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Week Ending: May 12th , 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
May 4th , 2007
'Louie, me and hepatitis C'
http://news.bbc.co.uk
By Jane Elliott
BBC News, Health reporter
When Gemma Peppe needed a subject for her MA in documentary research, she decided to use her own battle with the potentially fatal liver condition hepatitis C.
She hoped it would be an opportunity to raise awareness about the condition, which is thought to affect up to 500,000 people in the UK - 10 times more than those with HIV.
She also wanted to learn more about her condition, and the treatment options available to her.
Gemma attracted the support of the Hepatitis C Trust and the Community Channel, and her film became a documentary of her treatment over a year - and how it affected her 14-year-old son Louie.
Now 'Louie, me and hepatitis C' - a documentary narrated by Gemma and including her video diary - is being used to educate the public and medical professionals.
Fear
Gemma, a single parent, aged 40 from London, first became sick in the late 1980's following drug use.
She became weak and jaundiced and spent months in hospital. But at the time there was no test for the disease and Gemma was told she had non-specific hepatitis.
None of the medical professionals she saw seemed to know much about it, and as Gemma grew stronger she forgot about her liver problems and got on with her job in the music industry.
But then she started to feel tired and have unexplained illnesses.
Tests were ordered and in January 2002 she was told she had hepatitis C.
"I did not know about hep C and my doctor did not either.
"He just said he was sure I would be fine. But when I told some people about what I had they said 'you can die from that'."
Gemma says she was terrified.
"The fear was physical, I could feel it coursing through my veins."
Research
So Gemma embarked on her own research.
She found that her ill health could continue, get worse and eventually kill her so she looked into having a treatment that, if successful, could rid her body of hepatitis C.
In the film she said: "I felt that, at my age, I'm too young to resign myself to a life of not working, or just working part time. I don't feel, for me, this is a full life.
"This is just half a life that I'm living. It really swayed my decision. It made me think 'I've got to give it a go'."
So she decided to embark on the Pegasys, or pegylated interferon, treatment - a version of a naturally occurring molecule - and chronicles her progress in her film.
Gemma says: "The treatment was very like chemotherapy and by the end I was so debilitated that I could hardly leave the house."
She endured appalling side effects - exhaustion, flu-like symptoms, raging hormones and thinning hair.
In the film her son Louie agrees that it had been an ordeal: "You've done well. You've been annoying, you've been horrible at times...but you've done well."
But at the end of the course she was given the devastating news that she was one of the 50% for whom the treatment had not worked.
"Now I just have to hope that there will be another treatment that will work for me," said Gemma.
"Although I stopped the treatment a year-and-a-half-ago I am still suffering from the side effects.
"The odds of 50% seemed like a good gamble to take, but if I knew then what I know now."
Moving
Charles Gore, from the Hepatitis C Trust, said the film will do a great deal to improve understanding of the condition.
"It gives a remarkable insight into what it is like to have hepatitis C.
"It is also extremely moving - Gemma is so open about why she wants to undertake a year of often gruelling treatment, how important it is to her that the treatment works and the challenges of completing it.
"It was wonderfully brave of her to let the camera follow her and watch her as she is given the crucial news about whether the treatment is working.
"Anyone who sees this film will appreciate how important it is for people with hepatitis C, and especially those on treatment, to receive adequate support and yet how often that support is lacking.
"But the film is not just Gemma's personal story - it is also an examination of some of the major issues surrounding hepatitis C and in particular the problem of stigma.
"Gemma is unusually candid in disclosing that she contracted this disease through drug use but many people are scared to admit to having hepatitis C, even when they contracted it another way, and many more are dissuaded from getting tested.
"As the film so vividly shows, stigma is damaging not just to individual lives but to the public health of the country and it is simply the product of ignorance.
"Anyone in any way connected with hepatitis C needs to see this film and with up to one in 100 of the UK population infected, that means just about everyone.'
The documentary will be broadcast at 11pm on the 11 and 18 May on the Community Channel.
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May 5th, 2007
Young people’s rate of hepatitis C cases doubles, state says
http://ledger.southofboston.com
By SUE REINERT
The Patriot Ledger
The numbers are still small, but state health officials are concerned about a doubling of the rate of hepatitis C infections among teenagers and young adults.
The disease is most commonly spread among intravenous drug users who share needles, and is the leading cause of liver transplants in the United States.
For people from 15 to 25 years old, the figure rose from 15 cases per 100,000 population to 32 cases per 100,000 between 2002 and 2005, said Dr. Alfred DeMaria, chief of infectious diseases at the Department of Public Health.
The figures represent young people who tested positive for the hepatitis C virus, not necessarily those with symptoms of the disease, DeMaria said.
Hepatitis C attacks the liver and spreads when an infected person’s blood enters body of another person. Many infected people have no symptoms for years; about 70 percent develop chronic liver disease and up to 5 percent die.
Many people contracted the virus from blood transfusions until the blood bank industry developed a reliable test for the virus in the early 1990s. Today, about 60 percent of new infections occur in people who inject drugs, health officials say.
The rise in reported infections among young people surprised state health officials, DeMaria said. People in their 40s still have the highest prevalence of hepatitis C virus, he said.
‘‘What we’re seeing is a little blip now (among teens and young adults),’’ he said.
‘‘We want to know if (the increase) is a real increase in prevalence’’ or comes from doctors testing more patients with high risks of infection, DeMaria said.
The state Department of Public Health has asked doctors who report infected patients between 15 and 25 to submit detailed information about those patients’ risk profiles.
‘‘If we find out that a lot were tested because they were sick, that would be different than if they were tested because they were injection drug users,’’ DeMaria said.
Department investigators formerly visited or called doctors to collect the information, but staffing cuts have made it difficult to keep up with reported cases, he said.
Hepatitis C is the most prevalent of reportable infectious diseases in Massachusetts, with 52,000 confirmed cases, DeMaria said. State officials believe about 110,000 residents actually have the disease, based on national statistics, he said.
Sue Reinert may be reached at sreinert@ledger.com.
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Multidisciplinary Approach Offers New Hope for Patients with Liver Cancer
http://www.exduco.net/
The American Liver Foundation and Yale-New Haven Hospital recently sponsored a symposium for physicians throughout the region to provide a comprehensive update on the treatment and care of patients with liver cancer. Hepatologists, oncologists, surgeons, and interventional radiologists from Yale Cancer Center and Yale-New Haven Hospital addressed the therapeutic options and prognosis for patients with liver cancer, a disease that kills about 170 persons in Connecticut each year.
The incidence of primary liver cancer is very high; hepatocellular carcinoma is the fifth most common malignant disease worldwide. Once a rare disease in the western countries, the incidence of primary liver cancer has doubled in the last 20 years and is expected to rise even further because of a combination of factors, including infection with hepatitis B and 7 or C viruses, alcohol consumption, steatohepatitis, iron overload, and a combination of genetic factors.
Liver cancer is also the third highest cause of cancer mortality. The physicians at Yale Cancer Center are actively working to improve the treatment options for liver cancer through coordinated efforts between specialists and the application of rigorous diseases management protocols tailored for each specific patient. With these efforts, the prognosis for patients with liver cancer is beginning to improve.
While traditional chemotherapy still has little role in treatment of liver cancer, a combination of interventional radiology and surgical techniques, including liver transplantation are now available and in selected patients can even cure the disease. For patients diagnosed with early disease, liver transplantation can provide the definitive cure for both the cancer and the advanced liver disease that frequently always accompanies a diagnosis of cancer. For patients that do not have advanced liver disease or for patients that cannot receive a liver transplant, surgical resection, ablative therapy or transarterial chemoembolization can provide excellent survival, if applied to the correct candidate.
