Matt's Blog

Influence of Genotype and HIV Coinfection on CD4 and CD8 Cell Responses to HCV
HIV positive individuals are less likely to clear hepatitis C virus (HCV) after
exposure, and HIV-HCV coinfected people tend to have more rapid liver disease
progression and poorer responses to interferon-based therapy, but the reasons
are not fully understood.
As reported in the May 2007 Journal of Medical Virology, Spanish researchers
conducted an analysis to assess immunological response to HCV.
As background, they noted that while the role of T-cells in clearance of HCV
during acute infection is critical, the relevance of this immunological response
in the control of HCV replication during chronic infection is less clear.
The authors examined HCV-specific T-cell responses in 92 interferon-naive
individuals with chronic hepatitis C. A panel of 441 overlapping peptides
spanning all expressed HCV proteins was used to measure HCV-specific T-cell
responses, using flow cytometry after stimulating peripheral blood mononuclear
cells with different pools of these peptides.
Results
. Most patients showed responses to at least 1 HCV protein.
. The NS5B protein was identified most frequently for CD8 responses.
. The E2 protein was most frequent for CD4 responses.
Conclusion
In conclusion, the authors wrote, "Both the prevalence and breadth of CD4 and
CD8 responses were lower in co-infected patients, independently of the HCV
genotype."
07/13/07
Reference
L Capa, V Soriano, J Garcia-Samaniego, and others. Influence of HCV genotype and
co-infection with human immunodeficiency virus on CD4+ and CD8+ T-cell responses
to hepatitis C virus. J Medical Virology 79(5): 503-510.May 2007.
http://www.hivandhepatitis.com/hiv_hcv_co_inf/2007/071307_a.html
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
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"I have studied many philosophers and many cats. The wisdom of cats is
infinitely superior." - Hippolyte Taine

Uninsured Adults With Chronic Illnesses Use More Health Care Services When They
Qualify for Medicare Than Those Who Were Insured, Study Finds
Uninsured adults with common chronic illnesses had greater health
expenditures and more frequent physician office visits and hospitalizations
after they became eligible for Medicare compared with those who had insurance
before age 65, according to a study published Thursday in the New England
Journal of Medicine, Reuters reports. For the study, researchers from Harvard
Medical School used data from the federal Health and Retirement Study to compare
Medicare expenses for 1,385 people who were uninsured before becoming eligible
for the program at age 65 and 3,773 who had private coverage before becoming
eligible for Medicare (Emery, Reuters, 7/11).
According to the study, 2,951 beneficiaries were diagnosed with either
cardiovascular disease or diabetes -- conditions for which treatment can prevent
severe consequences that can require extra doctor visits and hospitalization.
Health care expenses were 51% greater for previously uninsured beneficiaries who
were diagnosed with chronic conditions before they turned age 65, the study
found. In addition, the previously uninsured beneficiaries had 13% more doctor
visits and 20% more hospitalizations than the previously insured group (Kolata,
New York Times, 7/12).
"However, among adults without these conditions, adjusted health care use and
expenditures after age 65 did not differ significantly between previously
insured and uninsured adults," according to the study (Reuters, 7/11).
Lead researcher John Ayanian, an associate professor of medicine and health care
policy at Harvard, said the study suggests the cost of providing universal
health coverage might be less then expected, because it would prevent people
from waiting until late in life to receive treatment for chronic illnesses.
Ayanian said, "A lot of the prior research focused on the health benefits of
extending insurance coverage. Our study suggested that it may be cost effective"
(New York Times, 7/12).
Reaction
Commonwealth Fund President Karen Davis in a statement said, "This study
highlights the importance of health insurance coverage for all Americans to
improve the efficiency of our health care system, as well as the quality of our
health care and health outcomes" (Reuters, 7/11).
Jonathan Weiner, professor of health policy at the Johns Hopkins Bloomberg
Schools of Public Health, said he was disappointed that the study did not
include an estimate of potential Medicare savings if coverage had been provided
earlier for the uninsured. However, he said, "I could hazard a guess that
society would save money, and there is no question these people would be
healthier and have a higher quality of life if they had insurance earlier."
Weiner said, "Health care is especially expensive for this age group," adding,
"Fixing this part of the problem clearly will not be cheap, and exactly where
health insurance policy would impact longevity is unclear" (Edelson,
HealthDay/Washington Post, 7/11).
Mark Pauly, a health economist at the University of Pennsylvania Wharton School,
said, "The quick interpretation is, 'Well this saves money,' but it's a partial
savings," adding, "You get some money back, but it's still going to cost money"
to implement a universal coverage system.
Former CMS Administrator Mark McClellan, a visiting fellow at the AEI-Brookings
Joint Center for Regulatory Studies, said a more effective system for providing
care to the uninsured could include assigning case managers who would make sure
patients take their drugs or report high levels of blood sugar for diabetics,
rather than just paying for doctors and leaving beneficiaries to seek their own
care. "Health insurance is supposed to not just prevent the complications of
chronic diseases but also to keep you healthier," McClellan said, adding that
Medicare "historically has not done a very good job of that" (New York Times,
7/12).
The study is available online.
Broadcast Coverage
American Public Media's "Marketplace Morning Report" on Thursday reported on
the study. The segment includes comments from study author Michael McWilliams
(Barshay, "Marketplace Morning Report," American Public Media, 7/12). Audio and
a transcript of the segment are available online.
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=46181
Peace and Love
·´¨¨)) -:¦:-
¸.·´.·´¨¨))
((¸¸.·´ ..·´ -:¦:- Pam
-:¦:- ((¸¸.·´*
"Women and cats will do as they please,
and men and dogs should relax and
get used to the idea" - Robert Heinlein

Diabetes Is a Risk Factor for Liver Cancer Recurrence after Surgery in Patients
with Viral Hepatitis
Most experts agree that diabetes is a risk factor for the initial development of
hepatocellular carcinoma (HCC), a form of liver cancer that can develop in
people with chronic liver disease, including chronic hepatitis B or C. However,
the impact of diabetes on post-operative HCC recurrence is not clear.
HCC may be treated using a variety of methods, including chemotherapy,
radiation, and surgery known as hepatic resection (removal of cancerous tumors
or heavily affected sections of the liver). However, HCC often recurs after
treatment.
As reported in the June 15, 2007 advance online edition of the American Journal
of Gastroenterology, Japanese researchers analyzed the relationship between
post-operative HCC recurrence and co-existence of diabetes in the patients with
viral hepatitis.
The study included 90 patients who had undergone curative resection for HCC.
They were divided into 2 groups -- those with and without diabetes -- and the
recurrence-free survival rates after surgical treatment and factors contributing
to recurrence were assessed.
Results
a.. Kaplan-Meier survival analysis showed that the HCC recurrence-free
survival rates in the diabetic group were significantly lower than those in the
non-diabetic group (P = 0.005).
b.. Overall survival rates in the diabetic group were significantly lower than
those in the non-diabetic group (P = 0.005).
c.. These results were emphasized in the analysis of patients infected with
hepatitis C virus.
d.. Univariate and multivariate analyses showed diabetes was a significant
factor contributing to HCC recurrence after treatment.
e.. Furthermore, multivariate analysis in HCC patients with diabetes showed
Child-Pugh classification B (P = 0.001) and use of insulin therapy (P = 0.049)
were significant factors contributing to HCC recurrence after treatment.
Conclusions
"The results of the present study suggest that diabetes is a risk factor for the
recurrence of HCV-related HCC and decreases the overall survival rates after
surgical treatment," the authors concluded. "HCV-related HCC patients with
diabetes should be closely followed for postoperative recurrence."
07/13/07
Reference
T Komura, E Mizukoshi, Y Kita, and others. Impact of Diabetes on Recurrence of
Hepatocellular Carcinoma after Surgical Treatment in Patients With Viral
Hepatitis. American Journal of Gastroenterology. June 15, 2007 [Epub ahead of
print].
http://www.hivandhepatitis.com/hep_c/news/2007/071307_b.html
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"I have studied many philosophers and many cats. The wisdom of cats is
infinitely superior." - Hippolyte Taine

Decision is due on archbishop
Doctors at the Aretaio Hospital in Athens will meet with a US-based liver
specialist today to decide on the treatment that Archbishop Christodoulos should
undergo, which includes the possibility of a transplant.
Greek-American surgeon Andreas Tzakis arrived in Athens yesterday and examined
the head of the Church of Greece before holding talks with the hospital's
doctors, in a meeting that was also attended by Deputy Health Minister Thanassis
Yiannopoulos.
The physicians are due to reconvene today to decide how to treat Christodoulos's
suspected liver cancer.
This could involve the archbishop undergoing a liver transplant but he may have
to travel abroad, to Germany or the USA, to have the operation.
Medical experts from Germany have also examined Christodoulos and Tzakis said
their opinions would also be taken into account during today's meeting.
The archbishop's aides said that he is improving gradually after spending more
than a month in the hospital.
http://www.ekathimerini.com/4dcgi/_w_articles_politics_100014_12/07/2007_85589
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"I have studied many philosophers and many cats. The wisdom of cats is
infinitely superior." - Hippolyte Taine

