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Week Ending: August 5th , 2006
Alan Franciscus
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July 29th, 2006
Musicians Set to Repay Ill Mentor
SourceURL:http://www.azcentral.com
Katie Nelson
The Arizona Republic
Local bands headline Marquee fund-raiser
A dozen local bands and DJs are coming together on Friday, turning the tables on Tempe's music scene. They are taking part in a show, featuring all-Arizona musicians, to raise money for a former club owner who helped them get notoriety in the first place.
When Mark Covert was still an active owner, his focus was scouting out the best musicians he could find for Nita's Hideaway. As a result, Nita's became one of the area's premiere venues for live shows. At the same time he became a friend that experienced musicians and budding bands alike came to rely on.
Then Covert came face to face with hurdles both professionally and personally. A move to a new Tempe location spurred fighting with neighbors and haggling with the landlord, prompting Nita's to shut down in January of 2004. And an illness Covert had endured during college, came back to haunt him.
It was 1968 when Covert was in the summer of his junior year at Louisiana State University. He was hospitalized for three weeks with Hepatitis AB, as it was known then. But once it went away, he thought that was the end of it. Little did he know the disease was still in him, dormant for decades.
"It turns out it was in my system for 30 years," Covert said. "There it was, all this time, just waiting.
"It came down to I didn't think I could save my life and save the club at the same time. It was just non-stop lawyers. We just said, 'This has got to stop. This is sucking the life out of us.' "
Hepatitis C has no symptoms, according to information from the Mayo Clinic. A person finding out they have the disease long after they contracted it isn't rare. Although it may go undetected, it is still at work, slowly causing the liver to become inflamed and interfering with its ability to function.
No cure exists, and Covert has had several go-rounds with treatments with no luck. He said the medications given to him were sickening and ineffective. Now, the disease affects him so much, he hasn't been working, and has memory loss and severe fatigue. He urgently needs a new liver.
Covert and his wife, Abby, live on a limited income of what she makes as an accountant, and disability checks from the government. A liver transplant costs $350,000. Covert's insurance will cover 90 percent of the surgery expense, leaving about $35,000 to come up with, plus travel and aftercare costs.
"So I'm trying to raise as close to the $35,000 spot as possible, so I can put it away until it's time to use it," he said.
Covert has been on the list to receive an organ for two years, and hopes to receive one within a year.
Help is on the way.
The local bands and DJs, including some of the state's signature acts, have joined up to raise money for Covert during a one-of-a-kind show Aug. 4 at the Marquee Theatre. Even Tom Lapenna, who runs the Marquee and used to be a music-venue competitor is donating space for the concert.
"Everyone wanted to help out," said promoter Charlie Levy, a former Nita's booker. "I think Mark is one of those owners that owned a music club that put the artists and the production and the audiences ahead of the money and bottom line and I think a lot of people saw that. . . . People saw that, especially the bands, saw how much he tried to help out and they are just giving back."
The show itself is worth the ticket price, Levy said, because of the homegrown nature and diversity of the lineup.
"It's a combination of a lot of acts that have graced Nita's in the past," said Lapenna. "We're grateful and proud. No matter whether they are local or have gone onto national prominence, they have all chosen to donate their time and efforts to this fine cause."
This is the third such show titled Scottie Stock III. Two others were put on in Tempe in the past to raise money for other local musicians in need of money for medical problems.
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Former MP Glowing over Hep C Package
http://www.cowichannewsleader.com/
By Angie Poss
Cowichan Valley News Leader - Duncan,British Columbia,Canada
A new compensation package for people who contracted Hepatitis C through tainted blood transfusions is good news for a former Valley MP who lobbied on their behalf.
"I'm very pleased," said Reed Elley.
Elly was the vice-chair of the standing committee on health when the Liberal government announced their compensation package in 1998.
The original agreement offered payment only to those who became infected between Jan. 1, 1986 and July 1, 1990.
"We were always of the opinion that people who contracted Hepatitis C outside this narrow window should be compensated," said Elley of the then-Canadian Alliance Party in Official Opposition.
On Tuesday Prime Minister Stephen Harper announced $1 billion would be made available to those who were infected outside those dates.
"All should be compensated equally, because all of the victims have endured pain and suffering," said Harper when he made the announcement.
An estimated 5,500 Canadians who contracted Hepatitis C through blood transfusions before or after that period will now be eligible for a portion of the $1-billion compensation package.
However, it will likely be another year before those eligible will see payment. The agreement must still be approved by the courts and an administration system set up to handle claims.
Elley also co-founded the Mid-Island Hepatitis C Society. The new compensation fund may prove too late for some clients of the society who now need a liver transplant because they contracted Hepatitis C from a blood transfusion.
"Unfortunately for a lot of them it is going to be very late in the day for them," said Elley.
Harper's announcement included no mention of an emergency relief fund to help seriously ill Hepatitis C patients while they wait for the new package to be distributed.
A B.C,-based national group called the Hepatitis C Compassion Umbrella of Canada is lobbying for an immediate $20,000 payment to patients.
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July 29th, 2006
Xoma Stops Work on Experimental Hepatitis Drug
SourceURL:http://www.bizjournals.com
East Bay Business Times
Xoma Ltd. said late Friday it stopped work on an experimental hepatitis B drug after the company that developed it backed out of a research deal.
Berkeley-based Xoma (NASDAQ: XOMA) was working with Cubist Pharmaceuticals Inc. (NASDAQ: CBST) on the drug HepeX-B, but said Cubist stopped its investment in the project because of stringent Food and Drug Administration requirements. Xoma and Cubist made a deal in September 2005 in which Xoma worked to find new ways of manufacturing HepeX-B.
Xoma has notified Cubist that it will terminate their contract, although the two companies are discussing other options for the drug. HepeX-B has been granted Orphan Drug Status by both European and American regulators.
Cubist is based in Lexington, Mass., and has 360 employees.
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Group Hopes to Stem Hepatitis in Hawaii's Homeless
SourceURL:http://news.yahoo.com
A consortium of groups started a new campaign on Friday to help prevent the spread of highly-infectious hepatitis among Oahu's homeless population.
One thousand hygiene kits will be given to homeless people at the Kakaako Next Step Transitional Shelter starting Friday night. The kits include razors, toothbrushes and nail clippers. The items are things that homeless people sometimes share that can spread infectious blood-borne diseases.
"It's a very needed step in helping to prevent the spread of infectious diseases, such as hepatitis B and C and in just increasing awareness for this very vulnerable population," said Dr. Jill Omori of the UH Medical School.
It is a joint project sponsored by private companies, nonprofit groups and the UH Medical School.
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July 31st, 2006
High Body Mass Index and Hepatitis C Are Risk Factors for Posttransplant Diabetes: Presented at WTC
SourceURL:http://www.docguide.com
By Charlene Laino
BOSTON, MA -- July 31, 2006 -- Patients who are overweight or who have impaired fasting glucose or positive hepatitis C serology before renal transplantation are at high risk of developing new-onset diabetes mellitus, a multicenter observational study suggests.
Kidney recipients who are administered tacrolimus rather than cyclosporine are also at risk for new-onset diabetes, reported Nassim Kamar, MD, transplant surgeon, Hospital Rangel, Toulouse, France. Dr. Kamar presented the findings here on July 26th at the World Transplant Congress (WTC).
The study, which enrolled 527 renal transplant recipients at 17 centers, was designed to identify the risk factors for new-onset diabetes in patients who receive a calcineurin inhibitor after kidney transplantation.
