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Week Ending: November 17th , 2007
Alan Franciscus
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November 11th, 2007
Some Genotype 3 Hepatitis C Patients May Require Increased Doses or Longer Treatment: Presented at AASLD
http://www.docguide.com
By Maria Bishop
BOSTON, MA -- November 8, 2007 -- Actual treatment outcomes among patients with genotype 2 and 3 hepatitis C virus (HCV) are slightly lower than in those reported in interventional clinical trials, according to research from the Canadian Peginterferon alfa-2b prospective Optimal Weight-based dosing Response (POWeR) program, which was reported here at the 58th Annual Scientific Meeting of the American Association for the Study of Liver Disease (AASLD).
Robert J. Bailey, MD, Gastroenterologist, Royal Alexandra Hospital, and Clinical Professor of Medicine, University of Alberta, Edmonton, Alberta, Canada, author of a POWeR program substudy on genotypes 2 and 3, noted that genotype 3 patients with advanced fibrosis or cirrhosis especially may need increased doses or duration of treatment.
The POWeR program was a large, open-label observational trial conducted in community and academic clinics across Canada between 2002 and 2007 to determine the impact of hepatitis C virus (HCV) genotype, baseline viral load, weight, and fibrosis stage on sustained virological response (SVR) rates. All patients had chronic HCV, were treatment-naïve, and were treated with pegylated interferon alfa-2b (PegIntron) and weight-based ribavirin in a "real-life" observational setting.
This substudy analysed the 38% of POWeR patients with HCV genotype 2 (n = 276) and 3 (n = 389). These patients received pegylated interferon alfa-2b (1.5mcg/kg/wk) plus ribavirin (800 to 1200 mg/d) for 24 weeks, and achieved undetectable HCV ribonucleic acid (RNA) levels at 24 weeks post-treatment.
Overall, SVR rates were significantly higher among genotype 2 than genotype 3 patients (79% vs 72%, P =.01). While the genotype 3 patients had significantly lower end-of-treatment response and SVR rates than genotype 2 patients, both groups had similar, consistently low relapse rates (genotype 3: 6.4%, genotype 2: 7.6%).
Dr. Bailey also noted that predictors of treatment outcome in genotype 3 patients (but not genotype 2 patients) included baseline viral load and Metavir fibrosis score. Liver disease was also a predictor of outcome for genotype 3 patients, with 47% SVR for those patients with cirrhosis (75% in patients with minimal fibrosis).
The researchers concluded that future studies would benefit from separating genotype 2 and 3 patient populations when reporting results in patients with HCV.
This trial was supported by funding from Schering-Plough Canada Inc.
[Presentation title: Response to Peginterferon Alfa-2b + Ribavirin Combination Therapy in Genotype 2 and 3 Patients With Poor Baseline Prognostic Factors: Results of the Canadian POWeR Program. Abstract 246]
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"Real Life" Success Treating Chronic Hepatitis C Can Match That in Clinical Trials: Presented at AASLD
http://www.docguide.com
By Maria Bishop
BOSTON, MA -- November 8, 2007 -- Successful treatment of patients with chronic hepatitis C virus (HCV) matching the outcomes of rigorous clinical trials can be achieved in routine clinical practice, according to research from the Canadian observational program pegylated interferon alfa-2b prospective Optimal Weight-based dosing Response (POWeR), discussed here at the 58th Annual Scientific Meeting of the American Association for the Study of Liver Disease (AASLD).
Observational trials include a more heterogeneous patient population than populations observed in controlled trials, and provide useful information to practitioners on post-approval drug use, noted lead author, Paul Marotta, MD, Medical Director of Liver Transplantation, London Health Sciences Centre, London, Ontario, Canada.
The POWeR program was a large, open-label observational study conducted in community and academic clinics across Canada between 2002 and 2007 to determine the impact of hepatitis C virus (HCV) genotype, baseline viral load, weight, and fibrosis stage on sustained virological response (SVR) rates.
All 1,977 patients in the POWeR program had chronic HCV, were treatment-naïve, and were treated with pegylated interferon alfa-2b (PegIntron) (1.5 mcg/kg/wk) and weight-based ribavirin (800 to 1200 mg/day) in a "real-life" observational setting for either 24 weeks (genotypes 2 and 3) or 48 weeks (genotype 1).
This analysis is based on 1,800 patients, including those who discontinued because of side effects, lack of response, or personal reasons. Most patients were infected with genotype 1 disease (60.4%), followed by genotype 3 (21.8%), and genotype 2 (15.5%).
Despite poor predictive factors, such as advanced fibrosis and high baseline viral load in this difficult-to-treat population, an excellent sustained viral response (SVR) rate of 54.3% overall was achieved with pegylated interferon alfa-2b plus ribavirin.
Low relapse rates with pegylated interferon alfa-2b plus ribavirin were also attained (mean of 11.9%; 17.2% in genotype 1; 7.5% in genotype 2; 6.4% in genotype 3; and 6.9% in genotype 4 to 6).
Dr. Marotta noted that this study will be useful in adding to the published data on chronic HCV management in actual care settings.
This trial was supported by funding from Schering-Plough Canada Inc.
[Presentation title: Final Results of the Canadian POWeR (Peginterferon alfa-2b Prospective Optimal Weight-based Dosing Response) Program. Sustained Virologic Response (SVR) to Weight-Based Peginterferon alfa-2b + Ribavirin in a Large, Mixed Community and Academic Observational Study. Abstract 254]
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First Clinical Trial With Investigational Agent Telaprevir Phase II Open Label Study In Treatment-Naïve Chronic Hepatitis C Patients
http://www.medicalnewstoday.com
Tibotec BVBA announced that it has opened 5 trial sites in Belgium and Germany in its first clinical study of telaprevir (VX-950) an investigational protease inhibitor (PI) for the treatment of chronic hepatitis C (HCV) infection. The phase II study will open shortly in France, Italy, the Netherlands and Spain, subject to the necessary approvals.
VX-950-C208 is a randomized, open-label, exploratory phase II study in treatment-naïve patients with chronic genotype-1 HCV infection to investigate the efficacy, safety, viral kinetics and pharmacokinetic / pharmacodynamic relationship of different treatment combinations of telaprevir. Patients will be randomized to one of four treatment arms and will receive either 1125 mg telaprevir every 12 hours or 750 mg telaprevir every 8 hours for 12 weeks in combination with standard therapy, either Pegasys® + Copegus® (peg interferon alfa-2a + ribavirin) or Pegintron™ + Rebetol® (peginterferon alfa-2b + ribavirin), which will be given for at least 24 weeks and up to 48 weeks depending on individual virologic response. The total daily dose of telaprevir will be the same in all treatment arms. A total of 160 patients will be enrolled. Telaprevir is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is one of the most advanced investigational agents in development that specifically targets HCV.
