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•Patient Who Contracted Hepatitis C Dies
•Back from Hell
•NIH Action Plan Charts Future Challenges for Liver Disease Research
•Hemispherx Biopharma Initiates Enrollment in HIV/HEP-C Clinical Program; Clinical Trial with Ampligen in Collaboration with Esteve Laboratorios Targets HIV/HEP-C Twin Epidemics
•Hepatitis C at Epidemic Levels among Young Injectors in London: Study
•Health Officials Probe Hepatitis C Cases
•Counties Studying Law OK'ing Needle Sales
•Physician on Medical Staff at Baylor University Medical Center Predicts Prevalence of Hepatitis C in Texas
•Elevated Prevalence of Hepatitis C in United States Veterans
•Coley Reports Results from Phase I Studies of Actilon(TM) for Hepatitis C
•ViroPharma Announces Submission of Investigational New Drug Application for HCV-796
•Penal Reform Trust Slams Mandatory Drug Tests for Prisoners
•Schering-Plough's Pegintron Also Effective in Hepatitis B
•Noninvasive Assessment of Liver Fibrosis
•Cardiac Alterations in Cirrhosis: Reversible after Liver Transplant
•Caffeine Reduces Risk of Elevated Alanine Aminotransferase
•Mouse to Help Fight Hepatitis-C
•Hepatitis C Poses Threat of Big Crisis
•Health Worker May Be Source of Hepatitis C

January 2nd, 2005

Patient Who Contracted Hepatitis C Dies
SourceURL:http://www.hometownannapolis.com
The Capital, Annapolis, Md
By RYAN BAGWELL, Staff Writer

A Brooklyn Park man who contracted hepatitis C from a disease-tainted cardiac test in October has died from complications with the illness, his family said.

John Leto, 80, died at Harbor Hospital in Baltimore on Christmas after developing pneumonia, his wife, Dorothy, said. He developed hepatitis C from the contaminated test Oct. 15, she said, along with several other individuals in the Baltimore region.

"I think this is terrible," Mrs. Leto said. "I can't believe it. There's no reason why he should be dead."

State health officials launched an investigation into the hepatitis C cluster in the Baltimore metropolitan area in November. Each patient included in the investigation underwent tests prepared by a Timonium pharmacy owned by Ohio-based Cardinal Health Inc., the company said in a statement.

"Our thoughts and condolences go out to the family of that individual and we're going to continue to support the investigation to quickly resolve and find out the cause of the infection," said Jim Mazolla, a Cardinal Health spokesman.

Hepatitis C is a chronic liver disease that most people live healthy lives with, according to the U.S. Centers for Disease Control. There is no known cure, but the disease is controllable and most patients never feel sick, the CDC says.

It is most often spread through contact with human blood, but can also be spread through sexual activity.

Twenty-eight people in Maryland were diagnosed with hepatitis C last year, the highest number since 1999, said John Hammond, a spokesman for the Maryland Department of Health and Mental Hygiene.

Across the state, only six people with the disease have died since 1999, but complications from the infection and not the hepatitis virus itself might have caused those deaths, Mr. Hammond said.

Twelve people were infected with the disease from tests administered on Oct. 15, according to Gordon Troup, president of Cardinal Health Nuclear Pharmacy Services. No more than 16 patients were injected with the infected material, a radioactive tracer agent used to track circulation in the body, he said.

Mr. Leto was diagnosed with the disease about a month after developing symptoms consistent with the virus. He developed nausea and was hospitalized twice.

Until then, Mr. Leto was a healthy senior who walked several miles almost every day, his wife said.

Mr. Leto's age and diabetes worked against him, his daughter, Delma J. Macey, said, and led to his death.

"I know my father would not have lived forever," she said. "But I know how healthy he was and two months later he was dead."

The Department of Health and Mental Hygiene, the agency leading the investigation, has released few details about the scope of the outbreak.

State officials declined to say where the tests were administered, although a county health department official said last month it was "multijurisdictional."

One of those locations was Arundel Heart Associates, a north county cardiology group with an office in Glen Burnie, said Dr. Paul Young-Hymen, a cardiologist at the practice. An internal investigation last month pointed to a contaminated test and not physician error, he said.

