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Alan Franciscus
Editor-in-Chief
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In This Issue:
Infants Infected With Hepatitis
C at Low Risk for Progressive Liver Disease
How Does Combo Therapy Stack Up Against Post-Transplant
Hepatitis?
Interferon-Alpha May Be Safe, Effective In Preventing
Hepatocellular Carcinoma Recurrence After Ablation Therapy
Martin Studies Tainted Blood Lawsuit
BioLife Solutions Signs Supply Agreement With
Hepatotech Inc.
Genencor to Start Phase I Study for Therapeutic
Vaccine for Hepatitis B
Chronic Liver Disease Mortality in the United
States
The Silent Epidemic
SARS-Associated Viral Hepatitis Caused by a
Novel Coronavirus
UK Physicians Back Organ Donation Plan
Micrologix Buys Hepatitis C Drug, Shares Soar
Effect of Peginterferon Alfa-2a on Liver Histology
in Chronic Hepatitis C
New Funding Offers Hepatitis C Patients Chance
for Cure
EU Drugs Agency Warns of "Hidden Epidemic"
of Hepatitis C Infections
January 27th, 2004
Infants
Infected With Hepatitis C at Low Risk for Progressive Liver
Disease
Source: Reuters Health
Hepatitis C virus (HCV) infection acquired
from neonatal blood transfusions has a relatively benign course
for at least 35 years, results of an Italian study suggest,
with low rates of disease progression. All viremic cases were
associated with the 1b genotype, considered to be the most
aggressive.
HCV onset during adulthood is associated
with a higher risk of progression to cirrhosis within 20 years
than that acquired earlier in life, senior investigator Dr.
Alessandro Remo Zanetti and colleagues note in their report,
published in the January issue of Hepatology. However,
most studies of associated disease progression rarely encompassed
more than 20 years of follow-up.
To gain further insight into outcomes of
HCV infection, Dr. Zanetti, at the University of Milan and
his group identified 31 individuals who, in 1968, had received
blood from donors later found to be positive for anti-HCV
antibodies. They obtained blood samples from these subjects
in 1998, and found that only 18 subjects had anti-HCV antibody,
16 of whom were HCV RNA positive.
Those negative for HCV RNA remained nonviremic
during a 5-year prospective follow-up.
"We do not know whether the 13 recipients
found to be anti-HCV and HCV RNA negative were resistant to
the infection or whether they lost HCV markers over time,"
the authors write.
There were no cases of cirrhosis. Liver
biopsies obtained in 1998 from 11 subjects revealed histologic
signs of progressive liver damage in only three individuals.
Repeat biopsies five years later in five subjects showed that
only one case progressed from absence of fibrosis to mild
portal fibrosis.
"Taking into account the limited study
sample," the authors conclude, "these findings suggest
that HCV infection acquired early in life shows a slow progression
and mild outcome during the first 35 years of infection."
Hepatology 2004;39:90-96.
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January 28th, 2004
How Does
Combo Therapy Stack Up Against Post-Transplant Hepatitis?
John C. Martin
Hepatitis Neighborhood
Combination therapy using pegylated interferon
and the anti-viral medication, ribavirin, is an effective
way to treat recurrent hepatitis C in patients following liver
transplantation, says one group of doctors in Nebraska. But
side effects, should be taken into account since they're one
limiting factor.
Testing A Therapy
Doctors at the University of Nebraska Medical Center in Omaha
launched a study to try to find out whether combination therapy
with pegylated interferon would be more effective than standard
interferon.1
The research is published in Transplantation
Proceedings, an Elsevier journal.
"Recurrent hepatitis C is often treated
with an interferon and ribavirin combination therapy, but
the results have been disappointing," wrote the study
team headed by Sandeep Mukherjee, M.D., in the Section of
Gastroenterology and Hepatology. "Given the promising
results reported with pegylated interferon and ribavirin for
HCV, we were interested in determining the effectiveness of
this treatment for a cohort of liver transplant recipients
with recurrent HCV."
This study was an extension of previous
work investigating the effectiveness of standard interferon
monotherapy, and in combination with ribavirin, for patients
with recurrent HCV after liver transplant procedures, Mukherjee
told Priority Healthcare.
"It's quite clear that the pegylated
ones are better than the old-fashioned interferons [for recurrent
HCV]," he said. "We still don't know whether PEG-Intron
is better than Pegasys. I think that's probably going to be
answered by pre-transplant studies."
Evaluating The Impact of Therapy
During a one-year period between 2001 and 2002, Mukherjee
and his colleagues evaluated a group of patients who presented
with recurrent hepatitis following liver transplantation.
Each patient was screened to determine if they were eligible
for therapy.