For more about information on the study, visit http://www.clinicaltrials.gov.
"Despite treatment advancements in the last 10 years, there is still an urgent need for new therapeutic options for chronic hepatitis C - especially those compounds that prevent viral replication," said Roger Pomerantz, M.D., President of Tibotec Research and Development.
Tibotec is jointly developing telaprevir with Vertex and has the exclusive rights to telaprevir in Europe, South America, Middle East, Africa and Australia. Vertex is conducting a global Phase 2b clinical development program for telaprevir consisting of three large clinical trials, PROVE 1, 2 and 3, that have enrolled approximately 1,000 patients with genotype-1 HCV at clinical centers in the United States, Canada and Europe.
6 abstracts submitted by Vertex on telaprevir were presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), November 2-6, 2007 in Boston, including presentations of interim data from PROVE 1 and PROVE 2.
About Tibotec
Tibotec BVBA, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche
Pegintron™ and Rebetol® are registered trademarks of Schering Corporation
http://www.tibotec.com
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November 12th, 2007
Hepatitis C: The disease no one's talking about
http://www.statesmanjournal.com
ALAN GUSTAFSON
The Statesman Journal
The disease is a 'silent epidemic' that is getting little public attention, state official says
Ann Shindo takes to task the federal government for failing to confront hepatitis C in Oregon and across the country.
"Remember when Reagan didn't say AIDS? That's where we are with hep C," said Shindo, the coordinator of viral hepatitis prevention for the Oregon Department of Human Services. "It's (like) 1988, pal, and no one's talking about hep C.
"We have four times as many people nationwide living with hep C as HIV (the virus that causes AIDS) and we have no federal funds and state funds to address this epidemic."
The national Centers for Disease Control and Prevention estimates that nearly 2 percent of all Americans, more than 4 million people, are infected with hepatitis C. It kills about 10,000 people per year. Each year, there are anywhere from 20,000 to 30,000 new infections, according to the federal agency.
Often called the "silent epidemic," hepatitis C can hibernate in the liver for decades, often taking 20 to 30 years before symptoms surface.
Shindo said an estimated 65,000 Oregonians have hepatitis C, and most of them do not know they are carrying it. For some, it's a devastating, potentially lethal time bomb.
"The reality is, someone may be clean and sober for 25 years, then find out they have hep C, and it dramatically changes their life," Shindo said. "That's a very common story. It can detrimentally impact peoples' lives to the point of losing their jobs, losing their homes, and becoming homeless."
Hepatitis C is spread mainly by exposure to infected blood. The most common way it's transmitted is by the sharing of needles by drug users, which accounts for nearly 70 percent of new infections.
There is no vaccine for hepatitis C. The virus wasn't identified until 1989, and testing wasn't available until 1992.
For unknown reasons, the majority of people with hepatitis C won't develop severe symptoms or need treatment. But about one in five among the chronically infected will develop life-threatening complications, such as cancer, cirrhosis and liver failure.
Hepatitis C is the leading cause of liver transplants in the U.S. Of the 18,000 Americans waiting for a transplant, an estimated 40 percent to 60 percent have hepatitis C.
Further complicating matters is the "tricky business" of treatment, Shindo said. Antiviral medication for hepatitis C is expensive, often causes severe side effects, and fails to eradicate the virus in about half of all patients.
Treatment generally is not recommended for those without liver damage. But regular monitoring is seen as crucial for everyone with hepatitis C.
Educating a poorly informed public about the harsh realities of hepatitis C poses an uphill fight, Shindo and other activists say.
"It's a highly stigmatized disease," Shindo said. "People believe, 'Oh, it's just drug injection drug users who get it.' "
In Oregon City, a nonprofit advocacy organization called the Hepatitis C Caring Ambassadors Program is trying to pump up the volume about the "silent epidemic."
As it stands now, Lorren Sandt, the program director, said "most people don't know what hepatitis C is because there's a lack of education and awareness. Also, there's a shortage of testing that is available within the public health departments."
Shindo holds the news media partly to blame for widespread lack of know-ledge about hepatitis C.
"I think there's a lot of mythology and just cluelessness around this epidemic nationwide," she said, "and part of the reason for that is there's been a lack of media coverage and a lack of funding for folks like me to get out there and address all the high-risk folks that need to be addressed."
Shindo's job is funded by the CDC, which pays for hepatitis C coordinators in nearly all 50 states. However, states only get enough funding to cover the cost of the coordinator's salary, leaving most coordinators with little or no budget for programs and services, such as testing and education.
"I'm the program," Shindo said. "We have no federal or state funding for hepatitis C screening or education. We can't even afford billboards to put up the information regarding who should be screened."
agustafs@StatesmanJournal.com or (503) 399-6709
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State OKs settlements for Oregon inmates with Hepatitis C
http://www.kmtr.com/
SALEM, Ore. (AP) - The state of Oregon has paid more than $300,000 to settle claims of five inmates who say they were denied adequate treatment for hepatitis C.
The Salem Statesman Journal reports four of the inmates are dead, and a fifth is seriously ill at the Snake River Correctional Institution in Eastern Oregon.
About 70 percent of new infections are a result of drug users sharing needles.
The Statesman Journal has obtained copies of the settlements, approved in July, through a public records request.
Family members or friends of the four got settlements ranging from $12,000 to $150,000. The men died in the years since 2003.
Hepatitis C attacks the liver and can lead to cancer, cirrhosis and liver failure.
Officials say an estimated 65,000 Oregonians have hepatitis C, most unknowingly.
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November 13th, 2007
St. Vincent Medical Center Opens Innovative Clinic to Fight Hepatitis
http://au.biz.yahoo.com
In a unique effort to fight hepatitis in the greater Los Angeles area, St. Vincent Medical Center has opened the Asian Pacific Liver Center (APLC), the only clinic in Southern California dedicated to the prevention, detection and treatment of hepatitis, with special emphasis on the high rate of disease in the Asian-American Community.
While the APLC is ready to diagnose and treat all forms of hepatitis, it is especially focused on preventing and treating hepatitis B, a serious liver infection caused by the hepatitis B virus (HBV) that can lead to liver cirrhosis and cancer.
The Centers for Disease Control and Prevention (CDC) estimate that 1.25 million Americans are already chronically infected with HBV. Between 5,000 and 6,000 Americans die of HBV-related liver complications each year. The disease rate is especially high for people of Asian descent. As many as one in 10 Asian Americans is infected with HBV, with most infections occurring at birth or during early childhood.
