Matt's Blog

Interferon for the Treatment of Chronic Hepatitis Delta)
By Liz Highleyman
Hepatitis delta virus (HDV) is a defective virus-like pathogen that can only
replicate in the presence of hepatitis B virus (HBV). HDV is transmitted through
the same routes as HBV (direct blood contact, sexual contact, mother-to-child).
People may either become coinfected with HBV and HDV at the same, or may acquire
HDV while already infected with HBV.
A 1-year course of high-dose interferon alpha is the only established treatment
for chronic HDV infection, but it has a high relapse rate after therapy is
completed.
As reported in the November 2007 Journal of Viral Hepatitis, researchers from
the University of Ankara in Turkey conducted a study to determine whether
treating HDV for 2 years would improve sustained response rates.
In this study, 23 patients were treated with 10 million unit (MU) of interferon
alpha-2b (Intron-A) 3 times weekly for 2 years. Treatment response was assessed
as follows at the end of treatment (24 months) and after a 6-month follow-up
period (30 months total):
. Virological response: undetectable HDV RNA;
. Biochemical response: normal alanine aminotransferase (ALT);
. Histological response: at least 2-point decrease in the Knodell score
(histological activity index measuring liver necroinflammation and fibrosis).
Results
. 15 patients completed the 2-year course of treatment and 6-month follow-up
period.
. Out of these patients, 7 (47%) had a biochemical response, but only 2 (13%)
still had normal ALT at the end of follow-up.
. ALT decreased from the mean baseline value of 143.1 to 39.7 IU/L at the end
of treatment.
. 6 patients had a virological response at the end of treatment, but only 2
had sustained virological response at the end of the follow-up period.
. 2 patients lost hepatitis B surface antigen (HBsAg).
. Among the 12 patients with paired liver biopsies, 8 experienced histological
improvement.
Conclusion
Based on these findings, the authors concluded, "Interferon treatment leads to a
complete or partial response in a substantial number of patients, but 2 years of
treatment does not appear to increase sustained response rates over 1 year
treatment."
10/26/07
Reference
C Yurdaydin, H Bozkaya, H Karaaslan, and others. A pilot study of 2 years of
interferon treatment in patients with chronic delta hepatitis. Journal of Viral
Hepatitis 14(11): 812-816. November 2007.
http://www.hivandhepatitis.com/hep_b/news/2007/102607_a.html

FDA Orders Black Box Pregnancy Warning for Transplant Agent
By Peggy Peck, Executive Editor, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of
Pennsylvania School of Medicine.
October 29, 2007
ROCKVILLE, Md., Oct. 29 -- The FDA said today it has ordered a black box warning
on the use of mycophenolate mofetil (CellCept) during pregnancy.
In announcing the label change, the agency cited an increased risk of
spontaneous abortion or congenital malformation for transplant patients who
become pregnant while using the immunosuppressant.
Post-marketing data from the National Transplantation Pregnancy Registry (NTPR)
and worldwide adverse event reporting found an increased risk of cleft lip and
palate, malformation of the external ear, and anomalies of distal limbs, heart,
esophagus, and kidney.
Roche, the drug's maker, said that in December 2006 NTPR published data from
prospective cases where 24 female transplant patients reported 33 pregnancies
exposed to mycophenolate mofetil-containing regimens.
Forty-five percent of those pregnancies resulted in spontaneous abortions and 18
live-born infants. Four of the infants had structural malformations.
According to post-marketing data collected from 1995 through 2005, 77 pregnant
women exposed to the drug had 25 spontaneous abortions and 14 congenital
malformations. Six of the 14 malformations involved ear abnormalities.
In a letter to health care professionals, Lars E. Birgerson, M.D., Ph.D., vice
president of medical affairs at Roche, said that women of childbearing age
should not be started on mycophenolate mofetil until a negative pregnancy test
is obtained.
He said women should be advised to use two methods of birth control -- or total
abstinence -- for four weeks prior to starting mycophenolate therapy and should
continue contraception or abstinence during treatment and for six weeks after
stopping mycophenolate.
Other adverse events associated with the drug are neutropenia and
gastrointestinal bleeding.
http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/7152

58th Annual Meeting of the American Association for the Study of Liver Diseases
(AASLD) Set for Boston, November 2-6, 2007
The 58th annual meeting of the American Association for the Study of Liver
Diseases (AASLD) -- aka "The Liver Meeting" -- is the premier conference
covering the science and practice of hepatology, including the latest findings
on new drugs, novel treatment strategies, and results from pilot studies of
investigational agents.
Approximately 10% of Americans have some form of liver disease, which strikes
disproportionately among certain populations.
HIV and Hepatitis.com will provide coverage of selected highlights from the
Boston meeting over the course of the first 2 weeks in November, with a focus on
treatment for chronic hepatitis C, chronic hepatitis B, and HIV/HBV and HIV/HCV
coinfection.
http://www.hivandhepatitis.com/2007icr/aasld/article1.html
Peace and Love
(`'·.¸(`'·.¸ ¸.·'´) ¸.·'´)
«´¨ *Pam* ¨`»
(¸.·'´(¸.·'´ `'·.¸)`' ·.¸)
¸.·´
( `·.¸
`·.¸ )
¸.·)´
(.·´
`*.
*.
Mahatma Gandhi put it well: "Be the change you want to see in the
world." It always begins with one person.

I guess it was only a matter of time! LOL First water and now oxygen......
what will *they* think of next!
http://www.bigoxrox.com/index.aspx

Hep C infection after test missed
A PATIENT has contracted Hepatitis C from an organ transplant after a test that
would have detected the disease was not performed until after the operation.
The nucleic acid test (NAT) was not done before the transplant because it was
not available after hours.
Had the test been done before the operation, the patient would not have had the
transplant and would not have contracted Hepatitis C, a spokeswoman for NSW
Health has admitted.
The name of the hospital where the incident occurred, and the exact time it
happened, has not been revealed because these details could lead to
identification of the organ donor - who died on the night in question - or the
recipient.
But the incident, which occurred at a major Sydney teaching hospital in the past
six months, has led to calls for NAT tests to be available 24 hours a day across
the country.
NAT tests are generally used before organ transplants because they can more
accurately pick up Hepatitis C and HIV than the antibody tests that are
mandatory before any transplant.
In the wake of the incident NSW Health has committed to funding 24-hour-a-day
availability for NAT testing, and the Australian Red Cross Blood Service, which
provides the tests, is in the process of implementing the new service.
Australians Donate - the peak body for organ and tissue donation - has backed
similar changes for the whole of Australia.
NAT testing is not mandatory.
In the case of the the patient who contracted Hepatitis C, a spokeswoman for the
Red Cross Blood Service said the organisation had fulfilled all its
responsibilities and that, in the end, the decision to go ahead was up to the
doctors.
"NAT testing was undertaken according to our standard procedures and the results
communicated to the treating physicians as soon as they were available," she
said.
The NSW Deputy Chief Health Officer, Kerry Chant, said while a NAT test was
performed in the case of the infected patient, "it was done on the routine run
the next morning" rather than at the time.
Had the test been ordered immediately "it would have come back in time for the
transplant", Dr Chant said.
She also admitted: "It would have changed the decision in this case if the
testing had been done."
http://www.smh.com.au/news/national/hep-c-infection-after-test-missed/2007/10/22\
/1192940991633.html

The Accuracy of Sonography in Predicting Steatosis and Fibrosis in Chronic
Hepatitis C.
Chen CH, Lin ST, Yang CC, Yeh YH, Kuo CL, Nien CK.
Digestive Disease Center, Changhua Show-Chwan Memorial Hospital, No 542, Section
1, Chung-Shang Road, Changhua, 500, Taiwan.
The accuracy and clinical significance of sonography (US) in demonstrating fatty
liver and hepatic fibrosis in chronic hepatitis C (CHC) are rarely reported. US
had sensitivity 71.1%, specificity 72.9%, 58.7% positive predictive value (PPV),
and 82.3% negative predictive value (NPV) in demonstrating histological
steatosis
NPV in demonstrating histological steatosis
predicting prognosis and therapeutic response in CHC. Subjects with fatty liver
on US had a greater prevalence of body mass index (BMI)
inflammation-necrosis grade
analyses. US had sensitivity 27.4%, specificity 62.5%, 71.9% PPV, and 19.7% NPV
in demonstrating histological fibrosis of stage II or above, and sensitivity
13.6%, specificity 66.3%, 9.4% PPV, and 75.0% NPV in demonstrating fibrosis of
stage III or above. There was no correlation between fibrotic sonographic
patterns and histological stage of fibrosis (r = -0.167, P = 0.083). Besides
hepatic steatosis, clinicians should be alert to the possibility of advanced
necrosis-inflammation grade in interpreting a report of bright liver on
gray-scale US. Gray-scale US cannot replace liver biopsy as the optimal
diagnostic procedure for the prediction of hepatic steatosis and fibrosis prior
to initiating therapy for CHC.
PMID: 17939048 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=179390\
48&dopt=AbstractPlus

L: -Carnitine Treatment Reduces Steatosis in Patients with Chronic Hepatitis C
Treated with alpha-Interferon and Ribavirin.
Romano M, Vacante M, Cristaldi E, Colonna V, Gargante MP, Cammalleri L,
Malaguarnera M.
Department Of Senescence, Urological And Neurological Sciences Ospedale
Cannizzaro, Viale Messina, 829-95125, Catania, Italy, malaguar@....
Background Hepatic steatosis is a common presentation in patients with chronic
hepatitis C. Interferon alpha exerts both antiviral and immunomodulating
actions, and influences on lipid metabolism. The aim of our study was to test
whether L: -carnitine reduces steatosis in patients treated with interferon and
ribavirin. Patients and methods A total of 70 patients were randomly assigned to
receive either leucocyte IFN alpha at a dose of 3 MIU thrice a week plus 1,000
mg ribavirin per day for 12 months (group A) or IFN alpha and ribavirin at the
same dose plus 2 g carnitine per day (group B). Results Comparison of the two
treatments showed significant differences between the mean values of the
following parameters at the end of the treatment: ALT -68 vs -95 IU/ml (P <
0.05), total cholesterol 0.08 vs -0.91 mmol/l (P < 0.05) and triglycerides +0.25
vs -20 mmol/l (P < 0.05); and at the follow-up: AST -35 vs -65 IU/ml (P < 0.05)
and ALT -55 vs -84 IU/ml (P < 0.05). All values were lower in group B (IFN +
Ribavirin + Carnitine) than in group A (IFN plus Ribavirin). When comparing
those patients treated with IFN + ribavirin with those treated with IFN plus
ribavirin plus carnitine, the response at the end of the treatment was 48% vs
56%, and the sustained response 39% vs 46%, respectively. Conclusions Combined
treatment with L: -carnitine, ribavirin and IFN alpha resulted in greater
antihyperlipidaemic effects and than with ribavirin and IFN alpha alone. The
results of this study suggest that L: -carnitine may have a role among the
reduction of steatosis strategies in patients with hepatitis C treated with IFN
alpha and ribavirin.
PMID: 17939042 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=179390\
42&dopt=AbstractPlus

