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Alan Franciscus
Editor-in-Chief
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In This Issue:
SA Researchers Make Stunning
Breakthrough: Hepatitis C Vaccine A Possibility
Needle Exchange Proposal Supported
Hepatitis C-infected Austrians 'sue Aventis'
Hepatitis Vaccine Given to Thousands of Babies
in Denver May be Ineffective; New Shots Offered
Breakthrough in Efforts to Create a Hepatitis
C Vaccine
Mount Sinai Investigator Reports Highest Hepatitis
C Therapy Response Rates to Date in Patients Infected with
HIV and Hepatitis C
Progression of Hepatic Fibrosis in Patients with
Hepatitis C
Losing Weight and Exercising Slows Chronic Liver
Disease
Diabetes Increases The Risk of Chronic Liver
Disease and Cancer
February 6th, 2004
SA
Researchers Make Stunning Breakthrough: Hepatitis C Vaccine
A Possibility
Source:The San Antonio Lightning, San Antonio Lightning
Staff
Roughly one in twenty-five Americans carries
a deadly strain of hepatitis, but now a global breakthrough
by San Antonio researchers suggests a vaccine can be crafted.
Dr. Robert E. Lanford, of the Southwest
Foundation for Biomedical Research, has visions of a generation
of humans immune to the silent killer, hepatitis C. HCV is
the leading cause of liver failure and liver transplantation
in the US, according to Lanford. Lanford’s research
supports the position that a single vaccine may prevent infection
of all of the complicated genotypes associated with HCV.
“Originally, several years ago, my
lab for the first time demonstrated that Chimpanzees that
have been infected with HCV, and have resolved their infections,
are protected when they are re-challenged with a similar virus
than the one they cleared.”
“We…demonstrated that if you
clear that virus, and see a similar virus, you will clear
it,” Lanford told the Lightning in an exclusive interview.
Like the AIDS virus, HCV is very diverse,
resulting in several strains or “genotypes.” Because
of the divergence of the virus, researchers have been pessimistic
that a single vaccine would prove an effective defense to
all of HCV’s variations. With HIV and influenza, no
single vaccine can protect the vaccinated individual from
various strains of the deadly organisms. Lanford’s research
strongly suggests that this is not the case with HCV.
Many if not most carriers of the disease
are unaware that they are victims until symptoms emerge years
after infection. Often, the victims learn of their conditions
decades after contraction. In the US, approximately 2 percent
of the general population carries HCV. Americans aged 40 to
60 years suffer at a rate of 4 percent. The numbers reach
as high as 6 percent within certain ethnic groups and social
strata. The implications for healthcare savings and global
health are considerable.
Lanford’s laboratory at the Southwest
Foundation for Biomedical Research continues to work closely
with other institutions, such as Dr. David Thomas’ lab
at Johns Hopkins University School of Medicine, through the
Southeastern Hepatitis C Cooperative Research Center. The
effort is funded by the National Institute of Health. Lanford
adds that the Southwest Foundation for Biomedical Research
is working closely with four major pharmaceutical companies
towards a cure for those already infected.
Lanford’s revelation was the result
of years of research on chimpanzees at the Foundation, located
in San Antonio, Texas. Besides humans, chimpanzees are the
only animals that are susceptible to the virus, though they
do not suffer the debilitating affects of the disease. In
fact, many of the study animals completely shake the bug.
The Foundation’s noble population of chimpanzees were
instrumental in this current breakthrough.
Lanford emphasized the Foundation’s
respect for chimpanzees as a wildlife resource, and explained
that due to the chimps’ forty-plus year lifespan in
captivity, many career animal care workers at the Foundation
develop lifelong friendships with the animals.
The Foundation has an investigator that
evaluates all proposed use of chimpanzees in experimentation.
Each proposal is then reviewed by an independent committee,
the Institutional Animal Care and Use Committee, comprised
of scientists and lay people from outside the Institute. The
process is in place to assure that chimps are only used in
“critical” research. The chimpanzees used in this
study were subject to very little discomfort, mostly blood
sampling, according to Lanford.
