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

Week Ending: March 4^th, 2006

Alan Franciscus
Editor-in-Chief

To download pdf version click here


This Issue:

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February 25^th, 2006


Green Tea Polyphenols May Cause Liver Damage in High Doses
SourceURL:http://www.medicalnewstoday.com

The polyphenols present in green tea plants or herbs could pose health risks to humans if extracted and packaged in highly concentrated doses, says a new University of Toronto study published in the current issue of Free Radical Biology and Medicine.

In small mammals, green and black tea phenolics -- a class of chemical compounds found in plants that include polyphenols -- have been proven to contain antioxidants that help reduce the risk of cancer and cardiovascular disease. Findings such as these have helped to make these teas popular choices among health-conscious tea drinkers around the world.

Working with a team of graduate students, Professor Peter O'Brien of the Leslie Dan Faculty of Pharmacy injected low and concentrated doses of polyphenols into mice. At low doses, "good" polyphenols protected the liver or isolated liver cells against oxygen radicals, while "bad" polyphenols caused liver toxicity at high concentrations.

"The low concentration is roughly equivalent to what people consume when they drink green or black tea," O'Brien says. "But the health benefits are not clear as only a small amount of the polyphenols in the teas seems to get absorbed across the intestine. We won't know how much is absorbed or metabolized without running large clinical trials involving humans."

O'Brien has no plans to stop drinking green or black tea anytime soon, but cautions those who might want to exploit the antioxidant and health promoting properties of tea polyphenols against consuming concentrated doses in pill form as this could create more health problems than it might fix.

"New drugs are subjected to exhaustive clinical trials," he says. "Our findings demonstrate that there simply isn't enough known at this time to substantiate green tea's health-promoting properties if taken in high concentrations."

http://www.utoronto.ca

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Tampa Firm's Medication Has Enormous Potential as Hepatitis Treatment
SourceURL:http://www.tbo.com
By CAROL GENTRY cgentry@tampatrib.com

TAMPA - Digestive disease specialist David Heiman has dozens of chronic hepatitis C patients who do not respond to the drugs now available. Their only hope is a transplant before their liver gives out.

"If only I had something new to offer them," the Tampa doctor said.

Soon, maybe, he will.

Romark Laboratories, an emerging drug-development company on the eastern end of Courtney Campbell Parkway, is testing a new treatment for the potentially fatal liver disease.

"Their data are astounding," said Heiman, who discussed overseas study results with Romark's medical director. "It blew my socks off."

Romark has been testing its diarrhea drug Alinia, approved for use against intestinal parasites, to combat a host of demons: Crohn's disease, a chronic inflammation of the digestive tract; Clostridium difficile, a common hospital-acquired infection, and the now-epidemic hepatitis C.

Because Alinia has received Food and Drug Administration approval as safe for both children and adults, Romark is seeking FDA permission for a fast-track route to approve the drug for other diseases.

"We're fixing to explode the indications on it," said Romark adviser Seymour Holt, who has a stake in the company. "I think we've got a blockbuster."

A Secret Until Recently
It would be highly unusual to find a drug that kills not only protozoa but also two entirely different types of organisms -a virus, which in this case is just a strand of RNA, and C. difficile, bacteria that have developed resistance to most antibiotics.

"It doesn't sound plausible," said Tampa gastroenterologist Hunter Eubanks. "It sounds way out on a limb."

Romark's experiments with Alinia on hepatitis C during the past year have been a well-kept secret. As a closely held company, Romark has not had to report to stockholders.

Word began to get out last month, though, when Romark sent its plans for clinical studies to university review boards and to the FDA, said Marc Ayers, president and chief executive officer.

The Tampa company began posting its hepatitis C results in January on its Web site, www.romark.com, to make sure that accurate information trumped the rumors.

Romark, a little more than 12 years old, has until recently concentrated research on gastrointestinal illnesses. The company didn't think of trying its compound on viruses until late in 2004, when it was being tested on a parasite that afflicts AIDS patients, said chairman and chief scientist Jean-Francois Rossignol.

Researchers who were doing work under federal grants reported to the company that the compound seemed to be attacking not only the parasite, but also the virus. Test-tube studies on other viruses found it active against hepatitis.

So in early 2005, Romark began limited clinical trials of the compound in hepatitis patients at its Digestive Disease Research Center in Egypt.

Last month, the company announced the results were encouraging and that it soon will begin clinical trials in the United States - although skeptics point out that the viral strains are different in Egypt than in the United States, thus the results may not apply here.

Company officials, however, say basic research on how the drug works suggests it may be active on all strains.

"Fifteen months ago, this was not on our radar screen," Ayers said. "It's changing the direction of the company."

An Overwhelming Prospect
Hepatitis C virus, or HCV, is passed through blood and usually shows no symptoms for years or decades. It is estimated to have infected almost 4 million Americans - most of whom don't know it.