"The Asian Pacific Liver Center at St. Vincent Medical Center is addressing a very serious community health concern," said Tse-Ling Fong, M.D., program director of the APLC. "Hepatitis B presents a unique challenge because it does not present any symptoms in the early stages and many chronically infected individuals are undiagnosed until the disease is very advanced. There is also a lot of misunderstanding of how the disease is transmitted, with many people unaware that they may have contracted the virus from their mother when they were born."
Hepatitis B is transmitted through contact with blood and bodily fluids. Most adults are able to fight off an HBV infection and clear the virus from their blood. This may take up to six months. During the time that the virus is present in their blood, infected individuals can pass the virus on to others. Chronically infected people are at increased risk for liver problems later in life.
"While the high infection rates are a great cause for concern, it is important for people to realize that hepatitis B infection is treatable," said Ho Bae, M.D., medical director of the APLC. "The first step is knowing your status to find out if you have the hepatitis B virus. If you aren't infected, there is a vaccine that can protect you. If you do have the virus, you need to be evaluated and begin treatment if necessary."
The staff of the APLC is reaching out to the community to raise awareness about hepatitis B, offering educational materials and blood screenings at churches, community centers and local health fairs. Patients seeking screenings can also make an appointment at the clinic. Results of all screenings are communicated directly to the patient or referring physician. For patients testing negative, the APLC offers vaccinations. For patients testing positive, comprehensive treatment plans are developed and put into action.
"It is very important that we take a comprehensive approach to this challenge," said Cathy Fickes, president and CEO of St. Vincent Medical Center. "The scope of the APLC extends beyond the hospital campus to reach the people who need this care. It is a powerful example of the hospital's mission made visible in the community."
For more information about the Asian Pacific Liver Center at St. Vincent Medical Center, including scheduling a screening or community education event, call 1-888-236-APLC (2752).
About St. Vincent Medical Center
Providing compassionate healthcare for those who need hope and healing has been the mission of St. Vincent Medical Center for 150 years. Located just west of downtown, St. Vincent is a world-renowned, 347-bed state-of-the-art facility offering comprehensive medical services, including acute, tertiary and primary care. St. Vincent Medical Center is part of the Daughters of Charity Health System, a nonprofit healthcare system spanning the California coast.
Contact:
St. Vincent Medical Center
Paul Silva, 213-484-5593
paulsilva@dochs.org
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Scientists at University of Navarra release new data on hepatitis C virus therapy
http://www.therapeuticsdaily.com
Hepatitis Weekly - Nov. 12, 2007
Current study results from the report, 'HCV structural proteins interfere with interferon-alpha Jak/STAT signalling pathway,' have been published (see also Hepatitis C Virus Therapy). According to a study from Pamplona, Spain, "Hepatitis C virus (HCV) is remarkably efficient at establishing persistent infection. The current treatment with IFN-alpha given alone or in combination with ribavirin is ineffective in eliminating the virus in a large proportion of individuals with chronic hepatitis C."
"Recent data suggest that HCV blocks IFN-alpha signalling, an effect that facilitates viral persistence. We have used the HCV genomic and subgenomic replicon system to analyze the effect of structural and non-structural viral proteins on the activation of the Jak/STAT pathway and induction of antiviral activity by IFN-alpha. Our results show that IFN-alpha-mediated STAT activation (but not IFN-gamma-stimulated STAT phosphorylation) is blocked in Huh7 cell line containing the genomic replicon, while this is not observed in cells with the subgenomic replicon. In agreement with these findings, the transcriptional activity and the antiviral effect of IFN-alpha were significantly lower in cells harboring the genomic replicon than in cells with the subgenomic replicon," wrote E. Luquin and colleagues, University of Navarra.
The researchers concluded: "These results indicate that HCV structural proteins play an important role in the escape of HCV from the interferon system."
Luquin and colleagues published their study in Antiviral Research (HCV structural proteins interfere with interferon-alpha Jak/STAT signalling pathway. Antiviral Research, 2007;76(2):194-7).
For more information, contact E. Luquin, University of Navarra, Division of Hepatology and Gene Therapy (CIMA), Pamplona, Spain.
Publisher contact information for the journal Antiviral Research is: Elsevier Science BV, PO Box 211, 1000 AE Amsterdam, Netherlands.
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Lobbying Stalls Generic Drug Legislation
http://www.therapeuticsdaily.com
AP Online
WASHINGTON_Legislation aimed at speeding the availability of cheaper generic drugs has stalled in Congress in the face of major lobbying by the drug industry.
The Senate bill would ban most settlements known as "reverse payments," in which a brand-name company pays a generic manufacturer to delay the introduction of the generic drug. The Federal Trade Commission, which has called on Congress to take action, says such settlements could cost American consumers billions of dollars.
An Associated Press review of lobbying reports, from July 1, 2006, through June 30, 2007, found that $38.8 million was spent by at least a dozen generic and brand-name companies and their trade associations on issues including the Senate legislation. The lobbying reports do not specify how much of that money was directed at the reverse payment bill, and they are not required by law to do so.
More than half of those expenses were piled up by the Pharmaceutical Research & Manufacturers of America, or PhRMA, which represents brand-name drug companies. PhRMA spent $19.5 million in the 12-month period ending June 30 on in-house lobbying expenses, an increase of about $3 million over the previous 12-month period.
And the Generic Pharmaceutical Association reported lobbying expenses of around $420,000 for the first six months of this year. It did not report lobbying on the bill in its year-ending 2006 report. The remaining $19 million was spent by a variety of drug companies, including Bayer Corp., Schering-Plough, Pfizer and Teva Pharmaceuticals USA.
"Lobbyists have a lot of influence in Washington," said the bill's sponsor, Sen. Herb Kohl, who chairs the Senate Judiciary subcommittee on antitrust, competition policy and consumer rights. "If we can just get this to a vote, it will be pretty hard for people to vote against it. A vote against this is a vote against consumers."
Kohl, D-Wis., also chairs the Senate Special Committee on Aging, where he has pushed for generic drugs as a way for seniors to save money on their medications. Generic drugs are 30 to 80 percent cheaper than brand-name drugs, according to the Generic Pharmaceutical Association.
Kohl has offered the reverse payment legislation for the past two sessions of Congress. This year, House supporters introduced a similar bill, which remains in committee. Neither bill has come up for a vote, although the Senate bill did make it through the Judiciary Committee a few months ago.
In May, Kohl tried to get a vote on the Senate floor under a procedure known as unanimous consent, but Republicans objected. Sen. Mike Enzi, R-Wyo., said Sen. Jon Kyl, R-Ariz., and others involved with the legislation wanted more time to work on it.
Kyl asked the Justice Department's antitrust division for its views on the bill and is waiting for a response, said Kyl spokesman Andrew Wilder. The antitrust division declined to comment.
