| Back
to News Review
Alan Franciscus
Editor-in-Chief
To download pdf version click here
In This Issue:
NIH Forming Conflicts-Of-Interest
Panel
Many Civil Suits Now Filed
A National Survey of Split-Liver Transplantation
in the United States
Schering-Plough CEO: Consent Decree Lasts Through
2005
Rigel Pharmaceuticals, Inc.'s (RIGL) R803 for
HCV Achieves Favorable Safety Profile
Novartis Resumes Merger Search; Talks Up Schering,
Ups Stake In Roche
Hepatitis C Infection Early in Life Rarely Serious
Reported Hepatitis Cases on the Rise in Parts
of Pennsylvania
Hepatitis B Virus Reactivation in Breast Cancer
Patients
Health-Related Quality of Life in Patients with
HIV and Hepatitis C Coinfection
Valeant Pharmaceuticals Advances Funding for
Viramidine Clinical Trials -Company Focuses Additional R&D
Investment on Viramidine
Go-Ahead for Hepatitis C Drug
Board OKs Free Hepatitis C Tests
Global Challenges | British Health Department
Launches Hepatitis C Testing Campaign
UK to Ban Chinese Herbal Remedy
Drug Effective For Resistant Hepatitis B
Hepatitis C Virus; FDA Approves Pegasys Prefilled
Syringes
MISSISSIPPI: Hepatitis Investigation Ongoing
at Neshoba Nursing Home
January 22nd, 2004
NIH Forming Conflicts-Of-Interest
Panel
By RANDOLPH E. SCHMID
Associated Press Writer
WASHINGTON (AP) -- Reacting to reports
that researchers received thousands of dollars as consultants
with private firms, the head of the National Institutes of
Health said Thursday he is forming a special task force to
review such relationships for possible conflicts.
Dr. Elias A. Zerhouni told the Senate Health
and Human Services appropriations subcommittee that he will
ask the panel to report in 90 days on what types of collaboration
are appropriate and to make recommendations for any rules
changes that may be needed.
The subcommittee called in Zerhouni to
respond to reports that some NIH scientists have been paid
thousands of dollars in cash and stock to serve as consultants.
He did not discuss specific cases other that to say they were
under review.
But Zerhouni stressed that under rules
changes made in 1995, NIH scientists are allowed to consult
with private firms on projects that are not part of their
direct government research work. He said his office is currently
reviewing the 365 such collaborations currently in effect
to make sure they follow the rules.
Crossover between NIH researchers and the
private sector is important to move basic research into treatments
that improve health, he said, "but in that process the
people at NIH need to have absolutely clean hands."
Sen. Arlen Specter, R-Pa., said be feels
the relationships could pose a substantial problem that needs
to be investigated, particularly if a scientist collaborates
with one company to the exclusion of others.
But Sen. Ted Stevens, R-Alaska, stressed
the benefits of government-industry relationships, commenting,
"I believe we need to encourage collaboration rather
than putting some sort of taint on it."
Zerhouni said no new approvals for outside
consulting will be issued until the new committee completes
its study.
He said the approximately 200 scientists
with approved consulting arrangements represent about 3 percent
of the agency's researchers. None of the NIH's institute directors
have consulting agreements, he said.
Zerhouni's office later announced that
the new review panel will be headed by Bruce Alberts, a biochemist
who is president of the National Academy of Sciences, and
Norman R. Augustine, chairman of the executive committee of
Lockheed Martin and former head of the National Academy of
Engineering.
Marilyn L. Glynn, acting director of the
Office of Government Ethics, told the panel that her agency
conducts periodic ethics reviews at government branches and
is currently doing one at NIH.
The review will focus on the structure
of NIH's ethics program, the public financial disclosure system
and the process for approving outside activities, she said.
The last NIH review, in 2000, found that
a new ethics official at the National Institute of Diabetes,
Digestive and Kidney Disease could not locate approvals for
outside activity granted before he took the position, Glynn
said in testimony. She said that has been corrected.
Dr. Stephen I. Katz, director of the National
Institute of Arthritis and Musculoskeletal and Skin Diseases,
said in testimony that he previously had done outside consulting
but had terminated the one remaining agreement in November.
The consulting arrangements generally involved
his critiquing company programs to address specific scientific
issues, said Katz, who was been a focus of reports on NIH
scientists' outside work.
"In no instance did I ever discuss,
with any company with which I was consulting, any research
that it might be conducting with the NIH or any application
it might have submitted to NIH for funding," he said
in testimony.
On the Net:
National Institutes of Health: http://www.nih.gov/
Source: Associated Press.
Back to top
January 24th, 2004
Many Civil
Suits Now Filed
Beverly J. Lydick/Tribune staff
In October 2002, Nebraska Department of
Health officials created an emotional firestorm in the Fremont
area by asking more than 600 people to be tested for a strain
of hepatitis C.
State officials issued 612 letters suggesting
the screening after a cluster of people identified as having
hepatitis C, genotype 3A, were discovered to have been under
the care of Dr. Tahir Javed and the Fremont Cancer Center.
Officials surmised an individual who had
received care at the center was hepatitis C positive prior
to seeking treatment, and may have introduced the disease
to the facility.