When patients develop jaundice and other symptoms, the disease is often well-advanced. Long-term therapy combines two antivirals, including one - interferon - that requires frequent shots.

Hepatitis C, more serious than its better-known namesakes A and B, accounts for about half of cirrhosis cases, end-stage liver disease and liver cancers. Hepatitis C kills 10,000 Americans each year.

Many of today's patients were infected before 1990, when an effective screening test for HCV became commercially available. The global total of those infected may be 150 million.

The idea that they may have unwittingly been sitting on a treatment for a major worldwide killer has Ayers and Rossignol, who together own 80 percent of the company, both excited and a bit overwhelmed.

"The market for an oral drug that could treat hepatitis C could clearly be billions [of dollars] in the United States alone," Ayers said.

Ayers said Romark's sales are about $15 million a year and that it has just reached the point of breaking even.

Over A Dining Table
For nitazoxanide, the compound that lies at the heart of the excitement, this is just the latest twist in a strange history. Rossignol, a French chemist, discovered the compound and its family of drugs, the thiazolides, in 1974. The parasite treatment didn't seem to offer anything more than existing treatments.

He left chemistry to go to medical school, and afterward moved to the United States to lead drug development against tropical diseases for major pharmaceutical companies. Rossignol is credited as a key figure in developing the antiparasitic blockbuster albendazole while working for the company now known as Glaxo- SmithKline.

When he retired in 1994, he remembered nitazoxanide and wondered whether it might be useful in fighting parasites that plagued AIDS patients. With that kind of market, it would be worth the cost of developing.

He approached Ayers, a Tampa-based investment banker who knew a lot about the pharmaceutical business, and the two started a drug-development company over Ayers' dining room table.

They found a few investors, including C. Stan Harrell, who had sold a Tampa-based health company, Pharmacy Management Services Inc., for a handsome profit in December 1994. Holt, who had been a leading developer of Prozac for Eli Lilly, also invested in Romark and served as part-time adviser. He stayed on when Harrell and others sold their shares back to the co-founders in 2000.

Meanwhile, Rossignol used his international connections to find scientists, clinical study programs and manufacturers. That's how a small Tampa company can claim a global reach, with a dedicated research laboratory in Liverpool, a research center in Egypt, drug manufacturing in Belgium and packaging in Latin America.

Medication Spreads
From 1995 to 2000, Romark obtained 10 U.S. patents for nitazoxanide, along with others abroad, for use against parasites. It was sold first in 1996 in Mexico under the name Daxon, then spread to other countries.

The next year, Romark licensed the drug to another company, IDEXX Pharmaceuticals, for veterinary use.

In November 2002, the leading British medical journal, The Lancet, reported that Alinia reduced illness and deaths from diarrhea among malnourished children. The FDA approved the drug for pediatric use, and later, for adults, against Giardia Lamblia and Cryptosporidium parvum.

Then, the hint that the compound might have antiviral properties spurred the studies in Egypt. According to company officials, nitazoxanide stamped out signs of virus in the blood of half the hepatitis C patients who received it, while there was no effect in those who received placebo.

It is important to note that these results have merely been posted on the company's Web site, not subjected to scrutiny, much less published in a peer-reviewed journal. The company says the results will be prepared for publication and presented at a digestive disorders meeting later this year.

'A Second Bullet'
Even if the hepatitis C application doesn't work out, Romark executives say they have plenty of other indications on which to try Alinia before its patent expires in 2017. The company can also develop the other thiazolides, to which Romark has exclusive rights.

Romark president Ayers said he spends much of his time these days talking to prospective strategic partners, larger companies that "have the muscle" to market a major drug in this country, Europe and Asia.

As it goes about the business of marketing Alinia to gastroenterologists, Romark has to be mindful of the FDA rule against promoting any use for which it has not yet received approval. The federal agency can and has imposed big fines for this.

On the other hand, there's nothing to prevent doctors from prescribing Alinia for uses that are still under clinical study.

"It's done all the time," an FDA spokeswoman said.

As for Heiman, he's counseling his patients who've failed existing treatment to have a little more patience until some solid data emerge publicly from Romark at medical meetings later this year.

"If they even get a poster at a national meeting, I'll be offering this," he said. "I need a second bullet for my gun."

TYPES OF HEPATITIS
Hepatitis is an inflammation of the liver caused by one of several viruses.

Hepatitis A: Flulike short-term illness, with usually no long-term damage. It is caused by contaminated water or food.

Hepatitis B: Can be short-term but is often long-term, with no symptoms, or with mild fatigue, jaundice and sometimes serious liver damage. Infection is passed through unprotected sex, blood exposure, or mother-to-newborn. There is an effective vaccine.

