LiverHope
VOLUME 6, ISSUE 8 August 2004
Are you newly diagnosed or do you want more information
about Hepatitis C?
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Attend LiverHope
too -
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By Appointment -
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September 19th,
2004 -
In This Issue
7th
Annual Minnesota Hepfest 2004
HCV
May Respond to Herbal Concoction
Thyroid
Disorders Common with Hepatitis C
Bioartificial
Liver Improves Survival
7th Annual Minnesota Hepfest 2004
We will not hold our regularly scheduled LiverHope meetings in August. Instead, we encourage everyone to attend the Minnesota Hepfest on August 5-8 from 9am-9pm at my home. My address is 901 Meadowwood Drive, Brooklyn Park, MN. It really is a weeklong support group.
Along with our local support group members and other lovely Minnesotans, we have confirmed people from many other states. This event is open to all of you. If you need more information or directions to my house, send me an email or give me a call and I will get right back to you.
Just a word about Hepfests ---The original Hepfest was held in Plymouth, MA in June 1996. It was hosted by a late dear friend, Jeanne Mclaughlin and was organized when someone from out-of-state planned to visit her. All of a sudden, everyone from our online chat group decided to go and meet Jeanne that same weekend. Jeanne finally sent a notice of it to the online hep lists and she coined the term hepfest.
Jeanne hosted her hepfest every year in June until she got too sick to continue them. As more of us began attending each year, others decided to start holding hepfests too. It was a way for more of us from different
parts of the country to meet one another face to face. I held my first hepfest in August 1998. It went over really well so I decided to make mine an annual event also. The hepfest experience is indescribable! You feel such love and understanding from someone who really does care how you are. You will make lifelong friends and come away from the time spent together with tears of joy and the pain of having it end. This event does not have a schedule and we will not have politicians, or representatives from the medical community or drug companies speak. We will have lots of food and plenty of hugs to go around.
We will hold a silent auction to benefit LiverHope, so bring something to donate if you can. Don't forget your swimsuit; the pool and hot tub are here waiting for your arrival. This event is open to all Heppers and their families and friends. Hope to see you there!
Love and hugs,
Pat Buchanan
763 566-3839
www.liverhope.com
pat@liverhope.com
Driving directions to the Hepfest:
From WI: Follow I-94 west to Minnesota and watch for the I-694 exit. Follow I-694 west until you cross the Mississippi River. Take an immediate right onto 252 north. Follow 252 to 73rd Ave and turn left. From 73rd, take the first right, which is Aldrich Ave. Follow Aldrich until you come to the T in the road, which is Meadowwood Drive. Turn left onto Meadowwood. I'm the 4th house on the left side of the street. My address is 901 Meadowwood Drive, Brooklyn Park, MN 55444.
From the South: Take I-35W north to I-94 West to 252 North. Follow 252 to 73rd Ave and turn left. From 73rd, take the first right, which is Aldrich Ave. Follow Aldrich until you come to the T in the road, which is Meadowwood Drive. Turn left onto Meadowwood. I'm the 4th house on the left side of the street. My address is 901 Meadowwood Drive, Brooklyn Park, MN 55444.
Call for directions from anywhere: (763) 566-3839
Map removed from e-mail
version to minimize the size of the newsletter. If you would like a
map, just e-mail bruce@liverhope.com
with the Subject: “Request Map”.
United Way Campaign 2004
When the 2004 United Way Campaign begins at your place of employment, we hope you consider designating LiverHope as one of your choices for your United Way contribution this year. We are in their database as an eligible recipient because of our non-profit status. Thank you.
HCV May Respond to Herbal Concoction, Including Mistletoe, When Interferon Fails
By Karla Gale
NEW
ORLEANS (Reuters Health) May 19, 2004 - Treatment with a mix of herbs that
includes extracts of mistletoe and green tomato may lead to a sustained
response in patients with hepatitis C (HCV) for whom treatment with pegylated
interferon-alpha has failed or is contraindicated, according to findings
presented here at Digestive Disease Week.
Dr.
Harald Matthes and colleagues included 85 patients in their sample, 7 of whom
withdrew from the study. Treatment included subcutaneous injections of
mistletoe extract (Viscum album), and oral extracts of green tomato (Solanum
lycopersicum) and Hepatodoron (Fragaria vesca and Tritis vinifer).
After
12 months, 18% were complete responders, 49% were partial responders and 33%
were nonresponders. After one more year of treatment and an additional six
months' follow-up, the corresponding rates were 44%, 28% and 28%.
