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HCV ADVOCATE WEEKLY NEWS REVIEW: A Review of HCV, HBV and HIV/HCV Coinfection Related News and Highlights

Week Ending: July 10^th, 2004

Alan Franciscus
Editor-in-Chief

In This Issue:

• Hepatitis C Trials to begin in January
• Killer Virus Hits Past Drug Users
• Chinese Herbs Hold Little Benefit for Hepatitis C
• Inquiry Confirms Medicare Chief Threatened Actuary
• Ligation Versus Propranolol for the Primary Prophylaxis of Variceal Bleeding in Cirrhosis
• Selective Digestive Decontamination Reduces Infection in Liver Transplant Patients
• Hemispherx Biopharma Initiates HIV/HEP-C Clinical Program; Clinical Trial with Ampligen in Collaboration with Esteve Laboratorios Targets HIV/HEP-C Twin Epidemics
• Hepatitis C Victims Want to Know What Happened to $300-Million Fund for Care
• Differences Exist in the Use of Orthotopic Liver Transplantation among Black and White Patients
• Thyroid Disorders Common with Hepatitis C
• Disease-Specific Analysis of Survival after Liver Transplant in the United States
• First Reported Cases of Rabies Transmission through Solid Organ Transplantation
• Prevalence and Predictors of Herbal Medication Use in Veterans with Chronic Hepatitis C
• HIV High Among IV Drug Users in Uruguay
• McGuinty Government Commits to Hepatitis C Federal Funding
• Hepatitis C Help Pledged: Ontario Vows to Act ‘Quickly’ on Compensation



July 2nd, 2004

Hepatitis C Trials to Begin in January

A schedule has been set for the first three cases to be tried in the Fremont hepatitis C outbreak.

Eleanor Daehnke's case will be the first to be tried, said her attorney, Larry Johnson. The trial is set to begin Jan. 10.

The trial in Scot Schlecht's case is scheduled to begin Feb. 21, Johnson said. The trial in Terry J. Gentry's case will begin April 18.

Gentry's wife, Cheryl, died in March of 2003 from liver complications after contracting hepatitis C at the Fremont cancer clinic.

The trial schedule was announced earlier this week by District Court Judge John Samson.

Nebraska health officials have linked 99 cases of hepatitis C - believed to be the largest outbreak of its kind in the United States - to poor infection control practices at Dr. Tahir Javed's former cancer clinic in Fremont.

In April, it was decided the trials for the first cases would be moved to the old Fremont Middle School on Broad Street. The lunchroom is being made into a courtroom because of limited space at the Dodge County Courthouse.

-Kamahria Hopkins

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July 4th, 2004


Killer Virus Hits Past Drug Users
Jo Revill, health editor
The Observer

Thousands of middle-aged professionals who experimented with drugs during their student days will be warned in a major government health campaign this autumn that they may be infected with hepatitis C. It is thought that up to 400,000 British people may be carrying the potentially fatal virus without knowing it, because there is such a long delay between infection and symptoms appearing.

Ministers have decided to go ahead with a national public awareness campaign in September, warning that anyone who has ever injected drugs, particularly sharing a needle, used straws to sniff cocaine or had a blood transfusion before 1991, is at risk and should consider having a blood test. However, they are worried about causing mass panic and want to adopt a 'softly-softly' approach by focusing on the treatment available for the disease, rather than its potential consequences.

The co-ordinators are hoping to find a celebrity who has been infected with the virus to spearhead the campaign, but so far those approached have declined publicity, such is the embarrassment associated with the condition. The general public view about hepatitis C is that only hardened drug addicts are at risk, but increasingly doctors are seeing patients who have been infected after just one or two injections.

The virus is passed on through blood-to-blood contact, and those at risk also include people who had a blood transfusion before blood screening was brought in 13 years ago. Sexual transmission, tattooing and piercing are the other possible methods of transmission.

At present only 2,000 people a year are treated for hepatitis C on the NHS, but estimates of the numbers infected in the UK vary from around 0.4 per cent of the population, some 240,000, to 1 per cent, some 600,000.

It is potentially fatal, but effective new antiviral drugs can cure between 50 to 80 per cent of sufferers who have a chronic form of the disease. Of those who carry hepatitis C, about 80 per cent go on to develop a chronic infection in the liver, and about one-fifth of these will develop serious liver disease.

However, many people do not know they are carriers until they have serious symptoms such as severe liver pain. Many of those at risk will be people who experimented with drugs in their youth. Charles Gore, chief executive of the Hepatitis C Trust, said: 'How do you reach the man on the street, who might have had a blood transfusion 20 years ago, or who might have injected drugs in his youth and warn him that he could be wandering around with this virus?'

People can have the disease for 20 years or more before they develop symptoms, which means those who experimented at college might not realise the risks.

