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Alan Franciscus
Editor-in-Chief
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In This Issue:
• Even with Undetectable
Levels, Hep B Persists in Liver with Chronic Hep C Infection
• NIH Director Announces Reforms: Agency
Director Tightens Policies that Have Allowed Hundreds of Consulting
Deals Between Drug Companies and Scientists
• Pilot Program for U.S. Drug Benefit Is
Set to Begin
• As Doctor Writes Prescription, Drug Company
Writes a Check
• EU Active in the Fight against Killer
Viruses
• Eugene Needle Exchange Cut unless Others
Step Up
• AMA Develops Guide to Appropriate Reimbursement
Coding for Populations at Risk of Viral Hepatitis
• European Union's CHMP Recommends Approval
of Shorter 24-Week Course of Pegintron(R) and Rebetol(R) Combination
Therapy for HCV Genotypes 2 or 3
• Schering-Plough Could Plead Guilty on
Pricing
• Latest Impact Factors: Who’s up
and Who’s Down?
• Improvements Made over Time in Right
Lobe Living Donor Liver Transplants
• Re-Examining Questions about Hepatitis
C
• Relaxing the Hold on Hepatitis C
• Racial Differences in Chronic Hepatitis
C-Related Liver Inflammation and Fibrosis
• Occult Hepatitis B Infection Present
in 2% of HIV-Positive Patients in US Study
• Hepatitis C Action Plan Launched
• IHS slams Martin on ‘Lack of Political
Will'
• African Americans and Hepatitis C
• Hepatitis C Virus Genotype 3 Infection
May Resolve Spontaneously
June 21st, 2004
Even
With Undetectable Levels, Hep B Persists in Liver with Chronic
Hep C Infection
Will Boggs, MD
Source: www.medscape.com
NEW YORK (Reuters Health) Jun 21 - Hepatitis
B virus (HBV) can persist in the liver of patients with chronic
hepatitis C without detectable hepatitis B virus DNA in serum,
according to a report in the June Journal of Medical Virology.
“Our data suggest that the overall prevalence of HBV
infection is higher than that known at present, since patients
may have HVB-DNA in liver without any other viral marker in
serum,” lead author Dr. Vicente Carreno from Fundacion
para el Estudio de las Hepatitis Virales, Madrid, Spain, told
Reuters Health. “Since according to our data, the presence
of HBV-DNA in liver accelerates the progression of the histological
damage in patients with chronic HCV infection, it seems reasonable
to consider vaccination against HBV in patients with chronic
hepatitis C.”
HBV can persist in the liver in the absence of serum HBV-DNA
after self-limited acute hepatitis B, the authors explain,
but the prevalence and impact of occult HBV infection in patients
with chronic hepatitis C (HCV) infection has not been studied.
Dr. Carreno and colleagues used PCR and in situ hybridization
to determine the prevalence and histological impact of HBV
infection in the livers of patients with chronic HCV infection
in whom HBV-DNA was undetectable in serum.
More than a third of patients with chronic HCV infection (37.7%)
had intrahepatic HBV-DNA detectable by PCR without detectable
serum HVB-DNA by PCR, the authors report.
Patients with and without HBV-DNA in the liver did not differ
with respect to clinical and epidemiological characteristics,
the report indicates, except that the known duration of HCV
infection was shorter in patients with HBV-DNA detectable
in the liver.
Among patients whose HCV infection duration was shorter than
20 years, biopsies from those with HBV-DNA in the liver had
a higher fibrosis score and tended to have a higher necroinflammatory
index than did biopsies from HBV negative patients, the researchers
note. Such differences were not evident in patients with longer
HCV infection durations.
The known duration of HCV infection was significantly shorter
in patients with a necroinflammatory index of 4 or lower and
in patients with a fibrosis score of 2 or lower when isolated
intrahepatic HBV-DNA was present, the results indicate.
“Since there are patients with HBV-DNA in liver in the
absence of any other HBV marker in serum, the incidence of
HBV infection among relatives of these patients should be
studied,” Dr. Carreno said. “We are now performing
an epidemiological study on the family members of patients
with chronic hepatitis C and HBV-DNA detectable only in liver.”
“We are also analyzing the HBV genome in these patients
in comparison with the HBV-DNA found in patients with chronic
hepatitis B to determine if mutations in the HBV-DNA are the
cause of the lack of detection of the viral genome in the
sera of these patients,” Dr. Carreno added.
J Med Virol 2004;73:177-186.
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June 23rd, 2004
NIH
Director Announces Reforms: Agency Director Tightens Policies
that Have Allowed Hundreds of Consulting Deals between Drug
Companies and Scientists
David Willman, Times Staff Writer
Source: Los Angeles Times
WASHINGTON -- The National Institutes of
Health will drastically tighten policies that have allowed
hundreds of consulting deals between drug companies and scientists
at the nation's leading center for public health research,
its director told a congressional panel Tuesday.
Announcing a sweeping set of reforms, NIH Director Elias A.
Zerhouni also said that he would demand public disclosure
of any future industry payments to agency employees.
He said that, in hindsight, he should have
acted sooner to crack down on the private deals that have
created potential conflicts of interest between scientists'
duties at NIH and their financial ties to industry.
"I have reached the regrettable conclusion
that some NIH employees may have violated these [existing]
rules and that the agency's ethics system does not adequately
guard against these violations," Zerhouni told the House
Energy and Commerce subcommittee on oversight and investigations.
The NIH is the nation's premier agency
for medical research, spending $27.9 billion this year.
Zerhouni said that as congressional investigators
continued to sift through potential conflicts of interest
in recent weeks - including the discovery of at least 100
deals that had not been properly reported - he reached a "tipping
point" regarding reform at NIH. He vowed that he and
his staff would "move diligently to completely change
the system of ethics at NIH."
"You have my pledge: Any employees
who violated the rules will be subject to appropriate penalties,"
he said. "It's very painful to me that the actions of
a few may have tainted the good work of thousands of scientists
who have not participated in any of these actions and who
work daily at NIH to solve the mysteries of disease and to
advance treatments and cures for these diseases."
Zerhouni said that while not all of the
changes could be made overnight, he was "working aggressively"
with the office of Health and Human Services Secretary Tommy
G. Thompson and with the Office of Government Ethics to implement
his proposals.
The announced reforms were greeted warmly
by Democrats and Republicans on the subcommittee. The panel
opened its investigation of company consulting deals with
NIH employees in response to a Dec. 7, 2003, report in the
Los Angeles Times.
The article noted that until late 1995,
top NIH officials were prohibited from accepting consulting
fees and stock options from drug companies, but that restriction
was lifted by the then-director of NIH, Dr. Harold E. Varmus.
