hepatitis C, along
with detailed descriptions, suggested dosages, possible interactions with other
supplements, any clinical studies or research about them, food sources of
certain
antioxidants, and testimonials from hepatitis C survivors.

THE FIRST E-BOOKS ON THE WEB TO BE EXCLUSIVELY DEVOTED TO NATURAL SOLUTIONS
FOR HEP C. Ideal for interferon NON-RESPONDERS, those on interferon seeking
ADJUNCT
THERAPY, those who seek ALL NATURAL TREATMENT and those who had to stop
interferon.   www.healthyhepper.com

To: All

I would like to find out what you all think about stem cell reseach in
the creating of new organs. Do you feel this is something good for the
transplant patients waiting on livers? Let me know what you all feel
about this so we can discuss it as a group. I will post a few web
pages which I think you all should see regarding this issue.

Merry Christmas
BD

Title: Combination of Pegylated Interferon and Ribavirin as Therapy
for Patients with Chronic Hepatitis C with and without Renal Disease
Number: 02-DK-0065
Summary: This study will examine the effectiveness of pegylated
interferon, or peginterferon (a long-acting form of alpha
interferon) plus ribavirin in treating hepatitis C (genotype 1)
infection with and without kidney disease. (Genotype 1 is a strain
of hepatitis C virus that has a lower success rate of therapy.)
Combination therapy with alpha interferon and ribavirin is the
recommended treatment for hepatitis C infection in patients without
kidney disease. However, it is not successful in all patients. An
early predictor of who is or is not likely to respond to therapy
would allow treatment to be stopped in non-responders within 2 to 4
weeks rather than 6 or 12 months. This study will determine whether
early changes in viral levels with treatment predict the ultimate
outcome. It will also compare responses in patients without and with
kidney disease to better evaluate problems of therapy in the latter
group. Ribavirin is not given to people with kidney disease because
of possible severe drug side effects. However, because patients with
kidney disease are poor treatment responders and because ribavirin
increases the success of therapy in patients without kidney disease
2- to 3-fold, however, this study will look for a dose of the drug
that can safely be given to patients with kidney disease.

Patients 18 years of age and older with hepatitis C, genotype 1,
with or without kidney disease may be eligible for this study.
Candidates will be screened with a medical history and physical
evaluation, blood tests, symptom questionnaires, 24-hour urine
collection, chest X-ray, electrocardiogram, and liver ultrasound. A
liver biopsy (removal of a small piece of liver tissue) will be done
in patients who have not had one within the last year. Additional
procedures, such as eye examination, treadmill stress test, hearing
test, or others may be required depending on the individual's
medical condition.

Patients without kidney disease will be randomly assigned to one of
two treatment groups: Group A will take both peginterferon (by
injection under the skin once a week) and ribavirin (capsules by
mouth) from the start of therapy; Group B will start treatment with
peginterferon alone and add ribavirin after 4 weeks. Patients with
kidney disease (Group C) will start with peginterferon alone and add
ribavirin 4 weeks later. All patients will be admitted to the NIH
Clinical Center for a few days when treatment starts in order to
draw blood at precise intervals (6, 12, 24, 48, and 72 hours after
the first peginterferon injection) for measurements of viral levels.

Blood will then be drawn once a week for 4 weeks (just before each
injection) to determine how rapidly viral levels decrease with
treatment and to measure blood levels of interferon and ribavirin.
After 4 weeks of therapy, patients will have a blood test and check
of symptoms and side effects every 4 weeks for 24 weeks (every 2
weeks for Group C patients until the optimum ribavirin dose is
found) and then every 8 weeks for the remainder of the study. They
will have a physical examination and urine test every 12 weeks.

Patients will be tested for hepatitis virus RNA after 24 weeks of
therapy to determine if they are a responder or non-responder.
Responders will be advised to continue therapy for a full 48 weeks
to ensure a continued response when treatment stops. Non-responders-
whose chances for a lasting response are estimated at only 2%-will
be offered the option to continue treatment, to stop treatment and
continue being followed without treatment, or to enroll in other
studies of non-responders.

At the end of the 72-week treatment and follow-up, patients will
have the same blood and urine tests as were done at the beginning of
the study and a repeat liver ultrasound.


Sponsoring Institute:
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

All Patients:


-Age 18 years or above, male or female.


-Presence of HCV RNA (with or without anti-HCV) in serum.


-Genotype 1 HCV as determined by probe specific hybridization (Inno-
Lipa assay).


-Evidence of chronic hepatitis on liver biopsy done within the
previous 48 months with a necroinflammatory histology activity index
of at least 3 (out of a maximum of 18).