'Typically, it might be someone who didn't know how to inject drugs into the vein and who borrowed a syringe from someone who was more experienced. The virus can then be passed directly into the bloodstream.'

Gore added: 'Between 1975 and 1985, in particular, there was a huge experimentation with drugs. It was before the Aids crisis, no one was aware of the dangers of blood-borne viruses, and many more were injecting than was commonly supposed.'

Gore, who backs the government's efforts, says that Britain is far behind other European countries in identifying patients. 'It is hard to get people to admit that they might be at risk. It involves them owning up to their past.'

The chair of the Department of Health's advisory group on hepatitis, Professor Howard Thomas, re-iterated the warning that patients don't have to be drug addicts to be at risk. 'Many of those infected will be people in influential positions who dabbled with drugs years ago while at college,' he told the Health Service Journal last week. While admitting there is more to be done in making GPs aware of the disease, he said that they have now taken the first steps in setting up a national system of clinical centres for hepatology, or liver disease.

The first signs of the disease are not easy to spot. They commonly include fatigue and aching joints, which are fairly usual for people in their middle age. Patients also experience differing degrees of pain. Some have a mild form of the virus and are in acute pain, others have serious liver damage before they realise anything is wrong.

Ministers, highly aware of how the HIV campaign in the Eighties scared a generation of people, want to take a more 'softly-softly' approach. They started last week by sending out an action plan to all GPs and health professionals.

A spokeswoman for the Department of Health would say little about the campaign, other than to state that an outside consultancy firm had been brought in to work on strategy. 'We will have a public awareness campaign, but in order not to get people panicked, you have to do it in stages, so the first stage is to make the professionals aware of the potential problems.'

For more information, call the Hepatitis C Trust's helpline on 0870 200 1200.

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July 5th, 2004


Chinese Herbs Hold Little Benefit for Hepatitis C
Alison McCook
Source: Reutershealth

NEW YORK (Reuters Health) - A Chinese herbal treatment often used to treat hepatitis in Asia does not appear to reduce liver inflammation or improve quality of life in people with hepatitis C, new research reports.

Moreover, after 3 months of treatment, herb-takers who participated in the study did not show any change in the amount of virus in their bodies.

“Unfortunately, our results suggested that the herbal compound was no different than placebo,” study author Dr. Jeffrey H. Albrecht told Reuters Health.

“At this point in time, I am aware of no conclusive data that these herbs provide any meaningful benefit in” hepatitis C, added the researcher, who is based at the University of Minnesota in Minneapolis.

Albrecht noted that the Chinese herbs may have been ineffective either because they simply do not work, or because he and his colleagues used an incorrect dose or combination of herbal agents.

“I think that the long tradition of herbal treatments for viral hepatitis in China and Japan suggest that there may indeed be useful agents that should be tested,” he said.

Hepatitis C is a liver disease caused by infection with the hepatitis C virus (HCV), which is spread through contact in some way with contaminated blood. In many patients, the virus is never completely cleared from the body and, after years of infection, serious liver problems, such as scarring and cancer, can occur.

The recommended treatment for HCV—interferon injections and orally administered ribavirin - is effective in, at most, 60 percent of patients. It also has potentially severe side effects such as nausea, fatigue, depression and, in some cases, suicidal impulses.

As a result, many HCV patients either fail to clear the virus from their bodies or cannot tolerate the treatment.

In the current study, Albrecht and his team investigated whether 12 weeks of treatment with either a combination of 10 Chinese herbs often used to treat hepatitis in Asia or a placebo drug helped 45 HCV patients.

The researcher explained that even though no research supports the use of Chinese herbs in HCV, the treatment likely remains popular due to “positive publicity” from the alternative health industry, which leads people to believe these treatments work.

Alternative medicine is also largely unregulated, Albrecht noted, which makes it easy for people to obtain treatments without the added step of going through a healthcare provider. And many HCV patients are willing to try whatever treatments they can get their hands on, he noted.

“In the case of HCV, many patients can’t be successfully treated with pharmaceuticals, and are willing to try unconventional approaches out of desperation,” Albrecht said.

He added that the preparation and dosage of the herbs used in the current study were likely safe, but other herbal treatments have been linked to liver problems.

SOURCE: Archives of Internal Medicine, June 28, 2004.

July 6th, 2004


Inquiry Confirms Medicare Chief Threatened Actuary
Robert Pear
Source: NY Times

WASHINGTON, --- An internal investigation by the Department of Health and Human Services confirms that the top Medicare official threatened to fire the program’s chief actuary if he told Congress that drug benefits would probably cost much more than the White House acknowledged. A report on the investigation, issued Tuesday, says the administrator of Medicare, Thomas A. Scully, issued the threat to Richard S. Foster while lawmakers were considering huge changes in the program last year. As a result, Mr. Foster’s cost estimate did not become known until after the legislation was enacted.