The Foundation’s chimpanzee population
are provided with indoor-outdoor habitats and color TV. “It’s
something that they enjoy,” Lanford said.
Lanford, his colleagues at the Southwest
Foundation, and collaborators at the Johns Hopkins University
School of Medicine in Baltimore detail their discovery in
an article to be published in the Journal of Virology
for its first edition for the month of February.
Back to top
Needle Exchange Proposal Supported
Adam Taylor
Source: Delaware: News Journal
On Thursday, Wilmington City Council adopted,
12-1, a resolution supporting a state senator's effort to
start a needle- exchange program for intravenous drug users
in the city. Supporters said the program would slow the spread
of HIV/AIDS, while opponents said it would condone drug use
and attract more users to Wilmington.
Sen. Margaret Rose Henry (D-Wilmington
East) recently introduced the bill to the General Assembly.
She proposes a five- year pilot program, costing about $175,000
annually in state funds. State health workers would distribute
needles to addicts from a van at several yet-to-be-selected
locations throughout Wilmington. The senate Health and Social
Services Committee will debate the measure, Senate Bill 209.
Nearly 39 percent of the 2,636 HIV/AIDS
cases in Delaware live in Wilmington, according to John D.
Baker, executive director of AIDS Delaware. Sixty-five percent
of HIV-positive people in Wilmington contracted the virus
through needle sharing, he said, compared to a statewide rate
of 35 percent.
Mayor James M. Baker, no relation to John
D., said the program is a perfect fit with one goal of Healthy
Wilmington
2010: reducing the city's HIV infection
rate by 20 percent in the next six years. Healthy Wilmington
2010, produced by city health officials, is a guide that identifies
seven key health issues, sets goals for improvement, and suggests
ways to reach the goals.
Police Chief Michael Szczerba opposes the
program. He said putting clean needles into the hands of drug
users allows them to continue illegal and dangerous activities
and sends mixed messages to children.
Needle-exchange participants would not
be prosecuted under the state law that makes possession of
a syringe without a prescription a misdemeanor. Under Henry's
bill, the needle- exchange program would include education
about how sharing needles can transmit HIV and other diseases.
Back to top
February 8th, 2004
Hepatitis
C-infected Austrians 'sue Aventis'
HAMBURG, Germany, Feb 8 (AFP) - Sixty-three Austrians infected
with Hepatitis C have filed suit against Franco-German pharmaceuticals
giant Aventis blaming contaminated plasma injections, Der
Spiegel news weekly reported in its issue to be published
Monday.
The patients are claiming damages against
Aventis, the parent company of Seroplas, responsible for the
infusions.
In 2001, courts in the Austrian cities
of Linz, Klagenfurt and Vienna awarded EUR 7.5 million (USD
9.5 million) to 259 plaintiffs over the case based on insurance
claims by Seroplas.
But this time, the insurance companies
only offered each plaintiff one-third of the settlement amount.
"It is unacceptable to have second-class
victims here," Vienna-based lawyer Hans-Otto Schmidt
told Der Spiegel.
Back to top
February 10th, 2004
Hepatitis
Vaccine Given to Thousands of Babies in Denver May be Ineffective;
New Shots Offered
Hepatitis vaccines given to about 4,300
babies born at a Denver hospital may have frozen while in
storage, rendering the shots ineffective against the liver
disease, officials said.
Although there is no evidence the vaccine
was ineffective, "we just can't assume they're all OK,"
Sarah Ellis, a spokeswoman for University Hospital, said Monday.
She recommended infants who received the shots for hepatitis
B be revaccinated.
Parents will be notified by letter and
will not be charged for revaccination. The cost to the publicly
funded hospital could exceed $300,000 because the vaccine
costs $75 a shot.