Based in part on documents obtained over five years under
the Freedom of Information Act, The Times identified hundreds
of consulting payments, totaling millions of dollars, to senior
NIH scientists. Two of the scientists had pledged to abstain
from matters affecting their clients, but nonetheless participated
in decisions involving company products used in NIH studies
on patients.
In addition, the article reported that
94% of the highest-paid employees at NIH were not required
to publicly disclose payments from outside employers, including
drug companies.
Zerhouni described these reforms to the
subcommittee:
- Scores of senior officials - including
the directors, deputy directors, scientific directors and
clinical-research directors of all of NIH's 27 research institutes
and centers - would be subject to a "total ban"
on paid consulting with pharmaceutical or biotechnology companies.
These employees also would be banned from taking consulting
or speaking fees from nonprofit institutions.
- Other employees, including laboratory
chiefs, would be allowed to continue accepting industry consulting
fees. However, those scientists could no longer collect unlimited
sums; they would be barred from taking fees totaling more
than 25% of their federal salary. The employees would be limited
to no more than 400 hours a year of outside income-generating
activity - equivalent to roughly one hour per workday.
- All NIH employees would be prohibited
from receiving company stock or stock options as compensation
from industry.
- More than 5,000 NIH employees would be
prohibited from holding any stock in a drug company. This
prohibition, Zerhouni said, is modeled after an ethics policy
in place at the Food and Drug Administration.
- All NIH employees would be banned from
serving on the boards of directors of companies in the drug
industry.
- All employees would be banned from accepting
any form of remuneration from universities or other entities
that receive research-grant funding from NIH.
- Employees at NIH would not be allowed
to accept any award unless it were first "pre-screened"
for legitimacy by agency ethics officials. This reform is
a response to congressional criticism of awards made by recipients
of NIH grants to the then-director of the National Cancer
Institute, Dr. Richard D. Klausner.
Asked Tuesday by Rep. Greg Walden (R-Ore.)
whether arrangements entered into by six NIH officials showcased
in December by The Times would be permissible under his announced
reforms, Zerhouni said that the deals of "three or four"
of the employees would be prohibited.
Zerhouni referred indirectly to several
officials whose consulting payments would no longer be approved,
including Dr. Stephen I. Katz, director of the National Institute
of Arthritis and Musculoskeletal and Skin Diseases, and Dr.
John I. Gallin, director of the NIH Clinical Center, the nation's
largest site of medical research on humans.
The announcement of the revised practices
came seven months after leaders in the House of Representatives
wrote to Zerhouni and asked him to divulge all drug company
payments to NIH employees.
After at first citing the advice of government
lawyers and the restrictions of the federal Privacy Act, NIH
officials in recent weeks have provided Congress with a more
extensive accounting of industry payments received by employees
from 1999 through 2003.
However, while waiting for NIH to hand
over the data, the House leaders also asked for similar information
from 20 large drug companies. That inquiry resulted in the
discovery of roughly 100 industry consulting deals that had
not been properly vetted or reported to NIH, according to
the senior Democrat on the House Energy and Commerce Committee,
John D. Dingell of Michigan.
"What else is out there?" Dingell
asked.
Said Joe Barton (R-Texas), chairman of
the Energy and Commerce Committee: "It appears that there
may be a substantial number of NIH scientists who engaged
in outside activities, such as drug company consulting, in
stealth - without any notice to, or approval by, NIH. If our
suspicions are confirmed, these unapproved, compensated activities
would represent a very serious breach of NIH policies, federal
ethics regulations, and possibly, in a few cases, criminal
laws."
The chairman of the oversight and investigations
subcommittee, James C. Greenwood (R-Pa.), saluted Zerhouni's
tougher approach to conflicts of interest.
"Dr. Zerhouni is offering a number
of substantial restrictions that will curb some of the kinds
of cases that are of the greatest concern," Greenwood
said.
The chairman said that he envisions at
least one more hearing - the fourth this year - to examine
conflicts of interest at NIH.
Zerhouni, who in public remarks in December
had sought to minimize the gravity of ethics problems at NIH,
was contrite and conciliatory while announcing the package
of reforms. Accompanied at the witness table by Alex Azar
II, the general counsel of the Department of Health and Human
Services, Zerhouni said the Bush administration was determined
to achieve a "major reform" of ethics policies at
NIH.
Rep. Diana DeGette (D-Colo.) warned Zerhouni
that, although his announced reforms sounded like prudent
steps, "the devil is in the details."
"These conflicts of interest deserve
scrutiny and must be resolved," DeGette said. "The
ethos of this organization must changed. These [NIH] scientists
also should remember that their work is the hope for many
Americans who are ill or who are taking care of a family member
with an illness. Their scientific work, for some Americans,
is the difference between life or death. A conflict of interest
or even the appearance of a conflict of interest could have
devastating effects."
Times researcher Janet Lundblad in
Los Angeles contributed to this report.
Back to top
June 25th, 2004
Pilot
Program for U.S. Drug Benefit Is Set to Begin
Sarah Lueck
Source: The Wall Street Journal
WASHINGTON -- A limited group of Medicare
beneficiaries taking medications for cancer, rheumatoid arthritis
and other diseases will be the first to receive prescription-drug
coverage from the federal health program.
Under a demonstration project included in the drug-benefit
law, 50,000 people soon will be able to receive oral treatments
for cancer and injections for multiple sclerosis paid for
by Medicare. Drug companies and patient groups lobbied hard
for a piece of the $500 million program, which will last only
until the drug benefit starts for all Medicare beneficiaries
in 2006. Many of the 25 drugs included so far in the program
cost tens of thousands of dollars a year.
Medicare officials estimated that 500,000
Medicare beneficiaries fit the criteria for the project, including
not having comprehensive drug coverage. Currently, the Medicare
program covers prescription drugs when they are administered
in a doctor's office, not when patients can take them on their
own.
Backers of cancer drugs scored an important
victory: Medicare officials agreed that 40% of the funds available
will go to treat that disease. So far, 11 cancer drugs, including
AstraZeneca PLC's Iressa and Novartis AG's Gleevec will be
covered for particular types of cancer. Tamoxifen, which is
sold as a generic drug and also under the brand name Nolvadex
by AstraZeneca, will be available to some breast-cancer patients.
Three arthritis drugs -- Abbott Laboratories'
Humira and Amgen Inc.'s Kineret and Enbrel, which is co-marketed
with Wyeth -- will be covered. Tracleer, a pulmonary-hypertension
drug by Actelion Pharmaceuticals Ltd., also will be included.
Those diseases will share 60% of the money with several other
illnesses, such as the bone disorder Paget's Disease and Hepatitis
C.