But neither the threat nor the withholding of information violated any criminal law, the report said. It accepted the Justice Department’s view that Mr. Scully had “the final authority to determine the flow of information to Congress.” Moreover, it said, the actuary “had no authority to disclose information independently to Congress.”

Mr. Scully, who resigned in December, in part to become a lobbyist for health care companies, had denied threatening Mr. Foster but had acknowledged having told him to withhold the information from Congress.

The report, by Dara Corrigan, the department’s acting principal deputy inspector general, said, “Our investigation revealed that the Centers for Medicare and Medicaid Services did not provide information requested by Congressional members and staff, and that Scully threatened to sanction Foster if he disclosed unauthorized information.”

The report said that if Mr. Scully still worked for the government, he might be subject to disciplinary action for possible violation of the department’s standards of ethical conduct.

But Ms. Corrigan discovered “no criminal violations,” though she sent her findings to the General Accounting Office, a Congressional investigative arm, to determine if Medicare officials had violated an appropriations law that protects the right of federal employees to communicate with Congress. In May, the Congressional Research Service said Mr. Scully’s order to Mr. Foster apparently violated that law, which has been on the books in various forms since 1912.

William A. Pierce, a spokesman for the department, said Tuesday that the threat was not illegal because the actuary was supposed to report to the head of the Medicare program, who, Mr. Pierce said, had a right to dismiss him in case of insubordination. “No laws were broken,” Mr. Pierce said.

But Representative Pete Stark of California, the senior Democrat on the House Ways and Means Subcommittee on Health, said, “It sounds as though the Bush administration examined itself and found it did nothing wrong.”

The senior Democrat on the Senate Finance Committee, Max Baucus of Montana, said that given a limited scope of the investigation, “we cannot know about the involvement or knowledge of White House officials” in the suppression of information.

When President Bush signed the Medicare bill on Dec. 8, he hailed it as “the greatest advance in health care coverage for America’s seniors since the founding of Medicare” in 1965. Republicans were counting on the measure to help them win votes from the elderly in this year’s elections. But Democrats, including Senator John Kerry, the party’s expected presidential nominee, have waged a campaign to discredit the law, which they say is more helpful to drug companies and insurers than to elderly and disabled people.

The internal investigation was ordered by Tommy G. Thompson, the secretary of health and human services, on March 16, four days after House Democrats requested such an inquiry, and nearly four months after Congress approved the Medicare overhaul.

In recent weeks, Mr. Scully has registered as a lobbyist for major drug companies, including Abbott Laboratories and Aventis; for Caremark Rx, a pharmacy benefit manager; and for the American Chiropractic Association and the American College of Gastroenterology, among other clients. All are affected by the new Medicare law, which Mr. Scully helped write.

Mr. Scully did not reply to messages left Tuesday at his office and his home and on his cellphone. In an interview in March, he acknowledged disagreements with Mr. Foster but said, “I never told Rick he would be fired.”

Mr. Foster had estimated that the Medicare legislation would cost $500 billion to $600 billion over 10 years. The White House told Congress the cost would not exceed $400 billion.

Ms. Corrigan said she had uncovered numerous requests from Congress for data and cost estimates prepared by the Bush administration. In many cases, she said, Mr. Scully did not recall the requests.

“On June 17 and Nov. 7, 2003,” the report said, “the minority staff director for the House Ways and Means Subcommittee on Health made written requests to Foster for estimates of the total cost of the Medicare bill. Scully did not recall the staff director’s requests.”

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Variceal banding ligation and propranolol are similarly effective for primary prophylaxis of variceal bleeding, finds a study of 152 cirrhotic patients.

Writing in the July issue of the journal Hepatology, researchers from Germany compared endoscopic variceal banding ligation (VBL) with propranolol (PPL) for primary prophylaxis of variceal bleeding.

They compared the two methods of intervention in a randomized controlled multicenter trial, using 152 cirrhotic patients with two or more esophageal varices of diameter greater than 5 mm, who had no prior bleeding.

The patients were randomized to VBL (n = 75) or PPL (n = 77), with the groups well matched with respect to baseline characteristics (age 56 ± 10 years, alcoholic etiology 51%, Child-Pugh score 7.2 ± 1.8).

The mean follow-up was 34 ± 19 months and data were analyzed on an intention-to-treat basis.

Neither bleeding incidence nor mortality differed to any extent between the two groups, with variceal bleeding occurring in 25% of the VBL group and 29% of the PPL group.

After 2 years, the actuarial risks of bleeding were 20% (VBL) and 18% (PPL).

Fatal bleeding was observed in 12% (VBL) and 10% (PPL) of patients and was associated with the ligation procedure in 2 patients (2.6%).

Overall mortality was 45% (VBL) and 43% (PPL) with the 2-year actuarial risks being 28% (VBL) and 22% (PPL).

A total of 25% of patients had to withdraw from PPL treatment, with 16% withdrawing due to side effects.