The vaccine is usually given in a series
of three shots. Babies who have had more than two additional
shots probably do not need to be revaccinated, said Dr. William
Letson, a pediatric epidemiologist at the Colorado Department
of Public Health and Environment. However, an extra shot would
not do any harm, he said.
The suspect vaccine was given to babies
born at the hospital between February 2002 and October 2003.
The shots would not have harmed the infants, hospital officials
said.
A state inspector who was reviewing records
discovered temperature variations in the refrigerator where
the vaccine was kept, Letson said.
Hospital officials blamed a defective thermometer
and said it had been replaced.
Hepatitis B is caused by a virus that attacks
the liver. It can cause lifelong infection, scarring of the
liver, liver cancer, liver failure and death.
Source: Associated
Press
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February 11th, 2004
Breakthrough
in Efforts to Create a Hepatitis C Vaccine
(SAN ANTONIO) -- Researchers in Texas said Monday a breakthrough
has sparked hope that a vaccine can be found to prevent hepatitis
C, one of the most stubborn and intractable diseases in the
world.
A team headed by Dr. Robert E. Lanford
of San Antonio's Southwest Foundation for Biomedical Research
has found that chimpanzees infected with hepatitis C develop
immunity to all strains of the disease, not just the specific
infection strain. Their research will be published this week
in the Journal of Virology.
"There's been a lot of skepticism
about our ability to do this because hepatitis C has a great
deal of divergence," Lanford told 1200 WOAI news. "We're
run into this before with HIV, we've had trouble making a
vaccine for HIV because of the divergence. People felt the
same way with Hepatitis C, and our work now indicates that
this won't be a problem. An animal that has developed immunity
to one strain of hepatitis C should be immune to all the other
strains."
Lanford said the goal is to develop a vaccine
that could be administered at birth to prevent the development
of hepatitis C through a lifetime.
"We vaccinate for hepatitis B at birth
now. We could raise a population of people who won't have
to deal with this in future years."
Hepatitis C is a blood disease which in
the past had been acquired through blood transfusions of the
use of blood clotting agents. Currently the most common source
of hepatitis C infection is intravenous drug use.
Hepatitis C, known as the 'silent epidemic,'
is the number one cause of liver failure and the leading cause
of liver transplantation in the US. An estimated one in 25
adults in the country between the ages of 40 and 60 are infected
with hepatitis C, which accounts for one quarter of all cases
of liver cancer.
"A vaccine on the market is still
a long ways off," Lanford said. "What we have done
with this research is prove that a vaccination is possible."
Back to top
February 12th, 2004
Mount Sinai
Investigator Reports Highest Hepatitis C Therapy Response
Rates to Date in Patients Infected with HIV and Hepatitis
C
Study findings offer new hope for the estimated 300,000 Americans
infected with HIV and Hepatitis C
New York, /PRNewswire/ -- A Mount Sinai
School of Medicine researcher reported results from a study
with a drug combination that showed the highest hepatitis
C treatment response rates ever reported in patients infected
with hepatitis C and HIV virus on Tuesday, February 10 at
the 11th annual Conference on Retroviruses and Opportunistic
Infections (CROI).
The multinational APRICOT (AIDS PEGASYS(R)
Ribavirin International CO-infection Trial) study found that
the drug combination of Pegasys(R) (peginterferon alfa-2a)
and Copegus(R) (ribavirin) were much more effective than the
previous generation of hepatitis C therapy standard interferon
and ribavirin. Efficacy was measured as the sustained virological
response (SVR) rate, which is defined by the absence of detectable
HCV RNA in the serum for at least six months after treatment.
The study results were presented at the meeting by Dr. Douglas
Dieterich, Professor of Medicine, Mount Sinai School of Medicine,
New York City, and lead investigator on the APRICOT trial.
The study was funded by Roche, the developers of Pegasys.