-Written informed consent.


Additional inclusion criteria for Groups A, B and D:


-Serum alanine (ALT) or asparatate aminotransferase (AST) above the
upper limit of the normal range (ALT 41 greater than IU/L: AST
greater than 31 IU/L) on any serum testing during the previous six
months.


Additional inclusion criteria for Group C:


-Chronic renal disease with creatinine clearance less than 50 cc/min
or serum creatinine greater than 2.0 mg%.


-If on chronic hemodialysis or peritoneal dialysis, stable clinical
condition including stable hematocrit.


-If on chronic dialysis, potential candidacy for renal
transplantation.


EXCLUSION CRITERIA:


Previous treatment with alpha interferon.


If cirrhosis is present, decompensated liver disease, as marked by
bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin
time greater than 2 sec prolonged, or history of bleeding esophageal
varices, ascites or hepatic encephalopathy.


Serum ALT or AST levels greater than 1000 U/L (greater than 25 times
ULN). Such patients will not be enrolled but may be followed until
three determinations are below this level.


Pregnancy or, in women of child-bearing potential or in spouses of
such women, inability to practice adequate contraception, defined as
vasectomy in men, tubal ligation in women, or use of condoms and
spermacide, or birth control pills, or an intrauterine device.


Significant systemic or major illnesses other than renal failure (in
Group C), including congestive heart failure, organ transplantation,
serious psychiatric disease or depression, human immunodeficiency
virus (HIV) infection, and angina pectoris.


Pre-existing anemia (hematocrit less than 33%) or known history of
hemolytic anemia. In patients in patients in Group C, erythropoetin
therapy will be modified to achieve an adequate hemocrit if
clinically indicated.


Other antiviral therapy within the last 6 months.


Immunosuppressive therapy with either corticosteroids (more than 5
mg of prednisone daily) or major immunosuppressive agents (such as
azathioprine or 6-mercaptopurine).


Evidence of another form of liver disease in addition to viral
hepatitis (for example autoimmune liver disease, Wilson's disease,
alcoholic liver disease, hemochromatosis, alpha-1-antitrypsin
deficiency).


Evidence of coronary artery disease or cerebral vascular disease,
including abnormalities on exercise stress testing in patients with
defined risk factors who will be screened for evidence of underlying
coronary artery disease.


Active substance abuse, such as alcohol, inhaled or injection drugs
within the previous year.


Evidence of hepatocellular carcinoma; either alphafetoprotein (AFP)
levels greater than 50 ng/ml (normal less than 9 ng/ml) and/or
ultrasound (or other imaging study) demonstrating a mass suggestive
of liver cancer.


Clinical gout.


Active, serious autoimmune disease such as lupus erythematosis,
ulcerative colitis, Crohn's disease or rheumatoid arthritis that in
the opinion of the investigators might be exacerbated by therapy
with alpha interferon.

Special Instructions: Currently Not Provided
Keywords:
Chronic Hepatitis
Cirrhosis
Hepatitis C Virus
Combination Therapy
Hemolysis
Ribavirin
Alpha Interferon
Peginterferon
Antiviral Agents
Viral Hepatitis
Hemosis
Hemolytic Anemia
Renal Failure
Renal Dialysis
Recruitment Keyword(s):
Hepatitis
Hepatitis C
Condition(s):
Hepatitis C
Investigational Drug(s):
Pegylated Interferon Alpha-2a and Ribavirin
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
N/A

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Title: Epidemiology, Infectivity and Natural History of Hepatitis C
Virus Infection in a Blood Donor Population
Number: 91-CC-0117
Summary: This study will evaluate hepatitis C virus (HCV) infection
in blood donors who test positive for antibodies to this virus. Most
HCV-infected people do not become ill and are not aware that they
have hepatitis or have had it in the past. Some infected people
recover completely, whereas others remain chronically infected. The
study will try to define infectivity of anti-HCV positive
individuals, routes of transmission of the virus, and the number of
HCV-infected persons who have evidence of liver disease.

Blood donors at the NIH Clinical Center or the Central Maryland
Chapter of the American Red Cross who test positive for HCV may be
eligible for this study. Participants will have a physical
examination and history, including questions about socioeconomic
status and current sexual practices. They will have 100 milliliters
(ml) (6 tablespoons) of blood drawn at the first visit and 50 ml (3
tablespoons) drawn 3, 6, 9 and 12 months after the initial visit.
Some participants may undergo plasmapheresis, a procedure for
collecting additional plasma (the liquid portion of the blood). For
this procedure, whole blood is collected through a needle placed in
an arm vein. The blood circulates through a machine that separates
it into its components. The plasma is then removed, and the red and
white cells and platelets are returned to the body, either through
the same needle used to draw the blood or through a second needle
placed in the other arm. In some individuals, other body fluids
(saliva, urine or semen) may also be collected.