Each patient during the study was prescribed
weekly doses of PEG-Intron (1.5 mg/kg of body weight)—a
pegylated interferon manufactured by Schering-Plough pharmaceuticals—combined
with daily doses of 800 milligrams of ribavirin and 1 milligram
of folic acid as a treatment to prevent anemia, a possible
side effect of ribavirin.2
The physicians performed liver function
tests, conducted genetic tests of the virus to determine its
presence in the liver, and performed liver biopsies. Tests
to detect presence of the virus were repeated three months
into treatment, at the end of therapy, and then again 6 months
following the end of therapy for patients who had no evidence
of the virus at the end of treatment.
The average age of the patients who took
part was about 50 years.
"Eighteen patients completed treatment,
four remain on treatment, and 17 were intolerant," the
research team wrote after the study was finished.
A Side Effect Issue
While approximately 43 percent of the patients were forced
to quit the study before their treatment schedule was completed
due to intolerable side effects, more than two-thirds who
had completed therapy had no evidence of the hepatitis C virus
in their bloodstream (eradication of HCV RNA), and this was
also the case at the 6-month post-treatment follow-up, Mukherjee
and his colleagues found.
"Side effects are an important limiting
factor in the treatment of recurrent HCV with pegylated interferon
and ribavirin," the team wrote. "However, these
results are encouraging as sustained HCV eradication occurred
in at least 66.7 percent of patients who completed treatment."
The physicians call for larger clinical
trials involving many more patients taking the same combination
therapy to confirm their findings, as well as to measure how
this treatment affects the quality of life for patients with
recurrent HCV.
Questions To Clarify
While the clinical course of recurrent hepatitis C after liver
transplantation is still not completely understood, experts
believe HCV can re-infect patients rather quickly if their
immune systems are compromised.
Studies have suggested that at least 50
percent of liver transplant recipients can re-develop full-blown
hepatitis and about 10 percent develop cirrhosis at five years
after surgery.3
The use of living-donor liver transplantation
has resulted in an increased risk of cholestatic hepatitis4,
or in outcomes similar to those using cadavers for liver transplantation.5
"The problem is that most patients who get transplants
for hepatitis C do okay, but there's a small group who don't,"
Mukherjee explained. "And the dilemma we have is that
we cannot always predict which patients will do well, and
which patients will do badly post transplant."
Treatment options for such patients have
been met with varied success, as well.
Other studies have found that retransplantation
after HCV re-infection is not very useful and results in poor
outcomes.6 "When someone gets very bad recurrent
hepatitis C, say, within one year post transplant, re-transplanting
them is not an option because it doesn't work," Mukherjee.
"If they lose their liver, say, 5,
6, 7 years post transplant, that's different because when
you re-transplant those patients, their outcomes are as good
as other re-transplant patients."
References:
1. Mukherjee S et al. Pilot study of pegylated
interferon alfa-2b and ribavirin for recurrent hepatitis C
after liver transplantation. Transplant Proc 2003 Dec;35(8):3042-44.
2. Sulkowski MS. Anemia in the treatment of hepatitis C infection.
Clin Infect Dis 2003;37 Suppl 4:S315-22.
3. Gane EJ et al. Long-term outcome of hepatitis C infection
after liver transplantation. N Engl J Med 1996 Mar 28;334(13):815-20.
4. Gaglio PJ et al. Increased risk of cholestatic hepatitis
C in recipients of grafts from living versus cadaveric liver
donors. Liver Transpl 2003;9:1028-35.
5. Everson Gt, Troter J. Role of adult living donor liver
transplantation in patients with hepatitis C. Liver Transpl
2003;9(suppl 10):S64-S68.
6. Berenguer M et al. Severe recurrent hepatitis C after liver
retransplantation for hepatitis C virus-related graft cirrhosis.
Liver Transpl 2003;9:228-35.
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January 30th, 2004
Interferon-Alpha
May Be Safe, Effective In Preventing Hepatocellular Carcinoma
Recurrence After Ablation Therapy
Jill Taylor
Interferon-alpha (IFN-alpha) therapy in
patients with hepatocellular carcinoma (HCC) may reduce recurrence
after medical ablation for primary tumours, according to Shi-Ming
Lin, MD, and colleagues of the Liver Research Unit, Chang
Gung Memorial Hospital, Chang Gung University, Taipei, Taiwan.
HCC recurrence after successful ablation
therapy for primary tumours is common and contributes to shortened
survival. Previous studies have demonstrated that IFN-alpha
is effective in preventing HCC recurrence related to hepatitis
C virus or hepatitis B virus, prompting the researchers to
evaluate the effectiveness of IFN-alpha in preventing HCC
recurrence after successful medical ablation.
The study population consisted of 30 patients
(35 nodular HCCs) who were successfully treated with nonsurgical
methods, including percutaneous acetic acid injection (PAI)
for 10 HCC tumours and transcatheter arterial chemoembolisation
with subsequent PAI for 25 HCC tumours.
Patients were randomised to treatment groups,
with 11 patients receiving 3 mega units (MU) of IFN-alpha
3 times weekly for 24 months (IFN-alpha-continuous group),
9 patients receiving 3 MU of IFN-alpha daily for 10 days monthly
over 6 months followed by 3 MU of IFN-alpha daily for 10 days
every 3 months for another 18 months (IFN-alpha-intermittent
group), and 10 patients receiving no IFN-alpha therapy (control
group).