Long-term phlebotomy with low-iron diet therapy lowers risk of development of
hepatocellular carcinoma from chronic hepatitis C.
Kato J, Miyanishi K, Kobune M, Nakamura T, Takada K, Takimoto R, Kawano Y,
Takahashi S, Takahashi M, Sato Y, Takayama T, Niitsu Y.
Fourth Department of Internal Medicine, Sapporo Medical University School of
Medicine, South-1, West-16, Chuo-ku, Sapporo, 060-8543, Japan.
BACKGROUND: We have previously demonstrated that in patients with chronic
hepatitis C (CHC), iron depletion improves serum alanine aminotransferase (ALT)
levels as well as hepatic oxidative DNA damage. However, it has not been
determined whether continuation of iron depletion therapy for CHC favorably
influences its progression to hepatocellular carcinoma (HCC). METHODS: We
conducted a cohort study on biopsy-proven CHC patients with moderate or severe
liver fibrosis who failed to respond to previous interferon (IFN) therapy or had
conditions for which IFN is contradicted. Patients were divided into two groups:
subjects in group A (n = 35) underwent weekly phlebotomy (200 g) until they
reached a state of mild iron deficiency, followed by monthly maintenance
phlebotomy for 44-144 months (median, 107 months), and they were advised to
consume a low-iron diet (5-7 mg iron/day); group B (n = 40) comprised CHC
patients who declined to receive iron depletion therapy. RESULTS: In group A,
during the maintenance phase, serum ALT levels decreased to less than 60 IU/l in
all patients and normalized (<40 IU/l) in 24 patients (69%), whereas in group B
no spontaneous decrease in serum ALT occurred. Hepatocarcinogenesis rates in
groups A and B were 5.7% and 17.5% at the end of the fifth year, and 8.6% and
39% in the tenth year, respectively. Multivariate analysis revealed that iron
depletion therapy significantly lowered the risk of HCC (odds ratio, 0.57)
compared with that of untreated patients (P = 0.0337). CONCLUSIONS: Long-term
iron depletion for CHC patients is a promising modality for lowering the risk of
progression to HCC.
PMID: 17940836 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=179408\
36&dopt=AbstractPlus

Greek Church Leader to Return Home
By LISA ORKIN EMMANUEL - 2 days ago
MIAMI (AP) - The leader of Greece's Orthodox Church will return home for
chemotherapy to treat a cancer that spread from his liver to his abdominal
cavity, his doctor said Tuesday.
Archbishop Christodoulos, 68, had come to Miami to seek a liver transplant, but
doctors abandoned the procedure after they discovered that the cancer had
spread.
The doctors could not go ahead with the transplant because anti-organ rejection
drugs that the archbishop would have had to take would fuel the tumor's growth.
The archbishop will probably go home this week, said transplant specialist
Andreas Tzakis, director of the University of Miami's organ transplant
institute.,
"Psychologically he is very strong and he seems to be dealing with this very
well," Tzakis said. "I just spoke to him earlier today ... He is ready to go on
for the next step."
Tzakis said the cancer cannot be removed with an operation.
Liver cancer can spread to the bones, brain and lungs through blood, but a
spread to the abdominal cavity is rare because of blood's circulation path,
Tzakis has said.
It is also unusual because the tumors had not burst - another way cancer can
spread.
"He is so strong he would have been able to survive the transplant had that been
possible," Tzakis said. "I feel disappointed that we could not help him more."
The archbishop was diagnosed with cancer in June after undergoing intestinal
surgery, and had spent 40 days in an Athens hospital. He waited 50 days for a
compatible liver.
"As he himself said, his life has been in the hands of God and we are all
hopeful that he will respond to the chemotherapy and he will continue serving
his people," Tzakis said.
Elected church leader in 1998, Christodoulos was instrumental in attempts to
improve ties with the Catholic Church.
The archbishop also often stirred controversy with politically tinged
statements.
In Greece, politicians accused him of meddling in their affairs. They were
angered by his criticism of homosexuality, globalization, among other issues.
http://ap.google.com/article/ALeqM5gDiB1SdqyPh6iBpuhbFMywhIpomw

Goulet Sedated While Awaiting Transplant
By RYAN NAKASHIMA - 1 day ago
LAS VEGAS (AP) - Singer and actor Robert Goulet is heavily sedated and breathing
through a respirator in a Los Angeles hospital while he awaits a lung
transplant, his wife told The Associated Press on Tuesday. "He can hear me but
he can't respond," Vera Goulet said of the 73-year-old crooner.
Vera Goulet said doctors told her the lung transplants are the most successful
operation of any transplant, with a success rate of 88 percent. A suitable donor
has yet to be found, she said.
"God willing, if we proceed with this, our doctors feel that there's no reason
he will not have at least 15 years of life doing what he does, going back on
stage and singing," she said. "That's very encouraging."
The singer fell ill when flying home to Las Vegas after performing at a Sept. 20
concert in Syracuse, N.Y., his wife said. Doctors initially assumed it was some
kind of bug, but he got weaker until he had to be rushed to the hospital 10 days
later, she said.
Goulet was diagnosed with a form of pulmonary fibrosis that his official Web
site described as a "rapidly progressive and fatal condition." He was
transported to Cedars-Sinai Medical Center in Los Angeles as a transplant
patient Oct. 13.
Speaking by phone from the hospital, Vera Goulet said doctors inserted a
breathing tube down her husband's throat and sedated him, and that they were
last able to speak two weeks ago.
"He said, 'Just give me a new pair of lungs and I'll hit the high notes until
I'm 100,'" she said.
"I told him I loved him. He told me he loves me. He was ready to have the tube
inserted. And he said, 'Just watch my vocal cords.'" The couple's 25th wedding
anniversary was Oct. 17.
Meanwhile, she said, fans and performers have been calling and e-mailing from
around the world, including comedian Jerry Lewis, actress Suzanne Somers and
singer Harry Connick Jr., she said.
"Tony Orlando called and said, 'Give him a punch in the stomach for me,'" she
said.
Goulet, born to French-Canadian parents in Lawrence, Mass., has won acclaim for
a Broadway career that took off after his debut performance as Sir Lancelot in
"Camelot" in 1960. Goulet's multiple appearances on "The Ed Sullivan Show"
helped make him a star.
Goulet won a Grammy Award in 1962 for Best New Artist and a Tony Award in 1968
for his role in "The Happy Time."
Over the years, Goulet continued to perform onstage.
His illness forced the cancellation of planned performances in Denver and a
commercial TV shoot, Vera Goulet said.
On the Net:
a.. Robert Goulet's Official Web site,: http://www.robertgoulet.com

More Accurate Diagnosis of Some Liver Diseases Using Alpha-Fetoprotein (AFP)
Levels: Presented at ASCP
By Lexa W. Lee
NEW ORLEANS, LA -- October 23, 2007 -- Serum alpha-fetoprotein (AFP) levels
above700 ng/dL appear to be diagnostic of hepatocellular carcinoma (HCC),
researchers reported here at the American Society of Clinical Pathologists
(ASCP) Annual Meeting.
The current literature cites a range of AFP values from above 20 ng/dL to 400
mg/dL as being associated with HCC; levels above that are reported as being
diagnostic of HCC. The findings of a new study trying to establish a more
accurate range for HCC screening were presented.
To establish a more accurate range of AFP values for HCC screening, Todd LeLeux,
MD, Resident Pathologist, Michael E. DeBakey VA Medical Center, Houston, Texas,
United States, and colleagues performed a retrospective chart review of patients
who had been tested for AFP at their institution in the previous 5 years.
Out of the total sample of 2,538 patients, the researchers identified 101
patients diagnosed with HCC who were then divided into three groups, based on
their AFP values. Patient records were reviewed for tissue confirmation,
clinical findings, X-rays, and follow-up.
Within the three groups, 18 patients had AFP < 20 ng/dL, 29 had AFP from 20-400
ng/dL, and 54 had AFP
radiography of the liver, and AFP values, for the most part.
Incidence of hepatitis C virus infection (HCV) and alcoholic cirrhosis (ETOH)
varied with AFP values (49% HCV, 44% ETOH in < 20 ng/dL; 85% HCV, 10% ETOH in
20-400 ng/dL; 98% HCV, 5% ETOH in
FNA, liver biopsy, or radiography. There were eight cases of metastatic
carcinomas and one germ cell tumour. Only AFP values
of HCC, in the absence of a germ cell tumour.
In patients with AFP values between 400 and 700 ng/dL, five did not have HCC.
These had nonalcoholic steatohepatitis (NASH), hepatorenal syndrome, and
interferon therapy. The patients without HCC who had AFP values
alcoholic hepatitis, liver failure, cirrhosis, and interferon therapy.
Values of AFP can be increased by factors such as cirrhosis, interferon therapy,
alcoholic hepatitis, nonalcoholic steatohepatitis, hepatorenal syndrome, germ
cell tumours, and metastatic carcinomas.
The study findings showed that values
diagnostic of HCC, the researchers said. In patients with HCC, AFP values < 20
ng/dL have a strong correlation to ETOH alone. Values
with HCV, with or without ETOH.
Dr. LeLeux said, "We concluded that AFP values
HCC in a sample of patients dominated by men with HCV-related liver disease.
Lower values cannot be used to make a definitive diagnosis of HCC without
radiography or biopsy."
[Presentation title: Screening AFP Levels in Hepatitis and ETOH Abuse in
Patients in the US: What Is a Diagnostic or Suggestive Value? Poster 46]
http://www.docguide.com/news/content.nsf/news/852571020057CCF68525737D0071FE7B

Treating Patients with Hepatitis-C
Joanna Small
10/23/2007
After three decades of infection, a patient with hepatitis C will most
likely need a liver transplant.
But it`s not a death sentence, and that`s the message hepatitis survivor
Lynn Beiswanger wants to emphasize.
He`s run 15 marathons, two while in treatment for hepatitis. Now he`s
reached a major milestone.
Before 1991, there was no test to determine if blood had been tainted by
the virus.
So Beiswanger was infected when he received a blood transfusion, but his
condition went undetected for 19 years.
Beiswanger has now recovered after 48 weeks of treatment through
injection, but that`s not always the case.
"C is a big challenge because 85 percent of people who get it cannot
recover from it spontaneously," says Dr. Kent Martin. "Their immune system is
not capable of ridding the body of virus."
There are three of six hepatitis C genotypes in the United States, and of
the three, the recovery rate for two of them is between 80 and 90 percent.
However, Genotype One, which Beiswanger had, is only eradicated 50 to 60
percent of the time.
Tonight, we`ll have more on hepatitis C as well as the more curable and
less serious hapatitis A and B.
http://www.kqcd.com/News_Stories.asp?news=12129