Hepatitis C: Infection is primarily passed through blood exposure, rarely through sex or mother-to-newborn. There are mild or no symptoms for years, with silent liver damage. There is no vaccine. Hepatitis C infects an estimated 3.9 million Americans.

Source: Living With Hepatitis C: A Survivors Guide, Everson and Weinberg, 1999

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Red Cross Screens for Safety: What's in Your Blood?
SourceURL:http://www.centralohio.com
By BRENDA J. DONEGAN
The Marion Star

What's uncovered when you donate may save your life

MARION- A local woman's hopes to do her part to help save lives may have helped save her own.

Deb French, a Marion City Health nurse, learned she had the HCV (hepatitis C virus) after she had gone to donate blood at a Red Cross bloodmobile.

French said they took her through all the pre-screening processes, took her blood, and after undergoing all the screening processes performed by the Red Cross, specifically for HCV, before using for transfusions for others, notified her she had the viral infection.

"I had no inkling," she said. "I had a blood transfusion in the early 80s before they screened blood like they do now. Knowing it is thoroughly screened should be a source of comfort for those who have to have a transfusion that the blood is safe."

She also noted that giving blood is free which makes the testing for HCV also free.

"I'm not sure how much those blood tests cost but I'm sure it's plenty," she said.

Judy Leonart, Galion, a licensed phlebotomist for the Central Ohio Region American Red Cross, agreed that attempting to donate blood or donating blood is a less expensive way to be tested and to gain re-assurance that you are not a carrier of some viral disease.

"They (Red Cross laboratories) test for everything that could be transferred through blood," Leonhart said. "The blood we draw is sent to the Detroit testing lab for very thorough examination and scrutiny. The blood doesn't go from here to the hospital. It goes to the testing center and processing before being released to any hospital. Any blood released is totally safe."

At a bloodmobile last week at the Moose Bingo Hall, Temtime Megerssa, mobile unit assistant, cross checked each unit of blood as it was unhooked from donors with the nurse on duty. The African-Ethiopian native said he has worked with the mobile unit for a little over three years.

"We double check the patients ID, the batch number, time and the bar codes," he said.

Lora King said she has never been able to give blood due to anemia nor has she ever had a transfusion because of being anemic.

"If I were to need a transfusion I would want the blood checked," she said. "Now that I know they are thoroughly checking it when people donate, it wouldn't bother me if I knew it would help me."

There is no vaccine to prevent hepatitis C

French said she had no symptoms for HCV which is common for 80 percent of those infected. Signs and symptoms may include jaundice, fatigue, loss of appetite, nausea, abdominal pain or dark urine.

While about 1-5 percent of people infected die from HCV, liver problems are prevalent. The disease has damaged French's liver and she was told she probably had it for more than 20 years.

A registered nurse who graduated from nursing school in 1976, French said she could have contracted it from contact with patients.

"I (and other health care professionals) am at high risk because of blood transfusions and my profession," she said.

She took treatments for six months and recently learned after six months without treatment that the virus has returned. The recommended regiment of treatment for French was a shot a week for six months and four anti-viral capsules per day for six months.

"It (weekly shot) just drained me," she said. "I took the shots on Friday night so I could go through the worst side effects over the weekend and to be able to go back to work on Monday."

Coming off the treatments, her doctor recommended she work with a personal trainer to gain some strength. She said she hooked up with Randy Hensel at the Marion Racquetball Club and goes three days a week for exercise and strengthening. She worked with Hensel 10 weeks who started her out slow, then gradually increased the exercise and strengthening regime.

"It (doctor's advice) was the best thing I ever did," she said. "I changed my dietary habits. I now eat a balanced meal and drink plenty of water and get lots of rest."

Her advice: donate blood.

"It should give you peace of mind to know you are safe (through testing and processing) and the blood you might receive is just as safe."

What is hepatitis C?

• It's a disease of the liver caused by the hepatitis C virus (HCV).
• Transmission of the virus occurs when blood from an infected person enters the body of a person who is not infected.
• HCV is spread through sharing needles or "works" when "shooting" drugs, through needlesticks or sharps exposures on the job, or from an infected mother to her baby during birth.

Who should be screened for HCV

• Injecting drug users.
• Recipients of clotting factors made before 1987.
• Hemodialysis patients.
• Recipients of blood and/or solid organs before 1992.
• People with undiagnosed liver problems.
• Infants born to infected mothers.
• People having sex with multiple partners or with infected steady partner have a low risk of infection and should ask their doctor if they should be tested.

Source: Center for Disease Control (CDC) at www.cdc.gov/hepatitis/

Web resources

• American National Red Cross www.redcross.org
• Marion County Chapter www.marionoh-redcross.org or 740-725-9141
• American Red Cross Blood Services www.bloodsaveslives.org or 1-800-GIVE LIFE (1-800-448-3543)
• The Hepatitis Information Network: www.hepnet.com/
• Hepatitis Foundation International: www.hepfi.org
• Hepatitis Neighborhood: www.hepatitisneighborhood.com

Brenda Donegan: 740-375-5150 or bdonegan@nncogannett.com

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February 27^th, 2006


Peregrine: Tarvacin Safe in First Trial
http://www.businessweek.com
Associated Press/TUSTIN, Calif.