The tests involved injecting patients with a radioisotope doctors track as it circulates through the body. Investigators are focusing on the tracer agent's preparation and not the agent itself, Mr. Troup said in his statement.

The Capital has identified two other north county residents who contracted the disease from the tainted tests. One, who spoke on the condition of anonymity, said he can no longer eat shellfish or drink alcohol and he often feels lethargic.

"It ain't like before, I used to go all day long," said the Pasadena resident." I was like the Energizer Bunny. But now I ain't got no batteries in the bunny no more."

"My life's ruined I think," he said. "That's how I feel."

The pharmacy that prepared the doses remains closed pending the investigation's outcome, Mr. Mazzola said Friday.

L. Clifton O'Connor, a Glen Burnie attorney representing an infected Glen Burnie resident, said he expects to file a lawsuit after the investigation is complete

rbagwell@capitalgazette.com

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Back from Hell
http://www.casperstartribune.net
By JENNI DILLON
Star-Tribune staff writer

She accepted drugs from strangers, even after an acquaintance got a bad batch that burned through the skin on his arms after he injected it in his veins. She shared needles with her dealers and buyers, eventually contracting Hepatitis C.

It's hard to picture Tammy Dominguez as a drug addict.

The 37-year-old single mother holds a steady, full-time job. She cuddles with her children and her cats in a modest, cottage-style home she owns. She spends her Sunday mornings at church and Friday nights listening to a Christian rock band perform. She drives a mini-van.

Not long ago, though, Dominguez was a different person -- "the worst of the worst," she says. Ten years ago, at age 27, Dominguez had her first hit of methamphetamine and, in an instant, went from a casual drug user to an addict. Her first taste of "crank," as the drug is called on the streets, was enough to hook her, starting a journey into a world of violence, poverty and promiscuity; a journey that ended only with the court-ordered removal of her children, months of treatment and counseling, and a plea to God to create a new woman.

Dominguez is one of many Casper residents who has fallen prey to the drug known as meth. She is one of few to escape its grasp to go on to a better and cleaner lifestyle.

Meth is a growing problem throughout the country, particularly in rural, Western communities. Surveys by the Office of National Drug Control Policy estimate that more than 12 million Americans ages 12 and older have tried meth.

The drug is blamed by law enforcement agencies for nearly 80 percent of the crime in Casper, and Wyoming Department of Family Services workers say it also is responsible for almost as many child-protection cases here.

"It's shocking and scary and it's got our community by the throat," said Jim Johnson of Casper's Mercer House.

This week, members of agencies ranging from law enforcement to DFS to the business community will meet for Casper's second annual Meth Conference, an attempt to address the prevalence of the drug and the social ills it spreads through the community like a crack spider-webbing through glass. Thursday night, the public will be invited to join the discussion, listening to a panel of eight former meth addicts, including Dominguez, share their first-hand stories of the disease of addiction and their struggles for recovery.

'I never grew up'

Dominguez, today, isn't the kind of person who makes excuses for her actions. A devout reborn Christian who has spent plenty of time in counseling and in church recounting and repenting for her past, she knows that her own choices led her through the hell of addiction -- and all it brought.

But she also knows that addiction has roots -- in genetics and in life experience.

The Casper woman grew up in a single-parent home, her father absent from the lives of her, her sister and her mother. Though a tight-knit clan, Dominguez said her family lacked a core, a set of values that held them steady. She never learned what she now considers basic concepts, like why it might be wrong to marry time and time again, why she should stay away from abusive men or why she should work for a living.

An overweight outsider in high school, she turned to a community of Mexican immigrants for belonging, adopting a false identity that included everything from a different name to a different language. She also experimented with drugs and alcohol through high school, drinking at parties, smoking marijuana and trying just about anything put in front of her, including hallucinogenic mushrooms and acid.

By the time she was 19, she was married with twins, Willy and Melly. At 22, she had a daughter, Cielo, with her second husband. Victor and Rio came later, with a live-in boyfriend, and Sam is a stepchild adopted from her third marriage.

Even before her casual drug use turned to addiction, Dominguez admits she probably wasn't a perfect parent.

"I was on welfare for 10 years," she said. "I'd never worked in my life. I never grew up until I was 30; I never learned how to pay rent or pay bills."

It wasn't until Dominguez was 27, though, with four kids and two divorces, that life started to turn truly bad.

