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Alan Franciscus
Editor-in-Chief
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In This Issue:
• South Korean Red Cross
Rapped for Tainted Blood Lapses
• Canada To Set Up Tattoo Parlors in Prisons
• Hepatitis C Conference in Vancouver Hears of
Efforts Underway in Prisons
• Hepatitis C Documentary Film
• Doctors Suggest Monitoring High-Risk People for
Hepatitis C Virus
• Hepatitis Spike Due to Needles
• Epimmune (EPMN) Announces Extension Of Collaboration
Agreement With New Partner Innogenetics on Vaccine Programs
For Hepatitis B, Hepatitis C And Human Papillomavirus; Approximately
US $60 Million
• Prolongation of HCV Treatment to 18 Months Reduces
Relapse Rates From 40 to 15 Percent
• InterMune Charts New Course For Future
• Dangerous Supplements: Still at Large
• HBV Reactivation in Patients Undergoing
Cytotoxic Chemotherapy
• S.F.'s Homeless with HIV Plagued by Hepatitis
C Virus -- Few Treated
• Freeze-Drying Can't Remove Virus from Tissue
Transplants
March 28th, 2004
South
Korean Red Cross Rapped for Tainted Blood Lapses
Source: Reuters
SEOUL -- South Korea's Red Cross mishandled
donor information and circulated blood donated by hepatitis
virus carriers, infecting nine people, government auditors
said on Monday.
The Board of Audit and Inspection (BAI)
called on the Korea National Red Cross to punish officials
responsible for shipping blood donated by hepatitis virus
carriers to hospitals and pharmaceutical companies for five
years up until January.
A board audit conducted at the end of 2003
found that 76,677 units of blood received from donors who
had been infected with the hepatitis C virus had been distributed
for transfusions or research by the Red Cross, a board official
said.
The South Korean chapter of the international
agency also put in circulation 228 units of blood donated
by 99 people who had been suspected of carrying the HIV virus,
but who later tested negative for the virus that causes AIDS,
the official said.
Nine people were found to have been infected with hepatitis
last month after receiving blood transfusions from the Red
Cross, the officials said.
South Korean Red Cross spokesman Lee Jae-sung
said the problems stemmed from a change in laws in April 2000
that banned donations from people who had been infected with
hepatitis. The previous law had allowed donations from people
who were hepatitis-free at the time they gave blood.
It was not immediately clear if there were
also cases of hepatitis infections through blood donations
made before April 2000 under the earlier rules.
"We changed the rules for donation
but we only acquired a system to investigate donors' disease
history in May 2003," Lee said by telephone.
"The nine people infected with the
hepatitis virus received blood during the period between April
1, 2000, and May 2003," he said.
One of the nine already had hepatitis before
receiving the tainted transfusion, he said.
"We take full responsibility for the
other eight people and plan compensation," Lee said,
adding the suspect units of blood had been used up by the
time last year's audit had been done.
New procedures for checking donors' medical
history had made it "impossible for people who had been
infected with viruses to donate their blood", he said.
Back to top
March 29th, 2004
Canada To Set Up Tattoo Parlors in
Prisons
Source: News World Communications, Inc.
VANCOUVER, British Columbia,(UPI) -- Canada's
prison authorities will set up tattoo parlors at six federal
prisons this year to reduce the spread of infectious diseases
like hepatitis C.
Citing a study, Francoise Bouchard, director
general of health services for Corrections Canada, told a
hepatitis C conference in Vancouver, British Columbia, that
more than a quarter of all federal inmates have hepatitis
C, the Canadian Broadcasting Corp. reported Monday.
It is not known how many of those cases
resulted from tattooing, but Bouchard said at least 45 per
cent of inmates engage in it with whatever they can get their
hands on.
"All kinds of things, metal, old metal
equipment," she said.
So, as a pilot project, Corrections Canada
will set up tattoo parlors in six federal prisons. The sites
have not been chosen.
Bouchard said the shops will be staffed
by inmates.
Back to top
Hepatitis
C Conference in Vancouver Hears of Efforts Underway in Prisons
Greg Joyce
Source: Canadian Press
VANCOUVER -- The federal prison system
is taking strides to combat hepatitis C among inmates but
the disease is still on the rise, the director general of
health services for Corrections Canada said Monday.
Francoise Bouchard outlined the current
state of hepatitis C in Canada's 52 federal institutions at
the 2nd Canadian Conference on Hepatitis C, telling delegates
that tracking and preventing spread of the disease remains
a daunting task but programs are gathering momentum.
In 2002, for instance, Bouchard said 1,856
inmates with hepatitis C were released "and this number
is growing."
"We do not have specific numbers of
how many get infected while in prison," she told the
delegates made up of clinicians and public health professions.
"In fact, we suspect the majority
are infected with hepatitis C when they come in."
And how many inmates contract the disease
after admission is still unknown.
"We do not document at this time sero-conversion
because we do not have the capacity to track from admission
through the course of the sentence."
Their tracking, however, made it clear
that the hepatitis C rates "are still going up in positivity
within the general population."
There are more than 12,000 inmates in federal
custody, the vast majority of them male. Among the males,
about 17 per cent are native.
Bouchard said it is vital for the government
to track, study and try prevent the spread of infectious diseases
such as hepatitis C because most of the inmates will eventually
be released into the community.
And there is no shortage of study material
in the system.
"Seventy to 80 per cent of our inmates
report drug substance abuse problems when they come in,"
she told the conference.
Over the past several years, Corrections
Canada has put in place a surveillance system, along with
a prevention and treatment system, and a harm reduction program
with an injection of $7.34 million from Treasury Board.
"Surveillance is the keystone to public
health," she said.
Corrections has in place now a methadone
treatment program and it also provides condoms and bleach
and is in the process of beginning a "safe tattooing"
program.
The methadone aspect also needs more work,
she said.
"We have no way to estimate the number
of people who would need methadone in
corrections," she said.
About 500 inmates are now on methadone
within the federal prisons and the Treasury Board has indicated
that more money will be forthcoming if as prison authorities
identify more who want to take part.
The Canadian Viral Hepatitis Network (CVHN)
is sponsoring the conference along with the federal and provincial
and territorial governments.
Back to top
March 30th, 2004
Hepatitis
C Documentary Film
Source: www.lcmedia.com/hepcfilm.htm
To those who knew her, Christen Graeber
Winter was the girl next door. She lived her entire life in
Aberdeen, South Dakota, and married her high school sweetheart.
She was the mother of a 15-year-old daughter, volunteered
for the school board, and worked as an administrator for the
town's 3M plant, that made medical supplies. When she died
in 1998, at the age of 42, over 1,000 people attended her
funeral. Chris died from Hepatitis C, a blood-borne virus
that silently attacks the liver. She was one of 400,000 Americans
who contracted the virus from a blood transfusion prior to
1992, when an HCV diagnostic test was first developed.
