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America's Blood
Centers Supports FDA Approval Of Nucleic Acid Testing
Thu Feb 28, 6:55 PM ET
WASHINGTON, Feb. 28 /U.S. Newswire/ -- America's Blood Centers, an
international network of community blood centers that collect nearly half of
the U.S. blood supply and a quarter of the Canadian blood supply, applauds
today's announcement from the U.S. Food and Drug Administration (news - web
sites) approving the licensure of NAT testing, a new gene-based, blood
testing system which has been used in an FDA-approved study over the last
three years to add an extra layer of safety when screening the blood supply
for HIV (news - web sites) and Hepatitis C.
America's Blood Centers' members began using NAT testing in 1999, when
the FDA allowed its use under a research study called an Investigational New
Drug protocol. The goal of this study has been to determine the
effectiveness of NAT testing for wide scale use by the entire blood banking
community. To date, seven HIV and 88 HCV positive blood samples have been
detected using the new screening system.
"NAT testing has truly been a breakthrough for the blood banking
community," said Celso Bianco, M.D., executive vice president and medical
director of America's Blood Centers. "This is an important milestone because
it now means this powerful research tool is officially recognized as
improving blood safety. This is especially important for the 4.5 million
Americans who receive life-saving blood transfusions every year. We are
pleased that the FDA has licensed the test."
NAT testing has reduced the window period, or number of days between the
time that a person contracts HIV or HCV and when the viruses can be detected
using current FDA-approved antibody and antigen tests, called serological
tests. Using serological tests, the window period for HIV is 16 days. With
NAT, it is now 12 days. The window period for HCV using serological testing
was about 72-82 days, but it is down to 25 days with NAT testing.
Members of America's Blood Centers have screened more than 30 million
donations using NAT testing, which is conducted at 16 laboratories
geographically dispersed nationwide. Approximately 35 percent of the blood
collected by members of America's Blood Centers is screened by the Chiron
Corporation test that today received FDA approval. The remainder is screened
by Roche Diagnostics test under an FDA approved research protocol. The
largest providers of blood products and services, America's Blood Centers'
members are located in 45 states and Canada, serving more than 125 million
people at 450 blood donation sites. For 40 years, America's Blood Centers'
members have been committed to serving the needs of their local communities
by saving lives through volunteer blood donation. Our members were also the
first to respond to national tragedies like Oklahoma City, Columbine and
September 11th.
For more information on America's Blood Centers or NAT testing, please
call America's Blood Centers toll-free at 1-888-USBLOOD or visit our Web
site at www.americasblood.org.
http://www.usnewswire.com/
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ICN
Pharmaceuticals Defends Ribavirin Patent
COSTA MESA, Calif., March 1 /PRNewswire-FirstCall/ -- ICN
Pharmaceuticals, Inc. (NYSE: ICN - news) today released the following
response regarding potential infringement on its ribavirin patent:
There have been questions raised in recent days about our patent position
with respect to the use of ribavirin in combination with interferon alpha or
pegylated interferon for use in the treatment of hepatitis C.
Last year three companies filed Abbreviated New Drug Applications
challenging ribavirin patents. Other challenges could come forward. Lawsuits
have been filed against two of the companies that will not come to trial for
thirty months from filing at the earliest. If other challenges come forward,
similar lawsuits will be filed.
ICN holds a very strong intellectual property position. There is no NDA
for ribavirin alone. There are broad method of use and related patents held
by ICN, and for combination therapy with interferon, by Schering-Plough,
that extend to 2015-17. (In the EU and Japan, ICN has applied for extensions
for important patents to about 2010.) In our license agreement with
Schering- Plough, they are prohibited from licensing ribavirin to other
companies either for mono or combination therapy.
ICN has licensed ribavirin to no other company, nor are we obliged to do
so, for use in combination therapy with interferon. Any such use would be
deemed a patent infringement and would be treated as such and responded to
vigorously.
ICN's legal position is formidable, and we will vigorously resist
attempts to weaken our market position by anyone claiming otherwise.
ICN is an innovative, research-based global pharmaceutical company that
manufactures, markets and distributes a broad range of prescription and non-
prescription pharmaceuticals under the ICN brand name. Its therapeutic focus
is on anti-infectives, including anti-virals, dermatology and oncology.
Additional information is also available on the Company's website at
http://www.icnpharm.com .