With so many treatment techniques available, patients with cancer of the liver should be referred to medical centers able to provide a diversified approach to the treatment of hepatoma. As the only National Cancer Institute designated Comprehensive Cancer Center in Connecticut, Yale Cancer Center is able to offer an entire spectrum of potential therapeutic approaches to our patients, from surgical resection, to liver transplantation, radiofrequency ablation, and transarterial chemoembolization.
At Yale Cancer Center and Yale-New Haven Hospital, patients with liver cancer are presented and discussed in weekly conferences among diagnostic radiologists (Drs. Jeffrey Weinreb and Gary Israel), hepatologists (Drs. Mario Strazzabosco and Tamar Taddei), abdominal surgeons (Drs. Ronald Salem and Charles Cha), interventional radiologists (Dr. Jeffrey Pollak), pathologists (Drs. Marie Robert and Dhanpat Jain), medical oncologists (Dr. Wasif Saif), and transplant surgeons (Drs. David Cronin and Sanjay Kulkarni). A consensus on the best treatment for each patient is then reached. Following treatment, the patients are then seen in follow up in the Yale Hepatology clinic to manage the underlying liver disease, preserve liver function, and survey for possible recurrence.
The symposium is part of the efforts from the Connecticut Chapter of the American Liver Foundation to provide the most current information to physicians on the management of liver cancer and to ensure that patients with liver cancer have access to the latest treatment options available.
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May 6th, 2007
Hepatitis C draws attention of state
http://www.columbiatribune.com
Missouri intends on Thursday to draw attention to the need for awareness of a blood disease with its first Hepatitis C Awareness Day.
Gov. Matt Blunt last June made May 10 the official day to "increase hepatitis C … education, tolerance and understanding," according to a news release from the Missouri Hepatitis C Alliance.
This year’s activities, from 8 a.m. to 1 p.m. in the Capitol Rotunda in Jefferson City, will include free testing and education about the disease, which is spread primarily through direct contact with infected human blood, according to the Centers for Disease Control and Prevention.
Health-care and social service organizations will staff booths with information and individuals to answer questions. A "Wall of Heroes" will also be set up with photographs of those affected by the disease.
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Chef Michael Ivy awaits liver transplant to save his life
http://www.al.com
By RHODA A. PICKETT
Staff Reporter
Restaurateur who once ran Michael's Midtown Cafe waits for life-saving liver transplant
It may seen a cruel irony that Michael Ivy, not long ago one of Mobile's most popular chefs, doesn't have much of an appetite for anything.
A diagnosis of hepatitis C in 2000 has so deteriorated Ivy's liver that he now needs a transplant. The restaurateur who once watched over the preparation and serving of fine cuisine at Michael's Midtown Cafe on Florida Street can now eat only fresh vegetables.
"It's quite the challenge now. I just can't eat anything anymore. It's not fun."
Soon he will have to move from the recreational vehicle park he has called home for the last three months.
"I'm going to have to go live with family," he said, adding that his doctors will soon perform a procedure that will make it difficult of him to care for himself. "I can't live independently anymore."
He said that he has end stage liver disease. "What it means is you're going to die if you don't get a liver."
Ivy said that he had been on the national liver transplant list after he was diagnosed, but his name was taken from the list when his body responded well to some medication he was given. Then, more than 18 months ago, his condition worsened and his name was put back on the transplant list, he said.
Liver disease has been something that Ivy said he has hesitated sharing with friends. He said he has personal reasons for talking to the Press-Register about his condition and his need for a liver transplant. The other reason is to encourage people to become organ donors and to tell their relatives of those wishes.
According to the American Liver Foundation Web site, there were 6,500 liver transplants performed in the U.S. in 2005. The national liver transplant waiting list is prioritized so the sickest people always go to the top of the list. About 17,000 Americans are currently on a waiting list for a liver transplant, according to the Web site.
On this particular day, Ivy preferred sitting outdoors at the makeshift patio area formed from a rectangular cream-colored carpet remnant with a large wooden cable spool serving as a table. Although the red short-sleeved T-shirt and gray sweat pants appear slightly oversized, it's the blackish blue bruises up and down his forearms that indicate Ivy's poor health.
"They look good today," he said.
This particular Tuesday afternoon was what Ivy described as "moderate day." He said he doesn't get out much because trips to the pharmacists or the grocery store are exhausting. Even sharing a breakfast with family members at a local restaurant requires energy he no longer has.
Ivy said he tried to keep his condition private, selling his restaurant and then settling for jobs that wouldn't require the amount of time and energy running the restaurant did. He started working as the chef at 15 Place, the day center for the homeless in downtown Mobile. He had also developed a program called Kids Cafe in three public schools near downtown Mobile and he wrote a column for the Press-Register's food section.
His worsening health caused him to eventually stop working altogether. He said he went from making around $40,000 a year to about $13,000 annually that he receives in disability income.
To make ends meet, Ivy first used funds in his individual retirement account. When that was gone, he sold his house and used some of the profit from that sale to purchase a recreational vehicle. He parked it a camp on Old Military Road.
"I couldn't pay the mortgage anymore," Ivy said. "I made just enough profit to buy this. I just had to downsize, you know."
He does his own cooking in the RV, and when he gets tired from the effort, he lies down on the couch for a few minutes and then gets up and continues.
He will soon move again.
"Since Thanksgiving it's been a really rapid decline," Ivy said.
Ivy said that since telling more people about his illness, he has received some positive feedback.
"I have really been surprised at the people who have come forward," he said. "I got several donations. It's kept me going the last couple of months."
The money has helped him pay expenses when he travels to New Orleans for his doctor's appointments at the Tulane Transplant Center.
Friends and family are planning a benefit for Ivy on June 15 at the Blue Gill restaurant on the Causeway.
Organizers hope to sell 300 tickets. There will be items available for a silent auction and a handful of local chefs who once worked under Ivy will prepare some five or six different entrees.
All the proceeds will go to the "Michael Ivy Special Fund Account" set up a Regions Bank, said Henry Brewster, a Mobile attorney who oversees the account. Donations can be made at Regions Bank branch.
"It's been really tough," Brewster said. "He really needs to get a transplant."
Brewster said that he and Ivy's brothers have taken Ivy to New Orleans on three separate occasions to wait on a transplant. When a liver is found, two candidates on the transplant list are called and have to be present. One candidate has to remain on standby at the hospital until doctors determine whether the liver is compatible with the transplant candidate undergoing surgery, Brewster said. If it isn't compatible, the liver is reharvested and given to the standby candidate.
"He's been up and down," Brewster said. "It's just yucky."
Ivy said he remains optimistic and the experience has taught him a few things.
"One of the really good things that has come out of this is I thought that people liked me because of my food. I've been surprised at the amount of people who have liked me in spite of my cooking. They have said, 'I want to help. I love you.'
"I never really thought that they liked me for me. I really thought that they tolerated me because I was a good cook. I thought it was because I danced well and danced fast and as long as I danced, they would love me and compliment me. I didn't realize that people didn't love me just because I cook, they loved me just because they loved me.
"I certainly have a bag full of faults. And people know how surly I could be. They have said so, publicly, in the newspaper."
After the fund-raiser, Ivy said he should have enough money to pay expenses for six months.
