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Alan Franciscus
Editor-in-Chief
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In This Issue:
Lamivudine Safe in Long-Term
Hepatitis B Therapy
Portugal Debates Setting Up Heroin Injecting
Rooms in Prison
Fraction of Vancouver Junkies Using Injection
Site, Rest too Paranoid, Lazy
Drugs in Development Hold Promise for Patients
with HIV and HBV Coinfection
Experts Seek New Effort to Control Hepatitis
A
Bolstered by Liver Transplant, HIV Patient Rebuilds
His Life
Hepatitis B Rates on the Decline in U.S.
Wendy Elizabeth Marx – Organ Transplant
Advocate Dies
Clinical Trials Begin for Procleix(R) Ultrio(TM)
Assay
Virus Sufferer is Forced to Wait Three Years
for Treatment
December 26th, 2003
Lamivudine Safe
in Long-Term Hepatitis B Therapy
by David Douglas
NEW YORK (Reuters Health) Dec 26 - Lamivudine
treatment for up to six years has an excellent safety profile
in patients with chronic hepatitis Be antigen (HBeAg)-positive
compensated liver disease, researchers report. However, documented
lamivudine resistance mutations, which can affect up to two-thirds
of patients by the fifth year of treatment, can be a marker
for significantly more hepatitis flares.
Dr. Anna S. F. Lok of the University of
Michigan Medical Center, Ann Arbor, and colleagues conducted
an analysis of safety data from multinational trials involving
998 patients with chronic HBeAg-positive compensated liver
disease who underwent lamivudine treatment for a median of
4 years.
The study, published in the December issue
of Gastroenterology, found that hepatitis flares
were seen in 10% of treated patients in the first year and
as many as 21% in the following 4 years. Furthermore, documented
lamivudine resistance mutations rose from 23% in the first
year to 65% in the fifth year. These patients also experienced
significantly more flares than did other patients.
Overall, 4 patients died, 2 from liver-related
causes, and 53 lamivudine-treated patients (5%) experienced
a total of 60 liver-disease related serious adverse events.
However, Dr. Lok told Reuters Health that
"liver failure is extremely uncommon during the first
three years after the emergence of lamivudine resistance,
in this patient population, so some patients may be maintained
on lamivudine and adefovir added at a later stage, provided
the patients are closely monitored."
Despite the apparent safety of lamivudine,
Dr. Lok also pointed out that "the findings in this study
may not apply to other patients, such as those with HBeAg-negative
compensated liver disease, patients with cirrhosis, and immunosuppressed
patients."
Gastroenterology 2003;125:1714-1722.
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December 29th, 2003
Portugal
Debates Setting Up Heroin Injecting Rooms in Prison
Agence France Presse: Levi Fernandes
A recently released government report recommends
Portugal set up heroin injection rooms in prisons, where widespread
drug use is leading to rising HIV rates among the nation's
14,000 inmates. Nearly one in two Portuguese prisoners uses
drugs and of those who do, 26.8 percent use injecting drugs
like heroin, said the report. Alarmingly, the report concluded
that more than three-quarters of those who use injecting drugs
behind bars share their needles - creating an ideal environment
for the spread of HIV.
Compiled by the office of Portugal's justice
ombudsman, the report says 14 percent of prisoners are infected
with HIV and 396 prisoners have AIDS. Along with other communicable
diseases like tuberculosis and hepatitis, the prevalence of
HIV/AIDS helped give Portugal the highest rate of prisoner
deaths in the European Union last year.
To slow the spread of HIV and cut the death rate among prisoners,
the report recommended the government set up injection rooms
where inmates would be provided with clean needles and a place
to shoot up in a supervised setting.
The recommendation was immediately backed by Portugal's lawyers
association and by former UN General Assembly President Diogo
Freitas do Amaral, who currently chairs a commission on prison
reform in Portugal. "There are unique circumstances in
prisons which can lead one to adopt a different approach to
drugs than that which is adopted in the wider society,"
he said just after the report's release.
Justice Minister Celeste Cardona, however, has flatly rejected
the proposal. Instead, government policy will continue to
focus on addiction treatment programs, including methadone
replacement therapy for heroin addicts, she said.