THE SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995. This press release contains forward-looking statements that
involve risks and uncertainties, including but not limited to, projections
of future sales, operating income, returns on invested assets, regulatory
approval processes, and other risks detailed from time to time in the
Company's Securities and Exchange Commission filings.
For further information please contact: Investors, Joe Schepers,
+1-212-754-4422, or Media, Peter Murphy, +1-714-545-0100 ext. 3213, both of
ICN Pharmaceuticals, Inc.
SOURCE: ICN Pharmaceuticals, Inc.
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Maxim says drug can stop
liver damage from alcohol
STOCKHOLM, March 4 (Reuters) - U.S.-Swedish biotech Maxim Pharmaceuticals
(NasdaqNM:MAXM - news) said on Monday an animal study showed that its drug
Ceplene could completely reverse damage to the liver caused by alcohol.
Pre-clinical testing showed that rats injected with ethanol and the
company's drug Ceplene sustained no liver damage, while rats given only
ethanol developed symptoms related to alcohol abuse, the company said.
``We've shown we could completely reverse the damage made by the
alcohol,'' Maxim Chief Scientific Officer Kurt Gehlsen told analysts at a
meeting in Stockholm.
Maxim expects clinical testing of Ceplene against alcoholic liver disease
and non-alcoholic steatohepatitis to start this year. Any drug must go
through three different phases of clinical trials, which typically take
several years, before being approved for sale to the public.
In the United States one out of 10 people suffer from chronic liver
diseases such as cirrhosis and fatty liver, Maxim said.
Ceplene, with the scientific name histamine dihydrochloride, is also in
clinical trials for use against hepatitis C and different forms of cancer.
``Hepatitis C is a two billion dollar market, but this is way bigger ...
I have to say we are pretty enthusiastic for the prospects of Ceplene
against chronic liver diseases,'' Maxim Chief Executive Larry Stambaugh
said.
The company's shares rose 3.7 percent to $5.94 in early U.S. trading,
while they gained 3.3 percent to 62.50 Swedish crowns ($5.99) in Stockholm
on Monday.
The company would not disclose any further details of the animal study,
which will be presented at the EASL conference for liver studies in Madrid
starting April 18.
In late 2000, the U.S. Food and Drug Administration rejected Maxim's
application to market Ceplene, then called Maxamine, for treatment of skin
cancer.
The company's shares then plunged 92 percent from levels above $60 in
late 2000 to a low of $5.
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http://www.gastrohep.com/news/news.asp?id=1164
Flumazenil improves hepatic encephalopathy in patients with cirrhosis
Flumazenil induces clinical and electroencephalographic improvement of
hepatic encephalopathy in patients with cirrhosis, finds a study reported
in March's Alimentary Pharmacology and Therapeutics.
Researchers from France conducted a meta-analysis to compare flumazenil and
placebo in hepatic encephalopathy in patients with cirrhosis.
For each end-point, both heterogeneity and treatment efficacy were assessed
by Peto and Der Simonian methods.
As most trials were crossover in nature, a sensitivity analysis was
performed including the 2 treatment periods.
Six double-blind randomized controlled trials, including 641 patients (326
treated with flumazenil and 315 with placebo), were identified.
The treatment duration ranged from 5 minutes to 3 days.
Patients with clinical improvement:
Flumazenil: 27%
Placebo: 3%
Alimentary Pharmacology & Therapeutics
Heterogeneity tests between control groups were not significant.
The mean percentages of patients with clinical improvement (5 trials) were
27% in treated groups and 3% in placebo groups. This difference was
significant by both methods (Peto: odds ratio = 6.2; Der Simonian: mean
rate difference, 29%).
The team found that the mean percentages of patients with
electroencephalographic improvement were 19% in treated groups and 2% in
placebo groups. This difference was significant only with the Peto method
(odds ratio = 5.8).
The sensitivity analysis showed similar results.
Author C. Goulenok, of the Pitié Salpêtrière Hospital, Paris, concluded
on behalf of colleagues, "This meta-analysis shows that flumazenil induces
clinical and electroencephalographic improvement of hepatic encephalopathy
in patients with cirrhosis."
Aliment Pharm Thera 2002; 16 (3): 361-72
06 March 2002
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Study: Better
Quality of Life With Pegylated Interferon |
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Although hepatitis C is life-threatening if not treated, many patients
discontinue treatment because of the significant reduction in their
quality of life. But researchers now report that the new pegylated
interferons appear to provide a better quality of life as well as a less
problematic cure.