Pharmasset and Roche Initiate New Toxicology Studies of HCV Polymerase Inhibitor
R7128
On July 12, Pharmasset and Roche announced that they had begun a new round of
animal studies to evaluate the long-term safety of the investigational HCV
polymerase inhibitor R7128.
Below is and excerpt from the Pharmasset press release:
Pharmasset and Roche Initiate Studies to Advance R7128 for HCV
PRINCETON, New Jersey, July 12 -- PRNewswire -- Pharmasset, Inc. (Nasdaq: VRUS)
announces the start of long-term chronic toxicology studies in two animal
species as part of their collaboration with Roche for the development of R7128
for the treatment of hepatitis C virus (HCV). R7128 is currently being evaluated
in a Phase 1 clinical trial. The primary objective of the chronic toxicology
studies is to assess the safety of R7128 when given for six months. Roche
triggered a US$7.5 million milestone payment to Pharmasset by initiating these
studies.
"As we progress the ongoing 14-day multiple ascending dose study of R7128, we
are encouraged that Roche has initiated the long-term chronic toxicology studies
in support of the potential advancement of R7128 into Phase 2 clinical trials,"
stated Schaefer Price, Pharmasset's President and CEO. "This achievement is a
clear indication that our cooperative partnership with Roche is focused on the
common goal of accelerating the development of R7128 in order to bring new
treatment options to patients with hepatitis C."
About R7128
R7128 is a polymerase inhibitor being developed for the treatment of chronic
hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated potency in
preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV
RNA polymerase, an enzyme that is necessary for hepatitis C viral replication.
Results from an oral single ascending dose study in 24 healthy male volunteers
showed that PSI-6130 was generally well tolerated with no serious adverse events
in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase I clinical trial is a multiple center, observer-blinded, randomized
and placebo-controlled study to investigate the pharmacokinetics,
pharmacodynamics, safety, tolerability and food effect of R7128 in healthy
volunteers and in patients chronically infected with HCV genotype 1. This Phase
1 study is comprised of two parts:
Part 1 is a single ascending dose study conducted in 38 healthy volunteers. The
primary objective of Part 1 is to assess the safety, tolerability and
pharmacokinetics of R7128 following single ascending doses under fasting
conditions. The secondary objective of Part 1 is to explore the effect of food
on the pharmacokinetics of R7128.
Preliminary data from the single ascending dose portion of the study indicate:
· All doses of R7128 studied were generally well-tolerated.
· All patients completed the study with no gastrointestinal adverse events or
serious adverse events reported during the study.
· No hematological or laboratory abnormalities of clinical significance were
noted.
Part 2 is a multiple ascending dose study being conducted in up to 40 patients
chronically infected with HCV genotype 1 who have previously failed interferon
therapy. The primary objective of Part 2 is to assess the safety, tolerability
and pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14
days. The secondary objective is to assess antiviral efficacy by measuring the
decrease in HCV RNA.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering,
developing and commercializing novel drugs to treat viral infections.
Pharmasset's primary focus is on the development of oral therapeutics for the
treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human
immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates: Clevudine for the
treatment of chronic HBV infection, which is expected to enter US, European and
South American Phase 3 registration clinical trials and is already approved for
HBV in Korea and marketed by Bukwang Pharmaceuticals under the brand name
Levovir; R7128, an oral treatment for HCV, in a Phase 1 clinical trial through a
strategic collaboration with Roche; and Racivir for the treatment of HIV in
combination with other approved HIV drugs, which has completed a Phase 2
clinical trial.
Web site: http://www.pharmasset.com.
07/13/07
Source
Pharmasset (via PRNewswire). Pharmasset and Roche Initiate Studies to Advance
R7128 for HCV. Press release. July 12, 2007.
http://www.hivandhepatitis.com/hep_c/news/2007/071307_a.html
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"I have studied many philosophers and many cats. The wisdom of cats is
infinitely superior." - Hippolyte Taine

Longer Hepatitis C Treatment Best?
Cure Rates Are Higher With Longer Treatment Of 6 Months, Research Suggests
(WebMD) Shortening treatment to less than six months does not appear to be a
good strategy for patients with the most curable types of hepatitis C virus
infection, new research suggests.
Patients with hepatitis C genotypes 2 and 3 who were treated for four months had
lower cure rates and higher relapse rates than those treated for six months.
The study, which appears in Thursday's New England Journal of Medicine, shows
that longer treatment benefits even those with highly treatable hepatitis C,
researcher Mitchell L. Shiffman, MD, tells WebMD.
"I tell patients if they can tolerate treatment and can stay on it for 24 weeks,
they have a better chance of achieving the best possible outcome, which is a
cure," he says.
Hepatitis C Treatment Strategies
Long-term infection with hepatitis C virus (HCV) is a leading cause of
cirrhosis, liver cancer, and liver transplants in the United States. As many as
4 million Americans are infected, but most don't know it, experts say.
About 70 percent of infected Americans carry the genotype 1 form of hepatitis C,
which tends to be less responsive to treatment than genotypes 2 and 3.
With aggressive treatment, nearly 80 percent of people with genotypes 2 or 3
achieve complete and sustained viral eradication, or cures, compared with about
40 percent to 45 percent of people carrying genotype 1 virus.
These days, most patients are treated with a long-acting version of the injected
drug interferon along with the antiviral drug ribavirin.
The standard course of treatment for patients with the more treatable types of
hepatitis C infection is half that of patients with genotype 1 hepatitis C - 24
weeks compared with 48 weeks.
In several recent studies, it was reported that shortening treatment to four
months and even three months had no impact on cure rates in hepatitis C genotype
2 or 3 patients.
In an effort to test these findings, Shiffman and colleagues from Virginia
Commonwealth University compared outcomes among genotype 2 or 3 patients treated
for four months and six months.
They report that 31 percent of patients treated with the shorter course of
therapy eventually relapsed, compared with 18% of patients who got the full six
months of treatment. Relapse was defined as having detectable levels of virus in
the blood at follow-up despite complete viral eradication at the end of
treatment.
Overall, 62 percent of patients treated for four months achieved sustained viral
responses, compared with 70 percent of patients treated for six months.
Among patients who achieved complete viral responses within a month of starting
treatment, 79 percent of those treated for four months achieved complete,
sustained responses, compared to 85 percent of the patients treated for six
months.
Individualized Hepatitis C Treatment
Shiffman understands the desire of patients and doctors to shorten treatment.
The drugs used to treat hepatitis C are very expensive and they can cause severe
fatigue, fever, depression, and other hard-to-tolerate side effects.
But he says a better strategy than shortening treatment is lowering drug dosage
in patients who have trouble tolerating hepatitis C treatments.
He adds that rapid response to treatment has become as important as viral
genotype for predicting response to treatment.
Patients who show no signs of hepatitis C infection within a month of beginning
treatment have a 90 percent cure rate, regardless of genotype, he says.
"We are learning that the optimal way to treat hepatitis C is to monitor the
virus during treatment, no matter what the genotype, and adjust treatment
duration based on response."
T. Jake Liang, MD, of the National Institutes of Health, says this
individualized approach to hepatitis C treatment will become more common as more
is learned about the virus.
Liang is chief of the liver disease branch of the National Institute of Diabetes
and Digestive and idney Diseases.
"As our technology improves we will be more able to identify patients who will
benefit from a shorter course of treatment," he tells WebMD. "For now,
though, genotype 2 and 3 patients who can tolerate the treatment should remain
on it for a full six months."
a.. Are you living with hepatitis C? Get support and meet others on our
Hepatitis C Support Group message board.
http://www.cbsnews.com/stories/2007/07/11/health/webmd/main3047056.shtml
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"There are two means of refuge from the miseries of life: music and cats." -
Albert Schweitzer
President
http://www.HEALSoftheSouth.org
http://www.HEALSoftheSouth.com

Mich. task force created to cope with hepatitis C
By COLLEEN MAXWELL
The State News
The list of celebrity victims includes Pamela Anderson, Naomi Judd, Mickey
Mantle, James Earl Ray and Steven Tyler.
But hepatitis C, a deadly virus which affects more than 4 million Americans, now
will be tackled by a new Michigan task force.
The Hepatitis C Advisory Task Force will advise the governor and Legislature on
policies for reducing the risk of hepatitis C, said T.J. Bucholz, a spokesperson
for the Michigan Department of Community Health.
Hepatitis C is a blood-born, infectious virus caused by the hepatitis C virus.
The virus, which has no cure, can lead to cirrhosis, liver failure or cancer.
This summer, Peter Gulick, an associate professor of medicine in the College of
Osteopathic Medicine, was appointed to the task force by Gov. Jennifer Granholm.
Along with 10 other appointees, part of Gulick's job will be to increase
awareness in Michigan.
Each appointee represents a different group in the state, from religious
organizations to the legal community, to the education community, Bucholz said.
"They will provide an annual report to the governor and Legislature on major
risk factors," he said.
Karen Hunter, a spokeswoman for the Center for Disease Control and Prevention,
or CDC, said those who are at especially high risk are people who have injected
illegal drugs or those who have received blood donations or solid organ
transplants before July 1992.
"Even health care workers can be at risk after an exposure to a needle stick,"
Hunter said.
It's the leading cause of liver cancer, Gulick said.
"A lot of people don't know that," he said. "In the next couple of years, it's
going to get worse if we don't start recognizing it, especially with baby
boomers."
Eighty percent of people with hepatitis C have no symptoms, according to the
CDC. If symptoms do occur, they can include joint pain, fatigue and stomach
pain, according to the American Liver Foundation.
In order to diagnose the disease, a blood test is done to test for antibodies in
order to see if the person has been exposed to the disease before, Gulick said.
If the person tests positive, they are then tested for the active virus in the
blood stream.
Blood banks perform the test before a person donates, he said.
"If a person wants to get tested and not have to pay, they can do it that way,"
he said.
The task force most likely will focus on finding ways to better diagnose and
treat the virus, and educate different groups about the virus - especially those
in the prison system, Gulick said.
"There are a lot of people with hepatitis C in prisons," he said.
Many prisoners with hepatitis C go unmonitored, and end up with liver disease.
By then, it is too late to help them, he said.
"It's not being appropriately treated," he said. "Were going to sit down and go
through it on different levels to try and see how we can go through with giving
it its proper awareness in the state."
Bucholz said hepatitis C is a continuing health issue and the task force's goal
will be to reduce the number of people infected with it.
"It's an incredibly debilitating disease," he said.
http://www.statenews.com/article.phtml?pk=41552
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"I have studied many philosophers and many cats. The wisdom of cats is
infinitely superior." - Hippolyte Taine

July 11, 2007
NEW ISSUE OF "VIRAL HEPATITIS" AVAILABLE ON VHPB WEBSITE
The Viral Hepatitis Prevention Board (VHPB) website has been
updated to include a new issue of the publication "Viral
Hepatitis."
"Viral Hepatitis," Volume 15, Number 2, reviews topics covered
at the VHPB meeting held on November 23-24, 2006, in Madrid,
Spain. The objective of the meeting was to review the current
situation relating to prevention and control of viral hepatitis
in Spain.
To access the ready-to-copy (PDF) version of this issue, go to:
http://www.vhpb.org/files/html/Meetings_and_publications/Viral_Hepatitis_Newslet\
ters/vhv15n2.pdf
To access the home page of the VHPB website, go to:
http://www.vhpb.org
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"I have studied many philosophers and many cats. The wisdom of cats is
infinitely superior." - Hippolyte Taine

July 11, 2007
HEPATITIS B FOUNDATION POSTS CONFERENCE PROCEEDINGS ONLINE
During the weekend of June 8-9, 2007, the Hepatitis B Foundation
(HBF) sponsored the seventh annual B Informed Patient
Conference. Almost 200 patients and family members gathered this
year in Philadelphia, PA, to learn the latest about the care and
management of chronic hepatitis B.
HBF has posted highlights from the main information sessions, as
well as copies of the speakers' slides. Some of the
presentations include links to additional print resources.
To access the conference proceedings, go to:
http://www.hepb.org/patients/patient_conference.htm
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"I have studied many philosophers and many cats. The wisdom of cats is
infinitely superior." - Hippolyte Taine