The man in her life that year brought home cocaine. Like she had with other drugs, she tried it.

"I started snorting it, then I learned how to cook it into crack," she recalled. "Then, somebody said, if you think that's good, try this."

"This" was meth.

A drug comprised of ephedrine, lithium and other corrosive chemicals, methamphetamines were developed at the turn of the century by the Japanese as a decongestant, said Johnson, who has researched the drug extensively as it has grown in prevalence with his Mercer House clients. Similar drugs were used to keep U.S. pilots awake during World War II and were abused by Adolph Hitler, Johnson said.

It wasn't until the mid-1990s that the drug hit American streets as an "upper," professed for its euphoric highs, weight-loss benefits and energy boosts.

While many drugs available today are addictive, meth is among the worst, according to experts.

For example, Johnson explained, while less than 10 percent of drinkers will become alcoholics, more than 80 percent of first-time meth users become addicted. Those users range from people experimenting, teenagers and young women concerned about their body image, and existing junkies searching for a new high, to upper-class members of society looking for stimulants to make them more productive at work.

'I was the worst of the worst'

For Dominguez, like many others, it took just one snort. She sniffed the drug in a powder substance, smoked it, and finally began injecting it into her veins for a quicker high.

"The minute (the woman who introduced me to meth) stuck that needle in my arm, I had to have it," she said. "I was an instant addict."

Dominguez's life began to revolve around finding the "next score," especially after the drug's euphoric effects turned into violence, paranoia and need.

"I lost my house. I lost everything I owned. I sold everything," she said. "I would trade my welfare checks, my food stamps to get more drugs."

She would hire baby-sitters -- first people she knew, later anyone who was available -- to watch her kids for whole weekends, so she could party.

She neglected to buy groceries for the children, spending her money instead on another "bump," or dose of the drug. She started selling the drug to support her own habit and became mixed up with Mexican drug lords and mafia members, building connections within the subculture to find more and more drugs.

"I was the worst of the worst," she confessed.

She even remembers her own drug dealer begging her to stop.

"He said, 'My uncle makes this, and if you knew what you were putting in your body,'" she recalled. "He said, 'If you quit, I will put up the deposit and two months' rent for you to get your life back together.'

"It's pretty bad when your dealer is trying to get you to quit," she said. "I couldn't do it."

Without money and desperate for more drugs, Dominguez made even more bad choices, marrying an illegal immigrant so he could get his Green Card and she and her family could have a place to live.

His son, Sam, joined her then-family of five living in squalor in an apartment as she furtively shot up and her new husband drank himself into oblivion.

Experts explain that the chemicals in methamphetamine produce an unnatural high in the brain of a user and eventually prohibit the person from producing their own natural mood-enhancing chemicals. After repeated use, the drug becomes the only way for a user to feel good.

Dominguez used more and more meth to sustain her highs, and her addiction began to take a toll, not only on her family and relationships, but on her body itself.

Drug-induced paranoia forced her to pull away from her mother and sister in an effort to hide her drug use and stay safe from the non-users she was convinced were "after her." She lost weight rapidly, dropping size after size in clothing.

The harsh chemicals in the drug caused her face to break out in sores, which she would pick at while in a drug-induced frenzy. Her hair was stringy, and she wore shirts with too-long sleeves to cover the track marks and bruises that extended from her biceps to wrists.

She accepted drugs from strangers, even after an acquaintance got a bad batch that burned through the skin on his arms after he injected it in his veins. She shared needles with her dealers and buyers, eventually contracting Hepatitis C.

She started seeing the "crank monsters" that appear to so many meth addicts in the throes of drug-induced hallucinations. She carried weapons to protect herself from the imaginary demons.

She would inject so much meth into her body that she lost the ability to move, nearly dying more than once.

She remembers being "up" for three weeks, then running out of money and slipping into withdrawal.

"My body would go into an almost comatose state," she said. "I was in my body, but I couldn't open my eyes or move. On two occasions, men broke into my house, and I could feel their hands on my body, but I couldn't move."

'We're not giving them back'

It was when Dominguez's mother heard about the strange men that she decided to take action.

In reality, men may have truly been in Dominguez's home, or they may have been part of the delusions caused by the meth.

Either way, though, her mother and sister realized that Dominguez's children were not safe.