The researchers
reported in the journal Hepatology on their analysis of three
monotherapy trials, which compared the investigational drug Pegasys - a
pegylated interferon - to standard interferon therapy, and included more
than 1,400 patients from 11 countries.
"It may sound
obvious, but the ability for a patient to maintain their quality of life
during treatment does improve their adherence to therapy, and therefore
their likelihood of achieving a cure," said Dr. David Bernstein, lead
author of the study, and Director of Hepatology at North Shore
University Hospital in New York.
The study included
health surveys, which were administered five times during treatment, and
addressed eight aspects of daily living, such as physical abilities and
limitations, vitality, mental health and pain. Fatigue, a common symptom
of hepatitis C and side effect of therapy, was gauged in a separate
survey.
Other studies have
shown that fatigue plays a vital role in whether a patient discontinues
treatment. Results of both surveys showed that patients taking Pegasys
reported having more energy, less pain and fewer problems overall when
compared to those taking standard interferon.
In addition, the
once a week dosage seemed to stay at a constant level in the patient's
bloodstream, eliminating the ups and downs typically associated with
interferon's negative side-effects.
Not only was
Pegasys better tolerated, it also had the highest overall efficacy of
any hepatitis C medication. According to Roche, 75 percent of patients
(responding at week 12 to Pegasys plus ribavirin) who adhered to their
full course of therapy were cured.
"Hepatitis C is
the only virus known that can be cured by medication, and interferon is
the only medication known that can cure it," Bernstein said. "Pegasys is
likely to be our mainstay for quite some time because of its effect on
adherence, although I expect it to be used in combination with other
antiviral agents as they are developed. And as the number of cures
increases, the spread decreases. I view Pegasys as a significant advance
on the hepatitis C front."
Approval for use
of Pegasys in the United States is expected in the coming months.
Other Sources: Hepatology, North Shore University Hospital, Roche |
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EPA Approves Disinfectant to Fight Spread of
Hepatitis B |
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The U. S. Environmental Protection Agency has approved BBJ Spray
Disinfectant/Cleaner for use to fight spread of the hepatitis B virus.
Many hospitals and
healthcare facilities currently use chlorine bleach. But makers of the
spray, which is odorless, low in toxicity, and won't burn skin, say
those added benefits should make the spray a highly sought-after
product.
"BBJ Spray
effectively combines the germ killing ability of a disinfectant with a
cleaning agent for use in (facilities) where housekeeping is of prime
importance in controlling the hazard of cross contamination," said
Robert Baker, Chairman and CEO of the company.
Other Sources: BBJ Environmental Solutions, Inc. |
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Study:
Hepatitis C Does Not Up Risk of Death in First 10 Years |
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British researchers have found that hepatitis C does not significantly
increase a person's risk of death in the first 10 years of infection.
In a study of
1,400 blood transfusion recipients in the United Kingdom, the
researchers found that death from all causes was "not significantly
different" between those infected with hepatitis C patients and those
not infected..
And they reported
that patients with hepatitis C were only slightly more likely to die
from liver disease in the 10-year time frame than those without
hepatitis C.
But the
researchers reported that after 10 years, liver function had become
abnormal in more than one-third of the hepatitis C patients (37.2
percent), and said that more than 100 patients (13.9 percent) showed
physical signs or symptoms of liver disease.
The researchers
also reported that 40 percent of those hepatitis C patients who died
directly from liver disease during the 10-year period consumed excessive
amounts of alcohol.
Other Sources: British Medical Journal |
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Study: Wine Daily Ups Liver
Cancer Risk for Hepatitis Patients |
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Alcohol drinkers who are infected with hepatitis B or C are more likely
to develop liver cancer than drinkers who are not infected with the
virus, according to a team of researchers at the University of Brescia
in Italy.
The study included
464 patients diagnosed with liver cancer and 824 patients with no liver
damage.
The researchers
reported in the American Journal of Epidemiology that that patients who
consumed four to five glasses of wine each day were at higher risk of
developing liver cancer, while those who consumed three to four glasses
a day were at moderate risk.
But the risk of
liver cancer in patients diagnosed with hepatitis C or hepatitis B
almost doubled if they consumed wine on a regular basis.