Soroka doctor convicted of knowingly infecting 25 patients with
Hepatitis C
By Ran Reznick
Dr. Sergei Pontus was convicted on Tuesday of willfully infecting 25
patients with the Hepatitis C virus while completing his anesthesiology
residence at Soroka Hospital in Be?er Sheva from 2001-2003. In his ruling, Judge
Natan Zlochover of the Be?er Sheva District Court stated that Pontus, who was
addicted to the anesthetic Fentanyl and infected with Hepatitis C, passed the
virus to patients in two ways: He used the same needle to inject anesthesia into
surgical patients that he used to inject himself with the drug, and he injected
patients with anesthetic medication stored in an ampule that was tainted with
his own infected blood.
Pontus, 40 from Dimona, was convicted on 25 counts of grave assault,
the willful spread of disease, theft (of anesthetics) in his place of
employment, fraud and breach of corporate trust, negligence, interference with
investigations and illegal possession and use of drugs. Pontus was fired from
Soroka Hospital after the case was exposed. As far as is known, he is not
currently employed in the health care system and is working in Dimona
According to the ruling, Pontus injected 1-5 ampules of the
anesthetic medication up to 25 times a day while caring for patients. Experts
say most of the patients whom Pontus infected developed chronic hepatitis and 20
percent developed cirrhosis of the liver, a disease which can be fatal.
The judge ruled that Pontus, understood the significance of his actions, because
he served as a physician and knew that his blood was infected with the virus. He
knew the ways in which the virus could be transmitted, primarily by direct
contact with infected blood, and his knowledge actually surpassed that of a
regular, inexperienced physician because he worked in surgery. Thus, he was
clearly aware of the risk that his behavior posed to patients.
The court declared that Pontus, was apathetic and indifferent to the presence of
risk. He did not seek medical treatment for himself because he believed that
there was little chance of a cure, and despite that, continued to inject himself
with Fentanyl in the rest room, where he sprayed his own blood onto the tiles
and the toilet, endangering everyone who used the rest room. The ruling
questions the conduct of hospital personnel, who did not promptly inform their
superiors of Pontus unusual behavior? This indicates that the incident could
have been discovered at an earlier date.
Several factors roused the hospital staff?s suspicions: Pontus? orders of
enormous amounts of drugs over an extended period from the hospital pharmacy,
lack of alertness while working in the operating room and intensive care,
multiple requests to be replaced by other personnel in surgery and presence of
an intravenous connection port in his leg. Despite the nature of these ?grave
issues,? this information was never transmitted to authorities in the hospital.?
The ruling also criticizes the conduct of operating rooms and the system of
anesthesia delivery in the major medical center in the South of the nation,
owned by Clalit Health Services, Israel?s largest HMO. Among other misconduct,
the ruling revealed that anesthesiologists at Soroka commonly replaced their
colleagues in surgery, for various periods of tine, without documenting this in
patient charts, as required.?
However, the judge noted that when the case was uncovered, the hospital acted in
a decisive and commendable fashion, and invested considerable efforts and
resources to identify all those who may have been exposed to the virus to dispel
public fear roused by the incident.
In January 2008, there will be a hearing to consider Pontus sentence. Until
then, he will be sent for evaluation at the parole board. The criminal
indictment of Pontus was presented by attorney Aviva Hatzroni, of the Southern
District of the State Prosecutor's Office. Pontus will be represented by
attorney Robert Barel.
http://www.haaretz.com/hasen/spages/880966.html
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
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*.
Dogs come when they're called. Cats take a message and get
back to you.
-- Missy Dizick

Lettuce most likely source for E. coli?
Wednesday, July 11, 2007
By STEVE DOYLE
Times Staff Writer steve.doyle@...
Health officials point to Little Rosie's, but 'it's safe to eat there'
Lettuce was the likely source of an E. coli bacteria outbreak that has now
sickened 18 people, the Huntsville-Madison County Health Department's assistant
director said Tuesday.
Dr. Debra Williams said all signs point to shredded lettuce served by Little
Rosie's Taqueria as the probable culprit. Fourteen of the 15 people who have
tested positive for E. coli O157:H7 poisoning ate at the Whitesburg Drive
restaurant June 28-29, she said. The other victim did not eat there.
Health officials are awaiting test results on three other Little Rosie's
customers who have symptoms of E. coli exposure.
"We think it was a cross-contamination handling issue" by a restaurant employee,
Williams said.
Fred Grady, chief of the state health department's epidemiology division, said
it's "a little premature" to call lettuce the source of the outbreak because his
agency is still reviewing information collected from victims and the restaurant.
"There are so many things we can't say yet because we haven't looked at the
data," Grady said Tuesday. "Statistically, we ought to be able to make some
pretty strong assumptions, but (the investigation) is not nearly complete."
Alabama restaurants are required to toss fresh produce after four days, so any
tainted lettuce served by Little Rosie's in late June is probably long gone,
Grady said. "It's safe to eat there," he said.
Health officials considered closing the popular Mexican eatery, but Williams
said the contamination was apparently just a "two-day event." Little Rosie's
scored a 94 out of 100 on its most recent Health Department inspection June 29.
Little Rosie's set up a toll-free hotline Tuesday - 1-800-328-7761 - for
customers who have questions or concerns about the E. coli outbreak.
Pam Ritz, who helps run the restaurant's risk management program, urged health
officials not to speculate on the source of the illness until epidemiologists in
Montgomery finish their work.
"We're being a little too quick to say it's any specific product before all
those cultures are done," Ritz said Tuesday. "Allow the guys to go back to the
state lab and begin putting the pieces together."
Tod Craig, co-owner of Little Rosie's, said his company is having all 80
restaurant workers tested for E. coli bacteria. To prevent cross-contamination,
lettuce is chopped by a single employee who does not handle meats, he said. The
restaurant has also taken steps to make sure different tongs are used for raw
and cooked meats on the grill.
"We're trying to be proactive on this and do even more than what the Health
Department is asking us to do," Craig said.
State epidemiologist Dr. J.P. Lofgren and two other senior state Health
Department employees spent much of Monday and Tuesday at Little Rosie's. The
group had lunch there Tuesday so Lofgren could watch the kitchen in action.
"Epidemiologists always go where the outbreak is because that's the safest place
to eat," Williams said. "Everybody's on their toes."
Little Rosie's is just as anxious as Health Department officials to solve the
mystery and has fully cooperated with the investigation, Ritz said.
"We let them have free access to our people, our products, our procedures," she
said.
It was not clear late Tuesday how many E. coli victims remain hospitalized. The
youngest victim, 5-year-old Samuel Coggin of Meridianville, was supposed to have
surgery Tuesday at Vanderbilt University Medical Center to prepare for dialysis.
Kidney failure is the biggest danger of E. coli poisoning; other symptoms
include bloody diarrhea and painful abdominal cramps.
"He wants to go home, but he's been brave," Samuel's mother, Dinah Rene' Coggin,
said by telephone Tuesday afternoon. "We're hanging on prayers."
She said doctors hope that dialysis will flush the toxic bacteria from Samuel's
system and allow his ailing kidneys to recover.
Grady said this is Alabama's worst E. coli O157 outbreak in "a couple decades."
Investigators are checking for any links to other, seemingly unrelated cases of
E. coli poisoning nationwide, he said.
E. coli O157 bacteria is found in the intestines of cattle, deer, goats and
sheep and can accidentally contaminate meat during slaughter. Most infections in
the U.S. are traced to eating undercooked ground beef, but sprouts, leafy
vegetables and unpasteurized milk or juice also can be sources.
Farm vegetables can become contaminated if they come in contact with
bacteria-laden manure or water, Williams said.
In December, the federal Centers for Disease Control and Prevention determined
that tainted lettuce was the probable source of an E. coli outbreak at Taco Bell
restaurants in New York, New Jersey, Pennsylvania and Delaware. Of the 71 people
who got sick, 53 spent time in a hospital, and eight developed a type of kidney
failure called hemolytic-uremic syndrome.
http://www.al.com/news/huntsvilletimes/index.ssf?/base/news/1184145446135050.xml\
&coll=1&thispage=1
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"I have studied many philosophers and many cats. The wisdom of cats is
infinitely superior." - Hippolyte Taine

Trying this yet again. Please click on link and give it a 5 vote por favor
:-)
http://www.robinhoodfund.com/cast-your-votes/wish/id/8463
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
Dogs come when they're called. Cats take a message and get
back to you.
-- Missy Dizick

We've lost a sense of humour
Wendy Tuohy
July 12, 2007 12:00am
MELBOURNE'S comedy stars must be sighing a collective, "There but for the grace
of God go I", as one of our most affable stand-up men, Peter Helliar, is
pilloried for an innocent quip.
Helliar wondered jokingly on Rove Live what to give Pamela Anderson, the actor
who has everything, for her 40th birthday.
"Hepatitis C," he mused. "Oh wait, she already got that last year."
Pretty much instantly, Helliar found himself the target of a storm of barbs.
The comic was branded "irresponsible", "discriminatory" and "ignorant" by
Hepatitis Australia and the joke was described as "cheap and cruel".
Helliar was even accused of having "added to the pain" of Australia's 260,000
hepatitis sufferers.
The comic, who earned his popularity playing the footy-tragic everyman, Bryan
Strauchan, apologised immediately, and sincerely.
He said he had not meant to cause offence and was sorry if anyone was offended.
For the record, Pamela Anderson is very open about having contracted the disease
by sharing a tattoo needle.
In 2003, she speculated it would kill her within a decade. Currently she is well
and let's hope she stays that way.
But Helliar did not make any malicious or prejudicial comment about the disease
or about people who might have it.
Nor did he say anything pejorative about hepatitis C, Pamela Anderson's illness
or anyone else's.
The comic, who has been described by one respected TV editor as "the ultimate
nice guy, the boy next door, friendly, matey and accessible", must have wondered
what hit him.
People in the comedy-loving Australian audience must wonder, too, just when we
traded cheekiness, broadmindedness and good-natured irreverence for the wave of
political correctness that broke over Helliar.
It goes without saying that no one wants anyone with any disease or any other
affliction to be humiliated.
But sending up the serious and even the painful is the life blood of comedy.
Comedy in its many forms casts light on our lives.
Culture and pop culture show our sensitivities and society's ills.
Comedy's job is to challenge social norms. That's the job description.
Australian comedians excel at it, but they didn't invent it.
Monty Python was the trail blazer in the art of ridiculing the complexities of
life.
In The Life of Brian, they demonstrated that anything should be fair game, even
the death of Jesus on the cross.
The morbidly obese Mr Creosote, who clearly had an eating disorder, exploded in
The Meaning of Life.
Mike Myers followed with the Fat Bastard character in the Austin Powers series.
Matt Lucas and David Williams Little Britain make us think as we laugh at their
definitely un-PC characters.
What about "the only gay in the village" and a man who pretends to be disabled.
Closer to home, we have Chris Lilley's internationally acclaimed We Can Be
Heroes.
His characters include a disabled woman who rolls instead of walking and a deaf
and partially disabled twin who is often ridiculed by his brother.
There is also a Chinese-Australian physics student who plays an Aborigine in his
uni musical.
On the live scene, Judith Lucy has regaled audiences with her painful story of
discovering she was adopted.
Comedy reflects images that don't always make for cosy viewing.
But in a broadminded culture such as ours, allowing comedians to go to the edge
is surely a healthy thing.
http://www.news.com.au/heraldsun/story/0,21985,22058322-5000117,00.html
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"There are two means of refuge from the miseries of life: music and cats." -
Albert Schweitzer
President
http://www.HEALSoftheSouth.org
http://www.HEALSoftheSouth.com