The demonstration "gives a taste of
the savings coming for seniors and people with disabilities"
once the drug benefit begins, Health and Human Services Secretary
Tommy Thompson said.
Patients will be picked randomly by Medicare's
contractor, which will sort their applications into cancer
and noncancer categories to make sure 40% of the funds are
spent on cancer drugs. Applications will be accepted beginning
July 6, with coverage beginning, at least for some, by Sept.
1. Beneficiaries will have to pay part of the cost of their
drugs, in a structure similar to what they will encounter
in the full-fledged drug benefit.
The demonstration helped win some key votes
in Congress for the Medicare law, especially from lawmakers
who wanted Medicare to cover oral treatments for cancer. The
program represents an early test of the government's ability
to implement the complex law, despite the disparate demands
of the various companies and other stakeholders.
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June 27th, 2004
As
Doctor Writes Prescription, Drug Company Writes a Check
Gardiner Harris
Source: The New York Times
The check for $10,000 arrived in the mail
unsolicited. The doctor who received it from the drug maker
Schering-Plough said it was made out to him personally in
exchange for an attached ''consulting'' agreement that required
nothing other than his commitment to prescribe the company's
medicines. Two other physicians said in separate interviews
that they, too, received checks unbidden from Schering-Plough,
one of the world's biggest drug companies.
''I threw mine away,'' said the first doctor,
who spoke on the condition of anonymity because of concern
about being drawn into a federal inquiry into the matter.
Those checks and others, some of them said
to be for six-figure sums, are under investigation by federal
prosecutors in Boston as part of a broad government crackdown
on the drug industry's marketing tactics. Just about every
big global drug company -- including Johnson & Johnson,
Wyeth and Bristol-Myers Squibb -- has disclosed in securities
filings that it has received a federal subpoena, and most
are juggling subpoenas stemming from several investigations.
The details of the Schering-Plough tactics,
gleaned from interviews with 20 doctors, as well as industry
executives and people close to the investigation, shed light
on the shadowy system of financial lures that pharmaceutical
companies have used to persuade physicians to favor their
drugs.
Schering-Plough's tactics, these people
said, included paying doctors large sums to prescribe its
drug for hepatitis C and to take part in company-sponsored
clinical trials that were little more than thinly disguised
marketing efforts that required little effort on the doctors'
part. Doctors who demonstrated disloyalty by testing other
company's drugs, or even talking favorably about them, risked
being barred from the Schering-Plough money stream.
Schering-Plough says that the activities
under investigation occurred before its new chief executive,
Fred Hassan, arrived in April 2003, and that it has overhauled
its marketing to eliminate inducements.
At the heart of the various investigations
into drug industry marketing is the question of whether drug
companies are persuading doctors -- often through payoffs
-- to prescribe drugs that patients do not need or should
not use or for which there may be cheaper alternatives. Investigators
are also seeking to determine whether the companies are manipulating
prices to cheat the federal Medicaid and Medicare health programs.
Most of the big drug companies, meanwhile, are also grappling
with a welter of suits filed by state attorneys general, industry
whistle-blowers and patient-rights groups over similar accusations.
In many ways, the investigations are a
response to the evolution of the pharmaceutical business,
which has grown in the last quarter-century from a small group
of companies peddling a few antibiotics and anti-anxiety remedies
to a $400 billion behemoth that is among the most profitable
industries on earth.
Offering treatments for almost any affliction
and facing competition in which each percentage point of market
share can represent tens of millions of dollars, most drug
makers now spend twice as much marketing medicines as they
do researching them. Their sales teams have changed from a
scattering of semi-retired pharmacists to armies of young
women and men who shower physicians with attention, food and
-- until the drug industry recently agreed to end the practice
-- expensive gifts, just to get two to three minutes to pitch
their wares. A code of conduct adopted in 1990 by the American
Medical Association suggests that doctors should not accept
any gift worth more than $100, but the guidelines are widely
ignored.
A quarter-century ago, the Food and Drug
Administration was the lone cop on the drug industry beat.
But the F.D.A.'s enforcement powers over drug marketing have
been severely curbed since 1976 by a series of court rulings
based mainly on the companies' free-speech rights. That left
a vacuum that many companies decided to exploit, said William
Vodra, a former F.D.A. lawyer.
''A lot of people decided there was no
check on what they were allowed to do,''
Mr. Vodra said. Using fraud, kickback and antitrust statutes,
federal prosecutors, state attorneys general and plaintiffs
lawyers stepped into the void, asserting that the companies'
sales pitches have cost the government billions of dollars
in payments for drug benefits.
This legal scrutiny can be expected to
intensify. Once the new Medicare drug benefit takes full effect
in 2006, the government will pay for almost half of all medicines
sold in the nation. So the marketing programs will cost the
government even more money and, if they are uncovered and
determined to be illegal, will probably result in even larger
fines.
Last month, Pfizer agreed to pay $430 million
and pleaded guilty to criminal charges involving the marketing
of the pain drug Nuerontin by the company's Warner-Lambert
unit. AstraZeneca paid $355 million last year and TAP Pharmaceuticals
paid $875 million in 2001; each pleaded guilty to criminal
charges of fraud for inducing physicians to bill the government
for some drugs that the company gave the doctors free.
Over the last two years, Schering-Plough,
which had sales of $8.33 billion last year, has set aside
a total of $500 million to cover its legal problems -- mainly
for expected fines from the Boston investigation and from
a separate inquiry by federal prosecutors in Philadelphia
who are investigating whether Schering-Plough overcharged
Medicaid.
Besides looking into whether Schering-Plough
paid doctors large sums to prescribe the company's drug for
hepatitis C, prosecutors are investigating whether many company-sponsored
clinical trials for the drug were simply another way to funnel
money to doctors.
Dr. Chris Pappas, director of clinical
research for St. Luke's Texas Liver Institute in Houston,
said that Schering-Plough ''flooded the market with pseudo-trials.''
Dr. Pappas and eight other liver specialists
who were interviewed say the system worked like this: Schering-Plough
paid physicians $1,000 to $1,500 per patient for prescribing
Intron A, the company's hepatitis C treatment. In conventional
clinical trials, participants are given drugs free, but the
doctors said that in these cases the patients or insurers
paid for their medication. Because patients usually undergo
Intron A treatment for nearly a year and the therapy costs
thousands of dollars, Schering-Plough's payments to physicians
left plenty of room for the company to profit handsomely,
the doctors said.
In return for the fees, physicians were
supposed to collect data on their patients' progress and pass
it along to Schering-Plough, the doctors said. But many physicians
were not diligent about their recordkeeping, and the company
did little to insist on accurate data, according to Dr. Pappas
and the others.
