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Alan Franciscus
Editor-in-Chief
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In This Issue:
Finally – A Therapy For Treating
Chronic Hepatitis C In African Americans
New Database to Help Fight Against Hepatitis C
A New Way To Fight Hepatitis C
Hepatitis C Virus Is Unsuspected Time Bomb for Millions of
Americans
Results of Retransplantation for Recurrent Hepatitis C
Role of Reproductive Factors in Hepatocellular Carcinoma
Hoffman LaRoche to Cut 250 Sales Jobs
High-School Students Launch Hepatitis C Campaign on Capitol
Steps
Humoral and Cardiac Effects of TIPS in Cirrhotic Patients
Jury Finds Tattoo-Hepatitis Link
Schering-Plough Plans To Trim Payroll By At Least 10 Percent
Anadys Pharmaceuticals Reports Interim Results of Phase 1B
Hepatitis C risk not increased in emergency workers
December 1st, 2003
Finally –
A Therapy for Treating Chronic Hepatitis C in African Americans
Dana Gleeson
Chicago Standard Newspapers
Hepatitis C is a blood-borne virus that,
in its chronic form, infects the liver of 2.7 million people
in the United States and results in more than 10,000 deaths
each year.
Hepatitis C can be transmitted from an
infected mother to an infant and through unsanitary body piercing
tools. Earlier this year, Baywatch star Pamela Anderson said
that she got hepatitis C from her ex-husband, Tommy Lee, after
they shared a tattoo needle. And there has been a link between
hepatitis C and high-risk sexual behaviors such as having
unprotected sex with multiple partners.
Most new cases of hepatitis C can be found
in intravenous drug users who share infected needles, according
to Dr. Donald Jensen, director of the Department of Hepatology,
Division of Digestive Diseases at Rush-Presbyterian St. Luke’s
Medical Center in Chicago.
“Forty percent [of people]
will acquire hepatitis C through prior injection drug use,”
he explained during an interview. “And it can lay dormant
for a long, long period [that goes as far back as] 20 or 30
years.”
Many people with chronic hepatitis C do
not have symptoms of the disease, which can cause cirrhosis,
liver failure and liver cancer. If symptoms occur, they are
often mild, nondescript and include fatigue, nausea, poor
appetite, muscle and joint pain, and mild tenderness in the
upper, right part of the torso.
African Americans have hepatitis C more
than any other racial or ethnic group in the
United States, and are almost always infected with the more
difficult to treat genotype 1 viral strain.
Despite this, hepatitis C has a milder
disease course in African Americans, according to Dr. Jensen.
“The silver lining is that they don’t have as
aggressive a disease. The risk of developing cirrhosis is
20 percent after 20 years, 30 percent after 30 years and 40
percent never get it,” he said.
But for those who do acquire advanced
hepatitis C, common therapies have not worked as well, in
part because African Americans have been left out of drug
studies, until now.
Clinical data presented last month in
Boston at a meeting of the American Association for the Study
of Liver Diseases suggest that a combination of intravenous
Pegasys® and Copegus® pills can better treat chronic
hepatitis C in African Americans.
The drugs’ manufacturer, Roche Laboratories,
Inc., sponsored the study. A team of researchers, led by Dr.
Lennox Jeffers, chief of the Hepatology department at Miami
Veterans Affairs Medical Center, compared the safety and effectiveness
of the combination therapy in 106 patients, 78 African Americans
and 28 Caucasians.
Each of the participants had hepatitis
C genotype 1 infections and received a treatment of 180 mcg
of peginteferon alfa-2a and either 1,000 mg or 1,200 mg of
ribavirin for 48 weeks.
The goal in treating hepatitis C is to
lower the amount of the virus found in the blood, which is
measured by sustained virological response levels. Dr. Jeffers
and his team found that African-American patients had a 26
percent sustained virological response compared to 39 percent
in Caucasians.
While the sustained virological response
in African Americans was lower than that of Caucasians, this
is still significant, according to Dr. Jensen. “It’s
a big deal because a response rate of 26 percent is better
than what was previously estimated,” he said.
Dr. Jensen noted that additional research
about hepatitis C in African Americans is needed and is being
conducted at the CORE Center, founded by the Cook County Bureau
of Health Services and Rush-Presbyterian St. Luke’s
Medical Center, in Chicago.
In addition, Dr. Thelma Wiley, medical
director for Liver Transplantation at Rush, is leading a large
hepatitis C study, sponsored by the National Institutes of
Health, that will provide free medication, lab work and medical
care to participants. This is especially important, according
to Dr. Wiley, for chronic hepatitis C patients who do not
have health insurance.
Back to top
New Database
to Help Fight Against Hepatitis C
By Leslie Hoffman, Associated Press
ALBUQUERQUE — Patricia Monaghan wishes
there was a better way to vanquish the invader attacking her
liver. For now, she copes with a treatment that forces the
46-year-old lawyer and mother of two to ration her life, predicting
the days she’ll feel well enough to venture out or be
too sick to leave her house.
Monaghan is among the estimated 4 million
Americans with hepatitis C, the most common blood-borne viral
infection in the United States. It kills around 10,000 Americans
annually, with that toll expected to triple by 2010.
