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Alan Franciscus
Editor-in-Chief
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In This Issue:
• Last
Cases against Palo Alto Lab Worker Dismissed
• 50 Years of Organ Transplants
• NHS Knew of Hepatitis Risk at Blood Bank:
Haemophiliacs’ Anger at Revelation in Letter
• Federal Compensation Fund Makes Money
while Victims Denied
• The Australian Government Response to
Senate Inquiry into Hepatitis C and Blood Supply
• Organ Transplant, Finding a Match
• Hepatitis C Virus Elucidated
• Reported Hepatitis C Cases up Statewide
• Herpes Zoster after Liver Transplantation
• Effects of Contrast Media on Renal Function
in Patients with Cirrhosis
• Dynavax Announces Completion of Enrollment
of Phase II/III Hepatitis B Prophylactic Vaccine Trial
• Roche Seeks Expanded Use of Its Hepatitis
C Drugs
• Hepatitis C Recurrence after Living Donor
Transplantation
August 28th, 2004
Last
Cases against Palo Alto Lab Worker Dismissed
Source: Associated Press
PALO ALTO, Calif. - Two people who believe
they were infected with HIV and hepatitis C by a lab worker
who reused needles, plan to appeal a judge's dismissal of
their cases.
The woman, known as Jane Doe in court documents,
discovered she was HIV-positive after Elaine Giorgi drew her
blood in 1997 and 1999.
"I just remember being shocked, like
the feeling you get when someone dies," Doe, who asked
not to be identified, told the San Jose Mercury News
for a story Saturday. "You know your life is never going
to be the same again."
Doe is one of dozens who sued Giorgi and
her employer, SmithKline Beecham Clinical Laboratories, seeking
financial compensation in a case that drew national attention.
But last month, a judge dismissed the last two cases, including
Doe's.
Doe is one of about 3,600 people who had
their blood drawn by Giorgi, who admitted reusing needles
to draw blood from patients at a Palo Alto laboratory from
1997 to 1999.
Giorgi, 57, served about half of a one-year
jail sentence after pleading no contest in June 2002 to felony
charges of illegally disposing of medical waste, said her
public defender Brian Matthews. She also had six months of
electronic monitoring and is serving the remainder of her
five-year probation sentence. She did not return a call to
the Mercury News.
Jerry Orzoff, 72, who contracted hepatitis
C, also had his case dismissed last month after Santa Clara
County Superior Court Judge Leslie C. Nichols said there was
insufficient evidence the infections were caused by Giorgi.
"We do not believe that the technician
was responsible for the infection of the plaintiffs in this
case, and the court agreed," said Patricia Seif, a spokeswoman
for GlaxoSmithKline, formerly SmithKline Beecham. She said
Doe's and Orzoff's were the last cases outstanding.
No one knows why Giorgi reused the needles,
though investigators said it may have been a misguided attempt
to save the company money. SmithKline denied she was encouraged
to cut costs.
Back to top
August 29, 2004
50
Years of Organ Transplants
Source: Chicago Sun-Times – www.suntimes.com
This year marks the 50th anniversary of
one of the most remarkable feats in medical history. In 1954,
surgeons at Brigham and Women's Hospital in Boston performed
the first successful organ transplant.
Doctors removed a kidney from 23-year-old
Ronald Herrick and transplanted it into his identical twin,
Richard, who was dying of kidney failure. Richard recovered,
married his nurse, had two daughters and lived another eight
years.
Since then, there have been more than 400,000
transplants in the United States, including more than 25,000
last year. Thanks to less-invasive surgical techniques, better
anti-rejection drugs and other improvements, transplant patients
are recovering faster and living longer.
“It's one of the modern medical miracles,
and it keeps getting better," said Dr. Robert Higgins,
a heart-transplant surgeon at Rush University Medical Center.
But while transplant surgery has become
routine, many of the stories behind the operations remain
as dramatic as the Herrick twins' story, replete with suffering,
sacrifice, hope, courage, tragedy, triumph, extraordinary
generosity and a fierce will to live.