Sen. Orrin Hatch, R-Utah, has expressed concerns about Kohl's bill. Hatch issued a statement saying he voted to move the bill through committee this year "with the reservation that we find a balanced solution, one that bars anticompetitive settlements without jeopardizing the very kind of settlements that are critical to consumers and taxpayers."
"We haven't reached that balance yet, so it's understandable this bill has not moved forward," Hatch said.
In 1984, Congress passed the Hatch-Waxman Act, which established procedures to encourage generic companies to challenge patents before their expiration. In recent years, generic companies have increasingly resolved such challenges through settlements in which the generics receive cash or lucrative licensing and marketing agreements.
The drug companies are required to file their settlements with the FTC. Two federal appeals court rulings in 2005 upholding the legality of reverse payments have made it more difficult for the agency to block them.
In one of those cases, Barr Laboratories Inc. abandoned its successful challenge to AstraZeneca PLC's patent for the breast cancer drug tamoxifen. In exchange, Barr received a $21 million payment and entered an agreement with AstraZeneca under which Barr sold tamoxifen provided by AstraZeneca.
Consumers filed a lawsuit. The 2nd U.S. Circuit Court of Appeals upheld a federal judge who had concluded that the agreement did not violate federal antitrust laws. In June, the Supreme Court refused to take up an appeal.
A plaintiff in that case, Helen Donega of North Adams, Mass., said she was saving only about 5 percent off the brand-name price when she purchased the Barr generic tamoxifen in 1998 and 1999. Donega, who had insurance through Medicare but no drug coverage, said she had to pay between $85 and $90 a month for the drug.
She eventually bought tamoxifen in Canada for about one-10th of the price she was paying in the U.S.
Donega, 75, who had a mastectomy and has been cancer-free for several years, said she was amazed when she learned of the deal between Barr and AstraZeneca, which sold tamoxifen under the brand name Nolvadex. AstraZeneca's patent on the drug has since expired.
"I must have been naive. I thought the government was on our side," she said. "No, the government isn't on our side. Big PhRMA is powerful and has a lot of money. That's whose side they're on."
AstraZeneca spent just under $2.4 million in lobbying expenses over the 12-month period ending July 1 on issues including the reverse payment bill.
In an e-mail statement, AstraZeneca spokesman Tony Jewell said the settlement with Barr Laboratories was meant to resolve a patent dispute, not to delay the generic tamoxifen.
Barr spent $660,000 in the same 12-month period. At a Senate Judiciary Committee hearing this year, Barr Chairman and CEO Bruce L. Downey said the company settled the case with AstraZeneca because it thought it would lose its patent challenge on appeal.
"We took payment, we took a license, and we entered the market early with tamoxifen," he said. "And over the course of our license, we saved consumers about $300 million on that product."
Not all patent litigation settlements between generic and brand name companies involve payments, and Kohl's bill bans only those where the generic company receives something of value. The legislation would allow, for example, a deal in which the two sides merely compromise on the date that a generic can enter the market. And Kohl recently agreed to add a provision that would exempt some reverse payment settlements if the FTC determines they would benefit consumers.
The FTC has called on Congress to pass legislation to crack down on the reverse payment settlements, although it hasn't endorsed any specific bill.
"Such settlements restrict competition at the expense of consumers, whose access to lower-priced generic drugs is delayed, sometimes for many years," FTC Chairwoman Deborah Platt Majoras said in testimony before a House task force in September.
Generic and brand name drug companies argue that a ban would be counterproductive. PhRMA senior vice president Ken Johnson said in a statement that pharmaceutical research companies invest billions of dollars developing new medicines, and that patent rights help the companies recoup those investments and fund new research.
Jake Hanson, a lobbyist for Barr Laboratories, said that the settlements are sometimes necessary when a generic company considers all the ramifications behind a patent challenge.
"Sometimes as you're moving through discovery and different levels of a court case, you realize that it may not be a slam dunk," Hanson said.
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November 14th, 2007
Donor Risk Must Be Factored Into Transplant Decisions
www.medscape.com
Tinker Ready
November 6, 2007 (Orlando) — The key challenge facing transplant surgeons is how to get the right liver into the right patient, according to Robert Merion, MD, from the University of Michigan, who spoke here at the American Association for the Study of Liver Diseases (AASLD) 58th Annual Meeting.
Because the donor pool is aging, the use of "expanded criteria" donor livers has become more common, Dr. Merion said. These organs come with higher risk of graft failure and death, so surgeons need to think about how to better incorporate donor risk into their thinking about how to offer the best transplantation services to patients, he added.
About 2000 patients die on the waiting list each year, Dr. Merion said, adding that "liver waiting list deaths continue to drive a use of livers that we might consider to be less than ideal."
Donors are more likely to be older than 50 years now than in the past and are more likely to have died of stroke or cardiovascular disease, Dr. Merion said. About half of all donor livers now come from patients who died from stroke, even though risk of failure is 15% higher for their organs.
Rather than ask how a patient will do with a particular organ, the question may be instead how a patient will do with that organ compared with waiting for a lower-risk organ to come available, according to Dr. Merion.
He uses a "transplant benefit" paradigm that looks at both the benefit of accepting a particular organ and the benefits — and risks — of waiting for another organ with a better donor risk index (DRI). Dr. Merion's approach takes into account that a suitable organ may not become available again to patients who turn them down.
Often, patients with low Model for End-stage Liver Disease (MELD) scores were better off waiting for another organ than accepting a high-risk organ, Dr. Merion said. MELD is a measure of mortality risk for people with liver disease that has been used to allocate organs in the United States since 2001.
"The conventional wisdom that high-risk organs are more appropriate for low-risk patients really doesn't hold up under the transplant benefit paradigm," he said.
By looking at transplant benefit, the sickest patients with the highest MELD scores were more likely to benefit from a transplant with a high-risk donor than from waiting.
"Some surgeons already consider all these factors informally," Dr. Merion said.
"In practice, when we make decisions about particular organ offer in the middle of the night, we're actually considering what the actual posttransplant benefit will be and factoring that into the equation about whether or not to accept an organ for a given patient," he said. "It's not officially a part of our algorithm, it's not an official part of our allocation system, and we mostly don't talk about it."
As researchers develop tools to both assess the risks of deceased donor liver and calculate transplant survival benefit for recipients, researchers need to use them in an "open and transparent manner," Dr. Merion said.
Transplant surgeons have spent a lot of time trying to figure out risk factors for transplant outcomes, said Douglas Hanto, MD, PhD, a member of the AASLD governing board and a transplant surgeon at Beth Israel Deaconess Medical School in Boston, Massachusetts. There has been progress, and Dr. Merion is trying to take that one step further, Dr. Hanto said.