Researchers also
found that the age of patients when they began drinking and the length
of time they'd been drinking did not affect the results.
Other Sources: American Journal of Epidemiology |
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Study:
Hepatitis C Patients Not on Antiviral Therapy More Depressed |
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A large number of patients with chronic hepatitis C who are not
receiving antiviral therapy suffer increased emotional distress,
according to University of Michigan researchers..
Researchers
studied 220 patients not receiving antiviral therapy, and found that 77
(35 percent) reported "significantly elevated" symptoms of depression.
Patients with existing psychiatric problems reported even higher levels
of depression.
But depression was
only one of many psychological symptoms observed in the study group, the
researchers reported in the Journal of Hepatology.
"In addition to
depression, a broad array of psychological symptoms was observed," Dr.
Robert J. Fontana of the University of Michigan Medical School said.
"Further investigation into the (treatment) of emotional distress in
(chronic hepatitis C) patients is warranted."
Other Sources: Journal of Hepatology |
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Roche Expects Approval of Pegasys in
2002
Roche Holding AG
expects US regulators to approve its Pegasys (peginterferon alfa-2a)
drug for treating hepatitis C late this year, chairman and chief
executive Franz Humer said on Wednesday. He said Roche had generated
additional data on the manufacturing process for Pegasys, which is Roche
's main product launch this year.
"We are
therefore confident that the product will be approved, as planned, in
the fourth quarter of this year," he said in remarks prepared for
delivery at a news conference on the 2001 results.
03/1/02
Introduction
Manufactured by Hoffmann-La Roche (Roche), Pegasys is currently in Phase
III testing as monotherapy for the treatment of chronic hepatitis C.
Trials of Pegasys plus ribavirin for the treatment of patients with
chronic hepatitis C are also underway. In addition, clinical trials of
Pegasys for the treatment of HIV positive individuals who are
co-infected with hepatitis C virus (HCV) are now enrolling nationwide.
Call 1-800-526-6367 for information about study sites and
eligibility requirements for trials of HIV/HCV co-infected patients.
The results of two studies published in the December 7, 2000 issue of
the The New England Journal of Medicine (NEJM) show that once
weekly treatment (by subcutaneous injection) with Pegasys (pegylated
interferon alfa-2a) produces a significantly better response than
therapy with Roferon A (standard interferon alfa-2a) dosed three times
weekly (also by subcutaneous injection).
US Panel Advises Tattooed
and Pierced Not Give Blood
Thu Mar 14, 9:43 PM ET
By Alicia Ault
GAITHERSBURG, Md. (Reuters) - U.S. health advisers voted on Thursday
to continue a policy that requires people who have been pierced or
tattooed to put off donating blood for a year after the procedure, but
said those who have received acupuncture can safely give blood.
The advisers to the Food and Drug Administration (news - web sites)
(FDA) said they were concerned that loose regulation of tattoo and
piercing establishments meant non-sterile procedures might be used,
increasing the potential for transmission of viruses.
"In a non-sterile environment, I have very serious concerns about
tattooing and body piercing," said panelist James Allen of Scientific
Technologies Corp. of Phoenix, Arizona.
The panelists recommended that blood banks try to verify if tattoos
or piercings were performed at a licensed facility.
The FDA usually follows the advice of its panels.
Currently, people who have received a tattoo, a piercing, or
acupuncture in a non-sterile environment must wait a year before
donating blood. As a result, about 100,000 people are turned away from
donating each year, blood banks estimate.
The concern is that these people may have contracted viruses such as
hepatitis B or hepatitis C through dirty needles or reused tattoo inks,
and that these infections may be too recent to be picked up by blood
screening. That worry has grown with the increased popularity of
tattooing and piercing.
One study of New York state university students found that half had
body piercings, and 23 percent had tattoos.
Miriam Alter, of the viral hepatitis division of the U.S. Centers for
Disease Control and Prevention (news - web sites), told the committee
that based on available studies, tattoo and piercing recipients are not
at increased risk for viruses. CDC is recommending against a routine ban
on donations from people with tattoos or body piercings.
Blood banks also said that new testing procedures now catch these
viruses early in the infection process, which means contaminated blood
can be discarded.
But panelists said there still is a risk of contamination.
North Shore-LIJ Physician Is Lead Author
of Hepatitis C Study; Results Indicate New Drug Therapy Improves
Adherence and Cure Rate
The Next New Epidemic?