To mark the 50th anniversary, the Chicago
Sun-Times asked nine people to tell their transplant
stories. Their accounts, written with Chicago Sun-Times
health reporter Jim Ritter, will appear today through Friday
and next Sunday.
Back to top
NHS
Knew of Hepatitis Risk at Blood Bank: Haemophiliacs’
Anger at Revelation in Letter
Liam McDougall, Health Correspondent
Source: www.sundayherald.com
The Department of Health knew in 1981 that
haemophiliacs were at risk of hepatitis infection from imported
US blood products but continued to use them, a previously
unseen document has revealed.
A Sunday Herald investigation has uncovered
a letter in which NHS chiefs acknowledge the danger to haemophiliacs
years before thousands contracted deadly liver diseases from
NHS blood products.
Around 5000 Britons – most of them
haemophiliacs – contracted hepatitis A, B, C and G through
blood transfusions and treatments in the 1980s and 1990s.
More than 1000 are estimated to have died and many have developed
diseases such as liver cancer as a result.
Successive government ministers have refused
to admit liability for the tragedy, saying they did everything
to ensure blood was safe and could not have averted the crisis
as they were unaware of the hepatitis risk.
However, in a letter dated July 31, 1981,
Douglas R Harris at the Department of Health wrote to then
Treasury Minister Michael Prescott expressing deep misgivings
about the quality of NHS blood products. He also revealed
that the Blood Products Laboratory (BPL) – where most
NHS blood was processed – was in such a poor condition
it was “unsafe and potentially hazardous to patients”.
He wrote: “Health authorities are
obliged to supplement supplies from BPL with expensive and,
because of the hepatitis risk, less safe imported commercial
blood products at a cost of up to £10m annually.”
Harris also warned: “In 1979 the
laboratory was inspected by the Medicine’s Inspectorate.
The report concluded, ‘If [BPL] were a commercial operation
we would have no hesitation in recommending that manufacture
should cease until the facility was upgraded to a minimum
acceptable level.’”
Last night, the news was greeted with anger
by campaigners, who seized on it as evidence that ministers
were fully aware they were putting lives at risk, but did
nothing. They said the revelation made the case for a public
inquiry.
John McAughey, from Stanley, Perthshire,
who in February was given a year to live as a result of his
infection in the 1980s, said: “We were told these blood
products were the greatest things since sliced bread but it
is clear they knew the dangers.”
Philip Dolan, chairman of the Scottish
Haemophilia Forum, said: “This document shows they knew
about the risks to our health. If ever there was proof we
needed a public inquiry to get answers this is it.”
Glasgow lawyer Frank Maguire, who has launched legal action
against Health Minister Malcolm Chisholm to force an inquiry,
said: “This is another piece of evidence which is a
cause for concern. It demonstrates they knew of the hepatitis
risk, and still imported commercial products.”
Lord Morris of Manchester, who is the president
of the Haemophilia Society and has campaigned for an inquiry,
said he would raise the matter “urgently” with
health ministers. He added: “This is highly important
… I congratulate the Sunday Herald on obtaining the
document.”
The document, never before made public,
was among papers submitted in a 1990 legal action by haemophiliacs
who had contracted HIV. Despite judges believing the government
had a case to answer, it was dropped when ministers offered
to compensate victims.
The new revelation comes as thousands of
UK haemophiliacs – including hundreds of Scots –
are set to launch a legal case against the US drug firms that
sold contaminated blood products to the UK in the 1970s and
1980s. Five companies have been accused in the class action,
to begin in the US next month, of dumping drugs on the European
market that were considered unsafe for the US.
If the case succeeds, the firms –
Alpha Therapeutic, Armour, Aventis, Baxter and Bayer –
could have to pay out a minimum of £1.35 billion.
A Department of Health spokeswoman said
the revelation contained in the letter would not alter its
stance on the hepatitis issue.
“From the evidence we have, we don’t
accept wrongful practices were employed,” she said.