"My mom heard me talking about (the men), and she thought, 'Those men could go down the hall to where the children are.' That pushed her," Dominguez said.

Dominguez's family members went to every agency they could think of to get help for the children -- and for Dominguez, if she would have it. They asked DFS to take the children away; they called the police repeatedly; they even sat down with Casper Police Chief Tom Pagel, then director of the state Division of Criminal Investigation.

"He had my name all over his desk. He knew who I was," Dominguez said of Pagel, whom she has never met but credits for his efforts to fight the meth epidemic in Casper.

In the late 1990s, though, meth was still a new plague in Casper, and the government agencies did not have the resources or expertise to deal immediately with Dominguez's case.

Finally, Dominguez recalled, her mother and sister called to ask to take the kids to McDonald's for dinner. She remembers thinking, "Good, I'll have more time to score."

When she came home that night, her house was surrounded by police cars.

"(My mom and sister) had called the police from McDonald's and said, 'We took the kids and we're not giving them back. Now, you make it legal."

The bare cupboards and empty refrigerator were enough to legally remove Dominguez's children and place them in the care of her mother and sister.

Today, Dominguez thanks the DFS workers and judge who took away the children. She thanks the police who took action against her. And she thanks her mother and sister for their courage.

"There have to be consequences that hurt bad enough," Dominguez said. "Losing your kids might not be bad enough for everyone, but that happened to be it for me."

But while it was the loss of her children that eventually scared Dominguez straight, it still would take years to end meth's hold on her life and start anew.

'Salvation Day'

Dominguez tried several times to quit her meth habit. She temporarily moved to West Virginia to meet her long-absent biological father and, while there, didn't touch meth. Instead, she substituted alcohol and marijuana, both readily available in her father's home. In Casper, she had two stays at Seton House, where she would temporarily stop using but invariably start again. She went through a six-week outpatient program, and later an inpatient program in Sheridan. She went to meetings of Alcoholics Anonymous and Narcotics Anonymous.

In the end, though, Dominguez believes it is faith that turned her life around.

Dominguez's mother and sister joined a church in her meth years and began taking her children to regular services. While in treatment and trying to regain custody of the children, Dominguez was forced to attend services in order to see her kids.

"I would sit and listen and think, 'These people are in a different world,'" she said. "My mom would say, 'Are you saved?' and I'd say, 'I don't know.' She said, 'If you were, you'd know.'"

To this day, Dominguez doesn't remember the day she last used drugs; instead, she remembers her "salvation date."

On Oct. 11, 1998, Dominguez was in church, listening to a sermon on integrity.

"I didn't know what that meant," she said. "But it meant saying what you think and mean, having one face and being up-front."

She chose, with the help of God, she said, to become a person of integrity, to put away the person she had become and turn into someone new.

The road back wasn't an easy one.

Dominguez "jumped through hoops" for both police and DFS for years, she said.

She had to cut ties with all her old acquaintances and, for a long time, lived in fear of dealers and mafia members coming after her for money. She kicked her alcoholic third husband out of the house and filed for custody of the stepson he abandoned with her. She slowly regained custody of her three youngest children, but the older twins, who remembered the abuse and neglect of their mother's drug days, refused to come home.

It was five years before Willy and Melly would leave their grandmother's home. Now 18, Willy avoids contact with his mother.

"I know they suffered," Dominguez said. "They all have issues in different ways as a consequence of my choices."

She thinks back in horror to the string of men who wandered through their home and the abuse the children likely experienced, not to mention the lack of food and attention from their mother.

She thinks about what she could have done, what she considered doing when she was high, paranoid and armed.

"I think of these children (killed by meth-using parents), and I think how close my kids got," she said.

"They're OK, though. They're going to be OK."

'I want to give back'

Dominguez has been clean for six years.

The majority of the people she used to associate with have been imprisoned, deported or killed, she said.

Ironically, she says it was her intense addiction that kept her from climbing higher on the ladder of dealers in Casper -- and from ending up in prison.

Dominguez is working for Mountain Plains Agricultural Services, where she puts the Spanish language skills she learned from years in the drug world to good use. It's a job she says she loves.

She and five of her children live in a house she recently bought in Casper and attend church regularly. Thanks to her mother and sister, the children were brought up with Christian values that Dominguez said she believes protect them from following in her footsteps.