"He's trying to identify how...we predict benefit in an individual patient knowing that patient and knowing the donor," Dr. Hanto said.
As of now, the DRI, which was developed in 2006, is not in routine use, he noted. "It is there, it's of interest, we know about it, we think about it," he said. "But, do we use it and apply to every donor? We don't really."
Dr. Merion has disclosed no relevant financial relationships.
American Association for the Study of Liver Diseases 58th Annual Meeting: Thomas E. Stasrzl Transplant Surgery State-of-the-Art Lecture. Presented November 4, 2007.
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Tumor Down-Staging for Hepatocellular Carcinoma Has Good Results
www.medscape.com
Tinker Ready
November 7, 2007 (Boston) — More than 90% of 35 hepatocellular carcinoma (HCC) patients with down-staged tumors were alive and cancer-free 4 years after liver transplantation, according to research presented here yesterday at the American Association for the Study of Liver Diseases 58th Annual Meeting.
The data were collected between June 2002 and January 2007 as a follow-up to a smaller 2005 study of down-staging HCC to meet conventional criteria for orthotopic liver transplantation, said Francis Yao, MD, from the University of California, San Francisco. Some surgeons are very wary of the approach, for fear of cancer recurrence, and Dr. Yao acknowledged that.
"The idea of expanded criteria and as well as downsizing has generated a great deal of interest, as well as some controversy, in the past few years," he said.
For more than 10 years, the Milan protocol has limited liver transplantation to HCC patients with a single lesion smaller than 5 cm or up to 3 smaller lesions, each 2 to 3 cm.
The 61 patients enrolled in the UCSF study had (1) 1 lesion larger than 5 cm but within 8 cm; (2) 2 or 3 lesions with at least one larger than 3 cm but all within 5 cm and with total tumor diameter up to 8 centimeters; or (3) 4 to 5 nodules, but none greater than 3 cm, with total tumor diameter within 8 cm.
The researchers used transarterial chemoembolization (TACE) to down-stage tumors in 15 study subjects, laparoscopic or open radiofrequency ablation (RFA) alone in 11 patients, TACE combined with percutaneous ablation in 15 patients, laparoscopic RFA plus TACE in 14 patients, and resection in 6 patients, according to the study abstract.
Down-staging was successful in 43 patients (70.5%). Each patient was observed for at least 3 months before transplantation, and 35 patients (57.4%) had received transplants. Six patients were awaiting transplantation at the time of the study. Eighteen patients (29.5%) were considered treatment failures — 3 patients died awaiting transplant and 15 dropped out due to tumor progression.
Of 3 explanted organs of the 35 transplant patients, 13 had complete tumor necrosis, 17 met T2 criteria, and 5 exceeded T2 criteria. More than 96% of patients were alive at 1 year after transplantation, and 92.% were alive after 4 years.
Alastair MacGilchrist, MD, from the Royal Infirmary of Edinburgh, Scotland, congratulated Dr. Yao on his "excellent results." He agrees the approach will continue to be controversial. "But, the patients did very well," he said.
Dr. Yao has disclosed no relevant financial relationships.
American Association for the Study of Liver Diseases 2007 Annual Meeting: Abstract 163. Presented November 6, 2007.
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Imaging May Help Diagnose Hepatic Encephalopathy
www.medscape.com
Tinker Ready
November 5, 2007 (Boston) — Near-infrared spectroscopy (NIRS) has potential as a tool for the early diagnosis of hepatic encephalopathy (HE), according to a study presented at the American Association for the Study of Liver Diseases (AASLD) 58th Annual Meeting.
Because the technique has been used to image brain function in psychiatric disorders, researchers thought it might be useful for the diagnosis of HE, said lead author Hiroyuki Nakanishi, MD, of the Musashino Red Cross Hospital, Tokyo, Japan.
Hepatic encephalopathy is a psychiatric decline that accompanies cirrhosis. Some liver disease patients have a mild or subclinical level of HE, but there is no way to diagnosis it. NIRS measures blood hemoglobin concentrations related to brain activity.
Dr. Nakanishi's multidisciplinary team, which included specialists from 3 hospitals, enrolled 45 patients with chronic liver disease and 12 healthy control patients. Sixteen patients had already been diagnosed with HE. Seven patients with chronic liver disease and abnormal electric encephalography (EEG) were defined as minimal HE.
The relative concentrations of oxyhemoglobin (oxy Hb) — the measure of brain function — were measured every 0.1 seconds while researchers conducted a word fluency task. The researchers found that the overt HE patients had smaller and slower oxy Hb increases during the task compared with the healthy patients. The average peak value of oxy Hb was 0.24 ± 0.14 in overt HE patients compared with 0.68 ± 0.41 in patients without HE (P < .001). The average peak value was small in patients with minimal or overt HE.
The increases of oxy Hb concentration were also smaller and slower during the word fluency task in 18 patients with abnormal EEG than in 31 individuals with normal EEG (P = .02). The average peak value was significantly smaller in minimal or overt HE. The patients with minimal or overt HE showed smaller increases in oxy Hb concentration than did patients without HE.
Because NIRS showed smaller increases in oxy HB in patients with minimal or overt HE, it could be used as a noninvasive, bedside diagnostic tool, said Dr. Nakanishi.
Kevin D. Mullen, MD, of Case Western Reserve University and MetroHealth Medical Center in Cleveland, Ohio, called the study "kind of neat.... HE does, in many studies, correlate with blood flow."
A lot of patients with cirrhosis have subtle changes in cognitive function, said Arun Sanyal, MD, a member of the AASLD governing board and a researcher at Virginia Commonwealth University in Richmond, so there is a need for an objective measures. At the same time, he said, the NIRS test, although not invasive, might be "cumbersome.... It's a step. It's not the step."
American Association for the Study of Liver Diseases 58th Annual Meeting: Abstract 768. Presented November 4, 2007.
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How nurse led two hepatitis patients to one doctor
http://www.newsday.com
BY RIDGELY OCHS AND MICHAEL AMON
ridgely.ochs@newsday.com
michael.amon@newsday.com
One day in December 2004, a nurse with the Nassau County Health Department noted striking similarities between two hepatitis C cases among the county's roughly 1,000 that year.
Both were patients of the same doctor.
And both had received spinal injections for back pain around the same time.
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The nurse's sharp eye triggered an ongoing epidemiological dragnet and political storm stemming from improper infection controls practiced by Plainview physician Dr. Harvey Finkelstein and the state's subsequent investigation into the case. The state Department of Health has sent letters to 628 patients, who have been told they might be at risk for hepatitis C, hepatitis B and HIV.