Analysis showed that the cumulative HCC
recurrence rate among untreated patients was 40% at 1 year,
70% at 2 years, and 90% at 4 years, which was consistently
higher than the rate among patients treated with IFN-alpha
(25% at 1 year, 30% at 2 years, and 47% at 4 years).
Furthermore, intermittent IFN-alpha administration
appeared to be the most effective of the 2 therapeutic regimens.
Cumulative HCC recurrence rates in the IFN-alpha-intermittent
and IFN-alpha-continuous groups were 22.2% and 27.3% at the
end of 1 year, and 33.3% and 54.6% at the end of 4 years.
Although no significant adverse effects
of IFN-alpha therapy were observed, 3 patients in the IFN-alpha-continuous
group discontinued therapy due to severe malaise, arthralgia,
and depression.
"Despite the small sample size, the
differences observed were significant," the researchers
note. "Nonetheless, a larger sample size would increase
the power of the study."
Source: Cancer 2004
Jan 15;100:2:376-82. "Prospective randomized controlled
study of interferon-alpha in preventing hepatocellular carcinoma
recurrence after medical ablation therapy for primary tumors."
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February 1st, 1004
Martin Studies
Tainted Blood Lawsuit
by Richard Oakley
Source: Sunday Times
The government is considering hiring an
American law firm to take a multi-million-dollar case against
US-based drug companies implicated in infecting Irish haemophiliacs
with HIV and hepatitis C.
Micheal Martin, the health minister, has
sought advice from the attorney-general on filing a lawsuit
in America. A decision on whether to proceed is expected within
weeks.
Haemophiliacs and their families from Britain,
Italy and Germany have already filed claims in America. Martin
has been approached by Lieff Cabraser Heimann and Bernstein,
a California law firm that began a case for 15 people last
summer. If the minister proceeds, the contract will go out
to tender The firm, which has won damages for Holocaust victims,
cigarette smokers and businesses affected by the Exxon Valdez
oil tanker wreck, is alleging that the drug companies sold
blood products that they knew, or should have known, were
infected with HIV and hepatitis C agents.
The blood products of some of the drug
companies cited in the claim are implicated in the cases of
Irish victims. The fact that the law firm is taking cases
for non-Americans prompted the department to consider pursuing
a case there too. Martin's officials became aware of the case
after it was brought to their attention by legal representatives
of the Irish Haemophilia Society.
The department has been examining ways
of holding an inquiry into the role played by US drug companies
in the contamination of blood products ever since the Lindsay
report was published in 2002. It considered setting up a tribunal
of inquiry, but received legal advice that there was no guarantee
the American authorities would provide judicial assistance.
Since then Martin has contemplated sending
a team to America to see what information could be obtained
from those willing to volunteer it, and from material publicly
available. Last week in the Dail, however, he said his department
was considering a "potential alternative route".
The American companies named in Lieff Cabraser's
lawsuit include Baxter Healthcare Corporation, Armour Pharmaceutical
Company and Alpha Therapeutic Corporation.
The lawsuit alleges that the defendants
manufactured and sold blood factor products as beneficial
"medicines" when they were contaminated with HIV
and resulted in the mass infection or deaths of thousands
of people with haemophilia.
The defendants are also accused of using
or purchasing blood plasma knowingly obtained from the highest-risk
populations, including prisoners and intravenous drug users.
The companies contest the claims.
A number of Irish haemophiliacs have already
taken private cases against drug companies, including Baxter
and Armour. In 2001, five drug firms settled a £5.3m
case taken by 60 haemophiliacs infected with HIV from contaminated
products.
Back to top
February 02, 2004
BioLife Solutions
Signs Supply Agreement With Hepatotech Inc.
Source: PRNewswire
BioLife Solutions Inc.(OTC Bulletin Board:
BLFS) announced today that it has signed a multi-year supply
agreement with Pittsboro, NC-based Hepatotech Inc., a privately-held
manufacturer and distributor of hepatocytes (liver cells).
Under the terms of the agreement, BioLife will sell Hepatotech
its off-the-shelf Hypothermosol(R) and Cryostor(TM) preservation
solutions to support Hepatotech's cell harvest and shipment
services. The agreement with the collaborating entities of
Hepatotech further expands the sales opportunities for BioLife's
technology.
BioLife President and CEO John G. Baust, Ph.D., said, "We
look forward to working with Hepatotech to expand the distribution
of our product offerings to their customers. This agreement
represents a key milestone in the implementation of our Company's
strategy to expand our customer base via such sole source
agreements to position BioLife to derive growing revenue streams
from a broader base of customers."
BioLife's HypoThermosol family of products
includes solutions optimized for the "chill" storage
of human cells and tissues. Its recently developed CryoStor
product line of cryopreservation media provides a superior
approach to the low temperature preservation of many biological
systems.
About BioLife Solutions, Inc.