Back to top
Federal
Compensation Fund Makes Money while Victims Denied
Source: CNW
VANCOUVER-- Last year the federal government's
Hepatitis C Compensation Fund earned $56 million more in income
than it spent on claims and expenses. The fund, set up in
1998 to assist victims of hepatitis C tainted blood transfusions,
recently released its 2003 - 2004 annual report which shows
that it ended the fiscal year with more than $1.1 billion
still in the fund.
"The compensation fund actually made
money while an entire group of victims of tainted blood transfusions
has been denied access to the fund," says David Klein
of Klein Lyons, a Vancouver BC law firm that has been working
on class actions on behalf of pre-86/post-90 Hepatitis C victims
for more than six years.
Thousands of persons across the country
who were infected with hepatitis C through blood transfusions
before 1986 or after 1990 were ruled ineligible for inclusion
in the $1.2 billion federal/provincial/territorial compensation
program set up in 1998. The federal government decided that
it was responsible for only those persons who received tainted
blood between January 1, 1986 and July 1, 1990.
According to then Health Minister Allan
Rock, inclusion of all hepatitis C victims of tainted blood
would bankrupt medicare. Current evidence shows that the estimated
numbers in both the 86/90 group of hepatitis C victims and
the pre-86/post-90 group were hugely overestimated. More than
four years after the $1.2 billion fund was set up to provide
compensation for the 86/90 group, there is more than enough
money in the compensation program to include the hepatitis
C victims who received the virus from tainted blood transfusions
before 1986 and after 1990. Those who contracted the virus
prior to 1986 are among the longest-suffering and many are
among the sickest of the hepatitis C victims.
"In the light of the financial information
contained in the compensation fund's annual report, it is
impossible to justify shutting pre- 86/post-90 hepatitis C
victims out of the fund," says Klein. "The federal
government should immediately open the fund to hepatitis C
victims in the pre- 86/post-90 group. This would provide access
to desperately needed financial assistance for thousands of
victims across Canada who are struggling with ill health,
cannot afford needed medication, and are unable to work and
take care of their families."
Klein Lyons, along with law firms Roy Elliott
Kim O'Connor, LLP in Ontario, and Lauzon Belanger in Quebec,
all of whom have been pursuing class actions, are working
with a coalition of community and advocacy groups, the Hepatitis
C Compensation Umbrella Of Canada (HCCUC), to urge the federal
government to immediately expand the eligibility for the existing
86/90 compensation program to include hepatitis C victims
now in the pre- 86/post-90 excluded group.
For further information: David Klein,
(604) 874-7171
Back to top
The
Australian Government Response to Senate Inquiry into Hepatitis
C and Blood Supply
Source: News-Medical.Net
The Australian Government today announced
its response to the Senate Inquiry into Hepatitis C and the
Blood Supply.
The Senate Community Affairs References
Committee has produced a balanced report on a sensitive and
difficult topic.
Although the Inquiry found that decision
makers had made reasonable decisions in the 80s, based on
the evidence available, medically acquired hepatitis C has
hurt many people.
The Government has agreed to fund access
to recombinant clotting factors for haemophilia patients.
A small number will not be able to use recombinant products
and will continue to be provided with plasma-derived clotting
factors. The Government will provide ongoing funding of $80.7
million over four years, to be supplemented by the States
and Territories.
The Government has asked the Pharmaceutical
Benefits Advisory Committee to conduct a review of access
to drugs to treat hepatitis C.
Mr Abbott said that the Government would
consider a public awareness campaign in the context of finalising
the second National Hepatitis C strategy later in the year.
The Senate Inquiry made three other recommendations which
are a matter for discussion between the Commonwealth Government
and State and Territory Health.
www.health.gov.au
Back to top
August 31st, 2004
Organ
Transplant, Finding a Match
Source: www.newschannel6.tv
Gene Williams was number 2 on the national waiting list for
a liver transplant. Nancy Noles with Willis Knighton says
Williams` critical condition made him a priority.
Patient condition goes into a computer
and this database determines who gets priority. Michael Whatley
needs a liver too. He has Hepatitis C. He`s been on the waiting
list for five years. His Hepatitis C also causes fatigue,
fluid build up in his stomach and bleeding in his esophagus.
Whatley`s condition isn`t critical like Williams` was.