Despite his illness, Ivy said he "has no bitterness in his heart" for the course his life has taken.
"You are not measured by the things that you have, but by what you do when your life is difficult. That's when the true grit comes out."
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May 7th, 2007
Duke Clinical Research Institute update understanding of anemia therapy
www.newsrx.com
New research, "Strategies for managing anemia in hepatitis C patients undergoing antiviral therapy," is the subject of a report. "Anemia is a common side effect that begins soon after the initiation of peginterferon/ribavirin in the treatment of hepatitis C virus (HCV) infection. It can cause symptoms that negatively impact quality of life (QOL) and is the most common reason for reducing the dose and temporarily or permanently discontinuing ribavirin," researchers in the United States report.
"Such dose modifications have been shown to reduce the efficacy of treatment. Administering erythropoietin can improve anemia caused by peginterferon and ribavirin therapy and is more effective than dose reduction at improving QOL during treatment. However, erythropoietin, which is not approved by the USA. Food and Drug Administration (FDA) for use in patients with HCV infection, adds another parenteral drug to the patient's treatment regimen, and is associated with additional costs, inconvenience, and potential side effects. A new ribavirin analog, viramidine, is expected to be associated with a lower incidence of anemia and, if proven effective, may eventually be substituted for ribavirin in combination with peginterferon to treat chronic hepatitis C," wrote J.G. McHutchison and colleagues, Duke University, Duke Clinical Research Institute.
The researchers concluded: "In the meantime, physicians must make the best possible use of the available options for managing anemia, especially in select patient groups who are most at risk for anemia and its complications."
McHutchison and colleagues published their study in The American Journal of Gastroenterology (Strategies for managing anemia in hepatitis C patients undergoing antiviral therapy. The American Journal of Gastroenterology, 2007;102(4):880-9).
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New Hepatitis C vaccine being tested on chimpanzees
http://www.vaccinerx.com
Written by OJ Fagbire
Hepatitis is a virus that attacks the liver and claim thousands of American lives each year. Millions of Americans are afflicted with the disease. A new experimental vaccine is being tested in the hopes of reducing the prevalence of the disease, and it is being tested on chimpanzees.
Chimps have a genetic structure that is very similar to humans, and they are the only other animal that can be infected with the virus. The chimps are being used to test a new and exciting vaccine that researchers at the Southwest Foundation for Biomedical Research say could eventually save thousands from the chronic health problems associated with Hepatitis C
Their findings were recently published in the Proceedings of the National Academy of Sciences. The researchers explain that the vaccine uses a virus like particle that the immune system recognizes and produces a quick response to. This immune response is hoped to later help the body fend off exposure to the real Hepatitis C virus. The study has had good results and vaccinated chimps exposed to Hepatitis C developed far less severe symptoms than normal.
The researchers say that more work has to be done to perfect the vaccine, but that these promising results show that an effective human vaccine is likely in the near future.
There are an estimated 170 million people worldwide infected with the Hepatitis C virus.
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Hepatitis C on the rise
http://gay.nl/
Website Gay.com, among others, reports that the rate of Hepatitis C infections in London is increasing by almost one-third each year. This was one of the most important conclusions of a conference held by the British HIV Association that closed last month.
The figures for the UK appear to correspond with the Dutch trend: although it seems that in Holland the number of infections is smaller than the UK figure.
Infection rate up
2002 showed sixty Hepatitis C cases in London clinics, whereas in the first six months of 2006 this number was surpassed with 67 reported cases.
The overall infection rate in HIV positive men was one infection per 110 clinic patients per year, but by 2006 this had gone up to one infection per 83 patients a year.
Silent killer
Hepatitis C is sometimes seen as a silent killer, due to the fact that during the first stages symptoms may be absent. The treacherous nature of this disease brings with it that it may take twenty years before any signs occur. In 80 percent of all cases this leads to chronic liver cirrhosis or liver cancer. Worldwide, Hepatitis C is the prime reason for liver transplantations.
Groups at risk are: drug addicts who use needles, people from non-western countries where hepatitis C infections are common, people who got a tattoo or piercing in an unhygienic manner and men, who have unsafe sex with other men, whereby in consequence the mucous membranes are being damaged.
The UK National Health Protection Agency reports that from 2002 till June 2006 the 15 clinics that treat 85% of all HIV patients in London recorded 389 cases of recent hepatitis C infections in gay HIV positive men.
Future
The most pessimistic estimations expect that 7,575 people suffer the consequences of a hepatitis C associated liver disease. At the moment it’s clear that 3,700 people in the UK have liver cirrhosis.
Although treatable in three quarters of all cases, the treatment itself is often depicted as “unbearable” because of the psychic side effects. Dutch authorities meanwhile have started a new awareness campaign in some parts of the country.
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Thousands Infected with Hepatitis C
http://www.sr.se
Members of the National Union of Hepatitis C patientsIt’s been revealed that thousands of people in Sweden could have been infected with Hepatitis C after being given blood transfusions between 1965 and 1991, and the risk has been known for years.
The National Board of Health and Welfare thinks up to 23,000 people who might have the liver disease should be traced.
In the past it was thought it might be ethically wrong to contact patients and tell them they were at risk, as there wasn’t much that could be done to help those who were infected. But the health board says now there are relatively effective treatments, patients should be traced and informed.
The National Union of Hepatitis C patients is welcoming the recommendation but says people should have been told before to reduce suffering and to help stop the illness being passed on to others.
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OMRIX Biopharmaceuticals Submits Regulatory Filing for Hepatitis B Immunoglobulin (HBIG) in Sweden
http://biz.yahoo.com/
NEW YORK--(BUSINESS WIRE)--OMRIX Biopharmaceuticals, Inc. ("OMRIX" or the "Company") (NASDAQ: OMRI - News), a fully-integrated biopharmaceutical company that develops and markets protein-based biosurgery and passive immunotherapy products, announced today that the Company has submitted a regulatory filing to expand the commercialization of its Hepatitis B Immunoglobulin product, or HBIG, in Sweden.
"Our regulatory submission for HBIG in Sweden is part of our stated objective and strategy to launch our marketed immunotherapy products in new territories," stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. "Our HBIG product has done very well in Israel and we expect that once commercialized it will have the same success in Sweden. We anticipate that introducing HBIG in Sweden will allow us to submit additional filings throughout Europe."
The Company anticipates obtaining approval for HBIG in Sweden by the second quarter of 2008 (2Q08).
About Hepatitis B Immunoglobulin (HBIG)
HBIG is a product that contains antibodies specific to the Hepatitis B Virus, or HBV, which can cause lifelong infection, scarring of the liver, liver cancer, liver failure and death. Patients with chronic HBV often require a transplant. However, because HBV can reside in tissue other than the liver, there is a high risk of reinfection. This results in the transplanted liver becoming infected with HBV, which destroys the transplanted liver. To prevent reinfection, patients require lifelong treatment for HBV. OMRIX' HBIG is one of the treatments used to prevent reinfection of the transplanted liver.
About OMRIX Biopharmaceuticals, Inc.
OMRIX Biopharmaceuticals is a fully-integrated biopharmaceutical company developing and marketing protein-based biosurgery and passive immunotherapy products. OMRIX' biosurgery product line includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. OMRIX' novel Fibrin Patch, a biological-device convergence product candidate, addresses an unmet medical need. The Company's passive immunotherapy product line includes antibody-rich products and product candidates for the treatment of immune deficiencies, infectious diseases and potential bio-defense applications. For more information, please visit: www.omrix.com .