Fernando Negrao, head of Portugal's Drugs Institute, a branch
of the health ministry that tackles drug addiction, argued
that injection rooms could be effective but only after prisons
become less crowded.
Source:[AEGiS] CDC HIV/STD/TB
Prevention News Update 12/29/03
Back to top
Fraction
of Vancouver Junkies Using Injection Site, Rest too Paranoid,
Lazy
AMY CARMICHAEL
Canadian Press
Source: www.canada.com
VANCOUVER (CP) - A woman comes flying down
the street and pounds the doorbell at the city's safe injection
site, hands wringing and covered in scabs.
The door doesn't open, the place is busy
and she has to wait, but she can't. She moans and cries at
a dealer for a flap of heroin and races back into the doorway
of the shooting gallery. She whips up her pant leg and jams
the needle into her skin. People can't wait to get their fix,
said Doreen Littlejohn, a counsellor at the Vancouver Native
Health Society.
"It's great to have a safe place for
people to go, but a lot of our clients won't walk the half
block down the street to use it.
"They need to use the drugs the minute
they get their hands on them, no matter where they are. So
they're still doing it in the street, in our doorway, in the
alley."
That's not to say the safe injection site
isn't popular among many of the estimated 5,000 heroin addicts
in Vancouver's gritty downtown eastside neighbourhood.
Those who can make it there say they prefer
it over the street.
Clients have to register but are told by
a tattooed receptionist they can give initials or a fake name.
The waiting room is sterile, except for a strung-out man frantically
trying to brush make-believe bugs off his skin. A massive
injection wound stands out on his arm, red and angry.
When there's space, people are buzzed into
a second room where they give their code name to another staffer,
this one heavily pierced. He offers needles and bands to tie
off veins.
The lighting is soft, the music is good
and mellow. Clients take a seat at a caral, which looks like
a library cubby.
There's no rush. A nurse, who oversees
the room but doesn't intrude, will help people find a vein
if they are having trouble.
A woman who runs out to smoke crack before
shooting up confides the nurses will perform the injection
for people if they're too out of it.
"It's safe man, honestly. Way safer
than the street," says the thin woman with tell-tale
lesions on her face and stringy brown hair.
"Everything is clean, the people are
really nice, the cops can't bother you, you can chill out
after. They'll give you coffee and sometimes there's food."
"You can survive out here if you do
it right. It's my 50th birthday today and I've been using
for 35 years," she says.
The site's chillout room isn't exactly the best place to celebrate.
Hot Hot Heat, a punk band from Victoria,
plays on the radio while a man rifles through a garbage can
in the middle of the floor. The space is lined with hard chairs
and resembles a hospital waiting room.
It's not bad, but Canada's first legal
supervised injection site is not going to make much of a difference,
said Ann Livingston, a project co-ordinator with the Vancouver
Area Network of Drug Users.
"All the research on different sites
anywhere in the world shows that the idea of having one in
a city is not enough," she says.
"The Downtown Eastside needs a minimum
of four with staggered hours and each with a different feel,
different setting to attract different groups of people."
The site is currently clocking about 500
visits each day, many of which are made by repeat users. People
on a cocaine bender inject hourly, sometimes creating lineups.
Livingston said the one facility can't possibly serve the
5,000 addicts.
"So you may not see a dent in overdose
and disease rates," Livingston says.
So far, the Vancouver Coastal Health Authority
says about 25 people have overdosed at the site. Some were
revived by nurses at the site and some were taken to hospital
and saved.
Meanwhile, another problem grips the city
slum.
In the past five years, crack has hit Vancouver
streets in a big way. Smokers' lips have been left burnt and
split and they are spreading Hepatitis C.
It's estimated that about 90 per cent of
intravenous drug users in the area are already infected with
the disease and that about 30 per cent are HIV positive.
An inhalation room was built in the federally
sanctioned injection facility and staff are lobbying for an
exemption to allow people to smoke crack there but haven't
won it yet.
John Turvey, the founder of the city's
first needle exchange, says he is amazed how overboard people
are going with harm-reduction.
"They're jumping all over this (the
safe injection site) and forgetting about the treatment programs
that were supposed to go with it. What about abstinence and
the 12 steps?"