One of the nation's most prominent liver
disease specialists, who spoke on condition of anonymity for
fear of angering big drug makers, called the trials ''purely
marketing gimmicks.''
''Science and marketing should not be mixed
like that,'' the doctor said.
Schering-Plough did more than encourage
physicians to place patients on Intron A, many of the physicians
said. They said the company would remove any doctor from its
clinical program -- and shut off the money spigot -- if he
or she wrote prescriptions for competing drugs, participated
in clinical trials of alternatives to Intron A or even spoke
favorably about treatments besides Intron A.
The main competitor to Intron A, which
Schering-Plough now sells as Peg-Intron, is Roche's comparably
priced drug Pegasys.
Dr. Donald Jensen, the hepatology director
at Rush University Medical Center in Chicago, said he wanted
to perform clinical trials using drugs from both Schering-Plough
and Roche. ''I was told by Schering-Plough that I couldn't
do both -- that I had to sign an exclusive agreement with
them,'' Dr. Jensen said. ''That was the juncture when Schering
and I parted ways.''
Six specialists in liver disease said Schering-Plough
also paid what it called consulting fees to doctors to keep
them loyal to the company's products. The letter accompanying
a check for $10,000 explained that the money was for consulting
services that were detailed on an accompanying ''Schedule
A,'' said a doctor who insisted on anonymity. But when the
doctor turned to the attached sheet, he said, ''Schedule A''
were the only words printed on an otherwise blank sheet of
paper.
Dr. Pappas, who in the past has consulted
for Schering-Plough and worked for Roche, said that stories
about the enormous sums that Schering-Plough paid its consultants
were common among liver specialists. ''These were very high-value
consulting agreements with selected opinion leaders that looked
like payments of money with no clear agreements on what was
supposed to be executed,'' Dr. Pappas said.
In an interview, Mr. Hassan and other top
executives declined to discuss past marketing practices. Richard
Kogan, the company's previous chairman and chief executive,
declined to be interviewed.
Schering-Plough's current management says
that much has changed at the company since Mr. Hassan took
over. The company no longer allows sales representatives or
marketing executives to have any say over its clinical trials,
physician education or medical consulting, they said. And
in all clinical trials begun in the last year, they said,
drugs have been provided free to the enrolled patients, rather
than being billed to them or their insurers.
''The temptation to give clinical grants
to high prescribers and consulting agreements to high prescribers
is why we pulled those decisions out of the hands of the sales
representatives,'' said Brent Saunders, who was named senior
vice president for compliance and business practices last
year. ''Sales representatives had an input into that process
before, which I think is still fairly normal in the industry.''
In the separate Philadelphia investigation,
Schering-Plough is expected to plead guilty soon to charges
that it failed to provide Medicaid with its lowest drug prices,
as is required by law, and to pay a fine. Investigators are
examining whether Schering-Plough, to gain sales with some
private insurers, offered premiums, such as free patient consulting
arrangements, with its drugs.
Prosecutors are arguing that such incentives
had a market value and meant that Schering-Plough was offering
drugs to private payers at prices well below those offered
to Medicaid. Many other drug companies are the targets of
similar inquiries.
The Boston inquiry into suspected kickbacks
and improper marketing by Schering-Plough could take months
more to resolve, people close to the investigation say. Schering-Plough
may also be charged with obstruction of justice and document
destruction as part of the Boston inquiry, according to the
company's filings with securities regulators.
Industry experts say the federal inquiries
into Schering-Plough and the other drug giants have led some
companies to adopt significant changes in the way they peddle
drugs to doctors. Other companies have been slower to react.
''These investigations came out of left field, and no one
saw them coming,'' said Peter Barton Hutt, a former F.D.A.
general counsel who now advises drug companies.
"The industry has since had to reshape entirely what
they are doing, but it was too late to redo what they'd been
doing for years.''
Tony Farino, leader of the pharmaceutical
consulting service at PricewaterhouseCoopers, said that as
a result of the investigations many companies in the drug
industry were hiring executives to police marketing and sales
practices.
''Reputational risk is something they're
all trying to manage,'' Mr. Farino said, ''because the damages
from failure can be significant.''
Back to top
June 28th, 2004
EU
Active in the Fight against Killer Viruses
A new EU project to address the increasing
resistance of some viruses to drugs was launched in Lyon,
France, on 28 June.
Some viruses growing resistance to drugs
indicates that certain diseases are becoming increasingly
difficult to treat. The European Commission is therefore providing
nine million euro to the Vigilance against Viral Resistance
(VIRGIL) project, coordinated by the French Institute for
health and medical research, INSERM. The project brings together
European experts from 12 countries.
Initially, the project will look into drug resistance to three
major diseases, namely hepatitis B and C and influenza, with
the aim of broadening its scope later down the line. The project
will be built around seven research and technological platforms
that will monitor existing, and anticipate future, drug resistance,
explains the European Commission. The interacting platforms,
all centred around the patients, will exhaustively cover the
issue of virus resistance to antiviral drugs.
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Eugene
Needle Exchange Cut unless Others Step Up
Source: Associated Press
EUGENE, Ore. -- Budget cuts are forcing
the non-profit HIV Alliance to scrap its needle-exchange program
by the end of the year, raising fears of more disease and
of dirty needles littering the city.
The 5-year-old alliance hopes government,
medical and charitable groups will pick up the program.
"What we've been doing is great, but
it goes way beyond our mission," said Diane Lang, executive
director of the Eugene-based agency. "Our mission is
to stop HIV, not to control health care costs and side effects
of drug abuse in our community."
Staffers pass out clean needles in exchange
for dirty ones on streets and in parks several times a week.
The program also puts addicts in touch
with people who can help when they're ready to quit using
drugs.
Addicts who use the program are said to
be less likely to share needles, reducing the spread of diseases
such as HIV and Hepatitis C. Reused needles can cause infections
that lead to costly hospital visits.
The agency had to cut 10 percent of its
$840,000 budget for the fiscal year starting July 1. Rather
than trim several programs, the board opted to cut what may
be its most effective one.
The HIV Alliance, which will staff the
program if others pick up the cost of supplies, spent $145,000
in this fiscal year for the program.
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AMA
Develops Guide to Appropriate Reimbursement Coding for Populations
at Risk of Viral Hepatitis
Source: CDC
The American Medical Association (AMA)
has joined with CDC to help protect MSM [men who have sex
with men] and other at-risk individuals from HBV [hepatitis
B virus] and HAV [hepatitis A virus] infection. On March 8,
2004, four CDC divisions released a “Dear Colleague”
letter urging health care professionals to help prevent STDs
among MSM. At the same time, CDC launched a section of related
online resources at http://www.cdc.gov/ncidod/diseases
/hepatitis/msm.