Peregrine Pharmaceuticals Inc., which develops drugs to treat viral diseases and cancer, on Monday said its Tarvacin drug candidate appeared "safe and well-tolerated" in an early stage clinical study of patients with hepatitis C.

The company said its Tarvacin Anti-Viral is designed to stimulate the body's immune defenses to kill the hepatitis C virus particles and infected cells. Hepatitis C is a blood-borne viral disease that can cause liver inflammation, fibrosis and cancer.

Peregrine said the goals of the Phase I clinical trial were to determine the safety profile and distribution properties of Tarvacin in patients with chronic hepatitis C infections. In this single-dose trial, 24 patients with chronic hepatitis C who had either failed or no longer responded to standard treatments were given Tarvacin Anti-Viral.

In a statement, the company said the drug "was well tolerated, with no serious adverse events reported at any of the four dose levels tested, and no potential dose limiting toxicities were observed."

Adverse effects were "mild, infrequent, transient and likely not drug-related."

The company expects to conduct repeat dose and combination therapy trials later this year.

Peregrine shares added 8 cents, or 5.4 percent, to $1.57 in midday trading on the Nasdaq.

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February 28^th, 2006


Expected Increase in Hepatitis C-Related Mortality
SourceURL:http://www.gastrohep.com/

Hepatitis C-related mortality is expected at least to double in the next 20 years, although the use of antiviral therapies can lower these predictions, finds the latest issue of the Journal of Hepatology.

Egypt has the highest prevalence of Hepatitis C in the world, apparently due to mass parenteral antischistosomal therapy.

Estimating the future burden of Hepatitis C in Egypt is important to support health policies to combat the epidemic.

Dr Sylvie Deuffic-Burbanab and colleagues adapted a previous back calculation model to the situation in Egypt.

The researchers combined a model of the natural history of Hepatitis C infections with available epidemiological data.

The research team then back calculated the past Hepatitis C incidence from observed hepatocellular carcinoma mortality between 1980 to 1999.

In turn, the Hepatitis C-related mortality burden was projected in the future based on pre-2000 infections.

Globally, the model predicts over a 2-fold increase in Hep C-related mortality – Journal of Hepatology

Compared with the observed number of hepatocellular carcinoma deaths in 1999, the model predicts a 4-fold increase in this mortality in the next 20 years.

Globally, the model predicts just over a 2-fold increase in the Hepatitis C-related mortality.

The team noted that these predictions do not take into account the new infections that may occur after 2000.

The researchers observed that further infections post-2000 would increase the estimated future mortality burden.

Dr Deuffic-Burbanab's team concluded, "Hepatitis C-related mortality is expected at least to double in the next 20 years."

"The use of antiviral therapies can lower these predictions."

"Efficient prevention policies are needed to avoid these predictions being exceeded."

J Hepatol 2006: 44(3): 455-61

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March 1^st, 2006


Factor XIII Deficiency Associated with Reduced Survival in Cirrhosis
SourceURL:http://www.gastrohep.com

Factor XIII deficiency is rare in patients with liver cirrhosis, but is associated with a clinical bleeding tendency and an unfavorable prognosis for future hemorrhages and survival, finds the latest Liver International issue.

Alterations of plasma coagulation factor XIII may contribute to bleeding disorders in patients with liver cirrhosis.

Standard clotting tests such as prothrombin time or activated thromboplastin time cannot detect factor XIII deficiency.

Therefore this deficiency may often be overlooked in clinical practice.

Dr Frank Tacke and colleagues from Germany defined factor XIII's clinical and prognostic role in chronic liver disease.

Factor XIII activities were assessed among various other parameters in 111 patients with chronic liver diseases.

Factor XIII of less than 50% increased the risk of severe upper gastrointestinal bleed – Liver International

The patients were assessed for these parameters during evaluation for liver transplantation in a prospective study.

Unlike coagulation factors II, V or VII, factor XIII activity was maintained in the majority of patients with liver cirrhosis.

The researchers noted that factor XIII deficiencies occurred, although rarely, especially in Child C cirrhosis.

The team found that factor XIII levels correlated with liver's biosynthetic capacity.

Factor XIII levels also correlated with platelet count, global coagulation tests and other single coagulation factors.

Patients reporting a current systemic bleeding tendency at study entry had significantly reduced factor XIII.

In a 6-year follow-up, patients with factor XIII of less than 50% had a significantly increased risk of severe upper gastrointestinal bleed.

The team observed that a reduced factor XIII was associated with increased mortality.