About
60% of patients exhibited local responses to the injection, but otherwise
adverse events were mild and uncommon. The group estimates the cost to treat
each patient who achieves a sustained response is $5,600 with the herbal
extracts, compared with $28,000 for treatment with interferon.
In
an interview with Reuters Health, Dr. Matthes, based at Charite University of Berlin
in Germany, explained that the mistletoe extract activates CD4 T helper-1 cells
to induce an HCV-specific immune response, and the Hepatodoron stimulates liver
regeneration.
The
green tomato contains alkaloids that induce apoptosis through the caspase 8
pathway. "This is important because HCV blocks heaptocyte apoptosis, which
is required to clear infected cells from the liver," he said.
As
a result, liver enzyme levels actually increase during the first 4 to 8 weeks
of treatment, he added, but then drop to normal levels as liver inflammation
and necrosis resolve.
He
noted that mistletoe is used as an adjuvant to treat approximately 60% of
oncology patients, so its safety profile is well established.
However,
he would not recommend these agents as first line treatment, since interferon
is associated with a better response rate and requires only one year of
treatment.
Dr.
Paul Pockros, from Scripps Clinic in La Jolla, California, told Reuters Health
he was concerned that herbal treatment could induce heaptocyte apoptosis,
"which could be quite dangerous for patients with an impaired hepatic
reserve." He also thinks it should not be recommended until its mechanism
of action is better understood.
However,
he agrees with Dr. Matthes that such treatment could be appropriate for
patients who have no other choice of treatment for HCV.
But
that remains a moot point in the U.S., he added, because subcutaneous
injections of mistletoe are considered a drug rather than a dietary substance,
and have not been approved by the FDA.
Digestive
Disease Week is jointly sponsored by the American Association for the Study of
Liver Diseases, the American Gastroenterological Association, the American
Society for gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary
Tract.
Thyroid Disorders Common
with Hepatitis C
Will Boggs, MD
Source: Reuters Health
NEW YORK--- People chronically infected with hepatitis C virus (HCV) have a significantly increased rate of thyroid abnormalities, according to a new report.
This association “implies that these patients should be screened for thyroid function on a periodic basis,” lead author Dr. Alessandro Antonelli from the University of Pisa School of Medicine, Italy, told Reuters Health. “A substantial proportion — 13 percent in our series — have hypothyroidism, and thus might benefit from treatment.”
Thyroid involvement in HCV-infected patients has been reported previously, the authors explain in The American Journal of Medicine, but little is known about the prevalence and nature of thyroid disorders in such patients. Antonelli and colleagues looked into this in a study of 630 patients with chronic hepatitis due to HCV infection.
Significantly more HCV-infected patients than uninfected subjects or hepatitis B virus-infected patients were positive for anti-thyroid autoantibodies, the authors report.
Also, low thyroid function (hypothyroidism) was significantly more common among HCV-infected patients (13 percent) than among the comparison groups (3-5 percent).
“We are planning a population-based epidemiological study to assess the association between thyroid disorders and HCV infection,” Antonelli added. A possible association of HCV infection with thyroid cancer and diabetes is also under investigation.
SOURCE: American Journal of Medicine, July 1, 2004
BRISBANE, Calif., June 15 /PRNewswire-FirstCall/ -- InterMune, Inc. today announced that the Company has initiated the DIRECT Trial, a Phase III clinical trial designed to evaluate the safety and efficacy of daily Infergen(R) (Interferon alfacon-1) in combination with ribavirin for the treatment of patients chronically infected with hepatitis C virus (HCV) who have failed to respond to a previous course of therapy with pegylated interferon alfa-2 plus ribavirin. These patients are referred to as HCV nonresponders.
"HCV nonresponders represent a growing unmet medical need because retreatment options are limited and generally provide very poor response rates," said Robert L. Carithers Jr., M.D., University of Washington Medical Center and Lead Principal Investigator of the study. "Pilot studies of daily Infergen plus ribavirin in the U.S. and in Europe have shown promising response rates in the treatment of nonresponders. We hope to confirm these preliminary findings in this large, well-controlled Phase III study."