The authors conclude that VBL and PPL were similarly effective for primary prophylaxis of variceal bleeding, and that VBL should be offered to those patients who cannot tolerate long-term PPL treatment.

Hepatology 2004; 40(1): 65 – 72

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Selective Digestive Decontamination Reduces Infection in Liver Transplant Patients
Source: www.gastrohep.com

The use of selective digestive decontamination to reduce gram-negative infections in patients undergoing liver transplantation is of benefit, suggests a report in the latest issue of the journal Liver Transplantation.

The use of antimicrobials to reduce levels of aerobic gram-negative bacteria and/or yeast in the intestinal tract and thus prevent infections caused by these organisms is known as selective digestive decontamination (SDD).

SDD has been proposed as a tool for preventing infection in liver transplant patients, who are at high risk of bacterial infection within the first month after transplantation. Such patients are particularly susceptible to gram-negative bacteria, hence the suggestion that SDD may be of particular value in such cases.

However, the true value of SDD has remained controversial. Therefore, Nasia Safdar and colleagues from the University of Wisconsin Medical School, USA, conducted a systematic review and meta-analysis to determine whether SDD is beneficial in patients following liver transplantation.

The researchers examined all studies that evaluated the efficacy of SDD in liver transplant patients, as well as including randomized trials that included liver transplant patients given SDD versus either placebo or no treatment or minimal treatment (e.g. oral nystatin alone) and that provided adequate data to calculate a relative risk ratio.

The researchers found most studies showed SDD to be effective in reducing gram-negative infection.

“The risk of antimicrobial resistance must be considered.” Nasia Safdar, Liver Transplantation.

They also found the non-randomized and uncontrolled trials showed benefit with SDD in reducing overall infection.

However, the effect on overall infection was limited in the 4 randomized trials evaluated; the pooled relative risk was 0.88, indicating no statistically significant reduction in infection with the use of SDD.

The summary risk ratio for the association between SDD and gram-negative infection was 0.16, indicating an 84% relative risk reduction in the incidence of infection caused by gram-negative bacteria in patients receiving SDD in randomized trials.

The authors conclude that the available literature supports a beneficial effect of SDD on gram-negative infection following liver transplantation.

They caution however, that the risk of antimicrobial resistance must be considered and add, “ Larger multicenter randomized trials in this patient population to assess the effect of SDD in reducing infection and mortality, while assessing the risk of antimicrobial resistance, are needed.”

Liver Transpl 2004; 10(7): 817 – 827

In March 2002, Hemispherx S.A., a subsidiary of Hemispherx Biopharma, entered into a Sales and Distribution Agreement with Esteve. Pursuant to the terms of the Agreement, Esteve was granted the exclusive right to market Ampligen® in Spain, Portugal and Andorra for the treatment of Chronic Fatigue Syndrome (CFS). In addition to other terms and other projected payments, Esteve agreed to conduct, at its expense, certain clinical trials using Ampligen® in the patient population coinfected with Hepatitis C and HIV viruses. At present, no single drug or biological product has been deemed by internationally recognized regulatory agencies as effective against both viruses, when coexisting in the same patients.

About HIV/Hep-C Coinfection
About 40% of people living with HIV are coinfected with HCV, with disproportional high coinfection rates among intravenous drug users. Both HIV and HCV are chronic viral illnesses, and there are similarities in the mechanisms of viral reproduction (also known as replication) and acute infection. Both HIV and HCV replicate in the body at an incredibly fast rate. Data gathered from 4,000 HIV-infected individuals indicates that liver failure due to HCV is the leading non-AIDS cause of death in people with HIV. Additionally, studies have shown that HIV worsens HCV infection. Individuals coinfected with HIV and HCV are about twenty times as likely to experience liver failure as individuals infected with HCV alone. Just as HIV mutates, resulting in drug-resistant strains, HCV can also mutate. If HCV is under pressure from medications that block replication, it will mutate at increased rates.

About Esteve Laboratorios
Laboratorios del Dr. Esteve, founded in 1929, is privately owned and dedicated to the manufacture of a broad range of active pharmaceutical ingredients and pharmaceutical specialties. Esteve has successfully expanded its commercial activities into more than 100 countries around the world and has manufacturing plants in Europe, America and Asia. The company has a workforce of 2,400 employees and had year 2003 sales of 844 Million Euro. For more information please visit www.esteve.es.

About Hemispherx
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Its flagship products include Alferon N® and the experimental immunotherapeutics/antivirals Ampligen® and Oragens™. These novel proteins, approved for a category of STD infection, and experimental nucleic acids are being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis. Its platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has approximately 270 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N®) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net.

Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the company (including Ampligen® and Oragens™) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Only Clinical Studies under well-controlled conditions can establish efficacy and safety of any product. Clinical trials for other potential indications of the approved biologic Alferon® do not imply that the product will ever be specifically approved commercially for these other treatment indication.