Those aren't sexy and controversial and
they're not the magic bullet people seem to think harm-reduction
is, he says. But abstinence, Turvey says, is what works.
Counsellors at Vancouver Native Health
agree, saying the injection site just enables addicts.
"Some of our clients are working there,
getting a $25 stipend for hanging out and giving peer support
and they have been triggered to use," says David Ramsay.
Ramsay says it's wrong to fund the injection site when there
are a shortage of detox beds. The wait list for a junkie who
rushes up to him begging for help to get clean is at least
five days.
"And in that time we loose them,"
says Ramsay's colleague Patti Smith.
"We need to be able to respond to
these people the minute there is a window. They're taking
responsibility and we need to acknowledge it right away."
The end-goal of the safe-injection facility
is actually to get people off drugs, though it's hard to imagine
anyone comfortably getting high there would make that choice.
But apparently they do.
That's according to those who have worked
at illegal supervised injection sites operating in Vancouver
for years.
Maxine Davis, director of the Dr. Peter
Centre, said that in the year and a half their centre has
offered a supervised injection service five users have quit.
She said the centre's operation is the
way of the future.
The service is part of its day health program,
which also includes art and music therapy, counselling, hot
meals, showers, and medical services.
About 30 people use the injection site
every day. Unlike the sanctioned safe injection site, users
at the Dr. Peter Centre could be charged by police.
"What's most profound is how it has
opened up the dialogue. These people are hard to reach and
in this setting they have a much greater engagement with staff
and really open up about their addiction. And we are there
to help them make choices in their lives."
Most stay at the centre after fixing and
use the art room, watch TV, have something to eat and talk
to people.
"This is an amazing model. I think
supervised injection will eventually go the way of the needle
exchange.
"(Needle exchange) was ground-breaking
and radical when it first took off in stand-alone sites. Now
it's offered in every health clinic alongside the baby programs."
Soon, she said, supervised injection facilities
will be widely recognized as an important way to stop the
spread of disease and reach out to addicts.
Here are some facts about the safe injection
site:
• Opened: Sept. 21, 2003.
• Number of injection drug users in Vancouver: About
5,000.
• Number of clients who have registered at the site:
About 2,100.
• Visits per day: About 500, though many visits are
made by the same people
going in to inject several times per day.
• Number of overdoses: 25. Some were administered oxygen
at the site and some were treated in hospital.
• What they're using: 40 per cent are injecting cocaine,
40 per cent shoot heroin, 10 per cent are morphine or prescription
drug injectors and the final 10 per cent use several substances.
• Clients: Average age is between late 30s and early
40s. Three clients are youths.
© Copyright 2003 The Canadian Press
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Drugs
in Development Hold Promise for Patients with HIV and HBV
coinfection
NEW YORK (Reuters Health) - Nearly four fifths of patients
with HIV infection also have serologic evidence of past or
present hepatitis B infection. In these patients, HIV exacerbates
liver disease, creating a situation in which the hepatitis
virus can behave in an opportunistic manner.
This problem, and therapeutic approaches to it, are reviewed
in the December 15th issue of Clinical Infectious Diseases
by Dr. Marina Nunez of the Hospital Carlos III in Madrid,
Spain, with colleagues there and in Italy.
"The treatment of chronic hepatitis B poses specific
problems in the context of HIV infection," the authors
write.
"On the one hand, anti-HBV drugs show poorer performance,
with lower response rates and faster selection of HBV-resistant
strains. On the other hand, nucleoside analogues active against
both HBV and HIV...if not used appropriately, can induce the
selection of resistance mutations in the HIV genome. Therefore,
the management of both infections should be carefully coordinated."
The researchers point out that most patients with both infections
become resistant to lamivudine after long-term use. There
are no data yet on results with pegylated interferon alpha
in coinfected patients, but the new agent tenofovir, a nucleoside
analogue reverse-transcriptase inhibitor, has shown "excellent"
results in short-term studies.
The newly approved emtricitabine, a nucleoside analogue, has
activity against both viruses and is "well tolerated
and...potent."
According to the authors, preliminary results with emtricitabine
and similar agents "are quite promising and probably
will widen the therapeutic armamentarium against hepatitis
B in patients with HIV infection."