MANHASSET, N.Y., March 5 /PRNewswire/ -- If you have a serious
disease that is curable by medication, you take the medication. That
should go without saying, but it often is not the case with hepatitis C,
a blood-borne virus that affects the liver. The side effects with the
standard therapy (interferon in combination with ribavirin) are so
unpleasant that patients frequently abandon treatment, even though when
left untreated hepatitis C is a life-threatening illness.
An investigational drug, PEGASYS®, promises improved quality of life
over the standard therapy, which could increase the likelihood that
patients adhere to the one-year course of therapy necessary for
treatment success, according to a study published this month in
Hepatology. The study's lead author is David Bernstein, MD, of North
Shore University Hospital (NSUH) in Manhasset, New York.
The study is significant because hepatitis C is viewed by many as
``the new epidemic''; unless it can be controlled, it threatens to
overwhelm the U.S. healthcare system.
PEGASYS is a pegylated interferon. To define this term simply, there
is a strand of an inert, synthetic polymer called polyethylene glycol
(PEG) attached to the interferon molecule. This PEG strand sweeps around
like a tail and keeps the medication from being broken down too quickly.
That means it can be administered once a week as compared with three
times. And, most important, the PEG seems to help keep the drug at a
fairly constant level in the patient's bloodstream, preventing ``peaks
and valleys'' which have been linked to negative side effects.
In Dr. Bernstein's study, entitled ``Relationship of Health-Related
Quality of Life to Treatment Adherence and Sustained Response in Chronic
Hepatitis C Patients,'' PEGASYS was compared to standard interferon in
over 1,400 patients from 11 countries, including the United States.
Based on health surveys and fatigue severity scales administered to
these patients at five points during their treatment, they had more
energy, less fatigue, less bodily pain and fewer problems doing their
job than patients taking standard interferon. In addition to being
better tolerated, PEGASYS has the highest overall efficacy of any
hepatitis C medication and provides an early indication (at three
months) of whether the patient might or might not succeed on therapy. Of
patients on PEGASYS plus ribavirin for whom success was projected based
on early response, 75 percent who adhered to the full course of therapy
had virus below the limits of detection after finishing their course of
therapy.
Background on Hepatitis C
It is estimated that 2.7 million people are infected with hepatitis
C, many of them still undiagnosed, according to Dr. Bernstein, who is
director of hepatology of the Division of Gastroenterology and
Hepatology at NSUH in Manhasset, one of the cornerstone hospitals of the
North Shore-Long Island Jewish Health System. He starts seeing patients
at 6:30 a.m. in his hospital office to get through his caseload--92
percent diagnosed with hepatitis C.
``The practices of most hepatologists I know are bursting at the
seams,'' he said. ``Cirrhosis may occur in 20 to 30 percent of cases
within 20 years. Hepatitis C is the leading predisposing factor for
liver cancer and liver transplant. It's already overburdening our
transplant facilities. And we're seeing just the leading edge. There's
no way our medical system can handle this epidemic.''
Hepatitis C patients represent all socioeconomic classes and have
been infected in a variety of ways, including intravenous or intranasal
drug use, blood transfusion prior to 1992, when procedures were put in
place to safeguard the U.S. blood supply, and other less risky-seeming
procedures such as manicures, tattooing and body piercing. Patients can
be symptom free for decades, while the disease progresses, which is part
of the adherence problem.
``Maybe they're diagnosed as a result of a blood test performed by an
insurance company, but they feel fine,'' said Dr. Bernstein. ``Then they
start on the medication and they feel terrible. I find that 80 to 90
percent of my patients suffer some side effects: flu-like symptoms,
irritability, depression, thyroid problems. They find it hard to do
their jobs or take care of their children. It affects their
relationships -- they know that the therapy can cure them, but their
quality of life is so seriously diminished that they quit, even though
it's their only chance for a cure.'' Studies show that between 4 and 27
percent of patients discontinue conventional therapy within 24 weeks.
``Hepatitis C is the only virus known that can be cured by
medication, and interferon is the only medication known that can cure
it,'' Dr. Bernstein said. ``PEGASYS is likely to be our mainstay for
quite some time because of its effect on adherence, although I expect it
to be used in combination with other antiviral agents as they are
developed. And as the number of cures increases, the spread decreases. I
view PEGASYS as a significant advance on the hepatitis C front.''