Dates of exposure were narrowed to between
March 1, 2000, and Dec. 31, 2001.
The announcement quickly grabbed the attention
of the general public, with print and broadcast journalists
descending on Fremont to cast light on what would come to
be known as "the largest hepatitis C outbreak of its
kind in the nation."
Of the 612 cancer patients who received
that initial notification from the health department, 485
chose to be screened for hepatitis C. Initially, 82 tested
positive for the virus.
Following those results, several patients
filed claims of malpractice against the clinic and Javed.
On March 7, a 49-year-old woman who had
tested positive for hepatitis C died in an Omaha hospital
while awaiting a liver transplant.
As the community struggled to deal with
rumors and misinformation about the virus and its effects,
support groups formed. A public forum was held March 16, drawing
state and federal medical officials - and about 100 citizens.
In June, following a second round of tests,
another 17 cases of the virus were detected among Javed's
former patients. In all, 99 people tested positive for hepatitis
C genotype 3a. The state health department ultimately blamed
unsanitary medical procedures at the cancer clinic for the
epidemic.
By August, 81 lawsuits filled a shelf in
the office of the Dodge County District Court Clerk. Most
named as defendants Javed, his nurse Linda Prochaska, Dodge
County and the Fremont Area Medical Center, the county-owned
facility where the oncologist's office was located.
On Oct. 1, the state pulled Javed's license
to practice medicine in Nebraska. The doctor, who left the
state in July 2002, currently serves as a minister of health
in his native country of Pakistan.
By January of this year, 99 civil suits
had been filed in district court. On Jan. 16, District Court
Judge John Samson announced the first case would not be tried
until at least January 2005.
Source: Fremont Tribune
Back to top
January 26th, 2004
A National
Survey of Split-Liver Transplantation in the United States
Source: www.gastrohep.com
Biliary and vascular complications account
for the majority of morbidity in split-liver transplantations,
find researchers in the February issue of Annals of Surgery.
Split-liver transplantation is a theoretically
attractive mechanism to increase cadaver organ supply. In
this study, a team of researchers assessed the application
and outcomes of split-liver transplantation in the United
States.
They surveyed 89 surgical teams between
2000 and 2001. The researchers collected data on graft type,
recipient status, procurement method, graft sharing, graft
outcomes, recipient outcomes, and experience with whole-organ
transplantation.
Of the 89 surgical teams, 83 provided the
researchers with data on 207 left lateral segment, 152 right
trisegment, 15 left lobe, and 13 right lobe grafts.
The research team established that the
split procedure was performed ex vivo in 54% and in situ in
46% of grafts.
They determined that complications occurred
frequently in all graft types. Biliary and vascular complications
were evenly distributed between grafts procured by either
technique.
The researchers found that primary nonfunction,
graft failure, and recipient death correlated with transplant
status.
Dr John Renz's team concluded, "Split-liver
transplantation has been principally applied to adult-child
pairs with at least one recipient critically ill".
"Biliary and vascular complications
account for the majority of morbidity in grafts procured by
either split technique with graft failure and recipient death
observed more frequently in critically ill recipients".
"Enhanced utilization and improved results may be possible
through improved information sharing and modification of allocation
criteria".
Ann Surg 2004; 239(2): 172-81
Back to top
Schering-Plough CEO: Consent Decree
Lasts Through 2005
Hollister H. Hovey
NEW YORK (Dow Jones)--There are still too
many moving parts in Schering-Plough Corp.'s (SGP) business
to offer specific 2004 guidance, Chairman and Chief Executive
Fred Hassan said Monday on the company's fourth-quarter conference
call.
However, the beleaguered drug maker still
expects 2004 to be worse than 2003, he said, echoing previous
statements that the company won't start to see a turnaround
until 2005.
It's unclear if that means that Schering-Plough
will be in the red in 2004. In 2003, the company swung to
a loss of $92 million, or 6 cents a share. But that included
$350 million to increase litigation reserves and charges related
to a voluntary retirement program. In 2002, Schering-Plough
had profit of $1.97 billion, or $1.34 a share.
Hassan's outlook that 2004 will be worse
than last year doesn't include any charges like the $350 million
charge it took in 2003.
The company is suffering from a massive
decline in sales in its allergy franchise since Claritin lost
patent protection in 2002. Its hepatitis-C franchise has also
seen big declines since Roche launched a competitor and the
market for these drugs shrunk as a whole. One of the drugs
in the hepatitis-C group, Rebetol, faces generic competition
imminently, so the company has been trying to get rid of extra
inventory.
The company also remains under the eye
of the Food and Drug Administration with a consent decree
in effect until December 2005. The company has to satisfy
the FDA's concerns about its manufacturing by certain dates
or will face fines. So far, the company has completed 91 significant
steps of the consent decree, Hassan said. There are 129 more
to go, he added. The company didn't have to pay any fines
for missteps in 2003, he said.
At the same time, the company is getting
ready to launch a cholesterol pill that combines its drug
Zetia with Merck & Co.'s (MRK) Zocor. It will increase
promotional spending for that drug and Zetia itself in 2004.