In New Mexico, roughly 32,000 people are
infected with the virus. The state also has the country’s
highest rate of deaths due to chronic liver disease and cirrhosis
— which both can be caused by hepatitis C.
The standard 48-week treatment is only
about 45% effective for those with the most common form of
hepatitis C and can cause nasty side effects.
“They say it’s flu-like symptoms,
but I tell people it’s death,” said Monaghan,
who began the treatment regiment in September.
But help for patients like Monaghan could
be on the way thanks to a new research tool developed at Los
Alamos National Laboratory.
The lab has launched an Internet-based
hepatitis C genetic database designed to help researchers
better understand the chameleon-like virus, one known for
its genetic variability.
“It will be very valuable in anti-viral
drug design, in clinical treatment of hepatitis C and in designing
a vaccine,” said Steven Jenison, the physician administrator
of the state Department of Health’s Infectious Disease
Bureau. “It’s really the design and use of hep
C specific anti-viral drugs, which we don’t have yet,
and a vaccine, which we don’t have yet, that holds the
real hope for bringing hep C under control.”
The database is the only one of its kind
in the Americas, said Carla Kuiken, a Los Alamos molecular
epidemiologist and one of the chief architects of the database.
Two others are in Japan and France, but she said the lab’s
version is better funded.
The heart of the lab’s database is an electronic library
that serves as a storehouse for thousands of pieces of hepatitis
C’s genetic recipe.
Researchers have already plugged about
20,000 genetic sequences of the virus into the database, which
was launched in September. Of those, only 200 to 250 are complete
genetic recipes; the rest are just genetic fragments of the
virus.
What makes the Los Alamos database special
is the tools it offers to interpret its genetic information.
One of them is a feature called TreeMaker, which allows users
to do what bascially amounts to genealogical research, but
tracing genetic history instead of family history.
The feature spits out what looks like alphabet
soup to the untrained eye. But it allows a researcher to compare
one patient’s viral form against others to figure out,
for instance, where that patient’s virus may have come
from.
Kuiken said the site’s tools are
based on technology the lab developed for HIV databases. The
HIV work began 20 years ago and has resulted in four databases
covering HIV genetics, immunology, vaccine trials and the
virus’ genetic mutations that make it resistant to drugs.
“We’ve had to develop a whole
set of tools to study HIV because of its variability and hepatitis
C is the same,” Kuiken said.
Variability means the two blood-borne viruses
mutate quickly, forcing researchers to try to hit a moving
genetic target when designing drugs and vaccines to either
prevent or kill the virus.
“When you’re talking about
hep C, you’re not talking about one thing,” Jenison
said. “You’re talking about a family of related
viruses” because of its constant genetic mutation.
Overall, there are six recognized genotypes
of hepatitis C. About 70% of those infected have the first
type. The standard treatment, which requires a weekly self-administered
shot of one drug and daily tablet doses of another, is only
about 45% effective for those folks.
About thirty percent have the second and
third types, of which 75% to 80% respond to the treatment.
“We need more research to get better
medication,” said Monaghan, who contracted the virus
through blood transfusions after a severe car accident in
1989. Blood screening for the virus didn’t begin until
1992.
Los Alamos’ database is the first
step in a five-year lab project funded by the National Institutes
of Health. The second step is a database that catalogues immunology
information about hepatitis C, again mirroring the technology
Kuiken and her fellow scientists developed for the HIV immunology
database. The hepatitis C immunology database should be up
and running next year.
In the meantime, Monaghan said she’s
committed to educating the public about the virus and helping
those infected get better access to information and treatment.
The promise of future advances gives her hope.
“The more resources out there, I
think, are important,” she said.
Los Alamos National Laboratory’s
hepatitis C database is online at: hcv.lanl.gov
or hcv-db.org.
Back to top
A
New Way To Fight Hepatitis C
Arlene Weintraub Edited by Catherine Arnst,
BusinessWeek
MORE THAN 170 million people worldwide
are infected with hepatitis C, a virus that can cause liver
cancer. Patients are commonly treated with a drug called ribavirin.
But it's less than ideal, triggering anemia in more than 20%
of patients, and leaving some so debilitated they are forced
to abandon treatment.
An experimental drug called Viramidine
may eventually provide an alternative. It is a close chemical
cousin of ribavirin, but while the older drug can pool destructively
in red blood cells, Viramidine is better at bypassing the
blood cells and going straight to the liver.
Valeant Pharmaceuticals, formerly ICN Pharma-ceuticals,
developed both drugs. And it announced in early November that
results from a Phase 2 clinical trial had shown that Viramidine
may be as effective as ribavirin against hepatitis C but can
slash the patients' risk of developing anemia in half. The
company will begin late-stage trials this year, hoping to
have the drug on the market by 2007.
Back to top
Hepatitis
C Virus Is Unsuspected Time Bomb for Millions of Americans
Peter Gorner
Chicago Tribune
Dec. 1--A stealthy enemy is lurking inside
the bodies of millions of Americans that some medical experts
fear may prove as devastating as AIDS.
These people feel perfectly healthy, unaware
that a virus is quietly destroying their liver, cell by cell.
"The first sign I got was two years
ago when I crashed with end-stage liver disease," said
Robert Kolling, 55, of Bolingbrook. "I'm one of the lucky
ones. I received a liver transplant a year ago."