She is open with her drug addiction with everyone, including the kids.

"I try to brainwash them," she said. "I tell them they can't ever try it. They've got a double-whammy. Their mother was an addict and their fathers were all alcoholics and addicts. They'll each have to make their own choice about alcohol, but they don't like to be around it. And there's no such thing in our family as 'it's OK to smoke one joint.'"

Dominguez says she believes it is her mission in life to share her story with others -- to help the community see the depth of the meth epidemic and to help other users turn their lives around.

"My greatest pleasure is running into somebody I used to sell to or use with who has changed their life," she said. "There are a lot still out there who are still using. That kills me; I feel responsible."

Dominguez said she still is working to make peace with the lost years of her life, but believes that good can come of all sorts of evils.

"I think God said, 'See, you didn't waste all those years,'" she said. "'You have six kids, and it doesn't matter that they have no fathers. They are still a beautiful gift.'

"I'm going to do whatever his will is for my life," she said. "I want to give back to this community I took so much from."

Staff writer Jenni Dillon can be reached at (307) 266-0619 or Jenni.Dillon@casperstartribune.net.

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January 3rd, 2005

NIH Action Plan Charts Future Challenges for Liver Disease Research
SourceURL:http://www.eurekalert.org

The National Institutes of Health (NIH) today released the trans-NIH Action Plan for Liver Disease Research, a comprehensive plan that addresses the burden of liver diseases in the United States and maps out challenges for future research. The Action Plan is available on-line at http://liverplan.niddk.nih.gov.

"Over the last 25 years medical research in liver disease has greatly improved the survival and quality-of-life of patients with liver disease," said Allen M. Spiegel, M.D., Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the NIH institute with lead responsibility for drafting the plan. "This trans-NIH plan summarizes challenges to advancing liver disease research and delineates the major goals for future research."

Goals of the Action Plan for Liver Disease Research include: Improving the success rate of therapy of hepatitis C. The currently recommended regimen of antiviral therapy results in long-term viral eradication in only 50-60 percent of patients; therefore, improved therapies are needed to benefit more patients with hepatitis C.

Developing noninvasive ways to measure liver fibrosis. Currently, liver biopsy is the standard means of evaluating the severity of liver disease both in clinical practice as well as in clinical trials of new therapies. Availability of reliable and safe means of measuring fibrosis (tissue scarring) and cirrhosis (excessive scarring and destruction of liver structure) would improve management of liver disease and facilitate clinical research.

Developing sensitive and specific means of screening individuals at high risk for early hepatocellular carcinoma (liver cancer). Liver cancer is often fatal and difficult to diagnose at an early stage when it is easier to treat and possible to cure by surgery. Simple and accurate diagnostic techniques could detect liver cancer early and improve patient survival.

Developing standardized and objective diagnostic criteria of major liver diseases and their grading and staging. Standards will benefit clinical research on all types of liver disease, including the evaluation of new diagnostic and therapeutic agents.

Decreasing the mortality rate from liver disease. Improved means of prevention and treatment should enable a decrease of at least 20 percent in the age-adjusted death rates from liver disease in the United States.

Liver disease is an important cause of sickness and death in the United States. According to statistics from the Centers for Disease Control and Prevention (CDC), liver and biliary (gallbladder) disease, including liver cancer, accounts for about 46,000 deaths each year and ranks ninth in overall causes of death. Because of the high rates of liver disease, liver transplantation is now considered standard therapy for patients with end-stage liver disease, regardless of diagnosis. Currently, about 5,000 liver transplants are performed yearly in the United States at more than 120 medical centers. As a consequence of the limited supply of livers, there are more than 17,000 persons on the liver transplant waiting list and at least 1,500 will die annually while waiting.

"Acute and chronic liver disease affects people of all ages, with the greatest burden among minority individuals and persons between the ages of 40 and 60," said Jay H. Hoofnagle, M.D., director, NIDDK's Liver Disease Research Branch. "The major focus of this Action Plan is to stimulate translation of basic research findings to practical and effective means of prevention and control of liver diseases, including such important conditions as hepatitis B and C, biliary atresia, liver cancer, alcoholic and nonalcoholic fatty liver, primary biliary cirrhosis, and autoimmune hepatitis. The explosion of knowledge about fundamental biology and genetics in the past 20 years now promises to provide significant improvements in management of liver disease and specific prevention of many of these important causes of disease and mortality among Americans."