So, to save money - the company wants to
find more than $200 million in cost savings - there will be
more layoffs this year. In 2003, 900 people out of the 2,400
who were eligible, opted to take early retirement. Schering-Plough's
goal is to cut 10% of its payroll expenses.
Cost cuts will come from all over the company,
except in areas covered by the consent decree and sales force.
Schering-Plough swung to a fourth-quarter
loss, as it saw those key franchises decline, lost revenue
from AstraZeneca PLC (AZN) as its alliance with heartburn
drug Losec ended and the company paid charges related to that
voluntary retirement program.
Earlier Monday, the Kenilworth, N.J., company said its fourth-quarter
loss was $181 million, or 12 cents a share. The loss included
$179 million of employee termination costs, mostly from a
voluntary early retirement program, and asset-impairment charges
of $50 million.
Excluding items, the company reported fourth-quarter
income of a penny a share. Schering earned $313 million, or
21 cents a share, for its year-ago fourth quarter.
Fourth-quarter sales fell 18% to $1.95
billion from $2.37 billion last year, slowed by sales at the
Intron franchise, which includes the anticancer/antiviral
agent Intron A Injection, as monotherapy and in combination
with Rebetol capsules for treating hepatitis C, and Peg-Intron
Powder for Injection, a longer-acting form of Intron A, as
monotherapy and in combination with Rebetol for treating hepatitis
C.
Analysts surveyed by Thomson First Call
were expecting Schering to earn 4 cents a share on sales of
$2.03 billion for its fourth quarter.
Hassan said that in the future, the company,
which has been a powerhouse in allergy and cholesterol drugs,
will start to refocus on oncology.
Back to top
Rigel
Pharmaceuticals, Inc.'s (RIGL) R803 for HCV Achieves Favorable
Safety Profile
SOUTH SAN FRANCISCO, Calif., Jan. 26 /PRNewswire-FirstCall/
-- Rigel Pharmaceuticals, Inc. today announced positive clinical
safety data from a Phase I trial for R803, an experimental
drug to treat Hepatitis C Virus (HCV), the blood-borne virus
that affects nearly 170 million people worldwide. Clinical
data indicates that R803 is well tolerated with no notable
adverse effects reported in the dose levels that Rigel plans
to use moving forward. Rigel plans to launch a Phase I/II
efficacy clinical trial in the U.S. during the second quarter
of 2004 in HCV-infected patients. This trial will monitor
viral clearance and safety over numerous days of drug administration.
In the Phase I trial, an escalating dose
regimen of R803 was studied in 42 volunteers and was compared
with placebo controls. The safety data collected indicated
that subjects treated with R803 were indistinguishable from
the placebo controls across a wide range of clinical and laboratory
safety tests, including clinical signs and symptoms, serial
electrocardiography, and clinical chemistry and hematology
studies. Pharmacokinetic data, which will aid in planning
dosing in the next clinical study, was also collected. The
trial was conducted in the U.K. and the results will be part
of the U.S. IND package that Rigel expects to file with the
FDA later in the first quarter of 2004.
"A leading issue for the millions
of Americans infected with chronic HCV are the side effects
of current therapies and their relatively limited efficacy,"
noted Jules L. Dienstag, M.D., Professor of Medicine and Associate
Dean for Academic and Clinical Programs at Harvard Medical
School and a steering committee member of the upcoming study.
"R803 continues to show promise as a unique first-line
anti-HCV therapeutic, directly targeting HCV by interfering
with the viral polymerase protein that is needed for replication."
"The successful completion of Phase
I safety trials represents another major step in Rigel's efforts
to advance the clinical development of R803," said Elliott
Grossbard M.D., Senior Vice President, Medical Development.
"The availability of a new oral therapy that is convenient,
safe and effective would be an important addition to currently
available treatment options for patients with HCV."
Rigel's R803, a non-nucleoside HCV polymerase
inhibitor, is an oral, small-molecule compound. To date, R803
has demonstrated potent efficacy in inhibiting viral replication
in cell-based assay systems and in live virus assays. R803
has been shown to be efficacious against various genotypes
of HCV, including genotype 1, the most common in North America
and Europe. In various assays, R803 appears to act within
days to reduce viral levels significantly. In addition, as
a result of R803's novel viral binding site, resistance may
be slow to develop.
HCV: Current Treatments and Market
Opportunity
Hepatitis C is an inflammation of the liver caused by the
hepatitis C virus. As the most common blood-borne infection
in the U.S., HCV affects 4 million Americans and 170 million
individuals worldwide. Approximately 85 percent of those with
acute illness will go on to develop chronic hepatitis, a condition
that has been linked to cirrhosis, hepatocellular carcinoma
(liver cancer) and liver failure. HCV accounts for 30 percent
of end-stage liver disease and liver cancer and is the leading
cause of liver failure, which can result in the need for liver
transplantation. Public health officials in the U.S. and abroad
have mobilized to address this medical crisis by identifying
detection guidelines for HCV and implementing therapies to
eradicate chronic infection.
Currently available HCV therapies are only
modestly effective at treating the disease. The most prevalent
treatment regimen is with interferon alpha (IFN), usually
in combination with ribavirin. IFN shows only a 20 percent
to 40 percent success rate in patients who complete therapy,
and significant side effects result in up to half the patients
either quitting treatment or moving to a lower dose regimen.