Finkelstein's spokesman said he had improved his infection control practices and "cooperated fully" with state health officials. Several patients, however, came forward and told Nassau health officials he had said they weren't at risk and discouraged from them getting tested, according to the state health department's case-investigation summary. He denied it.
It all began in October 2004. That month, two people who had received injections by Finkelstein were diagnosed with hepatitis C. The first person had received an epidural spinal injection on Oct. 1, 2004, by Finkelstein at an ambulatory surgical center in Melville, Long Island Surgicenter. The second patient had received two epidural spinal injections in the previous summer.
One of those two patients had gone to Finkelstein for chronic back pain. He only found out later he had hepatitis C -- after routine blood work, said his attorney Michael Glass of Hauppauge.
Adter the nurse noticed the two cases, the Nassau health department notified state health authorities on Dec. 1. "... the investigation focused more closely on this physician and his practice."
Finkelstein soon provided the state with a list of patients who had had epidural injections from June 1, 2004 to Oct. 31, 2004, to identify any previously reported cases of the virus by comparing Finkelstein's list with the state database of hepatitis C cases. Apparently the process was slowed, according to the report, because of a backlog of cases not entered into the database by Suffolk County.
Using this method, a third case of hepatitis C diagnosed in December 2004 was found. It was ultimately determined that this case -- also a patient of Finkelstein's -- did not contract hepatitis C because of lapses in the doctor's infection control practices.
In January, 2005, both county and state officials visited Finkelstein's pain management clinic in Plainview, Pain Care of Long Island. They wanted to watch him at work.
There, the report says, they observed "during two separate epidural spinal injections that the physician removed the needle from a previously used syringe (from the same patient), attached a new needle to this syringe and reused the syringe to draw up medications and dye from multidose vials. Backflow of blood was noted during the procedures."
It was this breach of proper infection control procedures that the county and state officials determined was the source of the infection.
Finkelstein was immediately notified and told not to reuse syringes to draw up medications from multiple-dose vials once they have been used on a patient. He was also told to immediately dispose of any needles and syringes right after their use.
The county and state visited the doctor again a week later to ensure he was following proper practices.
They then sent him a letter, dated Jan. 31: "The site visit on January 6, 2005, demonstrated that some of the practices at your clinic could place patients at risk for transmission of blood-borne pathogens," the letter read.
The letter detailed 11 recommendations for Finkelstein to improve his infection control. Among them:
Labeling syringes with "appropriate information."
Making sure that unused portions of medications were discarded.
Providing soap and towels for each handwashing sink.
Because of the hepatitis C cases and "observed breaches in infection control practices" by Finkelstein, the state decided to notify other patients of potential exposure to the virus and to recommend they get tested.
On May 23, 2005, 98 patients who had been treated by Finkelstein on nine dates in 2004 were sent certified letters. Of these, 84 were tested. Seven were found to have hepatitis C, the report said: the initial three cases, three known chronic cases and once newly identified case.
Meanwhile, a patient who had been told of Finkelstein's practices filed a complaint with the Office of Professional Medical Conduct, the state disciplinary board for doctors. He was cleared of any wrongdoing but agreed to be monitored for three years.
Ultimately, based on genetic testing both by the state and the Centers for Disease Control and Prevention, both the third and fourth case were determined not to have been caused by Finkelstein's infection control lapses.
Between May and July 2006, health officials debated internally about whether to expand the investigation and notify all of Finkelstein's patients for five years prior to Jan. 15, 2005, said acting Nassau County Health Commissioner Dr. Abbey Greenberg.
In a July 2006, state health department officials decided to seek out all patients who had received injections between Jan. 1, 2000, and Jan. 15, 2005. That meant they would have to go through Finkelstein's medical records to determine who had received injections, a process that took more than a year.
This week, 628 patients received letters advising them to be tested for hepatitis C, hepatitis B and HIV.
Staff writer Delthia Ricks contributed to this report.
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Patients Contract 2 Viruses in Transplants
http://www.nytimes.com
By DENISE GRADY
Four transplant recipients in Chicago have contracted H.I.V. from an organ donor, the first known cases in more than a decade in which the virus was spread by organ transplants.
The organs also gave all four patients hepatitis C, in what health officials said was the first reported instance in which the two viruses were spread simultaneously by a transplant.
Though exceedingly rare, this type of transmission highlights a known weakness in the system for checking organ donors for infection: the most commonly used tests can fail to detect viral diseases if they are performed too early in the course of the infection. Officials say the events in Chicago may lead to widespread changes in testing methods.
“There are important policy implications,” said Dr. Matthew Kuehnert, director of the Office of Blood, Organ and Other Tissue Safety at the federal Centers for Disease Control and Prevention, which is investigating the case. “Clearly, the organ transplant community is going to think about the issues raised by this, and we look forward to being involved in those discussions.”
The cases were first reported yesterday by The Chicago Tribune. Two patients were infected at the University of Chicago Medical Center, and one each at Rush University Medical Center and Northwestern Memorial Hospital. The transplants were coordinated by an organization called the Gift of Hope of Elmhurst, Ill.
Officials would not say what organs were transplanted, but a transplant expert not connected with the case said they were most likely the kidneys, liver and either the heart or lungs. Only four organs, and no other tissue, were taken from the donor.
The University of Chicago said that the operations took place in January, and that the donor was an adult who died in an Illinois hospital “three days after traumatic injury.” Neither the donor’s age nor sex were disclosed. The other hospitals declined to discuss what happened, except to confirm that each had an infected patient.
The situation came to light earlier this month when one of the recipients, who was being evaluated for a retransplant, tested positive for H.I.V. and hepatitis C. At that point, blood preserved from the donor was given a highly sensitive test for viruses, and the infection was found.
Dr. J. Michael Millis, the chief of transplantation at the University of Chicago, said the patients were devastated, and the doctors heartbroken. But Dr. Millis said the diseases were treatable.
Initially, the donor had tested negative for H.I.V. and hepatitis C, apparently because the infection was too recent to be detected by commonly used blood tests. Those tests do not find the virus itself, but instead look for the body’s reaction to the infection — the antibodies produced by the immune system. But the body takes time to react, and if the test is done too soon, within 22 days of H.I.V. infection or 82 days for hepatitis C, antibodies may not yet be detectable.
Doctors say that is what probably occurred in Chicago. It has always been known that this kind of transmission was theoretically possible, but it was considered highly unlikely. And indeed, since 1994 nearly 300,000 transplants from cadavers have occurred without any reported cases of H.I.V. transmission.
Another more sensitive type of test can pick up viral infections earlier, but was not used. That test looks for evidence of the virus itself, and can reduce the “window,” the early period in which the test does not work, to 12 days for H.I.V. and 25 days for hepatitis C.