Participants may be asked to bring their household contacts and
sexual partners to NIH for interview and blood testing for evidence
of HCV infection and liver disease. Although this is not required
for participation in the study, it would provide additional valuable
information.

Participants found to have chronic viral infection will be seen more
often and will provide additional blood samples for routine medical
care. Further medical evaluation may include X-rays or liver scans
and referral to a specialist for additional tests or therapy.

Ten people in this study will be recruited to participate in a
secondary investigation to analyze changes in the level of HCV and
the immune response to it, and to relate these changes to the degree
of liver damage. In addition to blood collected for the primary
study, participants in this investigation will have an additional 50
ml (3 tablespoons) of blood drawn from an arm vein every week for 10
weeks to measure levels of virus, ALT (a liver enzyme), and immune
response.


Sponsoring Institute:
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Blood donors will be enrolled from among participants in the blood
programs of the National Institutes of Health/Clinical
Center/Department of Transfusion Medicine (NIH/CC/DTM) and the
American Red Cross/Central Maryland Chapter/The Greater Chesapeake
and Potomac Regional Blood Services (ARC).


Enrollment will be restricted to those who test positive in the anti-
HCV screening assay.


To fulfill criteria for study entry, the donor must:


a) be anti-HCV+ at the time of donation.

b) be 18 years of age or older.

c) be able/willing to travel to NIH for blood sampling 4 times in
the first year of study and semi-annually thereafter and willing to
have an annual history and physical examination.

d) provide informed consent.


EXCLUSION CRITERIA:


Donors who do not consent or who do not meet eligibility criteria
will be excluded from the study with appropriate explanation.


Special Instructions: Currently Not Provided
Keywords:
Hepatitis C Virus
Blood Donors
Liver Biopsy
ALT
Natural History
Recruitment Keyword(s):
None
Condition(s):
Hepatitis C
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
N/A

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@...

Citation(s):
An assay for circulating antibodies to a major etiologic virus of
human non-A, non-B viral hepatitis genome

Routes of infection, viremia and liver disease in blood donors found
to have hepatitis C virus infection

The incidence of transfusion-associated hepatitis G virus infection
and its relation to liver disease




If you have:

Questions about participating in a study, please contact the Patient
Recruitment and Public Liaison Office, CC.
Technical questions regarding the Clinical Center web site, please
contact the Department of Networks and Applications, CC.

Title: Immunogenetics of Hepatitis C Virus Infection
Number: 00-DK-0125
Summary: The course of hepatitis C varies among people infected with
the virus. Some people respond to treatment while many do not; some
recover completely while others remain chronically infected; and
among those who remain infected, some have mild symptoms while
others' symptoms are severe. This study will look for genetic
factors that may contribute to these differences.

Children over 2 years of age and adults with hepatitis C virus
infection or with other kinds of liver disease (such as hepatitis B
virus infection, primary biliary cirrhosis, Wilson's disease and
others), and normal volunteers may be eligible for this study.

Participants will provide 40 to 60 centiliters (1 to 2 ounces) of
blood. DNA will be isolated from the white blood cells for analysis
of genes involved in certain immune functions. The genetic findings
from patients with hepatitis C, patients with other forms of liver
disease, and normal volunteers will be compared to try to learn how
the differences may influence the symptoms and course of hepatitis C
and to understand how the virus causes disease.

The results of this study may provide information useful for
developing a vaccine and better treatments for hepatitis C.

Sponsoring Institute:
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: Yes
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Patients who have recovered from past HCV exposure (positive anti-
HCV but negative HCV viremia and absent liver disease).


Patients with asymptomatic HCV infection (positive anti-HCV and HCV
viremia, but persistently normal or minimally elevated ALT and
normal or mild disease on liver biopsy).


Patients with active liver disease (positive anti-HCV and HCV
viremia, persistently elevated ALT and/or moderate disease on liver
biopsy).


Patients with active extrahepatic manifestations of HCV infection
(cryoglobulinemia, glomerulonephritis, vasculitis, etc.).


Patients with rapidly progressive, severe liver disease and/or
hepatocellular carcinoma.


Patients who have undergone or are undergoing treatment.


Patients from a single-source outbreak of HCV infections (in which
the viral factors should be identical and the patients are often
from a homogeneous population with less genetic variability).


HCV infected family members and twins.