Source: Clin Infect Dis 2003;37:1678-1685
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December 30th, 2003
Experts Seek
New Effort to Control Hepatitis A
by ANAHAD O'CONNOR
In the wake of recent food-borne hepatitis A outbreaks, scientists
and medical experts are urging the federal government to intensify
its efforts to quash the disease.
Now more than ever, some argue, there is
a need for widespread vaccination against hepatitis A.
Since 1999, the Centers for Disease Control
and Prevention and the American Academy of Pediatrics have
recommended childhood vaccination in 11 Western states where
incidence rates are twice the national average. But much of
the responsibility for enforcing immunization falls on parents
and schools, and vaccination recommendations can often go
unheeded.
Some experts also say that focusing efforts
in only a small number of states may leave millions of people
vulnerable to the threat of contaminated produce shipped from
regions where hepatitis A is endemic. Contaminated green onions
from Mexico set off an outbreak in western Pennsylvania that
killed 3 people and sickened over 600 others in late October.
Smaller outbreaks in Georgia, North Carolina and Tennessee
were also traced to Mexican scallions.
"The evidence shows that trying to
focus on high-risk people has been only marginally successful
over the years," said Dr. Michael Osterholm, a University
of Minnesota epidemiologist. "Produce is emerging as
an important cause of food-borne disease, and we have only
a limited ability to affect conditions in those countries
where it's coming from."
In October, as health officials scrambled
to screen thousands of people for hepatitis A after the Pennsylvania
outbreak, a group of doctors at the Children's Hospital of
Pittsburgh released a study outlining the need to vaccinate
all children over 2 years old.
In 1997, the last year for which figures
are available, hepatitis A cost the United States about $489
million in work loss, lost productivity and medical costs,
according to the study. Vaccinating children nationwide, according
to the study in The Pediatric Infectious Disease Journal,
would not only be cost-effective but would also prevent about
75,000 cases of the disease.
Vaccinating every child "would prevent
twice as many cases than just vaccinating children in the
11 states with the highest rates," said Dr. David P.
Greenberg, a vaccine expert at the children's hospital and
a study author. "Years from now, if most adults and children
are immunized, then an outbreak like the one in Pennsylvania
could be avoided."
Hepatitis A is spread by fecal matter from
infected people. Children, who often show few signs of the
disease, tend to infect adults, who can suffer more severe
symptoms. Adults who contract the disease in childhood are
immune for life, providing protection in countries where hepatitis
is widespread. But in the United States, where it is not as
common, the disease can cause devastation because an outbreak
can begin with a single infected person.
Dr. Paul Offit, a former member of the
C.D.C. advisory committee that recommended the vaccine in
11 states, said the agency had gradually moved toward universal
vaccination against hepatitis A in the last few years. Some
school districts require students to receive the shots, but
that varies by state.
Holding the agency back, he said, is uncertainty
over the benefits of the vaccine compared with expenses. "It's
a financial decision," said Dr. Offit, chief of infectious
diseases at the Children's Hospital of Philadelphia. "The
answer to the question of whether the vaccine is of benefit
is yes, it only has benefits. But the government often bases
a decision like this on whether it is cost effective."
Still, even if a nationwide plan were put
into effect, says Dr. Dean Cliver, a professor of food safety
at the University of California at Davis, its progress would
be stifled by fears about vaccine safety. "People in
this country are phobic about immunization," he said.
"We really are losing ground on childhood vaccinations,
mainly because of some bad misinformation."
Back to top
December 31st, 2003
Bolstered
by Liver Transplant, HIV Patient Rebuilds His Life
Associated Press
A liver transplant performed as part of a nationwide clinical
trial for HIV-positive people has revived musician Terry LaBolt.
After 20 years of combined HIV and hepatitis B infection,
he was the first HIV-positive patient in the Cincinnati area
to receive a new liver.
Earlier in the epidemic, people with HIV
were rejected for organ transplants because it was assumed
they would not live long enough to justify the procedure.
But since the introduction of successful antiviral therapy,
liver damage has become one of the leading causes of death
for people with HIV, who can also have hepatitis B and C viruses.
Still, however, HIV patients were rejected as transplant candidates
because doctors feared post-surgery antirejection drugs would
interfere with HIV medications.