When she died, her family, including her
sister Carey Graeber, was left with many questions. What is
Hepatitis C? How did it affect her for over a decade without
visible symptoms? If four million Americans are dying from
it, why hadn't the family ever heard of Hepatitis C or known
how serious it was? Carey's search for those answers over
the past four years has led to the production of a groundbreaking
documentary film, the first film to take a comprehensive look
at Hepatitis C, for theatrical and festival release and public
television broadcast.
This groundbreaking documentary film will
alert the public to the fact that the Hepatitis C epidemic
effects four million Americans, half of whom, like Carey's
sister, don't know they have this lethal illness because its
symptoms are not apparent. We will also follow Carey's search
to find out why more was not done to alert the public to this
epidemic before the death of her sister, and her work as an
advocate to bring this issue to the public's attention. The
documentary will also chronicle efforts to help pass the federal
bill providing funding for research and treatment, which includes
the efforts of a school full of kids in Virginia who are working
to get the legislation passed. The film will also investigate
the shocking failures of those responsible for insuring the
safety of the nation's blood supply; it's the story of AIDS
combined with R.J. Reynolds.
We are hopeful that the film will generate
a much-needed national dialogue about this fatal virus, with
the goal of earlier and increased diagnosis of those affected
and greater public support for research and treatments. This
groundbreaking 90-minute documentary will be accompanied by
a one-hour public radio program and community and educational
outreach effort. Together they will offer an engaging account
of those living with the illness, along with a comprehensive
examination of the disease from the medical, scientific, social,
political, public health and economic perspectives.
The film is being produced by Lichtenstein
Creative Media, the Peabody Award-winning producer of public
television and radio programs focusing on health and related
social issues. Our work includes The Infinite Mind, the highly-acclaimed
national, weekly public radio series, and West 47th Street,
the award-winning documentary film about four people living
with serious mental illness which will just aired on the PBS-TV
series P.O.V. this past summer to overwhelming reviews ("Must
see" - Newsweek; "Remarkable" - Washington
Post; "A life-altering cinema experience." - Tulsa
World).
The Hepatitis C documentary film is in
the national public television outreach pipeline for airing
in Fall 2004.
Back to top
Doctors
Suggest Monitoring High-Risk People for Hepatitis C Virus
Source:www.chinaview.cn
BEIJING -- The first guideline for doctors
and nurses to diagnose and treat hepatitis C virus (HCV) carriers
was published here Tuesday while doctors are calling for a
rigid monitoring of the population at high risk of contracting
HCV.
The Chinese Medical Association (CMA) published
such a guideline for the first time to help medical workers
detect, diagnose and treat HCV carriers as soon as possible
by elaborating on the symptoms, infection and treatment of
the epidemic and on how to detect those who are at high risk
of the virus.
China has approximately 40 million HCV
carriers, according to a national survey conducted in 1992
to 1995, one third of the carriers of the hepatitis B virus.
However, less than one third of the HCV
carriers have been to hospital, said Zhuang Hui, academician
of the Chinese Academy of Engineering (CAE) from Beijing University.
"These carriers will be a hidden hazard
for the public health if they do not receive medical treatment
in time," he said.
The population at high risk of HCV are
not well monitored since doctors are not aware enough of the
epidemic and some are not well informed of relevant knowledge,
said Prof. Weng Xinhua, director of the Society of Infectious
and Parasitic Diseases attached to the CMA.
He suggested that each high risk person
be monitored for HCV.
HCV, which can lead to hepatitis and liver
cancer, can be transmitted through blood, sex and from mother
to child.
China has carried out HCV detection during
blood donation since1992, which considerably reduced the transmission
through blood donation and blood products.
In some regions in China, 60 to 90 percent
of HCV infections resulted from sharing syringes among drug
users, according to the CMA.
Back to top
Hepatitis
Spike Due to Needles
Matthew Van Dusen
Source: Casper Star-Tribune
On Monday at a joint HIV/hepatitis conference in Cheyenne,
Wyoming health officials said methamphetamine users who shared
water to rinse their needles and dissolve the drug contributed
to last year's hepatitis B (HBV) outbreak that sickened 57
people in Natrona County. State Department of Health Hepatitis
Coordinator Clay Van Houten and High-Risk Population Specialist
Rob Johnson presented a study conducted during the outbreak
that found that those meth users who shared rinse water were
22 times more likely to get HBV than drug users who did not.
Van Houten first noticed a spike in HBV cases in February
2003. Reported cases in the county went from zero or two in
the preceding months to around five a month in the winter
and spring. The outbreak peaked in June with 10 new cases.
State and county health officials determined that many of
the cases were related to meth use.
In addition to local and state health officials tracking down
infected cases and their contacts, CDC also sent a team to
investigate the outbreak; it plans to release a report soon.
According to Johnson, 21 people in the 113-person study group
had HBV, and 18 of those injected meth. Among the 92 people
who did not get HBV, 45 were injection drug users. Most people
in both groups shared needles. Though sharing accessories
such as spoons and cotton to filter drug impurities was also
common, sharing rinse water was the strongest indicator of
HBV infection. Van Houten reported one user told him that
rinse water - often shared by many users in a common glass
at parties - "looks like pink Kool-Aid by the end of
the night" from the blood dissolved in it.
An HBV vaccination campaign seems to have curbed the outbreak.
Johnson said officials might need to consider other prevention
approaches, such as signs warning users not to share rinse
water.
Back to top
Epimmune
(EPMN) Announces Extension Of Collaboration Agreement With
New Partner Innogenetics (INGTF.PK) On Vaccine Programs For
Hepatitis B, Hepatitis C And Human Papillomavirus; Approximately
US $60 Million
Source: PRNewswire
SAN DIEGO -- Epimmune Inc. today announced
that it has entered into an agreement with Belgian-based biopharmaceutical
company Innogenetics NV (Euronext Brussels: INNX), its new
partner in vaccine programs focused on Hepatitis B virus (HBV),
Hepatitis C virus (HCV) and Human Papillomavirus (HPV), to
extend the term and modify certain other provisions of their
collaboration. Innogenetics acquired the worldwide rights
to the programs, including a license to the Epimmune technology,
from Genencor International, Inc., which has indicated its
desire to focus its research and development resources on
targeted biotherapeutics. Innogenetics plans to develop and
commercialize current vaccine candidates as well as future
products based on the technology.
Epimmune and Innogenetics have agreed to
extend the term of the collaboration by more than a year,
through September 2005, which is intended to enable Innogenetics
to complete development efforts and generate all clinical
vaccine candidates. Innogenetics also agreed to an increase
in the reimbursement rate payable to Epimmune for its services
on the programs. Innogenetics will now be responsible for
payment of development milestones as they are achieved and
royalty payments on sales of any products that may be developed,
both in accordance with the terms of the original license
agreement with Genencor.
Separately, Epimmune announced that Genencor
has entered into a standstill agreement, providing that it
will not sell any Epimmune common stock it owns for a period
of twelve months and thereafter, for a further twelve-month
period, it will be subject to certain trading and volume restrictions.
"We are excited to have the opportunity
to work on these important therapeutic vaccines with a company
like Innogenetics that has established expertise in immunology
and therapeutic vaccines," said Dr. Emile Loria, President
and Chief Executive Officer of Epimmune. "It also further
validates the Epimmune multi-epitope vaccine technology approach.