Technique predicts hep C treatment success
FOR IMMEDIATE RELEASE
July 11, 2007
BLOOMINGTON, Ind. -- By identifying genes that respond to interferon -- a drug
commonly used to treat hepatitis C viral infections and certain types of cancers
-- researchers have devised a novel way of predicting patient response to
treatment.
Scientists from Indiana University Bloomington, the University of Haifa (Israel)
Insititue of Evolution, St. Louis University and the University of Pittsburgh
used a blind, statistical approach to identify 36 genes that are not only
actively expressed in the presence of interferon, but also are turned on in
patients whose virus counts are dramatically diminished. The researchers
describe the technique and report the results of the first test in last week's
Public Library of Science (PLoS): ONE.
"This method gives us the opportunity of identifying genes that are import in
the response to any drug," said IUB biologist Milton Taylor, who led the study.
"This method is not necessarily confined to hepatitis C. In this case we were
just using interferon and hepatitis C to see if the method works."
A growing consensus among medical scientists holds that one reason why patients
respond differently -- sometimes very differently -- to a given treatment is due
to the patients' unique genetic identities. But how are scientists to know which
genes -- out of the 50,000 that make up the human genome -- are actually
involved in mitigating, say, the flu, herpes or Hodgkin's Lymphoma?
It is not enough to simply look at what genes are turned on in the midst of an
infection, or even to look at which genes are most active in patients who are
faring well with a prescribed treatment, Taylor says. So he and University of
Haifa mathematician Leonid Brodsky decided to delineate the most important genes
by combining viral counts in the blood with gene expression across time for each
individual patient.
The scientists examined expression patterns of 22,000 genes in 69 patients at
six different time points during treatment. Their analysis turned up 36
candidate genes that are closely associated with virus removal in patients. A
quarter of these 36 have no known function. Lending credibility to their
methodology, however, a sweep of the literature shows that nearly all 36 genes
have previously been identified as playing a role -- known or unknown -- in the
human response to interferon treatment. Using other methods, Taylor says, a
researcher would have to examine perhaps 1,000 genes altered by the treatment
and from these decide by other means which were most important.
Milton Taylor and Takuma Tsukahara (Indiana University Bloomington), Leonid
Brodsky (University of Haifa), Abdus S. Wahed and Jia Li (University of
Pittsburgh) and John Tavis (St. Louis University) contributed to this report. It
was funded by the National Institutes of Health (National Institute of Diabetes
and Digestive and Kidney Diseases) virahepC program.
To speak with Taylor, please contact David Bricker, IU Media Relations, at
812-856-9035 or brickerd@....
"A Novel Unsupervised Method to Identify Genes Important in the Anti-viral
Response: Application to Interferon/Ribavirin in Hepatitis C Patients" PLoS:
ONE, 07/04/2007
http://newsinfo.iu.edu/news/page/normal/5962.html
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"There are two means of refuge from the miseries of life: music and cats." -
Albert Schweitzer
President
http://www.HEALSoftheSouth.org
http://www.HEALSoftheSouth.com

Thank you Dennis for your comments on the news article on the woman who believes
she was cured by Amantadine. I always look forward to reading your posts.
Thanks also to Pam for all you do to help so many.
Best wishes,
Bonnie

Study finds variable drug sensitivity among hepatitis C viruses
July 11, 2007
by Jill Sakai
Hepatitis C infection presents many patients with a troubling Catch-22
situation.
Chronic infection with the hepatitis C virus (HCV) is the leading reason
patients receive liver transplants today. Unfortunately, infection of the new
liver by residual HCV in the blood is inevitable, and the immune system
suppression crucial to prevent transplant rejection can worsen HCV-mediated
disease in transplant patients.
Now, a study from the University of Wisconsin-Madison School of Medicine and
Public Health offers new promise for a double-duty treatment that may provide
both immune suppression and anti-HCV activity in a single drug.
A common immunosuppressive drug, called cyclosporine A, has hinted of such
antiviral activity - at least in a lab dish - but past clinical studies have not
shown conclusive evidence that it effectively fights HCV in patients.
"The thought was that maybe cyclosporine was doing something good because it has
this antiviral activity, but in fact the clinical data doesn't really support
that very well," says Robert Striker, UW-Madison professor of medicine and
medical microbiology and immunology, who led the new study.
In spite of past unconvincing clinical studies, the circumstantial evidence is
strong enough to have kept many scientists intrigued. For example, another
immunosuppressant, tacrolimus, has largely replaced cyclosporine for transplant
patients in recent years - a time period also marked by a trend toward poorer
post-transplant recovery of HCV-infected patients.
The Wisconsin study, which was published online June 28 in the journal
Hepatology, provides new support for anti-HCV effects of cyclosporine - plus a
possible reason why previous studies may have missed it.
By monitoring the evolution of cyclosporine resistance, the group discovered
that HCV forms with slight genetic differences - varying at only a handful of
their 9,000 genetic bases and in just two proteins - have dramatically different
sensitivities to cyclosporine.
HCV is highly genetically variable, Striker says - in fact it is the most
variable virus known, meaning that many different versions exist with slightly
different genetic sequences.
The new finding suggests that patients with cyclosporine-sensitive HCV variants
may show antiviral benefit from cyclosporine treatment, while those with
resistant variants would not.
"One of the more exciting aspects of this study is that it fits some data
already [known] that in fact there is an effect from cyclosporine but that it is
a genotype- or strain-specific effect," says Striker.
Naturally occurring genetic variations may have masked the effects of
cyclosporine against HCV in previous clinical trials, he says. "This study
reveals a complexity of the issue that was previously not studied very
rigorously."
Though the results from the current analysis are too preliminary to determine
whether individual patients should switch drug regimens, he suggests that more
rigorous investigations are needed that will take into account viral variability
and differential drug sensitivities.
The high degree of HCV variability means there will probably never be a
one-size-fits-all treatment, but rather that many factors will likely play
important roles in deciding the best course of action for an individual patient,
including which viral strain is involved and which drugs are used.
"We don't know how important these factors are in patient care right now, but
they are impacting decisions that are made right now," Striker says.
Understanding how cyclosporine acts against HCV should help doctors choose
complementary drug combinations to reduce the development of drug resistance,
Striker says, while the specific proteins identified - important in viral
replication - offer a novel target for antiviral drugs.
"Slightly altered versions of cyclosporine that may be better as antivirals are
in clinical trials now," he says. "This paper strengthens the rationale to give
these compounds a chance."
Funding for this work was provided by the UW-Madison School of Medicine and
Public Health from "The Wisconsin Partnership Fund for a Healthy Future" and by
the National Institutes of Health and American Cancer Society.
http://www.news.wisc.edu/13928
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"There are two means of refuge from the miseries of life: music and cats." -
Albert Schweitzer
President
http://www.HEALSoftheSouth.org
http://www.HEALSoftheSouth.com

Good find, Pam, since the amantadine question came up.
This is recent high level labaoratory research published in 2007. I
extracted the quote below as this is the direct result of the
research as it pertains specifically to Amantadine and HCV which was
discussd in some previous posts.
QUOTE:
genotypes, amantadine affected neither RNA replication nor the
release or infectivity of HCV particles. In agreement, p7 ion channel
activity was not affected by amantadine, demonstrating that
amantadine is not an HCV-selective antiviral.<< END QUOTE
To simplify, they found that amantadine has no effect on HCV of any
genotype, it does not inhibit HCV replication nor inhibit release
of new HCV viral copies nor inhibit these new copies from infecting
new cells and finally that Amantadine is not an antiviral that works
against Hep-c.
This supports my comments in an earlier post questioning Mary
Moppins claims that she cured herself with Amantadine. So, it is
likely that there were other reasons why she (allegedly) became
undectable for the virus if in fact that is even true. I wonder if
she had a follow up PCR to verify? Whatever.
Dennis near Seattle

Donald and all,
This is just a reminder, the HepCingles Group Webpage does not accept
forwarded messages, nor do these appear in the Digest. Those who
recieve individual emails might get them, I don't know, I never use
that, I get everything in digest.
Remember not to forward articles but instead copy and past the
original article into your email, otherwise it will not appear on the
HepCingles board (web page) or in the digest. what you see below is
exactly how it came through in the digest and on the HepCingles Group
site. As you can see there is no message, just the note about a
forwarded attachment:

The journalist makes it sound as if this is a new top secret drug,
not mentioning the name of it because it is in a clinical trial.
Duh!
I'm fairly positive that they are talking about the phase III
clinical trials of Albuferon which is interferon bound with human
albumin rather than polyethylene glycol(PEG) and is dosed once every
two weeks. It has already undergone extensive studies and clinical
trials, at least outside the USA (in Australia, Canada, Czech
Republic, France, Germany, Israel, Poland and Romania). I have an e-
friend in Canada who completed a clinical trial of albuferon and
ribavirin more than a year ago and the 24 week (six month) post trial
SVR results were published a couple of months ago, so this is nothing
new, exotic or secret.
Below are the final results of the phase 2b clinical trials. I also
noticed that the company omitted the days of missed work for the
whole second half of the 48 week treatment protocol- they only
reported up to 24 weeks. They definately try to show their product
in the most favorable light, which may be the reason that they
omitted that data from weeks 24 to 48 in their press releases. These
sorts of reports are always presented with marketing in mind, for
example they imply how much more convenient it is to dose every two
weeks with their product instead of every one week (with the supposed
inferior brands). Does anyone really give a damn about that
marketing hype, two week dosing rather than one week?? Hell no, we
only care if it works!! But, they can fool some people to think that
dosing every two weeks compared to every one week is some kind of
benefit (it isn't and in fact could present problems) but it is a
sales gimmick to be exploited.
If you can read between the lines and cancel out the marketing hype
(if that is even possible in some of these reports) then you might
get a more accurate picture of Albuferon. Whenever there is any
marketing hype at all in a study report or clinical trial report, you
should be very critical and suspicious of some of the findings as
they may be a manipulation- such as in this case the omission of
number of days missed from work during the second half of the
treatment. This indicates to me that they are "cherry picking" the
most favorable data and presenting it in the most favorable light.
That may involve twisting and misrepresenting the truth, or what is
referred to in the 'Safe Harbor' disclaimers (to warn stock
investors) as 'forward sounding statements that may or may not
reflect the actual facts'- something like that.
They do this to lure investors, increase stock market prices and to
build a marketing platform.
There are a couple of items that make me very suspicious of some of
these findings, (I might address one of them in another post)
especially with regard to side effects. All of these companies seem
to be looking for any slight advantage they can get over competitors
on the 'side effects' issues and since this is an objective and they
are looking precisely for any seeming advantage there is a tendancy
for 'cherry picking' and bias in how they interpret and present the
information. Anyhow, some of this data does not fit in with all of
the research that I am familiar with and that has been alot over the
years. Therefore I highly suspect some manipulation of data for
marketing purposes.
As far as the SVR rates at 6 months post treatment, that is pretty
much solid evidence, but 12 months post treatment is more acceptable.
However, they didn't say how many people were in this phase 2b
trial. If it was only 100 patients for example alot of these
comparisons with Pegasys could be way off, and of course it is much
easier to exploit parts of the results and mislead when the studies
or clinical trials are very small- less likely in larger trials. The
bottom line question is "does it work" and most of the rest is
bullshit. I wish we didn't have to deal with marketing hype (and
incompetent journalists), but we do.
Anyhow, here is one published report from the phase 2b final
results. In fact the second word of the report itself (after the
inroductory paragraphs) is completey psychological HYPE. They call
this 'top-line' final results. (yeah, as if their product is 'Top-
Line') I would rather see the 'bottom-line' final results without all
of the hype.
In any case, here it is:
Source: http://www.medicalnewstoday.com/medicalnews.php?newsid=73544
Human Genome Sciences Announces Positive Final Results Of Phase 2b
Trial Of Albuferon(R)
Article Date: 08 Jun 2007 - 0:00 PDT
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the top-
line final results of a Phase 2b clinical trial of Albuferon(R)
(albinterferon alfa-2b) in combination with ribavirin in treatment-
naive patients with genotype 1 chronic hepatitis C. The Company
expects to make a full presentation of the final results at an
appropriate scientific meeting later in 2007.
"The final Phase 2b results confirm and extend the findings of
several studies, which suggest that Albuferon may offer efficacy at
least comparable to peginterferon alfa-2a, with half the injections
and possibly less impairment of quality of life," said John
McHutchison, M.D., Coordinating Center Principal Investigator for the
Phase 2b trial, and Professor of Medicine and Associate Director,
Duke Clinical Research Institute and Duke University Medical Center,
Durham, North Carolina. "We are extremely pleased with the high
quality of the data that have emerged from the Phase 2b study, and we
look forward to continuing the evaluation of the 900-mcg and 1200-mcg
doses of Albuferon in larger populations in Phase 3 trials."
The primary efficacy endpoint of the Phase 2b trial of Albuferon was
sustained virologic response (SVR), defined as undetectable viral
load (HCV RNA<10 IU/mL) at 24 weeks following completion of therapy.
The final results demonstrated that Albuferon provided at least
comparable efficacy vs. Pegasys (peginterferon alfa-2a), based on an
ITT analysis. The treatment group receiving Albuferon 900-mcg doses
every two weeks achieved an SVR rate of 58.5%, vs. 57.9% for the
group receiving Pegasys once every week (ITT analysis). This
Albuferon treatment group also had more favorable health- related
quality-of-life scores than the Pegasys treatment group. Among
heavier patients (
in the combined groups receiving Albuferon every two weeks achieved
SVR, versus 53.3% for patients receiving Pegasys once a week. The
ability to maintain efficacy in heavier patients is of particular
importance in certain markets, including the United States, where a
large percentage of patients weigh more than 75 kg.
The top-line final results of the Phase 2b trial at Week 24
following the completion of therapy include the following SVR rates
and other findings:
Albuferon 900-mcg Every Two Weeks (Albuferon 900 Q2w)
-- Based on an intention-to-treat (ITT) analysis, 58.5% of patients
in the Albuferon 900 Q2w treatment group achieved SVR, vs. 57.9% for
Pegasys administered every week.
-- In heavier patients (
those in the Albuferon 900 Q2w treatment group achieved SVR, versus
53.3% for Pegasys.
-- Among all treatment-adherent patients in the Albuferon 900 Q2w
treatment group, 72.3% achieved SVR, versus 66.7% for Pegasys.
-- Based on the SF-36 Health Survey, patients in the Albuferon 900
Q2w treatment group reported less impairment of health-related
quality of life, compared with patients in the Pegasys treatment
group, as measured by both physical component and mental component SF-
36 summary measures at all time-points throughout the 48-week
treatment period.
-- Fewer working patients in the Albuferon 900 Q2w treatment group
reported missing 7 days or more of work during the month prior to
their visits at Weeks 12 and 24, vs. the Pegasys group (Week 12:
3.0% for Albuferon 900 Q2w vs. 19.2% for Pegasys; Week 24: 5.8% for
Albuferon 900 Q2w, vs. 22.4% for Pegasys).
-- The rate of discontinuations due to adverse events was 9.3% in the
Albuferon 900 Q2w treatment group, vs. 6.1% in the Pegasys group.
"The 900-mcg Albuferon dose has the potential to offer patients an
attractive therapeutic option, requiring half as many injections as
Pegasys, with more favorable quality of life effects and favorable
sustained virologic response data," said David C. Stump, M.D.,
Executive Vice President, Research and Development, HGS.
Albuferon 1200-mcg Every Two Weeks (Albuferon 1200 Q2w)
-- ITT analysis shows that 55.5% of patients in the Albuferon 1200
Q2w treatment group achieved SVR, vs. 57.9% for Pegasys administered
every week.
-- In heavier patients (
those in the Albuferon 1200 Q2w treatment group achieved SVR, versus
53.3% for Pegasys every week.
-- Among all treatment-adherent patients in the Albuferon 1200 Q2w
treatment group, 70.6% achieved SVR, versus 66.7% for Pegasys.
-- ITT analysis shows that the Albuferon 1200 Q2w treatment group
exhibited a robust early antiviral response (reduction in hepatitis C
RNA viral load to below the level of quantitation): 74.5% for
Albuferon 1200 Q2w at Week 12, vs. 65.8% for Pegasys. The Albuferon
1200 Q2w treatment group also had the most rapid time to HCV RNA
negativity.
-- The rate of discontinuations due to adverse events was 18.2% in
the Albuferon 1200 Q2w treatment group, vs. 6.1% in the Pegasys
group. Adverse events observed were those typically expected with
interferon therapy. Dose reductions were attempted in only 30.0% of
Albuferon subjects prior to discontinuation, versus 42.9% for
Pegasys.
"In the Albuferon Phase 3 trials, we will strongly encourage
titration of dose where necessary to ensure tolerability, reduce the
rate of discontinuations, and maximize the therapeutic benefit of the
robust early antiviral response offered by the 1200-microgram dose on
a two-week administration schedule," said Dr. Stump.
Albuferon 1200-mcg Monthly (Albuferon 1200 Q4w)
-- ITT analysis shows that 50.9% of patients in the Albuferon 1200
Q4w treatment group achieved SVR, vs. 57.9% for Pegasys administered
every week.
-- In heavier patients (
those in the Albuferon 1200 Q4w treatment group achieved SVR, versus
53.3% for Pegasys administered once every week.
-- Among all treatment-adherent patients in the Albuferon 1200 Q4w
treatment group, 62.0% achieved SVR, versus 66.7% for Pegasys.
-- The rate of discontinuations due to adverse events was 12.1% in
the Albuferon 1200 Q4w treatment group, vs. 6.1% in the Pegasys
group.
-- The number of patients experiencing severe hematologic adverse
events was significantly lower in the Albuferon 1200 Q4w treatment
group (10.3%, vs. 23.7% for Pegasys, p=0.006).
"We are encouraged that more than half of the patients achieved
sustained virologic response in the treatment group receiving
Albuferon 1200-mcg once every month," said Dr. Stump. "These data,
along with emerging Phase 2 data for a monthly 1500-mcg dose, provide
an excellent rationale for the study that we and our collaborator,
Novartis, are currently planning to evaluate higher doses of
Albuferon administered monthly."
The top-line final Phase 2b results include data through Week 24
following completion of 48 weeks of therapy. The open-label, multi-
center, active- controlled, dose-ranging trial enrolled and
randomized 458 patients with genotype 1 chronic hepatitis C. Patients
were randomized into four treatment groups, three of which received
subcutaneously administered Albuferon (900 mcg every two weeks, 1200
mcg every two weeks, and 1200 mcg every four weeks). The fourth
treatment group served as the active control group and received 180
mcg of subcutaneously administered peginterferon alfa-2a (Pegasys)
once a week. All patients received weight-based oral ribavirin daily.
The study was conducted in Australia, Canada, Czech Republic, France,
Germany, Israel, Poland and Romania.
About Albuferon
Albuferon is a novel long-acting form of interferon alpha created by
HGS using its proprietary albumin fusion technology. Albuferon
results from the genetic fusion of human albumin and interferon
alpha. Human albumin is the most prevalent naturally occurring blood
protein in the human circulatory system, persisting in circulation in
the body for over twenty days. Research has shown that genetic fusion
of therapeutic proteins to human albumin decreases clearance and
prolongs the half-life of the proteins. Recombinant interferon alpha
is approved for the treatment of hepatitis C, hepatitis B and a broad
range of cancers.
Albuferon is being developed by HGS and Novartis under an exclusive
worldwide development and commercialization agreement entered into in
June 2006. Under the agreement, HGS and Novartis will co-
commercialize Albuferon in the United States, and will share clinical
development costs, U.S. commercialization costs and U.S. profits
equally. Novartis will be responsible for commercialization in the
rest of the world and will pay HGS a royalty on those sales. Clinical
development, commercial milestone and other payments to HGS could
total as much as $507.5 million, including $92.5 million received to
date.
Source: http://www.medicalnewstoday.com/medicalnews.php?newsid=73544
===============================================