BioLife Solutions has pioneered the next generation of preservation
solutions designed to maintain the viability and health of
cellular matter and tissues during freezing, transportation
and storage. Based on the Company's proprietary bio-packaging
technology and a patented under-standing of the mechanism
of cellular damage and death, these products enable the biotechnology
and medical community to address a growing problem that exists
today. The expanding practice of cell and gene therapy has
created a need for products that ensure the biological viability
of mammalian cell and tissue material during transportation
and storage. The HypoThermosol(R) and CryoStor(TM) products
that the Company is selling today are a significant step forward
in meeting these needs.
This news release contains forward-looking
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include any statements that relate to the intent, belief,
plans or expectations of the Company or its management, or
that are not a statement of historical fact. Any forward-looking
statements in this news release are based on current expectations
and beliefs and are subject to numerous risks and uncertainties
that could cause actual results to differ materially. Some
of the specific factors that could cause BioLife Solutions'
actual results to differ materially are discussed in the Company's
recent filings with the Securities and Exchange Commission.
BioLife Solutions disclaims any obligation to update any forward-looking
statements as a result of developments occurring after the
date of this press release.
For further information please contact:
investors, Jill Bertotti, jill@allencaron.com,
or media, Len Hall, len@allencaron.com,
both of Allen & Caron Inc, +1-949-474-4300, for BioLife
Solutions Inc.
SOURCE: BioLife Solutions Inc.
Back to top
Genencor
to Start Phase I Study for Therapeutic Vaccine for Hepatitis
B
SourcE: PRNewsire
Genencor International, Inc. (NASDAQ:GCOR)
today announced it will begin Phase I safety and immunogenicity
testing for its DNA-based therapeutic vaccine to treat hepatitis
B. Trials are scheduled to begin later this month under an
Investigational New Drug Application (IND) filed by Genencor
in December. Epimmune Inc. collaborated on the design and
preclinical development of the vaccine under its collaboration
agreement with Genencor and will receive a milestone payment
as a result of the IND filing.
"This first IND for Genencor represents
important progress in our health care business," said
Mark A. Goldsmith, M.D., Ph.D. Genencor's senior vice president,
Health Care. "In less than 3 years, we've shown that
we can leverage Genencor's core technology to envision and
build an innovative immunotherapeutic product candidate for
treating chronic hepatitis B infection, to prepare and qualify
this candidate for advancement into the next stage of development,
and to design a quality plan for human studies. Genencor looks
forward to the launch this month of a Phase I study to establish
safety and immunogenicity profiles for this product candidate."
"Hepatitis B is an enormous world wide health problem
without a solution," said Frank Chisari, M.D., Professor
and Head of Experimental Pathology, and Director of the General
Clinical Research Center at the Scripps Research Institute
and a leading investigator of hepatitis viruses. "As
a member of both Genencor's and Epimmune's Vaccine Scientific
Advisory Boards, I have followed the progress of this program
and contributed to it scientifically. I am thrilled that this
well-designed vaccine candidate is moving into clinical development
for evaluation in people."
About Genencor
Genencor International is a diversified biotechnology company
that develops and delivers innovative products and services
into the health care, agri-processing, industrial and consumer
markets. Using an integrated set of technology platforms,
Genencor's products deliver innovative and sustainable solutions
to many of the problems of everyday life. Genencor traces
its history to 1982 and has grown to become a leading biotechnology
company, with over $350 million in year 2002 annual revenues.
Genencor has principal offices in Palo Alto, California; Rochester,
New York; and Leiden, the Netherlands.
This press release contains forward-looking
statements as defined by the Private Securities Litigation
Reform Act of 1995 concerning the commencement of Phase I
safety and immunogenicity testing for Genencor's DNA-based
therapeutic vaccine to treat hepatitis B. These include statements
concerning plans, objectives, goals, strategies, future events
or performance and all other statements which are other than
statements of historical fact, including without limitation,
statements containing words such as "believes,"
"anticipates," "expects," "estimates,"
"projects," "will," "may," "might"
and words of a similar nature. Such statements involve risks
and uncertainties that could cause actual results to differ
materially from those projected. Drug and vaccine research
and development involves a high degree of risk. Some important
factors that could cause actual results to differ include
dependence on the efforts of third parties; dependence on
new and uncertain technology and its uncertain application;
regulatory actions or delays, or uncertainties related to
product development, testing or manufacturing; dependence
on certain intellectual property rights of both Genencor and
third parties including Epimmune, Inc.; the competitive nature
of Genencor's industry; risks of obsolescence of certain technology;
and the possibility that clinical testing reveals unsuccessful
results or undesirable side effects. These and other risk
factors are more fully discussed in Genencor's most recent
Annual Report on Form 10-K and Quarterly Report on Form 10-Q
filed with the United States Securities and Exchange Commission.
The forward-looking statements contained in this release represent
the judgment of Genencor as of the date of this press release.
Genencor disclaims, however, any intent or obligation to update
any forward-looking statements.