CONTACT:Hemispherx Biopharma, Inc. Dianne Will, 518-398-6222
ir@hemispherx.net
or CEOcast Kevin Theiss, 212-732-4300
ktheiss@ceocast.com

www.hemispherx.net

SOURCE: Hemispherx Biopharma, Inc.

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Hepatitis C Victims Want to Know What Happened to $300-Million Fund for Care
Dennis Bueckert
Source: Canadian Press

OTTAWA (CP) - Vikki Boddy, who was infected with hepatitis C through a blood transfusion in 1984, has declared bankruptcy twice because of expenses arising from her disease. She hopes she won’t have to do it again.

“I hope to God I’m dead before I do it a third time,” said Boddy of Lethbridge, Alta., in an interview Wednesday.

Boddy is one of hundreds of hepatitis C victims who want to know what happened to a $300-million fund that former health minister Allan Rock announced in 1998 to cover their medical expenses.

The “care instead of cash” program, as it’s known, was aimed at victims excluded from cash compensation because their infection with the virus occurred outside the 1986-1990 period for which Ottawa admitted liability.

Rock told the Commons at the time the money would be given to the provinces to make certain “anyone who got hepatitis C through the blood system will have access to the needed medical services and drugs for treatment and care without paying out of their own pockets.”

Health Canada spokeswoman Paige Raymond Kovach said this week that about half of the fund, $150 million, has so far been transferred to the provinces and the rest will be disbursed in coming years.

Yet when Boddy sent Alberta Health Minister Gary Mar a bill for $53,000 to cover drug treatment and other costs last year, she was told the “care instead of cash program” was not intended for that purpose.

That has been the standard response for all victims who have tried to tap the fund, say victims’ representatives.

“We have no recorded case in the country where a patient has received out-of-pocket expenses (from the fund),” said John Plater, vice-president of the Canadian Hemophilia Society.

Toronto lawyer David Harvey, who represents many of the victims, has asked Auditor General Sheila Fraser for an audit to determine what happened to the money.

“I am unaware of any enhanced access to medications or services that have been provided to this group as a result of the $300-million transfer,” said Harvey in a recent letter to Fraser.

“In fact I have been contacted numerous times by people unable to afford medications necessary to treat their illness.”

Raymond Kovach of Health Canada said the federal agreement with the provinces requires them to report on their use of the money within five years. The five-year deadline hasn’t been reached so Health Canada has no accounting yet.

The agreement specifies that the money was to be used for services such as drug therapy, “such that there will be reasonable access to them by persons infected . . . before Jan. 1 1986 and after July 1, 1990.”

Victims have been trying in vain to get information from health ministers about the fund.

The only detailed reply has come from Mar, who wrote that the money was being used to enhance services for all hepatitis C victims in Alberta, not just those infected through tainted blood.

“Alberta signed the agreement on the condition that funding would be used for health services of benefit to medically eligible persons . . . regardless of the source of their infection,” said Mar in his letter to Harvey.

But Raymond Kovach of Health Canada said she knew of no such condition. The spirit of the agreement was to help victims infected before 1986 or after 1990, she said.

The confusion is likely to fuel debate about provincial accountability for the use of federal funds in the health area.

Hepatitis C activist Mike McCarthy said the “care instead of cash” deal has been a fiasco, and called on Ottawa to provide cash compensation to all victims of hepatitis C, regardless of when infected.

Prime Minister Paul Martin said during the election campaign he was willing to reconsider the issue.

http://www.canada.com/health/story.html?id
=4A0E74A9-A294-4FE5-832D-7D0C2EFE9AD8


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July 7th, 2004


Differences Exist in the Use of Orthotopic Liver Transplantation Among Black and White Patients
Source: www.gastrohep.com

Black patients are more likely to die or become too ill to proceed while waiting for orthotopic liver transplantation than their white counterparts, suggests a study in the July issue of Liver Transplantation.

Writing as a rapid communication in the latest issue of the journal, researchers from the Massachusetts General Hospital and the Harvard Medical School, USA, have investigated whether there are disparities among black and white patients in the use of orthotopic liver transplantation.

Orthotopic liver transplantation (OLT) is considered the best treatment for end-stage liver disease, but limited data is available as to the access of ethnic minorities to OLT.

Time to OLT among recipients did not differ by race

Andrea E. Reid and colleagues collected data from the United Network for Organ Sharing, on black and white patients between the ages of 18 and 70 who were on OLT waiting lists (n = 29,013).

They also gathered information from the same source on patients who were OLT recipients between 1994 and 1998 (n = 15,805).

Standardized transplant ratios were generated by comparing the racial distribution of OLT patients with the US population and demographic and clinical characteristics of OLT registrants were compared by race.