The virus that nearly killed Kolling is
hepatitis C, which is thought to have infected 170 million
people around the world, including 3.9 million Americans.
The major cause of liver transplants, chronic infection with
hepatitis C can lead to cirrhosis, liver failure, liver cancer
and death.
Last month researchers in St. Louis announced
plans to begin human testing of the first vaccine against
the virus, which is spread by direct contact with blood.
But many people with hepatitis C were unknowingly
infected years ago through organ transplants, surgical procedures
or blood transfusions before 1992, when stringent testing
eliminated the virus from the nation's blood supply.
As those people age, and the virus does
its damage, their plight is slowly becoming evident. Many
specialists say they are being swamped with patients.
"It's a huge problem--perhaps 70 percent
of my practice," said Dr. Donald Jensen, director of
hepatology at Rush University Medical Center. "Each year,
I'm seeing 700 new patients, and keeping track of another
3,000. Most are in their late 40s and early 50s and had no
idea they were infected. Their only symptom was feeling fatigued.
It was picked up through general screening or blood donation."
Between 8,000 and 10,000 people in the
U.S. die each year from hepatitis C-related disease and liver
cancer, and another 5,000 are listed for liver transplants.
About 4,000 liver transplants are performed each year because
of hepatitis C, according to the Centers for Disease Control
and Prevention.
But those numbers may double or even triple
over the next decade, Jensen said.
"The number of new cases is actually
going down, but those that have been out there since the 1970s
and '80s will be developing cirrhosis and liver cancer and
needing liver transplants, particularly over the next 10 or
20 years."
Quiet 30-year assault on liver
It took the virus more than 30 years to destroy Kolling's
liver. In 1969, as a 20-year-old infantryman in Vietnam, he
had been wounded in a machine gun ambush. After several operations,
he lost his right leg.
Eighteen units of blood saved his life,
but the gift was tainted by a virus that at the time was unknown.
After recovering from his war wounds for
10 months, Kolling came home and resumed his life. He retired
after 35 years as a technical writer for Lucent Technologies
in Naperville. But for decades the hepatitis C virus had been
replicating inside him, making a trillion new viral particles
a day, all of them aimed at his liver.
"The liver is a most forgiving organ,"
said Jensen, who is Kolling's doctor. "It has a lot of
reserve and regenerative capacity, so you can feel perfectly
well as your liver is being slowly destroyed and never realize
it."
At a recent meeting of the American Association
for the Study of Liver Diseases held in Boston, French and
U.S. researchers presented mathematical models that predicted
the growing costs of the hepatitis C epidemic may supplant
the public health costs associated with HIV infection.
"This is a silent disease," Jensen
said. "HIV-AIDS has garnered the headlines, but hepatitis
C infects many more people than HIV."
The researchers also said U.S. death tolls
due to HIV infection are expected to drop to 4,200 to 6,700
by 2030 as a result of antiretroviral therapies. But while,
the annual mortality from hepatitis C infection was expected
to rise to 14,000 to 19,000 by then.
Sharing needles and other items among drug
users causes most new infections. Current and former injection
drug users, prisoners, hemophiliacs, HIV-AIDS patients, and
long-term kidney dialysis patients have estimated infection
rates of 25 percent to 90 percent.
About 35,000 new cases are being reported
annually in the U.S. The dangers are much higher in less developed
countries, where the rates of infection are increasing and
health experts believe a vaccine is the only hope for slowing
the disease.
Dr. Robert Belshe, head of the team that
made the vaccine announcement, said they are just beginning
the first phase of clinical testing with 45 volunteers, many
of whom are health-care workers. They will receive differing
strengths of the vaccine and be evaluated for antibody response
over 18 months.
"Our vaccine is designed to prevent
infection, and hence the long-term complications of the disease,"
said Belshe, director of the Center for Vaccine Development
at St. Louis University.
The vaccine, developed by Chiron Corp.,
uses gene-splicing techniques to present parts of the virus
to patients' bodies in hopes of stimulating an immune response.
New vaccines typically take a decade or
more to make their way to the market.
Charles Rice, head of the Laboratory of Virology and Infectious
Disease at Rockefeller University in New York, is also trying
to come up with an effective vaccine against the virus. He
and colleagues at other institutions formed the Center for
the Study of Hepatitis C.
Rice said 30 percent of infected people
naturally clear their systems of the virus, which might provide
clues to developing a vaccine.
"However, even these people can get
re-infected again, so surviving an infection doesn't seem
to lead to the kind of memory responses by the immune system
we'd like to stimulate by a vaccine," he said.
What Rice calls "the incredible variability"
of the virus also makes a vaccine difficult.
"Within a single person, about a trillion particles are
produced each day. Each one of those, on the average, has
a genetic sequence different from the other ones," he
said.
When someone is diagnosed with the disease,
all isn't lost.
"If we know about it, we can treat
it," Jensen said. "We have about a 55 percent cure
rate for chronic disease. Those who don't have cirrhosis or
advanced liver disease may go back to normal. They may lead
perfectly normal lives."
One of Jensen's patient, David Sherman
of Glencoe, has been infected for 25 years but has only minimal
liver damage.