Source: Genencor International, Inc.
CONTACT: investors, Tom Rathjen +1-650-846-7500, or media,
Valerie
Tucker, +1-650-846-7571, both of Genencor International, Inc.
Web site: http://www.genencor.com
Back to top
Chronic Liver
Disease Mortality in the United States
Source: www.gastrohep.com
Nearly 20% of chronic liver disease deaths
in 1998 were due to viral hepatitis, find investigators in
the latest issue of Hepatology.
In 1998, chronic liver disease (CLD) was
the tenth leading cause of death in the United States.
Important etiologies included alcohol and hepatitis C.
It is thought that the methods used for
calculating CLD mortality rates using death certificates may
underestimate hepatitis C-related CLD mortality.
In this study, investigators from Atlanta,
Georgia, assessed patterns of CLD deaths from 1990 to 1998.
The team used an expanded definition that included death certificates
where CLD, viral hepatitis, or CLD-related sequelae were reported
as the underlying cause.
They calculated overall age-specific and
age-adjusted mortality rates.
The investigators found that CLD mortality
had declined by 5% overall from 1990 to 1994. However, it
remained unchanged from 1995 to 1998.
They established that corresponding decreases
occurred for all causes of CLD, except hepatitis C. Rates
of hepatitis C increased 220% from 1993 to 1998.
Rates of CLD mortality declined in all
ethnic groups, except American Indians and Alaska Natives.
In these groups rates remained unchanged.
Rates of hepatitis C increased 220% from
1993 to 1998.
The team found that, of the 30,933 CLD
deaths in 1998, 39% were coded as alcohol related, 15% as
hepatitis C, 4% as hepatitis B, and 44% had no recorded cause.
They determined that age-adjusted rates
were higher among males than females, and among Hispanics
compared with non-Hispanics.
The rates of CLD mortality among American
Indians and Alaska Natives were more than twice those of African
Americans and whites.
Drs Sirenda Vong and Beth Bell concluded,
"1998 CLD deaths and the proportion attributable to viral
hepatitis increased by 23% and 19%, respectively, compared
with traditional methods."
"Mortality declines of the early 1990s
were not sustained after 1994."
"Large disparities in CLD mortality
remain, particularly among American Indians and Alaska Natives."
Hepatology 2004; 39(2): 476-83
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The Silent
Epidemic
Source: www.Independent.co.uk
Almost half a million Britons have
an incurable form of hepatitis that was unknown 15 years ago.
Maxine Frith hears how easy it is to catch, and how difficult
it is to treat --
02 February 2004
For almost as long as she can remember,
Jane Wynn Parry has felt unwell, plagued by bouts of extreme
fatigue and debilitating pain which leave her unable to work
and confined to bed.
Over 20 years she went to numerous doctors and specialists
who either dismissed her problems as "all in the mind"
or said they could find no explanation for the exhaustion
and sickness she suffered.
Then, six years ago, she was given a devastating
diagnosis: she had hepatitis C, a potentially fatal liver
disease which is caught from infected blood.
"I was just totally shocked,"
says Jane, 44, who is from south London. "It has taken
me a long time to come to terms with the fact that I have
a chronic, infectious disease which dominates my life and
could kill me. It affects everything - my work, social life,
relationships with men. It is very difficult to live with."
Hepatitis C has been dubbed "the silent
epidemic" by doctors, who are warning that rates of the
disease in Britain are soaring while most people remain unaware
they are infected. More than 400,000 people in the UK have
the disease, and 100 new infections are occurring every week.
It is already the main reason for liver transplants, and experts
say that by 2020 it will be killing more people than Aids.
Hepatitis C causes inflammation of the
liver, and in severe cases can cause jaundice, cancer and
liver failure. Early symptoms include weight loss, vomiting,
flu-like feelings and fatigue. Yet because many people do
not suffer any symptoms, and those that do are often misdiagnosed,
only 20 per cent of victims actually know they have the disease.
Less than one per cent are receiving treatment, even though
60 per cent could benefit from the drugs available.
The virus is spread via blood, but was
only identified in 1989. A screening test was introduced in
1991, but before then, many thousands of people were contaminated
by blood transfusions during operations.
Jane Wynn Parry believes she was infected
from a blood transfusion she was given at birth. "All
through my teens, I just felt generally unwell," she
says. "I would just have bouts of extreme fatigue when
I would just have to go to bed for days at a time. I had pain
around my liver area, but no-one even knew about hepatitis
C then. It was very depressing, especially as there were times
when there was an inference from doctors that it was all in
my mind, or there was nothing really wrong."
The exhaustion and pain meant it was difficult
to work, and an endless round of GP visits, hospital appointments
and specialist referrals still failed to find a cause for
Jane's problems.
Then, in 1998, a doctor said she had gall
bladder problems and ordered a series of tests. "I was
in his room expecting to hear about the gall bladder, when
he just said, almost by-the-by, 'Oh, you have hepatitis C'.