SafeHarbor Statement
This press release contains forward-looking statements. Forward-looking statements provide the company's current expectations or forecasts of future events. Forward-looking statements include statements about the Company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the company's filings with the SEC, including sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the company's Form 10-K as filed with the Securities and Exchange Commission on March 13, 2007 and the company's most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless required by law, the company undertakes no obligation to publicly update or revise any forward-looking statement to reflect circumstances or events after the date of this press release.
Contact:
OMRIX Biopharmaceuticals, Inc.
Francesca M. DeMartino, 212-887-6510
Director, Investor Relations
francesca.demartino@omrix.com
Source: OMRIX Biopharmaceuticals, Inc.
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'AIM For The B' Public Education Program To Raise Awareness Of Chronic Hepatitis B Among Communities Most Affected By The Disease
http://www.medicalnewstoday.com
Today, Bristol-Myers Squibb and the Hepatitis B Foundation announced the launch of the fourth annual "AIM for the B: Awareness, Involvement and Mobilization for Chronic Hepatitis B" program, a public education initiative taking place during National Hepatitis B Awareness Week (May 7-11). "AIM for the B" events in San Francisco, Los Angeles, Honolulu and New York this week will provide a forum to increase awareness of chronic hepatitis B as a serious health issue in the United States and emphasize the importance of active disease management, especially among Asian Americans who are disproportionately affected by the disease.
"Education is essential to helping patients and their families understand hepatitis B, its health effects and the options available to them to manage the disease," said Molli Conti, executive director of the Hepatitis B Foundation. "The 'AIM for the B' events will teach people more about chronic hepatitis B and help them understand the importance of talking about the disease as a way to overcome the stigma that can be associated with it."
This year's program will feature educational events in four cities where prevalence of chronic hepatitis B is high -- San Francisco, Los Angeles, Honolulu and New York. At these events, a panel of well-regarded physicians, chronic hepatitis B patients and representatives from patient advocacy organizations will share their personal experiences with the disease, and discuss the importance of increasing education and awareness of liver health. The panel will also discuss the benefits of early diagnosis and appropriate care.
"As we enter the fourth year of the 'AIM for the B' program, BMS and the Hepatitis B Foundation are committed to increasing dialogue within the most affected communities through these important educational events," said Ann Kolokathis, M.D., vice president, virology, global medical affairs, Bristol- Myers Squibb. "As a company, BMS aims to support people combating serious diseases such as hepatitis B. With the care of a doctor and a commitment to treatment, many patients have seen positive results."
Hepatitis B Background
In the United States, approximately one out of every 10 Asian Americans is chronically infected with hepatitis B. Asian Americans account for more than half the chronic hepatitis B cases, many of which can result in serious liver damage. Today, only a small percentage of diagnosed chronic hepatitis B patients are being actively managed for their disease.
About the Hepatitis B Foundation
The Hepatitis B Foundation is dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide through a comprehensive program of research, education, and patient advocacy. The organization is committed to raising funds for focused research, promoting disease awareness, supporting immunization and treatment initiatives, and serving as the primary source of hepatitis B information for patients and their families, the medical and scientific community, and the general public. Visit the Hepatitis B Foundation at http://www.hepb.org .
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb at http://www.bms.com.
Bristol-Myers Squibb
http://www.bms.com
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May 8th, 2007
US FDA staff cautious on anemia drugs' risks
http://www.therapeuticsdaily.com/
Reuters Health - May. 08, 2007
WASHINGTON (Reuters) - U.S. Food and Drug Administration staffers on Tuesday expressed continued caution over the use of anemia drugs sold by Amgen Inc. and Johnson & Johnson, according to an agency document released on Tuesday.
More data is needed on the risks with the drugs, which include Amgen's Aranesp and Epogen and J&J's Procrit, the agency staff said. Changes to the products' labeling may also be appropriate, they added.
The document was released ahead of an FDA advisory panel meeting on Thursday to discuss the risks of using the erythropoiesis-stimulating agents in cancer patients.
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Lyrica Significantly Reduced Pain and Helped Patients Manage the Symptoms of Fibromyalgia, Data Show
http://pharmalive.com
BOSTON--(BUSINESS WIRE)--May 1, 2007 - Significantly more patients treated with Pfizer's Lyrica reduced their pain by 50 percent or more compared with placebo, according to study results presented today at the American Academy of Neurology annual meeting. Clinically, this outcome would equate to a patient with severe pain reporting a reduction to mild to moderate pain.
Fibromyalgia is one of the most common chronic, widespread pain conditions and is thought to result from neurological changes in how patients perceive pain. Fibromyalgia is usually accompanied by poor sleep, stiffness and fatigue. The pain of fibromyalgia can hamper a patient's ability to work and often results in increased medical costs and disability. There are no medications approved to treat fibromyalgia.
"A growing body of evidence is defining the biology behind fibromyalgia that causes such devastating and constant pain," said Dr. I. Jon Russell, one of the study's authors and associate professor of medicine in the division of clinical immunology and rheumatology and director of the university clinical research center at the University of Texas Health Science Center, San Antonio. "A reduction in pain is critical for people living with this condition. With positive new data and new treatments on the horizon, the outlook for people with fibromyalgia has never been better."
The 14-week placebo-controlled study included 745 patients with fibromyalgia who were randomized to receive Lyrica (300mg, 450mg or 600mg) or placebo daily. Patients were asked to measure their pain on a scale of zero to 10; the baseline score for study participants was 6.7 on this 10-point scale.
The study found that patients receiving 600mg a day of Lyrica reduced their pain by 2.05 on the pain scale; 2.03 for patients taking 450mg a day; 1.75 for patients taking 300mg a day, and 1.04 for patients taking placebo.
Significantly more patients treated with Lyrica reduced their pain by 50 percent or more compared with placebo. Of those patients taking 600mg of Lyrica a day, 30 percent said their pain was cut in half or better; 27 percent of those taking 450mg a day and 24 percent of those taking 300mg also reported this level of pain relief. Of those taking placebo, 15 percent reported pain reduction of 50 percent or greater.
Patients receiving Lyrica also reported significant improvements in overall health status and outcomes, including measures such as physical function and ability to perform everyday tasks.
The most common side effects in the study were dizziness and somnolence, followed by weight gain, headache and peripheral edema.
The results of these data were submitted to the FDA as part of a supplemental New Drug Application for Lyrica for the treatment of fibromyalgia. Pfizer also intends to pursue a fibromyalgia indication in other major markets worldwide.
About Lyrica
To date, more than five million patients worldwide have used Lyrica.
In the United States, Lyrica (pregabalin) capsules CV is approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia, and in epilepsy for the adjunctive treatment of partial onset seizures in adults.
Outside of the United States, Lyrica is approved for use in adults for the treatment of various peripheral and central neuropathic pain indications, including diabetic pain and post-herpetic neuralgia, pain resulting from spinal cord injury, and adjunctive therapy for partial seizures in more than 60 countries. In 2006, Lyrica was also approved in Europe for the treatment of generalized anxiety disorder.
DISCLOSURE NOTICE: The information contained in this release is as of May 1, 2007. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding a potential additional indication for Lyrica that is under review by the Food and Drug Administration (FDA). Such risks and uncertainties include, among other things, whether and when the FDA and regulatory authorities in other countries will approve supplemental new drug applications for this additional indication and their decisions regarding labeling and other matters that could affect its availability or commercial potential, as well as competitive developments.