PEGASYS has been approved for use in 13 countries to date. Approval
for use in additional countries, including the United States, is
expected to be granted in the coming months.
SOURCE: North Shore University Hospital |
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New Molecular Tests Make It Easier to Measure
Hepatitis Viral Load |
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LabCorp has announced a new group of molecular tests designed to improve
management of hepatitis B and hepatitis C patients.
Among the new
tests is the SuperQuant, which is capable of confirming the presence of
the virus at viral load levels below that of tests currently on the
market. In addition, it is capable of assessing disease prognosis, and
useful for monitoring patients on therapy.
The GenoSure,
another new test for hepatitis B, is capable of detecting all currently
known mutations that contribute to hepatitis B drug resistance, meaning
that physicians can more accurately manage therapy options.
Similar to the
SuperQuant, the new hepatitis C QuantaSure test detects extremely low
levels of the hepatitis C virus, while the QuantaSure Plus, allows
physicians to measure more accurately the response in patients with high
viral levels.
The range of the
test also will allow physicians to assess the likelihood of cure at the
end of treatment.
"No longer does
the diagnosis of these infections precede a life of continuous
therapeutic trial and error for the patient," said Dr. Myla P.
Lai-Goldman, Labcorp's executive vice president, chief scientific
officer and medical director. "Advances in molecular medicine like
LabCorp's suite of hepatitis B and C tests, as well as improved
therapeutics, result in far better patient management and enhanced
quality of life."
Other Sources: Laboratory Corporation of America |
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New Research Encouraging on Hepatitis
B Combination Therapy |
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Researchers
report that a 12-month followup to a study in Turkey further
suggests that a combination therapy of Zadaxin and interferon may
provide patients with long-term independence from hepatitis B.
The original
study analyzed patients with a difficult to treat strain of chronic
hepatitis B, which doesn't consistently respond to treatment.
Twenty-one
patients received Zadaxin for 26 weeks, followed by interferon
therapy for an additional 26 weeks. Ten patients received 52 weeks
of interferon treatment only.
In the six
month treatment-free follow-up, 76 percent of patients using Zadaxin
in combination with interferon had normal liver enzymes, and were
void of the virus's DNA, while patients treated with interferon --
one of the most widely used therapies in the treatment of hepaptitis
B --showed a sustained response of 40 percent.
After an
additional 12-month follow-up, 71 percent of patients receiving
Zadaxin continued to show a sustained response, compared to only 10
percent of those treated with interferon alone.
"These
long-term data provide additional clinical evidence of Zadaxins's
ability to increase sustained responses, in even the most difficult
to treat cases of chronic hepatitis B," said Dr. Eduardo Martins,
Medical Director of SciClone Pharmaceuticals.
Other Sources:
Sciclone Pharmaceuticals |
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Rivarin-High Dose Interferon Combination
Improves Responses In Hepatitis C A DGReview
of :"A
randomized trial of high-dose interferon alpha-2b, with or without ribavirin,
in chronic hepatitis C patients who have not responded to standard dose
interferon"
Alimentary Pharmacology & Therapeutics
03/18/2002
By David Loshak
Patients with hepatitis C who do not respond to standard doses of
conventional interferon might benefit from higher doses plus ribavirin.
This combination was well tolerated among patients in a pilot study reported
by specialists at the University of Texas Southwestern Medical Center,
Dallas, Texas, United States. They pointed out that conventional interferon
monotherapy fails to achieve virological clearance in most patients infected
by hepatitis C.
However, the specialists conjectured, high-dose induction regimens might
improve the initial clearance of virus. Also ribavirin might improve
sustained response rates once clearance was achieved.
The specialists recruited 25 chronic hepatitis C patients who had not
responded to standard dose interferon monotherapy. The study compared the
efficacy and safety of re-treatment with an induction regimen of high-dose
interferon alpha-2b either alone or with ribavirin.
Previous virological non-responders to standard dose interferon (3-5 MU
three times weekly for 12 weeks) were randomised to receive one of two
open-label regimens for 36 weeks.
Ten patients (Group A) received interferon alpha-2b 10 MU daily for 10 days
followed by 5 MU daily for 74 days and then 5 MU three times weekly for 24
weeks. A further 15 patients (Group B) received the same regimen plus
ribavirin 1000-1200 mg/day at day 11. All 25 patients were followed up for
24 weeks.