Dr Tacke's team concludes, "Factor XIII deficiency is rare in patients with liver cirrhosis, but is associated with a clinical bleeding tendency and an unfavorable prognosis for future hemorrhages and survival."

Liv Int 2006: 26(2):173

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China to Survey Hepatitis B Epidemic Situation
SourceURL:http://www.angolapress

XIAMEN, 03/01 -- China's Ministry of Health is going to launch a nationwide survey on the current epidemic situation of hepatitis B in a bid to give scientific support to the country's prevention of the disease.

The control of hepatitis B has been listed on the 11th national five-year program (2006-2010) and is one of the priorities of the ministry on its infectious disease control agenda, said Qi Xiaoqiu, director of the Department of Disease Control under the ministry.

The survey will focus on the current epidemic situation, changing trends, transmission elements, financial burdens and immunization evaluation of hepatitis B, noted Qi at a national conference on the immunization plan of 2006 held on Tuesday.

"The control of hepatitis B is a crucial task of the ministry this year. We are organizing experts to assess the survey and will work out a detailed plan soon," said Qi.

Hepatitis B is one of the major infectious disease in China, which carried out nationwide surveys about the epidemic situation of hepatitis on 1979 and 1992. According to experts, the country currently has 20 million people infected with chronic hepatitis B.

On Jan. 28, the ministry issued a national prevention and control plan on hepatitis B for the next five years, which set a goal of significant decrease in the incidence of hepatitis B and deaths caused by hepatocirrhosis and liver cancer by 2010.

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March 2^nd, 2006


NDRI Researchers Evaluate Prison Hepatitis Program
SourceURL:http://www.eurekalert.org/

In an article published in the Journal of Correctional Health Care, researchers from the National Development and Research Institutes, Inc. (NDRI) reported on an evaluation of an intervention program within a prison system addressing Hepatitis C virus (HCV). Findings include recommendations for increasing Hepatitis C education and staff training, and expanding peer educators programming.

Hepatitis C virus is the most common chronic blood transmitted infectious disease in the United States today. The incidence is even higher among inmates in correctional facilities, with about a 9 times greater rate of infection. In addition, previous studies indicated that among those in the general population with the virus, a third or more pass through a correctional facility within a year's period. For those maximizing the public health impact of preventive and treatment interventions, the correctional facility is a vital location; and for those running correctional facilities or setting policy in the criminal justice area, attention to the public health impact of Hepatitis C has become extremely important.

Researchers at NDRI examined the HCV-related educational, testing, and medical services offered within a drug treatment program at a correctional facility in California. The study describes the services offered, assesses client and staff perceptions of the advantages, benefits, and barriers to delivering services, and made recommendations for the future.

"This approach presents a tremendous opportunity to limit the spread of HCV," noted Dr. Shiela Strauss, one of the authors. Yet such programs do not exist at many correctional facilities. The authors also recommend the relatively low cost and sustainable approach of peer to peer educational programs to address this pressing public health challenge within the budget limitations of many correctional programs.

The study was supported by a grant from the National Institute on Drug Abuse, Grant Number R01 DA013409.

Journal of Correctional Health Care, Volume 11, Issue 4, 2005, pp. 347-368. Copyright © 2005, National Commission of Correctional Health Professionals. Hepatitis C Service Delivery in Prisons: Peer Education From the "Guys in Blue". Corrine E. Munoz-Plaza, MPH; Shiela M. Strauss, PhD; Janetta M. Astone, PhD; Don C. Des Jarlais, PhD; Holly Hagan, PhD.

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Waffle House to Pay Ex-Cook $50K
SourceURL:http://www.jacksonsun.com
By NED B. HUNTER
nhunter@jacksonsun.com

Lawsuit said Jackson restaurant fired employee because of hepatitis C

Waffle House owners have agreed to pay $50,000 to settle a lawsuit stemming from the 2004 firing of a cook at a Jackson location.

The restaurant was accused of unlawful employment policies and practices, violating the Americans with Disabilities Act of 1990 and the Civil Rights Act of 1964 when it fired the unnamed cook. The cook had hepatitis C, according to court documents filed in the U.S. District Court in Jackson.

Agreeing to pay the $50,000 - $20,400 in back pay and $29,600 in compensatory damages - "does not constitute an admission" of guilt on the part of the Waffle House franchise, court records state.

The franchise is required to provide training for its management officials and all of its employees in the Jackson restaurant where the cook was employed, regarding the disability act, according to court documents.

The franchise is owned by Alpharetta, Ga.-based River Waffles LLC and Collis Foods, Inc. No specific Waffle House location in Jackson was named in court documents on the case.

"There was no court ruling of any type; it was simply a settlement," said Deidre Smith, senior trial attorney for the Equal Employment Opportunity Commission, which sued on behalf of the cook. The commission sued because it is an enforcement agency, Smith said.