In 2003, the NIH created the Liver Disease Research Branch to focus and accelerate research on liver disease at the NIDDK and to coordinate liver-related research across the NIH and among other federal agencies. The Branch worked with the Liver Disease Subcommittee of the congressionally authorized Digestive Diseases Interagency Coordinating Committee to coordinate the drafting of the Action Plan. Representatives from 17 NIH institutes and approximately 250 experts in liver disease research from across the country, including researchers, practicing physicians, academicians, representatives of liver disease professional societies, patient voluntary and non-profit groups, and other interested members of the public, participated actively in the development of the plan.

"This year-long process was open and inclusive and engaged a great number of scientists and experts in the field of liver disease research," said Hoofnagle. "We have highlighted specific goals for the next ten years that are focused upon further reducing the frequency and burden of liver disease."

Along with introductory and summary statements, each chapter of the Action Plan includes a background section, a summary of recent advances, a central section describing important future research goals, and a final section that outlines active steps to achieve each goal. A total of 214 research goals identified in the Action Plan are categorized by their degree of difficulty and time frame, with several research goals overlapping. The Action Plan also includes an implementation plan and a list of benchmark goals that will be used to gauge its effectiveness and success.

Source: NIH/National Institute of Diabetes and Digestive and Kidney Diseases

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Hemispherx Biopharma Initiates Enrollment in HIV/HEP-C Clinical Program; Clinical Trial with Ampligen in Collaboration with Esteve Laboratorios Targets HIV/HEP-C Twin Epidemics
SourceURL:http://www.medadnews.com

PHILADELPHIA--(BUSINESS WIRE)--Jan 3, 2005 - Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that its partner Esteve Laboratorios, Spain, initiated a clinical program to evaluate the antiretroviral effect of Ampligen in the treatment of patients infected by HIV-1 (with or without co-infection by HCV) and virological failure with a randomized pilot study in Phase II, controlled with standard treatment.

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(R) 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(R) in the patient population co-infected 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 Co-Infection

About 40% of people living with HIV are co-infected with HCV, with disproportional high co-infection 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 co-infected 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

Esteve is one of the largest pharmaceutical-chemical corporations in Southern Europe, with an international presence through subsidiaries in Italy and Portugal and worldwide licenses and distributors. Since 1960, Esteve has established strategic alliances with multinational pharmaceutical chemical companies to develop and market their products in Europe. Esteve has established its own successful research and development capabilities, developing new chemical entities and manufacturing active pharmaceutical ingredients with its research products marketed in over 90 countries.

More information about Esteve is available at www.esteve.com.

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(R) and the experimental immunotherapeutics / antivirals Ampligen(R) and Oragens(TM). 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(R)) 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(R) and Oragens(TM)) 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(R) do not imply that the product will ever be specifically approved commercially for these other treatment indication.

Contact Hemispherx Biopharma Investor Relations: Dianne Will, 518-398-6222 ir@hemispherx.net www.hemispherx.net or Investor Relations Group John Nesbett / Erik Lux 212-825-3210 jnesbett@investorrelationsgroup.com

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January 4th, 2005

Hepatitis C at Epidemic Levels among Young Injectors in London: Study
SourceURL:http://www.pharmabiz.com

London

Levels of hepatitis C among young injecting drug users across London are reaching epidemic levels, report researchers from Imperial College London, the Health Protection Agency and the London School of Hygiene and Tropical Medicine.

According to the study, published in the British Medical Journal, four in ten new young injectors now has hepatitis C, while three per cent are now infected with HIV.

Hepatitis C, which can cause serious and sometimes fatal liver damage, is mainly spread by sharing needles and syringes. Preventing HCV transmission among injecting drug users is critical to avoiding significant later health consequences in the population and associated treatment costs.

Dr Ali Judd, from Imperial College London, based at Charing Cross Hospital, and one of the authors of the study, comments: "Hepatitis C is now spreading at epidemic levels across London and HIV incidence is worryingly high, which if unchecked will lead to an increase in the total number of HIV infections. There is an urgent need for new and comprehensive programmes to tackle this growing problem."