In order to complement this program and
assist physicians in implementing this call to action, the
AMA created a trifold pocket guide to appropriate reimbursement
coding for immunizing populations at risk against hepatitis
B and hepatitis A. You can download “Coding Guidelines
for Vaccine-Preventable Hepatitis (VPH)” at http://www.ama-assn.org/ama1/pub/upload/mm/36
/ama_hep_coding_trifo.pdf
A hotline phone number is also available
for answers about reimbursement on a patient-by-patient basis:
(888) 822-2749. GlaxoSmithKline underwrites this service;
information is given regardless of the vaccine used.
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European
Union's CHMP Recommends Approval of Shorter 24-Week Course
of Pegintron(R) and Rebetol(R) Combination Therapy for HCV
Genotypes 2 or 3
Source: PR Newswire Europe
BRUSSELS, Belgium, --Schering-Plough Europe
today reported that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMEA) hasissued
a positive opinion recommending approval of a shorter 24-week
course of PegIntron(R) (peginterferon alfa-2b) and Rebetol(R)
(ribavirin)combination therapy for patients chronically infected
with hepatitis C virus(HCV) genotypes 2 or 3.
PegIntron is currently approved in the
European Union (EU) for a 48-weekcourse of therapy. Infection
rates for HCV genotypes 2 and 3 vary by geography and account
for approximately 30 percent to 50 percent of HCV infections
among European patients.
The CHMP recommendation serves as the basis
for a European Commission approval. A Commission Decision
will result in Marketing Authorization with unified labeling
covering the shorter 24-week course of PegIntron and Rebetol
combination therapy for genotypes 2 and 3 that will be valid
in the current EU 25 member states as well as in Iceland and
Norway.
The positive opinion recommending the labeling
change for PegIntron and Rebetol is based largely on results
of a clinical study published in the June 2004 issue of the
Journal of Hepatology(1) investigating the safety
and efficacy of a shorter, 24-week course of individualised,
weight-based PegIntron and Rebetol combination therapy compared
with an historical control of 48 weeks of treatment.
In the study, patients infected with chronic
hepatitis C genotypes 2 or 3were treated effectively with
only 24 weeks of PegIntron and Rebetol combination therapy,
with 81 percent of patients overall (93 percent for genotype
2 and 79 percent for genotype 3) achieving a sustained virologic
response (SVR). SVR is defined as the sustained undetectability
of HCV six months following the end of treatment and was the
study's primary endpoint. The study also showed that the overall
safety profile of the 24-weekPegIntron and Rebetol treatment
regimen was improved compared with that of the historical
control of patients treated for 48 weeks and receiving >10.6mg/kg
of ribavirin daily.
"The results of this clinical study
clearly demonstrate that shorter treatment durations can be
effective for specific hepatitis C patient groups," said
Robert J. Spiegel, M.D., chief medical officer and senior
vice president of medical affairs, Schering-Plough Research
Institute. "The study also showed that the shorter treatment
regimen was better tolerated by patients as compared with
a 48-week historical control group."
About PegIntron and Rebetol Combination
Therapy
PegIntron and Rebetol combination therapy for chronic hepatitis
C was approved in the European Union (EU) in March 2001. PegIntron
had previously received centralized marketing authorization
in the EU and is marketed as a monotherapy in cases of intolerance
or contraindication to ribavirin for the treatment of adult
patients with chronic hepatitis C.
PegIntron is a longer-acting form of Intron(R)
A (interferon alfa-2b,recombinant) Injection that uses proprietary
PEG technology developed by Enzon, Inc. (Nasdaq: ENZN) of
Bridgewater, N.J., USA. PegIntron, recombinantinterferon alfa-2b
linked to a 12,000 dalton polyethylene glycol (PEG)molecule,
is a once-weekly therapy dosed according to patient body weight
that is designed to achieve an effective balance between antiviral
activity and elimination half-life. Schering-Plough holds
an exclusive worldwide license to PegIntron.
Rebetol is an oral formulation of ribavirin,
a synthetic nucleoside analog with broad-spectrum antiviral
activity. It is approved worldwide for use in combination
with PegIntron or Intron A for the treatment of adult patients
with chronic hepatitis C. Schering-Plough has rights to market
oral ribavirin for hepatitis C in all major world markets
through a licensing agreement with Valeant Pharmaceuticals
International (NYSE: VRX; formerly ICN Pharmaceuticals Inc.)
of Costa Mesa, Calif., USA.
Chronic hepatitis C is estimated to affect
more than 10 million people in major world markets, including
5 million in Europe. It is a leading cause of chronic liver
disease and one of the most common reasons for liver transplant
in Europe.
Schering-Plough Europe, based in Brussels,
Belgium, is part of Schering-Plough Corporation (NYSE: SGP)
of Kenilworth, N.J., USA.
Schering-Plough is a global science-based
health care company with leading prescription, consumer and
animal health products. Through internal research and collaborations
with partners, Schering-Plough discovers, develops, manufactures
and markets advanced drug therapies to meet important medical
needs. Schering-Plough's vision is to earn the trust of the
physicians, patients and customers served by its more than
30,000 people around the world.
Note to Editors:
PegIntron and Rebetol are licensed to Aesca in Austria, Essex
Pharma inGermany and Essex Chemie in Switzerland.
References:
(1) Zeuzem S, Hultcrantz R, Bourliere M, Goeser T, Marcellin
P, Sanchez-Tapias J, Sarrazin C, Harvey J, Brass C, Albrecht
J. Peginterferon alfa-2b plus ribavirin for treatment of chronic
hepatitis C in previously untreated patients infected with
HCV genotypes 2 or 3. J of Hepatology. June 2004;
40(6): 993-999.
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Schering-Plough
Could Plead Guilty on Pricing -NYT
Source: Reuters
NEW YORK-- Schering-Plough Corp. (SGP.N:
Quote, Profile, Research) is expected to plead guilty soon
to federal charges that it failed to provide Medicaid with
its lowest drug prices, and will pay a fine, The New York
Times reported.
Federal prosecutors in Philadelphia claim
the company illegally failed to charge its lowest prices and
they are examining whether the company offered premiums, such
as free patient consulting arrangements, with its drugs, the
paper said on Sunday, citing sources close to the investigation.
Schering-Plough spokesman Steve Galpin
said the company could not comment on alleged activities,
but said it had nothing new to report on several government
probes since it gave an update in an April regulatory filing.
In that filing, the company said it was
cooperating with investigators and that the Pennsylvania probe
involves the company's contracts with pharmacy benefit managers,
and marketing.