LaBolt's transplant was part of a clinical
trial run by researchers at the University of California-San
Francisco. The University of Cincinnati is one of 14 participating
medical centers.
The study calls for performing 130 liver
transplants on HIV- positive patients over the next three
years. This represents less than 1 percent of the 15,000 liver
transplants expected to be performed nationwide in the same
period. The goal is to determine which HIV medications work
best with antirejection drugs and which drug combinations
to avoid post-surgery.
Across the country, 17,679 people are on
liver transplant waiting lists, according to the United Network
for Organ Sharing. Through September, 4,244 such operations
were performed in 2003.
Researchers say it is too early to tell
how many of the 900,000 Americans with HIV will get sick enough
to need a new liver. Before the study started, about 50 people
with HIV got liver transplants from 1997 to 2002 at medical
centers in San Francisco, Pittsburgh, Philadelphia and Miami.
Back to top
Hepatitis
B Rates on the Decline in U.S.
by THE ASSOCIATED PRESS
ATLANTA (AP) -- Hepatitis B infections have declined by two-thirds
in the United States in the past decade, reflecting the routine
use of childhood vaccinations against the liver-attacking
virus, the government said Wednesday.
However, infections are still on the rise
among adults, the Centers for Disease Control and Prevention
said. Since 1999, hepatitis B cases have risen by 5 percent
among men ages 20 to 39 and by 20 percent and 31 percent,
respectively, for men and women 40 or older.
The CDC said the overall number of cases
dropped 67 percent between 1990 to 2002, with the greatest
decrease -- 89 percent -- in the newborn-to-19-year-old age
group.
"There have been overall declines
-- that is good,'' said Dr. Beth Bell, chief of the epidemiology
branch in the CDC's division of viral hepatitis. "But
the recent rise among adults is concerning and highlights
the need to improve our ability to vaccinate adults at high
risk.''
Adults infected with the bloodborne or
sexually transmitted virus commonly have risk factors such
as multiple sex partners or intravenous drug use, the CDC
said.
Hepatitis B is part of a class of viruses
that strike the liver.
Hepatitis C, like
hepatitis B, is sexually transmitted or spread by sharing
needles and can lead to chronic liver disease, liver scarring
and liver cancer. Hepatitis A is spread primarily by eating
something contaminated though unsanitary food handling by
an infected person. Most hepatitis A victims get better after
a few weeks.
[Editor’s Note: Hepatitis C can
be transmitted sexually, but the risk is very low. It is difficult
to study sexual transmission of HCV, but the majority of studies
conducted to date have shown a 0-3% chance of contracting
HCV through unprotected sex in stable monogamous heterosexual
relationships.]
Back to top
Wendy Elizabeth
Marx – Organ Transplant Advocate Dies
Wendy Elizabeth Marx was just out of college when she was
diagnosed with a devastating case of hepatitis B. Within weeks,
she was in a coma. Doctors said she would most likely die
within 24 hours if she didn't receive a new liver. Olympic
athlete Carl Lewis, who was working with Marx's brother on
a book, flew to San Francisco and held a press conference
to plea for a donor for Ms. Marx and for more donors overall.
Ms. Marx received her liver. She recovered.
And she dedicated her life to raising awareness
about the chronic shortage of organ donors. She co-founded
the Wendy Marx Foundation for Donor Awareness, which helped
sign up new donors, created a transplant fellowship for doctors
and publicized the U.S. Transplant Games, an Olympics of sorts
for transplant recipients. And despite enduring two liver
transplants and the challenges of living with hepatitis, Ms.
Marx married and worked at a series of Internet firms and
for the Foundation for Accountability.
Ms. Marx died Oct. 28 of multiple organ
failure while awaiting her third liver transplant. She was
36 and lived in San Francisco.
Source: DEATHS IN
2003: People we'll miss, Chuck Squatriglia, SFGate.com
Back to top
Clinical
Trials Begin for Procleix(R) Ultrio(TM) Assay
Innovative Molecular Test Further Safeguards Blood Supply
by Detecting Hepatitis B in Addition to HIV-1 and Hepatitis
C
Chiron Corporation announced that clinical
trials of the Procleix(R) Ultrio(TM) Assay, for the simultaneous
detection of HIV-1, hepatitis C virus (HCV) and hepatitis
B virus (HBV) in donated blood, plasma, organs and tissue,
have begun in the United States.