The study was made possible through the use of saliva and blood spot tests for HCV and HIV developed at the Health Protection Agency Centre for Infections. Of those that were HCV negative or HIV negative at the first interview they found 42 per cent and 3.4 per cent were infected with HCV and HIV respectively one year later. The researchers also found high levels of syringe sharing, with one in four reporting injecting with needles and syringes that had been used by someone else in the last four weeks and one in two sharing other injecting paraphernalia.

The researchers believe a number of factors may have contributed to the rise in the incidence of HCV and HIV. These include a rise in the number of injectors, without any increase in the number of syringes distributed through syringe programmes, more risky injecting behaviour in newer injecting drug users, and greater levels of crack injection. There has also been a lack of targeted health promotion campaigns about hepatitis C in recent years.

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Health Officials Probe Hepatitis C Cases
SourceURL:http://wjz.com/

Baltimore, MD (AP) A vial of a radioactive solution, 12 hepatitis C cases and one death so far are the elements of a mystery health officials are pondering.

The cases were from a group of 16 people injected with the solution Oct. 15 for routine heart-stress testing, all from a single vial produced by a Timonium pharmacy run by Cardinal Health, the Dublin, Ohio-based company said.

Among them was John Leto, 80, a Brooklyn Park man who died of pneumonia on Christmas Day after suffering from hepatitis, a disease of the liver.

Investigators are now trying to learn how the 12 were infected, a probe that could take months to complete, said John Hammond, a spokesman for the state health department.

Cardinal said the investigation is focusing on the way the doses were prepared and not on the pharmaceutical tracer contained in the doses.

Prof. Fadia Shaya, who chairs the state council that evaluates the state's plan for monitoring and controlling hepatitis C, said the panel is following the case closely.

The University of Maryland School of Pharmacy professor said the needles used were prefilled and shipped to the institutions where the 16 people were tested. The virus could have entered the process at a number of points, she said.

"How does the tracer, container or the needle get infected? It could be any one of these," she said.

Shaya said it seemed unlikely that all of the needles filled from the vial could have been infected before they were filled, "but the whole event is unlikely, so all possibilities should be explored."

The federal Centers for Disease Control said recent studies have found the hepatitis C virus can survive on surfaces at room temperature for at least 16 hours, but no longer than four days. Medical and dental procedures in the United States generally do not pose a risk for spreading hepatitis C, but it has occurred in a few situations when supplies or equipment were shared, according to the CDC web site.

Hepatitis C is a liver disease caused by a virus of the same name. It can be transmitted when blood or body fluids from an infected person enters the body of a person who is not infected.

The disease causes between 8,000 and 10,000 deaths in the United States each year, according to the CDC.

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Counties Studying Law OK'ing Needle Sales
SourceURL:http://www.mercurynews.com
By Barbara Feder Ostrov

A new law that took effect Saturday will allow California pharmacies to sell needles without a prescription to help prevent HIV/AIDS and hepatitis C, but addicts can't head to their local drugstore for a clean fix just yet.

Local governments must approve such sales and, so far, only Contra Costa County has given the go-ahead. Most Bay Area public health departments are still studying the issue.

The legislation, introduced by state Sen. John Vasconcellos, D-San Jose, and signed into law last year by Gov. Arnold Schwarzenegger, permits pharmacists to sell up to 10 sterile syringes and needles at a time to people older than 18. Pharmacists must sign up to participate in a “demonstration” program that will be tracked by state health authorities for its usefulness in preventing disease.

Pharmacists' participation is voluntary, and life won't change for diabetics and other patients who routinely get prescriptions to purchase syringes to inject insulin or other medications.

Because previous laws have made it illegal to purchase or possess a syringe without a prescription, drug addicts have found themselves in a precarious position if they wanted clean syringes to protect themselves against disease. Some rely on California's 23 legally authorized needle exchange programs, while others buy them underground. Still others use dirty, blunt needles, known among drug users as "nails,'' said Joey Tranchina, who runs an authorized needle exchange program based in Redwood City.

Although some law enforcement groups opposed the legislation, it has been hailed by public health advocates as a welcome addition to their arsenal of methods to combat HIV/AIDS and hepatitis C transmission. Despite concerns that providing syringes on demand could encourage drug use, numerous studies of needle exchange programs have shown no evidence of that, Tranchina said.