The Pennsylvania prosecutors argue that
such incentives have a market value and therefore the company
was offering drugs to private payers at prices well below
those offered to Medicaid. Other drug companies are the targets
of similar inquiries, the paper said.
The New York Times also said prosecutors
in a separate, ongoing inquiry by federal prosecutors in Boston,
are specifically looking at whether Schering-Plough illegally
wrote checks to doctors to prescribe its drug for hepatitis
C and to take part in clinical trials that were effectively
marketing tools.
Schering-Plough's Galpin said the company
has been "undergoing a company-wide transformation since
the arrival of new leadership in mid 2003," key of which
is a "commitment to quality compliance and business integrity."
The current management said that many of
its practices have changed since the new chief executive,
Fred Hassan, took over from Richard Kogan in early 2003.
Neither of the prosecutors involved, the
U.S. Attorney's office in Pennsylvania, nor the U.S. Attorney's
office in Boston, could be reached for comment.
Shares of Schering-Plough were up a penny
at $18.19 in early trade on the New York Stock Exchange.
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June 29th, 2004
Latest
Impact Factors: Who’s up and Who’s Down?
Source: www.gastrohep.com
The latest impact factors to be released for journals in the
fields of gastroenterology and hepatology show that, while
some journals have gone up in the ratings, others, inevitably,
have gone down.
The impact factor of a journal is a measure of the frequency
with which the “average article” in that journal
has been cited in a particular year. It allows a comparison
to be made of the relative importance of two journals, especially
when you compare journals within the same field of study.
The higher the impact factor of a journal, potentially the
more influence and “impact” that journal is felt
to have. For this reason, the impact factor of a journal is
one tool that can be used by authors in deciding which journal
to submit their manuscripts to.
The latest impact factors for journals in gastroenterology
and hepatology, (which can be found listed alongside each
publication in the Journals section of GastroHep.com) come
from citations gathered by each journal in 2003.
Overall, most journals have maintained
their ranking amongst other journals, despite some climbers
and fallers. Gastroenterology and Gut, the
top two journals as ranked by impact factor in the field of
gastroenterology, have both lost ground slightly (down from
13.4 to 12.7, and 6.3 to 5.9 respectively), but nonetheless
remain above the next highest ranked journal, The American
Journal of Gastroenterology (up to 4.2 from 3.9).
Similarly the top-ranked Hepatology journal, Hepatology
has maintained its position, while still falling slightly
from 9.8 to 9.5.
The journal Alimentary Pharmacology and Therapeutics
has shown proportionately one of the most impressive gains,
rising from 3.0 to 3.5.
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Improvements
Made over Time in Right Lobe Living Donor Liver Transplants
Source: www.gastrohep.com
A study reported in the journal Annals
of Surgery has evaluated the first 100 adult right lobe
living donor liver transplants in a single center to determine
whether technical modifications and better experience have
improved results.
Chung-Mau Lo and colleagues examined 100 consecutive adult
right lobe living donor liver transplants (LDLT) performed
between May 1996 and May 2002.
The LDLTs were studied retrospectively, to determine whether
the numerous modifications in technique and better experience
would improve results.
The first 50 patients (group 1) were compared with the last
50 patients (group 2), with a median follow-up of 37 (27 to
79) months and 15 (7 to 27) for each group respectively.
The characteristics of donors and liver grafts were similar.
However, in group 2 fewer recipients required a visit to an
intensive care unit or had hepatorenal syndrome before transplantation.
There was also a lower disease severity as shown by a lower
Child-Pugh score and Model for End-Stage Liver Disease (MELD)
score.
In both operation line, blood loss, ICU stay and postoperative
complication rate of the donors significant improvements were
noted in group 2.
In addition, operation time, transfusion requirements, number
of reoperations, ICU stay and hospital stay were all also
lower for group 2 compared to group 1.
The hospital mortality rate of recipients was reduced from
16% to 0%, while graft survival rates at 12 months and 24
months were improved from 80% and 74%, respectively, in group
1, to 100% and 96%, respectively, in group 2.
Commenting on the findings, Dr Lo concluded, “There
is a learning curve in adult right lobe LDLT. The results
have significantly improved with technical refinement and
better experience.”
Ann Surg 2004; 240(1): 151-158
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Re-Examining
Questions about Hepatitis C
The Star-Ledger
SourceURL:http://www.nj.com/
Thanks for writing about the aunt who had
a hepatitis C infection. I’m the “aunt,”
asking if there are conflicting thoughts on a person with
hepatitis C touching or hugging a baby? I’m having a
relative visit with her 4-year-old. I don’t feel I have
to warn her about my medical situation; I know my responsibilities
and precautions. Am I out of line in my thinking?
Inflammation of the liver is termed hepatitis.
The diagnosis of hepatitis is made by testing for elevation
of liver enzymes. Determining whether the hepatitis was caused
by a virus is done by looking for evidence of specific viral
particles or the body’s response to specific viral types.
Hepatitis C virus is one member of a viral family that preferentially
invades the liver for reproduction. The other members include
Hepatitis A, B, D and E.
Hepatitis C is almost always spread through contact with infected
blood. Most patients with viral hepatitis have a self-limited
course that resolves without treatment. Some individuals will
be unable to eliminate the virus completely and remain chronically
infected. They can potentially develop long-term liver problems
and are sources for future spread of the infection.
The issue of disclosure of about an infection or disease that
a person might have should be individualized and determined
by the person infected. Medical information is confidential
and recent laws have been passed (Health Insurance Portability
and Accountability Act) to help insure the privacy rights
of individuals. I’ve always believed that common sense
should be used in determining who and what should be told
to others regarding medical illnesses.
In the case of infections with hepatitis C, the vast majority
of infections occur after exposure to blood containing the
live virus. Infection from sexual contact is possible, but
statistically unlikely. Touching, holding, hugging or playing
with another person is not a likely method of transmission,
unless there is blood exposure from the infected person to
an uninfected person. A reasonable person, understanding the
facts, should not fear risk of infection from the type of
contact expected during the visit from your relatives.
I do not think that you have an obligation to inform your
relatives of your infection status prior to their visit. You
should take the necessary precautions to prevent possible
exposure to your blood, which might be on items such as toothbrushes
or razors. It’s also important to look into, if you
haven’t already, combination therapies that have been
able to eradicate the virus to non-detectable levels in the
blood of chronically infected patients.
Write to Dr. Kendall Sprott , at Children’s Hospital
of New Jersey at Newark Beth Israel Medical Center, 166 Lyons
Ave., Newark, N.J. 07112. Or e-mail him at ksprott@sbhcs.com.