At the end of treatment, virological response was noted in one group A
patient and in eight Group B patients. The sole responder in group A and
three in group B relapsed on follow-up.
The apparent difference between the groups, with a 33 percent sustained
response rate in Group B compared with none in Group A, nearly reached
statistical significance.
Alimentary Pharmacology & Therapeutics 2002; 16(3):381-388.
"A randomized trial of high-dose interferon alpha-2b, with or without
ribavirin, in chronic hepatitis C patients who have not responded to
standard dose interferon"
Living with Hepatitis C
Fri Mar 22, 5:10 PM ET
By Randy Dotinga
HealthScoutNews Reporter
FRIDAY, March 22 (HealthScoutNews) -- Pamela Anderson
announcement this week that she has hepatitis C is the talk of
Tinseltown, but her future may not be that grim.
Many people infected with the liver disease go for decades without
symptoms, experts say, and those who do become ill can turn to antiviral
drug treatments that can be effective.
"Not everyone who gets hepatitis (C) dies from it. In fact, most
people don't," says Frank Myers, an epidemiologist with Scripps Mercy
Hospital in San Diego. Fifteen percent of hepatitis C patients actually
get better on their own as their bodies eliminate the virus from their
blood.
However, hepatitis C can ravage the liver and cause other symptoms.
As many as 10,000 Americans die from the disease each year, while the
side effects of drug treatment can be devastating.
Anderson, 34, says she suspects she was infected when she shared a
tattooing needle with her ex-husband, rock star Tommy Lee. Anderson, a
former star of the TV show "Baywatch," is undergoing outpatient
treatment.
For his part, Lee, 39, claims he doesn't have the disease.
There are three major types of hepatitis -- A, B and C. All affect
the liver, which acts a kind of clearinghouse for cholesterol,
nutrients, blood-clotting products and other substances, says Dr.
Kenneth Gould, an infectious disease consultant with the Southern
California Permanente Medical Group in Los Angeles.
An estimated 4.5 million Americans are infected with hepatitis C, and
it kills 8,000 to 10,000 people a year, making it only slightly less
deadly than HIV which kills about 12,000 Americans annually.
Hepatitis C is a bloodborne virus, like HIV, which causes AIDS .
However, unlike AIDS, hepatitis C seems to be much easier to transmit
through shared needles and much harder to spread through sex.
The chances of HIV infection through a contaminated needle stick are
estimated to be one in 333, while they're just one in 50 for hepatitis
C, Myers says.
Viruses try to survive by developing different ways of infecting
people, he explains.
"Each virus develops its own niche strengths and weaknesses," Myers
says. "I don't think we know enough to know what hepatitis C gained by
designing itself in a way that does not allow itself to easily be
sexually transmitted."
Infection through tattooing is unusual because the sharing of needles
is uncommon, Myers says. It could happen "only if the tattoo artist
completely violated his or her training."
Even if both Lee and Anderson were found to have the same strain of
hepatitis C, it would be difficult to determine exactly how it was
transmitted, he says. Shared razors or even toenail scissors could
spread the virus.
Once a person is infected with hepatitis C, the prognosis can vary.
It's possible to live for 20 to 30 years without encountering symptoms,
Gould says. In some cases, infected people aren't diagnosed until their
blood is tested for some other reason.
"Many times, it's serendipitously found," he says.
Even if someone doesn't notice any signs of infection, hepatitis C is
usually still at work. Often, Myers says, "the liver is slowly attacked
by the virus, but (the patients) die of something else before the virus
destroys their liver."
Hepatitis C scars and inflames the liver, potentially blocking
circulation within the organ, Gould says. Liver cancer is also a
possibility.
Only a few years ago, there was no treatment for hepatitis C. Now,
doctors use antivirals such as interferon and ribavinin.
However, drug treatment can make patients feel like they have the flu
and even cause anemia, so it's generally limited to those whose livers
are already damaged, Gould says. The treatment typically takes six to 12
months.
"Most people don't opt for therapy because it's prolonged and
somewhat difficult," he says.
There's also a risk that treatment may not vanquish the virus, Myers
says. While blood levels of the virus disappear in nearly half of people
on drug treatment, hepatitis C returns in about half of them.
Despite the limitations, Gould says, the future for hepatitis
patients is much brighter than it was just a few years ago.
"We have improved knowledge, and there are options for therapy that
weren't available previously," Gould says. |
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