They had done a hepatitis C test without telling me. I went
into shock, but in a way I was relieved because I finally
knew what was wrong with me."
However, Jane discovered there was very
little support for people with the disease - and still very
little awareness among doctors and the world at large about
it. She suffered a further blow when tests showed that the
type of virus she had meant the drug treatments available
would not work for her.
"I felt very alone," she says.
"Basically I was told there was nothing they could to
help me and there were no support groups because so few people
are even aware they have the disease. I would have periods
of feeling better, then times when I would be laid completely
low by the symptoms, as well as depression because of how
I felt.
"I couldn't go out, couldn't meet
friends or family, and it is obviously difficult to form relationships
when you have to tell someone that you have this disease.
I have been out with one man since I was diagnosed, but he
was a friend who already knew so I didn't have to broach the
subject."
Hepatitis C can be passed through sexual
contact, and there is a small risk of infection from toothbrushes,
razors and other objects which may have blood on them. It
is ten times more infectious via blood-to-blood contact than
HIV, although less infectious than the virus via sexual contact.
Alarmed by the soaring number of cases,
the Government published a strategy on hepatitis C 18 months
ago, and promised an action plan to tackle the epidemic. However,
no plan has emerged and doctors have become frustrated by
the lack of progress.
Graham Foster, professor of hepatology
at the Royal London Hospital said: "There is much disappointment
in the lack of an action plan. Absolutely nothing is happening."
He added: "The figures are horrifying. Over the next
10 to 15 years liver disease and cancer rates will soar. The
Government is talking the talk but it is doing nothing else."
Last week, a new drug for people with a
chronic form of hepatitis C was approved by the National Institute
for Clinical Excellence, the body which approves medicines
and therapies for use on the NHS. The drug, peginterferon
alfa, is more effective than current treatments, and has been
welcomed by patients and doctors.
And after years of prevaricating, the Government
has finally announced a compensation package for people infected
with hepatitis C through blood transfusions. They will receive
£20,000 each, and those with the advanced form of the
disease will get a further £25,000.
More than 1,000 people who contracted hepatitis
C from contaminated blood have already died and thousands
more are infected. The total payout is expected to be £100
million.
While blood is now screened and heat treatment
can kill off the virus, the disease is still being spread,
partly because many people are unaware they are infected and
therefore take no precautions with their partners.
The former Baywatch star Pamela Anderson
has hepatitis C, which she believes was contracted by sharing
a tattoo needle with her ex-husband Tommy Lee. She has spoken
openly about having the disease, which has helped to bring
it into the open. But charities are still pushing for a national
awareness campaign in order to get more people tested and
treated. One reason for the lack of action and commitment
is that hepatitis C has previously been regarded as a "low-life"
disease mainly affecting drug users who share needles.
Charles Gore, of the Hepatitis C Trust, said: "We are
going to have to face the consequences of this disease and
it is better to do it sooner rather than later. There are
hundreds of thousands of people out there with hepatitis C
who at the moment are undiagnosed and are a risk to themselves
because they are not getting treatment, and a risk to others
because they could infect them. There is also a wider problem
of the huge burden this is going to put on the NHS."
The Government is set to launch a publicity
campaign this year. Meanwhile, Jane Wynn Parry has found ways
of living with the fact that she has an incurable and infectious
disease. "I have found that alternative therapies like
acupuncture and Chinese medicine have helped me a lot,"
she says. "Spiritual exercises have helped me to focus
on the positive things and to come to terms with the disease.
I don't dwell on what could happen in the future, I just try
to stay focused on feeling well in the present."
The Hepatitis C Trust is at www.hepcuk.info
Back to top
February 3rd, 2004
SARS-Associated
Viral Hepatitis Caused by a Novel Coronavirus
Source: www.gastrohep.com
Hepatic impairment in patients with severe
acute respiratory syndrome is due to SARS-associated coronavirus
infection of the liver, find physicians in the February issue
of Hepatology.
Liver impairment occurs in up to 60% of
patients who suffer from severe acute respiratory syndrome
(SARS).
In this study, physicians from Hong Kong,
China, report the clinical course and liver pathology in 3
SARS patients with liver impairment.
The patients all fulfilled the World Health
Organization case definition of probable SARS. They also developed
marked elevation of alanine aminotransferase.
The physicians performed percutaneous liver
biopsies, and specimens were examined using light and electron
microscopy, as well as immunohistochemistry.
RT-PCR found evidence of SARS-associated
coronavirus in the liver tissues. Hepatology
In addition, the team used RT-PCR to find
evidence of SARS-associated coronavirus infection.
The physicians found a marked accumulation
of cells in mitosis in 2 patients, and apoptosis in all 3.
The team also identified ballooning of
hepatocytes and mild to moderate lobular lymphocytic infiltration.
There was no eosinophilic infiltration,
granuloma, cholestasis, fibrosis, or fibrin deposition.
The immunohistochemical studies showed
that 0.5% to 11% of nuclei were positive for proliferative
antigen Ki-67.