A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and in its reports on Form 10-Q and Form 8-K.
Contact
Pfizer
Jack Cox, 212/733-5017
or
Stephen Borboroglu, 212/733-1787
Onsite: 917/622-8724
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Survival Rates Stall for HCV Patients after Liver Graft
http://www.medpagetoday.com
By Judith Groch,
Senior Writer, MedPage Today
Reviewed by Robert Jasmer, MD;
Associate Clinical Professor of Medicine,
University of California, San Francisco
BALTIMORE, May 7 -- For patients with hepatitis C virus (HCV) infection, the likelihood of surviving over a three-year period after a liver transplant has not improved in 10 years, said researchers here.
However, patients who were not HCV-infected showed significant improvement in patient and graft survival during the same period, reported Paul J. Thuluvath, M.D., of Johns Hopkins, and colleagues.
Their study, reported in the May issue of Liver Transplantation, covered three three-year periods from 1991 to 2001.
Hepatitis C virus-induced liver disease is the most common indication for liver transplantation in the U.S., Dr. Thuluvath said. However, he noted, previous studies from Europe have shown that recipients with HCV have a 10% to 15% lower five-year graft and patient survival compared with non-HCV controls.
To determine whether this difference held for patients transplanted in the U.S., the Hopkins team turned to data from the United Network for Organ Sharing.
Their database included 28,193 patients who underwent a liver transplant from January 1991 through October 2001. Of these, 5,708 who had hepatitis C were eligible for the study, as were 16,116 patients without HCV.
On the basis of time of transplantation, patients were divided into three groups: 1991-1993 (period 1), 1994-1997 (period 2), and 1998-2001 (period 3).
The overall three-year patient survival rate, adjusted for confounding variables, was lower for HCV patients compared with non-HCV patients (78.5% vs. 81.4%, hazard ratio 1.14, 95% confidence interval 1.05 to 1.23, P=0.001), the researchers said.
Patient survival rates remained unchanged during the three study periods at 77.4% for period 1, 79.6% in period 2, and 78.5% in period 3, the researchers reported. Graft survival rates also remained unchanged from period to period at 72.8%, 71.0%, and 69.8%, respectively.
By contrast, the graft and patient survival rates of patients not infected with HCV improved markedly during the two study periods from 1994 to 2001, compared with the first period (1991 to 1993).
Dr. Thuluvath acknowledged limitations of the study that included missing or partial data for recipient and donor liver histology, complications after transplant, treatment for rejection episodes, and maintenance immunosuppressive regimens.
Moreover, the investigators said, it is often difficult to make a firm distinction between rejection and recurrence when they coexist, leading to over- or under-treatment.
Despite some of the study's weaknesses, the large UNOS data set used for this study was robust enough to compare trends in survival, the researchers said.
Results of an Italian transplant-survival study in HCV-infected patients, covering roughly the same time span and published in the same issue of the journal, seemed to produce different results.
We noted a "trend for better patient survival [among those infected with HCV] in recent years," wrote Luca S. Belli, M.D., of Niguarda Hospital in Milan, and colleagues.
They acknowledged, however, that the cumulative probability of developing severe recurrent disease remained unchanged.
In the Milan study, the researchers conducted a multicenter retrospective analysis of 502 consecutive HCV-positive transplant recipients from January 1990 through December 2002. Patients came from hospitals in Milan and Padua, Italy, and from London.
Protocol liver biopsies were obtained at one, three, five, seven, and 10 years after transplant in almost 90% of the patients. All 502 patients were included in the overall survival analysis, while only the 354 patients with a follow-up longer than one year were considered for the analysis of predictors of disease progression.
The overall survival rates were 78.7%, 66.3%, and 58.6%, at 12, 60, and 120 months, respectively, and a trend for better patient survival over the years emerged from all three centers after Kaplan-Meier analysis, the researchers reported.
However, they noted, the cumulative probability of developing HCV-related recurrent severe fibrosis in the cohort of 354 patients who survived at least one year remained unchanged.
Multivariate analysis indicated that older donors (P=0.0001) and female gender of the recipient (P=0.02) were the two major risk factors for the development of severe recurrent disease, while the use of antilymphocytic preparations was associated with a less aggressive course (P=0.03).
Two of the prognostic factors, donor age and recipient gender and their combination showed an important synergy, Dr. Belli said. A female recipient not only has a much higher probability of severe recurrent disease than a male recipient but her risk increases with the increasing age of the donor, reaching almost 100% when the donor is 60 or older.
In conclusion, the researchers said, although a trend for a better patient survival was observed in more recent years, the cumulative probability of developing severe recurrent disease remained unchanged. The combination of a female recipient receiving an older graft emerged as a strong risk factor for a severe recurrence.
In an accompanying editorial, Marina Berenguer, M.D., Ph.D., of Hospital La Fe in Valencia, Spain, considered the conflicting data from these and other studies, and said that advanced donor age together with steroid pulse therapy and excess immunosuppression can explain differences in outcomes.
"The association with worse outcomes in recent years," she said, "and the controversy that seems to surround this observation, is likely due to differences in distribution of these variables from study to study, from center to center, and from year to year."
Although more effective antivirals will likely change disease management, such effective antivirals are not yet close at hand for HCV patients having liver transplantation. In the absence of such therapies, she said, "we are obliged to make sure through a better understanding of factors associated with outcome that we are minimizing harm to patients with our current management strategies."
Most importantly, she added, using large, controlled multicenter trials to determine which are the least harmful immunosuppressive regimens will eventually lead to improved results.
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Liver Stiffness Predicts Portal Hypertension in HCV Cirrhosis
http://www.medpagetoday.com/
By Judith Groch,
Senior Writer, MedPage Today
Reviewed by Rubeen K. Israni, M.D.,
Fellow, Renal-Electrolyte and Hypertension Division,
University of Pennsylvania School of Medicine
FLORENCE, Italy, May 3 -- An ultrasound measurement of liver thickness -- also known as liver stiffness -- predicted portal hypertension in patients with hepatitis C-related cirrhosis, researchers here found.
In a comparison with the standard technique, measuring the hepatic venous pressure gradient, there was a statistically significant positive correlation between the ultrasound technique and the gradient measurement.
Nevertheless, the positive correlation applied only to hepatic venous pressure gradient levels of less than 10 or 12 mm Hg, Massimo Pinzani, M.D., Ph.D., of the University of Florence, and colleagues, reported in the May issue of Hepatology.
Although pressure gradient measurement is the gold standard for assessing portal hypertension, the technique is invasive, expensive, and requires technical expertise found only in large tertiary care centers, Dr. Pinzani said.
In search of a better method, the researchers evaluated transient elastography, a rapid, noninvasive ultrasound technique, to measure liver stiffness, and compared its accuracy with that of measuring hepatic venous pressure gradients.
In transient elastography, the tip of an ultrasound probe is placed between two intercostal spaces at the level of the right lobe of the liver. A low-amplitude vibration induces an elastic shear wave throughout the liver tissue. Pulse-echo ultrasound permits measurement of wave velocity, which corresponds directly with liver stiffness across the organ, reflecting a larger sample than liver biopsy.
From March 1, 2005 to July 1, 2006, 61 patients (ages 32 to 75) with diagnosed or suspected cirrhosis from chronic HCV infection underwent transient elastography, followed by a hepatic venous pressure gradient measurement and liver biopsy. Patients with a body mass index of 35 kg/m2 or higher were excluded.