"I found out when I got a blood test
in early 1990 and my liver enzymes were elevated," said
Sherman, 43. "I'd received a blood transfusion in 1978
when I was 17 years old and ended up with the virus."
He attributes his health to a vigorous
life. He owns a real estate business, runs two marathons a
year and says he doesn't cater to his illness, except to monitor
it closely.
"The medications for my type of virus
are nasty, so I want to avoid them," he said. "I
don't think my case is uncommon--if it's caught early, the
vast majority of patients can live very well with this disease."
Far too many of those infected keep quiet
about it, Sherman has observed.
"They're afraid other people will
think they have a drinking problem or other lifestyle issues.
That's a tragedy," he said.
When Kolling became ill, he had difficulty
learning what was wrong with him. Diagnosis nearly came too
late to help him.
"I began adding weight due to fluid
retention. I showed signs of jaundice, and would tire easily.
I would have lapses of memory and at times would be incoherent,"
he said.
Finally, on the brink of a coma, he was rushed to Rush and
placed on the organ donor waiting list. "I was fortunate
enough--or sick enough--to receive a liver transplant 10 days
later," Kolling said.
He is celebrating his first year post-transplant
and devotes a lot of time as a volunteer for various organizations,
including the American Liver Foundation and the veterans group
VietNow, based in Rockford.
In order to not reject the liver he must
take 15 pills a day. The pills would cost $1,600 a month if
the Department of Veterans Affairs did not pay for it. Side
effects include headaches, mild diarrhea and sleep disorders.
Still, as his wife is fond of saying, "It's
better than being dead," he said.
UNDERSTANDING THE HEPATITIS C VIRUS
Hepatitis C is one of three main viruses in the U.S. known
to cause hepatitis, a disease that invades the liver and sometimes
causes permanent damage and death. Transmitted by blood, the
hepatitis C virus often goes undetected for years.
WHO IS AT RISK
Nearly 4 million Americans have hepatitis C, and 8,000 to
10,000 people die from it each year. In about 10 percent of
cases, no source of infection is identified.
Those at risk include:
-- Blood transfusion recipients before 1992, there
was no standard screening for the virus, and as a result,
people who received blood transfusions in the 1970s and 1980s
are at risk for having the disease. People who received transfusions
before 1992 should be tested for the virus.
-- People exposed to needles. People also have contracted
the virus by infected needles through:
•IV drug use
•Tattooing
•Body piercing
•Needle-stick injuries
Other means of transmission
The virus can be transmitted through sexual activity, and
people who have had multiple partners are at greater risk.
Transmission also has occurred among drug users sharing straws.
SYMPTOMS OF HEPATITIS C
People infected by the virus usually experience very mild
symptoms, which often go unnoticed. The virus often is detected
through routine blood tests or during the donation of blood.
Symptoms include:
•Fatigue
•Mild fever
•Nausea
•Muscle and joint aches
•Abdominal pain
•Diarrhea
•Loss of appetite
LONG-TERM EFFECTS AND TREATMENT
-- Effects
As many as 70 percent of victims of chronic hepatitis C eventually
develop active liver disease within 20 years, which can turn
into liver cancer or cirrhosis, necessitating a liver transplant.
-- Treatment
A combination of two drugs has been shown to control the virus
in about half of all patients. For people who have advanced
liver disease, liver transplantation is an option, but the
virus will continue to exist in the body afterward.
SOURCES: Centers for Disease
Control and Prevention, C. Everett Koop Institute at Dartmouth
College and the American Liver Foundation
Back to top
December 2nd, 2003
Results
of Retransplantation for Recurrent Hepatitis C
SourceURL:http://www.gastrohep.com
Survival after liver retransplantation
for recurrent hepatitis C infection is significantly shorter
than after retransplantation for other causes, find investigators
in the latest issue of Hepatology.
Retransplantation for recurrent hepatitis
C virus (HCV) has been evaluated in small series.
In this study, investigators from the United
States evaluated patients who underwent transplantation for
HCV-related cirrhosis and retransplantation >90 days later
for recurrent HCV.
They compared these patients with a simultaneous
cohort of patients who did not have HCV infection, but who
underwent retransplantation >90 days after primary transplantation.
Overall, 42 patients underwent retransplantation
for recurrent HCV. Median survival after retransplantation
= 12.9 months.
They had a median survival of 12.9 months
after retransplantation.
The team found that 48% of patients were
dead at 6 months, and that 65% of these deaths were due to
sepsis.
Creatinine level, platelet count, prothrombin
time, alkaline phosphatase level, gamma-glutamyltransferase
level, and donor age all correlated with survival after retransplantation.
However, the team identified prothrombin
time and donor age as predictors of survival on multivariate
analysis.
The investigators found that patients undergoing
retransplantation for recurrent HCV had a significantly shorter
median survival than patients undergoing retransplantation
for other reasons.
Dr Sasan Roayaie's team concluded, "Median
survival after liver retransplantation for recurrent HCV is
significantly shorter than after retransplantation for other
causes of late graft loss".
"Most deaths occur in the first 6
months and are due to sepsis".
"Candidates for retransplantation
with a preoperative prothrombin time <16 seconds and those
receiving grafts from donors younger than 60 years can expect
a significantly longer median survival after retransplantation".