Easing the Grief of the Family of an Organ Donor
July 10th, 2007 @ 9:51am
Paul Nelson, KSL Newsradio
An accidental meeting in a hospital cafeteria becomes bittersweet for two
families.
After hearing that her son might not survive for long without a liver
transplant, Melissa Moss was delighted to hear they found a donor. She then went
down to the cafeteria at Primary Children's Medical Center and coincidentally
bumped into Ben Howard.
Moss said, "His daughter had unfortunately passed during the night, and they had
donated her liver."
That was not the liver the boy received, but it freed another liver so he could
get one. Moss says at first she felt bad, but the accidental meeting did help
Ben Howard.
"He said it was really comforting for him to meet somebody on the receiving end
and to see what joy and stuff that can bring," said Moss.
She says her four-month-old son is recovering very well.
http://www.ksl.com/?nid=148&sid=1460699
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
Dogs come when they're called. Cats take a message and get
back to you.
-- Missy Dizick

South Florida's Viragen delisted from AMEX
July 9, 2007
PLANTATION, FL-Viragen , which is developing drugs to treat cancers and viral
infections, has been delisted from the AMEX stock exchange.
The company will switch to the Over-the-Counter Bulletin board July 12 under a
symbol not yet assigned.
The company completed a $3 million financing with RAB Capital of London in
April, but its stock price has traded under $1 for a year, most recent at only 4
cents a share.
In June the company subsidiary Viragen International announced a reverse stock
split in which each 40 shares of its common stock would be converted to one
share of common stock.
The company has operations in the U.S., Scotland, and Sweden.
Its lead product is Multiferon, highly purified, multi-subtype, natural alpha
interferon derived from human white blood cells.
For more see: www.viragen.com
http://www.techjournalsouth.com/news/article.html?item_id=3447
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
Dogs come when they're called. Cats take a message and get
back to you.
-- Missy Dizick

US firm sues Cadila in patent row
P B Jayakumar / Mumbai July 10, 2007
Three Rivers Pharmaceuticals, a US-based speciality drug
manufacturer, has sued Zydus Cadila (Cadila Healthcare) and its US subsidiary
Zydus Pharmaceuticals (USA) for infringing on the former's patent on a process
for manufacturing an anti-viral drug Ribavirin used in the treatment of
Hepatitis C.
Three Rivers Pharma has alleged that Zydus Cadila infringed on its
patent on an improved process for manufacturing Ribavirin pellets using wet
granulation.
The lawsuit was filed in the district court of Virginia about a
month ago to prevent Zydus Cadila from making, selling or importing finished
dosage forms of ribavirin in the United States.
Ribasphere, Three Rivers' Ribavirin drug, was approved by the US
Food and Drug Administration in April 2004. Ribavirine is an old-generation
molecule used in the treatment of Hepatitis C as a combination therapy with
drugs such as Roche's Pegasys.
Zydus Cadila declined to comment on the development. It also
declined to reveal the abbreviated new drug applications (ANDA) with a Para IV
certification filed in the US.
According to the US rules, ANDAs with Para IV certifications are a
challenge on an innovator's drug patent. The challenge has to be notified to the
innovator company, which in turn has to sue the challenger within 45 days of the
notice.
"We expected Zydus to respect our intellectual property without the
need for litigation. But they refused to provide us with any meaningful
assurance that it had not used and would not use our patented process," Donald
Kerrish, president and CEO of Three Rivers, stated on the company's website.
Zydus Cadila has around 27 approvals since the commencement of
filing process with the US Food and Drug Administration (FDA) in 2003-04, and
has filed over 60 ANDAs and 51 drug master files (DMFs). However, most of its
ANDAs were for patent non-infringing processes.
Three Rivers Pharmaceuticals is a privately held company based in
Cranberry Township, Pennsylvania, and focuses on specialised therapies.
http://www.business-standard.com/common/storypage.php?autono=290604&leftnm=1&sub\
Left=0&chkFlg=
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"I have studied many philosophers and many cats. The wisdom of cats is
infinitely superior." - Hippolyte Taine

Antiviral effects of amantadine and iminosugar derivatives against hepatitis C
virus.
Steinmann E, Whitfield T, Kallis S, Dwek RA, Zitzmann N, Pietschmann T,
Bartenschlager R.
Department of Molecular Virology, University of Heidelberg, Heidelberg, Germany.
Current therapy of chronic hepatitis C is based on the combination of pegylated
interferon-alpha and ribavirin. In spite of 50% sustained virological response,
therapy is still limited by unsatisfying success rates with genotype 1
infections and adverse side effects. One attempt to increase success rates is
triple combination therapy of interferon and ribavirin with amantadine, a drug
assumed to interfere with HCV p7 ion channel function. However, results from
clinical trials indicate limited efficacy and the antiviral activity is unclear.
In contrast, NS3 protease inhibitors have shown potent antiviral effects in
clinical trials but rapid selection for drug resistance may limit their benefit.
Targeting cellular factors required for HCV is therefore an attractive
alternative. In this study, employing a system for production of infectious HCV
particles in cell culture, we determined the antiviral effects of amantadine and
iminosugar derivatives; the second of which primarily target host cell
glucosidases required for folding and maturation of HCV envelope glycoproteins.
We found that across a spectrum of HCV isolates and genotypes, amantadine
affected neither RNA replication nor the release or infectivity of HCV
particles. In agreement, p7 ion channel activity was not affected by amantadine,
demonstrating that amantadine is not an HCV-selective antiviral. In contrast, a
dose-dependent reduction of virus titers was achieved with iminosugars.
Furthermore, HCV was rapidly eliminated from cell culture upon passage in the
presence of a long alkyl chain deoxynojirimycin (DNJ). Conclusion: Iminosugar
derivatives are potential drugs for treatment of HCV infections. (HEPATOLOGY
2007.).
PMID: 17599777 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=175997\
77&dopt=Abstract

Roche and Alnylam form alliance on RNAi therapeutics
9th July 2007
By Staff Writer
Roche and Alnylam Pharmaceuticals have struck deal worth up to $1 billion under
which Roche will obtain a non-exclusive license to the US firm's technology
platform for developing RNA interference therapeutics.
The alliance will initially cover four therapeutic areas: oncology, respiratory
diseases, metabolic diseases and certain liver diseases. Alnylam and Roche also
will collaborate on RNAi drug discovery for one or more disease targets in these
therapeutic areas.
In addition, Roche will acquire Alnylam's European research site located in
Kulmbach, Germany (Bavaria), subject to regulatory approval. This site will
become Roche's center of excellence for RNAi therapeutics discovery.
RNAi is a natural mechanism that the body uses to inhibit expression of certain
genes. The companies claim that harnessing the activity of RNAi creates a direct
opportunity to develop specific and potent drugs against diseases that are
difficult to treat.
The alliance could be valued at over $1 billion in consideration of upfront
payments, potential product milestone payments for multiple products and field
expansion payments, excluding potential royalties on future sales of commercial
products.
Under the terms of the agreement, Roche will pay Alnylam $331 million in upfront
cash payments and equity investment, including 1.975 million shares of Alnylam
common stock the Roche Venture Fund agreed to purchase at $21.50 per share,
representing just less than 5% of Alnylam's outstanding common stock.
Roche will also pay Alnylam milestones on products as they advance in
development and commercialization as well as royalties on future sales of
commercial products. Further, Roche may pay Alnylam field expansion payments to
increase the number of therapeutic areas
http://www.pharmaceutical-business-review.com/article_news.asp?guid=41A95057-87C\
8-4A51-B830-796722041EA0

Doctor Convicted on Infecting Patients With Hepatitis C
(IsraelNN.com) A Be'er Sheva doctor was convicted Tuesday of infecting dozens of
patients with Hepatitis C, a serious illness, by injecting the patients with
sedatives after first having used the syringe to inject himself with narcotics.
Dr. Sergei Puntos was accused of infecting 31 patients with the illness.
He was convicted in the Be'er Sheva court on 25 counts of causing serious bodily
harm, intentionally spreading a disease, possession and use of narcotics,
stealing from an employee, fraud and negligence. Puntos, an anesthesiologist at
Soroka Hospital, was acquitted of aggravated assault.
http://www.israelnationalnews.com/News/Flash.aspx/129693
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
"There are two means of refuge from the miseries of life: music and cats." -
Albert Schweitzer
President
http://www.HEALSoftheSouth.org
http://www.HEALSoftheSouth.com