The average age of patients studied was 47.5 years and 61.1% of them were male. Nearly all (95.2%) were Caucasian, and 3.7% had positive hepatitis C serology. Of the total, 261 patients (49.5%) were administered cyclosporine and 266 (50.5%) were given tacrolimus.
Of the total, 7.0% of the patients developed new-onset diabetes mellitus, defined as a fasting plasma glucose of 7 mmol/L or greater or initiation of insulin or oral hypoglycemic therapy. Patients developed diabetes a median of 1.6 months after transplantation.
In univariate analysis, risk factors for new-onset diabetes mellitus were age, impaired fasting glucose (6.1 mmol/L to 7 mmol/L) before transplant, 2 or more cardiovascular risk factors, positive hepatitis C serology, body mass index (BMI) >25 kg/m2 prior to and at the time of transplant, and tacrolimus therapy.
Patients treated with tacrolimus were more likely to develop diabetes (10.2% vs. 3.8%, P = .006). The median time to the development of new-onset diabetes mellitus was 2.9 months in the cyclosporine arm and 0.9 months in the tacrolimus arm (P = .09).
Surprisingly, patients with a family history of diabetes were not at heightened risk of developing the condition themselves, the researchers reported.
Multivariate analysis showed that patients whose maximal BMI was higher than 25 kg/m2 before transplantation were 5.1 times more likely to develop new-onset diabetes mellitus than those with lower BMIs (CI 95% 2.0-12.9).
Patients whose fasting glucose levels 6.1 mmol/L to 7 mmol/L before transplant, were 4.7 times more likely to develop diabetes than those who did not have impaired fasting glucose levels (CI 95% 1.4-15.3).
Finally, positive hepatitis C serology (OR = 4.7, CI 95% 1.2-17.4) and use of tacrolimus rather than cyclosporine OR = 3.0, CI 95% 1.4-6.7) also raised the risk of new-onset diabetes mellitus.
Knowing which factors increase a renal transplant's risk of diabetes will allow clinicians to step up preventive efforts in susceptible patients, Dr. Kamar said.
[Presentation title: Incidence and Risk Factors for New Onset Diabetes Mellitus After Renal Transplantation: Results of the Multicentric Observational Study Diapason. Abstract 857]
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August 1st, 2006
‘Long, Sad Saga’ of Tainted Blood Scandal Ends, Says MP
http://www.theprogress.com
By Robert Freeman, Jeff Nagel
Black Press
rfreeman@theprogress
Chilliwack-Fraser Canyon MP Chuck Strahl says the Tory government is “righting a wrong” with a $1-billion fund announced this week for the “forgotten” victims of the tainted blood scandal.
Prime Minister Stephen Harper unveiled the $1.1-billion package Tuesday for 5,500 victims who contracted hepatitis C before 1986 or after 1990 outside the window of a previous compensation plan offered to nearly 10,000 other victims in 1998. There are about 1,200 victims in B.C.
Compensation is expected to vary according to the level of illness from $10,000 to $250,000 equivalent to previous pay-outs and Harper said it will be paid to both survivors and to the estates of victims who have died.
Strahl said he hopes “this is the final chapter in the long, sad saga of the tainted blood scandal.” “We need to right a wrong by giving equal compensation for the pain and suffering endured by all victims,” he said.
Jane Dyson, spokesperson for the Hepatitis C Compensation Umbrella of Canada (HCCUC), said it is a “good day” for a whole group of people “who have been ignored or forgotten about.”
“We’re very happy they will be getting money to live with more dignity and independence in the community,” she said.
The HCCUC is still asking Health Minister Tony Clement to make “interim” payments to the victims, some of whom have been waiting years for compensation. Dyson said the interim payments would be deducted from the final compensation.
For years the federal government resisted paying compensation to some victims like Surrey resident Allen Blumenfeld on the basis that money should only go to victims who contracted hepatitis C between 1986 and 1990 when Ottawa knew of a test that could have detected tainted blood but did not use it.
Blumenfeld said no amount of money would compensate for the pain and suffering he and his family have been put through.
“All the money is going to do is take the stress off of me,” he said. “I won’t have to worry about my car payment or where my medicine is going to come from.”
Blumenfeld, a 61-year-old former steel mill worker, contracted the disease when he got a transfusion of tainted blood in 1981 from the government-regulated blood supply.
“It’s going to be a bit of a cloud taken off of us,” he said, but added that “it doesn’t take away from the fact I’m going to die from a disease I didn’t deserve to get in the first place.”
Blumenfeld said only victims who have been through a liver transplant or cancer are likely to get anywhere near the maximum $250,000.
He said the full impact of the disease is only just beginning to become clear.
“Here’s a disease that crawls into your body and it’s there for an 18- to 20-year dormancy,” he said, adding the first signs fatigue can be ignored for longer yet.
And he said the government must do more to address the stigma that surrounds the disease.
“The people who got hepatitis C did nothing wrong they just got a blood transfusion to save their lives.”
A final agreement must still be reached and be approved by the courts, ending class action lawsuits now before the courts.
Blumenfeld said he understands it could take until next summer to get paid and wishes it would be sooner.
He said victims also want answers to other questions like whether a third of any money will end up going to lawyers’ fees or other expenses.
“Are we going to have to pay taxes on this?” he asked. “Nobody’s saying anything.”
The Canadian Red Cross was fined $5,000 for its role in the tainted blood scandal, but no criminal charges were laid.
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Diabetes Increases Fibrosis in Patients Transplanted for Hep C
SourceURL:http://www.gastrohep.com
Diabetic status is one of the more important variables determining the severity of Hep C recurrence, and is synergistic with donor age, finds the latest issue of the American Journal of Transplantation.
Numerous factors for aggressive Hepatitis C virus recurrence after liver transplantation have been recognized.
Despite this recognition, the understanding of this phenomenon is incomplete.
Dr John O'Grady and colleagues from England tested the hypothesis that diabetes mellitus was implicated in this phenomenon.
The investigative team evaluated 163 patients undergoing primary liver transplantation for Hepatitis C virus from 1990 to 2004.
The team scored biopsies according to the modified Ishak score.
Severe recurrence of Hepatitis C virus was defined as a fibrosis score of 4 within 6 years of liver transplantation.
The team assessed risk factors that included recipient, donor and transplant variables.
Fibrosis risk increases 8-fold with a liver received from an older donor, and having diabetes -- American Journal of Transplantation
The investigators found that 33% of patients had a fibrosis score of 4 at the end of the study period.
Factors associated with progression to severe fibrosis was donor age, especially donor age above 55 years.
The team observed that pre-liver transplantation diabetes mellitus, and diabetes mellitus post-liver transplantation were also associated with severe fibrosis.
The combination of receiving a liver from a donor older than 55 years and having diabetes mellitus post-liver transplant gave an 8-fold risk of severe fibrosis.
Dr O'Grady's team concluded, "These data indicate that diabetic status is one of the more important variables determining the severity of Hepatitis C virus recurrence and is synergistic with donor age."
"This observation may provide an additional management opportunity to modify the impact of Hepatitis C virus recurrence."
Am J Transplant 2006: 6(8): 1922
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Bioenvision's Data on Suvus™ in Chronic Hepatitis C to Be Released at Scientific Conference in Dublin - Quick Facts
SourceURL:http://www.tradingmarkets.com
(RTTNews) - Bioenvision, Inc. said its abstract on Suvus™ has been accepted for the British Association for the Study of the Liver's 2006 Annual Meeting in Dublin.