Moreover, IFN is least effective against HCV genotype 1, the
strain responsible for 70 percent of chronic HCV infection
cases in the U.S. Rigel believes that its approach is substantially
different than that of IFN: instead of working to boost the
immune system, experiments indicate that R803 directly, rapidly,
selectively and potently targets HCV by interfering with a
viral polymerase protein that is needed for replication.
With the current high prevalence and projected
increase in cases of HCV and related diseases, and with the
limited success of currently available therapies, Rigel believes
that the potential for new direct HCV therapeutics is large
and that R803 has the potential to be at the forefront of
this opportunity.
About Rigel (http://www.rigel.com/)
Rigel's mission is to become a source of
novel, small-molecule drugs to meet large, unmet medical needs.
Rigel has identified four disease areas with which to focus
its lead product development programs: asthma/allergy, virology,
immunology and oncology Rigel has begun clinical testing of
its first two product candidates, R112 for allergic rhinitis
and R803 for hepatitis C, and plans to begin clinical trials
of two additional drug candidates, for the treatment of rheumatoid
arthritis and asthma, by the end of 2004.
This press release contains "forward-looking"
statements, including statements related to Rigel's plans
to pursue clinical development of drug candidates and the
timing thereof and the potential efficacy of drug candidates.
Any statements contained in this press release that are not
statements of historical fact may be deemed to be forward-looking
statements. Words such as "plans," "intends,"
"expects" and similar expressions are intended to
identify these forward-looking statements. There are a number
of important factors that could cause Rigel's results to differ
materially from those indicated by these forward-looking statements,
including risks associated with the timing and success of
clinical trials and the commercialization of product candidates,
as well as other risks, detailed from time to time in Rigel's
SEC reports, including its Quarterly Report on Form 10-Q for
the quarter ended September 30, 2003 and Annual Report on
Form 10-K, as amended, for the year ended December 31, 2002.
Rigel does not undertake any obligation to update forward-looking
statements.
CONTACT: Raul Rodriguez of Rigel Pharmaceuticals,
+1-650-624-1302; orMelinda Bagatelos, or Ayanna Anderson,
both of Schwartz Communications,+1-415-512-0770, or rigel@schwartz-pr.com,
for Rigel Pharmaceuticals
Web site: http://www.rigel.com/
Source: BioSpace
Back to top
Novartis
Resumes Merger Search; Talks Up Schering, Ups Stake In Roche
Novartis is resuming its search for a merger partner, CEO
Daniel Vasella indicated during the company's 2003 results
conference Jan. 22 in Zurich.
Vasella encouraged speculation about Novartis'
plans by offering a pointed non-answer to a question about
the company's potential interest in Schering-Plough.
"As to specifics, I would not comment,"
Vasella responded. "But, that is very interesting, I
would say."
Novartis attempted to pull off an acquisition
at the end of the 1990s with the goal of boosting its U.S.
presence ahead of a string of expected product launches. The
company submitted a bid for Monsanto/Searle but was rejected;
Pharmacia subsequently acquired Searle and then merged into
Pfizer.
In 2001, Vasella announced that the company
felt the time had passed for an acquisition and said it would
"prefer" to wait for two or three years before making
its next move ("The Pink Sheet" May 7, 2001, p.
19).
True to his word, Vasella is kicking off
2004 by stirring up speculation about Novartis' aims.
He pointed out that the dynamics of the
international equity markets play to the advantage of Novartis.
"For a European company, a U.S. company
currently with the low dollar has become less expensive,"
he said.
However, Vasella added, "I do not
think that anybody would be foolish enough to just buy a company
because it is less expensive."
"In the long run, if it is the right
acquisition or the right merger, people tend to forget the
price and they remember if the result is good or bad,"
Vasella said.
In analyzing a merger, Novartis will ask:
"What is the product portfolio, the pipeline, the area
of activities, and the geographic fit?" Vasella said.
"It is a cold, fact-based analysis
which is different for different companies as they look at
a certain partner or target."
"As to specifics," he concluded,
"I would not comment. What is really interesting, I won't
say."
Novartis has clearly indicated its interest
in one potential merger partner: Swiss neighbor Roche. Novartis
purchased a 21.3% stake in Roche in 2001 and upped the stake
to 32.7% in 2003 ("The Pink Sheet" Jan. 27, 2003,
p. 22).
Novartis raised its stake in Roche to 33.3%
in the fourth quarter, although Vasella characterized the
added investment as "irrelevant."
"We think it is a good investment
and we are very appreciative of their turnaround and the success
they have now," he said. "If we were to go beyond
33.3% that would be worth mentioning because then we would
have to make an offer for the entire company under Swiss law."
One interpretation of Vasella's comments
on possible interest in Schering-Plough is that it is another
attempt to put pressure on Roche's controlling shareholders
to consider a deal.
It is unlikely that Novartis would acquire
both Schering and Roche, given the two firms' competitive
position in the interferon market. By encouraging speculation
that it is interested in Schering, Novartis is also reminding
Roche's owners that it has other options.