Overall, a strong relationship between liver stiffness and pressure gradient measurements was found in the total population (r=0.81, P<0.0001).
However, although the correlation was excellent for pressure gradient values less than 10 mm Hg or less than 12 mm Hg (r=0.81, P<0.0003 and r=0.91, P<0.0001, respectively), linear regression analysis was not optimal for values ≥10 mm Hg (r2=0.35, P<0.0001) or ≥12 mm Hg (r2=0.17, P=0.02).
The researchers also noted a correlation between liver stiffness and the presence of esophageal varices (P=0.002), although the negative and positive predictive values for their detection were unsatisfactory, at 66% and 77% in a population where the prevalence of varices was 64% (30 of 47 patients), respectively, they said.
Moreover, they added, this study failed to demonstrate a correlation between liver stiffness and the size of esophageal varices.
The researchers noted that whereas the correlation between the two measurements seemed optimal only for hepatic venous pressure gradient values less than 10 and 12 mm Hg, this important observation suggests that beyond a certain degree of portal pressure, the development of portal hypertension becomes at least partially independent of the simple accumulation of the fibrillar extracellular matrix responsible for the increase in liver stiffness.
The measurement of liver stiffness by this ultrasound technique may represent a reliable noninvasive method for screening patients to be given standard testing, including upper GI endoscopy and hemodynamic studies, the researchers said. However, they added, the technique is not good enough to replace endoscopy for detection of esophageal varices.
Finally, they noted, these results need to be validated in larger populations, especially among those patients with a body mass index greater than 30 kg/m2 for whom liver stiffness reproducibility may not be optimal.
In an accompanying editorial, Joseph K. Lim, M.D., and Roberto J. Groszmann, M.D., of Yale, praised the study as the first to evaluate the correlation between liver stiffness and clinically significant portal hypertension, as reflected by both direct pressure gradient measurement and identification of esophageal varices on upper GI endoscopy.
However, to date, they said, direct measurement of hepatic venous pressure gradient remains the gold standard for the diagnosis and staging of portal hypertension.
Although the use of noninvasive modalities is attractive, additional validation studies measuring diagnostic accuracy in a representative American population are needed prior to regulatory approval, they wrote.
Of note, they said, the mean BMI of patients in this study was 23, and those with a BMI of 35 kg/m2 or greater were excluded, which contrasts with the higher means reported in large U.S. trials for HCV therapy.
Liver-stiffness measurement represents one of several noninvasive tools that appear to be useful in diagnosing and staging liver fibrosis in selected patients, although the current data supporting its role in evaluating the consequences of portal hypertension remain unconvincing, Drs. Lim and Groszmann said.
"Additional data in carefully designed studies will help define its appropriate role in clinical practice," they added.
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Hepatitis C Infection Ups Lymphoma Risk
http://www.forbes.com
TUESDAY, May 8 (HealthDay News) -- People with the liver disease hepatitis C face a higher risk of developing lymphoma, a cancer of the immune system, new research suggests.
Overall, the risk is almost 30 percent higher, but for a certain type of lymphoma called Waldenstrom's macroglobulinemia, the risk is almost 300 percent higher, according to the study.
"If I had hepatitis C, this would be one more piece of evidence that might make me consider treatment, though hepatitis C treatment can be difficult and is often unsuccessful," said the study's lead author, Dr. Thomas Giordano, an assistant professor of medicine at Baylor College of Medicine in Houston.
"On the other hand," he added, "the risk of these cancers is so small, I wouldn't panic if wasn't getting treatment either. The overall risk is low."
More than 4 million Americans have hepatitis C, and about 26,000 new cases are diagnosed each year, according to the U.S. Centers for Disease Control and Prevention. Lymphomas are cancers that originate in the lymphatic system, a part of the body's immune system. The two most common forms of lymphoma are Hodgkin's and non-Hodgkin's lymphoma. About 8,000 Americans develop Hodgkin's lymphoma and more than 56,000 develop non-Hodgkin's lymphoma each year, according to the Leukemia and Lymphoma Society.
"At least five agents -- four viruses and one bacterium -- are associated with an increased risk of lymphoma, said Dr. Marshall Lichtman, executive vice president for research and medical programs at the Leukemia and Lymphoma Society.
But, Lichtman said he couldn't speculate as to why hepatitis C might increase the risk of lymphoma.
Giordano suspects that the chronic stimulation of the immune system caused by hepatitis C might be contributing to the development of certain lymphomas.
For the new study, Giordano and his colleagues reviewed data from the Veterans Administration. First, they found almost 150,000 veterans with a diagnosis of hepatitis C, and then they matched by age and sex four healthy veterans for each person infected with hepatitis C. Nearly all of the veterans included in the study were male, and the average age was 52.
The researchers found that just under 1,400 people included in the study developed non-Hodgkin's lymphoma and 165 developed Waldenstrom's lymphoma.
The risk of non-Hodgkin's lymphoma was 28 percent higher for those with hepatitis C, and the risk of Waldenstrom's was 276 percent higher, according to the study.
While women only comprised 3 percent of the study population, both Giordano and Lichtman think the results would probably apply to women as well.
The findings are published in the May 9 issue of the Journal of the American Medical Association.
Giordano said there aren't any immediate practical implications from the findings, because there's no standard screening tool for lymphoma. He said the findings may help researchers, and they may alert physicians to think of the possibility of lymphoma in their hepatitis C patients.
Lichtman agreed that lymphoma screening isn't feasible at this point. "Lymphoma is not a disease that can be detected early," he said. "Once it's clinically apparent, it's usually advanced."
Another important point, Lichtman added, is that no one yet knows if the treatments for hepatitis C would reduce the risk of lymphoma, too.
More information
To learn more about hepatitis C infection and how to prevent it, visit the U.S. Centers for Disease Control and Prevention.
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Actor-Author Christopher Kennedy Lawford to Join Debbie Delgado-Vega and Lola for 3rd Annual Hepatitis C Walk
http://www.prnewswire.com
City Council Majority Leader Joel Rivera to Provide Major Support
NEW YORK, May 8 /PRNewswire/ -- With the incidence of the Hepatitis C Virus (HCV) dramatically on the rise in New York, the Latino Organization for Liver Awareness (LOLA) will focus attention on the importance of people in every community getting tested and treated when it stages its 3rd annual Hepatitis C Walk, on Tuesday, May 15th from Battery Park to City Hall Park. Leading this year's walk will be LOLA president and founder Debbie Delgado-Vega, a two-time liver transplant recipient, and actor-author Christopher Kennedy Lawford, a nephew of the late President John F. Kennedy, who has been diagnosed and successfully treated for the virus.
Registration for the walk will take place from 9 a.m. to 11:00 a.m. in Battery Park, amid a festival of artistic and musical performances. Promptly at noon, leading HCV public health advocates, doctors, medical professionals, supporters and private citizens touched in some manner by the HCV virus will make the 1 mile walk to City Hall Park. They will be greeted by City Council Majority Leader Joel Rivera.
A blood-borne viral infection that is four times more prevalent than HIV, Hepatitis C has infected 342,000 New Yorkers, 5 million individuals in the United States and as many as 300 million people worldwide. Commonly referred to as a "silent disease", less than five percent of those with HCV are aware that they have been infected by the virus. Over the past 10 years, Hepatitis C has been the leading cause of liver transplants in the U.S. and, if left untreated and undetected, it can lead to cirrhosis, liver cancer or death.