Patients with other forms of liver disease including HBV infection,
primary biliary cirrhosis, autoimmune hepatitis, nonalcoholic
steatohepatitis, hemochromatosis, and Wilson's Disease, as well as
normal volunteers.


EXCLUSION CRITERIA:


Adult subjects with a Hct of less than 30 or pediatric subjects less
than 25 will be excluded.


Children with HCV infection younger than 2 years of age will be
excluded.


Unaffected healthy volunteers who are minors are not eligible for
this study.

Special Instructions: Currently Not Provided
Keywords:
Cytokines
Treatment
Genetic Polymorphism
Chronic Hepatitis C
Mononuclear Cells
Recruitment Keyword(s):
None
Condition(s):
Hepatitis C
Liver Disease
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
N/A

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@...

Citation(s):
Human leukocyte antigen and leprosy: study in northern Louisiana and
review

Common west African HLA antigens are associated with protection from
severe malaria

The immunogenetics of human infectious diseases




If you have:

Questions about participating in a study, please contact the Patient
Recruitment and Public Liaison Office, CC.
Technical questions regarding the Clinical Center web site, please
contact the Department of Networks and Applications, CC.

Title: Long-Term Therapy with Ribavirin for Chronic Hepatitis C
Number: 99-DK-0042
Summary: Chronic hepatitis C is a disease of the liver caused by the
hepatitis C virus. The disease can be serious and even fatal.
Approximately 25% of patients with chronic hepatitis C will develop
cirrhosis and some of these patients will develop cancer of the
liver or liver failure.

Presently the disease is treated with a combination of alpha
interferon or peginterferon (antiviral and immune stimulating drugs)
and ribavirin (an antiviral drug). Alpha interferon is given by
injection three times a week whereas peginterferon is given by
injection only once a week. Ribavirin is given as a tablet by mouth
twice a day. The combination therapy is given for 6 to months. About
half of the patients given these medications will receive a lasting
benefit and many patients do not respond well to the combination
therapy.

This study will select up to 50 patients will chronic hepatitis C
who have not responded to combination therapy or who could not stand
the side effects associated with interferon or peginterferon
therapy. These subjects will be evaluated and undergo liver biopsy
to determine their present liver condition. If selected as subjects
they will be started on single drug therapy with ribavirin. The drug
will be given orally twice a day at a dose based on the patient's
body weight.

The patients will be followed on an out-patient basis. They will we
asked to return for regular check-ups and blood tests every 2 to 8
weeks for the duration of the study. After 6 months, the medication
will be stopped or adjusted based on the results of the subject's
blood tests (liver enzymes). A response is considered if a decrease
of 50% or more of the initial liver enzyme (alanine
aminotransferase, ALT) is noted. A complete response will be
considered if liver enzymes return to normal levels.

Therapy will be discontinued after 6 months if patients do not
respond. However, patients that respond to the single drug therapy
will continue to receive the medication at a decreased dose. The
patients will remain on an appropriate dose for up to 8 years with
repeat liver biopsies at 2, 4 and 8 years to assess progress.

This study will determine if long-term therapy with ribavirin is
safe and effective.


Sponsoring Institute:
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Age above 18 years, male or female.


Elevated alanine (ALT) or asparate (AST) aminotransferase activities
averaging at least twice the upper limit of normal on three
determinations taken at least one month apart during the previous 6
months. The mean of these three determinations will be defined
as "baseline" ALT and AST levels.


Presence of anti-HCV and HCV RNA in serum tested at least once
during the previous six months.


Evidence of chronic hepatitis on liver biopsy done within the
previous 12 months with a histology activity index of at least 6
(out of a maximum of 22).


Contraindications to the use of alpha interferon, either in the form
of specific contraindications to its use (depression, psychiatric
illness, neurological impairment, severe thrombocytopenia,
autoimmune disease), or the history of severe side effects or
intolerance during a previous course of alpha interferon, or lack of
a sustained virological (sustained lost of HCV RNA from serum for
more than six months after stopping treatment) response to an
adequate course (6 months) of the combination of alpha interferon
and ribavirin or (after September 1, 2003) the combination of
peginterferon and ribavirin.


Written informed consent.


INCLUSION CRITERIA FOR PATIENTS IN 98-DK-0003:


An important group of patients who were enrolled in the current
study, were patients who participated in the Clinical Research
Protocol 98-DK-0003 (Combination of alpha interferon with long-term
ribavirin for patients with chronic hepatitis C) and who did not
have a sustained virological response to this treatment. These
patients were eligible to enroll into the current study once they
had finished the therapy and follow up period in that trial. These
patients fit the inclusion criteria listed above with one exception:
some patients were receiving ribavirin monotherapy as a part of
their participation in 98-DK-0003. These patients were eligible to
be immediately enrolled into this study without a medication-free
period in between.