The political appeal of a Roche/Novartis
merger could increase if the speculation about a French mega-merger
between Sanofi and Aventis comes to fruition (see preceding
story).
A Sanofi/Aventis merger would also bump
Novartis farther down the ranking of global pharma companies.
Novartis began operations following the Ciba/Sandoz merger
as the world's largest pharmaceutical company.
It currently ranks fifth, behind Pfizer,
GlaxoSmithKline, Merck and Johnson & Johnson.
Whether or not Novartis steps up to make
an offer for Schering, Vasella's comments are sure to renew
speculation about Schering's future.
Nine months into the tenure of CEO Fred
Hassan (who led Pharmacia's successful bid for Searle), Schering
is showing the first signs of a turnaround.
At the very least, Schering appears to
have reached the point where potential suitors could feel
comfortable putting a value on the company.
The impact of the Claritin OTC switch is
now clear, the company says it has "stabilized"
market-share losses for other products, and the launch of
the cholesterol agent Zetia has given the company a potentially
attractive new product.
Schering's product line appears to be a
good fit for Novartis in the U.S. Schering's strengths in
asthma/allergy, oncology/virology and cholesterol would complement
Novartis' line. The two companies would also have a strong
combined presence in the OTC market.
However, there are also several potential
obstacles to bids for the company. First, Zetia is tied up
in a joint venture with Merck, and the "change in control"
provisions would allow Merck to buy out the joint venture
if Schering enters into any merger where its shareholders
retain less than 40% ownership ("The Pink Sheet"
Nov. 4, 2002, p. 6).
In addition, Schering is facing potential
criminal charges stemming from an investigation of its marketing
and pricing practices.
The company has so far reserved $500 mil.
to cover potential liabilities in the criminal case, spearheaded
by the Boston U.S. Attorney, and another investigation led
by the Philadelphia U.S. Attorney ("The Pink Sheet"
March 3, 2003, p. 4).
Finally, any potential suitor for Schering
may have difficulty wringing significant synergies out of
the company.
Hassan has initiated some steep cuts in
Schering's expenses - sparing only the sales force and employees
necessary to the firm's Good Manufacturing Practices consent
decree with FDA ("The Pink Sheet" Aug. 25, 2003,
p. 15).
Back to top
January 27th, 2004
Hepatitis
C Infection Early in Life Rarely Serious
Source: Reuters Health
NEW YORK (Reuters Health) - Hepatitis C
(HCV) infection acquired early in life rarely, if ever, progresses
to the liver-scarring disease cirrhosis, new research suggests.
HCV infection during adulthood is associated
with a higher risk of progression to cirrhosis within 20 years
than that acquired earlier in life, senior investigator Dr.
Alessandro Remo Zanetti and colleagues note in medical journal
Hepatology. However, most studies of disease progression
rarely encompassed more than 20 years of follow-up.
To gain further insight into outcomes of
HCV infection, Zanetti, at the University of Milan in Italy,
and his group identified 31 individuals who, as children in
1968, had received blood from donors later found to be infected
with HCV.
The researchers obtained blood samples
from these subjects in 1998, and found that only 18 had any
evidence of infection. Although mild liver damage was noted
in a few subjects on follow-up 5 years later, none had cirrhosis.
"Taking into account the limited study
sample," the authors conclude, "these findings suggest
that HCV infection acquired early in life shows a slow progression
and mild outcome during the first 35 years of infection."
SOURCE: Hepatology, January 2004.
Back to top
Reported
Hepatitis Cases on the Rise in Parts of Pennsylvania
Joann Loviglio
Associated Press
CDC figures show that reported acute cases
and new infections of hepatitis C dropped more than 50 percent
nationwide from 1980 to 2002. But the Pennsylvania Department
of Health's (PDH) statistics show the total number of hepatitis
cases in Luzerne County rose from 32 in 1993 to 67 in 2001.
PDH's annual County Health Profiles list only hepatitis A
and B, two of five recognized strains of the disease. But
Wilkes- Barre physician Robert Czwalina went from treating
one patient with hepatitis C to treating 30 within a year.
He said changing demographics, notably people with drug and
alcohol problems who acquire hepatitis C elsewhere and move
to rural Pennsylvania, account for the rise.
State regulations that took effect last
year require health professionals to report all cases of hepatitis
including the three most common US strains: A, B and C. Reported
cases of hepatitis A and B increased only moderately in Pennsylvania
from 1994-2001: 903 to 1,097 for hepatitis A and 829 to 864
for hepatitis B.
In York, hepatitis C cases jumped from
10 in 1999 to 105 in 2003. Health officials believe the rise
comes from improvements in health care rather than changing
demographics.
Dr. David L. Hawk, director of the York
City Bureau of Health, said greater awareness of hepatitis
in the medical community, more testing and better reporting
account for the rise in cases, and that the increase in hepatitis
B and C represents people who have had the virus for years.
Whether the numbers come from a changing
population or more vigilant doctors, health professionals
agree that there is too little money for drug and alcohol
treatment and medication.
Back to top
Hepatitis
B Virus Reactivation in Breast Cancer Patients
Source: www.gastrohep.com
A high hepatitis B viral load before cytotoxic
chemotherapy is a significant risk factor for the development
of HBV reactivation, find doctors in the January issue of
the Journal of the Viral Hepatitis.