"We are very pleased to begin clinical
trials of the Procleix Ultrio Assay in direct response to
requests from major blood bank customers," said Henry
L. Nordhoff, chairman, president and CEO of Gen-Probe. "The
addition of an HBV assay provides another layer of protection
for the blood supply."
"The start of clinical trials of the
Procleix Ultrio Assay marks a major milestone in the continuing
expansion of the Procleix franchise," said Jack Goldstein,
president, Chiron Blood Testing. "This achievement demonstrates
the long-standing commitment of Chiron and Gen-Probe to attain
the highest possible standards in the safety and supply of
blood products in the U.S. and around the world."
The Procleix Ultrio Assay was developed
by Gen-Probe in collaboration with Chiron. The test, which
will be distributed and marketed by Chiron, adds an assay
for HBV to the previously approved Procleix(R) HIV-1/HCV Assay.
The Procleix Ultrio Assay is designed to detect the presence
of all known HIV-1 groups and subtypes and HCV and HBV genotypes
in human plasma during the very early stages of infection,
when those agents are present but cannot be detected by immunodiagnostic
tests. The HBV component of the assay has the potential to
reduce the window period between infection and detection of
hepatitis B from 59 to 34 days, an improvement of 42 percent
over currently available tests.
The new test, initially being evaluated
on the semi-automated instrumentation system, will be used
at three blood centers in the United States under an investigational
new drug (IND) application. Clinical trials of the Procleix
Ultrio Assay on the semi-automated instrumentation will establish
a benchmark of equivalence for the clinical trial of this
assay on the Procleix(R) TIGRIS(R) instrumentation system.
Hepatitis B is the most common serious
liver infection in the world and is transmitted through contact
with blood and body fluids. Hepatitis B infection can lead
to liver failure, cirrhosis or cancer. According to the World
Health Organization, more than 350 million people worldwide
are chronically infected with the hepatitis B virus. More
than one million people die annually as a result of HBV infections.
Amplified nucleic acid testing (NAT) is
a highly sensitive method of detecting infectious organisms
in donated blood, thereby improving the safety of the world's
blood supply. The Procleix Ultrio Assay uses a family of technologies
developed by Gen-Probe, including a unique nucleic acid amplification
technique called transcription-mediated amplification (TMA).
Researchers have demonstrated that TMA technology, by efficiently
amplifying the genetic contents of each specific virus, allows
significantly earlier detection of infection than tests that
rely on antibody or viral protein detection.
About Procleix(R) System
The Procleix(R) System incorporates state-of-the-art NAT technology
to detect viral RNA and DNA in donated blood and plasma during
the very early stages of infection, when these infectious
agents are present but cannot be detected by immunodiagnostic
tests. The Procleix HIV-1/HCV Assay has been commercially
available in Europe since 1999 and was granted FDA approval
in 2002. The Procleix System is approved for use in 16 countries
and is under evaluation in several other European, South American
and Asian countries.
About Chiron
Chiron Corporation, headquartered in Emeryville,
California, is a global pharmaceutical company that leverages
a diverse business model to develop and commercialize high-value
products that make a difference in people's lives. The company
has a strategic focus on cancer and infectious disease. Chiron
applies its advanced understanding of the biology of cancer
and infectious disease to develop products from its platforms
in proteins, small molecules and vaccines. The company commercializes
its products through three business units: BioPharmaceuticals,
Vaccines and Blood Testing. For more information about Chiron,
visit the company's website at www.chiron.com. For more information
about Chiron Blood Testing visit www.eBloodBank.com.