By extending the collaboration term at the outset, Innogenetics
is clearly showing its commitment to become a leading player
in this field."
Dr. Philippe Archinard, Chief Executive
Officer of Innogenetics said, "One of our Company's main
objectives is to focus on the development of therapeutic vaccines
and broaden our vaccine portfolio in the field of infectious
diseases. Innogenetics has evaluated a number of vaccine technologies
to complement its own expertise. We are convinced that Epimmune's
multi-epitope vaccine technology, acquired through Genencor,
represents a perfect fit. This provides us with an optimal
toolbox to achieve our ambitions. We look forward to collaborating
with Epimmune for the development of these promising vaccines."
Epimmune originally entered into the collaboration
with Genencor in July 2001 pursuant to which it exclusively
licensed to Genencor its PADRE(R) and epitope technologies
for vaccines to treat or prevent HBV, HCV and HPV. In connection
with the initial collaboration, Epimmune received an upfront
license fee and Genencor made a ten percent equity investment
in Epimmune common stock. Under the agreement, Epimmune may
receive a total of approximately US $60 million in payments,
including amounts already paid by Genencor and future amounts
payable by Innogenetics. In February 2004, the Company announced
that it had earned a milestone payment on the program as a
result of the filing of an Investigational New Drug application
(IND) for a vaccine to treat HBV.
About Epimmune Inc.
Epimmune Inc., based in San Diego, is focused on the development
of pharmaceutical products using multiple epitopes to specifically
activate the body's immune system. Epitopes, critical signaling
molecules, stimulate the T cell arm of the immune system to
respond to specific regions of cancer cells or infectious
agents. By combining multiple, selected epitopes into a single
drug candidate, the immune response can be both targeted and
optimized for strength. Epimmune's therapeutic drug candidates
have been designed to treat disease by stimulating the body's
immune system to respond aggressively to infections such as
HIV, hepatitis C virus and hepatitis B virus, and tumors such
as breast, colon, lung and prostate. The Company's preventative
drug candidates have been designed to protect against disease
by teaching the body's immune system to react quickly when
exposed to infectious agents. Epimmune's technology can also
be used to identify and potentially eliminate undesirable
reactions to therapeutic drugs or consumer products by modifying
specific epitopes to suppress the unwanted immune response.
For more information on Epimmune, visit http://www.epimmune.com/.
About Innogenetics
Innogenetics is a Belgian-based international biopharmaceutical
company building parallel businesses in the areas of specialty
diagnostics and therapeutic vaccines. In its Diagnostics Division,
Innogenetics develops a large number of specialty products
covering three areas: infectious diseases (hepatitis C, hepatitis
B, and HIV), genetic testing (HLA tissue typing and cystic
fibrosis), and neurodegeneration (Alzheimer's disease). In
2003, total revenues increased by 16% to euro 73 million,
with specialty diagnostics reaching an operating profit of
euro 7 million. The Company's candidate therapeutic vaccine
for the treatment of hepatitis C -- a global unmet medical
need -- is currently in phase 2 clinical development stage.
With a strong commercially oriented management team and distinctive
dual business model, Innogenetics provides a low-risk biotech
investment with potentially high returns. Founded in 1985,
Innogenetics is listed on Euronext Brussels. Innogenetics'
headquarters are in Gent, Belgium, with sales affiliates in
the United States, Germany, France, Spain, and Italy. Innogenetics
employs 590 people worldwide and has a market capitalization
of approximately US $450 million. For more information on
Innogenetics, visit http://www.innogenetics.com/.
Forward-Looking Statements
This press release includes forward-looking statements that
reflect Epimmune's management's current views of future events,
including statements regarding the benefits of the epitope
and PADRE(R) technologies, the use of these technologies in
products being developed by Innogenetics, the possible utility
of those products under development, Innogenetics' plans to
develop and commercialize current vaccine candidates as well
as future products based on Epimmune's technology, the ability
of Innogenetics to complete all development efforts and generate
clinical vaccine candidates by the end of the extended collaboration
period, and potential milestone and royalty payments from
Innogenetics. Actual results may differ materially from the
above forward-looking statements due to a number of important
factors, such as risks associated with the utility of the
epitope and PADRE(R) technologies in eliciting an immune response
with vaccines, the utility of Innogenetics' technology, Epimmune's
reliance on the development and commercialization efforts
of Innogenetics and Innogenetics' ability to develop and commercialize
product candidates resulting from the collaboration. Other
factors that could cause or contribute to differences in actual
results include, but are not limited to, the risks associated
with the ability to develop vaccines using epitopes, the ability
of epitope-based vaccines to control or treat infectious diseases,
the safety and efficacy of epitope-based vaccines in humans,
the ability to enter into and maintain collaborations, achievement
of research and development objectives, reliance on licensees
and collaborators, the timing and cost of conducting human
clinical trials, the regulatory approval process, and the
possibility that testing may reveal undesirable and unintended
side effects or other characteristics that may prevent or
limit the commercial use of proposed products. These factors
are more fully discussed in the Company's 2003 Form 10-K and
other periodic reports filed with the Securities and Exchange
Commission. Epimmune expressly disclaims any intent or obligation
to update these forward-looking statements, except as required
by law.
For further information, please contact Robert De Vaere, VP,
Finance & Admin. & CFO of Epimmune, +1-858-860-2500;
or General Information, Moira Conlon, +1-310-407-6524, mconlon@financialrelationsboard.com,
Investor/Analyst Information, Tricia Ross, +1-310-407-6540,
tross@financialrelationsboard.com, both of Financial Relations
Board, for Epimmune.
Epimmune Inc.
CONTACT: Robert De Vaere, VP, Finance & Admin. & CFO
of Epimmune, +1-858-860-2500; or general information, Moira
Conlon, +1-310-407-6524, mconlon@financialrelationsboard.com,
investor/analyst information, TriciaRoss, +1-310-407-6540,
tross@financialrelationsboard.com,
both of FinancialRelations Board, for Epimmune
Web site: http://www.innogenetics.com/
Web site: http://www.epimmune.com/
Back to top
March 31st, 2004
Prolongation
of HCV Treatment to 18 Months Reduces Relapse Rates From 40
to 15 Percent
Source: HIVandHepatitis.com
Treatment of chronic hepatitis C with interferon
can be ineffective due to relapse. We aimed to reduce the
40% relapse rate of 6 months interferon–ribavirin combination
therapy by prolonging treatment to 18 months.
Three hundred patients with treatment-naive
hepatitis C, were randomized to 18 months combination therapy
with interferon (3 MU tiw) and ribavirin (1000–1200
mg/day), 18 months interferon combined with placebo, or 6
months combination therapy with interferon and ribavirin,
in a double blinded manner. All 295 patients who received
at least one dose of treatment were included in the intention
to treat analysis.