Hepatitis B virus (HBV) reactivation during
cytotoxic chemotherapy for cancer complicates treatment and
can cause liver damage.
HBV reactivation occurs in to 10% and 50%
of HBV carriers, however, risk factors are unclear.
In this study, doctors from Hong Kong assessed
whether prechemotherapy HBV DNA levels influence HBV reactivation.
The optimal cut-off was at a serum HBV
DNA level of 3 x 105.
The team evaluated 41 who underwent cytotoxic
chemotherapy for breast cancer.
Of these patients, 17 developed reactivation
and 24 did not.
The doctors developed a novel, ultra-sensitive,
real-time PCR assay for the measurement of HBV DNA. The team
measured the sera of 37 patients using this technique.
The team found that patients in the reactivation
group had a significantly higher median HBV DNA load (1.03
x 106 copies/mL) than the nonreactivation group (<2.9 x
103 copies/mL).
The doctors calculated that the optimal
cut-off between the 2 groups was at a serum HBV DNA level
of 3 x 105. This gave a sensitivity of 81% and a specificity
of 85%.
Dr Zhong's team concluded, "A high
HBV viral load prior to the administration of cytotoxic chemotherapy
is a significant predictive factor for the development of
HBV reactivation".
"Such information may be useful in
determining which patients would benefit most from prophylactic
antiviral therapy during cytotoxic chemotherapy".
J Viral Hepat 2004; 11(1): 55-9
Back to top
January 28th, 2004
Health-Related
Quality of Life in Patients with HIV and Hepatitis C Coinfection
Source: www.gastrohep.com
Patients with HIV/HCV coinfection have
similar health-related quality of life to patients with either
HCV or HIV alone, find researchers in Clinical Infectious
Diseases.
Health-related quality of life (HRQOL)
is diminished in patients with both hepatitis C virus (HCV)
and HIV.
However, the impact of HIV/HCV coinfection
on HRQOL is unknown.
In this study, researchers from Massachusetts,
USA, examined the HRQOL in patients with HIV/HCV coinfection.
The team compared this HRQOL in patients with either HCV or
HIV alone.
Patient groups were then compared to the
United States population. Patients groups had decreased quality
of life compared with the general population.
The researchers found that patients with
HIV/HCV coinfection had similar HRQOL to that of patients
with either HCV or HIV alone.
However, the 3 patients groups had a significantly
decreased HRQOL than did the United States population.
The team found that age, unemployment,
injection drug use, and depression were all associated with
decreased HRQOL.
Dr Catherine Fleming's team concluded,
"These findings underscore the importance of a multidisciplinary
approach to the treatment of these patient populations".
Clin Infect Dis 2004; 38: Early online publication
Back to top
Valeant
Pharmaceuticals Advances Funding for Viramidine Clinical Trials
-Company Focuses Additional R&D Investment on Viramidine
COSTA MESA, Calif., /PRNewswire-FirstCall
via COMTEX/ -- Valeant Pharmaceuticals (NYSE: VRX) today provided
an update on its clinical program for the development of its
antiviral compound, Viramidine(TM), a nucleoside (guanisine)
analog, in oral form for the treatment of hepatitis C. In
addition, the company announced that it will increase its
investment in research and development to support an accelerated
schedule for progressing development of Viramidine.
Robert W. O'Leary, Valeant Pharmaceuticals'
Chairman and Chief Executive Officer, commented, "Our
clinical data have allowed us to begin Phase 3 clinical trials
for Viramidine after 12 weeks of our 72-week Phase 2 program.
Our evaluation has led us to decide to further increase our
total research and development expenditures in 2004 to between
$85 million and $95 million to accelerate the clinical trials
for Viramidine while continuing to support other discovery
and development programs."
Valeant Pharmaceuticals has initiated the
first of two global Phase 3 studies for Viramidine that will
be conducted at approximately 80 sites with approximately
1,000 patients in each study. Global patient enrollment in
the first study, known as VISER1 (Viramidine's Safety and
Efficacy vs. Ribavirin), has commenced, and the company expects
to complete enrollment in 2004.
The second Viramidine Phase 3 study, known
as VISER2, is now scheduled to commence by mid-2004 with investigator
meetings in the U.S., Europe and Australia. Patient enrollment
in the second study is expected to begin shortly thereafter.
Valeant also noted that the accelerated schedule for Viramidine
may or may not accelerate the timetable for submission for
approval.
The studies will compare Viramidine and
ribavirin, each in conjunction with a pegylated interferon.
The company has selected PEG-INTRON, a pegylated interferon
marketed by Schering-Plough, for use in its first study, and
has now added Pegasys, marketed by F. Hoffmann-La Roche, for
use in its second study.
The Phase 3 studies are designed to treat patients for either
24 or 48 weeks, depending on viral genotypes, take patients
off therapy for an additional 24 weeks, and then determine
the percentage of patients with undetectable virus in their
blood, as well as the incidence of anemia during the course
of the entire 72-week study period.