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Relaxing
the Hold on Hepatitis C
Source:URL:http://www.storyhunters.com
Here’s something you don’t
hear every day: a giant pharmaceutical company forgoing profit
for the good of mankind. Biotech company Chiron Corp. has
done just that, relaxing its strict licensing policy on their
hepatitis C research. Chiron discovered the disease in 1987,
and has carefully guarded their research ever since with high
licensing fees and up-front payments. Most smaller companies
simply couldn’t afford to research hepatitis C. People
in the scientific community complained. Now, Chiron has loosened
the noose a bit, granting a free research license to small
California company Prosetta.
I’m sure the 41 million Chinese people who have hepatitis
C will be happy to hear this, as will the estimated 3 million
Americans who have been infected with the disease. It’s
sort of disturbing that Chiron would sit on their research
for so long, guarding it so carefully when progress could’ve
been made in fighting the disease. Hepatitis C is passed through
infected blood—through transfusions, drug needles, mothers
to unborn children, et cetera. A lot of people have the disease
and don’t know it because there are often no symptoms.
According to the Illinois Department of Public Health, some
of the most common symptoms of hepatitis C are mild fever,
headaches, muscle aches, fatigue, and nausea. Hepatitis C
frequently leads to liver failure. There is no cure.
Hey, it’s about time someone started rolling the ball
on this disease. In November 2003, Senator Heather Wilson
(R-NM) introduced the Hepatitis C Epidemic Control and Prevention
Act into Congress. The bill included provisions for increased
public awareness and epidemic management of hepatitis C, and
the formation of a Liver Disease Research Advisory Board.
The bill was referred to the House Committee on Energy and
Commerce and has languished there ever since. Maybe, with
Chiron’s newfound generosity, someone will finally give
hepatitis C the attention it needs.
Posted by vanderson at June 29, 2004 08:03 AM
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June 30th, 2004
Racial
Differences in Chronic Hepatitis C-Related Liver Inflammation
and Fibrosis
Source: www.gastrohep.com
Variance in hepatic iron loading does not
explain the differences in liver histology between black and
white patients with chronic hepatitis C, suggests a study
in the journal Clinical Gastroenterology and Hepatology.
Hepatitis C virus (HCV) infection is more prevalent in black
Americans than their white counterparts. Yet the natural course
of HCV in black patients has not been defined.
In an attempt to remedy this, Kester Crosse and colleagues
from The University of Maryland Baltimore School of Medicine,
in Baltimore, Maryland, USA, performed a retrospective comparison
of 87 black and 136 white American chronic hepatitis C patients.
Initial liver tests, HCV genotype and viral liver load as
well as liver histology findings were assessed from the subjects,
who had all been evaluated at the University of Maryland between
1995 and 1998.
Liver biopsy examinations were interpreted using the Knodell
Histologic Activity Index (HAI) criteria.
The findings of the study show that black patients were older
(46.3 years compared to 43.3 years for white patients). They
were also more likely to be infected with HCV genotype 1 (95%
versus 75%).
There was no major difference in the modes of HCV transmission,
estimated duration of HCV infection or prevalence of alcohol
abuse between either group.
“Liver necroinflammation was more severe in white patients
than black patients.” Clinical Gastroenterology
& Hepatology
Despite this, black patients had lower mean total HAI scores
(7.6 vs. 8.7), periportal hepatocyte necrosis scores and liver
fibrosis scores.
Black patients were found to have a lower mean serum alanine
transaminase level (85.5 vs. 122.7), a result in keeping with
lower hepatic necroinflammatory activity.
Serum iron levels were also lower in black patients than white
patients, although there were no racial differences in the
prevalence of increased iron studies and hepatic iron loading.
The researchers conclude that back chronic HCV patients have
milder liver necroinflammation and fibrosis than white patients
with similar HCV duration. They add that differences in liver
histology were not explained by a variance in hepatic iron
loading.
Clin Gastroenterol Hepatol 2004; 2(6): 463
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Occult
Hepatitis B Infection Present in 2% of HIV-Positive Patients
in US study
Michael Carter
Source: www.aidmap.com
Occult hepatitis B infection was present
in 2% of HIV-positive individuals participating in two clinical
trials in the USA in the mid-1990s according to a study published
in the July 1st edition of the Journal of Acquired Immune
Deficiency Syndromes. The study investigators recommend
that patients who experience side-effects involving the liver
after starting anti-HIV therapy should have occult hepatitis
B infection ruled out by having a test for hepatitis B DNA
should they test negative for hepatitis B antibodies but positive
for hepatitis B core antigen (anticore).
A patient is said to have occult, or hidden, hepatitis B infection
if they test positive for hepatitis B DNA and are positive
for hepatitis B anticore but do not have the usual markers
of hepatitis B infection: hepatitis B surface antigen and
hepatitis B antibodies.
There are conflicting data on the prevalence and clinical
significance of occult hepatitis B infection in HIV-positive
individuals.
Accordingly US investigators conducted a retrospective analysis
using the stored plasma samples from 240 HAART-naïve
HIV-positive individuals who participated in two clinical
trials in 1996 and 1997. The investigators wished to establish
the prevalence of current and past hepatitis B infection in
these patients and the prevalence and significance of occult
hepatitis B infection.
Stored plasma samples were tested for hepatitis B surface
antigens, antibodies to hepatitis B and hepatitis B DNA. Serum
alanine aminotransferase (ALT) and aspartate aminotransferase
(AST) levels were measured to determine individuals’
liver function.
The study population was selected because it was geographically
and demographically representative of the HIV infected population
in the US. The median age of the study participants was 37
years, 50% were white, and 81% were male. Patients had a median
CD4 cell count of 137 cells/mm3 and 40% of patients had an
HIV viral load above 100,000 copies/ml.
A total of 64.6% of individuals had a marker of past or current
infection with hepatitis B. Only 2.5% of patients had laboratory
results suggesting vaccination against hepatitis B. Six patients
tested positive for the hepatitis IgM antibody indicating
acute infection.
A total of 7.5% of all patients tested positive for hepatitis
B DNA. Over 80% of patients with hepatitis B DNA had either
hepatitis B surface antigen or hepatitis B antibodies implying
acute or chronic infection. However, 10% of patients without
hepatitis B anticore (four individuals, 2% of entire study
population) had detectable hepatitis B DNA which is suggestive
of occult hepatitis B infection.
Levels of detectable hepatitis B DNA were similar between
patients with chronic or acute infection and those individuals
with occult hepatitis B infection. There were no significant
differences in ALT or AST levels between patients with chronic
and acute hepatitis B infection and individuals with occult
hepatitis B.