Results
At the end of treatment, HCV RNA was undetectable in 55 and
49% of those on 6 and 18 months combination therapy, respectively,
versus 26% of those on monotherapy (P<0.001). The relapse
rate was 38% for 6 months combination therapy, 38% for 18
months monotherapy, and only 13% for 18 months combination
treatment (P=0.002). The sustained response rates were 34%
for 6 months combination therapy, 16% for 18 months monotherapy
and 43% for 18 months combination therapy (P<0.05).
Conclusions
Reduction of relapse rates to 15% or less is feasible by prolongation
of interferon–ribavirin treatment to 18 months.
Reference
J T Brouwer and others. Reduction of relapse rates by 18-month
treatment in chronic hepatitis C. A Benelux randomized trial
in 300 patients. Journal of Hepatology 40(4): 689-695.
April 2004.
Back to top
InterMune
Charts New Course For Future
Source: PRNewswire
NEW YORK,-- InterMune, Inc. unveiled the
company's new strategy, corporate realignment and pipeline
initiatives to achieve its new vision of becoming a leader
in the development and commercialization of innovative therapies
in hepatology and pulmonology.
"InterMune has successfully charted
a new course for the future and transformed itself into much
more than an Actimmune IPF story," said Dan Welch, the
company's Chief Executive Officer and President, at its investment
community meeting held here today. "We have worked diligently
to complete a strategic plan and implement operational changes
that have positioned us for a promising future. There have
also been a number of important developments in our focused,
late-stage clinical pipeline aimed at large and underserved
indications, especially in hepatology. We have strengthened
our foundation to fortify and maintain our position as one
of the few companies in the biotechnology industry with revenue-generating
products to fuel a deep pipeline. This combination is unique
and can drive sustained shareholder value."
During the meeting, Mr. Welch and his executive
management team outlined and described the following strategic
goals for InterMune:
Primary Goals:
1. Maximize the value of InterMune's hepatology franchise;
2. Maximize the value of InterMune's pulmonology franchise;
and
3. Achieve financial self-sufficiency in 2006.
Supporting Goals:
4. Grow Infergen(R) (interferon alfacon-1) revenues by focusing
on the
seriously underserved and growing patient population of hepatitis
C
nonresponders;
5. Leverage the commercial capability of InterMune's sales
and marketing
teams in the hepatology and pulmonary disease marketplaces;
6. Create near-term value from non-core assets that no longer
fit within
InterMune's new strategic plan;
7. Establish value-creating strategic partnerships to leverage
the value
of InterMune's core assets in hepatology and pulmonology;
and
8. Leverage InterMune's research and development investments
to create
value from ex-U.S. territories.
Enhanced Fiscal and Corporate Discipline
Critical to the company's strategic changes has been the implementation
of procedures aimed at reducing overall expenses, enhancing
efficiency, ensuring compliance with relevant regulations
and improving fiscal discipline.
"InterMune continues to focus on our
corporate goal of profitability in the fourth quarter of 2005
and financial self-sufficiency thereafter," added Welch.
"By financial self-sufficiency, we mean we intend to
fund our deep and late-stage development pipeline entirely
from the cash flow generated from our revenues. We have already
succeeded in significantly reducing overall research and development
expenses while increasing our investment in our core hepatology
and pulmonology programs. We have narrowed our therapeutic
focus from four areas to two and realigned our organization
around these areas. We will also pursue strategic partnerships
that will help further decrease our rate of cash burn, increase
development speed, mitigate risk and further maximize value
for shareholders."
InterMune has several late-stage and differentiated
development programs that show potential to address unmet
medical needs in the hepatology and pulmonology specialty
markets, which are large, growing, and significantly underserved.
One of the Strongest HCV Pipelines
in the Industry
Infergen(R) (interferon alfacon-1), which is approved for
the treatment of chronic HCV infection in patients 18 years
of age or older with compensated liver disease, is currently
the only FDA approved interferon with data in its label specifically
for retreatment of nonresponder or relapsing patients. InterMune
intends to make Infergen an important source of revenue growth
and has significantly increased its commercial efforts on
Infergen, focusing on the large and rapidly growing market
of HCV nonresponders.
Over the last year, InterMune's hepatology
portfolio has risen to prominence as a major development opportunity
for the company. The company is currently conducting research
to lead the development of new treatment paradigms for HCV
and expand the options for patients suffering from chronic
hepatitis C.
First line therapy of patients treated
with pegylated interferons plus ribavirin is effective in
approximately half of the patients treated, while the other
half do not respond (nonresponders). There are approximately
150,000 nonresponders in the United States and the number
is growing by an estimated 50,000 each year. Unfortunately,
existing retreatment options deliver extremely poor response
rates. InterMune's near-term clinical programs in hepatology
are focused on expanding treatment options for this seriously
underserved patient population.
Throughout 2003, promising data were presented
demonstrating that Infergen, in combination with ribavirin,
may have the potential to address the unmet medical need of
the most treatment-resistant HCV nonresponders. Based on these
data, InterMune is planning to initiate a Phase III clinical
trial of this combination in this patient population in the
first half of 2004. The company is also particularly excited
by the prospects of combining its two marketed interferon
products, Infergen and Actimmune(R) (interferon gamma-1b)
for the treatment of hepatitis C nonresponders, for which
there is strong scientific rationale. Pioneering in vitro
experiments undertaken at InterMune demonstrated very strong
synergistic effects for a range of doses of Infergen and Actimmune
in combination. Further promising results were observed from
an independent retrospective clinical analysis evaluating
the use of Infergen plus Actimmune for the treatment of chronic
hepatitis C nonresponders. This combination therapy represents
a significant opportunity for InterMune, and the company plans
on advancing this clinical program in the first half of 2004
with a Phase II study.
The company is also now exploring the potential
of combining Actimmune with marketed pegylated interferons
to treat naive HCV patients in the first half of 2005. This
approach, if proven successful, could potentially help the
company penetrate the large patient population of untreated
or naove patients.
Finally, InterMune is working on small
molecule approaches to treating HCV that are rapidly progressing
through preclinical development. The company and its partner,
Array Biopharma, have identified and characterized several
highly potent preclinical protease inhibitor candidates with
improved bioavailability over competitive compounds.
Industry Leader in the Development
of Innovative Therapies for IPF
In the area of pulmonology, InterMune is committed to developing
therapies for the treatment of idiopathic pulmonary fibrosis
(IPF), a disease characterized by progressive scarring or
fibrosis of the lungs, which ultimately results in death,
and for which there is no approved therapy. InterMune is developing
Actimmune and pirfenidone, which are the two most clinically
advanced compounds for the treatment of this condition. The
company's pivotal Phase III INSPIRE Trial, which is designed
to evaluate the impact of Actimmune on survival time in IPF
patients with mild to moderate disease, is actively enrolling
patients at sites in North America and Europe. The trial was
designed in collaboration with thought leaders and based on
observations from its 330-patient randomized, double-blind,
placebo controlled Phase III clinical trial, GIPF-001, as
well as two other independently conducted randomized, controlled
trials of Actimmune for the treatment of IPF.