Hepatology 2003; 38: 1428-36
Back to top
December 3rd, 2003
Role of Reproductive
Factors in Hepatocellular Carcinoma
www.gastrohep.com
Increased exposure to estrogen during adulthood
may provide a protective effect against hepatocellular carcinoma,
find doctors in the December issue of Hepatology.
Hepatocellular carcinoma (HCC) is more
prevalent in men than in women. It is possible that estrogen
may play a role in its development.
In this study, doctors from Taiwan evaluated
the effects of reproductive factors on HCC risk. They also
assessed whether the association differs between hepatitis
B surface antigen (HBsAg)-positive and -negative women, in
which hepatitis C virus (HCV) is the major cause of HCC.
The study included 218 women with HCC.
The team also evaluated 729 controls selected from nonbiological
and first-degree female relatives of the patients. Hormone
replacement therapy was associated with a lower risk of hepatocellular
carcinoma.
The doctors found that the risk of HCC
was inversely related to the women's number of full-term pregnancies
(FTP), and their age at natural menopause.
They identified oophorectomy at age 50
during premenopausal years as a risk factor for the development
of HCC (multivariate-adjusted OR 2.57).
However, the use of hormone replacement
therapy (HRT) was associated with a lower risk of HCC. There
was a trend in the risk with increasing duration of HRT.
The team determined that all reproductive
factors had a similar impact on HBsAg-positive and -negative
women, with the exception of an early menarche. This increased
the risk of HCC in HBsAg carriers (multivariate-adjusted OR
6.96).
Dr Ming-Whei Yu's team concluded, "Increased
exposure to estrogen during adulthood may provide a protective
effect against HCC".
"Nevertheless, an early menarche,
which results in early estrogen exposure, does not confer
protection for HBsAg carriers".
Hepatology 2003; 38: 1393-1400
Back to top
Hoffman LaRoche
to Cut 250 Sales Jobs
Star-Ledger
Ed Silverman
Hoffmann-La Roche tomorrow will eliminate about 250 sales
positions -- or more than 10 percent of its nationwide sales
force, a company spokesman confirmed said last night.
The move reflects disappointment with the
Xenical diet pill, a once-promising drug that will no longer
be promoted to doctors, according to an internal memorandum
written to sales representatives by Tom Klein, vice president
of primary-care product sales at the drug maker.
On a larger scale, the cutbacks are part
of a growing trend in the pharmaceutical industry to cut costs.
The belt-tightening come amid increased competition from lower-cost
generics and Wall Street demands for more big-selling drugs
that can quickly boost profits.
As a result, nearly every big drug maker
is trimming. Merck is axing 4,400 jobs; Johnson & Johnson
is slashing nearly 500 by closing a North Brunswick plant
and Schering-Plough is eliminating another 1,000. At the same
time, Pfizer, which bought Pharmacia, is shedding hundreds
of employees.
While the impact has been spread throughout
the country, it is felt especially hard in New Jersey because
so many drug makers have a significant presence here.
Charles Alfaro, a Hoffmann-La Roche spokesman,
confirmed the job cuts will occur, but he said the Nutley-based
drug maker is simply trying to hold down rising costs for
products that are experiencing sales declines.
"This is due to the changing nature
of our product portfolio and anticipated launches," he
said. "We're shuffling resources to be more flexible
and efficient. This is not the result of a financial downturn.
It's just the opposite -- our U.S. performance has been strong."
Hoffmann-LaRoche, which employs more than
5,000 people nationwide in its drug division, is experiencing
something of a rebound.
During the late 1990's, several products
hailed as blockbusters never reached their potential. Two
medicines, in fact, were withdrawn. And controversy surrounded
the Xenical diet pill and its Accutane medication for acne.
More recently, however, the company has
crowed about its Pegasys treatment for hepatitis C, which
has trumped an older rival from Schering-Plough. And a new
AIDS treatment has won praise, although a high price tag has
also generated criticism.
During the first half of this year, the
company's pharmaceutical division saw global sales rise 21
percent. In North America, sales were up 12 percent.
The job cuts, however, reflect the downward
sales trends posted by two medicines, in particular.
The first is the Xenical diet pill. Launched
five years ago amid great hoopla, Xenical was touted as a
potential blockbuster, especially since it works differently
in the body than the fen-phen diet pills that were withdrawn
over serious health concerns.
Instead, Xenical was haunted by its own
side effects that included oily stool and an inability to
help patients lose much weight. Some insurers are reluctant
to pay for the drug and, as a result, sales fell 16 percent
last year and are down 14 percent this year.
Meanwhile, sales of the controversial Accutane
acne medicine are off 40 percent this year, because of generic
competition. For this reason, the drug will no longer be promoted
to doctors and dermatology sales reps are among those losing
their jobs, Alfaro said.
Back to top
High-School
Students Launch Hepatitis C Campaign on Capitol Steps
Business Wire
On December 4th at 3:30 p.m., over 100
DECA marketing students and members of the National Hepatitis
C Advocacy Council will rally on the steps of the U.S. Capitol
Building, to kick-off DECA students' new campaign to raise
awareness of hepatitis C. A press conference will follow at
4:00 p.m., and a full House lobby is scheduled from 4:30-6:30
p.m. on the Capitol grounds.