The investigators recommend that “patients treated with
HAART who exhibit serum transaminase abnormalities, hyperbilirubinemia,
or liver failure should be tested for HBV markers, and if
found to be positive for anti-HBc alone they should be further
tested for HBV DNA.” They further recommend that a clinical
trial be designed to guide the choice of specific anti-HIV
drugs for individuals who are hepatitis B anticore positive.
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July 01, 2004
Hepatitis
C Action Plan Launched
SourceURL:http://www.4ni.co.uk/
The Department of Health, Social Services
and Public Safety has published an action plan for consultation
on the prevention and control of hepatitis C in Northern Ireland.
Commenting on the plan, which was published on National Hepatitis
C Awareness Day, Chief Medical Officer for Northern Ireland,
Dr Henrietta Campbell, said: “The overall aim of our
plan is to achieve a reduction in the level of hepatitis C
infection in Northern Ireland. We also wish to make sure that
individuals with the infection have the opportunity to be
identified and receive high quality treatment.”
Injecting drug use is the main way by which hepatitis C is
spread. There are however other, less common, routes of transmission,
including sexual intercourse, mother to baby, and skin piercing
and tattooing when sterile equipment is not used.
The Department is proposing ten areas for action, including
enhanced public and professional awareness of hepatitis C
infection.
Today’s document will go out for consultation for 12
weeks, however, many aspects of the plan are already in train.
For example, in January 2004, the National Institute for Clinical
Excellence (NICE) recommended the use of combination therapy
with pegylated interferon, for the treatment of people aged
18 years and over, with moderate to severe chronic hepatitis
C.
This specialist drug has already started to be introduced
in Northern Ireland. Information materials for the public
and health professionals are under development and will be
available after the summer.
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IHS
Slams Martin on ‘Lack of Political Will'
Source: RTE News
The Irish Haemophilia Society has accused the Minister for
Health of lacking the political will to take on drug firms
linked to the death of almost 90 of its members.
However, Mr Martin said he was taking legal advice on the
issue and he hoped to take a decision to sue by the end of
the year.
Officials from the Irish Haemophilia Society went to meet
Minister Martin today to discuss the issue of contaminated
blood products which have caused the deaths of more than 80
people.
The society demanded that the State sue US-based drug companies
responsible for infecting people with HIV and Hepatitis C.
The case would hinge on charges that the firms knowingly accepted
blood donations from high-risk populations such as prisoners
and drug addicts living on skid-row.
The drug companies have long maintained that they did the
best they could with the information which they had, and contest
any suggestion of impropriety.
One large US legal firm has already offered to take the case
on a no-foal no-fee basis, however the minister today described
such action as very complex and the necessary legal advice
he required was some bit away just yet.
Mr Martin said the State needed to be cautious to ensure it
was not hit with a large legal bill but for people with haemophilia
this simply was not good enough.
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African
Americans and Hepatitis C
Source: Ebony
Hepatitis C is an often-chronic, slow-progressing liver disease
caused by the Hepatitis C virus (HCV). Known as a "silent
killer" because of the lack of disease-specific signs
and symptoms, Hepatitis C is the most common blood-borne viral
infection in the United States, and it is now the leading
cause for liver transplantation in the United States.
A recent study estimated that 1.8 percent (3.9 million) of
the U.S. population tested positive for the HCV antibody.
That percentage was higher in Blacks (3.2 percent) than among
Whites (1.5 percent). Because testing for the virus didn't
become available until the late 1980s, experts say they aren't
sure why it seems to affect Blacks at such higher rates. As
a result, doctors say there must be a focus on prevention
and education.
"Most people who have Hepatitis C don't have any symptoms,"
says Dr. Thelma E. Wiley Lucas, a hepatologist at Rush University
Medical Center in Chicago. "And if they do, they just
have symptoms of fatigue." Risk factors for Hepatitis
C include, but are not limited to, IV drug use, having unprotected
sex with multiple partners, and the use of unsterilized equipment
for tattoos and body-piercings. In the past, before testing
began, Hepatitis C could be transmitted through blood transfusions.
About 40 percent of Hepatitis C patients don't know how they
became infected, Dr. Wiley Lucas says.
The signs and symptoms are jaundice, fatigue, dark urine,
abdominal pain, loss of appetite and nausea. Those infected
with the Hepatitis C virus for many years may develop symptoms
of cirrhosis (severe liver scarring) or even kidney disease.
The current and best treatment, specialists say, is the Interferon
injection and the Ribavirin tablet. But some research indicates
that African-Americans do not respond well to drug therapy.
The reason, at least for now, remains a mystery.
"The 'whys' are not known," Dr. Wiley Lucas says.
"Over the last few years, a lot of researchers have taken
an interest in looking at the response [to drug therapy] according
to race. That's a good thing."
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July 02, 2004
Hepatitis
C Virus Genotype 3 Infection May Resolve Spontaneously
Will Boggs, MD
Source: Medscape
NEW YORK--- Infection with hepatitis
C virus (HCV) genotype 3 often clears spontaneously, sparing
the patient unnecessary treatment, German researchers report
in the July issue of the Journal of Medical Virology.
Early treatment of patients with acute HCV infection has been
advocated as an approach to preventing chronic infection,
the authors point out, but many patients may clear the virus
spontaneously and thus would not require treatment if they
were identified beforehand.
As senior investigator Dr. Heiner Wedemeyer told Reuters Health,
"patients should be genotyped. Wait and see for genotype
3, treat immediately for genotype 1."
Dr. Wedemeyer from Hannover Medical School and colleagues
sought to determine whether HCV genotype differences could
lead to different rates of spontaneous clearance of acute
HCV infection. They studied serum from 92 anti-HCV-positive
men in a German prison.
HCV genotype 3 was significantly more common among subjects
who were HCV-negative than among those with HCV viremia, the
authors report, and the prevalence of genotype 3 was even
higher after men who were HIV- or hepatitis B-positive were
excluded. Although acute HCV genotype 3 infection spontaneously
resolved in many individuals, most patients (63%) still developed
chronic infection. This rate of chronic HCV was, however,
substantially lower than the rate of chronic HCV infection
in those with genotype 1 (93%).
"Considering the high sustained virological response
rates of pegylated interferons plus ribavirin combination
therapy of chronic hepatitis C in patients with genotypes
2 and 3," the authors conclude, "different strategies
for acute HCV infection may be appropriate for different HCV
genotypes."
"Chronicity of acute HCV genotype 1 infection evolves
in the vast majority of cases," Dr. Wedemeyer concluded.
"However, unnecessary treatment can be avoided in genotype
3 infection."
J Med Virol 2004;73:387-391.
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