Doctors also say his five year wait is
indicative of the shortage of organs.
The Willis Knighton/LSU Transplant center
in our area has more than 350 people waiting for organs.
Dr. Gazi Zibari with LSU says nationwide
at least 16-20 people die everyday waiting for organs.
Back to top
September 01, 2004
Hepatitis
C Virus Elucidated
Yousuf Bhaijee
Contribution Writer
Source: Daily Californian
UC Berkeley researchers have joined the
battle against hepatitis C virus (HCV) infection, the most
common blood-born infection in the U.S., by helping to elucidate
the strategy that the virus uses to proliferate inside the
human body. Insights into the viral replication process could
lead to more effective drug treatment strategies.
“Hepatitis C is a serious pathogen,
and it is particularly dangerous because in 80% of cases infection
becomes chronic, leading to cirrhosis, liver cancer and death.
Furthermore, no cure is available, and control with currently
available therapies is difficult.” said postdoctoral
researcher Chris Fraser.
Primary investigator and professor of biochemistry
and molecular biology Jennifer Doudna and her lab focus on
the structure and function of the virus’ ribonucleic
acid (RNA), which serves as a template to produce the virus’
proteins within the infected cell.
Like all viruses, HCV uses the host cell’s
ribosomes to translate its genetic blueprint, in the form
of RNA, into the proteins needed to create more copies of
the virus. The Doudna lab has uncovered how HCV takes over
the ribosome and uses it to reproduce.
The initiation of protein synthesis is
a complex and highly regulated process in all organisms. In
viruses, the ribosome must be recruited to the RNA template
prior to actual transcription. In most cases, this is achieved
via a series of protein factors that guide and regulate synthesis.
“The amazing thing about the HCV
virus is that it sidesteps many of these factors, and thus
also sidesteps cellular regulation, because the RNA actively
wraps itself around the ribosome and forces its way in rather
than being guided by the cell’s protein factors.”
said research scientist Hong Ji.
The Doudna lab has succeeded in visualizing
this complex interaction, known as an internal ribosomal entry
site (IRES). These visualizations have been pivotal in understanding
the mechanism of viral RNA translation.
The Doudna lab now plans on conducting
further analysis by characterizing how the protein factors
bind to both the ribosome and to the virus’ RNA. This
sets the background for designing future drug treatments.
“We have been working on this project
for close to six years and we are very excited about where
it is going,” Doudna said. “We believe that the
IRES may be the so-called ‘Achilles heel’ of Hepatitis
C and that our research may eventually help drug development
efforts to treat this epidemic.”
Back to top
Reported
Hepatitis C Cases up Statewide
Jenny Price
Associate Press
Source: www.duluthsuperior.com
MADISON, Wis. - The number of reported
hepatitis C cases in Wisconsin topped 18,000 last year and
increased fivefold between 1997 and 2002, a state health official
said Wednesday.
Epidemiologist Angela Russell, the state's
hepatitis C surveillance coordinator, attributed the increase
to greater awareness of testing for hepatitis C and reporting
requirements for the virus.
Wisconsin reported 828 new hepatitis C
cases in 1997, the first year the state collected the data.
The number of newly reported cases increased
to 4,203 in 2002 before dropping to 3,593 last year, Russell
said. Overall, the state reported 18,082 people had hepatitis
C as of last year.
The data is based on reports submitted
to the state by laboratories and public health departments.
The virus is transmitted when blood or
body fluids from an infected person enter the body of a person
who is not infected.
Nearly 4 million Americans are infected
with hepatitis C, according to the Centers for Disease Control
and Prevention. The United States has 36,000 new cases of
acute hepatitis C infection each year.
CDC studies show the virus is the leading
cause of liver transplants and liver cancer and causes 8,000
to 10,000 deaths each year. Like other hepatitis strains,
including A and B, hepatitis C attacks the liver.
Two-thirds of the new cases reported in
Wisconsin between 1997 and 2003 were men and 70 percent were
age 40 and older, according to the state Division of Public
Health.
At least 29 percent were in the Milwaukee
area and 15 percent were among state prison inmates, the division
reported.