In addition, RT-PCR found evidence of SARS-associated
coronavirus in the liver tissues, but not in the sera, of
all 3 patients.
Dr Tai-Nin Chau's team concluded, "Hepatic
impairment in patients with SARS is due to SARS-associated
coronavirus infection of the liver".
"The prominence of mitotic activity
of hepatocytes is unique and may be due to a hyperproliferative
state with or without disruption of cell cycle by the coronavirus".
"With better knowledge of pathogenesis,
specific therapy may be targeted to reduce viral replication
and modify the disease course".
Hepatology 2004; 39(2): 302-10
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UK Physicians
Back Organ Donation Plan
By Stephen Pincock
Source: Reuters Health
British doctors have thrown their support
behind a proposal heard in parliament on Tuesday that suggests
making significant changes to the country's organ donation
system.
The British Medical Association said a
Ten Minute Rule Bill tabled by parliamentarian Siobhain McDonagh
(Labour, Mitcham and Morden) would increase the number of
donors and improve the current shortage of organs for transplantation.
Ten Minute Rule Bills are often used by
members of parliament as a way to make a point on the need
for a change to the law, and to stimulate debate, rather than
necessarily a serious attempt at making legislation.
The bill debated on Tuesday, "The
Organ Donation (Presumed Consent and Safeguards) Bill",
suggests presuming that people give consent for organ donation
unless they specifically opt out.
"We're seeing an increasing gap between
the number of people who need transplants and the number of
donors. At the moment we're particularly anxious about the
major source of organs, which are people who die in intensive
care units," Dr. Michael Wilks, Chairman of the BMA's
Ethics Committee, told Reuters Health.
Whereas 10 years ago, about 30% of relatives
refused to allow the deceased's organs to be donated, now
it is more like 50%, he said. At the end of December 2003,
there were 7278 people on the transplant waiting list in the
UK.
"We must increase the number of donors
available and we believe that a system of presumed consent
with safeguards, will do this. The BMA fully supports Siobhain
McDonagh's efforts to promote debate on this issue,"
he said.
Studies show that around 90% of the population
would be willing to donate organs after their death, the BMA
said, but only 19% of the population are on the NHS Organ
Donor Register.
The scheme proposed by McDonagh would use the register to
record the names of those who opt out of donating. Experience
in Belgium, where a similar set-up is in place, suggests that
only 2% of people would opt out, Dr. Wilks said.
The issue of presumed consent for organ
donation is also being discussed in relation to the Human
Tissue Bill that is now progressing through parliament.
That draft legislation, a response to organ
donation scandals in hospitals over recent years, aims to
put in place strong guidelines for retaining human tissue
for research.
During meetings of a standing committee
for the bill last week, Dr. Evan Harris (Liberal Democrat,
Oxford West and Abingdon) raised the subject of presumed consent.
That subject is expected to be taken further next time all
MPs have an opportunity to debate the bill, Dr. Wilks said.
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Micrologix
Buys Hepatitis C Drug, Shares Soar
Source: Reuters
Shares of Micrologix Biotech Inc. (MBI.TO:
Quote, Profile, Research) soared 37 percent on Tuesday morning
after the company said it bought the global rights for a drug
being developed to treat chronic hepatitis C and would start
phase II trials this year.
Shares of Vancouver, British Columbia-based
Micrologix, were ahead 25 Canadian cents to 92 Canadian cents
at noon.
Micrologix said it will pay an upfront
fee in equity to Britain's Virogen Ltd., from which it acquired
celgosivir, an oral anti-viral agent.
"This positions us well to address
the unmet medical need that exists globally in the area of
hepatitis," Micrologix CEO Jim DeMesa said in a statement.
The company gave no financial details,
but it said it will pay milestone payments in cash and/or
equity as development objectives are met, as well as royalties
on sales and sublicensing revenues.
About 170 million people worldwide are
infected with the hepatitis C virus and the number is expected
to increase fourfold from 1990 to 2015, Micrologix said.
By 2010, the global market for hepatitis
C treatments is expected to reach $6 billion.
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February 4th, 2004
Effect
of Peginterferon Alfa-2a on Liver Histology in Chronic Hepatitis
C
Source: www.gastrohep.com
Fibrosis is significantly reduced in patients
with chronic hepatitis C who are treated with peginterferon
alfa-2a, find physicians in the February issue of Hepatology.
Previous studies have determined that pegylated
interferon (peginterferon) alfa-2a is more effective than
conventional interferon alfa-2a (IFN) in patients with chronic
hepatitis C.
In this study, an international team of
physicians conducted a meta-analysis of 1013 previously untreated
patients from 3 randomized trials.
All patients had pre- and post-treatment
liver biopsies.
The team evaluated the effect of peginterferon
alfa-2a and IFN on patients' liver histology.
There was no significant reduction in fibrosis
in nonresponders.
The physicians found that peginterferon
alfa-2a significantly reduced fibrosis in patients with chronic
hepatitis C, compared with IFN. They observed a reduction
in fibrosis in sustained virologic responders and patients
with recurrent disease. The team did not find a significant
reduction in nonresponders.