Characteristics of Persons With Chronic Hepatitis B-San Francisco, California,
2006
JAMA. 2007;298:167-168.
MMWR. 2007;56:446-448
2 tables omitted
Chronic hepatitis B is the most common cause of cirrhosis and liver cancer
worldwide. Approximately 45% of the world's population lives in regions where
chronic hepatitis B virus (HBV) infection is endemic, including most of Asia and
the Pacific Islands, Africa, and the Middle East.1 Nearly one fourth of the
population of San Francisco was born in Asia and the Pacific Islands.* In 2006,
the San Francisco Department of Public Health (SFDPH) received reports
consistent with probable chronic HBV infection for 2,238 persons. To
characterize persons with reported confirmed chronic HBV infection in San
Francisco in 2006, SFDPH collected additional data on a subset of 567 cases
reported to the SFDPH chronic hepatitis B registry. Eighty-four percent of the
persons were Asians/Pacific Islanders (A/PIs), 80% of whom were foreign born.
Fewer than half had been referred to a gastroenterologist/hepatologist for
evaluation at the time of reporting. Persons with chronic HBV infection can
benefit from medical care by providers with expertise in viral hepatitis. In
addition, close contacts of infected persons should be screened and offered
vaccination if found to be susceptible to HBV infection. Culturally appropriate
counseling for and follow-up of persons with chronic HBV infection and their
contacts could help reduce the transmission of HBV infection.
Hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), HBV DNA, and
immunoglobulin M antibody to hepatitis B core antigen (IgM anti-HBc) are
detectable during acute HBV infection. The presence of HBsAg, HBeAg, or HBV DNA
for more than 6 months is evidence of chronic infection. The California Code of
Regulations requires laboratories to report all positive test results for HBsAg
to local health departments. Health-care providers also are required to report
cases of acute and chronic hepatitis B. Reporting requirements for both
laboratories and providers include supplying the name, age, sex, and contact
information of persons with positive tests and the contact information for the
associated health-care provider, although not all reports contain this
information. SFDPH has maintained a registry of persons with positive HBsAg test
results reported to SFDPH since 1984; the registry contains HBsAg test results
for approximately 25,700 persons. Based on the standard case definitions
approved by state epidemiologists for 2007, a confirmed case of chronic HBV
infection is defined as an infection in a person who tests HBsAg positive, HBV
DNA positive, or HBeAg positive two times at least 6 months apart. A probable
case is defined as an infection in a person with a single HBsAg-positive,
HBV-DNA-positive, or HBeAg-positive laboratory result with either a negative IgM
anti-HBc or no IgM anti-HBc test reported.
To further characterize persons with known chronic HBV infection, in January
2006, SFDPH began requesting data from health-care providers on persons who met
the case definition for confirmed HBV infection for whom a second positive HBsAg
result was reported to SFDPH during 2006. SFDPH formed an advisory panel of
clinicians from public, private, and academic settings, who provided input into
the development of the supplemental data collection form and endorsed the
activity in a letter mailed by SFDPH to local health-care providers. SFDPH faxed
supplemental data forms to the providers who had ordered the most recent
positive HBsAg test, requesting information on patient race/ethnicity, primary
language, reasons for HBsAg testing, risk factors for HBV infection, referral
for specialist care, and treatment history. Providers used information obtained
from a chart review or during patient visits to complete the form. Providers who
did not respond were sent faxes two more times and then contacted by telephone
one time.
During 2006, SFDPH received reports of 2,238 persons with test results
consistent with probable chronic HBV infection; all were reported by
laboratories. Of these, 1,156 (52%) were male, and 1,090 (49%) were aged 30-49
years. Among the 714 women of childbearing age (i.e., aged 12-45 years) for whom
a positive HBsAg test result was reported to SFDPH, 170 (24%) were pregnant when
follow-up was conducted by the perinatal hepatitis B coordinator.
Of the 2,238 positive HBsAg reports received by the registry in 2006, a total of
1,162 (52%) met the case definition for confirmed chronic HBV infection. Of
these, 736 had available health-care provider contact information. Supplemental
data forms were faxed to these providers; 567 forms were returned to SFDPH with
at least partial information. Of persons for whom place of birth was reported,
84% were foreign born; of persons for whom both race/ethnicity and place of
birth were reported, 80% were foreign-born A/PIs. Cantonese Chinese was reported
to be the primary language of 52% of persons. Reasons for HBsAg testing included
screening (43%), follow-up of a history of hepatitis B (41%), or evaluation of
abnormal liver enzymes (9%). The most frequently reported risk for HBV infection
was birth in an HBV-endemic region (74%); male-to-male sexual contact accounted
for 12%. A total of 21% of persons were reported to have been treated for
chronic HBV infection, and 32% were reported to have been referred to a
gastroenterologist/hepatologist at the time of reporting.
Reported by:
S Huang, MD, S Shallow, MPH, D Stier, MD, P Shiono, PhD, A Nishimura, MPH, I
Bihl, San Francisco Dept of Public Health. S Bialek, MD, I Williams, PhD, Div of
Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention, CDC.
CDC Editorial Note:
The findings in this report suggest that, in 2006, nearly 85% of persons with
confirmed chronic HBV infection in San Francisco were A/PIs, 80% of whom were
born outside the United States. These persons likely acquired their infections
in their countries of origin, countries where HBV infection is endemic and
infections usually are acquired at birth or during early childhood. Of persons
who acquire chronic HBV infection when they are aged <5 years, an estimated
15%-40% will eventually have chronic liver disease, including cirrhosis and
liver cancer.2 Treatment for chronic hepatitis B is increasingly effective and
can prevent or slow the development of these sequelae.2 However, fewer than one
third of persons with chronic HBV infection in San Francisco in 2006 had been
referred to a specialist for evaluation or undergone treatment at the time of
reporting.
Persons from countries where HBV infection is endemic might be unaware of their
increased risk for hepatitis-B-related liver disease.3-4 Hepatitis B screening
programs in A / PI communities in the United States can be an effective means of
identifying persons with chronic HBV infection and encouraging them to seek
medical care.5-7
Health departments and large health systems can use electronic disease
registries to characterize and provide services for persons with chronic HBV
infection and their close contacts. Persons with chronic HBV infection should
receive referrals for appropriate medical care, which can include treatment for
HBV infection. Their close contacts should undergo screening for HBV infection
and, if found to be susceptible, should receive hepatitis B vaccination.
Registries also can provide local population-based data on the epidemiology of
chronic HBV infection.
At least five factors are critical to ensuring that registry data are
representative and complete. First, legally mandated laboratory reporting of
test results is essential for complete ascertainment of cases. Second,
electronic information systems are needed to promote efficiency, allowing the
registry to receive data securely, account for duplicate case reports, and merge
data from multiple reporting sources. Third, collaboration with laboratories is
needed so that health departments can obtain additional patient demographic
information and clinician contact information through laboratory reports.
Fourth, communication with and timely feedback of surveillance data to
clinicians are needed to increase cooperation with health departments that are
requesting supplemental information on cases. Finally, because the majority of
infected persons and their contacts might not speak English as their primary
language, multilingual staff and culturally appropriate health education
materials are needed to support these activities.
The findings in this report are subject to at least three limitations. First,
the results are limited to persons who received medical care, who were tested
for chronic HBV infection, and whose laboratory results or diagnoses were
reported to SFPDH. Therefore, these findings do not represent the actual number
of persons with chronic HBV infection in San Francisco, especially among those
who do not have regular access to medical care. Second, persons included in the
analysis of confirmed cases were limited to those for whom provider contact
information was available. Although the California Code of Regulations mandates
reporting of provider name and contact information for all notifiable diseases
and conditions, this information is not reported frequently. Finally, the
findings are based on data collected from persons with confirmed chronic HBV
infection. Because the case definition for confirmed cases requires additional
laboratory testing, the 567 persons described in this analysis might represent a
subset of patients with greater access to care or those who were more likely to
have undergone follow-up and treatment.
During 2007, local organizations in San Francisco are planning low-cost,
community-based HBV screening and vaccination activities targeted to A/PIs and
educational outreach to promote awareness of HBV screening, prevention, and
treatment guidelines (http://www.sfhepbfree.org). SFDPH plans to provide persons
newly reported to the registry with information on how to reduce the risk for
transmission to others and the need for medical monitoring. SFDPH also will
explore different approaches to identifying persons who are household and sex
contacts of infected persons to inform them of their potential exposure to HBV,
to recommend testing and vaccination, and to better understand the barriers to
obtaining HBV preventive services.
With proper resources, chronic hepatitis B registries can help health
departments characterize the burden of chronic HBV infection. Such registries
also enable health departments and health-care providers to link HBV-infected
persons and their contacts with recommended prevention and care services.
Acknowledgments:
This report is based on contributions by L Afu-Li and S Rose, MPH, San Francisco
Dept of Public Health; N Bzowej, MD, L Johnson, MD, M Khalili, MD, A Li, MD, K
Man, MD, K Shafer, PhD, J Sun, MD, N Terrault, MD, and H Yu, MD, San Francisco
Chronic Viral Hepatitis Registry Advisory Panel; reporting laboratories; and San
Francisco clinicians.
*US Census Bureau. American factfinder. Available at
http://factfinder.census.gov.
California Code of Regulations. 17 CCR 2500. Reportable diseases and conditions.
Available at
http://www.dhs.ca.gov/ps/dcdc/disb/pdf/Title%2017%20lab%20reportable%20condition\
s.pdf.
CDC. National notifiable diseases surveillance system. Chronic hepatitis B
virus. Available at http://www.cdc.gov/epo/dphsi/casedef/hepatitisbcurrent.htm.
REFERENCES
1. Custer B, Sullivan SD, Hazlet TK, Iloeje U, Veenstra DL, Kowdley KV. Global
epidemiology of hepatitis B virus. J Clin Gastroenterol.
2004;38(10)(Suppl):S158-S168. FULL TEXT | ISI | PUBMED
2. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology. 2007;45:507-539. FULL
TEXT | ISI | PUBMED
3. Choe JH, Chan N, Do HH, Woodall E, Lim E, Taylor VM. Hepatitis B and liver
cancer beliefs among Korean immigrants in western Washington. Cancer.
2005;104(12)(Suppl):2955-2958. FULL TEXT | ISI | PUBMED
4. Taylor VM, Yasui Y, Burke N, et al. Hepatitis B testing among Vietnamese
American men. Cancer Detect Prev. 2004;28:170-177. FULL TEXT | ISI | PUBMED
5. CDC. Screening for chronic hepatitis B among Asian/Pacific Islander
populations-New York City, 2005. MMWR. 2006;55:505-509. PUBMED
6. Chao S, Lee PV. Prapon, Su J, So S. High prevalence of chronic hepatitis B
(HBV) infection in adult Chinese Americans living in California. Hepatology.
2004;40(Suppl 1):717A.
7. Lin S, Chang E, So S. Why we should routinely screen Asian American adults
for hepatitis B: a cross-sectional study of Asians in California. Hepatology. In
press.
http://jama.ama-assn.org/cgi/content/full/298/2/167