While the Hepatitis C virus is extremely prevalent in Hispanic communities, medical experts estimate that one in five members of the general population have engaged in an activity that puts them at risk for the disease. These activities include: receiving a blood transfusion prior to 1992; being HIV/AIDS positive, having been infected with other viral Hepatitis (A-B or both), having tattoo or body piercing; sharing a toothbrush or a shaving razor. Getting a manicure, using cocaine intranasally, or having been employed as a healthcare worker can also pose a danger.
"After getting over the initial shock of learning I had the Hepatitis C virus, I decided to fight back," Lawford explained. "Now, four years after successfully completing treatment, I want to encourage others to request a simple blood test that can determine whether or not they have been infected with the virus. While the test is available through most health care providers, it is not generally part of the routine tests performed during an annual physical."
"The Hepatitis C virus does not discriminate - anyone is at risk," said LOLA's Delgado-Vega. "On a national level, Latinos are especially vulnerable; and as a Latina and CEO of a Latino based liver disease organization, this becomes one of my primary and personal concerns. The goal of this march is to get New York City residents from all walks of life to make the positive choice of getting a free HCV blood test, seeking appropriate medical assistance and, if necessary, obtaining support and treatment."
Anyone living in the New York City area can obtain a FREE HCV blood test referral by calling LOLA at 718-892-8697. To register on line for the May 15th Hepatitis C walk, log on to http://www.lola-national.org. To volunteer or acquire additional information about LOLA's Get Tested, Get Treated Hepatitis C campaign, please call toll free 1-888-367-LOLA.
About LOLA
The Latino Organization for Liver Awareness (L.O.L.A.) is the first bilingual/bicultural organization in the United States dedicated to raising awareness and providing prevention, education and treatment referral services to the Latino and American community, as well as to underserved populations that suffer from liver disease and/or are in need of a liver transplant.
Delgado-Vega founded LOLA 14 years ago while waiting for a liver transplant and learning that Spanish language information on nearly 100 different liver diseases, particularly the disease she was diagnosed with (Autoimmune), and organ transplantation, was relatively nonexistent in the Latino community worldwide.
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May 9th, 2007
May is National Hepatitis Awareness month
http://www.zwire.com
By Sun Times Staff
What do illegal drugs, unprotected sex, tattoos and body piercing have in common? They're all things parents probably lecture kids to avoid. But there's another connection as well - they can all lead to hepatitis, a serious liver infection.
The Centers for Disease Control and Prevention (CDC) estimated 164,000 new hepatitis A, B and C infections in the United States in 2003. Collectively, they result in approximately 15,000 deaths in the United States each year. It is estimated that 300,000 Florida residents are infected with Hepatitis C and many are unaware of their infection. In Area 8, which includes Collier, Lee, Charlotte, Hendry, Glades, DeSoto and Sarasota counties, there were a total of 2,013 reported Hepatitis cases in 2006.
Viral hepatitis can cause severe signs and symptoms, chronic illness and even death, but prevention and early detection can help avoid long-term complications. Fortunately, hepatitis A and B are vaccine-preventable diseases. Anyone who may be at risk should know his or her vaccination history and get tested.
During May, National Hepatitis Awareness Month, the Collier County Health Department will offer free hepatitis screenings every Wednesday. Free information and materials will also be available. Hepatitis testing and vaccines will be available to those who qualify. Free, rapid HIV testing will also be available.
Testing is available from 2 to 6 p.m. May 9, 16, 23 and 30 at the Collier County Health Department, 3301 E. Tamiami Trail, Government Center, Building H, room 142.
For more information, call 774-8593.
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Conatus Pharmaceuticals Completes Second Closing of $27.5 Million Private Placement Financing
http://www.pr-inside.com/
SAN DIEGO, May 9 /PRNewswire/ -- Conatus Pharmaceuticals Inc. today completed the $22 million second closing of the $27.5 million Series A Preferred Stock private placement announced in January this year. This closing is associated with the achievement of a preclinical milestone with CTS-1027, the Company's novel clinical stage drug candidate. "CTS-1027 is a potent and effective compound in a well established model of liver damage. This drug represents an exciting first-in-class approach for patients suffering from liver disease," said Alfred P. Spada, Ph.D., Senior Vice President of Research and Development at Conatus. The investors are Aberdare Ventures, Advent Venture Partners, Bay City Capital, and Gilde Healthcare Partners.
The proceeds will be used for multiple Phase 2 studies in patients with liver disease. The drug will be initially evaluated in patients infected with the Hepatitis C virus (HCV) who have failed existing treatments (refractory to the standard of care) and is scheduled to begin at the end of 2007. Conatus licensed in CTS-1027 from F. Hoffmann-La Roche Ltd in November 2006.
"The Conatus management team pioneered the development of novel drugs to treat inflammation of the liver (hepatitis) and looks forward to bringing CTS- 1027 forward into clinical trials for this under-served patient population," said Steven J. Mento, Ph.D., President and Chief Executive Officer.
Conatus Pharmaceuticals Inc. is a privately-held specialty pharmaceutical company engaged in the development of innovative human therapeutics to treat liver disease. Chronic liver disease affects millions of people worldwide and can be caused by many different conditions or "insults" to the liver including viral infection, obesity, chronic alcohol abuse or autoimmune diseases. Conatus was founded by the executive management team of Idun Pharmaceuticals in July 2005 following the successful sale of Idun to Pfizer.
Source: Conatus Pharmaceuticals Inc.
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May 10th, 2007
Hepatitis C sufferer: ‘If I don’t get treatment I will die’
http://www.abbynews.com
By SHEENA JACKSON
Abbotsford News
Wendy was diagnosed with hepatitis C seven years ago.
The 52-year-old contracted the potentially fatal liver condition through her job as a laboratory assistant.
“It’s been tough. It’s turned my whole life around,” she said. “I’m moody. I’m just not the same person I used to be. I could go on and on, you know?”
After her husband died several years ago, Wendy made Abbotsford her full-time home last year. One of the hardest things about her battle with the condition is the problem of stigma.
“It’s pretty bad when the landlady says people are scared that I’m living in the building,” she said. “They treat me like I have leprosy.”
Wendy isn’t working and is struggling to survive. Arthritis in her knees makes it hard for her to get around and she can’t afford the special diet she is supposed to be on. To top it off, Wendy is almost towards end-stage liver disease and she said PharmaCare has refused to cover the costs of treatment.
“If I don’t get treatment I will die.”
Wendy’s situation is not isolated, according to Dr. John Farley, a specialist in infectious diseases treating patients in Abbotsford twice a week.
“There are so many ridiculous bureaucracies into getting the treatment approved that many people who are eligible for treatment are not able to get it,” he said. “I’ve had a number of patients where, because of criteria established by PharmaCare, are not eligible for treatment, but who elsewhere would be afforded treatment.”
PharmaCare’s eligibility criteria for hepatitis C treatment drugs such as Pegetron and Pegasys RBV is based on several factors, such as the patient’s level of liver function which shows enzyme levels. However, Farley said the criteria has been shown time and again to be unreliable, with levels set too high.
Between 15 and 20 of Farley’s patients eligible for treatment have been turned down based on that criteria.
“If levels don’t reach that number they (the patient) don’t get the treatment. If they don’t, they require a liver biopsy and, for this to happen, sometimes you have to wait three to six months in some cases. Unless you have that, PharmaCare will not approve the treatment.”