The Progressive Nature of Cirrhosis: Implications for an Aging Hepatitis
C-Infected Population
Posted 10/12/2007
Nizar N. Zein, MD
Introduction
In the early years after the discovery of hepatitis C virus (HCV), its primary
role in posttransfusion hepatitis and its tendency to induce persistent
infection after exposure were widely documented.[1,2] These early observations
were followed by considerable debate within the scientific community as to
whether HCV may lead to life-threatening complications or increased mortality in
the infected host. Compelling evidence, however, linked HCV infection to liver
cirrhosis and its associated complications of liver failure and hepatocellular
carcinoma (HCC). Subsequently, a series of well-designed studies suggested an
increase in liver-related mortality among patients with HCV infection.[3,4] Now
it is firmly believed that HCV infection is associated with substantial
morbidity and mortality and that it clearly represents a global public health
challenge.
HCV infection has reached epidemic proportions and is currently the most common
chronic blood-borne infection in the United States. Hepatitis C represents a
global epidemic as well, with an estimated 120 million infected individuals
worldwide (2% of the world population).[5] The lack of a prophylactic vaccine or
a universally effective therapy has delayed control of this emerging epidemic.
Although the link between chronic HCV infection and histologic cirrhosis is well
established, there is a significant variation in the outcome of chronically
infected patients.[6] In a retrospective study of patients with posttransfusion
hepatitis C, Tong and colleagues[7] suggested that in the United States, the
mean time to develop cirrhosis was approximately 18 years after transfusion
exposure. However, the development of cirrhosis was not universal and some
patients had mild degrees of fibrosis despite a long-term ongoing infection. It
was estimated that 20% of patients with chronic HCV infection developed
cirrhosis after 20 years of infection.[3] Several independent predictors of
fibrosis progression in patients with chronic hepatitis C have been identified,
including male sex, age at the time of infection (
consumption (
The Natural History of HCV CirrhosisCirrhosis is the most advanced histologic
injury associated with chronic liver diseases, including hepatitis C, and almost
always precedes the onset of liver failure and HCC. Progression to cirrhosis is
often silent, but once it is established, the rate of developing decompensated
liver disease is about 4% per year.[10,11] The survival rate following hepatic
decompensation is less than 50% at 5 years as compared with an 80% to 90% 5-year
survival rate in patients with compensated cirrhosis.[11] Consistent with most
complications of chronic hepatitis C, duration of infection is by far the most
significant risk factor for decompensation -- although other cofactors, such as
alcohol intake, may play an important role.[12]
For individuals with hepatic decompensation in the setting of HCV infection,
liver transplantation may be the only viable therapeutic option. While
effective, liver transplantation is a suboptimal treatment alternative given its
complexity, risks, and the high rate of HCV recurrence post transplant.
Unfortunately, recurrent HCV infection is a universal event, with serious
consequences, including cirrhosis and liver failure, and has emerged as an
important cause of retransplantation in the United States.[13-15] Indeed,
recurrent infection leads to cirrhosis in 10% to 25% of transplant recipients
within 5 to 10 years, and once cirrhosis occurs, the 1-year risk for hepatic
decompensation reaches 40%.[13-15]
The development of HCC in the setting of HCV infection is of particular
significance given the number of patients with chronic hepatitis C worldwide and
the poor outcome associated with HCC. In a meta-analysis of 21 case-control
studies, the risk for HCC was increased 17-fold in HCV-infected patients
compared with HCV-negative controls.[16] The presence of underlying cirrhosis
appears to be a prerequisite for HCC in the setting of chronic HCV infection.
Once cirrhosis is established, the annual incidence of HCC is estimated to be 1%
to 4%.[17,18] Higher annual incidence rates (5% to 7%) have been reported from
Japan.[19]
Multiple studies attempted to measure the time interval between infection and
development of HCC. Although complicated by lack of knowledge of the exact time
of infection, most studies suggested that this interval ranges between 25 and 30
years.[7,20]
Although not entirely proven, the use of interferon-based antiviral therapy in
patients with chronic HCV infection may improve survival and reduce the risk for
HCC. In one recent study from the United Kingdom, 150 HCV-infected patients with
advanced fibrosis were followed for a median time of 51 months.[21] HCC or
decompensation was diagnosed in 25% of patients after a median interval of 41
months. A multivariate analysis showed that previous combination antiviral
therapy was independently associated with improved survival.[21]
Interferon-based therapy may also prevent HCC in patients with HCV-cirrhosis;
the incidence of HCC seems to be most substantially reduced in individuals who
achieve sustained viral eradication after therapy.[22,23]
Implications for an Aging HCV-Infected Population
Given the progressive nature of hepatitis C, prediction of its future burden is
mostly driven by estimates of past incidence. The most informative studies of
hepatitis C incidence and prevalence in the United States are those derived from
the National Health and Nutrition Examination Survey (NHANES).[24] It seems that
the incidence of HCV infection increased steadily during the 1960s, 1970s, and
most of the 1980s, with an estimated 230,000 new cases occurring annually in the
1980s. The incidence of new HCV infections declined sharply in the 1990s,
particularly among injection drug users. The number of new HCV infections in
2004 in the United States has been estimated to be about 26,000.[25,26] This
sharp decline in new cases is mostly attributed to screening of blood and blood
products for HCV antibodies and to a lesser extent to increased awareness among
injection drug users regarding the risk for HCV transmission.
Despite the encouraging decline in the incidence of hepatitis C, most of the
detrimental complications associated with this infection, including cirrhosis,
liver failure, and HCC, occur more than 20 years after initial infection.[7] The
number of patients with more than 20 years of infection in the United States is
expected to quadruple by the year 2015, leading to a potential explosion in the
number of patients with end-stage liver disease and HCC.[27] These estimates
have major implications for an aging HCV population that was infected primarily
in the 1960s through the 1980s and may have major implications on the
utilization of healthcare resources. It is anticipated that without a more
universally effective therapy, there will be a substantial increase in the
demand for liver transplantation over the next 15 years.[28]
The estimated rate of increase in complications due to HCV cirrhosis in the next
2 decades may even be an underestimation, in that it did not account for the
impact of aging on the rate of fibrosis progression. In studies from Europe, the
probability of fibrosis progression per year for men aged 61 to 70 years was 300
times greater than that for men aged 21 to 40 years.[9,29] Potential
explanations for these findings may include greater vulnerability of an "aging
liver" to environmental factors, a decrease in hepatic blood flow, and a
decrease in liver volume.[30]
Future efforts to decrease morbidity and mortality associated with chronic HCV
infection may therefore be focused on viral eradication to prevent the onset of
liver failure and HCC and to slow progression to cirrhosis. Combination therapy
with pegylated interferon alpha and ribavirin is currently considered as the
standard of care for treatment of chronic HCV infection. However, as many as 50%
of patients will fail to achieve a sustained virologic response,[31,32] defined
as undetectable HCV RNA at 6 months after discontinuation of all antiviral
therapies, and will thus be at high risk for cirrhosis and future complications.
Emerging novel treatment concepts have the potential to revolutionize the
approach to managing HCV infection and may "interrupt" its natural history at an
early stage in the disease course, thus minimizing the incidence of serious
complications (liver failure and HCC).
Arguably, the most critical advance in therapy for hepatitis C over the past
decade has been the introduction of specifically targeted antiviral therapy for
HCV, referred to in the literature as STAT-C. STAT-C represents a group of
emerging therapies comprising agents that target specific enzymes important for
viral replication, such as the protease and polymerase enzymes. The potential
role of these investigational agents in achieving viral eradication was
demonstrated in a study assessing the safety and efficacy of a selective,
specific, and potent peptidomimetic inhibitor of the HCV NS3-4A serine protease
used in combination with pegylated interferon alpha-2a.[33] At 14 days after
initiation of therapy, a 5.5-log decline in HCV RNA was noted, with 6 of 8
patients becoming HCV RNA negative at this time point. Similar encouraging data
were recently presented in relation to a second NS3-4A protease inhibitor that
is currently being assessed for safety and efficacy in clinical trials.[34]
These data demonstrate the feasibility of this specifically targeted antiviral
approach to hepatitis C and suggest that viral eradication may indeed be
achievable in most HCV-infected patients in the future. The latter would
certainly have the greatest impact on future projections of HCV burden. Other
approaches besides the STAT-C agents have been introduced, including a modified
longer-acting formulation of interferon alpha (albumin interferon alpha),
insulin sensitizing agents, and tumor necrosis factor alpha inhibitors (in
combination with standard HCV therapy), but these are still in clinical
trials.[35,36]
Conclusion
Hepatitis C continues to pose a significant public health threat. Despite the
dramatic decline in new HCV infections in the United States, the number of
patients who have been infected for 20 years or more and who are at risk for
serious complications is rising. A consistent finding of studies in patients
with HCV cirrhosis is the beneficial role of viral eradication in reducing the
incidence of serious complications and improving overall survival. Thus,
attention has turned to new strategies on the horizon, such as the STAT-C
agents, for their potential to enhance the current therapeutic arsenal against
hepatitis C. If confirmed in phase 3 clinical trials, the introduction of these
agents into mainstream HCV therapy may enhance clinical outcome and optimize the
likelihood of achieving a sustained virologic response in most chronically
infected patients. Such an achievement is key to "winning the war" against HCV
infection.
Supported by an independent educational grant from Vertex
http://www.medscape.com/viewarticle/563077?src=mp

Hi bayla. alfottos please reply al.
Sent via BlackBerry from T-Mobile

Study: MRI scan can predict liver fibrosis
A U.S. study has determined moderate to severe chronic liver disease can be
predicted with the use of a type of magnetic resonance imaging.
The researchers at New York University Medical Center said the
diffusion-weighted MRI scans appear promising, although further study is needed.
"Due to the increased incidence of chronic hepatitis in the United States,
particularly hepatitis C, there is a strong need for non-invasive methods to
replace or supplement liver biopsy, which is relatively invasive and limited by
interobserver variability and sampling error," said Dr. Bachir Taouli, lead
author of the research.
"At this point, this is an experimental method that needs to be tested in a
larger series," said Taouli. "However, diffusion imaging does show potential for
decreasing the number of biopsies and decreasing the number of antifibrogenic
drug trials."
The study appears in the October issue of the American Journal of Roentgenology.
http://social.moldova.org/stiri/eng/75586/