The meeting on September 7-8th at Trinity College provides Bioenvision the first opportunity to present data from a Phase II study of Suvus™ in chronic hepatitis C and refractory hepatitis C.
Suvus™ showed clear evidence of activity and significantly reduced the viral load in chronic hepatitis C patients, many who have cirrhosis of the liver.
Hugh Griffith, Bioenvision's COO said, "Besides Suvus™ showing efficacy in hepatitis C, studies have also shown Suvus™ offers an indication of activity in the West Nile Virus and flu strain H5N1, otherwise known as the "avian flu." "We plan to initiate further clinical and preclinical trials of Suvus™ on the basis of this encouraging data."
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Marine City Man to Receive Son's Liver for Transplant
SourceURL:http://www.voicenews.com
by Jeri Packer, voice staff writer
Grant Harris is a lucky man, despite some very serious physical disabilities.
Harris was born with a hereditary medical condition called hemophilia "B." During treatments for the disease, he contracted HIV and hepatitis "C." Drug therapy for the HIV was successful, but his liver was damaged.
Early last August, he went into a coma and was not expected to live. Fortunately, he began to respond to some new medications, and was able to be released from the hospital and sent back home.
In November, he was accepted as a candidate to receive a cadaver transplant and was placed on the United Network for Organ Sharing list. He began the wait for the new liver that would eventually save his life.
The family received a call in late December with news of an available liver. He was hospitalized and on the operating table, waiting to be put under for surgery, when they discovered that the donor liver was damaged. The surgery was cancelled.
"At least they did their homework," Harris said, taking a positive approach. "I would have had to have another transplant if they had gone through with it."
Two other possible donor livers ended up not being matches, and Grant Harris went back on the waiting list.
And that's where Harris is really lucky. Two family members and a good friend, all healthy, stepped forward to donate their organs. His father, Grant E. Harris; his oldest son, Danny; and Danny's godfather, Tom McConnell, all volunteered to have two-thirds of their liver removed and transplanted into Harris' deteriorating body.
Harris' father was five years too old. The cut-off age for live organ donors is 55 years. Disappointed, he finally had to concede that he would not be able to help his son. McConnell, a Marine City resident and long-time family friend, was willing to take the risk to save Harris.
When Danny Harris learned that, at 18 years old, he qualified, he offered to be the donor. He argued that McConnell, married with a two year old son, was just starting a family, and that he should be the one to donate the needed organ, not McConnell.
"I initially didn't want him to," said Grant Harris. "I asked him to explain more why he wanted to do it,"
According to Danny Harris, it was a matter of helping out a friend.
"He's more than my dad. He's my best friend," he said. "Also, I wanted him to see my younger brother grow up and for him to see his grandchildren."
The father and son have a lot in common: They coach together, play poker together and share a lot of the same friends.
The two were co-directors of the Marine City Maritime Days for two years, after Crystal Harris directed the event the six years before.
"We do everything together," she said.
Crystal Harris is especially proud of her son.
"He's always acted older for his age. At two years old, he could carry on an adult conversation. He never talked baby talk," she said.
Danny Harris' maturity was demonstrated last year in August. When the family was told that Harris would probably not make it out of the hospital, he took charge.
"Mom was a mess," he said, "I had to make all the decisions. I was afraid she'd have a breakdown. I took the leadership role and took care of everyone."
Scottie, the Harris' youngest son, was in Europe with a national baseball team, National Team USA, when his dad's health started declining. He returned in time for his brother's high school graduation party, and to find out that his dad was dying.
One day, Harris, who had been slipping in and out of a comma, told the family gathered at his bedside: "Get my boys back up here. I want to say goodbye."
Kelly Ring, Danny Harris' aunt and godmother, phoned the two boys with their father's wishes.
"It was emotional for all of us," said Ring, "We're a big family, and we fall back on each other (in stressful times)."
"It was the fastest drive to Detroit we ever made," said the brothers, referring to the drive to Henry Ford Hospital from their home in Marine City that day.
Ring added that her nephew, Danny, has always taken care of others, even his grandmother, when she was living with the family.
"He's the child every parent wants to have," she said.
Danny Harris is feeling very positive about the surgical procedure he will be undergoing. According to the college sophomore, his surgeon has performed more than 600 of the procedures, and all of them have been successful, without any complications.
"They will take two-thirds of the liver," he said, "and in just eight weeks, 90 percent will be recovered; within two years, it will be 100 percent fully functional, as if nothing had happened."
The 19-year-old graduated 13th in his class at Marine City High School last year and is currently attending Wayne State University, majoring in education, and also works part-time at VG's grocery store in Marine City.
His surgery and follow-up care will be paid by the hospital because of the savings of having a live liver donation, as opposed to finding and preparing a cadaver liver for the transplant and also because the surgery is a life-saving procedure.
Grant Harris, 39, is a General Motors employee, on extended medical disability. His family has lived in Marine City for the last 18 years.
On Fathers Day, he wrote: "As I take time to reflect ... I am sure thankful as I received the best Father's day gift I could ever imagine. The gift of life."
The Harris' will be flying to the University of Pittsburgh Medical Center's Thomas E. Starzl Transplantation Institute for surgery on Aug. 1.
Just before the two men leave for the greatest father/son bonding experience of their lives, their family and friends will be celebrating Grant Harris' new chance at life at a party at their home on July 29.
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Dengue Virus Reveals Its Circular Secret
SourceURL:http://www.newswise.com
Scientists have identified a key enzyme that the dengue virus uses to replicate, triggering the potentially fatal dengue hemorrhagic fever. The finding could help researchers develop ways to prevent or treat dengue hemorrhagic fever and related viruses that cause West Nile, St. Louis encephalitis, and hepatitis C.
Newswise -- The first step in the transmission of mosquito-borne viruses is no mystery: it's the pesky insect's bite that allows the virus to enter its victim's bloodstream. But for some of the most dangerous insect-borne viruses, details of what happens next have been unclear.
In a finding that could help scientists develop ways to prevent or treat certain infections, researchers led by a Howard Hughes Medical Institute (HHMI) international scholar in Argentina have identified a genetic element that the dengue virus uses to replicate, triggering the potentially fatal illness known as dengue hemorrhagic fever.
In the August 15, 2006, issue of the journal Genes & Development, published online August 1, 2006, virologist Andrea Gamarnik and colleagues at Leloir Institute Foundation in Buenos Aires, describe how a viral enzyme recognizes and amplifies the genetic material needed to assemble new dengue viruses. Their findings provide the first model for RNA replication in the family of viruses that includes West Nile, St. Louis encephalitis, and hepatitis C.
These viruses, known as flaviviruses, cause millions of cases of human illness each year, but no vaccines or antiviral drugs exist to control most of the infections. Dengue fever is endemic in many tropical and subtropical regions, causing a severe, flu-like illness that sickens more than 50 million people and kills 25,000 each year.
Once a virus enters a host cell, its top priority is to copy its genetic code so that it can make more virus. Flaviviruses are so efficient at this task that they can churn out tens of thousands of copies of their genome--which is composed of ribonucleic acid, or RNA--within hours of infecting a cell.
For dengue and other flaviviruses, the first step is to produce viral proteins, including an enzyme that can copy RNA. But the viral RNA is not the only RNA in an infected cell. So once the enzyme, called RNA-dependent RNA polymerase (RdRp), is produced, it finds itself surrounded by cellular RNA, creating a dilemma: How does RdRp distinguish viral from cellular RNA, to replicate the right molecule?