Farley described it as a “catch 22 situation, because if you don’t have that live biopsy and you have to wait for treatment, then the person gets worse and the enzymes are not going to rise.”
And when requests for treatment are turned down, Farley claims to be having a hard time getting through to what he calls the “mysterious” review committee.
“There should not be any archaic regulations to who should be treated or not,” said Farley, who said it applies only to B.C.
“I would like to see a mechanism whereby if people don’t satisfy their artificial criteria we have a mechanism to discuss it as professionals.”
By highlighting the issue, Farley hopes to raise awareness about “how serious a problem it is in the Valley.”
However, Ministry of Health spokesperson Sarah Plank said the criteria established by PharmaCare is based on what has been shown by clinical trials and research studies to be the most effective.
“The criteria follow the guidelines from the Common Drug Review,” she said.
Plank said there is a mechanism in place to ensure that coverage is available for those patients who do not meet the enzyme level criteria but who have obvious symptoms of cirrhosis.
Plank added that more than 1,000 people received PharmaCare funding in 2006 for the drugs Pegetron and Pegasys RBV.
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May 11th, 2007
Hepatitis C epidemic in New York?
http://abclocal.go.com
By Dr. Jay Adlersberg
(New York-WABC, May 11, 2007) - Medical experts are calling it an epidemic across New York. The number of Hepatitis C cases have doubled in the past five years.
With what you can do to protect yourself, Seven's On Call with Dr. Jay Adlersberg.
Hepatitis C is the most common liver problem in the Hispanic-American community. It's only more common in Native Americans.
Debbie Delgado-Vega has had two liver transplants. When she realized how little other Hispanic-Americans knew about liver disease, she started LOLA, the Latino Organization for Liver Awareness.
"I thought, maybe I need to create an organization that would educate the Hispanic community about liver disease in a language they can understand," she said.
Infection with the Hepatitis C virus is the major liver problem for Latinos, perhaps because the illness is very common in the Spanish-speaking Caribbean. Liver transplant is the only treatment for the scarring and liver cancer that can result from Hepatitis C.
"There's a critical donor shortage," said Dr. Lewis Teperman, of the NYU Medical Center. "There are 17,000 people on the list as we speak, and we do, if we're lucky, 7,000 a year. The number one reason for liver transplants is the U.S. is Hepatitis C."
Risk factors for Hepatitis C are getting a blood transfusion before 1992, when a test for the virus came out; having HIV/AIDS; having tattoos or body piercings; and sharing a tooth brush or razor.
Possible risk factors include getting a manicure, using nasal cocaine and being employed as a health care worker.
Hepatitis B is another serious type of liver infections, but 95 percent of patients get over it without a problem. But with Hepatits C, the majority of patients develop an infection that does not go away.
LOLA has helped 50,000 of these patients find support and treatment. It's Debbie's way of giving thanks for her life.
"My only way to give back or just to continue living is by helping others to live as well," she said. "Isn't that what it's all about?"
And it's not just the Hispanic community. Anyone can be infected with the Hepatitis C virus. LOLA is bilingual and offers support to anyone wanting information about the illness and liver disease in general.
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Hepatitis awareness: Cure/treatments available, but most people go undiagnosed
http://www.newstribune.com
By Angie Hutschreider
angieh@newstribune.com
All of her hard work paid off Thursday, when Kathie Bryson set at a table in the Capitol Rotunda spreading the word about Hepatitis C (HCV).
She was there for the state's first Hepatitis C Awareness Day.
In June 2006, Gov. Matt Blunt signed House Concurrent Article (HCR) 12 into law making May 10 Missouri's Hepatitis C Awareness Day - the same day as Bryson's birthday.
Bryson was diagnosed on Halloween 2003 after a clean needle stick while she was working in an adolescent clinic dealing with chemical dependency and mental health problems.
“I got a call and they asked me if I knew I had HCV,” Bryson said.
Bruce Burkett, medical services coordinator with Rain, said that is alarming the number of people who have the disease and do not know it. “The Centers for Disease Control and prevention say that 2 percent of all Americans have Hepatitis, but 75 percent of them do not know it.”
If everyone who had the disease in Cole County were to be diagnosed, there would be 1,455 cases.
Hepatitis comes in various forms. Hepatitis A and B are both treatable and usually, according to Burkett, work their way through a person's system in a matter of weeks. “Usually people just think they have a bad case of the flu and never get tested,” he said. “Most people have had Hepatitis A and don't even know it.
“With 95 percent of Hepatitis B cases, people will be fine in a few weeks, but 5 percent of people will have it for life and it will become a chronic condition.”
There are vaccines available for both Hepatitis A and B. There is a cure for HCV, that works for about 50-70 percent of patients.
However, since the disease has few symptoms and is hard to detect, it can take anywhere from five to 45 years to get a diagnosis for HCV.
Burkett says he is finding that people are contracting or being diagnosed with the disease as young as 15. He says that he is finding that throughout the Northeast sections of the state the average age of diagnosis is 27.
“We are starting to see younger and younger people with the disease because of drugs and teens smoking meth,” he said. The average age of a patient with HCV is 40-65.
Bryson said it is important for people to remember that this (HCV) is not a sexually transmitted disease and urges people to get a Hepatitis C antibody test done.
Those in high risk category for HCV include those receiving a blood transfusion before 1992, anyone with tattoos or body piercings, military veterans, anyone having undergone hemodialysis, health care workers and anyone who ever had used an illegal intravenous drug or cocaine.
“If you look at the risks, don't stop reading with the first one; keep going; there are many risk factors,” Bryson said. “As I nurse, I don't care how anyone got HCV, no one deserves to die from a disease that can be treated.”
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Hepatitis E Takes A Piggyback
http://www.sciencedaily.com
Science Daily — Pigs carry hepatitis E virus (HEV), which they can pass on to humans. But now research from Japan published in Online Open Access journal BMC Veterinary Research says that pigs get HEV early enough to minimise the risk of human infection. The scenario humans need to worry about would occur if the infection rate in pigs drops. At low infection rates, there is actually a higher chance pigs will pass on HEV to humans at slaughter.
Kunio Satou and Hiroshi Nishiura analysed blood test data from 2,500 pigs, natural hosts for the virus, on Japanese farms at Hokkaido, Honshu and Kyushu. They found that by the age of 150 days, over 95% of pigs had been infected with HEV.
Inoculation studies have shown that the virus remains in pigs' faeces and some organs for up to 30 days after infection. This means that the chances of pigs excreting the virus when they are slaughtered at the age of 180 days are currently small. However, if the infection weakens and pigs don't get infected with HEV until they are older, more pigs will still be carrying the virus when they reach the slaughterhouse.
HEV, which is found worldwide, can potentially cause acute hepatitis in humans. So monitoring infection rates could help protect meat processors and vets. The disease can be transmitted by drinking water contaminated with faeces as well as by eating pork: uncooked wild boar liver is one Japanese delicacy that frequently leads to infection.
Suckling pigs don't contract the virus in their first 30 days, because a maternal antibody protects them. Vaccines are currently under development against HEV, although Satou and Nishiura suggest that changes in husbandry practices and avoiding eating raw liver might be more cost-effective measures should HEV's hold on pig farms weaken.
Article: “Transmission dynamics of hepatitis E among swine: Potential impact upon human infection,” Kunio Satou and Hiroshi Nishiura, BMC Veterinary Research
Note: This story has been adapted from a news release issued by BioMed Central.
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