The company is also very enthusiastic about
the promise of pirfenidone, a molecule with broad in vitro
biological activity and presented encouraging results of Phase
II data of pirfenidone in IPF at the meeting. In much of 2004,
InterMune obtained Orphan Drug Designation and expects to
complete the pre-clinical and manufacturing activities as
well as the clinical data analysis required to begin an IPF
registration program in the first half of 2005.
Leveraging Core Expertise with
Strategic Partnerships
A fundamental strength of InterMune is its commercial and
development organizations and expertise. The company's sales
organization and medical science liaisons are dedicated to
supporting Infergen for HCV and supporting Actimmune in its
marketed indications as well as educating the medical community
on the awareness and early diagnosis of IPF. InterMune plans
to more fully leverage this capability to achieve its commercial
goals by establishing appropriate co-promotion agreements
in hepatology and/or pulmonology, such as the one announced
earlier this week with Baxter to co-promote Aralast(R) (alpha1-proteinase
inhibitor (human)) to pulmonologists in the United States
for the treatment of hereditary emphysema.
Creating Near-Term Value From Non-Core
Assets
Consistent with its more focused strategy on hepatology and
pulmonology, InterMune intends to capture near-term value
from non-core assets, in particular by seeking another company
to assume the future development investment in oritavancin,
the company's novel hospital-based glycopeptide antibiotic
agent and divesting its antifungal agent, Amphotec(R). While
oncology is no longer a core area, InterMune has decided to
maintain control of Actimmune rights in oncology. The company's
800-patient Phase III clinical trial of Actimmune plus standard
therapy in ovarian cancer will soon be fully enrolled, and
InterMune will make a decision on the future of this program
when the company conducts an interim analysis of progression-free
survival anticipated to occur in mid-2005.
About Infergen(R) (interferon alfacon-1)
Dow Jones News Service via Dow Jones
Infergen is a bio-optimized type 1 interferon alpha indicated
for treatment of adult patients with chronic HCV infections
with compensated liver disease and is dosed three times a
week. Infergen is the only interferon alpha with data in the
label regarding use in patients following relapse or non-response
to treatment with certain previous treatments. The most common
side effects are flu-like symptoms (i.e., headache, fatigue,
fever, myalgia, and rigors). Physicians and patients can obtain
additional prescribing information regarding Infergen, including
the product's safety profile, by visiting www.infergen.com,
including the black box warning for all interferon alphas
regarding neuropsychiatric, autoimmune, ischemic and infectious
disorders.
About Actimmune(R) (interferon
gamma-1b)
Interferon gamma is a naturally occurring protein that stimulates
the immune system. InterMune markets Actimmune for the treatment
of two life-threatening congenital diseases: chronic granulomatous
disease and severe, malignant osteopetrosis. The most commons
side effects are flu-like symptoms, including fever, headache
and chills. InterMune is also conducting the INSPIRE Trial,
a Phase III study of interferon gamma-1b in idiopathic pulmonary
fibrosis and the GRACES Trial, a Phase III study of interferon
gamma-1b in ovarian cancer. Physicians and patients can obtain
additional prescribing information regarding Actimmune, including
the product's safety profile, by visiting www.actimmune.com.
About Pirfenidone
Pirfenidone is an orally active, small molecule that shows
a wide range of in vitro biologic activity. In vitro evidence
has shown that pirfenidone inhibits collagen synthesis, down-regulates
profibrotic cytokines and decreases fibroblast proliferation.
Data presented from Phase II clinical trials suggest that
pirfenidone may impact disease progression in patients with
IPF. In these clinical experiences, pirfenidone was generally
well tolerated with the most frequent side effects reported
being photosensitivity rash and gastrointestinal symptoms.
InterMune has worldwide rights, excluding Japan, Korea and
Taiwan, to develop and commercialize pirfenidone for all fibrotic
diseases.
About InterMune
InterMune is a biopharmaceutical company focused on developing
and commercializing innovative therapies in pulmonology and
hepatology. For additional information about InterMune please
visit www.intermune.com.
Except for the historical information contained
herein, this press release contains certain forward-looking
statements that involve risks and uncertainties, including
without limitation the statements indicating that InterMune:
(i) has a goal of profitability in the fourth quarter of 2005
and financial self-sufficiency thereafter; (ii) has several
development programs with potential to address unmet medical
needs in hepatology and pulmonology; (iii) intends to make
Infergen an important source of revenue growth; (iv) believes
that once-daily doses of Infergen, in combination with ribavirin,
may have the potential to address the serious unmet medical
need of HCV nonresponders; (v) believes that Infergen and
Actimmune combination therapy represents a significant opportunity
for InterMune; (vi) believes that combining Actimmune with
marketed pegylated interferons to treat naive HCV patients
could help the company penetrate the large patient population
of untreated or naove patients; (vii) believes that Actimmune
and pirfenidone are the two most clinically advanced compounds
for the treatment of IPF; (viii) believes that pirfenidone
has encouraging results; (ix) is seeking another company to
assume the future development investment in oritavancin and
to purchase Amphotec(R). Factors that could cause or contribute
to such differences include, but are not limited to, those
discussed in detail under the heading "Risk Factors"
and the other risks and factors discussed in InterMune's 10-K
report filed with the SEC on March 14, 2004, and other periodic
reports (i.e., 10-Q and 8-K) filed with the SEC, which are
incorporated herein by reference. The risks and other factors
that follow, concerning the forward-looking statements in
this press release, should be considered only in connection
with the fully discussed risks and other factors discussed
in detail in the 10-K report and InterMune's other periodic
reports filed with the SEC. The forward-looking statements
above are subject to additional risks and uncertainties, including
without limitation, the following: (i) clinical development
is long, expensive, risky and uncertain; (ii) planned clinical
trials may not begin on time, or at all; (iii) if InterMune
fails to comply with FDA or other government regulations prohibiting
the promotion of off-label uses and the promotion of products
for which marketing clearance has not been obtained, it could
result in regulatory enforcement action by the FDA or other
government authorities, which would harm InterMune's business;
(iv) there are significant regulatory, supply, intellectual
property and competitive barriers to entry to marketing or
developing Infergen for the chronic HCV infections market;
(v) InterMune's competitors may limit our products' revenues
potential or render them obsolete; (vi) litigation or third-party
claims of intellectual property infringement could require
us to spend substantial time and money and could adversely
affect our ability to develop and commercialize products.
Back to top
April 1st, 2004
Dangerous
Supplements: Still at Large
Source: Consumer Reports
If you can buy it at a clean, well-lighted store, if it’s
“all natural,” it’s not going to do you
serious harm, right? That’s what many Americans assume
about dietary supplements. But while most supplements are
probably fairly benign, Consumer Reports has identified a
dozen that according to government warnings, adverse-event
reports, and top experts are too dangerous to be on the market.
Yet they are. We easily purchased all 12 in Feburary in a
few days of shopping online and in retail stores.