EXCLUSION CRITERIA:


Pregancy or, in women of childbearing potential, inability to
practice adequate contraception. Men with spouses or sexual partners
of childbearing potential also be excluded if they are unable to
practice adequate contraception.


Significant systemic illnesses other than liver disease, including a
history of congestive heart failure, cerebral vascular disease,
renal failure (creatinine clearance less than 50 ml/min), and angina
pectoris.


Patients with an abnormal stress test or carotid untrasound will not
be enrolled into this study.


Pre-existing anemia (hematocrit less than 32%) or known history of
hemolytic anemia.


Interferon or immunosuppressive therapy within the last 6 months.


Evidence of another form of liver disease in addition to viral
hepatitis, such as autoimmune or alcoholic liver disease.


Active or recent (within one year) alcohol or drug abuse or
psychiatric illness that is likely to interfere with compliance and
requirements for safety monitoring during this study.

Special Instructions: Currently Not Provided
Keywords:
Ribavirin
Liver Disease
Antiviral Agent
Cirrhosis
Chronic Hepatitis
Iron
Viral Hepatitis
Hepatitis C Virus
Hemolytic Anemia
Hemolysis
Recruitment Keyword(s):
None
Condition(s):
Chronic Hepatitis C
Investigational Drug(s):
Ribavirin
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
N/A

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@...

Citation(s):
Hepatitis C: the clinical spectrum of disease

Hepatitis C and hepatocellular carcinoma

Ten-year follow up after interferon-alpha therapy for chronic
hepatitis C




If you have:

Questions about participating in a study, please contact the Patient
Recruitment and Public Liaison Office, CC.
Technical questions regarding the Clinical Center web site, please
contact the Department of Networks and Applications, CC.

Title: Low Dose Peginterferon and Ribavirin Therapy for Patients
with Chronic Hepatitis C Infected with Genotype 2 or 3
Number: 03-DK-0136
Summary: This study will examine the effectiveness of low-dose
peginterferon and ribavirin therapy for certain patients with
chronic hepatitis C-a liver disease that, in some patients, can
progress to cirrhosis of the liver, liver cancer, and liver failure.
This disease is caused by the hepatitis C virus (HCV). There are six
major strains, or genotypes, of HCV. Patients infected with
genotypes 2 and 3 respond better and more quickly to the standard
treatment for this disease-high-dose peginterferon and ribavirin for
24 to 48 weeks-than do patients with other genotypes. Although the
side effects of these medications are more severe at higher doses,
patients with all genotypes, including genotypes 2 and 3, currently
receive the same standard treatment. This study will examine whether
patients infected with HCV genotypes 2 and 3 will respond equally
well, and with fewer side effects, to lower doses of peginterferon
and ribavirin given for a shorter period of time.

Patients 18 years of age and older with chronic hepatitis C genotype
2 or 3 may be eligible for this study. Each candidate will be
screened with a medical history, physical examination, blood tests,
and liver ultrasound. Patients who have not had a chest x-ray or
electrocardiogram within a year of entering the study will have
those tests as well. Additional tests, such as eye examination,
hearing test, stress test, or others, will be done if deemed
necessary because of the individual's particular medical condition
or risk factors for side effects of therapy.

Participants will be admitted to the NIH Clinical Center for 1 day
for supervised administration of the first doses of peginterferon
and ribavirin and 24-hour observation. The treatment regimen
consists of two capsules of ribavirin twice a day every day and an
injection of peginterferon under the skin once a week. Patients will
return to the clinic at 2, 4, 8, 12, 16, 20 and 24 weeks after the
first dose of therapy for a brief medical history and physical
examination, blood test, and check on hepatitis symptoms and
treatment side effects. Women capable of becoming pregnant will also
have a pregnancy test at each visit.

Patients will be tested for HCV levels after 12 weeks of therapy.
Those who are negative for the virus at that time will continue
therapy for another 12 weeks to insure that the response lasts. They
will be monitored during that time and re-tested for the virus at
the end of that period. Patients who do not respond to treatment
after 12 weeks will stop low-dose therapy and be offered the higher-
dose standard treatment for 48 weeks. Patients who responded after
12 weeks and completed 24 weeks of therapy but subsequently became
positive after stopping treatment will also be offered standard high-
dose treatment for the full 48-week regimen. Patients on high-dose
therapy will return to the clinic every 4 weeks during the 48-week
course for evaluation and blood tests. Patients who remain positive
for HCV after 24 weeks of high-dose therapy will stop treatment, as
a response is unlikely to occur beyond that time.