About Gen-Probe
Gen-Probe Incorporated,
founded in 1983, is a global leader in the development, manufacture
and marketing of rapid, accurate and cost-effective nucleic
acid testing products used for the clinical diagnosis of human
diseases and for screening donated human blood. Using its
patented NAT technology, Gen-Probe has received FDA approvals
or clearances for more than 60 products that detect a wide
variety of infectious microorganisms, including those causing
sexually transmitted diseases, tuberculosis, strep throat,
pneumonia and fungal infections. Additionally, the Company
developed and manufactures the only FDA-approved blood screening
assay for the simultaneous detection of HIV-1 and HCV, which
is marketed by Chiron Corporation. Gen-Probe and Bayer Corporation
have formed a collaboration to develop, manufacture and market
nucleic acid diagnostic tests for certain viral organisms,
and under the agreement Bayer has the right to distribute
these tests, including the recently approved VERSANT(R) HCV
Qualitative Assay. Gen-Probe has 20 years of nucleic acid
detection research and product development experience, and
its products are used daily in clinical laboratories and blood
collection centers throughout the world. Gen-Probe is headquartered
in San Diego, California and has approximately 700 employees.
Additional information about the Company can be found on the
Internet at www.gen-probe.com.
This news release contains forward-looking
statements about the companies' expectations, beliefs, plans,
objectives, assumptions or future events or performance, including
statements regarding product development initiatives, the
success of clinical trials, new product marketing, and future
product sales, that involve risks, uncertainties and assumptions
and are subject to change. Forward-looking statements are
not guarantees of performance. A full discussion of Chiron's
and Gen-Probe's operations and financial conditions, including
factors that may affect the companies' businesses, operating
results and future prospects, is contained in documents the
companies have filed with the SEC, including the forms 10-K
for the year ended December 31, 2002, and the companies' quarterly
and current reports, and will be contained in all subsequent
periodic filings made with the SEC. These documents identify
important factors that could cause the companies' actual performance
to differ from current expectations, including the outcome
and timing of clinical trials, regulatory review and approvals,
manufacturing capabilities, intellectual property protections
and defenses, marketing effectiveness, the success of collaborations,
third-party distributors and suppliers. In particular, there
can be no assurance that Chiron or Gen-Probe will successfully
complete clinical trials of new products, develop and receive
approval to market new products, or achieve market acceptance
for such new products.
The companies do not undertake any obligation
to update the forward-looking information we are giving today
to reflect subsequent events.
NOTE: Procleix and Ultrio are registered
trademarks of Chiron Corporation. TIGRIS is a registered trademark
of Gen-Probe Corporation.
SOURCE: Chiron Corporation
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January 1st, 2004
Virus Sufferer
is Forced to Wait Three Years for Treatment
by Jeremy Laurance Health Editor
In the three years since Brenda Binge was
diagnosed with hepatitis C, she has seen a doctor once, a
nurse twice and had an ultrasound test but she is still waiting
for treatment.
The 57-year-old former hotelier has been
married for 30 years, never dabbled in drugs, and suspects
she became infected through a blood transfusion in the early
1980s. She is angry at the lack of urgency shown by the NHS
to people in her predicament.
"It is very distressing because I
feel I have a death sentence hanging over me," she says.
"Although there are drugs that can treat hepatitis C
I am denied them. You can have cirrhosis, liver cancer and
liver failure and no one is doing anything."
After being diagnosed in 2000, Mrs Binge
moved from Bath to Sussex where she was referred to a liver
specialist only after "constant pestering".
Her appointment has been cancelled twice
and she has not yet seen him. A week before Christmas she
received a letter telling her that the kind of hepatitis C
she had - genotype 1B - was one of the hardest to treat. "To
say I am upset is to put it mildly," she says. "I
was going to call my MP. The Government is burying its head
in the sand. A lot of people don't know they have got it and
because no one makes a fuss no one is doing anything. It's
a shocking neglect of the nation's health. This is a very
nasty illness."
Mrs Binge, who serves as a councillor on
Mid-Sussex District Council and once stood as a Tory parliamentary
candidate, has been told that after treatment starts with
a cocktail of drugs she will need an injection once a week
and pills each day for a year. The cost of the drugs is about
£7,000. "What are they waiting for?" she asks.
"Perhaps if I die they can save money and won't have
to treat me."
Although her marital status was known to
the NHS, she had never been given any advice about how to
prevent her husband, Rod, 59, a financial adviser, becoming
infected.
"We never had any advice about protective
sex even though the virus can be passed on that way,"
she adds. "I am anxious now to do anything I can to get
this issue more widely known."
More information on hepatitis C can
be found at www.hepcuk.info.
Source: http://www.independent.co.uk/
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