HCV and HIV are the two most prevalent
blood-borne infections in the United States. Of the nearly
one million people estimated to have HIV in the U.S., approximately
300,000 are believed to be co-infected with HCV. It can take
10 to 20 years following infection with hepatitis for a person
to progress to end stage liver disease. However, in patients
with HIV, the disease progresses far more quickly. With advances
in HIV therapy prolonging the life expectancy of HIV patients,
hepatitis C is now a major threat to people with HIV.
"The results from this trial are very
exciting news for the hundreds of thousands of Americans who
are living with hepatitis C and HIV," said Dr. Dieterich.
"They prove that, through treatment with Pegasys and
Copegus, these patients can be treated successfully for their
HCV -- without compromising their HIV status."
Results from the study report 40 percent
overall efficacy among co-infected patients and, when analyzed
by genotype, 62 percent efficacy in patients with genotypes
2 and 3, and 29 percent in those with genotype 1. Genotype
1 is typically the most difficult strain of HCV to treat.
Four times more genotype 1 patients cleared the hepatitis
C virus with Pegasys in combination with Copegus than with
those treated with standard interferon/ribavirin combination
therapy (29% vs. 7% respectively). Additionally, Pegasys monotherapy
showed superior efficacy to treatment with standard interferon
and ribavirin (20 percent vs. 12 percent), which is important
for patients who cannot tolerate ribavirin.
The randomized, partially blinded international
trial had a total of 868 HCV/HIV co-infected patients in 19
countries, and is currently, the largest study conducted among
this patient population. All patients were HCV positive, had
compensated liver disease, a CD4+ count greater than 100 cells/mL,
and stable HIV disease, with or without antiretroviral therapy.
Patients were randomized to 48 weeks of treatment with interferon
three times a week plus 800 mg/day of ribavirin, 180 mcg of
Pegasys once weekly plus placebo, or 180 mcg of Pegasys once
weekly with 800 mg/day of Copegus. Sustained virological response
(SVR) was accessed at the end of 24 weeks of treatment-free
follow up (week 72).
Negative predictability ranged from 98
to 100 percent at 12 weeks. Negative predictability means
that patients can determine by week 12 if they are unlikely
to respond to therapy with Pegasys so decisions about the
continuance of treatment can be made in that time. In addition,
HIV viral levels were not negatively impacted by treatment
with Pegasys and Copegus combination therapy, and no new safety
concerns were reported with this study. Pegasys is a well-tolerated
medication, even with the addition of full doses of ribavirin.
In this study, the most commonly reported side effects were
fatigue, fever and headache.
Co-authors on the study include J.
Torriani, University of California, San Diego, CA; J. Rockstroh,
University of Bonn, Bonn, Germany; M. Rodriguez- Torres, Fundacion
de Investigacion de Diego, Santurce, Puerto Rico; E. Lissen,
Virgen del Rocmo University Hospital, Seville, Spain; J. Gonzalez,
Hospital La Paz, Madrid, Spain; A. Lazzarin, San Raffaele
Vita-Salute University, Milan, Italy; G. Carosi, University
of Brescia, Italy; J. Sasadeusz, Royal Melbourne Hospital,
Australia; C. Katlama, Groupe Hospitalier de la Pitie Salpetriere,
Paris, France; J. Montaner, University of British Columbia,
Vancouver, Canada; H. Sette, Instituto de Infectologia Emilio
Ribas, Sao Paulo, Brazil; F. Duff, Roche, Nutley, NJ, USA , J. DePamphilis, Roche, Nutley, NJ,
USA; U. M. Schrenk, Roche, Basel; Switzerland.
SOURCE: PRNewswire
-- Mount Sinai
Back to top
Progression
of Hepatic Fibrosis in Patients with Hepatitis C
Source: www.gastrohep.com
Mild hepatitis C infection will rapidly
worsen in 1 out of 3 patients, find researchers in the March
issue of Gut.
Hepatitis C virus (HCV) is an important
cause of chronic liver disease. Treatment with interferon
is expensive and only works in approximately half those treated.
Dr Stephen Ryder's team evaluated 214 patients
with HCV (mean age 36 years, 126 male) who had mainly mild
liver disease.