Those of us living with Hepatitis C and HIV know all about this........ but I am
sure that many have forgotten. Take a look at the last line!
Clinton's Arkansas blood scandal

Pamela Anderson Says She's Curing Her Hepatitis C, Others Say She's An
Alcoholic/Drug Addict
Whaddaya say we check in with Pamela Anderson's liver? Mrs. Salomon recently
told OK! magazine:
"Every time I get tested my doctors tell me I am getting healthier. I believe
I'm going to cure my Hepatitis C."
But yesterday Jonathan Jaxson reported that Anderson consumes alcohol daily and
is addicted to crystal meth, cocaine, marijuana (no biggie), and pills.
Jaxson's source, a friend of Anderson's supposedly, said:
"She is out of control . . . She knows she is going to die soon, so she
continues to party out of control thinking nothing of it. Never does she mention
her kids. Her marriage to Rick Salomon, nicknamed by Pam and friends as 'Scum,'
was something to fulfill her immediate emotional needs. We have all known one
another for years and nothing ever sparked between them until recently!
"The 3-4 days a week cocaine binges are insane. There isn't a day that goes by
in the past 4-5 years of knowing her that I have seen Pam sober. She won't even
take care of her health properly and the drugs are only further causing her
liver trouble.
"I have witnessed her using several drugs over the past few years. Including:
Crystal Meth, Methadone, Ecstasy, Marijuana and her nearly daily drug of choice,
Cocaine."
If both Anderson and her friend are telling the truth (it's nice to give people
the benefit of the doubt sometimes, ya know?), then hard partying cures and
worsens the Hep all at once!
http://www.wendywayrad.com/2007/10/pamela-anders-3.html

R7128 Receives Fast Track Designation From The FDA For The Treatment Of Chronic
Hepatitis C Infection
Pharmasset, Inc. (Nasdaq: VRUS) has received fast track designation from the
U.S. Food and Drug Administration (FDA) for R7128 for the treatment of chronic
hepatitis C virus (HCV) infection. R7128 is a prodrug of PSI-6130, an oral
cytidine nucleoside analog polymerase inhibitor of HCV that is being developed
through Pharmasset's collaboration with Roche. Pharmasset is currently enrolling
a 28-day Phase 1 clinical trial to evaluate R7128 in combination with Pegasys(R)
(pegylated interferon) plus Copegus(R) (ribavirin) in treatment-naive patients
chronically infected with hepatitis C virus (HCV) genotype 1.
Under the FDA Modernization Act of 1997, fast track designation may facilitate
the development and expedite the review of a drug candidate that is intended for
the treatment of a serious life-threatening condition and demonstrates the
potential to address an unmet medical need for such a condition. R7128 was
granted the fast track designation primarily due to the need for HCV treatments
with novel mechanisms of action, oral administration, different resistance
profiles and improved safety and efficacy over the existing standard of care for
both treatment-naive and treatment-experienced patients.
"The FDA's fast track designation for R7128 acknowledges the urgent need for new
HCV drugs," stated Dr. Michelle Berrey, Pharmasset's Vice President, Clinical
Development & Chief Medical Officer. "Currently, there are no HCV polymerase
inhibitors approved for the treatment of chronic HCV infection. We continue to
work closely with our HCV partner, Roche, and the FDA on the development and
regulatory review of R7128, which has demonstrated compelling antiviral activity
and has been generally well-tolerated in clinical trials to date."
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, is enrolling Phase 3 clinical trials for
registration in the Americas and Europe. Clevudine is already approved for HBV
in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the
brand name Levovir. R7128, an oral treatment for chronic HCV infection, is
enrolling a 28-day Phase 1 clinical trial in combination with Pegasys(R) and
Copegus(R) through a strategic collaboration with Roche. Racivir, which is being
developed for the treatment of HIV in combination with other approved HIV drugs,
has completed a Phase 2 clinical trial.
About R7128
R7128 is being developed for the treatment of chronic HCV infection. R7128 is a
prodrug of PSI-6130, a pyrimidine nucleoside analog inhibitor of HCV RNA
polymerase. A prodrug is a chemically modified form of a molecule designed to
enhance the absorption, distribution and metabolic properties of that molecule.
Results from an oral single ascending dose study of PSI-6130 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 1 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
adaptive Phase 1 study is comprised of three parts:
Part 1 is a single ascending dose study of R7128 conducted in 46 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. Results from the single
ascending dose portion of the study indicated that all doses of R7128 studied
(500 mg to 9000 mg) were generally safe and well-tolerated. All patients
completed the study, and none experienced gastrointestinal adverse events or
serious adverse events during the study. No hematological or laboratory
abnormalities of clinical significance were noted.
Part 2 is a multiple ascending dose study of R7128 conducted in 40 patients
chronically-infected with HCV genotype 1 who previously failed interferon
therapy. The primary objective of Part 2 is to assess the safety, tolerability
and pharmacokinetics of R7128 after once-daily (QD) or twice- daily (BID) dosing
for 14 days. The secondary objective is to assess antiviral activity by
measuring the change in HCV RNA. Preliminary data from the multiple ascending
dose portion of the study indicated that R7128 demonstrated potent,
dose-dependent antiviral activity in four patient cohorts receiving 750 mg or
1500 mg administered either once-daily or twice-daily for 14 days as
monotherapy. Patients receiving 1500 mg BID demonstrated a mean 2.7 log10 IU/mL
(
cohort during the 14 days of dosing. R7128 was generally safe and well
tolerated. There were no serious adverse events, no adverse events requiring
dose modification, no dose-related gastrointestinal adverse events and no
clinically significant changes in hematologic or other laboratory parameters.
Part 3 is a multi-center, observer-blinded, within-cohort randomized,
placebo-controlled study being conducted in up to 75 treatment-naive patients
with genotype 1 hepatitis C virus. The primary objective is to assess the
safety, tolerability and pharmacokinetics of R7128 in combination with Pegasys
plus Copegus. The secondary objective of Part 3 is to evaluate the short-term
change in HCV RNA. The study will include two to three oral doses of R7128 (500
mg to 1500 mg) that are being administered twice-daily with Pegasys plus Copegus
for 28 days.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading
cause of chronic liver disease and liver transplants. The WHO estimates that
nearly 180 million people worldwide, or approximately 3% of the world's
population, are infected with hepatitis C virus (HCV). The CDC has reported that
almost four million people in the United States have been infected with HCV, of
whom 2.7 million are chronically infected.
Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation
Reform Act of 1995: Statements in this press release regarding our business that
are not historical facts are "forward-looking statements" that involve risks and
uncertainties, including without limitation the risk that the FDA withdraws the
R7128 fast track designation, the risk that the FDA does not expedite the review
or approval of any application for R7128, the risk that adverse events could
cause the cessation of the Phase 1 study and/or our development of R7128, the
risk that our collaboration with Roche will not continue or will not be
successful, the risk that the on-going or anticipated clinical trials for any
one or more of our product candidates will not be successful or will not provide
meaningful data and the risk that any one or more of our product candidates will
not be successfully developed and commercialized. For a discussion of these
risks and uncertainties, any of which could cause our actual results to differ
from those contained in the forward-looking statements, see the section of our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 filed with the
Securities and Exchange Commission entitled "Risk Factors" and discussions of
potential risks and uncertainties in our subsequent filings with the Securities
and Exchange Commission.
Pharmasset, Inc.
http://www.pharmasset.com
http://www.medicalnewstoday.com/articles/86615.php

Federal, State Authorities Raid Health Insurer WellCare; Target Unknown
Federal and state authorities on Wednesday raided the headquarters of
Tampa, Fla.-based health insurer WellCare, which provides Medicare and Medicaid
managed care plans and has 2.3 million members nationwide, the Miami Herald
reports. No information on the purpose of the investigation has been disclosed
(Stacy, Miami Herald, 10/25). The St. Petersburg Times reports that almost all
of WellCare's $4 billion in revenue comes from federal and state governments
(Hundley, St. Petersburg Times, 10/25). The company has about 155,000 people
enrolled in Medicare Advantage plans, making it one of the largest providers of
benefits through the program, according to Bloomberg/South Florida Sun-Sentinel
(Timmerman/Goldstein, Bloomberg/South Florida Sun-Sentinel, 10/25).
WellCare in a release said that service to its members would be uninterrupted
and that it is cooperating with authorities (St. Petersburg Times, 10/25).
Agents from the FBI, HHS and the Florida Medicaid Fraud Control Unit conducted
the raid (Francis, Wall Street Journal, 10/25).
Peter Costa, an analyst at FTN Midwest, said that it appears to be a criminal
investigation, the penalties of which could include "being barred from doing
business with the government if it is for fraud, which it most likely is given
the departments involved."
WellCare has been under scrutiny for several months. Last year, the company
admitted that independent sales agents in Georgia were enrolling deceased people
in Medicare plans. This year, WellCare was among several insurers cited to have
aggressive marketing practices of MA plans, which resulted in a temporary
suspension. WellCare in August was cited again for violating parts of its
Medicare contract, which includes sales practices (St. Petersburg Times, 10/25).
Georgia's Department of Community Health -- which administers Medicaid and
PeachCare, the state's SCHIP -- also is investigating WellCare. It has been
auditing payments to medical providers for the insurer, in addition to
Amerigroup and Peach State (Miller, Atlanta Journal-Constitution, 10/25).
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=48444

PAMELA ANDERSON: 'I'M GOING TO CURE MY HEPATITIS C'
Actress PAMELA ANDERSON is adamant she will cure the Hepatitis C virus she
contracted from ex-husband TOMMY LEE. In 2003, Anderson announced she was not
expected to live for more than 10 or 15 years. The former Baywatch star married
Rick Salomon in Las Vegas earlier this month (Oct07) and now insists she is
feeling more positive about the future. She tells Britain's OK! magazine, "Every
time I get tested my doctors tell me I am getting healthier. I believe I'm going
to cure my Hepatitis C."
http://www.contactmusic.com/news.nsf/article/pamela%20anderson%20im%20going%20to\
%20cure%20my%20hepatitis%20c_1047863