That test, the nucleic acid amplification test, or Naat, is not widely available, and doctors said it was more difficult and time-consuming than other tests — and there is usually no time to spare with transplants because organs deteriorate quickly when the donor dies. Another concern is that the test is more likely than others to give false-positive results, and lead to the needless destruction of healthy organs, a scarce resource.
Dr. Robert Brown, director of the liver transplant program at NewYork-Presbyterian/Columbia said, “There is always a drive toward better testing, but if it leads to more organ wastage, we’ll probably hurt more people than we help.”
According to the University of Chicago, the organ donor in Illinois was known to be “high risk,” based on a risk factor revealed by a close friend who provided “a health and social history.” The exact nature of the risk was not disclosed. Federal guidelines recommend against transplanting organs from high-risk people unless the recipients are so likely to die for want of a transplant that H.I.V. seems a lesser threat.
Dr. Millis said that he did not know whether the patients there had been informed of the donor’s status.
About 9 percent of organ donors qualify as high-risk based on behaviors like prostitution or drug use with needle-sharing. Transplant experts say the percentage would probably be higher if they had full information on all donors.
Dr. Brown said Columbia got offers of organs from high-risk donors every week.
He also said that at Columbia, patients (or family members) were informed if a donor was high risk, and were required to sign a special consent form acknowledging it.
Dr. Millis said that although the organ supply was generally safe, he hoped it could be made safer, probably by developing regional centers around the country to perform Naat testing reliably and quickly enough to meet transplant needs.
Although it is rare, other diseases like rabies, West Nile fever and a rodent virus called LCMV have also been spread by organ transplants. In all of those cases, patients died.
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November 15th, 2007
PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy
http://www.examiner.com
KENILWORTH, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission on October 30 approved 48-week standard-dose PEGINTRON(TM) (peginterferon alfa- 2b, 1.5 mcg/kg once weekly) and REBETOL(R) (ribavirin, 800 - 1,400 mg daily) combination therapy for retreating adult patients with chronic hepatitis C whose prior treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy did not result in a sustained response. PEGINTRON and REBETOL is the first and only pegylated interferon combination therapy approved in the European Union (EU) for retreating both hepatitis C relapsers and nonresponders.
The European Commission approval of this expanded indication for PEGINTRON and REBETOL results in Marketing Authorization with unified labeling that is valid in the current EU 27 member states as well as in Iceland and Norway.
"This approval is an option for the large number of hepatitis C patients who failed prior therapy because it gives them a second chance at success," said Nadine Piorkowsky, president of the European Liver Patient Association (ELPA). "These patients want to eradicate the virus and now can determine after 12 weeks of retreatment with PEGINTRON combination therapy whether they are likely to go on to achieve a sustained response with a 48-week course of therapy."
The approval is based on results from an ongoing non-comparative clinical study (EPIC3)(1) in which 1,336 patients with moderate to severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin therapy were retreated with PEGINTRON combination therapy. In this study, virological response at week 12 of treatment was shown to be an important predictor for achieving a sustained virological response (SVR), with 57 percent of patients who had undetectable virus (HCV- RNA) at week 12 going on to achieve SVR with a 48-week course of therapy. Within this subgroup, the SVR rates were 59 percent and 47 percent for patients who failed prior therapy with non-pegylated or pegylated interferon, respectively.
Approximately 37 percent of patients in the study overall had undetectable virus at week 12. Importantly, patients who achieved a significant reduction in virus (greater than 2 log decrease) but did not have undetectable virus at week 12, had little chance of achieving SVR (6 percent). Overall, 23 percent of patients in the study achieved SVR, including 16 percent of patients who failed prior peginterferon and ribavirin combination therapy. SVR is defined as undetectable HCV-RNA at 24 weeks post-treatment.
"Based on a patient's treatment history, these PEGINTRON data allow physicians to identify which patients in this hard-to-treat population are right for retreatment and are most likely to achieve a sustained response," said Thierry Poynard, M.D., professor of medicine, University of Paris VI, Hopital Pitie-Salpetriere, Paris, and a lead investigator of the EPIC study. "The predictability of response with PEGINTRON means patients with undetectable virus at week 12 have an even chance of success regardless of whether they failed previous therapy with pegylated or non-pegylated interferon and can be motivated to continue treatment, and those patients who fail to achieve an early response can have their therapy stopped with confidence."
In the study, failure to prior therapy was defined as relapse or nonresponse to one or more courses of interferon alpha plus ribavirin combination therapy (HCV-RNA positive at the end of a minimum of 12 weeks of treatment). Patients who were HCV-RNA negative at treatment week 12 continued treatment for a total of 48 weeks and were followed for 24 weeks post- treatment.
Based on results from the EPIC3 study, the recommended duration of dosing with PEGINTRON combination therapy for retreating patients who failed previous therapy and who have undetectable virus at week 12 is 48 weeks, regardless of HCV genotype.
PEGINTRON in the European Union
PEGINTRON and REBETOL combination therapy was previously approved in the EU for treating chronic hepatitis C in naïve (previously untreated) adult patients, including naïve patients with clinically stable HIV coinfection. The recommended dose in the EU for combination therapy is PEGINTRON 1.5 mcg/kg once weekly plus REBETOL 800-1,400 mg daily, adjusted to body weight. The recommended duration of treatment is 24 weeks for naïve patients with HCV genotype 1 with low viral load and rapid virologic response (RVR) or HCV genotype 2 or 3. The recommended duration of treatment is 48 weeks for naïve patients with HCV genotype 1 and high viral load or low viral load without RVR, HCV genotype 4 or HIV coinfection regardless of HCV genotype. PEGINTRON had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C.
Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including 5 million in Europe. It is a leading cause of chronic liver disease and one of the most common reasons for liver transplant in Europe.
PEGINTRON in the United States
In the United States, PEGINTRON is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age. PEGINTRON is not indicated in the United States for retreatment of patients who failed previous interferon therapy.
Reference:
(1) EPIC3 (Evaluation of PEGINTRON in Control of Hepatitis C Cirrhosis) is a large multicenter global clinical study evaluating the benefits of PEGINTRON in the fibrotic and cirrhotic patient at approximately 140 sites worldwide.
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Dermatologist's patients advised to get Hepatitis and HIV test
http://www.wzzm13.com
Phil Dawson
GRAND RAPIDS – The Kent County Health Department is issuing a large scale advisory following a doctor's alleged faulty medical practices.
Investigators say Dr. Robert Stokes may have exposed 5,000 patients to hepatitis B, hepatitis C, and even HIV after reusing syringes and other medical equipment over the past 13 years.