While in this case the hepatitis C was not disabling, the law allowed the commission to file the lawsuit because the law protects those "who are actually disabled, have a record of being disabled or are regarded as disabled as defined by the act," Smith said.

In court documents, the commission said the restaurant regarded the cook as disabled when the franchise fired him.

The company denied the allegations, but settled to avoid "the additional expense and delay in the litigation of this case," according to court records.

"It would be fair to say that the restaurant ownership took what they felt was appropriate action (when firing the cook)," said Joe Manuel, a Chattanooga-based attorney for Waffle House. "The government disagreed, and we resolved (the case)."

Health officials determined it was unnecessary for anyone working with the cook at the restaurant to be tested for hepatitis C, Manuel said, nor has any customer "ever reported (being) sick from eating at the restaurant."

Hepatitis C is a bloodborne disease that attacks the liver, said Jennifer Morcone, spokeswoman for the Center for Disease Control and Prevention in Atlanta. It is caught by coming in contact with the blood of an infected person.

Sharing intravenous drug needles, receiving a blood transfusion or a donated organ from an infected person are examples of transmission, she said.

"Transmission of hepatitis C has not been linked with food service," Morcone said. "There is no risk factor from food service members."

Hepatitis A is the disease that can be contracted from food service personal, Morcone said. It can be spread from person to person by putting something in the mouth that has been contaminated.

It can be transmitted by the unwashed hands of a food service worker who has hepatitis A, Morcone said. Treatment is available for both forms of hepatitis.

The franchise has 75 locations in North Georgia, Tennessee, Arkansas and Mississippi, according to its Web site. Each party is responsible for its own court costs.

Visit jacksonsun.com and share your thoughts.

- Ned Hunter, 425-9641

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March 3^rd, 2006


Hep B Infection in Australia Is Higher Than Expected
SourceURL:http://www.gastrohep.com

Hep B is higher than predicted on the basis of notifications to the passive surveillance scheme, and most patients had multiple risk factors for infection, finds the latest issue of the Journal of Viral Hepatitis.

There is little recent data of the seroprevalence of Hepatitis B in Australia.

Dr Tawk and colleagues surveyed a large cohort of endoscopy patients attending a teaching hospital in central Sydney.

The investigative team related the presence of Hepatitis B virus markers with putative risk factors for exposure using the SAS statistical package.

The investigators tested 2115 patients.

Of these, 2% were Hepatitis B surface antigen positive, 1% were viraemic, and 10% were anti-Hepatitis Bs and anti-Hepatitis Bc-positive.

A further 20% were vaccinated, and the remaining 70% were found to be susceptible.

The adjusted odds ratio of Hepatitis B infection was increased 36-fold in patients who had been diagnosed with human immunodeficiency virus (HIV).

The team noted that the adjusted odds ratio for risk of infection patients born in Asia or Pacific islands was increased 12-fold.

The odds ratio of Hep B infection was increased 36-fold in patients with HIV - Journal of Viral Hepatitis

For patients born in North Africa, Middle East & Mediterranean countries the odds ratio for risk of infection was increased 6-fold.

The investigators observed that those born abroad elsewhere in the world had a 3 -fold increased odds ratio.

Those who had household contact with someone diagnosed with Hepatitis between 1980 and 1990 had a 4-fold increased risk of infection.

Patients who injected drugs between 1980 and 1990 had a 4-fold odds ratio of infection.

The investigators found that patients who resided in a military establishment for 3 months, or in a hospital for 3 months, had a 2-fold increase.

Patients who had never been vaccinated for Hepatitis B had a 3-fold increase.

The team noted that those who received blood transfusion due to an accident and/or a haemorrhage, or were of male gender had about a 2-fold increase in risk.

Dr Tawk's team concludes, "The prevalence of Hepatitis B in this hospital population was higher than predicted on the basis of notifications to the passive surveillance scheme."

"Most Hepatitis B patients had multiple risk factors for infection."

"However, the hierarchy of odds ratios provides a rational basis for targeted programmes to identify asymptomatic Hepatitis B carriers who might benefit from treatment."

J Vir Hep 2006: 13(3): 206

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Validation of Cardiovascular Risk Scores for Liver Transplants
SourceURL:http://www.gastrohep.com

The Systematic Coronary Risk Evaluation Project and Prospective Cardiovascular Münster Study risk scores identify liver transplant recipients for their individual risk of cardiovascular events, reports this month's Liver Transplantation.

Increased prevalence of cardiovascular risk factors has been acknowledged in liver transplant recipients.

An increased incidence of cardiovascular events has been suspected.

Individual risk determination, however, has not yet been established.

Dr Olaf Guckelberger and colleagues from Germany reviewed outpatient charts of 438 primary liver transplants.