Last year, Gamarnik got her first hint when her group identified two RNA sequences located at the ends of the dengue virus genome. These short sequences interact during RNA replication, shaping the viral RNA genome into a circle. Gamarnik's team published those findings in the June 2005 issue of the Journal of Virology.
Further studies of the dengue virus life cycle revealed another piece of the virus's RNA that recruits the enzyme RdRp. Found at one tip of the genome, that sequence adopts a characteristic stem-loop structure that the scientists suspected might be important to its function.
To test whether RdRp was relying on that stem-loop shape to recognize the viral RNA, the scientists created copies of the dengue genome with minor changes that would alter its structures. The mutated RNAs were then inserted into mosquito cells or hamster cells to see if the viral RNA would be copied.
To their surprise, the scientists found that the stem-loop or SLA sequence was essential for viral replication. Changes in even one or two building blocks in this structure were enough to halt the replication process. "That told us that RdRp probably discriminates the viral RNA by recognizing SLA," Gamarnik said.
To confirm the vital link between RdRp and SLA, the researchers allowed virus particles that couldn't replicate to evolve in cells grown in lab dishes. Spontaneous mutations that occurred in the SLA often restored RdRp's activity and full viral replication capacity.
The scientists didn't expect to find that RdRp activity relies on a sequence at the far end of the genome, thousands of nucleotides away from the end where the enzyme begins copying the RNA.
The new discovery makes sense, Gamarnik said, because the circular shape adopted by the virus brings the distant ends of its genome together. "At first we were puzzled by the cyclization feature of this virus," said Gamarnik. "We now recognize that it serves a role in bringing the SLA promoter near the initiation site."
Paul Ahlquist, an HHMI investigator at the University of Wisconsin-Madison and an expert on RNA viruses, said that the Gamarnik team's findings explain prior observations from her lab and others that binding between the 5-prime and 3-prime ends of the viral genome is required for replication of dengue and several other medically important flaviviruses. "These insights suggest possible mechanisms by which flaviviruses may regulate some distinct replication steps, and might ultimately provide foundations for new antiflavivirus strategies," Ahlquist said.
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August 2nd, 2006
Vertex, Tibotec Announce Plans for Initiative to Increase Awareness of Hepatitis C
SourceURL:http://www.therapeuticsdaily.com
Vaccine Weekly - Aug. 02, 2006
Aug. 2, 2006--(NewsRx.com) -- Vertex Pharmaceuticals Incorporated (VRTX) and Tibotec Pharmaceuticals, Ltd., a Johnson & Johnson (JNJ) company, announced that the companies will establish a global health initiative to increase the prevention, diagnosis, treatment and cure of hepatitis C virus (HCV) infection to be principally directed toward developing countries.
The initiative is part of an agreement between Vertex and Janssen Pharmaceutica, N.V., another Johnson & Johnson company, and its affiliates, for the development and commercialization of VX-950, Vertex's investigational HCV protease inhibitor, in Europe and other territories. This initiative will be financially supported by Vertex and Tibotec following regulatory approval and commercialization of VX- 950.
Vertex and Janssen and its affiliates also announced the formation of a collaboration to develop and commercialize VX-950 in Europe and other territories. Vertex will continue to lead the global development plan of VX-950 and retains the exclusive right to develop and commercialize the compound in North America.
Hepatitis C is a liver disease caused by the infection by hepatitis C virus (HCV), which is found in the blood of people with the disease. HCV, a serious public health concern affecting 170 million people worldwide, is spread through direct contact with the blood of an infected person.
This article was prepared by Vaccine Weekly editors from staff and other reports.
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VIHA Targets $1.5 Million to Halve HIV/AIDS, Hep C
SourceURL:http://www.vicnews.com
By Andrea Lavigne
Victoria News
The Vancouver Island Health Authority will distribute $1.5 million to HIV/AIDS and hepatitis C community programs to reduce infection rates by 50 per cent in the next three years.
"We are looking to reduce infection rates by 2009 in keeping with objectives of the province," said Dr. Mark Gilbert, VIHA medical health officer.
More specifically, VIHA is looking for services and programs that are targeted at people most at risk -- intravenous drug users.
The search for programs follows a two-year consultation process with people living with HIV/AIDS and hepatitis C, community agencies, First Nations groups and corrections services -- the results of which were laid out in a recently-released report called Closing the Gap: Integrated HIV/AIDS and Hepatitis C Strategic Directions.
In 2005, 47 new cases of HIV infection and 538 new cases of hepatitis C were identified on Vancouver Island, mostly caused by infected needles. Ten to 25 per cent of individuals with HIV are co-infected with hepatitis C.
"These numbers are only a part of the picture," Gilbert said, adding that more people could be infected, but have yet to be tested.
VIHA will be looking at services that address testing, education, outreach and comprehensive needle exchange services.
For the first time, VIHA has issued a request for proposals from non-profit and private-sector organizations for a three-year contract.
The RFP competition closes Sept. 28 and contracts will be in place February 2007 and expire March 2009.
The funding is part of an overall harm reduction strategy, that includes a safe injection site, confirmed Gilbert.
The City of Victoria is conducting a study to look at supervised drug-use options for Victoria that will take between four and six months to complete.
Funding for the study comes from VIHA and the B.C. Ministry of Health.
alavigne@vicnews.com
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Clinicians Expect Bristol-Myers Squibb's Baraclude Use to Increase for the Treatment of Hepatitis B
SourceURL:http://biz.yahoo.com
However, Baraclude and Gilead's Hepsera Face Hurdles in Achieving Favorable Tier Status Amongst Surveyed Private Health Plans, According to a New Report from Decision Resources
WALTHAM, Mass., Aug. 2 /PRNewswire/ -- Decision Resources, Inc., one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that after one year on the market, more than 25% of clinicians surveyed say that they prescribe Bristol-Myers Squibb's Baraclude as a first-line therapy for the treatment of Hepatitis B and that clinicians expect that Baraclude usage will increase in the next two to three years.
The new PhysicianForum report entitled Hepatitis B: New Antivirals Replacing the Old?, also finds that while clinician use of Baraclude will increase, Baraclude and Gilead's Hepsera are facing hurdles in achieving favorable tier status amongst surveyed private health plans, in comparison to the tier status accorded to older antiviral agents.
"Although clinicians expect the use of Baraclude to continue to expand at the expense of Epivir-HBV, surveyed formulary directors, at this time, do not view Baraclude sufficiently differentiated to gain a tier placement similar to that of Epivir-HBV," said Aaron Woolsey, Ph.D., analyst at Decision Resources. "Thus Hepsera and Baraclude are more likely to be placed on higher or specialty tiers and are likely to have higher copayments than Epivir-HBV. Unless a novel therapy can clearly distinguish itself from existing therapies by offering a major improvement in efficacy, it can expect to face similar tier-status obstacles in the HBV market."
About PhysicianForum
PhysicianForum is a primary research service from Decision Resources that offers access to high volume-prescribing physicians, specialists, and managed care organization representatives in the United States; analysis of events and survey participants' responses to them; insight into prescribing patterns; and an examination of the implications of events and issues for the pharmaceutical market.
Hepatitis B: New Antivirals Replacing the Old? is based on a U.S. survey of 21 managed care pharmacy and medical directors, 95 gastroenterologists, and 47 hepatologists. Their responses were compared to assess similarities and differences of opinion regarding clinical, economic, and scientific factors.