Valeant Pharmaceuticals is continuing its
Phase 2 study of Viramidine and has completed that study's
24-week treatment evaluation of safety and efficacy. Valeant
intends to present the 24-week data from the Phase 2 study
at the 39th Annual Meeting of the European Association for
the Study of the Liver (EASL) in Berlin, Germany in April
2004, and additional data at the Digestive Disease Week (DDW)
Conference in New Orleans in May 2004.
The company will host a conference call
to discuss this announcement today, January 28, 2004 at 6:00
a.m. Pacific time. The dial-in number to participate live
on this call is (877) 295-5743, confirmation code 5217501.
International callers should dial (706) 679-0845, confirmation
code 5217501. A replay will be available approximately two
hours following the conclusion of the conference call through
midnight on Wednesday, February 4, 2004, and can be accessed
by dialing (800) 642-1687, confirmation code 5217501.
The company will also Web cast the call
live over the Internet, which will be hosted in the investor
relations section of its corporate Web site at www.valeant.com
. Participants should allow approximately five to ten minutes
prior to the call's start time to visit the site and download
any streaming media software needed to listen to the Internet
Web cast. An online archive of the Web cast will be available
following the end of the live call in the Web cast archive
portion of the investor relations section at http://www.valeant.com.
About Valeant
Valeant Pharmaceuticals International (NYSE:
VRX) is a global, publicly traded, research-based specialty
pharmaceutical company that discovers, develops, manufactures
and markets a broad range of pharmaceutical products. More
information about Valeant can be found at www.valeant.com
.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of the federal securities laws relating to expectations,
plans or prospects for Valeant Pharmaceuticals, including
funding and conducting clinical trials and expected research
and development expenses. These statements are based upon
the current expectations and beliefs of Valeant Pharmaceuticals'
management and are subject to certain risks and uncertainties
that could cause actual results to differ materially from
those described in the forward- looking statements. These
risks and uncertainties include market conditions and other
factors beyond Valeant Pharmaceuticals' control, the company's
success in identifying and enrolling patients in the clinical
trials program, the absence of adverse events that would require
the clinical trials to be prematurely terminated, clinical
results that indicate continuing clinical and commercial pursuit
of Viramidine is advisable, and the risk factors and other
cautionary statements discussed in Valeant Pharmaceuticals'
filings with the U.S. Securities and Exchange Commission.
CONTACT: Investors and Media, Jeff Misakian,
Investor Relations of Valeant Pharmaceuticals 714-545-0100,
ext. 3309.
SourceURL: http://www.guardian.co.uk/uk_news/story/
0,3604,1132720,00.html
Back to top
Go-Ahead
for Hepatitis C Drug
James Meikle, health correspondent
The Guardian
Thousands of patients who developed chronic
liver disease after being infected with hepatitis C will be
switched to more effective and expensive treatments. The decision
was announced as the government steps up its battle against
hepatitis C, a potential killer which has shown alarming increases
over the last decade.
Official endorsement for the drug pegylated
interferon, usually taken in combination with another anti-viral
drug, could significantly increase the drugs bill for fighting
one of Britain's most serious public health threats.
But the drug's success in treating many
patients has meant that the National Institute for Clinical
Excellence (Nice), the government's good-practice watchdog
in England and Wales, has backed its far greater use.
Only about 2,000 patients are thought at
present to use either pegylated interferon or the more standard
interferon alpha, but that number is expected to grow rapidly,
using regimes which could be £3,200 more expensive for
each patient. Even conservative estimates put the extra cost
at around £11m a year.
People infected with hepatitis C often
carry it unknowingly for years. Between 50,000 and 500,000
people may have the virus. If the higher figure is accurate,
far fewer than one in 10 people with the disease is diagnosed.
Around one in five known to have been exposed
to the virus will eventually develop acute hepatitis, which
can take more than 20 years to become evident.
Graham Foster, consultant hepatologist
with Barts and the Royal London NHS trust, said: "This
is the first positive step which will allow patients in the
UK to receive the same treatment choice which has been available
to patients in other parts of the world for many years."
Back to top
Board OKs
Free Hepatitis C Tests
Shanna McCord
Santa Cruz Sentinel
On Tuesday, the Santa Cruz County Board
of Supervisors announced that free laboratory testing will
be offered to uninsured hepatitis C patients. An estimated
70 percent of the 610 hepatitis C patients treated by the
county are uninsured.
With free tests available, about 30-40
additional patients can be treated annually, according to
Rama Khalsa, director of the county Health Services Agency.
The tests, which are part of ongoing treatment, measure enzymes
in the liver and normally cost $1,600 for each patient.
Officials estimate as many as 8,000 people in Santa Cruz County
have the virus, which can go undetected for two decades while
slowly eroding the liver. About 1,300 county residents know
they have it.
While there is no vaccine or cure for hepatitis
C, early detection allows patients the possibility of slowing
the virus with medication. The virus, spread from blood-to-blood
contact, most often occurs among intravenous drug users and
people who received blood transfusions before 1992. It can
also be contracted through body piercings and tattoos, and
people who have had multiple sex partners may also face an
increased risk.
The county Health Services Agency was directed
to update the board of supervisors on the progress of the
free tests at their meeting on March 23.