The dermatologist practiced in Grand Rapids and Greenville. Health officials are urging all former patients of Dr. Stokes who had a surgical procedure to have a blood test.
Former patient Edsel Allen of Stanton says he will follow that advice.
"I guess I'm going to call my family doctor and have him give me a blood test for Hepatitis," says Allen
Investigators say the East Grand Rapids dermatologist may have reused scalpels, gloves, needles and sutures intended for single use and without proper sterilization.
"Traditional sterilization methods stopped approximately 13 years ago," says Cathy Raevsky of the Kent County Health Department.
Dr. Stokes agreed to stop practicing medicine this spring when he was convicted of billing insurance companies for up to a million dollars worth of procedures he didn't perform. He faces up to 10 years in prison.
"I think he ought to get the maximum," says Allen. "The main thing I am concerned with is getting him off from hurting people.
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Mike Ray continues recuperation since long-awaited liver transplant
http://www.mexiadailynews.com/
Mike Ray was diagnosed with Hep C in 1997.He was initially treated in 1997 with interferon 3xs a week for 18 months. He did not respond. He then was treated a second time in 2001, for 6 months and again did not respond.
Subsequently, Mike developed hepatitis C cirrhosis and COPD. He was placed on the Liver Transplant List in June 2, 2005. Prior to his surgery, he had been hospitalized twice for esophageal varices bleeding - once in April of 2006 and once in January of 2007. He was hospitalized in July 2007 for bleeding from a Dieulafoy’s lesion and most recently in September and October for hepatic encephalopathy.
Ray just last week finally got the word that a match had been made, and got his liver transplant at Baylor Hospital in Dallas. The Daily News first reported on the transplant on Page 1 of Saturday’s edition. The surgery began at 3 p.m. and ended that night at 10:30.
His wife Mary Ann has been with him throughout the ordeal.
Mike held the low hurdles’ record in New Mexico from 1961 until 1996, and played football for the University of Arizona. He attended Aztec High School in New Mexico, and was named a National High School American for his athletic prowess. He is an avid water skier, instructor fisherman and boater and was with Northland Cable for several years. He has worked in the cable television business from 1982 until 1998, having worked in New Mexico, Texas, Louisiana, and in Seoul, South Korea.
Ray is a Founding Director for of the Texas Cable TV Association, is a recipient of the Paul Harris Fellow in the Rotary Foundation and has served as President of the Mexia Area Chamber of Commerce. He served on the Administrative Board of First United Methodist Church where he also has been an usher, and coached T-ball and basketball.
When you are placed on the waiting list, you receive a status code that reflects your medical condition (this status code changes as your medical condition changes). Donated organs go to candidates based on the Mayo Endstage Liver Disease (MELD) scoring system under the direction of the United Network for Organ Sharing (UNOS). The MELD scoring system takes into account your medical criteria, suitability and your condition. Other factors include your size and blood type.
Liver transplantation is needed for patients who are likely to die because of liver failure. Many diseases can cause liver failure. The most common is cirrhosis, which is the scarring and death of liver cells. Cirrhosis caused by hepatitis C is the most common reason for liver transplants, and Mike Ray fit into these categories.
In 2006, there were 28,930 organ transplants, and every 11 minutes, a name is added to the national transplant waiting list.
More than 97,014 people currently await transplants.
An average of 18 people die each day while waiting for organs. Mike Ray is one of the lucky ones, thanks to availability of his “new” liver - and in no small part, care from his family, and thousands of prayes by family and Mike Ray’s many friends.
The surgery was reported as a success, and apparently the liver was a successful match.
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November 16th, 2007
L.A. Officials Plan Hepatitis Coordinator Position
http://cbs2.com/
(CBS) LOS ANGELES The Los Angeles County Department of Public Health announced Friday the creation of the country's first-ever Hepatitis Coordinator position.
Officials planned to discuss the position Friday at the daylong Fifth Annual Hepatitis C Summit being held at the California Endowment Center in downtown Los Angeles.
The summit is designed to focus attention on the Hepatitis C epidemic, which affects an estimated 180,000 people nationwide, 30 percent of whom are also infected with HIV.
"Hepatitis C is a major global health issue -- a 'viral time time bomb,"' said Dr. Robert Kim-Farley, director of Communicable Disease Control and Prevention in the county's Public Health Department.
"With the additional resource of a coordinator, we will be able to expand and enhance our current activities," he said.
L.A.'s Public Health Department says there are more people living in the county who are infected with Hepatitis C than with HIV and that sharing syringes and men having unprotected sex with other men are broadening the scope of the epidemic.
"The new Coordinator's position is essential to addressing the needs of those with Hepatitis C and stopping the spread of the blood-borne illness," said Brian Risley, co-chair, Hepatitis C Task Force for L.A. County.
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Study: Gene mutations block hepatitis C therapy
http://www.asahi.com
Isao Tanabe
The Asahi Shimbun
Certain gene mutations in the hepatitis C virus negate a therapy combining interferon and an antiviral drug, a finding that could spare many patients from expensive, but fruitless, treatment, researchers said.
The group of researchers at Toranomon Hospital said an examination of the genes of a patient's virus should be conducted beforehand to determine if the treatment will be effective.
Patients found with those particular viral gene mutations could then be advised not to undergo the combination therapy, which usually takes at least one year and has possible side-effects, according to the group.
The group is led by Norio Akuta of the Tokyo-based hospital's Department of Hepatology and Hiromitsu Kumada, chief of its branch hospital in Kawasaki.
The research results were reported in an international journal on hepatology.
According to the group, mutations at two specific gene sequences were found to have blocked the therapy's effects.
About 15 percent of Japanese hepatitis C patients are believed to have the virus with those mutations, the researchers said.
There are several subtypes of the hepatitis C virus divided over gene differences.
About 70 percent of Japanese hepatitis C patients have subtype 1b, which is known to be often resistant to interferon treatment to eliminate the virus from the body.
But a standard treatment that combines interferon with the antiviral drug ribavirin is effective for more than half of patients with the subtype 1b virus.
In the study, the researchers examined differences in gene sequences among patients and found that the combination treatment was not effective for those with mutations at two particular sequences in their 1b virus.
They also found that the combination therapy did not work well for women in their 50s or older.
Currently, the combination therapy has to be administered for one year to see if it is effective for the patient.
Interferon treatment is costly, requiring patients to pay 700,000 to 800,000 yen a year, even with health insurance coverage.
The ruling coalition and the opposition parties are separately proposing plans to subsidize the treatment to reduce the financial burden on hepatitis patients.
The move is gaining momentum as the government seeks a court-mediated settlement in a damages suit filed by patients who were infected through tainted blood products.(IHT/Asahi: November 16,2007)
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