About Decision Resources
Decision Resources, Inc. (http://www.decisionresources.com) is a world leader in market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
For more information, contact:
Elizabeth Marshall
Decision Resources, Inc.
781-296-2563
emarshall@dresources.com
Source: Decision Resources, Inc.
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August 3rd, 2006
Higher Cholesterol Levels Improve Hep C Treatment Outcomes
SourceURL:http://www.gastrohep.com
Higher serum low density lipoprotein and cholesterol levels before Hep C treatment are prognostic indicators of improved treatment outcomes, reports the latest issue of Hepatology.
The low-density lipoprotein receptor has been proposed as a candidate receptor for the Hepatitis C virus.
Competitive inhibition of Hepatitis C binding to the low-density lipoprotein receptor by low-density lipoprotein has been shown in vitro.
If similar inhibition occurs in vivo, an elevated serum concentration of beta- lipoproteins may reduce the efficiency of infecting hepatocytes with Hepatitis C.
This may occur by competitively inhibiting Hepatitis C viral receptor binding.
Dr Albert Min and colleagues from New York investigated the role of baseline lipid values in influencing the outcome of Hepatitis C treatment.
Early viral response occurred in all 99 patients -- Hepatology
The investigative team conducted a retrospective chart review of patients treated with an interferon-based regimen at their liver and gastroenterology clinics between 1998 and 2004.
Of 99 patients enrolled in the study, 49 had Hepatitis C genotype 1, and 50 patients had genotype 2 or 3 infection.
The team documented early viral response, end-of-treatment response, and sustained viral response in 99, 88, and 77 patients, respectively.
Low density lipoprotein and cholesterol levels prior to treatment were found to be higher in patients with positive early viral response, end-of-treatment response, and sustained viral response.
The team observed that this difference remained significant independent of age.
Multivariate analysis controlling for genotype and age showed that the higher the cholesterol and low density lipoprotein levels prior to treatment, the greater the odds of responding to treatment.
Dr Min's team concludes, "Having higher serum low density lipoprotein and cholesterol levels before treatment may be significant prognostic indicators for treatment outcome of those with chronic Hepatitis C infection, particularly in genotypes 1 and 2."
Hepatology 2006: 44(2): 335-40
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Males Are More at Risk for Diabetes after Liver Transplantation
SourceURL:http://www.gastrohep.com
Male gender is an independent risk factor for the development of diabetes after liver transplantation, reports the latest issue of the American Journal of Transplantation.
The prevalence and risk factors for diabetes mellitus after liver transplantation are not well understood.
Dr Saaba and colleagues identified independent risk factors for the development of diabetes after liver transplantation.
The researchers studied the prevalence and risk factors in 253 adult recipients transplanted at UCLA between 1998 and 2002.
Analysis of the retrospective data was performed using demographic, immunosuppression and liver disease variables.
Factors found to be significant on a univariate analysis were further studied in a multivariate analysis.
The prevalence of diabetes after transplantation was 18% -- American Journal of Transplantation
The researchers included 158 men and 95 women, with a mean age of 51 years.
The research team noted that the mean pretransplant body mass index was 27.
Most patients were transplanted for Hepatitis C.
The prevalence of diabetes after transplantation was 18%.
Using a multivariate analysis, the researchers observed that only gender was independently predictive of the development of diabetes.
Dr Saaba's team concludes, "This study in a large liver transplant recipient population identifies male gender as an independent risk factor for the development of diabetes."
"Follow-up studies are needed to assess the impact of diabetes, and its intervention on post-transplant morbidity and mortality."
Am J Transplant 2006: 6(8): 1890
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Findings from Italy, France and Canada Advance Knowledge in Hepatitis C Virus Research
SourceURL:http://www.therapeuticsdaily.com
Genomics & Genetics Weekly - Aug. 11, 2006
Reports from Italy, France and Canada highlight recent research in hepatitis C virus.
Study 1: According to a study from Italy, hepatitis C virus (HCV)-associated lymphoproliferative disorders involve differing increases of interleukin (IL) inhibitors.
"HCV causes hepatitis, liver cirrhosis and hepatocellular carcinoma, and may also induce type II mixed cryoglobulinemia syndrome (MC), a disease characterized by clonal B-cell lymphoproliferations that can evolve into non-Hodgkin lymphoma (NHL)," wrote M. Libra and colleagues, University of Catania.
They continued, "IL-1 is a cytokine that plays an important role in initiating the cascade of events of immunoinflammatory responses through costimulation of T lymphocytes, B-cell proliferation, induction of adhesion molecules and stimulation of the production of other inflammatory cytokines."
"The role of IL-1 in immuno-inflammatory responses is highlighted by the presence of endogenous regulators (IL-1 receptor antagonist, soluble receptors type I and II, human IL-1 accessory protein) that, when secreted into the blood stream may serve as endogenous regulators of IL-1 action. The aim of this study was to evaluate whether abnormalities in the blood levels of IL-1 beta IL-1 receptor antagonist, soluble IL-1 receptor type II and human IL-1 accessory protein in HCV+ patients are associated with development of MC and/or NHL," the investigators explained.
"Relative to healthy controls, we observed: i) an increase in the circulating levels of IL-1 beta in HCV+ patients simultaneously affected by NHL; ii) increased levels of IL-1 accessory protein in patients singly infected by HCV; iii) increase of IL-1 receptor antagonist in HCV+ patients and in those affected also by NHL with or without MC; iv) a homogeneous increase of sIL-1R type II in all the subgroup of patients," wrote the researchers.
They concluded, "These data indicate that an attempt to increase circulating levels of IL-1 inhibitors occurs at different extent in the course of HCV infection as well as in its progression to NHL and/or MC."
Libra and colleagues published the results of their research in Oncology Reports (Analysis of interleukin (IL)-I beta IL-1 receptor antagonist, soluble IL-1 receptor type II and IL-1 accessory protein in HCV-associated lymphoproliferative disorders. Oncol Rep, 2006;15(5):1305-1308).
For additional information, contact M. Libra, University of Catania, Department of Biomedical Science, Via Androne 83, I-95124 Catania, Italy.
Study 2: Recent research from France has documented the characteristics and outcome of diffuse large B-cell lymphoma in hepatitis C virus (HCV)-positive patients.
"Epidemiologic studies show an association between HCV and B-cell non-Hodgkin's lymphoma (NHL). Treatment and outcome of patients with diffuse large-cell lymphoma (DLCL) and HCV infection are still a matter of debate.
"We studied the HCV-positive patients with B-cell DLCL included in the Groupe d'Etude des Lymphomes de l'Adulte (GELA) programs LNH 93 and LNH 98. They were compared with the other patients with DLCL included in these programs. HCV infection prevalence was 0.5% (26 of 5,586 patients)," wrote C. Besson and colleagues, Hopital Necker-Enfants Malades.
They continued, "Histologic types of HCV-positive DLCL were more frequently transformed from low-grade lymphoma than DLCL in HCV-negative patients (32% v 6%, p=.02). This is also supported by more frequent spleen involvement in HCV-positive patients (46% v 17%, p<.001). HCV-positive patients had more frequently elevated lactate dehydrogenase levels than other patients (77% v 55%, p=.02)."