The DIRECT Trial is a randomized, open-label pivotal phase III trial enrolling 510 HCV nonresponders at approximately 40 centers in the United States. There will be three arms to the study. Patients in the first two arms will receive combination therapy of daily Infergen at one of two dose levels (9 or 15 micrograms) plus 1000-1200 milligrams ribavirin (based on body
weight) daily for up to 48 weeks. The third arm will be a no-treatment control arm and will serve as the comparison for response rates for patients in each of the two treatment arms. Patients in the control arm who have less than a 2 log decrease in HCV RNA at 24 weeks may be eligible to roll over to an additional treatment protocol at the same two dosing levels.
The primary endpoint of the DIRECT Trial is the proportion of patients with sustained viral response (SVR), which is defined as the absence of detectable HCV RNA in serum 68 and 72 weeks after the initiation of treatment. The secondary endpoints of the study are: the proportion of patients with quantitative measurement of serum HCV RNA levels below the level of detection at weeks 24 and 48; and the proportion of patients with abnormal serum alanine transaminase (ALT) levels at baseline, a marker of liver function, that have normal ALT levels at various time points during the study.
"The launch of this trial comes on the heels of promising data presented at the Digestive Disease Week conference last month from two investigator-sponsored studies of daily Infergen plus ribavirin combination therapy in nonresponders," said Dan Welch, Chief Executive Officer and President of InterMune. "The results of those studies provide strong scientific rationale for a Phase III study of daily Infergen plus ribavirin. In addition to this Phase III trial, we are simultaneously conducting a Phase II study to assess the use of daily Infergen in combination with our other marketed interferon, Actimmune(R) (Interferon gamma-1b), in the treatment of HCV nonresponders."
On June 26th and 27th, we had a booth at Gay Pride. Approximately 400,000 people came through. We had all but one of our volunteers show up to help; some to draw blood, and others to staff the booth. Thank you to all of you (you know who you are and you are very special)! Without you, this could not have happened.
We tested 98 people for HCV, and all but four tested negative. We were pleased that more weren’t infected. Special thanks to The Memorial Blood Bank for providing our supplies! This event was a big success and we hope to repeat it again next year!
Bioartificial Liver Improves Survival in Acute Hepatic Failure
Laurie Barclay, MD
April 26, 2004 — A bioartificial liver (BAL) improves survival for patients with fulminant and subfulminant hepatic failure, according to the results of a study published in the May issue of the Annals of Surgery. This is the first large-scale, prospective, randomized, multicenter trial examining the efficacy of any artificial liver support.
During treatment with the HepatAssist BAL, plasma separated from venous blood is first pumped through a charcoal column and an oxygenator, and then through a bioreactor containing a fiber membrane and 7 billion cryopreserved pig hepatocytes.
"The blood is removed at a fixed rate, detoxified and treated in the various components of the bioartificial liver, reconstituted, and returned to the patient at the same rate at which it is being removed," says lead author Achilles A. Demetriou, MD, PhD, from Cedars-Sinai Medical Center, Los Angeles, California, in a news release. "Just before the patient is treated, the pig liver cells are thawed, reactivated and attached to small beads that serve as a scaffold for the cells. We put the cells and beads into the cartridge, and when the patient's plasma flows through the fibers, the pig liver cells detoxify it and replace missing nutrients."
At 20 centers in the US and Europe, 147 patients with fulminant or subfulminant hepatic failure and 24 patients with primary nonfunction after liver transplantation were randomized to BAL treatment or to standard supportive care.
For the total population of 171 patients, survival at 30 days was 71% in the BAL group and 62% in the traditional care group. For the subgroup of 147 patients with fulminant or subfulminant hepatic failure, the BAL was associated with a 44% reduction in mortality, after adjustment for confounding factors.
Each six-hour treatment provides benefits lasting about 24 hours. Most patients with acute liver failure may only need treatments for a few days or up to several weeks. "Typically, within that time the patient's condition is going to improve because his or her own liver kicks in or a liver will be available for transplantation," Dr. Demetriou says.
Circe Biomedical Inc. funded this study.
In an accompanying discussion, Michael Henderson, from Cleveland, Ohio, congratulated the investigators for the "huge undertaking" of this correctly performed randomized controlled trial, and he noted the apparent benefit of the BAL in patients with acute or subacute fulminant hepatic failure.
Annals of Surgery.2004;239:000-000
Reviewed by
Gary D. Vogin, MD
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Co-Facilitators
Email: info@liverhope.com
Fax: (763) 566-0589
Website: www.liverhope.com
Helen: (952) 933-0932 – helen@liverhope.com
Pat:
(763) 566-3839 – pat@liverhope.com