The researchers then performed multivariate analyses to identify predictors of time to OLT, as well as the likelihood of dying or receiving OLT within 4 years, while controlling for severity of illness and other factors.

Following this, the standardized transplant ration for black OLT recipients (0.65) was found to be significantly lower than the same ration for white OLT recipients (1.05).

Black patients were also younger and sicker than white patients.

However, after adjustment for severity and other factors, time to OLT among recipients did not differ by race.

Despite this, black patients were more likely to die or become too ill for OLT while waiting, and were less likely to receive OLT within 4 years.

Commenting on the results of the study, Dr Reid and her colleagues said, “ Adult blacks were under-represented among OLT patients. Although waiting times were similar once listed, black race affected outcomes while awaiting OLT.”

They concluded, “The process of referral and evaluation for OLT should be investigated further.”

Liver Transpl 2004; 10(7): 834 - 841

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July 8th, 2004


Thyroid Disorders Common with Hepatitis C
Will Boggs, MD
Source: Reuters Health

NEW YORK--- People chronically infected with hepatitis C virus (HCV) have a significantly increased rate of thyroid abnormalities, according to a new report.

This association “implies that these patients should be screened for thyroid function on a periodic basis,” lead author Dr. Alessandro Antonelli from the University of Pisa School of Medicine, Italy, told Reuters Health. “A substantial proportion -- 13 percent in our series—have hypothyroidism, and thus might benefit from treatment.”

Thyroid involvement in HCV-infected patients has been reported previously, the authors explain in The American Journal of Medicine, but little is known about the prevalence and nature of thyroid disorders in such patients. Antonelli and colleagues looked into this in a study of 630 patients with chronic hepatitis due to HCV infection.

Significantly more HCV-infected patients than uninfected subjects or hepatitis B virus-infected patients were positive for anti-thyroid autoantibodies, the authors report.

Also, low thyroid function (hypothyroidism) was significantly more common among HCV-infected patients (13 percent) than among the comparison groups (3-5 percent).

“We are planning a population based epidemiological study to assess the association between thyroid disorders and HCV infection,” Antonelli added. A possible association of HCV infection with thyroid cancer and diabetes is also under investigation.

SOURCE: American Journal of Medicine, July 1, 2004.

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Disease-Specific Analysis of Survival after Liver Transplant in the United States
Source: www.gastrohep.com

Researchers from the University of Pittsburgh, USA, have attempted to determine the factors that predict survival following liver transplant, but find that as a function of underlying liver disease, there is much variability in survival rates.

The researchers, led by Mark S Roberts, set out to describe disease-specific survival and the clinical variables that predict survival, using a large national cohort of adult liver transplant recipients.

They used the United Network for Organ Sharing to gather data on 17,044 adult patients who had received an initial orthotopic liver transplant between 1990 and 1996, with follow-up through to 1999.

From this information, disease-specific Kaplan-Meier survival plots and Cox Proportional Hazard models were estimated, and differences in the clinical characteristics of patients at the time of transplantation by disease were examined.

The study shows that overall post-transplant survival currently exceeds 85% in the first year, and is approaching 75% at 5 years.

Unadjusted Kaplan-Meier survival is improved for recipients who are younger, female, and in better clinical condition.

The study also shows that survival is a function of disease and level of illness. Cancer and fulminant liver failure have the poorest prognosis, along with alcoholic liver disease and the hepatitidies.

At the other end of the scale, transplant recipients with primary biliary cirrhosis and sclerosing cholangitis have the best prognosis for survival.

Furthermore, recipients who were outpatients before transplantation can expect to survive for longer than those transplanted from the hospital or intensive care unit.

Although the model for end-stage liver disease (MELD) score was designed to predict pre-transplant survival, patients with higher MELD scores have poorer post-transplant survival, but the MELD score is less predictive than the specific disease.

Post-transplant survival:
• 85% in the first year
• 75% at five years
Liver Transplantation

The researchers also found that differences in disease-specific survival are partially explained by differences in disease severity at the time of transplantation.

Concluding their report, the authors state that their findings show that disease-specific survival models indicate that there remains tremendous variability in survival as a function of underlying liver disease.

They add that a significant portion of the difference in survival between diseases arises from differences in clinical characteristics at the time of transplantation.

Liver Transpl 2004; 10 (7): 886 – 897

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First Reported Cases of Rabies Transmission Through Solid Organ Transplantation
Source: www.gastrohep.com

The first cases of rabies transmission through solid organ transplantation have been confirmed, reports the Centers for Disease Control and Prevention, USA.

In a press release, the Centers for Disease Control and Prevention (CDC), has announced that confirmation came after laboratory testing of autopsy samples.

The autopsy specimens were tested after three people who had received organ transplants from the same donor all died.

Although transmission of rabies has occurred previously through cornea transplants, this is the first instance of rabies transmission via solid organ transplant.