The team explained, "Outcome of HCV-positive patients was poorer for overall survival (p=.02) but not for event-free survival (p=.13). After matching on age and prognosis factors, at 2 years of follow-up, the overall survival was 56% (95% CI, 33% to 76%) among HCV-positive patients, versus 80% (70% to 89%), and the event-free survival was 53% (33% to 72%) versus 74% (64% to 84%).
"The short-term hepatic toxicity of chemotherapy was strongly increased among HCV-positive patients. After exclusion of the two subjects with chronic hepatitis B virus infection, the overall proportion of subjects undergoing hepatic toxicity was 65% (15 of 23 patients)."
"HCV-positive patients with DLCL differ from other patients both at presentation and during chemotherapy. Specific protocols evaluating antiviral therapy should be designed for these patients," the authors concluded.
Besson and colleagues published their study in the Journal of Clinical Oncology (Characteristics and outcome of diffuse large B-cell lymphoma in hepatitis C virus-positive patients in LNH 93 and LNH 98 Groupe d'Etude des Lymphomes de l'Adulte programs. J Clin Oncol, 2006;24(6):953-960).
For additional information, contact O. Hermine, Service d'Hematologie Adulte, Hopital Necker-Enfants Malades, APHP, Paris, France Hop Necker Enfants Malad, 149 Rue Sevres, F-75743 Paris 15, France.
Study 3: According to recently published research from Canada, expression of hepatitis C virus (HCV)-derived core or NS3 antigens in human dendritic cells (DCs) leads to induction of pro-inflammatory cytokines and normal T-cell stimulation capabilities.
"The majority of HCV-infected individuals become chronically infected, which can result in liver cirrhosis and hepatocellular carcinoma. Patients with chronic HCV are unable to prime and maintain vigorous T-cell responses, which are required to rid the body of the viral infection."
"DCs are the professional antigen-presenting cells that probably play a dominant role in priming and maintaining vigorous T-cell responses in HCV infection. Furthermore, inefficient DC function may play an important role in HCV chronicity," wrote W. Li and colleagues, University of Alberta.
"In order to determine the effect of HCV NS3 and core proteins on phenotype and function of human DCs, recombinant adenoviral vectors containing NS3 or core genes were used to infect human DCs. HCV NS3- or core-protein expression in DCs was confirmed by Western blotting and immunofluorescence staining."
The authors wrote, "The DCs expressing HCV NS3 or core proteins expressed several inflammatory cytokine mRNAs, had a normal phenotype and effectively stimulated allogeneic T cells, as well as T cells specific for another foreign antigen (tetanus toxoid)."
"These findings are important for rational design of cellular-vaccine approaches for the immunotherapy of chronic HCV," concluded the researchers.
Li and colleagues published their study in the Journal of General Virology (Expression of hepatitis C virus-derived core or NS3 antigens in human dendritic cells leads to induction of pro-inflammatory cytokines and normal T-cell stimulation capabilities. J Gen Virol, 2006;87(Part 1):61-72).
Additional information can be obtained by contacting B. Agrawal, University of Alberta, Faculty of Medicine & Dentistry, Department of Surgery, Edmonton, AB T6G 2S2, Canada.
This article was prepared by Genomics & Genetics Weekly editors from staff and other reports.
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Research from Denmark, Switzerland and Italy in Hepatitis C Virus Provides New Insights
SourceURL:http://www.therapeuticsdaily.com/
Health & Medicine Week - Aug. 07, 2006
Reports from Denmark, Switzerland and Italy highlight recent research in hepatitis C virus.
Study 1: A study from Denmark has reported that hepatitis C virus (HCV) coinfection increases mortality in human immunodeficiency virus (HIV)-infected individuals.
"Coinfection with HCV in HIV type 1 infected patients may decrease the effectiveness of highly active antiretroviral therapy. We determined the impact of HCV infection on response to highly active antiretroviral therapy and outcome among Danish patients with HIV-1 infection," wrote N. Weis and colleagues, Odense University Hospital.
"This prospective cohort study included all adult Danish HIV-1-infected patients who started highly active antiretroviral therapy from 1 January 1995 to 1 January 2004. Patients were classified as HCV positive (positive HCV serological test and/or HCV PCR results [443 patients {16%}]), HCV negative (consistent negative HCV serological test results [2183 patients {80%}]) and HCV-U (never tested for HCV [108 patients {4%}]). The study end points were viral load, CD4+ cell count, and mortality.
"Compared with the HCV-negative group, overall mortality was significantly higher in the HCV-positive group (mortality rate ratio, 2.4; 95% confidence interval [CI], 1.9-3.0), as was liver disease-related mortality (mortality rate ratio, 16; 95% CI, 7.2-33). Furthermore, patients in the HCV-positive group had a higher risk of dying with a prothrombin time <0.3, from acquired immunodeficiency syndrome-related disease, and if they had a history of alcohol abuse," the authors reported.
"Although we observed no difference in viral load between the HCV-positive and HCV-negative groups, the HCV-positive group had a marginally lower absolute CD4+ cell count. HIV-HCV-coinfected patients are compromised in their response to highly active antiretroviral therapy," the researchers continued.
They concluded, "Overall mortality, as well as mortality from liver-related and acquired immunodeficiency syndrome-related causes, is significantly increased in this patient group."
Weis and colleagues published their study in Clinical Infectious Diseases (Impact of hepatitis C virus coinfection on response to highly active antiretroviral therapy and outcome in HIV-infected individuals: A Nationwide Cohort Study. Clin Infect Dis, 2006;42(10):1481-1487).
For more information, contact N. Obel, Odense University Hospital, Department of Infectious Disease, Sdr Blvd., DK-5000 Odense C, Denmark.
Study 2: In a recently published article, scientists from Switzerland reported that hepatitis C virus (HCV) coinfection is independently associated with decreased adherence to antiretroviral therapy in a population-based HIV cohort.
P. Braitstein and colleagues, University of Bern, wrote that the study was done "to characterize the impact of HCV serostatus on adherence to antiretroviral treatment (ART) among HIV-infected adults initiating ART."
They continued, "The British Columbia HIV/AIDS Drug Treatment Program distributes, at no cost, all ART in this Canadian province. Eligible individuals used triple combination ART as their first HIV therapy and had documented HCV serology."
"Statistical analyses used parametric and non-parametric methods, including multivariate logistic regression. The primary outcome was greater than or equal to95% adherence, defined as receiving greater than or equal to95% of prescription refills during the first year of antiretroviral therapy.
"There were 1186 patients eligible for analysis, including 606 (51%) positive for HCV antibody and 580 (49%) who were negative. In adjusted analyses, adherence was independently associated with HCV seropositivity [adjusted odds ratio (AOR), 0.48; 95% confidence interval (CI), 0.23-0.97; p=.003], higher plasma albumin levels (AOR, 1.07; 95% CI, 1.01-1.12; p=.002) and male gender (AOR, 2.53; 95% CI, 1.04-6.15; p=.017), but not with injection drug use (IDU), age or other markers of liver injury."
"There was no evidence of an interaction between HCV and liver injury in adjusted analyses; comparing different strata of HCV and IDU confirmed that HCV was associated with poor adherence independent of IDU," reported the authors.
They concluded, "HCV-coinfected individuals and those with lower albumin are less likely to be adherent to their ART."
Braitstein and colleagues published their study in AIDS (Hepatitis C coinfection is independently associated with decreased adherence to antiretroviral therapy in a population-based HIV cohort. AIDS, 2006;20(3):323-331).
For more information, contact P. Braitstein, University of Bern, Institute of Social & Preventative Medicine, Finkenhubelweg 11, CH-3012 Bern, Switzerland.