After treatment, patients will return to the clinic at 4- to 8-week
intervals for evaluations until 6 months. At 6 months, they will
have a series of blood and urine tests and ultrasound of the liver.


Sponsoring Institute:
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Age above 18 years, male or female.


Presence of anti-HCV in serum.


Positive HCV RNA determination in serum.


HCV genotype 2 or 3 as determined by Inno LiPa assay or by direct
sequencing. Patients with mixed genotypes will not be eligible if
they have genotypes other than 2 or 3.


Written informed consent.


EXCLUSION CRITERIA:


Previous treatment with interferon alpha or peginterferon.


Decompensated liver disease, as marked by bilirubin greater than 4
mg/dL, albumin less than 3.0 g/dL, prothrombin time greater than 2
sec prolonged, or history of bleeding esophageal varices, ascites or
hepatic encephalopathy.


Patients with ALT levels greater than 1000 U/L (greater than 25
times ULN) will not be enrolled but may be followed until three
determinations are below this level.


Pregnancy or, in women of child-bearing potential or in spouses of
such women, inability to practice adequate contraception, defined as
vasectomy in men, tubal ligation in women, or use of condoms and
spermicidal, or birth control pills, or an intrauterine device.


Significant systemic or major illnesses other than liver disease,
including congestive heart failure, renal failure (creatinine
clearance less than 50 ml/min), organ transplantation, serious
psychiatric disease not controlled by psychotropic agents, and
angina pectoris.


Evidence of coronary artery disease or cerebral vascular disease,
including abnormalities on exercise stress testing in patients with
defined risk factors who will be screened for evidence of underlying
coronary artery disease.


Pre-existing, severe bone marrow compromise; anemia (hematocrit less
than 30%), neutropenia (less than 1000 neutrophils/microliter) or
thrombocytopenia (less than 70,000 cells/microliter).


History of hemolytic anemia.


Evidence of another form of liver disease in addition to hepatitis C
(for example hepatitis B, autoimmune liver disease, Wilson's
disease, alcoholic liver disease).


Active substance abuse, such as alcohol, inhaled or injection drugs
within the previous six months.


Evidence of hepatocellular carcinoma: either alfa-fetoprotein (AFP)
levels greater than 50 ng/ml (normal less than 9 ng/ml) and/or
ultrasound (or other imaging study) demonstrating a mass suggestive
of liver cancer.


Clinical gout.


HIV infection.


Quiescent or active, serious autoimmune disease such as lupus
erythematosus, ulcerative colitis, Crohn's disease or rheumatoid
arthritis that in the opinion of the investigators might be
exacerbated by therapy with alfa interferon.


The use of immunosuppressive medications, including corticosteroids
in doses of 10 mg of prednisone or its equivalent and higher.


Special Instructions: Currently Not Provided
Keywords:
Hepatitis C Virus
Antiviral Agents
Hemolysis
Neutropenia
Cirrhosis
Hemolytic Anemia
Viral Hepatitis
Ribavirin
Alfa Interferon
Pegylated Interferon
Recruitment Keyword(s):
Hepatitis C
HCV
Condition(s):
Hepatitis C
Investigational Drug(s):
Peginterferon alfa-2a and ribavirin for chronic hepatitis C
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
N/A

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@...

Citation(s):
Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH. Pathogenesis, natural
history, treatment, and prevention of hepatitis C. Ann Intern Med.
2000 Feb 15;132(4):296-305. Review.

Major ME, Feinstone SM. Related Articles, Links The molecular
virology of hepatitis C. Hepatology. 1997 Jun;25(6):1527-38. Review.
No abstract available.

Lauer GM, Walker BD. Related Articles, Hepatitis C virus infection.
N Engl J Med. 2001 Jul 5;345(1):41-52. Review. No abstract
available.




If you have:

Questions about participating in a study, please contact the Patient
Recruitment and Public Liaison Office, CC.
Technical questions regarding the Clinical Center web site, please
contact the Department of Networks and Applications, CC.

To: All

I just wanted to let you all know that I made it thruough Connie's 1
year aniversary of here death. It was hard for my son and I but we
are doing ok. I will be posting some of the pictures soon so you all
can see the stone which was put in her memory in our memorial garden
at our church. Connie meant very much to myself and my son in the
years we had her in our life. She was a incredible woman who I do
not know if I could find another as good as she was to us. I also
wanted to let you all know that my HCV is getting worse month by
month. In the past month I have been having some of the same symtoms
as Connie had. So I will be checking in on a regular basis to let
you all know how things are going for me. I would also like to say
we have another hepper who is Renee. I have been blessed to have her
in my life as a best friend. She does check into this site on a
regular basis. My request to you all is that you give her support as
she goes through dealing with her Hcv. She has two beautiful kids
who know me and call me there hero as my son and I went threw great
difficulty to get them out of Houston when they were trapped in
Houston due to hurricane Rita. I will look forward to hearing form
you all and may the Lord be with you.