These unsafe supplements include Aristolochia,
an herb conclusively linked to kidney failure and cancer in
China, Europe, Japan, and the U.S.; yohimbe, a sexual stimulant
linked to heart and respiratory problems; bitter orange, whose
ingredients have effects similar to those of the banned weight-loss
stimulant ephedra; and chaparral, comfrey, germander, and
kava, all known or likely causes of liver failure. (For a
complete list of the “dirty dozen,” see 12 supplements
to avoid.)
U.S. consumers shelled out some $76 million
in 2002 for just three of these supplements: androstenedione,
kava, and yohimbe, the only ones for which sales figures were
available, according to the Nutrition Business Journal,
which tracks the supplement industry.
The potentially dangerous effects of most
of these products have been known for more than a decade,
and at least five of them are banned in Asia, Europe, or Canada.
Yet until very recently, the U.S. Food and Drug Administration
had not managed to remove a single dietary supplement from
the market for safety reasons.
After seven years of trying, the agency
announced a ban on the weight-loss aid ephedra in December
2003. And in March 2004 it warned 23 companies to stop marketing
the body-building supplement androstenedione (andro).
Despite these actions against high-profile
supplements, whose dangers were so well known that even industry
trade groups had stopped defending them, the agency continues
to be hamstrung by the 1994 Dietary Supplement Health and
Education Act (DSHEA, pronounced de-shay). While drug manufacturers
are required to prove that their products are safe before
being marketed, DSHEA makes the FDA prove that supplements
on the market are unsafe and denies the agency all but the
sketchiest information about the safety record of most of
them.
“The standards for demonstrating
a supplement is hazardous are so high that it can take the
FDA years to build a case,” said Bruce Silverglade,
legal director of the Center for Science in the Public Interest,
a Washington, D.C., consumer-advocacy group.
At the same time, the FDA’s supplement
division is understaffed and underfunded, with about 60 people
and a budget of only $10 million to police a $19.4 billion-a-year
industry. To regulate drugs, annual sales of which are 12
times the amount of supplement sales, the FDA has almost 43
times as much money and almost 48 times as many people.
“The law has never been fully funded,”
said William Hubbard, FDA associate commissioner for policy
and planning. “There’s never been the resources
to do all the things the law would command us to do.”
The agency has learned that it must tread
carefully when regulating supplements. The first time it tried
to regulate the dangerous stimulant ephedra, in 1997, overwhelming
opposition from Congress and industry forced it to back down.
As a result, the FDA is sometimes left
practicing what Silverglade calls “regulation by press
release”--issuing warnings about dangerous supplements
and hoping that consumers and health practitioners read them.
There are signs of hope. The FDA has said
that if the ban on ephedra holds up against likely legal challenges,
it plans to go after other harmful supplements. Legislation
has been introduced to strengthen the FDA’s authority
under DSHEA and give the agency more money to enforce the
act.
But the supplement marketplace still holds
hidden hazards for consumers, especially among products that
aren’t in the headlines. “Consumers are provided
with more information about the composition and nutritional
value of a loaf of bread than about the ingredients and potential
hazards of botanical medicines,” said Arthur Grollman,
M.D., professor of pharmacological sciences at the State University
of New York, Stony Brook, and a critic of DSHEA.
A Question of Safety
Supplement-industry advocates say the ephedra ban demonstrates
that DSHEA gives the FDA enough power to protect consumers
from unsafe products. “I don’t think there’s
anything wrong except that FDA has only recently begun vigorous
and active enforcement of the law,” said Annette Dickinson,
Ph.D., president of the Council for Responsible Nutrition,
a major trade association for the supplement industry.
But critics of DSHEA think the ban illustrates
the extremes to which the FDA must go to outlaw a hazardous
product.
When the agency initially tried to rein
in ephedra use in 1997, after receiving hundreds of reports
of adverse events, it sought not an outright ban but dosage
restrictions and sterner warning labels. The industry mounted
a furious counter-attack, including the creation of a public-relations
group called the Ephedra Education Council and a scientific
review from a private consulting firm, commissioned by Dickinson’s
trade group, that concluded ephedra was safe. After the U.S.
General Accounting Office said the FDA “did not establish
a causal link” between taking ephedra and deaths or
injuries, the agency was forced to drop its proposal.
The industry continued to vigorously market
and defend ephedra. Metabolife International, a leading ephedra
manufacturer, did not let the FDA know that it had received
14,684 complaints of adverse events associated with its ephedra
product, Metabolife 356, in the previous five years, including
18 heart attacks, 26 strokes, 43 seizures, and 5 deaths. It
took the pressure of congressional and Justice Department
investigations to get the company to turn over the complaints
in 2002. Then Steve Bechler, a pitcher for the Baltimore Orioles,
died unexpectedly in 2003 while taking another ephedra supplement,
Xenadrine RFA-1. With sales suffering from the bad publicity,
manufacturers began to replace ephedra with other stimulants
such as bitter orange, which mimics ephedra in chemical composition
and function.
“All of a sudden Congress dropped
objections to an ephedra ban andstarted demanding the FDA
act,” said Silverglade.
To amass the necessary scientific evidence
that it hoped would satisfy the demanding standard set by
DSHEA, the FDA took aggressive action: It commissioned an
outside review from the RAND Corporation, analyzed adverse-event
reports, and pored over every available shred of scientific
evidence.
“We’ve gone the whole nine
yards to collect and evaluate all the possible evidence,”
Mark McClellan, commissioner of the FDA, said in announcing
the ban. “We will be doing our best to defend this in
court, and if that’s not sufficient, it may be time
to re-examine the act.”
Drugs vs. Supplements
In an October 2002 nationwide Harris Poll of 1,010 adults,
59 percent of respondents said they believed that supplements
must be approved by a government agency before they can be
sold to the public. Sixty-eight percent said the government
requires warning labels on supplements’ potential side
effects or dangers. Fifty-five percent said supplement manufacturers
can’t make safety claims without solid scientific support.
They were wrong. None of those protections
exist for supplements--only for prescription and over-the-counter
medicines. Here are the major differences in the safety regulations:
Testing for hazards. Before
approval, drugs must be proved effective, with an acceptable
safety profile, by means of lab research and rigorous human
clinical trials involving a minimum of several thousand people,
many millions of dollars, and several years.
In contrast, supplement manufacturers can
introduce new products without any testing for safety and
efficacy. The maker’s only obligation is to send the
FDA a copy of the language on the label (see Supplement labels).
“Products regulated by DSHEA were
presumed to be safe because of their long history of use,
often in other countries,” said Jane E. Henney, M.D.,
commissioner of the FDA from 1998 to 2001. “As their
use dramatically increased in this country after the passage
of DSHEA, the presumption of safety may have been misplaced,
particularly for products other than traditional vitamins
and minerals. Some, like ephedra, act like drugs and thus
have similar risks.”
The only exceptions to this “presumption
of safety” are supplement ingredients that weren’t
being sold in the U.S. when DSHEA took effect. Makers of such
“new dietary ingredients” must show the FDA evidence
of the products’ safety before marketing them. The FDA
invoked that rarely used provision in its action against androstenedione.
After years of allowing andro to be marketed without restriction,
the agency declared that it was “not aware” that
the supplement was used before DSHEA, so it couldn’t
be sold without evidence of safety.