Contact: Rachel Champeau
rchampeau@...
310-794-2270
University of California - Los Angeles
UCLA/VA develops tool to gauge quality of life of hepatitis B patients
"Am I going to die" I have no future." "I feel depressed at times, fearful I may
not see my children marry or be a grandparent." Such heart-rending statements
from patients with chronic hepatitis B reveal the social and mental impact of
this disease, which affects 350 million worldwide.
In a new study, UCLA researchers measured the effect of hepatitis B on patients'
quality of life - beyond just the physical symptoms of the disease - and created
a new tool to better assess patients' overall well-being, which may help
clinicians guide treatment. The study appears in the July issue of the journal
Hepatology.
"Our results revealed that to effectively treat hepatitis B patients, clinicians
need to consider the social and psychological impact of the disease, as well as
biological functioning," said Dr. Brennan M.R. Spiegel, principal investigator
and assistant professor of medicine at the David Geffen School of Medicine at
UCLA and the Veterans Affairs Greater Los Angeles Healthcare System.
Hepatitis B is caused by a viral infection that can damage the liver and lead to
chronic disease. It is contracted most often through contact with infected blood
or bodily fluids.
According to Spiegel, little research had been done previously on
quality-of-life issues for the majority of hepatitis B patients - those who do
not have advanced liver disease or, even rarer, end-stage complications.
In developing the first-of-its-kind assessment tool for patients, researchers
reviewed existing literature, conducted a focus group with health experts and
interviewed hepatitis patients. They then took the information and developed a
patient questionnaire that clinicians could use to measure patients' quality of
life.
"We were shocked to find that for many hepatitis B patients without advanced
liver disease, the psychosocial impact of the disease affected their lives more
than the physical symptoms," said Spiegel, who is also director of the UCLA/VA
Center for Outcomes Research and Education. "No one had ever documented this
before."
The questionnaire measures quality of life on several levels, including
psychological well-being, anxiety, vitality, disease stigma, vulnerability and
transmissibility.
"We hope that this quick questionnaire can become a 'vital sign' taken in the
doctor's office to help see how the patient is doing," added Spiegel.
Spiegel notes that the questionnaire could also be used in clinical trials to
help measure outcomes and also to equip patients with knowledge to help them
better select between competing disease management strategies.
###
The study was funded by the pharmaceutical company Novartis. Spiegel is a
consultant for Novartis and has received research support form the company.
Other study authors from the David Geffen School of Medicine at UCLA include
Roger Bolus, Ph.D., Dr. Eric Esrailian and Jennifer Talley, also of the UCLA/VA
Center for Outcomes Research and Education; Dr. Steven Han, also of the VA
Greater Los Angeles Healthcare System; Dr. Myron Tong; and Dr. Francisco Durazo.
Other authors include Dr. Tram Tran, Cedars-Sinai Medical Center; Jason Smith,
Pharm.D., VA Greater Los Angeles Healthcare System; Dr. Hetal A. Karsan, Atlanta
Gastroenterology Associates and Emory University School of Medicine; Dr. Bruce
Bacon, Center for Liver Diseases at Inova Faifax Hospital in Virginia; Dr. Paul
Martin, Emory University School of Medicine; Dr. Zobair Younossi, Center for
Liver Diseases at Inova Fairfax Hospital; Siew Hwa-Ong, Novartis Pharma AG in
Basel, Switzerland; and Dr. Fasiha Kanwal, St. Louis University.
http://www.eurekalert.org/pub_releases/2007-07/uoc--udt071007.php

Hepatitis C study seeks isle volunteers
Researchers will test a new drug that stays in one's body longer
By Helen Altonn / haltonn@...
Isle residents with hepatitis C have an opportunity to participate in a clinical
research trial for a drug to be taken every two weeks instead of weekly.
Dr. Alan Tice, infectious disease specialist, said 15 patients have signed up,
and he is seeking more. Interested people are asked to call him as soon as
possible at 373-3488 because the trial has been opened internationally, he said.
Only 200 slots are left out of 1,500 planned for the study, he said. Patients
must meet certain criteria for the trial, done under U.S. Food and Drug
Administration oversight. The tests and drugs are worth about $50,000 a year,
Tice said.
The study will investigate a new form of interferon, which must be taken with
ribavirin pills. It might have the same side effects as other forms of
interferon, such as anemia and depression, so patients will be closely followed,
Tice said.
The new formula stays in the body longer, but the patient must be treated for a
year, he said.
A part-time University of Hawaii faculty member with his own practice, Tice is
most interested in hepatitis and Staphylococcus aureus as two significant health
problems in Hawaii. He represented the Infectious Disease Society of America at
a recent American Medical Association meeting.
"Hepatitis is something that has been ignored in many respects," he said,
"because hepatitis C often affects primarily people who used drugs in the past,
people who don't have money, who often have adjustment problems and limited
medical resources."
A number of people became infected with the virus through transfusions before
1992, he said.
"It's a sneaky agent," Tice said, explaining hepatitis C causes cirrhosis, liver
scar tissue or liver cancer at a rate of 1 percent or 2 percent a year.
People do not realize for decades that they have the chronic blood-borne
infection because in the first years they are not sick, he said.
Many people who used drugs in the '60s and '70s thought they would be safe, Tice
said. "Now we have the highest rate of liver cancer per capita in the country.
The tip of the iceberg is coming to the surface, and they're coming down with
these things they didn't know they had for 20 to 30 years."
About 22,000 isle residents are infected with hepatitis C, according to the
Hepatitis Prevention, Education, Treatment and Support Network of Hawaii.
"The majority of people with hepatitis C probably don't realize they have it,"
he said.
"It's a difficult thing to get people to admit they used drugs. ... A lot of
people don't want to know."
http://starbulletin.com/2007/07/10/news/story07.html
Peace and Love
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Natural History of Hepatitis C in Patients with Severe Liver Fibrosis
As reported in the July 2007 Journal of Hepatology, British researchers
conducted a study to examine the morbidity and mortality of patients with severe
liver fibrosis related to hepatitis C virus (HCV) infection, within a population
unbiased by tertiary referral.
A total of 150 HCV positive patients were identified from the Trent HCV study
who had liver biopsies taken before 2002 that demonstrated severe fibrosis
(Ishak stage 4). Follow-up data were extracted from the study database and
hospital records. The median follow-up period was 51 months.
Results
. Of the 131 patients with no prior history of hepatic decompensation, 25%
either died (n=25) or received a liver transplant (n=8), after a median interval
of 42 months.
. Hepatocellular carcinoma (liver cancer) and/or hepatic decompensation were
diagnosed in 33 patients (25%), after a median interval of 41 months.
. The probability of survival without liver transplantation was 97% at 1 year,
88% at 3 years, and 78% at 5 years.
. In a multivariate analysis, interferon-based combination antiviral therapy
was associated with improved survival.
. Overall, prognosis was not affected by Ishak stage on the initial biopsy.
. However, the 19 patients with previous hepatic decompensation had worse
prognosis: 89% either died (n=15) or received a liver transplant (n=2).
Conclusion
In conclusion, the authors wrote, "This study demonstrates that severe liver
fibrosis (Ishak stage 4) secondary to hepatitis C is associated with a poor
prognosis, that may be improved following combination antiviral treatment."
07/10/07
Reference
A Lawson, S Hagan, K Rye, and others. The natural history of hepatitis C with
severe hepatic fibrosis. Journal of Hepatology 47(1): 37-45. July 2007.
http://www.hivandhepatitis.com/hep_c/news/2007/071007_a.html

Epidemiological Characteristics and Treatment Outcomes in Individuals with
Genotype 4 HCV Infection
By Liz Highleyman
Research has shown that the natural history of hepatitis C virus (HCV) infection
and response to interferon-based therapy are influenced by HCV genotype.
Genotype 1 is more difficult to treat and is associated with lower sustained
virological response (SVR) rates compared with genotypes 2 or 3.
There are less data -- some of it conflicting -- regarding genotype 4, which is
being seen with increasing frequency in Europe (though still uncommon in the
U.S.).
As reported in the July 2007 Journal of Viral Hepatitis, French researchers
analyzed epidemiological features and SVR rates in a retrospective study of 1532
genotype 4 patients, including 1056 infected in France, 227 immigrants infected
in Egypt, and 249 infected in sub-Saharan Africa.
SVR rates were assessed in 242 treatment-naive patients who received pegylated
interferon plus ribavirin for 48 weeks.
Results
. HCV subtypes 4a or 4d were most common among patients infected in France,
where the predominant route of transmission was injection drug use.
. Subtype 4a predominated (93%) among patients infected in Egypt, where
transmission was mostly related to parenteral treatment for schistosomiasis.
. More than 7 different genotype 4 subtypes were found among patients infected
in sub-Saharan Africa, a group with no apparent single predominant route of
infection.
. Liver fibrosis was significantly less severe in genotype 4 patients infected
in France or Africa compared with those infected in Egypt.
. However, SVR rates were higher in patients infected in Egypt, compared with
those infected in France or Africa (54.9%, 40.3%, and 32.4%, respectively; P <
0.05).
. Overall, better treatment response was observed in patients infected with
subtype 4a.
. In a multivariate analysis, the 2 factors independently associated with SVR
were infection in Egypt and absence of severe fibrosis.
Conclusion
In conclusion, the authors wrote, "the distribution of HCV-4 subtypes varies
with the geographical origin of transmission and affects the SVR following
antiviral treatment."
07/10/07
Reference
D Roulot, V Bourcier, V Grando, and others. Epidemiological characteristics and
response to peginterferon plus ribavirin treatment of hepatitis C virus genotype
4 infection. Journal of Viral Hepatitis 14(7): 460-467. July 2007.
http://www.hivandhepatitis.com/hep_c/news/2007/071007_b.html

Thousands of deaths from hepatitis B among London's black communities could be
prevented
Education is the best form of prevention
Thousands of deaths from hepatitis B among London's black communities could be
prevented through improved education and destigmatizing the disease, according
to experts.
This was the conclusion of a meeting involving representatives from London's
ethnic communities and media, organised last week by the B Aware Campaign to
explore methods of effectively containing the spread of the virus amongst
high-risk populations.
"Hepatitis B is a very dangerous virus because it is a stealth virus that kills
people slowly and does not advertise its presence", explained Graham Foster,
Professor of Hepatology at Barts and The London NHS Trust. "Children infected by
their mothers with hepatitis B can grow up without knowing they are affected,
providing plenty of opportunities to pass on the virus before they eventually
die from liver disease, which is the fate of many of those infected."
At the meeting participants were told that the majority of these deaths can be
prevented if the disease is detected early enough by testing those known to be
particularly at risk. Ninety per cent of babies infected by their mothers at
birth will develop chronic hepatitis B, yet babies born to infected mothers can
be effectively vaccinated just after birth. Infected adults can keep the levels
of circulating virus in their body effectively under control with drug therapy -
although once infected, they can never be completely cured.
London's black and Asian population is particularly at risk of hepatitis B
infection, as many will have been born in areas of the world where the
prevalence of hepatitis B is high, or born in the UK to infected mothers who
themselves have come from these areas. They are also more likely to visit
friends and relatives living in these high prevalence regions, and it is known
that 65 per cent of people travelling to at risk countries do not get vaccinated
against hepatitis B before they go.
Penny Webb, Coordinator of the Hepatitis B Foundation UK said that in London
there are thousands of people born abroad who are completely unaware that they
have liver a "ticking time bomb" of liver inside their bodies because they have
not been tested for hepatitis B.
"Despite the fact that we should be encouraging testing for these people and
vaccination for their families, in practice we are putting them off by charging
for these services in many cases. We are one of the few countries worldwide
where this happens, and the situation urgently needs to change," she added.
The meeting also discussed other potential ways of educating London's black and
Asian communities about hepatitis B, including workshops in community centres;
materials in schools and colleges/universities; an education programme for
midwives; pharmacy-based campaigns; and a stand at cultural events such as the
Notting Hill Carnival.
http://www.blackbritain.co.uk/news/details.aspx?i=2481&c=Health&h=Thousands+of+d\
eaths+from+hepatitis+B+among+London%E2%80%99s+black+communities+could+be+prevent\
ed