Back to top
Global
Challenges | British Health Department Launches Hepatitis
C Testing Campaign
The British Department of Health on Wednesday
announced a new campaign to encourage people to be tested
for hepatitis C, APM/Reuters Health reports. A health department
spokesperson said that the agency likely will publish an action
plan soon, according to APM/Reuters Health. The campaign will
encourage testing among high-risk groups, including injection
drug users. If a person tests positive for hepatitis C, the
patient would then be offered treatment and counseled about
the risks of alcohol consumption, which can contribute further
to liver damage caused by the disease. The plan includes a
hepatitis C awareness campaign targeting the public and health
care professionals. The initiative will "be centrally
funded and sustained over a number of years," the spokesperson
said. Officials believe that there are currently 500,000 people
living with hepatitis C in the United Kingdom, but most of
them do not know they are infected, according to APM/Reuters
Health.
Source: APM/Reuters Health
Back to top
January 29th, 2004
UK to Ban Chinese Herbal Remedy
Source: Reuters Health
LONDON (Agence de Presse Medicale for Reuters
Health) - British regulators issued proposals on Thursday
to ban the Chinese herbal remedy Qian Bai Biyan Pian in the
interests of public health.
The Medicines and Healthcare Products Regulatory
Agency said the unlicensed product, which is sometimes used
for rhinitis, could contain the Senecio plant, which can cause
serious liver damage.
The agency received five reports indicating
the product was still being supplied to the public, despite
its call in 2002 for a voluntary market withdrawal.
Back to top
Drug Effective For Resistant Hepatitis
B
Will Boggs, MD
Reuters Health
NEW YORK (Reuters Health) - Chronic hepatitis B is often treated
with a drug called lamivudine (brand name, Epivir) but the
virus can become resistant. In this situation, an antiviral
drug called adefovir, alone or in combination with ongoing
lamivudine therapy, seems to be effective.
The rate of lamivudine resistance can reach
69 percent after five years of treatment, explain the authors
of an article in the medical journal Gastroenterology.
Adefovir (also called Preveon) has been shown in lab experiments
to suppress lamivudine-resistant hepatitis B virus (HBV).
Dr. Marion G. Peters from the University
of California, San Francisco, and colleagues assessed the
safety and effectiveness of adefovir in 59 patients with lamivudine-resistant
HBV.
Levels of the virus in blood specimens
declined significantly in patients given adefovir alone or
in combination with lamivudine, the researchers report, but
not in patients receiving lamivudine alone.
Sixteen percent of patients receiving adefovir
alone and 11 percent of patients receiving adefovir and lamivudine
cleared the virus within 48 weeks, but none of those treated
only with lamivudine did so.
Peters told Reuters Health that there appears
to be no reason to continue lamivudine after beginning adefovir
therapy in most cases. Combination therapy, however, should
be continued in patients with cirrhosis.
Back to top
January 30th, 2004
Hepatitis C Virus; FDA Approves Pegasys
Prefilled Syringes
(NewsRx.com & NewsRx.net)-- Roche announced that the U.S.
Food and Drug Administration (FDA) has approved prefilled
syringes of Pegasys (Peginterferon alfa-2a) for the treatment
of chronic hepatitis C.
Pegasys, a pegylated alpha interferon,
and Copegus (ribavirin, USP) were approved by the FDA in December
2002 for use in combination for the treatment of adults with
chronic hepatitis C who have compensated liver disease and
have not previously been treated with interferon alpha. Patients
in whom efficacy was demonstrated included patients with compensated
liver disease and histological evidence of cirrhosis.
Pegasys is the most prescribed interferon
therapy in the United States for the treatment of chronic
hepatitis C.
Roche expects Pegasys prefilled syringes
to be available in pharmacies by the end of the month. Prefilled
syringes will be packaged four per box. Pegasys is currently
available in vials as a premixed solution.
"Taking a medication by self-injection
can be challenging for some people," said Dr. David Bernstein,
director of hepatology, North Shore University Hospital. "Reducing
the number of steps involved can make the process less intimidating
for patients and reduce the risk of errors."
Back to top
MISSISSIPPI:
Hepatitis Investigation Ongoing at Neshoba Nursing Home
Associated Press
The investigation into a hepatitis B outbreak
at the Neshoba County Nursing Home could take as long as two
months, according to Mississippi health officials. Since November,
16 patients at the facility have been treated for the virus.
While epidemiologists are seeking to determine the cause of
the outbreak, the Health Department's Office of Licensure
is reviewing procedures at the nursing home, which is publicly
owned but privately managed.
State health officials were notified after
a patient was diagnosed with hepatitis B in November, said
Lonnie Graeber, the home's administrator. That patient died;
the Health Department has not determined if the death was
related to the infection. After a second patient was found
to be infected, all 160 residents were tested.
Under federal regulations, the nursing
home was cited for a deficiency related to infection control,
said Liz Sharlot, Department of Health spokesperson. The determination
of a possible penalty will not be made until the investigation
is completed, she said.
Board of Supervisors President James
Young said board members were notified of the outbreak but
had not met with nursing home officials.
Source: CDC HIV/STD/TB Prevention News Update
Back to top
Back to News
Review |