In the great majority of cases rabies, although an acute fatal disease, does not occur from non-bite exposures, such as scratches, contamination of an open wound, or direct mucus membrane contact with infectious material (for example saliva or neuronal tissue).

It is generally only exposure through being bitten by a rabid animal, such as a dog, that can result in the disease being contracted.

Despite this, CDC is working with health officials from Texas, Alabama, Oklahoma and Arkansas, amongst others, to determine those who may have come into contact with either the transplant donor or recipients, in order to administer post-exposure treatment.

The organ donor had undergone routine donor eligibility screening and testing. However, rabies testing is not part of the routing screening process.

Lungs, kidneys, and liver were recovered and later transplanted on May 4 into four recipients, one of whom (the lung transplant patient) died during transplant surgery. No other organs or tissues were recovered from the donor.

Centers for Disease Control and Prevention

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July 9th, 2004


Prevalence and Predictors of Herbal Medication Use in Veterans with Chronic Hepatitis C
Source: www.gastrohep.com

Many US veterans with chronic hepatitis C make use of herbal and vitamin preparations, finds a study in the latest issue of the Journal of Clinical Gastroenterology.

Writing in the August issue of the journal, Dr Uzma Siddiqui and colleagues enrolled patients with hepatitis C who were seen at the VA New York Harbor Healthcare System in the gastroenterology, infectious disease and primary care clinics.

Herbal therapies are used by a large number of people in the USA (see a previous GastroHep.com news story on this) and the researchers hypothesized that use of these supplements may be even higher in those with chronic liver disease.

They carried out a prospective study to investigate the proportion of US veterans with chronic hepatitis C that are currently taking vitamins and herbal medications and then evaluated the factors associated with use of herbal preparations.

Five hundred suitable study patients were interviewed by trained research coordinators who collected detailed demographic and clinical data, as well as information on the use of antioxidants (vitamin C and E), multivitamins, and herbal medications.

As a control group, 250 healthy patients were also questioned in the same way.

“Documentation of the use of these supplements is critical to determine the potential for herbal-drug interactions and hepatotoxicity” Dr Uzma Siddiqui, Journal of Clinical Gastroenterology.

Vitamin use was much higher in the hepatitis C patients than in the control group.

Vitamin C was used by 34.8% of hepatitis C patients as compared to 19.6% in the control group.

A total of 25.8% of hepatitis C patients used vitamin E, and 43.6% multivitamins, compared to 13.2% and 28.0% of the control group, respectively.

The use of herbal therapies was also higher in the hepatitis C group compared to controls (21.0% versus 10.4%, respectively).

The most common herbal medications taken by hepatitis C patients were milk thistle (12.2%), ginseng (4.6%), and echinacea (3.0%).

After adjusting for age and gender, multivariate logistic regression identified 12 or more years of education and annual income of at least $20,000 as the only significant predictors of herbal medication use in patients with hepatitis C.

Dr Siddiqui concluded, “The use of herbal preparations is prevalent among veterans with chronic hepatitis C, especially those with higher levels of education and higher incomes.”

She added, “Obtaining a detailed medical history and documentation of the use of these supplements is critical to determine the potential for herbal-drug interactions and hepatotoxicity.”

J Clin Gastroenterol 2004; 38 (7): 605 – 610

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HIV High Among IV Drug Users in Uruguay
Source: United Press International

MONTEVIDEO, Uruguay,-- A study of intravenous drug users in the capital of Uruguay finds 30 percent are infected with either HIV or Hepatitis B or C.

Approximately 40 percent of this population is without health coverage.

The "First Study of the Prevalence of Infection of HIV, Hepatitis B and C in Intravenous Drug Users" was conducted by a partnership of the Institute of Development and Social Studies, the Faculty of Medicine and the Public Health Ministry and published in the current issue of the weekly magazine Búsqueda.

Researchers surveyed 200 intravenous drug users in Montevideo between October and December of 2003, asking questions about sexual practices, drug consumption, and other risk factors related to the three diseases.

In addition to information on the prevalence of these diseases, the study found that readily available cocaine is the gateway drug for this population and has recently increased in popularity.

Although it is not injectable, it is the most popular drug among intravenous drug users, with more than half responding that they use the drug regularly or have used it at one time or another. It is generally used in conjunction with another drug such as alcohol.

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McGuinty Government Commits to Hepatitis C Federal Funding
Source: Canada Newswire

Will Make Sure Hepatitis C Victims Get Treatment And Care They Need

TORONTO, July 9 /CNW/ - The McGuinty government is committed to spending all of the federal funding for Ontarians infected with hepatitis C through the blood system prior to 1986 and after 1990, Health and Long-Term Care Minister George Smitherman announced today.

"We will make sure that every penny of the funding from the federal government is spent on the treatment and care of hepatitis C victims," Smitherman said. "Unlike the previous government, we are taking decisive action to put a program in place so that victims of hepatitis C get the care they need."