Suspected cardiovascular risk factors were correlated with cardiovascular events observed during a follow-up period of 10 years.

Receiver operation characteristics curve analysis was performed to validate established cardiovascular risk scores.

For calibration, the Hosmer-Lemeshow test was performed.

The research team reported that a total of 303 of 438 patients were available for risk factor analysis at 6 months and demonstrated complete follow-up data.

The team noted that 13% of these patients experienced fatal or nonfatal cardiovascular events.

Age, gender, and cholesterol were the only independent predictors of events - Liver Transplantation

In univariate analysis, age, gender, body mass index, cholesterol, and creatinine were associated with cardiovascular events.

The researchers also found that diabetes mellitus, glucose, and systolic blood pressure were associated with cardiovascular events.

The team observed that cyclosporine A, tacrolimus, or steroid medication, were not significantly associated with cardiovascular events.

Multivariate analysis, however, identified only age, gender, and cholesterol as independent predictors.

Corresponding areas under the curve for Systematic Coronary Risk Evaluation Project (SCORE) was calculated as 0.8.

The team calculated areas under the curve for the Prospective Cardiovascular Münster Study (PROCAM), and Framingham risk scores as 0.778, and 0.707, respectively.

The team demonstrated with calibrations an improved goodness of fit for Prospective Cardiovascular Münster Study vs Systematic Coronary Risk Evaluation Project risk calculations.

Dr Guckelberger's team concludes, "Systematic Coronary Risk Evaluation Project and Prospective Cardiovascular Münster Study proved to be valuable in discriminating our liver transplant recipients for their individual risk of cardiovascular events."

"Furthermore, calibrated Prospective Cardiovascular Münster Study risk estimates are required to calculate the number of patients needed to treat in the set-up of prospective intervention trials."

Liv Transplant 2006: 12(3): 394-401

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New Treatment Strategy for Esophageal Varices Improves Prognosis
SourceURL:http://www.gastrohep.com

The 1- and 5-year mortality for esophageal varices in Sweden decreased between 1969 and 2002, suggesting the new treatment strategies for acute variceal hemorrhage and prophylaxis have improved prognosis, finds March's Hepatology.

Liver cirrhosis may be complicated by the development of esophageal varices.

The treatment of esophageal varices has changed radically during the last 30 years.

Dr Knut Stokkeland and colleagues from Sweden studied whether the prognosis for esophageal varices had improved in Sweden.

The researchers linked data from the Hospital Discharge Register, and the Causes of Death Register at The National Board of Health between 1969 and 2002.

The research team identified and followed-up all patients with esophageal varices according to International Classification of Diseases - 8, - 9, and - 10.

There were 12,281 patients hospitalized with esophageal varices.

Better survival occurred for women compared with men - Hepatology

The team noted that for all patients there was an increase in the 5-year survival from between 1969 and 1979 to the years between 1990 and 2002.

Better survival occurred for women compared with men, and for younger patients compared with older.

The researchers found that survival was improved for patients hospitalized in the latest decade compared with the earlier decades.

The team observed a significant decrease in the mortality caused by esophageal varices during the years studied but no decrease attributable to other causes.

Dr Stokkeland's team concludes, "Mortality for patients hospitalized with esophageal varices in Sweden decreased between 1969 and 2002."

"The decrease is seen for both 1- and 5-year mortality."

"This suggests that the use of new treatment strategies both for acute variceal hemorrhage and secondary prophylaxis has had an impact on prognosis."

Hepatol 2006: 43(3): 500-5

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Hepatitis C: Serum Viral Levels Recur Rapidly After Liver Transplant
http://www.xagena.it/

When a diseased liver is removed from a patient with Hepatitis C (HCV), serum viral levels plummet.

However, after receiving a healthy liver transplant, virus levels rebound and can surpass pre-transplant levels within a few days.

Hepatitis C is the number one reason for liver transplantation, however, the virus always recurs in the new liver.

Since mathematical models have been useful in the study of the viral dynamics of HIV and hepatitis B, researchers, led by Kimberly A. Powers and Ruy M. Ribeiro of the Los Alamos National Laboratory in New Mexico, sought to use a mathematical model to quantify the liver reinfection dynamics of HCV.

The researchers, in collaboration with a surgical team lead by John McHutchison now at Duke University Medical Center, followed six HCV-infected patients who received cadaveric liver transplants.

They collected blood samples before, during and after transplantation to assess changing levels of HCV RNA which was measured using reverse transcription polymerase chain reaction assay.

They then plugged the data into a mathematical model, correcting for fluid balance, and analyzed the results using linear regression.

"In most patients," the authors report," HCV RNA levels decreased rapidly during and after transplantation and subsequently began to increase – reaching above pre-transplant levels in all but one patient – within a few days of the procedure." They found that when the diseased liver was removed, virus levels dropped with an average half-life of 48 minutes. After the new liver was implanted, they found that virus levels continued to drop for up to 23 hours, then began to rise, doubling every 2 days.