Disclosing the risks.
Drug labels and package inserts must mention all possible
adverse effects and interactions. But supplement makers don’t
have to put safety warnings on the labels, even for products
with known serious hazards.
We bought a product called Relaxit whose
label had no warning about the kava it contained, even though
the American Herbal Products Association, an industry trade
group, recommends a detailed, though voluntary warning label
about potential liver toxicity on all kava products.
Ensuring product quality.
Drugs must conform to “good manufacturing practices”
that guarantee that their contents are pure and in the quantities
stated on the label. While DSHEA gave the FDA authority to
impose similar standards on supplements, it took until 2003
for the agency to propose regulations--as yet not final--to
implement that part of the law.
Contaminants, too, regularly turn up in
supplements. In 1998 Richard Ko, Ph.D., of the California
Department of Health Services reported that 32 percent of
the Asian patent medicines he tested contained pharmaceuticals
or heavy metals that weren’t on the label. The FDA has
seized supplements adulterated with prescription drugs, including,
in 2002, an herbal “prostate health” supplement
called PC SPES that turned out to contain a powerful prescription
blood thinner, warfarin.
Reporting the problems.
By law, drug companies are required to tell the FDA about
any reports of product-related adverse events that they receive
from any source. Almost every year, drugs are removed from
the market based on safety risks that first surfaced in those
reports.
In contrast, supplement makers don’t
have to report adverse events. Indeed, in the five years after
DSHEA took effect, 1994 to 1999, fewer than 10 of the more
than 2,500 reports that the FDA received came from manufacturers,
according to a 2001 estimate from the inspector general of
the U.S. Department of Health and Human Services. (Other sources
of reports included consumers, health practitioners, and poison-control
centers.) Overall, the FDA estimates that it learns of less
than 1 percent of adverse events involving dietary supplements.
THE ‘NATURAL’ MYSTIQUE
Many makers market their supplements as “natural,”
exploiting assumptions that such products can’t harm
you. That’s a dangerous assumption, said Lois Swirsky
Gold, Ph.D., director of the Carcinogenic Potency Project
at the University of California, Berkeley, and an expert on
chemical carcinogens. “Natural is hemlock, natural is
arsenic, natural is poisonous mushrooms,” she said.
A cautionary example is aristolochic acid,
which occurs naturally in species of Aristolochia vines that
grow wild in many parts of the world. In addition to being
a powerful kidney toxin, it is on the World Health Organization’s
list of human carcinogens. “It’s one of the most
potent chemicals of 1,400 in my Carcinogenic Potency Database,”
Gold said. “People have taken high doses similar to
the doses that animals are given in tests, and they both get
tumors very quickly.”
The dangers of aristolochic acid have been
known since at least 1993, when medical-journal articles began
appearing about 105 patrons of a Belgian weight-loss clinic
who had suffered kidney failure after consuming Chinese herbs
adulterated with Aristolochia. At least 18 of the women also
subsequently developed cancer near the kidney.
These findings prompted the FDA to issue
a nationwide warning against Aristolochia in 2001 and to impose
a ban on further imports of the herb. But in early 2004, more
than two years after the import ban went into effect, Consumer
Reports was able to purchase products online that were labeled
as containing Aristolochia.
In 2003, Gold identified more than 100
products for sale online with botanical ingredients listed
by the FDA as known or suspected to contain aristolochic acid.
Donna Andrade-Wheaton, a former aerobics
instructor in Rhode Island, learned those facts too late to
save her kidneys. After taking Chinese herbs containing Aristolochia
for more than two years, she suffered severe kidney damage;
her kidney tissues were found to contain aristolochic acid.
In late 2002, at age 39, she underwent a kidney transplant.
Andrade-Wheaton is suing both the acupuncturist
who gave her the herbs and several companies that manufactured
them. The acupuncturist declined to discuss the case on the
record, and the manufacturer did not return our phone calls.
There’s another widespread and false
assumption about natural supplements: that they’re always
pure, unprocessed products of the earth. Because DSHEA permits
the marketing of concentrates and extracts, supplement makers
can and do manipulate ingredients to increase the concentrations
of pharmacologically active compounds.
That’s especially true of the many
weight-loss supplements designed for “thermogenic”
stimulant effects--boosting calorie expenditure by revving
the metabolic rate.
On one Internet shopping tour, for instance,
we bought a product called Thermorexin--”the Hottest
new Thermogenic on the market!” Its label says it contains,
among its 22 ingredients, 30 milligrams of theophylline derived
from a black tea extract and the stimulant bitter orange.
Sold as Theo-Dur and other brands, theophylline is a prescription
drug and an effective asthma treatment, but most doctors seldom
prescribe it because it can cause seizures and irregular heartbeats
at relatively low doses.
Larry Berube, president of Anafit, Thermorexin’s
manufacturer, based in Orlando, Fla., described how the product’s
combination of ingredients was developed: “Once we find
out that the FDA says it’s OK, we put them together
in the lab, run our tests, and do our trials, and if it comes
up good, we capsulate it, put it online and in the stores
and sell it,” he said.
Those tests involved asking fitness professionals
to use the supplement, and measuring their heart rate and
blood pressure, Berube said. The company doesn’t use
a control group, he said. Then “we go to the fitness
discussion boards and let trainers and people know we have
a new product and do they want to try it,” he said.
“And then they try it, and they report back.”
Berube said he has not heard of any bad reactions to Thermorexin.
CR Quick Take
A CR investigation found that many dangerous supplements can
easily be purchased in stores and online. Many of these supplements
have been banned in other countries. Why can’t the U.S.
Food and Drug Administration ban these products now?
We found that regulatory barriers created
by Congress, supplement-industry pressure, and a lack of resources
at the FDA have resulted in major risks for consumers.
• These widely available dietary
supplements (see 12 supplements to avoid) may cause cancer,
severe kidney or liver damage, heart problems, or even death.
They should be avoided by consumers.
• These supplements are sold under a profusion of names,
making it difficult for consumers to know what they’re
purchasing.
• Most also appear in combination products marketed
for a broad array of uses, such as aphrodisiacs, athletic-performance
boosters, and treatments for anxiety, arthritis, menstrual
problems, ulcers, and weight loss.
Back to top
HBV Reactivation
in Patients Undergoing Cytotoxic Chemotherapy
Source: www.gastrohep.com
Pre-chemotherapy hepatitis B virus (HBV)
DNA level, steroid use, and a diagnosis of lymphoma or breast
cancer are factors associated with HBV reactivation following
cytotoxic chemotherapy, find physicians in the British
Journal of Cancer.
Several clinical features, as well as pre-chemotherapy
hepatitis B (HBV) viral load, have been associated with an
increased risk HBV reactivation.
In this study, physicians form Hong Kong,
China, assessed the clinical and virological factors associated
with the development of HBV reactivation. They also developed
a predictive model to quantify the risk of HBV reactivation.
The team evaluated 138 consecutive cancer
patients who were HBV carriers and underwent chemotherapy.26%
of patients developed HBV reactivation.