The students' campaign, aptly named "At
the Core of an Epidemic," was inspired by one of the
DECA students whose father is one of an estimated four million
Americans exposed to the hepatitis C virus. Their main goal
is to promote The Hepatitis C Epidemic Control and Prevention
Act (H.R.3539 / S.1143) currently before the U.S. Congress,
which will provide funding for hepatitis C testing, outreach,
education, and research. Other activities of their campaign
include:
-- promoting hepatitis C public awareness
and education throughout their community;
-- lobbying their local school board to
include hepatitis C education in the health curriculum; and
-- surveying local businesses to determine
if hepatitis C safety measures are being practiced for manicures,
pedicures, body piercings, and tattoos.
Peabody Award-winning producer Lichtenstein
Creative Media will be on-hand to chronicle efforts of the
students, patients, legislators and advocates for a Fall 2004
PBS documentary on hepatitis C.
MEDIA NOTE: Interviews, state-by-state
hepatitis C data, and media packets will be available.
SPEAKERS: DECA Students from Robinson High
School, Fairfax, VA
Karly Winter, Aberdeen, SD, daughter of
Christen Winter (deceased)
Andi Thomas, President, National Hepatitis
C Advocacy Council
Joe Moser, Legislative Assistant, Congresswoman
Heather Wilson
Cherri Branson, Legislative Counsel, Congressman
Ed Towns
Alpha Banks Blair, MD, Howard University
Hospital
WHEN: December 4, 2003 - Rally: 3:30 p.m.;
Press Conference: 4:00 p.m.;
House Lobby: 4:30 - 6:30 p.m.
WHERE: U.S. Capitol Building / West Steps
CONTACT: National Hepatitis C Advocacy
Council, North Miami, Fla. Andi Thomas, 954-931-8463
SOURCE: National Hepatitis C Advocacy Council
Back to top
December 4th, 2003
Humoral and Cardiac Effects of TIPS
in Cirrhotic Patients
www.gastrohep.com
The hemodynamic effects of TIPS differ
according to the pre-TIPS effective blood volume, find investigators
in the December issue of Hepatology.
In this study, investigators from Milan,
Italy, evaluated the cardiac effects of transjugular intrahepatic
portosystemic shunts (TIPS) in cirrhotic patients with different
effective blood volumes.
They performed a 2-dimensional echocardiography
was performed before and after TIPS insertion. Before TIPS
most cirrhotic patients showed diastolic dysfunction.
The team evaluated 7 cirrhotic patients
with normal effective blood volume (group A) and 15 patients
with reduced effective blood volume (group B).
Before TIPS, the team determined that most
cirrhotic patients showed diastolic dysfunction.
They found that patients in group B differed
from those in group A, due to smaller left ventricular volumes
and stroke volume, indicating central underfilling.
Following TIPS insertion, the investigators
noted that portal decompression was associated with a significant
increase in cardiac output, as well as a decrease in peripheral
resistances.
The team observed the most important changes
in group B. Patients showed a significant increase in end-diastolic
left ventricular volumes and the E/A ratio, and a significant
decrease in PRA.
Dr Francesco Salerno's team concluded,
"These results show that the hemodynamic effects of TIPS
differ according to the pre-TIPS effective blood volume".
"Furthermore, TIPS improves the diastolic
cardiac function of cirrhotic patients with effective hypovolemia".
"This result is likely due to a TIPS-related
improvement of the fullness of central blood volume".
Hepatology 2003; 38: 1370-7
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Jury
Finds Tattoo-Hepatitis Link
Associated Press
SAN ANTONIO (AP) A Bexar County jury has
awarded a woman $551,600 after finding she likely contracted
hepatitis C from a San Antonio-area business that applies
permanent cosmetics.
The jury on Wednesday found John Shumate,
owner of Permanent Cosmetics by John Shumate, and his daughter,
Julie, negligent for infecting Deborah Anderson.
Anderson, 52, received a series of permanent
coloring touchups to her lips at the studio, mostly in 1999.
She learned she had hepatitis C in February
2000 when a blood bank rejected her donation, her lawyers
said. During an earlier donation, she did not have the virus.
The San Antonio Express-News reported in
Thursday's editions that an inspection of the business found
several violations. They included dirty floors in a tattooing
area, employees not washing their hands between applications,
and incorrect or insufficient labeling of sterilized equipment.
“The jury has sent out a message to the public about
the seriousness of the health issues involved with tattooing,”
LoAn Vo, one of Anderson's lawyers, told the newspaper.
Roger Sanchez, an epidemiologist with the
San Antonio Metropolitan Health District, said getting hepatitis
C from a business is rare. He added that “it's difficult
to prove, but it's not impossible.”
Medical studies have linked the often-fatal
virus to tattoo parlors and related permanent cosmetic businesses.
However, few if any lawsuits on the issue have gone to trial,
allowing a jury to make the link, state and national health
experts said.
The case bolsters a study done 10 years
ago by researchers at the University of Texas Southwestern
Medical Center in Dallas.
It found that about 30 percent of hepatitis
C cases in Texas were transmitted through commercial tattooing.
Dr. Robert Haley, an epidemiologist who
formerly worked for the U.S. Centers for Disease Control and
Prevention, said the state uses a different standard in determining
infections.