Ministry vows to track down 280,000 at risk of hepatitis C
10/26/2007
THE ASAHI SHIMBUN
The embattled health ministry plans to survey 280,000 patients who were
administered a blood product that may have been contaminated with the hepatitis
C virus.
The plan was broached by health minister Yoichi Masuzoe during the Lower House
Health, Labor and Welfare Committee session Wednesday.
During the session, Naoto Kan, acting president of opposition Minshuto
(Democratic Party of Japan), criticized Masuzoe and the ministry for failing to
warn patients about the risk of hepatitis C infections even though ministry
bureaucrats had documents on 418 at-risk patients as far back as 2002.
Masuzoe indicated that the government and a drug company that provided the
contaminated blood product, fibrinogen, would shoulder the costs of examination
and treatment if the patients were infected with the hepatitis C virus.
"There is no question that those responsible should cover (the expenses)," he
said.
Masuzoe also indicated the government plans to seek out-of-court settlements by
year-end for five lawsuits over hepatitis C infections via fibrinogen and other
tainted blood products.
In 2002, the former Mitsubishi Pharma Corp. submitted to the ministry documents
on patients who had developed hepatitis C after being given fibrinogen, the
blood product the company manufactured and marketed.
Kan, a former health minister who helped to resolve the HIV tainted blood fiasco
in the 1990s, demanded the government conduct a thorough survey on the
conditions of the 418 at-risk patients after identifying them.
He also called for a study of about 280,000 individuals who had received
fibrinogen.
An estimated 10,000 of these people were infected with hepatitis C, according to
government officials.
Kan also insisted that the government and the drugmaker cover the medical
expenses of those infected with hepatitis C from the tainted fibrinogen.
In response, Masuzoe showed understanding to Kan's proposal, saying he wants to
"implement (measures) in such a manner."
When asked by reporters after the committee meeting if the government would
cover the patients' medical fees, Masuzoe answered, "Yes, in principle."
But identifying such a large number of at-risk patients will be a formidable
challenge.
The health ministry will have to work closely with medical institutions, the
primary source of information on those who had received fibrinogen.
Masuzoe, seeking cooperation from every possible source, said he would consider
revising the Pharmaceutical Affairs Law to allow the government to order doctors
and other medical staff to report on the at-risk patients.
About 7,000 medical institutions were provided with fibrinogen, which was first
approved in 1964 and administered until the 1980s.
Health ministry officials believe that some of these institutions have already
closed down.
In addition, medical institutions at the time were required to keep records on
patients for only five years. It is highly likely that most of the institutions
have already disposed of their records on administering fibrinogen.
Fibrinogen was originally produced by the now-defunct Green Cross Corp.
Mitsubishi Pharma took over Green Cross's blood product operations.
In 1987, eight women were found to have been infected with hepatitis C after
receiving fibrinogen during childbirth.(IHT/Asahi: October 26,2007)
http://www.asahi.com/english/Herald-asahi/TKY200710250417.html

http://dedge.com/flash/hangman/hangman.swf?a=300

Flamel Cites Positive Drug Trial Data
NEW YORK - Flamel Technologies SA Thursday cited positive preliminary data from
a clinical trial comparing its long-acting hepatitis C treatment to an already
marketed drug, sending the biopharmaceutical company's shares soaring.
Shares of French drug developer Flamel jumped $1.36, or 14.5 percent, to $10.76
in afternoon trading. Over the past year, the stock traded between $7.90 and
$37.42.
The trial compared the safety, tolerability and long-acting activity of the
drug, Interferon-alpha-XL, with Schering-Plough Corp. (nyse: SGP - news - people
)'s ViraferonPeg, in patients with chronic hepatitis C virus infection. The
trial included three groups of 12 to 14 patients.
Flamel said IFN-alpha-XL is designed to act longer with a higher tolerability
than approved interferon regimens, referring to substances that have been shown
to help fight hepatitis C.
Data showed a "statistically significant" reduction in viral load for the group
of patients who received the higher of two doses of IFN-alpha-XL compared with
similar patients who received the standard dose ViraferonPeg, also called
PegIntron in the U.S., according to Flamel.
Flamel also noted a "marked reduction" in side effects for patients givens its
treatment compared with those on PegIntron.
Side effects for both drugs included fever, flu-like symptoms, headache and
white blood count abnormalities.
In 2006, Schering-Plough's PegIntron booked $837 million in sales.
Flamel said it is seeking a licensing partner for its product.
Shares of Kenilworth, N.J.-based Schering-Plough rose 15 cents to $30.08 in
afternoon trading.
http://www.forbes.com/feeds/ap/2007/10/25/ap4263721.html

High School Final Paper by Honora Remak
Dear Pam,
Honora, my youngest daughter, is currently attending the University of Oregon
and is majoring in Biology. She wants to become a Biology teacher. This final
paper she wrote when she was seventeen and she got an A plus. She graduated with
honors and was applauded by a packed auditorium at the Hult Center of Performing
Arts in downtown Eugene. (below is a link to her essay which was posted on the
internet) It was a very proud moment for me. To give you an update about what
has happened since then follows.
On April 25th of this year (2007) after having been hospitalized at University
of California San Francisco for complications due to liver failure, I underwent
a second liver transplant. I had severe complications and had to go back into
surgery twice to resolveissues with bleeding and infections. After some days in
ICU I was transferred to the recovery ward and then to a rehabilitation hospital
in Petaluma, California. I remained there until the end of June at which point I
was released to relatives who cared for me further. After another month I
returned to my home where I live alone and several weeks later returned to work
with the two non-profits that I founded some years ago. My responsibilities and
duties are in event planning, patient /healthcare advocacy, medical education,
task force establishment, increasing public awareness and access to care.
http://www.heart-intl.net/HEART/010105/TakingaChanceatLife.htm
I am requesting that you send out by email Honora's essay and my update to your
group because I feel it will bring a greater awareness to the newly diagnosed
patients as well as their family and friends a greater understanding of HCV and
its treatment. You may note my current public e-mail address wmremak@...
should anyone wish to contact me for further information.
Thank you for your help.
Sincerely,
Bill Remak

Hello Everyone..Hey,its been awhile how ya'll doing???
I been having health issues first off with my thyroid and my Diet Dr. put me
back on thyroid pills to help with that THAN also with my HepC and tummy again
and yesterday I had another EGD done they took a biospy of my tummy and wont
know nothing about it until I see the Gastrologist on Nov.14th..I do know
however they did a test on my tummy and found that I have what you call a slow
tummy "Gastroperesis" its not to good but at least I know now why I am so
bloated all the time and cant seem to get the weight off very well and my liver
on top of the HepC is fatty..They will be putting me on some pills to fix this
and if at a certain time it doesnt help or work they will do surgery also this
could cause me to get Diabetes..
Sooo say some thoughts and prayers that things work out and I can be around for
along time..love Jan

Hepatitis C virus infection in Italian patients with Fibromyalgia - Source:
Clinical Rheumatology, Oct 18, 2007
by C Palazzi, et al.
ImmuneSupport.com
10-19-2007
We evaluated the prevalence of hepatitis C virus (HCV) infection in Italian
patients suffering from Fibromyalgia (FM), in comparison with patients affected
by non-HCV related rheumatic degenerative disorders.
Consecutive patients with FM and a statistically comparable group of patients
suffering from peripheral osteoarthritis (OA) or sciatica due to L4-L5 or L5-S1
herniated disc were tested for HCV infection with a third-generation
microparticle enzyme immunoassay (MEIA). In the positive cases, a
third-generation recombinant immunoblot assay (RIBA) confirmatory test and serum
HCV-RNA test were performed. Fisher's exact test was performed to compare the
prevalence of HCV infection (MEIA- and RIBA-positive results) obtained in the
two enrolled groups.
Enrolled were 152 subjects suffering from FM and 152 patients with peripheral OA
or sciatica.
Anti-HCV antibodies were found in 7 of 152 (4.6%) patients suffering from FM and
in 5 of 152 (3.3%) of control subjects. No statistically significant differences
in HCV prevalence were detected between cases and controls.
Our present report does not confirm previous data indicating an increased
prevalence of HCV in FM patients and does not seem to support a significant
pathogenetic role of HCV under this condition.
Source: Clinical Rheumatology. 2007 Oct 18; PMID: 17943229, by Palazzi C,
D'Amico E, D'Angelo S, Nucera A, Petricca A, Olivieri I. Division of
Rheumatology, Villa Pini Clinic, Chieti, Italy.
http://www.immunesupport.com/library/showarticle.cfm/ID/8427

Hepatitis C Testing Recommended For Anyone With A Tattoo
The connection between tattoos and hepatitis C virus (HCV) has long been
suspected but never completely substantiated. Tattoos and the connection to the
disease were clouded by a perceived propensity to other risk factors, such as
injection drug use. "Other studies did not exclude patients with other risk
factors for hepatitis C," explains principal investigator Dr. Edmund Bini,
"which made it difficult to assess the association between HCV and tattoos. The
strength of that association surprised us."
Researchers in New York studied 3871 people, approximately half of whom were
control subjects. Patients with HCV were more likely to have had one or more
tattoos, and this remained so even after adjusting for age, sex and
race/ethnicity.
Patients with tattoos but also with traditional risk factors for HCV --
injection drug use and drug transfusion prior to 1992 -- were excluded from the
final analysis of the data of the remaining 1887 patients with tattoos and no
other risk factors for HCV, patients with HCV were approximately three times
more likely to have had tattoos. This connection was significant even after,
once again, adjusting for age, sex, and race/ethnicity.
The researchers concluded that all patients with tattoos should be tested for
HCV. "It helps to be able to identify patients early who are eligible for
treatment," said Dr. Bini. This information will be further refined when they
complete analysis of assessing the risk of having multiple tattoos, as well as
whether the patient received the tattoo in the US or abroad.
Abstract title:
Strong association between tattoos and hepatitis C virus infection: A
multicenter study of 3,871 patients
AASLD is the leading medical organization for advancing the science and practice
of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and
cure liver diseases. This year's Liver Meeting, held in Boston, Massachusetts
November 2-6, will bring together almost 5,000 researchers from 55 countries.
American Association for the Study of Liver Diseases
http://www.aasld.org
http://www.medicalnewstoday.com/articles/86149.php