Of these, 128 patients had sera available
for real-time PCR HBV DNA measurement.
The patients were followed up throughout
their course of chemotherapy and the HBV reactivation rate
was determined.
The team compared the clinical and virological
features between those who did and did not develop viral reactivation.
They assessed age, sex, baseline liver
function tests, HBeAg status and viral load (HBV DNA) prior
to the chemotherapy, and the use of specific cytotoxic agents.
The physicians found that 26% of patients
developed HBV reactivation.
Multivariate analysis showed that pre-chemotherapy
HBV DNA level, the use of steroids and a diagnosis of lymphoma
or breast cancer were significant factors associated with
HBV reactivation.
Dr Yeo and colleagues concluded, "Detectable
baseline HBV DNA prior to cytotoxic chemotherapy, the use
of steroids and a diagnosis of lymphoma or breast cancer are
predictive factors for the development of HBV reactivation".
"A predictive model was developed
from the current data, based on a logistic regression method".
Br J Cancer 2004; 90: 1306-11
Back to top
April 2nd, 2004
S.F.'s
Homeless with HIV Plagued by Hepatitis C Virus -- Few Treated
Carl T. Hall, Chronicle Science Writer
San Francisco Chronicle
About 3 out of 4 HIV-positive homeless
or "marginally housed" people in San Francisco also
harbor the virus that causes chronic hepatitis C disease,
and nearly none of them is being treated for it, a new study
has found.
The study, by doctors at UCSF and San Francisco
General Hospital, is among the first to document how widespread
hepatitis C infections have become among the HIV-positive
urban poor. Results suggest that the indigent are a cauldron
of co-infections, by all accounts a widely ignored problem
that promises to significantly complicate the fight against
AIDS among San Francisco's down and out.
Hepatitis C tends to make the AIDS virus
even more dangerous and difficult to treat. One reason: HCV,
as the hepatitis C microbe is known, can seriously impair
liver function, increasing the risk of toxic side effects
from AIDS medications.
In the study, doctors tested and interviewed
249 HIV-positive people recruited from shelters, soup kitchens
and single-room-occupancy hotels. The tests showed that 69
percent were positive for the hepatitis C virus. After nearly
three years of follow-up, the figure had risen to 74 percent.
Yet only about 4 percent of those infected were being treated.
The results appear today in the Journal
of General Internal Medicine.
Dr. Christopher Hall, a fellow in infectious
diseases at UCSF and lead author of the new study, said the
situation is undoubtedly worse in other big cities that lack
San Francisco's public-health system and that may be paying
even less heed to what has been called a hidden epidemic.
Public health implications reach far beyond
San Francisco's homeless shelters and single-room-occupancy
hotels.
"It's a reservoir. It's there,"
Hall said.
"Theoretically at least, there's more of a potential
for the spread of infection than you would have if you were
more aggressive about treating this population."
The new study did not set out to identify
how many of those infected with the hepatitis C virus actually
needed treatment, although the study's authors said the number
was surely much higher than what was found.
Because of their HIV status, all the study
participants qualified for free care through San Francisco's
well-regarded public-health system. But Hall said the system
has yet to focus seriously on the growing problem of HIV-hepatitis
C co-infections.
"There is a profound lack of treatment,"
he said. "That's the big surprise. Had we looked at a
population that was out of the health care loop, that lack
of treatment would be more intuitive."
Hepatitis C, the leading cause of liver
transplants, is a blood-borne virus estimated to infect 4
million people in the United States -- about four times as
many as are infected with HIV. It is almost always contracted
through blood contact, such as from sharing needles and other
drug paraphernalia.
About 15 percent of those exposed manage
to clear the virus with their own immune systems. Most of
the remainder suffer no serious symptoms for years or even
decades. Chronic, sometimes life-threatening liver disease
occurs in about 70 percent of chronic infections, according
to the U.S. Centers for Disease Control and Prevention.
Treatment has been shown to work about
half the time, somewhat less for those co-infected with HIV.
But treatment is expensive, and because of the unpredictable
side effects, patients must be closely monitored. Standard
recommended treatment includes weekly injections of interferon
drugs for up to 18 months, along with a regimen of anti-viral
pills.
The study's senior author, Dr. David Bangsberg,
an associate professor at UCSF and director of San Francisco
General's Epidemiology and Prevention Interventions Center,
said the results document longtime indifference to chronic
liver disease in the poorest of the urban poor.
A new effort has begun at S.F. General
to address this problem, he noted, but it's too soon for results
to become evident on the streets. "One of the broader
issues here is that this city has done a great job making
sure everyone, regardless of housing status and income, is
getting high-quality care for HIV. The city has not done the
same in making sure there's access to treatment for HCV,"
Bangsberg said.
Even when HIV patients are found to carry
antibodies to the hepatitis virus, which indicates exposure,
problems arise during follow-up.
First, patients must find their way to
a primary care provider. If hepatitis C is found, they need
referral to a subspecialist for evaluation, followed by a
liver biopsy to stage the disease and make a decision as to
what treatment is needed. Then it's a wait for test results,
followed by the weekly injections for those prescribed medications.
"For each of these steps," Bangsberg
said, "you lose people along the way." Meanwhile,
the hepatitis C virus has ample opportunity to spread.
The San Francisco researchers found that
64 percent of those in the study had used intravenous drugs
at some point. About 21 percent had injected within the previous
month.
Back to top
Freeze-Drying
Can't Remove Virus from Tissue Transplants
Karla Gale
Source: Reuters Health
NEW YORK--- Freeze-drying does not inactivate
viruses from bone and connective tissue, according to investigators
at Michigan State University in East Lansing, suggesting that
this technique does not improve the safety of tissue used
for transplants.
Despite rigorous screening, HIV and hepatitis
C transmission has occurred after transplantation of infected
bone and tendon. "There has been a long-held belief based
on one article published in 1985 that freeze-drying may inhibit
or inactivate a virus, suggesting that it would provide an
extra measure of safety," senior investigator Dr. Steven
P. Arnoczky told Reuters Health.
As reported online in the American
Journal of Sports Medicine, Arnoczky's group obtained
tendons and bone tissues from cats infected with feline leukemia
virus. Samples were freeze-dried, providing tissue with less
than 2% residual moisture.
Using "an extremely sensitive"
system, they compared the samples of freeze-dried and fresh-frozen
tissue in cell cultures. Cultures from all samples were positive
for virus, regardless of which type of tissue was used.
His group's findings are logical, if you
consider that vaccines remain effective after being freeze-dried,
Arnoczky said, "but ours was the first well-controlled
experimental model" to provide conclusive evidence.
He noted the difficulty of eradicating
virus from soft tissues, such as tendons, ligament and cartilage.
"You can't do what is necessary to sterilize them without
altering their mechanical properties."
He emphasized that with current screening
methods, the likelihood of implanting infected tissues is
minute. But screening could miss an emerging infectious disease,
"and we don't know the effects of processing on prion-infected
tissue," he added.
SOURCE: American Journal of Sports
Medicine 2004.
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