“This was the perfect case because
you have a lady with no other risk factors,'' said Haley,
who testified for the plaintiff and was the author of the
study. “She has a very low-risk lifestyle ... so she
has no (other) reason to get hepatitis C.”
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Schering-Plough
Plans To Trim Payroll By At Least 10 Percent
Juliann Walsh
Dec. 4 (Bloomberg) -- Schering-Plough Corp.,
the drugmaker whose profits plunged because of competition
for its Claritin allergy pill, said it will cut payroll expenses
by at least 10 percent as part of a plan to save $200 million
a year.
Expenses from contractors and temporary
employees will also be trimmed by the same amount, the Kenilworth,
New Jersey-based company said in a release. How those cuts
are to be achieved will be determined after Dec. 15, the deadline
for about 3,000 workers to apply for early retirement, spokesman
Robert Consalvo said.
Chief Executive Officer Fred Hassan, who
vowed last month to restore profit growth at his “wounded
company,'' has slashed the dividend and reorganized businesses
to cut costs. Sales of Claritin, once the Schering-Plough's
biggest product, fell 84 percent to $289 million in the first
nine months of this year.
“Schering-Plough is facing tough
challenges,” Hassan said in the statement. “We
have set ambitious but, we believe, attainable goals aimed
at turning our company around and achieving the kind of results
we -- and our shareholders --expect.”
Shares of Schering-Plough fell 2 cents
to $16.87 as of noon in New York Stock Exchange composite
trading. The stock has slumped 24 percent this year, the worst
performance on the 12-member Standard & Poor's 500 Pharmaceuticals
Index.
Obligations
The payroll cuts will not apply to expenses related to employees
working to meet obligations imposed by a U.S. Food and Drug
Administration consent decree on flawed manufacturing, the
company said in the statement.
In August, the drugmaker announced plans
to pay a dividend of 5.5 cents a share, down from 17 cents.
The company, which also halted salary increases, expects about
1,000 employees to accept the early retirement offer.
Schering-Plough also is facing competition
for its Peg-Intron hepatitis treatment from Roche Holding
AG. Third-quarter U.S. Intron sales fell 60 percent to $171
million. The sales erosion of both Schering-Plough's allergy
and hepatitis lines has hurt profit for the past five quarters.
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December 5th, 2003
Anadys
Pharmaceuticals Reports Interim Results of Phase 1B
SAN DIEGO--(BUSINESS WIRE)--12/05/2003--
Data Presented at the 10th International Meeting on Hepatitis
C and Related Viruses Demonstrate Safety and Tolerability
and Show Anadys Pharmaceuticals, Inc. reported today at the
10th International Meeting on Hepatitis C and Related Viruses
in Kyoto, Japan that interim results from an ongoing clinical
trial of isatoribine (ANA245) demonstrate that the drug is
safe and well-tolerated. Although efficacy is not a stated
objective of the Phase 1B clinical trial and the number of
patients was small, results showed that isatoribine is biologically
active in adults with chronic hepatitis C virus (HCV) infection.
Isatoribine, which is believed to act by a mechanism of action
involving interaction with Toll-like receptor 7 (TLR7) and
stimulate the patient's own immune system, is one of a new
class of drugs being developed by Anadys to regulate innate
immunity, combat hepatitis C virus infection and overcome
limitations of current therapies. The data were presented
at the meeting by Devron R. Averett, Ph.D., Anadys' Senior
Vice President of Drug Development.
In an oral presentation at the meeting,
Dr. Averett presented data from the first three of four cohorts
of an ongoing open-label, dose-escalation Phase 1B clinical
trial of isatoribine administered intravenously over a period
of seven days to thirteen adults with chronic hepatitis C
infection. The trial was designed to determine the safety,
tolerability and pharmacokinetics of isatoribine. Results
corroborate and extend previously disclosed safety, tolerability,
and pharmacokinetic data derived from single doses of isatoribine
in healthy volunteers. The study revealed that no serious
adverse events were observed with a low frequency of mild
to moderate adverse events.
The data generated in this clinical trial
shows that isatoribine is biologically active in adults with
chronic hepatitis C infection based on statistically significant
changes in biologic markers; one such biological marker that
was measured in the trial was the level of 2'-, 5'-oligoadenylate
synthetase (OAS), which increases during interferon-alpha
treatment and is thought to mediate antiviral effects. Also,
a trend toward reduction of viral load over the seven-day
course of treatment was seen.
"The interim results of this ongoing
Phase 1B trial indicate that isatoribine is well tolerated
and biologically active in patients with hepatitis C,"
said Dr. Averett. "We observed induction of a recognized
biological marker for interferon-alpha activity in patients
receiving isatoribine, and the magnitude of this induction
appears to be dose related."
About isatoribine (ANA245)
Isatoribine is a patented nucleoside analog Anadys is developing
for the treatment of HCV infection. Isatoribine represents
one of a new class of drugs being developed by Anadys to regulate
innate immunity, combat HCV infection and overcome limitations
of current therapies. Anadys believes isatoribine interacts
with a specific receptor, Toll-like receptor 7, or TLR7, that
is present on certain immune system cells. Although results
of initial clinical trials are not necessarily predictive
of future results, interim results of the Phase 1B clinical
trial show that isatoribine is biologically active in adults
with chronic hepatitis C infection and indicate a trend toward
reduction of viral load. Anadys expects to initiate a Phase
I/II clinical trial of isatoribine in HCV patients in the
beginning of 2004.