Discovery Of New Antiviral Mechanism Promising For Hepatitis C Treatment
ScienceDaily (Oct. 22, 2007) - A team of researchers led by biologists at the
University of California, San Diego has discovered a completely new mechanism
that mammalian cells employ to fight infections of the Hepatitis C virus, which
affects approximately 2.7 million Americans and 170 million people worldwide.
The achievement, detailed in a paper published in the October 18 issue of the
journal Nature, could improve current antiviral regimens or result in new
treatments that are more effective and possess fewer detrimental side effects
for those with the Hepatitis C virus infection, which frequently leads to liver
cirrhosis and/or liver cancer.
"Approximately two percent of the human population worldwide is infected with
Hepatitis C virus," said Michael David, an associate professor of biological
sciences at UC San Diego who headed the research team. "And about 50 to 80
percent of those people develop persistent infections and are at great risk of
developing liver cancer."
The only approved therapy for Hepatitis C is alpha-interferon, a protein
produced by animal cells when invaded by viruses that induces healthy cells to
manufacture enzymes that counter the infection. Often alpha-interferon is used
in combination with an antiviral drug called ribavirin. However, only 40 to 80
percent of patients respond to this therapy and about half of those who do
respond relapse once interferon treatments are stopped. Only about 25 percent of
those treated with interferon, which can also induce flu-like symptoms and
kidney damage in some patients, rid themselves of the viral infections.
Explaining these varying response rates is difficult, since scientists do not
fully understand the mechanisms used by alpha-interferon to fight off Hepatitis
C virus infection.
What David and his team discovered is that microRNAs, short strands of RNA that
interfere with the expression of specific genes, may also be effective against
the Hepatitis C virus, because they are used by mammalian cells to reduce the
replication of the virus. Their discovery comes as a surprise because while
microRNA interference has been known to occur as a defense mechanism in plants
and invertebrates, many scientists doubted it was employed by mammalian cells.
David and his group began by identifying microRNAs whose expression is
controlled by alpha-interferon, then used computer prediction to identify
potentially affected viral RNAs. Hepatitis C virus emerged as a prime candidate
and the UCSD researchers--in collaboration with Hepatitis expert Francis Chisari
of The Scripps Research Institute--demonstrated that several alpha-interferon
induced microRNAs are able to potently inhibit viral infection and replication.
"This is an entirely new antiviral mechanism in mammalian organisms," said
David. "Use of synthetic microRNAs has become a promising strategy of antiviral
treatment. However, selecting the 'right' sequence is crucial in order to avoid
unwanted and potentially dangerous side effects. The microRNAs used by
alpha-interferon have been selected by evolution for efficacy and safety,and
might therefore provide a sound basis for the generation of new synthetic
antivirals."
"Now that we have identified this new antiviral pathway or mechanism,
pharmaceutical companies may be able to design a more effective therapy against
the Hepatitis C virus," said Irene Pedersen, a project scientist working in
David's laboratory who is the first author of the paper.
Other co-authors of the paper are Francis Chisari, Guofeng Cheng and Stefan
Wieland of The Scripps Research Institute and Carlo Croce and Stefano Volinia of
Ohio State University. The research was supported by grants from the National
Institutes of Health.
Adapted from materials provided by University of California, San Diego.
http://www.sciencedaily.com/releases/2007/10/071019180523.htm

She lent her courage - and more - to save him.
A new marriage, a crisis, and a second chance at life
By Ed Hille
Inquirer Staff Photographer
Steve Cannizzaro and Anna Cruz were introduced at a party by his sister-in-law
in March 2004. "It was like a whirlwind," Anna said. Almost from the beginning,
he wanted to get married, asking her again and again.
Two people who had made mistakes now had a shot at a second chance.
But the future had its own complications. Some medical tests revealed that Steve
had a low white blood count. Doctors suspected cirrhosis of the liver, and
advised him to see a specialist.
He paid no attention. He didn't want to trouble Anna, so he didn't mention it:
"I wasn't really worried."
A week later, he coughed up blood. Food poisoning, he thought, though he did
visit the Frankford Hospital emergency room. To his surprise, he was admitted
right away.
"They put me on a whole bunch of medicine. . . . I kept telling myself that 'I'm
healthy. I'm going to get through this.' I thought I was going to live to be
70."
On Oct. 7, the couple married in City Hall. He was 53; she was 50. They spent
their honeymoon in Puerto Rico and in November visited friends in New York.
Steve remembers waking up in their Manhattan hotel room about 5 a.m. He was
thirsty, so he drank a glass of water.
Soon his stomach became upset, and he began coughing up blood. He and Anna both
refer to this as the "episode."
That "episode" marked the beginning of a six-month nightmare, of scary news and
dire choices that changed their lives and tested their new love.
Anna wanted to get Steve back to Philadelphia, so she alerted the Hahnemann
University Hospital emergency room, and then made the trip south in 55 minutes.
More "episodes" followed. Steve needed a liver transplant. Every year, 18,000
people are put on waiting lists for the 5,000 livers available from deceased
donors. On average, 1,700 on the list will die waiting.
Doctors said this was Steve's best hope for survival.
Steve had two options: Wait for an organ from a deceased person, or hope that a
live donor would step forward.
As months went by, bringing more "episodes," Anna couldn't stand seeing her
husband so sick. She was going to take that step herself.
Steve didn't want her to. "I didn't want her to suffer. She just took control
and said, 'I'm going to do it and I don't care what you say!'
"I thought she was crazy. . . . I love her . . . but I still think she was
crazy."
On a beautiful Sunday in March 2006, Steve and Anna threw a party for family and
friends, then headed to the hospital, where they hid their anxiety behind jokes
at check-in. Once admitted, they went to the 19th Floor, which is reserved for
transplant patients.
"I just wanted it over with," Anna said afterwards.
At 5:30 the next morning, Anna kissed Steve and whispered, "We're going to be
fine." Then she climbed onto a waiting gurney.
Steve Cannizzaro grew up in South Philadelphia, where life taught him to be
tough. His parents divorced and remarried. He shuttled between households, never
fitting in, always feeling abandoned.
In school his only interest was sports. He dropped out and joined the Army. On
leave, he got into trouble and was jailed for assault. "I didn't back down from
anybody," he said.
Discharged in 1970, he started driving a truck for a vending company. After work
he played whatever sport was in season.
For the next 30 years, little changed in Steve's life. There was hard living,
failed relationships, five estranged children, and a short temper.
Then he began to suffer health problems. In 2004, he developed diabetes and then
cirrhosis.
Anna's family lived at 18th and Wallace Streets. Her father fixed appliances and
played baseball. Her mother was a homemaker. When Anna, the youngest of seven
children, was 10, her father died, sending the family onto welfare.
At 18, Anna married Julio Cruz, a technician for KYW-AM (1060) and a softball
team manager. They had three children. Anna worked at receptionist and clerical
jobs at Hahnemann University Hospital, and then later for The Inquirer.
In 1994, Anna and Julio broke up. Two years later, Anna met a younger man. "He
was a gorgeous, blue-eyed, pony-tailed guy. . . . He was in Mannequin II. . . .
He did voiceovers."
He was also a drug dealer. When he asked her to store his "inheritance," she
complied.
In 1998, Anna was charged along with him as part of a drug ring in Manayunk and
spent nine months in prison. The Inquirer fired her.
When she returned to Philadelphia, Anna was determined to get her life on track.
She resumed secretarial work and started a cleaning service. She got involved
with the Pennsylvania Prison Society and joined a support group to help female
inmates.
But she was single in a world of couples and "this close to moving to New York
when I met Steve."
The Hahnemann transplant team consisted of four surgeons supported by doctors,
nurses and technicians, working around the operating table for more than eight
hours.
Dr. Burckhardt H. Ringe was in charge. Like a conductor, he led his "orchestra"
through surgery's complicated score.
Armed with high-tech tools, Ringe resected Anna's liver with a high-pressure
stream of saline solution. Minutes later, Dr. William C. Meyers, chief of
surgery, closed Anna's wound, and after eight hours and four minutes of surgery,
she began her recovery. Sixty percent of her liver had been removed.
Steve was waiting, anesthetized, in an adjacent operating room, and over the
next six hours and 11 minutes, Ringe transplanted part of Anna's liver into his
abdomen.
Two days later, both patients were alert, and Anna was wheeled to Steve's side.
On Day Seven, she was released, but Steve's white blood cell count was still
high. The next day, however, Ringe decided he'd heal better at home, and Steve
was on his way back to Anna.
Fast-forward one year. "They are in excellent health," said Ringe, who monitors
the couple's progress. The fear of organ rejection is past, and the aches and
pains have subsided.
It took about six months for Anna to feel normal. "Steven was back to full life
very early after his surgery," Ringe said. "He is an excellent example as to how
it can go."
Steve quit his delivery job and began helping a friend do landscaping. "I like
being outside," he said. On the weekend, he cleans apartment buildings with
Anna. For fun, he bowls, plays softball, and rides his motorcycle.
On weekdays, Anna works as a receptionist at PMHCC, a health-care provider in
Center City. After work, she drives up Broad Street to her second job, Cruz
Cleaning. At 7 p.m., she's home with Steve.
Being an organ donor has made Anna grateful for her health, and she has become
an advocate for the procedure: "I tell my story to everybody." She helps raise
funds at the Gift of Life foundation. "Steve and I are living proof that it
works," she said.
"I don't know where I'd be without her," said Steve.
Anna added, "We feel more connected than ever."
And then she joked: "I told him, if he ever leaves, I want my liver back!"

Schering says data on hepatitis C drug promising
Thu Oct 18, 2007 9:16am EDT
NEW YORK, Oct 18 (Reuters) - Schering-Plough Corp (SGP.N: Quote, Profile,
Research) on Thursday reported promising early results from a mid-stage study
involving its experimental hepatitis C drug, boceprevir.
The company said the favorable results were seen in a Phase II trial of patients
who had never previously been treated for their infections with the
liver-damaging hepatitis C virus.
One group of patients received boceprevir along with Schering-Plough's widely
used current dual therapy -- the injectable interferon drug Peg-Intron and
anti-viral pill ribavirin -- while another group received only Peg-Intron and
ribavirin.
After 12 weeks of treatment, up to 79 percent of patients in the boceprevir
group had undetectable levels of the virus in their bloodstreams, compared with
34 percent of those taking only Peg-Intron and ribavirin.
The company noted that the results, although encouraging, were only preliminary.
(Reporting by Lewis Krauskopf and Ransdell Pierson, editing by Gerald E.
McCormick)
http://www.reuters.com/article/companyNewsAndPR/idUSWNAS693720071018