Notably, in three patients, the virus levels plateaued before rising, suggesting, say the authors "that a non-hepatic source supplied virions and balanced their intrinsic clearance." The authors estimate, however, that non-hepatic sources can only account for 4 percent of total viral production. Ninety-six percent of it occurs in the liver.

The patterns of viremia decline and increase seen in this study are consistent with previous studies, although this study indicates a much faster virion half-life than previously suggested.

The findings also support the notion that HCV can replicate rapidly in the post-transplant immunosuppressed patient, leading the authors to suggest that early antiviral therapy may delay or prevent reinfection.

The study was limited by the small number of patients and the single compartment model, which did not separately account for liver and extrahepatic sites of viral replication. " Nevertheless," report the authors, "the rapid HCV RNA decline in the anhepatic phase, followed by the postoperative increase observed in several patients…suggest that the liver is the primary site of viral replication, with at most small contributions from extrahepatic sites."

In conclusion, the authors write, " Continued work towards elucidating extrahepatic replication, the time-course of reinfection, the effects of immunosuppressive therapy, and the relationships among viremia, infection and liver damage will be beneficial in optimizing treatment for HCV patients undergoing liver transplantation."

Source: Liver Transplantation, 2006

XagenaMedicine2006

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Vertex's Hepatitis C Drug Has 'Gold Standard' Potential
www.forbes.com
Peter Kang
Vertex Pharmaceuticals

Deutsche Bank Securities initiated coverage of Vertex Pharmaceuticals with a "buy' rating and said the development-stage drug company's promising experimental drug candidate VX-950 has "gold standard" potential as a hepatitis C treatment.

"Despite a strong 52-week stock return of 269% fueled by increasing visibility of VX-950, we believe the commercial potential of VX-950 and an evolving early clinical pipeline represent meaningful upside to current valuation," wrote analyst Jennifer M. Chao, in a client note. "2006 to 2008 could be transforming years for Vertex."

Vertex (nasdaq: VRTX - news - people ) is expected to begin a three-month study in the second quarter, which will determine the benefits of VX-950 compared with pegylated interferon and ribavirin, the current standard of care. Vertex plans to begin Phase III trials in 2007 with the goal of filing a new drug application in 2008.

The lead drug candidate, which addresses market opportunities of $3 billion, is not the only potential blockbuster for Vertex. The company is also developing VX-702 for rheumatoid arthritis with preliminary results of a Phase II study expected in the second quarter.

"While the mechanism of action is intriguing, we remain cautiously optimistic about an uncharacterized safety profile," said Chao.

The analyst initiated a price target of $53 on Vertex shares.

"Lead product VX-950, an oral inhibitor of the hepatitis C virus, has the potential to be the new gold standard of care and dramatically improve the HCV treatment algorithm based on mid-stage proof-of-concept, in our view," the analyst said.

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Blood Test Looming for Local Body-Snatcher Victim
http://www.abcactionnews.com

TOWN 'N COUNTRY - Longtime Tampa residents Jeffrey King and his wife Nancy are living a nightmare. Jeffrey is getting a blood test next week to find out if he has HIV, hepatitis, or syphilis.

"Of course I'm nervous," he told Action News. "I mean, we're talking about a disease -- diseases that I could possibly transmit to my wife."

"It's emotional for me to see what he's going through, and it's emotional for me if I allow myself to think really long and hard about what does this hold for our future?" Nancy offered.

Jeffrey King, a 46 year-old businessman, is the first potential bay area victim of a nationwide scandal. Four men are charged in New York with cutting up corpses, stealing body parts without checking for disease, then selling them to tissue and bone processing plants, two of which are near Gainesville.

In October, Jeffrey had a cadaver bone implanted in his jaw because a rotted tooth had damaged his jawbone. A month later, his dentist told him the bone was among those stolen.

And, his dentist said, three other bay area patients also have stolen parts implanted.

"There are potential victims right here in the Tampa Bay area, and God only knows how many more victims there are in the Tampa Bay area," Jeffrey continued.

Jeffrey King is among hundreds of people nationwide could be walking around with a potentially deadly disease. He came forward after seeing Matthew Schwartz's report Tuesday night.

"I wanted to come forward because it totally upset me. I know there's a lot of people out there. There may be a lot of people out there that have no idea that they have these bones," Jeffrey said.

Jeffrey has a blood test kit, but has been afraid to use it.

"It's been sitting on my dresser for a month. And I'd look at it every day and I'd think, 'Do I really wanna know?' And then my mind says, 'You need to know.' "

Now, Jeffrey says, his blood test is scheduled for next week.

If you think you are affected by one of these transplants, you can contact us at 1-866-428-6397, or send an email to investigates@ABCactionnews.com.

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