The Minister has directed ministry officials to provide a full accounting of Ontario's portion of the Federal Hepatitis C Undertaking Fund to date.

"Eligible victims of hepatitis C have been waiting since 1998 for action by the province with no program in place to assist these individuals," Smitherman said.

In 1998, the federal government created the Federal Hepatitis C Undertaking Fund to provide care to individuals infected with hepatitis C through the blood supply prior to 1986 or after 1990. The fund was provided to provinces, beginning in 2001 until 2014/15.

Ontario's total portion of the fund is $132.6 million with $66.3 million received to date. The remaining $66.3 million of the federal funds will be provided to Ontario by 2014/15.

Ontario's publicly funded health care system provides a range of services and programs including drug treatment, testing, medical care and education for people with hepatitis C.

This news release is available on our website at: http://www.health.gov.on.ca

For further information:
Members of the media: Eva Lannon, Minister's Office, (416) 327-4320;
Dan Strasbourg, Ministry of Health and Long-Term Care, (416) 314-6197;
Members of the general public: (416) 327-4327, or (800) 268-1154

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July 10th, 2004


Hepatitis C Help Pledged: Ontario Vows to Act ‘Quickly’ on Compensation
ROB FERGUSON
QUEEN'S PARK BUREAU
Toronto Star
June 10, 2004

Activists angry over delay in assisting victims

The Ontario government says it will move "quickly" on a plan to help hepatitis C victims infected by tainted blood before 1986 or after 1990.

The announcement came a day after the Star reported concerns of hepatitis C activists that provincial governments, including Ontario, were not using their share of a $300 million federal fund to reimburse victims for medical expenses as intended.

"We will make sure that every penny of the funding from the federal government is spent on the treatment and care of hepatitis C victims," Health Minister George Smitherman said in a statement yesterday.

The promise is ironic given that government didn't appear to have the issue on its radar screen until Thursday, said Barry Wilson, a spokesperson for Progressive Conservative Leader Ernie Eves.

"It looks like the Liberals were shamed into this."

Toronto lawyer David Harvey, acting for hepatitis C victims, said in an interview he had written to Smitherman on May 26, concerned that no payments were being made from the fund. He has yet to receive a reply.

"On paper, it sounds like a good commitment. We'll follow up every step of the way," said John Plater, vice-president of the Canadian Hemophilia Society.

"People in the hundreds have died" and spent thousands of dollars on drugs and treatment while waiting for governments to honour the plan, Plater said.

Health ministry officials would not say when their plan will be ready or whether it will allow victims to apply for reimbursement of drug, private nursing or related medical expenses. ----“We will make sure every penny ... is spent on the treatment and care of hepatitis C victims.” George Smitherman, Ontario health minister----

"All that detail is to come," said Eva Lannon, a spokesperson for Smitherman, who was en route to an AIDS conference in Bangkok and could not be reached for comment. "We're going to develop a plan, put a program in place very quickly, so that those individuals get the care they need."

She added that the money — Ontario's share is $132.6 million with $66.3 million received so far — will be spent "the way it was intended by the feds." The rest of the money will come from Ottawa by 2015.

As for the $66.3 million already paid to Ontario during the previous years of Conservative rule, she said: "We need a full accounting of that portion."

Lannon disputed assertions from previous health minister Tony Clement that Clement's Tory government had approved a plan to "roll out the money" before last October's provincial election was called.

"There was nothing left for us by the previous government." But detailed documents obtained by the Star suggest proposals to implement a plan were presented to cabinet in May, 2003, with a full briefing for Clement's staff last August.

The plan included setting up a hepatitis C secretariat and spending $150 million over five years on enhanced treatment.

"It's absolutely impossible for these documents to be mislaid," Clement said yesterday.

"The bureaucracy makes sure these things are around for the next government."

The $300 million fund was announced in 1998 but Ontario was one of the last provinces to sign on in 2002. Called "care instead of cash," it was designed to cover out-of-pocket expenses for hepatitis C victims not covered by a larger $1.2 billion federal-provincial compensation plan. It was for people who got the disease, HIV or AIDS from 1986 to 1990, a period for which the federal government admitted liability for the quality of the blood supply.

Hepatitis C activists have called on the federal government to extend that $1.2 billion fund to those infected before 1986 and after 1990 because it has paid out less than $400 million in claims. Activists hope the minority government in Ottawa will increase pressure on Prime Minister Paul Martin to extend the compensation fund, given that Conservatives promised during the recent election campaign to compensate the "forgotten victims" of the tainted-blood scandal.

Talking to reporters in Knowlton, Que., Martin appeared surprised at the report that hepatitis C victims had been unable to receive compensation.

"They should be receiving their payments," he said. "I will certainly speak to the minister and find out exactly why not."

Health Minister Pierre Pettigrew said he did not know the cause of the problem.

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