Below you will find information about a study recently released by the Pew
Internet & American Life Project about e-patients and the increasing number of
people with chronic or serious illnesses who go online to research their health
problems. Some of the key findings from the study are below.
To see the study, entitled, "E-patients With a Disability or Chronic Disease",
click here.
a.. 34 million adults live with a disability or chronic disease; half go
online. Once online, they are avid consumers of health information.
b.. Those with chronic conditions have traditionally been less likely to use
the internet, but there has been major growth in this population in internet
adoption in the past four years.
c.. Those with chronic conditions are more likely than other e-patients to
report that their online searches affected treatment decisions, their
interactions with their doctors, their ability to cope with and manage their
condition. Nearly 69% said information found online led them to ask their
physicians new questions or get a second opinion.
d.. E-patients with chronic conditions have mostly positive things to say
about their online health searches, but they are more likely than others to
report frustration as well.
e.. Close to 67% of e-patients surveyed do not consistently check the source
and date of the health information they find online.
f.. The impact of the most recent search for health information was most
deeply felt by internet users who had received a serious diagnosis or
experienced a health crisis in the past year.
Tom Ferguson, MD, coined the term "e-patients" to describe individuals who are
equipped, enabled, empowered and engaged in thier health and health care
decisions. Dr. Ferguson's white paper, "E-Patients: How They Can Help Us Heal
Health Care", can be downloaded from http://www.e-patients.net/. Dr. Ferguson
envisioned health care as an equal partnership between e-patients and the health
professionals and systems that support them. The following definition of
e-patient from Wikipedia sets the tone for the e-patient white paper:
e-Patients represent the new breed of informed health consumers, using the
Internet to gather information about a medical condition of particular interest
to them. The term encompasses both those who seek online guidance for their own
ailments and the friends and family members (e-Caregivers) who go online on
their behalf. e-Patients report two effects of their online health
research-"better health information and services, and different (but not always
better) relationships with their doctors."
Based on the current state of knowledge on the impact of e-Patients on the
healthcare system and the quality of care received:
a.. Since the advent of the Internet many clinicians have underestimated the
benefits and overestimated the risks of online health resources for patients.
b.. Medical online support groups have become an important healthcare
resource.
c.. The net friendliness of clinicians and provider organizations-as rated by
the e-patients they serve-is becoming an important new aspect of healthcare
quality.
d.. This is one the most important cultural medical revolution of the past
century, mediated and driven by technology.
e.. The impact of the e-Patient cannot be fully understood and appreciated in
the context of pre-internet medical constructs. Research must combine expertise
from specialties that are not used to work together.
The Pew Internet Project is a nonprofit initiative of the Pew Research Center
and is funded by The Pew Charitable Trusts to examine the social impact of the
internet. The project is non-partisan and does not advocate policy outcomes.

Hepatitis C victims left in the dark for 5 years
10/23/2007
THE ASAHI SHIMBUN
The health ministry for five years had documents that may have identified at
least 165 people unknowingly exposed to the hepatitis C virus through tainted
blood products--but did nothing to warn them, ministry officials said Monday.
The ministry set up a team Monday to investigate why ministry officials had
denied the documents' existence for so long, and why it failed to alert the
at-risk patients.
The ministry received the documents on 418 patients in 2002 from the former
Mitsubishi Pharma Corp., now called Mitsubishi Tanabe Pharma.
On Monday, Natsuki Hayama, president of Mitsubishi Tanabe Pharma, separately
told health minister Yoichi Masuzoe that the company has found the names of 197
patients and initials for 170 patients who were exposed to hepatitis C
infections through its tainted blood products.
The Ministry of Health, Labor and Welfare has instructed Mitsubishi Tanabe
Pharma Corp. to notify people whose names or initials are contained on the
documents and urge them to seek treatment.
Hayama told reporters the company had not informed the patients of their
possible infection risk "to protect the patients' privacy."
However, he added his company now plans to set up a task force to quickly notify
the patients.
Health ministry officials said patients were not informed because of confusion
caused by personnel changes.
But the ministry's explanation so far on the issue has not been solid.
On Thursday, health ministry officials in a meeting with Minshuto (Democratic
Party of Japan) Diet members denied the ministry possessed documents containing
data that could identify at-risk patients.
On Friday, however, two documents were found in a ministry storage room that
listed the full names of two at-risk patients and initials for 116 others who
received tainted blood, ministry officials said.
Ministry officials admitted for the first time on Saturday that as far back as
2002, it had the documents the former Mitsubishi Pharma Corp. had submitted.
On one document, all data that could help establish the identity of patients was
blacked out. But on the other copy, nothing was blacked out.
In 2002, the ministry instructed Mitsubishi Pharma to provide data on patients
who had developed hepatitis C and other side effects after being treated with
fibrinogen, the tainted blood product provided by the company.
The documents found Friday contained partial information on 165 patients, such
as full names, initials, names of medical institutions, names of doctors or
other details that could help establish their identities, according to the
ministry.
In three patients' cases, for example, only the names of medical institutions
were entered.
Hayama told Masuzoe that of the 197 full names obtained by the company,
addresses are listed for 40. In 27 cases, only the city, town or village is
listed. In 12 cases, only the prefecture is listed.
Of the 170 patients listed by their initials, two had addresses, 13 had a city,
town or village, and 10 a prefecture.
Kazutaka Nakazawa, director of the General Affairs Division at the ministry's
Pharmaceutical and Food Safety Bureau, said, "The team probing the hepatitis
problem at that time disbanded, and the person who is now in charge had no
knowledge (the documents existed)."
Meanwhile, nine people in the ministry's documents may be plaintiffs in lawsuits
pending against the government and drug companies over the tainted blood product
infections, sources said.
Of the nine, two were not acknowledged by the government as receiving tainted
blood products. One of the two may be a plaintiff in an Osaka suit, the sources
said.(IHT/Asahi: October 23,2007)
http://www.asahi.com/english/Herald-asahi/TKY200710220364.html

Combination Therapy with HCV Protease Inhibitor Boceprevir Produces a High Rate
of Early Virological Response in Genotype 1 Hepatitis C Patients
Treatment-naive patients with chronic hepatitis C receiving the experimental
oral HCV protease inhibitor boceprevir plus pegylated interferon alfa-2b
(PegIntron) and ribavirin (Rebetol) experienced a high rate of early virological
response (EVR), according to preliminary results of an ongoing Phase II study.
Of the enrolled patients treated with boceprevir, 79% achieved an EVR, defined
as undetectable HCV RNA at week 12 of therapy, compared with 34% of patients
receiving PegIntron plus ribavirin alone.
Following are edited excerpts from the Schering-Plough announcement of the study
results:
"These initial results, while preliminary, are very encouraging, and showed that
boceprevir is a potent antiviral agent for hepatitis C," said Paul Kwo, MD,
associate professor of medicine and medical director, liver transplantation,
Department of Medicine, Division of Gastroenterology/Hepatology, Indiana
University School of Medicine, Indianapolis, and the lead investigator of the
study.
"In this study, boceprevir improved viral clearance rates at week 12 in genotype
1 hepatitis C infection compared to the control group. We look forward to
further results from this ongoing study."
Boceprevir is being evaluated in combination with PegIntron and Rebetol for the
treatment of patients chronically infected with hepatitis C virus (HCV) genotype
1 in two large Phase II clinical studies, in which more than 800 patients have
received boceprevir. One study involves treatment-naive patients and the other
involves patients who were nonresponders to previous peginterferon and ribavirin
combination therapy.
In these boceprevir studies, the most common adverse events have been fatigue,
headache, nausea, and anemia. No increase in skin adverse events (rash) beyond
what was seen in the PegIntron and Rebetol control arm was observed.
Gastrointestinal events were the most common adverse events leading to
discontinuation in the boceprevir arms.
Treatment-naive Study
In the treatment-naïve study, known as HCV SPRINT-1 (HCV Serine Protease
Inhibitor Therapy-1), boceprevir (800 mg TID [three times daily]) is being
evaluated in three treatment regimens:
a.. Boceprevir in combination with PegIntron (1.5 mcg/kg once weekly) and
Rebetol (800-1400 mg daily) for 28 or 48 weeks;
b.. 4 weeks of PegIntron and Rebetol combination therapy at the doses
described above followed by adding boceprevir to the combination for 24 or 44
weeks;
c.. Boceprevir in combination with PegIntron and low-dose Rebetol (400-1000 mg
daily) for 48 weeks, compared to a control of PegIntron and Rebetol alone for 48
weeks (a standard of care).
The primary endpoint of this study is sustained virologic response [SVR, defined
as undetectable HCV RNA 6 months following the end of treatment]. Patients
receiving these boceprevir regimens achieved a high rate of early virologic
response, with 70, 79, and 54 percent of patients, respectively, having
undetectable virus (HCV RNA) at week 12 of boceprevir therapy compared to 34
percent of patients in the control arm (Roche Cobas Taqman 1.0 assay; lower
limit of detection is 15 IU/mL).
Treatment discontinuations due to adverse events were 12, 9, and 8 percent for
patients in the boceprevir regimens, respectively, compared to 5 percent for the
control arm.
A total of 595 patients have been treated in the HCV SPRINT-1 study at sites
across the United States, Canada, and Europe, including 491 patients treated
with boceprevir. Overall, 77 percent of patients in the study were enrolled in
the United States. African-Americans represent 16 percent of the patients
enrolled in the study and 7 percent of patients in the study are cirrhotic.
Boceprevir in "Null" Nonresponder HCV Patients
Schering-Plough also reported top line results from a completed Phase II study
evaluating boceprevir dose response and the need for ribavirin in patients
chronically infected with HCV genotype 1 who were nonresponders to previous
peginterferon and ribavirin combination therapy (i.e., patients who did not have
undetectable HCV RNA or who did not achieve a 2 log decline in viral load with a
minimum of 12 weeks of peginterferon and ribavirin combination therapy). These
"null" nonresponders to peginterferon and ribavirin combination therapy
represent the most difficult-to-treat patient population. Patients who relapsed
following previous HCV therapy (relapsers) were not included in this study.
This study was complex, involving seven different treatment arms. Patients were
initially randomized to low doses of boceprevir (100, 200, or 400 mg TID) before
initiating an 800 mg TID boceprevir arm. Under the study protocol, patients
received these boceprevir doses in combination with PegIntron (1.5 mcg/kg
weekly) with or without Rebetol (800-1400 mg daily) for 24 or 48 weeks, or
received PegIntron and Rebetol alone as a control.
During the ongoing review of the study by the Data Safety Monitoring Board
(DSMB), it was recommended that patients in the lower-dose boceprevir arms who
demonstrated a substantial antiviral response during treatment cross over to
boceprevir 800 mg TID in combination with PegIntron and Rebetol for an
additional 24 weeks. Patients who did not demonstrate a substantial antiviral
response during treatment were discontinued from the study.
In addition, patients in the control arm who did not respond to PegIntron and
Rebetol alone were allowed to cross over to boceprevir 800 mg TID in combination
with Peg-Intron and Rebetol. Patients received a maximum of 24 weeks of the
optimized regimen (boceprevir 800 mg TID in combination with Peg-Intron and
Rebetol). In all, 357 patients were enrolled at centers in the United States and
Europe, including 348 patients who received boceprevir at some point in the
study.
In this study of well-documented null nonresponders, some patients achieved a
sustained virologic response (SVR). Overall, 7-14 percent of patients in the
boceprevir crossover arms achieved SVR compared to 2 percent in the control arm.
SVR was associated with early virologic response and a longer course of therapy
(more than 36 weeks). While potent antiviral activity with boceprevir was seen
in the study, with viral loads in some patients decreasing below the limit of
detection, viral loads for other patients decreased and then rebounded to
baseline levels while on therapy and some patients relapsed following the end of
treatment.
Several resistant variants were observed in these patients. These HCV variants
are similar to those reported after treatment with other HCV protease inhibitors
and those previously observed in boceprevir in vitro studies. Whether the
results of this study would have been different had all patients been started
with the optimized regimen of boceprevir 800 mg TID in combination with
PegIntron and Rebetol - and with treatment extending to 48 weeks - is not known.
"Although interferon nonresponders appear to respond to HCV protease inhibition,
it seems that some significant element of interferon response is needed to
achieve a sustained virologic response in the majority of these patients," said
Eugene R. Schiff, MD, chief, division of hepatology and director, Center for
Liver Disease, University of Miami Miller School of Medicine, and the lead
investigator of the study.
Schering-Plough said that in patients with little to no interferon response,
alternative treatment strategies are required, and the company will continue to
explore regimens containing boceprevir, PegIntron, and Rebetol in the Phase II
setting, using the insights gained in this initial study.
10/23/07
Source
Schering-Plough. Initial Results of Phase 2 Study with HCV Protease Inhibitor
Boceprevir in Treatment-naive Hepatitis C Patients Show a High Rate of Early
Virologic Response. Press Release. October 18, 2007.
http://www.hivandhepatitis.com/hep_c/news/2007/102307_a.html