Study 3: According to recently published research from India, hepatitis C virus (HCV) coinfection influences liver enzyme elevation in HIV-1.
"The independent role of HCV genotype 3 in liver transaminase elevation following highly active antiretroviral regimens is still controversial," wrote C. Torti and colleagues, Institute of Infectious & Tropical Diseases.
They continued, "Analysis of data from a cohort of 492 HIV/HCV-coinfected patients was conducted using an intention-to-treat approach. Incidence of gradegreater than or equal toIII liver transaminase elevation was estimated per 100 patient-years of follow-up."
The researchers wrote, "Univariate and multiple proportional hazards regression analysis of factors that may predict liver enzyme elevation was performed. The incidence of gradegreater than or equal toIII hepatotoxicity was 25 per 100 patient-years among patients coinfected with HCV genotype 3 and 11 per 100 patient-years among those with other genotypes.
"On multiple proportional hazard regression analysis, time-to-grade greater than or equal toIII liver enzyme elevation was directly correlated with HCV genotype 3 (hazards ratio [HR]: 2.0, 95% CI: 1.3 to 2.9; p=.001), male gender (HR: 2.7; 95% CI: 1.3 to 5.7; p=.007), chronic hepatitis B virus infection (HR: 2.9, 95% CI: 1.5 to 5.9; p=.002), and Ala aminotransferase level at baseline (per 10 IU/L HR: 1.10; 95% CI: 1.06 to 1.15; p<.001)."
"In the same model, higher CD4+ T-cell counts at baseline were inversely correlated with risk of hepatotoxicity (HR: 0.998; 95% CI: 0.997 to 0.999; p=.036). Moreover, among patients experienced to antiretroviral drugs, previous gradegreater than or equal toIII hepatotoxicity (HR: 2.8-195% CI: 1.8 to 4.3; p<.001) was an adjunctive independent risk factor," the authors reported.
The scientists concluded, "HIV-positive patients coinfected with HCV genotype 3 displayed a higher risk of relevant hepatotoxicity, independently from other clinical variables. The impact of HCV genotype outweighed the role of drugs in determining hepatotoxicity."
Torti and colleagues published their study in JAIDS - Journal of Acquired Immune Deficiency Syndromes (Influence of genotype 3 hepatitis C coinfection on liver enzyme elevation in HIV-1-positive patients after commencement of a new highly active antiretroviral regimen - Results from the EPOKA-MASTER cohort. J Acquir Immune Defic Syndr, 2006;41(2):180-185).
For additional information, contact C. Torti, Institute of Infectious & Tropical Diseases, P Le Spedali Civili 1, I-25123 Brescia, Italy.
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August 4th, 2006
Risk Factors for Peritonitis after Liver Transplantation
SourceURL:http://www.gastrohep.com
Peritonitis is a serious infectious complication after liver transplantation, for which risk factors include recipient age, and bowel leak or perforation after liver transplantation, reports this month's Liver Transplantation.
Peritonitis occurring after liver transplantation has been poorly characterized to date.
Dr Andrew Keaveny and colleagues from Florida defined the incidence, risk factors, and outcome of nonlocalized peritonitis occurring after liver transplantation.
The investigative team conducted a retrospective study of 950 cadaveric liver transplantation procedures in 837 patients, followed for a mean of 1086 days after transplant.
Peritonitis occurring after liver transplantation was defined as the presence of at least 1 positive ascitic fluid culture.
There were 108 peritonitis occurring after liver transplantation episodes in 91 patients at a median of 14 days.
Risk factors associated with the development of peritonitis occurring after liver transplantation by multivariate analysis included pre-liver transplant model for end-stage liver disease score.
The investigators found that duration of liver transplant surgery, Roux-en-Y biliary anastomosis, and renal replacement therapy after liver transplant were also risk factors.
Gram-positive cocci were isolated in 93% of ascitic fluid cultures -- Liver Transplantation
The team noted that biliary complications, intra-abdominal bleeding, and bowel leak/perforation were associated with 34%, 27%, and 19% of episodes, respectively.
Multiple organisms, gram-positive cocci, fungus, and multidrug-resistant bacteria were isolated in 61%, 93%, 26%, and 77% of ascitic fluid cultures, respectively.
The 28 fungal peritonitis after liver transplant episodes were associated with bowel leak/perforation and polymicrobial peritonitis.
The investigators observed that patients who developed peritonitis after their first liver transplantation had a greater risk of graft loss or mortality compared to unaffected patients.
Dr Keaveny's team concludes, "Parameters significantly associated with these adverse outcomes by multivariate analysis were recipient age at liver transplantation, and bowel leak or perforation after liver transplantation."
"In conclusion, peritonitis occurring after liver transplantation is a serious infectious complication of liver transplantation, associated with significant intra-abdominal pathology and reduced recipient and graft survival."
Liver Transplant 2006: 12(8): 1244-52
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Transition Therapeutics Inc. Announces 12-Week Data from HCV-I.E.T. Phase I/II Clinical Trial
http://www.newswire.ca/
Announces 12-week data from an open label, multi-centre Phase I/II clinical trial evaluating the interferon enhancing product, HCV-I.E.T., in hepatitis C non-responders.
TORONTO, Canada | Aug 04, 2006 | Transition Therapeutics Inc. ("Transition") (TSX: TTH - News), announces 12-week data from an open label, multi-centre Phase I/II clinical trial evaluating the interferon enhancing product, HCV-I.E.T., in hepatitis C non-responders. The clinical trial was designed to evaluate safety and HCV-I.E.T.'s ability to produce a positive therapeutic response in patients who have failed to respond to previous treatment with the current "gold standard" hepatitis C therapies consisting of pegylated interferon and ribavirin. HCV-I.E.T. combines Transition's interferon enhancer, EMZ702, with the current standard of care for hepatitis C, a combination therapy of pegylated interferon alpha and ribavirin. The study data demonstrated that 6 of 21 (28%) of the hepatitis C non-responder patients that were treated for 12-weeks had a greater than 99% reduction of virus levels (2 log10 decrease).
The patients in the study received twice weekly doses of EMZ702 along with a combination pegylated interferon and ribavirin product for 12 weeks. The dose escalation of EMZ702 was as follows: 500mg for week 1, 1000mg for week 2, and 1500mg for the remaining ten weeks. The six patients that achieved a 99% reduction in viral levels received between 4-12 weeks of treatment with the triple combination therapy suggesting that shorter duration of treatment or lower doses of EMZ702 may be equally effective.
The preliminary safety data collected to date reveals no serious safety concerns with EMZ702. The type of side effects observed in the study overlaps with previously reported and expected adverse events for interferon and ribavirin treatment. However, the highest dose of EMZ702 in combination with interferon and ribavirin appears to increase the incidence rate and/or severity of skin rash. Patients who experienced the skin rash discontinued treatment with EMZ702 before week 12 but continued receiving interferon alone or in combination with ribavirin for the remainder of the study. Four patients withdrew from the study before completing 12 weeks of treatment.
"This trial showed signs of efficacy in non-responding hepatitis C patients, a patient population without any approved treatments available. Our next steps in the development of the product will be to work with a partner to perform a larger study to identify the optimal dosing regimen for this therapy," said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition.