The patients were not treated, but were
biopsied every 2.5 years.
The team found that at the first biopsy,
the average fibrosis score (Ishak score) was 3. Gender, alcohol
consumption and virus type did not influence the rate of progression.
They determined that by the time of the
next biopsy the Ishak score had increased by 1 or more points
in a third of the patients, and by 2 or more points 10%. Factors
influencing progression of the disease were older age at infection,
and degree of fibrosis at the first biopsy.
The team did not find that gender, alcohol
consumption, virus type, or other indicators of poor liver
function influenced the rate of progression.
Dr Ryder's team concluded that even mild
HCV is a progressive disease, and those patients affected
are likely to require a considerable degree of health care
as they age.
This is particularly likely in those who
are older when first infected, and those who already have
a degree fibrosis at diagnosis.
Gut 2004; 53: 451-5
Back to top
Losing Weight
and Exercising Slows Chronic Liver Disease
Source: www.gastrohep.com
Losing weight and exercising regularly
slows progression of chronic liver disease in those who are
overweight, indicates a study in the March issue of Gut.
Non-alcoholic fatty liver disease is increasingly
being diagnosed in patients who are overweight, diabetic,
or who have insulin resistance syndrome.
Overweight and obesity are also recognized
risk factors for the progression of other chronic liver diseases,
such as hepatitis C.
Quality of life significantly improved
after losing weight.
In this study, Dr Elizabeth Powell's team
evaluated 31 overweight patients with fatty liver disease.
The patients dieted for 15 months and exercised regularly.
The patients were seen by a dietician every
week during the first 3 months and once a month thereafter.
They completed 2.5 hours of aerobic exercise every week for
the entire period.
The team measured blood samples for liver
enzymes, cholesterol, triglycerides, glucose and insulin at
months 0, 3 and 15.Liver biopsies were also taken.
In addition, patients completed questionnaires
on their health-related quality of life.
In the patients who had liver biopsies
between months 6 and 9 of the program, the amount of fatty
tissue present had fallen.
At the end of the study 68% of patients
had maintained their weight loss.
ALT levels were also significantly lower
than at the beginning of the study. Insulin levels also fell.
The team determined that these improvements
also occurred in patients who lost 4% to 5% of their body
weight.
After completion of the study 10 patients
regained their weight and their ALT levels worsened.
Patients reported that their quality of
life significantly improved after losing weight.
Gut 2004; 53: 413-19
Back to top
February 13th, 2004
Diabetes
Increases The Risk of Chronic Liver Disease and Cancer
Source: www.gastrohep.com
The risk of chronic nonalcoholic liver
disease and hepatocellular carcinoma is doubled in men with
diabetes, find researchers in the February issue of Gastroenterology.
There is an association between diabetes
and chronic liver disease. The temporal relationship between
these conditions remains unknown.
In this study, researchers from the United
States identified 173,643 patients diagnosed with diabetes
between 1985 and 1990. They also randomly selected 650,620
patients without diabetes. Overall, 98% were male and the
patients with diabetes were older (62 versus 54 years) than
patients without diabetes.
Any patients with concomitant liver disease
were excluded from the study.
The team followed the cohort until the
end of 2000. They recorded the occurrence of chronic nonalcoholic
liver disease and hepatocellular carcinoma.
The researchers determined that the incidence
of chronic nonalcoholic liver disease was significantly higher
in patients with diabetes. This trend was similar for the
occurrence of hepatocellular carcinoma.The highest risk was
in patients with more than 10 years of follow-up.
The team found that diabetes carried the
highest risk among patients with more than 10 years of follow-up.
Dr Hashem El-Serag's team concluded, "Among
men with diabetes, the risk of chronic nonalcoholic liver
disease and hepatocellular carcinoma is doubled".
"This increase in risk is independent
of alcoholic liver disease, viral hepatitis, or demographic
features".
Gastroenterology 2004; 126(2)
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