Adherence to Hepatitis C Treatment among Recovering Heroin Users on Methadone
Maintenance
By Liz Highleyman
Because hepatitis C virus (HCV) is easily transmitted via contaminated needles
and other drug injection equipment, a large proportion of injection drug users
(IDUs) have chronic hepatitis C.
However, IDUs are often denied treatment for hepatitis C due to concerns about
adherence. This is the case despite limited and conflicting data about the
impact on adherence of issues such as psychiatric conditions and concurrent
illegal drug use. HCV treatment guidelines state that IDUs should not be
excluded from treatment as a group, but that each individual should be evaluated
for treatment on a case-by-case basis.
Some past studies have produced good sustained response rates for IDUs treated
with interferon-based therapy, but results from clinical trials do not always
carry over into "real world" settings.
As reported in the September 2007 issue of the European Journal of
Gastroenterology and Hepatology, Diana Sylvestre, MD, from the University of
California at San Francisco and colleagues evaluated the impact of mental health
issues, active drug use, and other potential adherence barriers in a real-world
sample of recovering drug users on methadone maintenance therapy.
The prospective observational study included 71 patients on methadone
maintenance who received interferon plus ribavirin combination therapy in a
community-based clinic staffed by providers with expertise in treating addiction
disorders. Adherence was assessed using monthly interviews, medication counts,
and urine toxicology testing.
Results
· Overall, 48 patients (68%) were adherent to anti-HCV therapy.
· Adherent patients were significantly more likely than non-adherent
patients to achieve a sustained virological response (42% vs 4%, respectively).
· Patients with and without a prior psychiatric history had similar
rates of adherence (64% vs 72%, respectively; P
· Initiation of new psychiatric medications during HCV treatment was
associated with improved adherence overall (P = 0.02) and in patients that did
not have a pre-existing psychiatric diagnosis (P = 0.04).
· There was a trend towards reduced adherence in patients without a
period of drug abstinence before starting HCV treatment compared with those who
had been abstinent for at least 1 month (46% vs 72%; P = 0.10).
· Although occasional drug users were similarly adherent compared with
those who were completely abstinent, patients who relapsed to regular drug use
showed a significantly lower level of adherence (P = 0.03).
Conclusion
"We conclude that the majority of methadone-maintained drug users can adhere to
HCV treatment, even those with psychiatric illness and relatively limited
pretreatment drug abstinence," the study authors wrote.
"Lack of pre-HCV treatment drug abstinence and regular drug use during HCV
treatment may be relative barriers to medication adherence, but the initiation
of psychiatric medications during HCV treatment may be a helpful intervention,"
they added.
They concluded that, "This report provides further evidence for an
individualized approach to HCV treatment that does not categorically exclude
patients with potential barriers such as mental illness and limited drug
abstinence."
10/23/07
References
DL Sylvestre and BJ Clements. Adherence to hepatitis C treatment in recovering
heroin users maintained on methadone. European Journal of Gastroenterology and
Hepatology 19(9): 741-747. September 2007.
http://www.hivandhepatitis.com/hep_c/news/2007/102307_b.html

10/27 Hepatitis Symposium has add additional Seating & TeleConferencing to W. Ha
Please announce, forward and post this Flyer.
1) Our FREE Hepatitis Symposium at the Queens Conference Center this Sat. has
opened additional seating for those of you who have not registered yet!
TeleConferencing has also been added and is now available for this very
important Symposium since many people on our neighbor island are also infected
and are often in an area where there is no one who is treating hepatitis B or C
in that area.
2) TeleConference link & seating available through West Hawaii Community Health
Center, Kailua Kona (call Jasmine, 808- 326-5629 ext 223) or Shriners Hospital
on Oahu (call Jana, 808-951-3637). TeleConference site & linkups are
responsible for any fees involved.
3) For Media, please call Dr. Alan Tice, 808-373-3488.
Mahalo,
Ken Akinaka, MRA
Hepatitis Prevention, Education, Treatment & Support Network of Hawai`i
VIRAL HEPATITIS
The SILENT EPIDEMIC
Saturday, October 27, 2007
8 AM to 4
PM
Queens Conference Center
501 South Beretania Street
Honolulu,
Hawaii 96813
You are invited to attend a symposium to discuss the problems we face with viral
hepatitis in Hawaii. National experts will speak about evaluation and therapy.
The program will also include people with personal knowledge, experience and
expertise with viral hepatitis â from personal to professional perspectives.
They will each present the unique problems they face, their responses, and the
solutions they found.
Topics include epidemiology, screening, diagnosis, liver disease, therapies,
research, reimbursement, vaccines, and the future.
Speakers: Drs. Carroll Leevy, Robert Jao, William Haning, Joseph Humphry, Kay
Bauman, Tarquin Collis, Nancy Withers, Alan Tice, Neal Palafox, and,
Mariailiana Stark, ARNP, Ken Akinaka, and Heather Lusk
Join us to understand the breadth and depth and consequences of viral hepatitis
in our community and help us work together with the presenters and attendees to
identify ways to control this infection and stop its spread.
The symposium will be provided at no charge to health care workers and concerned
citizens. The Hepatitis Support Network of Hawaii, a non-profit organization,
will support and organize the event.
Participation is free, but seating is limited. Please register in advance by
contacting:
Hepatitis Support Network of Hawaii
Phone: 262-1680 or 373-3488
Fax: 263-3809 or 585-0206
Email: hepatitssupportnetwork@...
(Please include your *free* lunch preference â beef, turkey or vegetarian)
TeleConference link & seating available through West Hawaii Community Health
Center, Kailua Kona (call Jasmine, 808- 326-5629 ext 223) or Shriners Hospital
on Oahu (call Jana, 808-951-3637). TeleConference site & linkups are
responsible for any fees involved.

China signals organ trade crackdown with arrest
Fumiko Endo / Yomiuri Shimbun Correspondent
The arrest of a Japanese man who was allegedly engaged in the illegal brokerage
of human organs reflects the Chinese government's tough stance on such activity,
which had previously gone virtually unregulated.
Beijing's move may also have an impact on Japanese people hoping for an organ
transplant.
Hiroyuki Nagase, president of the China International Organ Transplant Support
Center in Shenyang, Liaoning Province, is believed to have moved the company's
operational base from China to Manila.
In explaining the advantages of organ transplants in China, Nagase told The
Yomiuri Shimbun in a series of interviews conducted in June and July that there
was a "well-coordinated system for organ transplants in China, drawing on
experienced surgeons and a long history of such cases."
The center's Web site is currently not operating, but it used to claim that the
center could arrange a kidney transplant in China for prices starting at 7.8
million yen, while liver transplants started at 13 million yen.
Concerning the costs, Nagase said: "If you undergo an organ transplant in
Australia or the United States, the cost is so high that it's unaffordable for
patients who don't have much money. I'm doing this to help such patients."
Nagase was concerned about China's tightening of regulations related to organ
transplant over the past year, saying "The Beijing Olympics [in 2008] may have
affected the Chinese government's decision."
A man involved in a human organ brokerage organization said Nagase seemed to
have good connections with China's Health Ministry. Nagase is believed to have
moved his base to the Philippines out of concern that business opportunities in
China would shrink due to the tougher regulations.
The Philippine government is considering whether to permit foreign patients to
undergo a kidney transplant if they meet certain conditions. In light of this
new development, Nagase had hoped his business would develop further in the
Philippines.
(Oct. 18, 2007)
http://www.yomiuri.co.jp/dy/national/20071018TDY02304.htm

Comparison of the Bayer VERSANT HCV RNA 3.0 and the Roche COBAS Amplicor HCV
Monitor, Version 2.0, assays in HCV genotype 4 infection.
Jessner W, Watkins-Riedel T, Müller C, Formann E, Gschwantler M, Ferenci P.
Department of Internal Medicine IV, Gastroenterology and Hepatology, Vienna
Medical University, Vienna, and Department of Internal Medicine,
Gastroenterology and Hepatology, Innsbruck Medical Univresity, Innsbruck,
Austria.
Prediction of treatment response is clinically important in chronic hepatitis C
virus (HCV) genotype 4 infection. Early viral kinetics is useful in this respect
for genotype 1 but interpretation is dependent on assay linearity and
reproducibility. The VERSANT HCV RNA 3.0 (bDNA-3.0) and the COBAS Amplicor HCV
Monitor 2.0 (HCM-2.0) have been widely used quantitative assays. We wanted to
comparatively evaluate the two tests in a large genotype 4 sample. Genotyping
was performed by NS5b sequencing. Viral load was tested in parallel in 32
patients at least six times on antiviral therapy with interferon alpha
(IFNalpha). Totally, 198 samples within a quantitative range from undetectable
to about 7 x 10(6) IU/mL (bDNA-3.0) were obtained and compared. Twenty-two
samples with viral load above 500 000 IU/mL tested by HCM-2.0 were 1:100 diluted
and retested. Quantitative values were fitted to a third order polynomial (M =
0.118303 + 1.07503 x V+ 0.0112128 x V(2) - 0.0055504 x V(3); M...HCM-2.0,
V...bDNA-3.0, both log IU/mL) showing progressive nonlinearity of HCM-2.0 above
100 000 IU/mL but better clinical sensitivity with respect to bDNA-3.0. Dilution
lead to a gain of at least a factor of 2.7 and thus, overestimation compared
with bDNA-3.0. Deviation from linearity and overestimation u