The numbers don't reflect the actual number
of people who have hepatitis C, because most people who have
it don't display any symptoms and are not tested, Russell
said. The symptoms include jaundice, fatigue, dark urine,
abdominal pain, loss of appetite and nausea.
"It's really like finding a needle
in a haystack," she said. "People have had this
for 20 to 30 years and just didn't know."
Russell said the data helps the state determine
where to focus its efforts on education and prevention.
Those who should be tested for hepatitis
C include people who:
• Were told they received blood from
a donor who later tested positive for hepatitis C.
• Have ever injected illegal drugs.
• Are a sex partner of an injection drug user.
• Received a blood transfusion or solid organ transplant
before July 1992.
• Received a blood product produced before 1987 for
clotting problems.
• Have ever been on long-term kidney dialysis.
• Have evidence of liver disease.
• Have HIV.
ON THE NET
Hepatitis C program: http://dhfs.wisconsin.gov/dph_bcd/hepatitis
Back to top
Herpes
Zoster after Liver Transplantation
Source: www.gastrohep.com
Herpes zoster is a relatively common complication
after liver transplantation, find doctors in the September
issue of Liver Transplantation.
Herpes zoster is the consequence of the
reactivation of latent varicella-zoster infection.
Immunosuppression may be a predisposing
factor for herpes zoster.
In this study, doctors from Spain assessed
the risk of herpes zoster, the risk factors for its occurrence,
and its evolution in 209 consecutive liver transplant recipients.
The team found that herpes zoster developed
in 12% of patients.
They calculated that the 1-, 3-, 5-, and
10-year actuarial rates of herpes zoster were 3%, 10%, 14%,
and 18%, respectively.
The doctors determined that the patients
who developed herpes zoster were younger, received a greater
number of immunosuppressive drugs, and were more frequently
receiving mycophenolate mofetil or azathioprine.
They found that the only factor related
to herpes zoster occurrence on multivariate analysis was treatment
with mycophenolate mofetil or azathioprine.
Treatment with mycophenolate mofetil
or azathioprine was the only factor related to recurrence—Liver
Transplantation
Of the patients who developed herpes zoster,
31% developed postherpetic neuralgia.
Dr Ignacio Herrero and colleagues concluded,
"Herpes zoster is a relatively common complication after
liver transplantation".
"It is related to immunosuppressive
therapy."
"Post-herpetic neuralgia develops
in one third of patients with post-transplant herpes zoster."
Liver Transpl 2004; 10: 1140-3
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Effects
of Contrast Media on Renal Function in Patients with Cirrhosis
Source: www.gastrohep.com
Cirrhosis does not appear to be a risk
factor for the development of contrast media-induced nephrotoxicity,
find researchers in the September issue of Hepatology.
Patients with cirrhosis often undergo radiological
procedures that require the administration of contrast media.
Contrast media can cause renal failure.
It is not known if cirrhosis is a risk
factor for contrast media-induced renal failure.
In this study, researchers from Spain assessed
the possible nephrotoxicity of contrast media in patients
with cirrhosis.
The team evaluated renal function before
and 48 hours after the administration of contrast media in
31 patients with cirrhosis.
They also measured solute-free water clearance,
urine sodium, prostaglandins, and markers of tubular damage.
The team determined that the administration
of contrast media was not associated with significant changes
in renal function tests.
They found that urinary prostaglandin E2
and N-acetyl--D-glucosaminidase increased significantly, but
sodium and solute-free water excretion remained unchanged.
The team also prospectively examined a
second series of 60 patients with cirrhosis and renal failure.
In this series, no patient had renal failure due to contrast
media.
They found that 1 patient with septic shock
contrast media a possible contributing factor.
Dr Monica Guevara and colleagues concluded,
"The administration of contrast media is not associated
with adverse effects on renal function in patients with cirrhosis".
"Cirrhosis does not appear to be a
risk factor for the development of contrast media-induced
nephrotoxicity."