About hepatitis C
Hepatitis C virus causes inflammation of the liver and degradation
of liver function. Hepatitis C infection is currently the
most common chronic blood-borne infection in the United States.
Approximately 2.7 million people in the United States are
chronically infected with the hepatitis C virus, and it causes
10,000 to 12,000 deaths a year in the United States. The Centers
for Disease Control and Prevention, or CDC, estimates the
annual mortality rate in the United States could increase
to 38,000 by the year 2010, surpassing the number of deaths
attributed annually to HIV/AIDS. The hepatitis C virus is
transmitted primarily through significant or repeated exposures
to infected blood. In the United States, intravenous drug
use and sexual contact with infected persons account for the
majority of new hepatitis C infections. Approximately two
thirds of new infections progress to chronic infection. Chronic
HCV infection may also progress to more serious complications
such as cirrhosis of the liver, liver cancer and death.
Anadys Pharmaceuticals, Inc.
(www.anadyspharma.com)
is a biopharmaceutical company committed to advancing patient
care by discovering, developing and commercializing novel
and powerful small molecule, anti-infective medicines for
the treatment of hepatitis C virus, or HCV, and bacterial
infections. Anadys integrates biology and chemistry into a
seamless, feedback-based, iterative process to facilitate
rapid and successful drug discovery. The approach is designed
to advance a strong and continual pipeline of drug candidates
into the clinic.
For more information, please visit www.anadyspharma.com.
Statements in this
press release that are not strictly historical in nature constitute
"forward-looking statements." Such statements include,
but are not limited to, references to the biological activity
of isatoribine in HCV infected patients, the trend toward
viral load reduction resulting from administration of isatoribine
in those patients, the believed mechanism of action of isatoribine
and its effect on a patient's immune system, and expectations
regarding further clinical trials of isatoribine. Such forward-looking
statements involve known and unknown risks, uncertainties
and other factors, which may cause the actual results of Anadys
Pharmaceuticals to be materially different from historical
results or from any results expressed or implied by such forward-looking
statements. In particular, the results of initial clinical
trials are not necessarily predictive of future results, and
Anadys can provide no assurances that isatoribine will have
favorable results in later clinical trials, or receive regulatory
approval. This and other factors that may cause actual results
to differ are more fully discussed in the "Risk Factors"
section of Anadys' Registration Statement on Form S-1 on file
with the SEC. Anadys is providing this information as of this
date and does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new information,
future events or otherwise.
CONTACT:Anadys Pharmaceuticals, Inc., San Diego
Michael Kamdar, 858-530-3667 cc@anadyspharma.com
or Atkins & Associates Liz Thompson, 858-527-3492 lthompson@irpr.com
SOURCE: Anadys Pharmaceuticals,
Inc.
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Hepatitis
C Risk Not Increased in Emergency Workers
Source:reutershealth.com
Last Updated: 2003-12-05 13:14:49 -0400
(Reuters Health)
NEW YORK (Reuters Health) - Even though
firefighters, paramedics and EMTs
are exposed to blood in the workplace, their risk of hepatitis
C virus (HCV) infection is no higher than that in the general
population, as long as standard recommended precautions are
employed, investigators report. Therefore, they suggest, routine
screening for HCV is not warranted for emergency personnel.
Studies published over the last decade
have shown that first responders' risk for HCV is not increased,
Dr. Gregory Armstrong and colleagues explain. However, in
1999, newspapers in Philadelphia reported a higher than normal
prevalence of HCV infection among firefighters, prompting
the current study, which is published in the Archives of Internal
Medicine.
Armstrong, with the Centers for Disease
Control and Prevention in Atlanta, and his group culled data
from surveys and blood screenings that included nearly 3000
firefighters and other first responders employed in Atlanta,
Philadelphia or Connecticut. Blood specimens were tested for
HCV.
In the Atlanta group, the rate was 2.1
percent in 1991. In Connecticut, it was 1.3 percent in 1992,
similar to that of men who participated in a large study of
the general population, the authors report.
The 3.6 percent rate in the 1999 Philadelphia
group was higher, but the authors point out that the rate
of infection was again not significantly different from that
in the general population.
Moreover, the rate of infection among first
responders followed the same pattern as that seen in the general
population, being highest among middle-aged men and African
Americans.
Data from the Atlanta survey showed that
HCV was associated a history of sexually transmitted disease.
In contrast, the risk was not affected by mucosal or intact
skin exposures, being bitten, administering injections, or
inserting intravenous lines.
In the Philadelphia study, there was an
association with illegal drug use,
black race, and history of blood transfusion before 1992.
Dr. Armstrong's group recommends that first
responders always use standard precautions, and that they
be vaccinated against hepatitis B.
However, testing for HCV should be considered
only for those with traditional risk factors or after a skin
puncture or mucosal exposure to HCV-positive blood.
SOURCE: Archives of Internal Medicine,
November 24, 2003.
Copyright © 2003 Reuters Limited
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