Using logistic regression analysis, the
physicians found that patients with sustained virologic responses
(SVRs) had an odds ratio (OR) of 1.61 for reduction in fibrosis
compared with patients without SVRs.
However, obese patients had an OR of 0.56
for reduction in fibrosis compared with normal-weight and
overweight patients.
Dr Calogero Cammà's team concluded,
"In patients with chronic hepatitis C with or without
cirrhosis, peginterferon alfa-2a (relative to IFN) significantly
reduced fibrosis".
"The beneficial effects of peginterferon
on liver histology are closely related to virologic response".
Hepatology 2004; 39(2): 333-42
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New Funding
Offers Hepatitis C Patients Chance for Cure
Source: NZPA (New Zealand Press Association)
Some New Zealand hepatitis C sufferers
living with "a time bomb in their livers" now have
a better chance of being cured with the Government's agreement
to a more effective treatment.
From March 1, pegylated interferon in combination
with ribavirin will be available fully funded for sufferers
of the most virulent form of the disease, type 1.
The combination therapy has a permanent
cure rate of 50 per cent for people with type 1 hepatitis
C - a considerable improvement on the previous cure rate of
36 per cent with standard interferon combination therapy.
Government drug-buying agency, Pharmac,
estimates about 250 people will be able to access the treatment
every year, at a cost of up to $5 million.
About half of the estimated 30,000 New
Zealanders infected with hepatitis C are genotype 1, but the
majority are unaware they have the disease, which can take
years to produce symptoms.
Pharmac chief executive Wayne McNee said
the deal with the pharmaceutical company Roche Products was
"a step forward" for sufferers of hepatitis C.
"We will be targeting the treatment
to the largest identifiable group, which is also the hardest
group to treat using the standard therapy," he said in
a statement.
"We also expect that improving treatment
will have downstream benefits in other areas of the health
sector, such as reducing the demand for liver transplants
as a result of hepatitis C infection."
Pharmac was also looking at ways of making
the new treatment even more widely available, he said.
Hepatitis Foundation chief executive John
Hornell, a long-time campaigner for the treatment, said hepatitis
infections had reached "epidemic proportions" in
New Zealand and yesterday's announcement was "great news".
"Having the most effective therapy
available means a cure has become a realistic goal for more
people," he said.
"Living with hepatitis C can be like
having a time-bomb in your liver."
Common symptoms included fatigue, feeling
unwell and alcohol intolerance.
Chronic infection can lead to advanced
liver disease (cirrhosis), liver failure and liver cancer.
Mr Hornell said he hoped that the treatment
would be rolled out over time to other hepatitis sufferers.
Such a move would save the health system
millions down the track, he said yesterday.
"We used to be streets ahead of Australia
when it came to hepatitis C control but Australia has funded
this drug since November last year."
The treatment had serious side-effects
and patients and their families and their primary health givers
would need on-going support, he said.
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EU
Drugs Agency Warns of "Hidden Epidemic" of Hepatitis
C Infections
Source: European Monitoring Centre for
Drugs and Drug Addiction (EMCDDA)
The European Union is facing a "hidden
epidemic" of liver-destroying hepatitis C infections
which threatens to overwhelm member states' health budgets,
the bloc's drugs monitoring agency warned Wednesday.
The Lisbon-based organisation said in a report that more than
one million people, "possibly up to several million",
were already infected with the virus in the 15-member EU.
While the virus can be spread by sex with
an infected person or transfusion of infected blood, the sharing
of contaminated needles by drugs users currently accounts
for between 60 to 90 percent of new infections, it said.
"Health-promotion activities are needed
to discourage people from injecting drugs or to change their
behaviour to reduce the risk of contracting the virus if they
are unable to stop," the report said.
Doctors warn that since a small amount
of blood from an infected person can contain a large dose
of the virus, the odds of contracting hepatitis C from a single
prick from shared needs are high.
Some medical experts believe the hepatitis
C virus can spread 10 times more easily through needle sharing
than the HIV virus, the virus which causes AIDS.
The European Monitoring Centre for Drugs
and Drug Addiction recommended in the report that governments
put in place needle-sharing programs and improve monitoring
systems for the disease in order to combat its spread.
It said each year in delay in preventing
new hepatitis C infections in the EU could lead to an increase
in treatment costs of an additional 1.4 billion euros (1.7
billion dollars).
"The implications of inaction for
EU public health budgets are likely to be considerable,"
the president of the drugs monitoring agency, Georges Estievenart,
said in the report.
"It is better to provide screening,
prevention education and treatment now than to let the disease
spread and to wait until sufferers become chronically ill."
The hepatitis C virus causes inflammation
of the liver in infected people. Roughly one in five patients
with the disease develop cirrhosis, which can lead to liver
failure and the need for expensive organ transplants.
European Monitoring Centre for
Drugs and Drug Addiction (EMCDDA)
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