Hepatology 2004; 40: 646-51
Back to top
September 02, 2004
Dynavax
Announces Completion of Enrollment of Phase II/III Hepatitis
B Prophylactic Vaccine Trial
Source: PRNewswire
BERKELEY, Calif., -- Dynavax Technologies
Corporation (Nasdaq: DVAX - News), today announced that it
has completed enrollment and administered the first round
of immunizations in a Phase II/III clinical trial of its hepatitis
B (HBV) prophylactic vaccine candidate containing Dynavax's
Immunostimulatory Sequence (ISS). The study conducted at two
study centers in Singapore began enrollment in June.
The double-blind study compared Dynavax's
HBV vaccine candidate with GlaxoSmithKline's marketed HBV
vaccine, Engerix-B® in 94 subjects. The subjects ranging
between 40 and 70 years of age had not previously been immunized
against HBV. The full immunization schedule will consist of
three injections over six months, with antibody levels measured
one month after each injection. The third injection is scheduled
to be administered in early 2005.
The primary endpoint of the study will
be comparative protective antibody levels measured after the
third injection. Comparative protective antibody levels measured
after the first injection are a secondary endpoint. The study
is being conducted by Dr. Lim Seng Gee at the National University
Hospital, and Dr. Chow Wan Cheng, at the Singapore General
Hospital.
"We are pleased with the rapid enrollment
of this study and are on track to receive interim results
from this trial early next year," said Dr. Dino Dina,
President and CEO of Dynavax. "If these data show that
our HBV vaccine can provide superior protection against HBV
infection for this sizeable segment of the population that
historically respond poorly to currently marketed vaccines,
we will initiate in the first half of 2005 phase III studies
that would confirm this efficacy on a larger scale. In parallel,
we will test this vaccine more broadly in young adults and
adolescents."
Hepatitis B is a common infectious disease
with an estimated 350 million chronic carriers worldwide.
Prevention of hepatitis caused by the hepatitis B virus is
central to managing the spread of the disease, particularly
in regions of the world with large numbers of chronically
infected individuals. Annual sales of hepatitis B vaccines
in 2001 exceeded $1.0 billion globally. Currently approved
hepatitis B vaccines confer protective hepatitis B antibody
responses to approximately 95% of healthy young adults, if
the full dosing regimen is completed. According to the Centers
for Disease Control, only 53% of all those who received the
first dose of vaccine typically receive the second dose of
vaccine, and only 30% receive the third, resulting in greatly
impaired protection levels. Furthermore, the protective hepatitis
B antibody responses achieved by conventional vaccines is
lower in older adults, and for persons who are overweight
or who smoke.
Data previously reported from Dynavax's
phase II hepatitis B prophylactic vaccine trial in young adults
showed superior efficacy after both one and two immunizations
as compared to Engerix-B®. These results demonstrated
that protective hepatitis B antibody responses were produced
more quickly and with fewer injections with Dynavax's HBV
vaccine.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and
intends to commercialize innovative products to treat and
prevent allergies, infectious diseases, and chronic inflammatory
diseases using versatile, proprietary approaches that alter
immune system responses in highly specific ways. Our clinical
development programs are based on immunostimulatory sequences,
or ISS, which are short DNA sequences that enhance the ability
of the immune system to fight disease and control chronic
inflammation. In addition to the hepatitis B vaccine, ISS
are being developed in other indications that include: a ragweed
allergy program in phase II/III, and an asthma program in
phase II testing.
Dynavax cautions you that statements included
in this press release that are not a description of historical
facts are forward-looking statements. The inclusion of forward-looking
statements should not be regarded as a representation by Dynavax
that any of its plans will be achieved. Actual results may
differ materially from those set forth in this release due
to the risks and uncertainties inherent in Dynavax's business
including, without limitation, statements about: the progress
and timing of its clinical trials; difficulties or delays
in development, testing, obtaining regulatory approval, producing
and marketing its products; the scope and validity of patent
protection for its products; competition from other pharmaceutical
or biotechnology companies; its ability to obtain additional
financing to support its operations; its ability to maintain
effective financial planning and internal controls; and other
risks detailed in the "Risk Factors" section of
Dynavax's Annual Report on Form 10-K filed on March 30, 2004,
and in the section titled "Additional Factors That May
Affect Future Results" within Dynavax's quarterly report
on Form 10-Q filed on August 9, 2004. You are cautioned not
to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary
statement and Dynavax undertakes no obligation to revise or
update this news release to reflect events or circumstances
after the date hereof.