Thanks
Blackdiamond

To: All

I just wanted to let you all know that there will be a dedication
service for Conniep1954 next week on Wednesday at 5:30 Pm at First
Presbyterian Church in Austin, TX. The will be dedicating her stone to
the memorial fountain there at the church. This will be a reminder to
us of Connie of all the good memories we had together as husband and
wife while she was waiting on her liver transplant. You are all
welcome to come to the service which will be one year from when I lost
my wife due to her liver failing because of HCV.

Thanks
Travis and Ryan

I take Vitamins all the time and as for my energy level I see slight
changes in it but nothing drastic...I recommend you read up on all the
natural remedies, One that works for me is called: The Liver Cleansing
Diet by Dr. Sandra Cabot you can get it at any book storeI would read
that book plus others to get a wide view of all that there is out
there ,what works for me doesn't nessarily work for others.  Hope this
helps..............Jina

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 ===




__________________________________
Yahoo! Music Unlimited
Access over 1 million songs. Try it free.
http://music.yahoo.com/unlimited/

Hell I can't even aford a home , I wonder if they would still refinace me any
way?   lol  Jina


There is 1 message in this issue.

Topics in this digest:

1. Follow my advice
From: lonestarheppers@...


________________________________________________________________________
________________________________________________________________________

Message: 1
Date: 12 Sep 2005 05:59:38 -0700
From: lonestarheppers@...
Subject: Follow my advice

Refinance your home now, take 30 seconds and fill out this free form.

http://refifastugftsn.badlink.net/


[Non-text portions of this message have been removed]



________________________________________________________________________
________________________________________________________________________



------------------------------------------------------------------------
Yahoo! Groups Links




------------------------------------------------------------------------







[Non-text portions of this message have been removed]

--- In lonestarheppers@yahoogroups.com, "Jina" <jjuiliano@s...> wrote:
> Awwwwwwwwww the miracle of life! you go girl. I will be sayin all
> kinds of prayers for you and your lil one.  Many blessings, Jina\

THanks Jina
It wont be long and I will post a picture of my miracle.  I look
forward to meeting some of you again after I have the little munchkin.
Travis I hope you are doing great, miss chatting with ya.

Take care everyone...
Tina-FLorida

Awwwwwwwwww the miracle of life! you go girl. I will be sayin all
kinds of prayers for you and your lil one.  Many blessings, Jina

Hi, I'm from st.paul,mn and been on pegasys treatment since feb. and i
have no one to talk to, i'm 37 swm never been married and am in
hazelden fellowship now for alcohol and drugs but i think i got hep c
through a blood transfusion back in 1991 so i am really interested in
talking to people in my area. thank you so much for reading this, god
bless,
   Doug

-------Original Message-------


Going to have a Baby?! Praying ALL goes Well!
I take it You are not the Average age of most Heppers, that being 50!
You aren't anywhere near 50 and Pregnant...Are YOU?!

I take it You meant Cheery, not Cherry. Only One Person I have ever
heard of being Cherry and Pregnant and that was a Rather Important
Lady in the Bible!

Again...Good Luck Tina and We will all be Praying for You!
Da Rev



Actually I was being sarcastic when I said cherry LOL  You are right.
I dont know who can be this miserable and happy about it LOL
I am 34 weeks & 4 days into a miserably HIGH risk pregnancy.  Baby is
doing well, mommy is old and toughing it out.
It's been a road, I am 37 and have been infertile for 10 years since
my last miscarriage.  It was a shock and scarey being that I have had
HCV for 17 years and Im in stage 4 of cerosis.  God has been good to
us with our baby girl.
Just went to have a 3/4 D sonogram today.  She is so far down and
ready to come out that the pictures stunk but I will post them so you
all can look if you want.  Enjoy!
Tina-Florida

WELL  I wish she were here to show you pictures of her, but this will
have to due LOL
I tried to attach them but i cannot

http://pg.photos.yahoo.com/ph/psychocat_lady/album?.dir=4864&.src=ph&store=&prod\
id=&.done=http%3a//photos.yahoo.com/ph//my_photos