Clinical Trial Design
Hepatitis C patients who have not responded to a pegylated interferon and ribavirin product, received twice-weekly treatments of EMZ702 administered along with the same pegylated interferon and ribavirin product for 12 weeks. Patients participating are chronically infected with the hepatitis C virus (HCV genotype 1) and have previously failed to respond to treatment with a pegylated interferon plus ribavirin product. HCV genotype 1 patients account for more than two-thirds of the infections in the United States yet are the most difficult to treat with current therapies.
About HCV-I.E.T
HCV-I.E.T. combines Transition's interferon enhancer, EMZ702, with the current standard of care for hepatitis C, a combination therapy of pegylated interferon alpha and ribavirin. The combination of EMZ702 with interferon and ribavirin in surrogate models for hepatitis C has demonstrated a two- to three-fold increase in anti-viral potency compared to interferon and ribavirin alone. The strong anti-viral response observed in surrogate models has enabled the rapid advancement of HCV-I.E.T. into clinical development with hepatitis C patients.
About Hepatitis C
Hepatitis C is a progressive disease of the liver caused by the hepatitis C virus. Currently, it is estimated there are about 170 million people worldwide who are infected with the hepatitis C virus, and 4 million of those are in the United States. Up to 80% of individuals infected with the virus are symptom-free initially, as the infection is typically mild in its early stages. As a result, diagnosis does not usually take place until liver damage has already occurred. Long-term effects of chronic hepatitis C infection include cirrhosis, liver failure and liver cancer. Current treatments for hepatitis C, including combination therapies, can eliminate the virus in approximately 55% of hepatitis cases.
About Transition
Transition is a product-focused biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include regenerative therapies E1-I.N.T.(TM) and GLP1-I.N.T.(TM) for the treatment of diabetes, AZD-103 for the treatment of Alzheimer's disease, MS-I.E.T. for the treatment of multiple sclerosis and HCV-I.E.T. for the treatment of hepatitis C. Transition has completed target enrolment for exploratory Phase IIa clinical trials of its lead regenerative product, E1-I.N.T.(TM) in type I and type II diabetes patients. Transition's shares are listed on the Toronto Stock Exchange under the symbol "TTH".
Notice to Readers: Information contained in our press releases should be considered accurate only as of the date of the release and may be superseded by more recent information we have disclosed in later press releases, filings with the OSC or otherwise. Press releases may contain forward-looking statements based on the expectations of our management as of the date of the release. Actual results may materially differ based on many factors, including those described in the press releases.
For further information on Transition, visit www.transitiontherapeutics.com or contact: Dr. Tony Cruz, Chief Executive Officer, Transition Therapeutics Inc., Phone: (416) 260-7770, x.223, tcruz@transitiontherapeutics.com Mr. Elie Farah, CFO and VP, Corporate Development, Transition Therapeutics Inc., Phone: (416) 260-7770, x.203, efarah@transitiontherapeutics.com
SOURCE: Transition Therapeutics Inc.
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'KC Star' Investigation Leads to $1 Billion Hepititis C Settlement
SourceURL:http://www.editorandpublisher.com
By E&P Staff
NEW YORK Evidence uncovered by The Kansas City Star helped bring about a $1 billion settlement for approximately 5,500 Canadians with Hepatitis C, the paper reported today.
Michael McCarthy, the lead plaintiff in the Canadian case, told the Star that documents that the paper printed helped to aid his case against the Canadian government. McCarthy was one of thousands who contracted Hepatitis C through tainted blood transfusions in the 1980s. In 2003, the Star published a series of articles that said Red Cross, Canadian, and United States officials knew of a test that could prevent Hepatitis C from entering the blood supply. The Star exposé dated the advent of this knowledge at 1981; Canada did not begin utilizing this test until the early 1990s.
The Star series of reports included documents from 1981 that quoted top U.S. blood experts as saying that blood collection agencies should begin testing for Hepatitis C.
The compensation package brings to a close the eight-year legal battle that pitted Hepatitis C victims against the Canadian government, the Star reported. The $1 billion settlement will be divided into payments ranging from $30,000 to $300,000, depending on the severity of the victim's illness. The settlement covers both living victims and the estates of those who have died.
Hepatitis C is a virus that can severely damage the liver. In the mid-1970s, nearly 300,000 or roughly 10% of transfusion patients in the United States were infected with it each year. It wasn't until 1986 that the U.S. began utilizing the Hepatitis C test for blood transfusions.
E&P Staff (letters@editorandpublisher.com)
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S.F. Leaders Call for Expanded Hep B Screening
SourceURL:http://news.asianweek.com
By Samson Wong
Community leaders and health professionals called for a plan to have every Asian Pacific American in San Francisco to be screened for Hepatitis B, the vaccine that causes 85 percent of all liver cancers.
The occasion was a report by Dr. Samuel So of the Asian Liver Center of Stanford University, on the Hepatitis B screening effort held at the 2nd Annual Asian Heritage Street Celebration last May.
There were 536 tested, from the ages of 18 to 87. Nearly half of those tested still needed follow-up care.
Twelve percent had the virus. Thirty-six percent were unprotected and needed vaccination from CHBV. Among those tested, 15 percent were positive with CHBV and from China, 10 percent from Vietnam, nine percent from Taiwan and eight percent from Hong Kong.
"We always find about 10-12 percent of people who we screen have chronic hepatitis B," said So.
Without care and screening, many hepatitis B carriers die from liver cancer or cirrhosis. Asian Pacific Americans make up more than half of up to 1.5 million hepatitis B carriers in the United States.
"If detected early, it could be successfully treated," said So.
The AHSC, organized by the AsianWeek Foundation on May 22, drew more than 80,000 celebrants into S.F.'s Sunset neighborhood.
The center said three-quarters of those tested in five hours were San Francisco residents. The rest were from 37 other cities, including Congressman Mike Honda.
ALC also presented commendations to Honda, Ma, the AsianWeek Foundation, GlaxoSmithKline, the Sunset Merchants Association and Niwa Public Relations.
CHBV Symptoms, Testing and Treatment
Unlike adults, children are covered since tests are mostly mandatory. Adults can “catch up” and get CHBV testing through a one-time test generally costing less than $10 from their health care provider.
- If a test is positive, a one-time, three-shot vaccine can protect against liver cancer and potential liver infections.
- No symptoms appear until it is too late.
- CHBV is transmitted at birth, by contaminated blood or unprotected sex.
http://liver.stanford.edu/index.php
"Hepatitis B is one of the most serious health threats to the Asian American community...Liver cancer is the second leading cause of cancer for Asian men, even living in the U.S. It's totally preventable with a vaccine."
--- Samuel So, director of the Asian Liver Center in Stanford
"My brother and I had the hepatitis B virus. And all these years I thought I was just a carrier, not a big deal. I had always been healthy every year... Some of my relatives said, 'You shouldn't tell anybody that you have this because people are going to think you are sick.'"
--- Supervisor Fiona Ma, who tested positive, and pledged as a state Assemblywoman to increase statewide awareness and obtain insurance coverage for Hep B vaccinations.
"The message here is we need to constantly, constantly educate and screen on this issue. I am committed, if you give me that info, to pass it to throughout 57,000 families in our school district."
--- Norman Yee, School board president, where half of the students are Asian American.
"The education not only needs to be with our community, but the education needs to be also with the medical community, to educate them, to screen Asian American immigrants for hepatitis B."
--- Lawrence Wong, College Board
"The next step after testing is to make sure our community can get the resources from our government, from the health plans to get the vaccine if you have it, to fight it. That is so critical to get it done."
--- James Fang, president of AsianWeek and BART Director
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