Source: Dynavax Technologies Corporation
Back to top
Roche
Seeks Expanded Use of Its Hepatitis C Drugs
Source: Reuters
NEW YORK--- Swiss drugmaker Roche Holding
AG (ROG.VX: Quote, Profile, Research) on Thursday said it
would seek approval from U.S. regulators to use its popular
hepatitis C combination therapy to treat patients with the
chronic liver disease who are also infected with HIV.
Pegasys, or peginterferon, in combination
with ribavirin, sold as Copegus, is already approved to treat
chronic hepatitis C and has been one of Roche's most important
growth drivers.
The U.S. Food and Drug Administration has
granted the the request for expanded use for patients co-infected
with HIV fast track status -- a designation used to expedite
development and review of drugs that address serious, unmet
medical needs -- Roche said.
"Hepatitis C has become one of the
leading killers of people with HIV today," Jeffery Smith,
director of clinical research for the American Foundation
for AIDS Research, said in a statement issued by Roche.
"The filing of Pegasys combination
therapy for this indication offers new hope to the 300,000
Americans co-infected with HIV and hepatitis C," Smith
said.
In a major study sponsored by Roche and
reported in The New England Journal of Medicine in
July, hepatitis C levels became undetectable in 40 percent
of patients infected with HIV who were treated with the Pegasys/ribavirin
combination.
That compared with just 12 percent of the
289 volunteer patients with both diseases who were treated
with the older form of interferon plus ribavirin.
In addition, the Roche combination did
not appear to interfere with the AIDS drugs the patients in
the study were receiving.
In July, Roche applied to the FDA for approval
of Pegasys as a treatment for chronic hepatitis B, which is
caused by a different virus that is also spread by bodily
fluids.
Back to top
Hepatitis
C Recurrence after Living Donor Transplantation
Source: www.gastrohep.com
Hepatitis C virus recurrence is more severe
in living donor liver transplantation compared to cadaveric
liver transplantation, find doctors in the September issue
of Hepatology.
Hepatitis C virus (HCV) infection may have
a more aggressive course following living donor liver transplantation
compared to cadaveric liver transplantation.
In this study, doctors from Spain examined
whether HCV disease recurrence differs between living donor
liver transplantation and cadaveric liver transplantation.
The team evaluated 116 consecutive HCV-infected patients undergoing
117 liver transplantations in a single center from March 2000
to August 2003.
They defined severe recurrence as biopsy-proven
cirrhosis and/or the occurrence of clinical decompensation.
Median follow-up was 22 months.
The team found that 22% of patients had
severe recurrence of hepatitis C.
22% of patients had severe recurrence of hepatitis C—Hepatology
Severe recurrence developed in 18% of patients
in the cadaveric liver transplantation group and in 41% of
patients in the living donor liver transplantation group.
The doctors calculated that the 2-year
probability of severe recurrence was significantly higher
in living donor liver transplantation compared to cadaveric
liver transplantation.
Using univariate analysis, the team found
that living donor liver transplantation and an ALT higher
than 80 IU/L 3 months after transplantation were predictors
of severe recurrence.
Using results from a subset of patients,
they established that a lobular necroinflammatory score >1,
living donor liver transplantation, and biliary complications
were associated with severe recurrence.
However, the only variables which were
independently associated with severe recurrence were living
donor liver transplantation and a lobular necroinflammatory
score >1.
Dr Montserrat Garcia-Retortillo and colleagues
concluded, "HCV recurrence is more severe in living donor
liver transplantation compared to cadaveric liver transplantation".
"Although our results were based on
a single-center experience, they should be considered in the
decision-making process of transplant programs, since severe
HCV recurrence may ultimately compromise graft and patient
survival."
Hepatology 2004; 40: 699-707
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