I am home finally, they made us wait over 1 1/2 hours for us to get
into the 3-D 4-D sonogram room.  We were in there viewing Jaidyn for
over one hour.  Disappointing as it was (glad I didnt pay)  She is so
far down in the birth canal and in the proper position (finally) that
we didnt get but 2 1/2 way profiles of her face.  When she did move so
we could possibly see her face the little stinker put her hand in
front looking like she was sucking her palm, and no matter how much we
pushed and prodded her she was set not to show us.
SHE HAS HAIR!!!!!!
Her face is FAT. Lovely beautiful lips and a little pudgy nose.  AWWW
My baby is so cute!!!!!
NO CLEFT PALET --- Praise the Lord!!!!
Her tummy has so much fat on it they tech was able to show us where it
was.  She must be fat because her arms and legs were pudgy also!
This is strange, but the 4D sono only showed her as 5 pounds 1 oz at
34 weeks.  Still a little big, but woo hoo, she's not 10 lbs.
Didnt get a girl stuff shot because her legs were crossed at the ankle
and up against her chest.  But I did get that shot LOL
Enjoy the pictures!
Tina, Paul & Jaidyn Alemany

Going to have a Baby?! Praying ALL goes Well!
I take it You are not the Average age of most Heppers, that being 50!
You aren't anywhere near 50 and Pregnant...Are YOU?!

I take it You meant Cheery, not Cherry. Only One Person I have ever
heard of being Cherry and Pregnant and that was a Rather Important
Lady in the Bible!

Again...Good Luck Tina and We will all be Praying for You!
Da Rev


--- In lonestarheppers@yahoogroups.com, "Tina" <psychocatlady@g...>
wrote:
> Well Im ready to pop my baby girl out any day now.. so I dont know
how
> cherry I can be ;)
> Tina
>
> -------Original Message-------
>
> From: Jina
> Date: 09/09/05 11:07:02
> To: lonestarheppers@yahoogroups.com
> Subject: [Lone Star Heppers] not sure!
>
> not sure and I am wonderin the same thing! Jina
>
>
>
>
>
>
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>
>  Visit your group "lonestarheppers" on the web.
>
>  To unsubscribe from this group, send an email to:
>  lonestarheppers-unsubscribe@yahoogroups.com
>
>  Your use of Yahoo! Groups is subject to the Yahoo! Terms of
Service.
>
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>
>
>
> [Non-text portions of this message have been removed]

Well Im ready to pop my baby girl out any day now.. so I dont know how
cherry I can be ;)
Tina

-------Original Message-------

From: Jina
Date: 09/09/05 11:07:02
To: lonestarheppers@yahoogroups.com
Subject: [Lone Star Heppers] not sure!

not sure and I am wonderin the same thing! Jina






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[Non-text portions of this message have been removed]

not sure and I am wonderin the same thing! Jina

Just Wondering what happened to Humorous Heppers.
Oh! By The Way! Hi Folks!
Rev.Frank

"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.

The group escalated from 100 to 400 had reduction of 0.8 log.

In cohort 7 individual patient HCV RNA reductions ranged from 0.68
to 1.94 log. One patient had reduction of 1.94 log; 2nd patient's
viral load declined by 1.37 log; three patients had 1 to 1.2 log
reductions.

SAFETY & TOLERANCE

Godofsky reported clinical safety satisfactory overall: no serious
adverse events or dose limiting toxicities; all 68 compliant
patients completed treatment; 1 patient (400 mg group) discontinued
for non-compliance. No grade 3 or 4 lab abnormalities during
treatment; no pattern of lab abnormalities.

GI side effects in some patients (typically transient nausea; total
of 5 patients with vomiting): seen primarily at doses >=400 mg/day;
23 of 26 nausea events rated "mild", 3 "moderate"; most with onset
in first 2 days; <1 day duration in 62% of affected patients; 5/14
(36%) placebo patients with miscellaneous GI complaints. Godofsky
said overall side effects favorable compared to current treatment.

Godofsky concluded: there was consistent antiviral activity in
patients, 87% of whom previously failed IFN; increased antiviral
activity with each higher dose: HCV RNA reductions after 15 days
treatment was --0.15 to 1.1 log IU/mL in completed cohorts; 1.1 log
viral load reduction equals 92% viral load reduction in 2 weeks; in
highest dose cohort, 9/9 previous IFN failures exhibited HCV RNA
responses (0.7-1.9 log: 79-99% HCV RNA reductions in individual
patients over 2 weeks); 800 mg/day cohort ongoing, will be highest
dose tested; overall safety satisfactory: no dose limiting
toxicities, transient nausea & vomiting in some patients, all
compliant patients completed treatment.

The next planned study is a 4-week combination trial of NM283 and
peginterferon.