More than a third of AIDS cases in the United States occurred in injection drug users or their partners or children, according to the Kaiser Family Foundation, a non-partisan think tank based in Menlo Park. In California, injection drug use accounts for 20 percent of all reported AIDS cases, making it the second-largest risk factor for the deadly disease.

“It's not a panacea, just like needle exchange is not a panacea, but we think it will help some,” said Dr. Wendel Brunner, director of public health for Contra Costa County, whose supervisors approved pharmacy syringe sales in mid-December.

In Santa Clara County, public health experts will soon meet with law enforcement groups and pharmacists to develop a program to take to county supervisors, said county health spokeswoman Joy Alexiou.

San Jose Police Chief Rob Davis said he's keeping an open mind about the new law but has concerns that the extra source of syringes could mean more used needles on the street, potentially endangering the public and his officers.

“There are a lot of question marks,” he said.

In San Mateo County, supervisors have been asked to reconvene a needle exchange task force to consider whether to allow non-prescription syringe sales in pharmacies, but a final recommendation is not expected until the spring, said Dr. Scott Morrow, the county's health officer.

In Santa Cruz County, “we haven't gotten too far yet,” said Leslie Goodfriend, health services manager for the county's health services agency. But prospects for approval look promising, with Goodfriend noting that the county has always supported needle exchange programs – “anything that can help reduce HIV/AIDS or hepatitis C.”

Pharmacies are also waiting for more information. Walgreens spokeswoman Phyllis Proffer said the chain had not made a decision on whether it would participate in the program.

Tranchina, executive director of the AIDS Prevention Action Network in Redwood City, says it's unclear how many of the estimated 15,000 to 20,000 injection drug users in the county would visit a pharmacy to purchase clean needles, even if those needles were sold for pennies. But someone who might be intimidated by a needle exchange program in a grim neighborhood might feel more comfortable going to a pharmacy, he said.

“We welcome all avenues,” Tranchina said. “This is a battle of survival. Every uptick in HIV increases the chance that one of our kids is going to have to live with it, and so much of it is unnecessary. This is low-hanging fruit. Why not pick it?”

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January 5th, 2005

Physician on Medical Staff at Baylor University Medical Center Predicts Prevalence of Hepatitis C in Texas
SourceURL:http://press.arrivenet.com

Researcher Says Disease Will Strain the State's Hospitals and Transplant Units

DALLAS, Jan. 5 /PRNewswire/ -- Using a sophisticated disease prediction model, Gary L. Davis, M.D., Director of the Division of Hepatology, and colleagues on the medical staff at Baylor University Medical Center at Dallas, estimated that 387,395 Texans are infected with the hepatitis C virus (Baylor University Medical Center Proceedings, January 2005 issue, paper can be found at http://www.baylorhealth.com/ ). The incidence ranges from 1.25 percent to 2.63 percent in Texas counties. While incidence is highest in counties along the United States and Mexico border, the actual number of cases is highest near major metropolitan areas.

Hepatitis C (HCV), a liver disease caused by the HCV found in the blood, is an important public health issue. Most infected persons do not realize they have the virus because they do not feel ill until late in the course of the disease.

While new cases of infection will decline in the future, Dr. Davis and colleagues predict that more people who already have HCV infection will experience progression of liver disease -- to cirrhosis and hepatocellular carcinoma, for example. Chronic HCV is the most common indication for liver transplantation in the U.S., affecting 50 percent of all patients receiving liver transplants. And, the disease frequently recurs following liver transplantation, sometimes leading to cirrhosis and liver failure a second time.

"Hepatitis C is common in Texas and will result in an increase in complications of cirrhosis in coming years. The disease will tax health care facilities and transplant units throughout the state," said Dr. Davis. "To meet this challenge we need to see urgency in identifying HCV-infected patients, continue to research and develop more effective therapies, and increase long-term, recurrence-free posttransplantation survival."

Nationally

On a national level, the estimated prevalence of HCV is as high as 1.8 percent or approximately 4 million people. Dr. Davis predicts that in the next two to three decades, the need for liver transplantation will continue to far exceed the capacity of transplant centers in the U.S. as a result of the increasing duration of HCV among the people infected with the disease.

"The peak time for new infections was the early 1980s, so more than half of people with chronic HCV have now had their infection for more than 20 years. As a result, they have had time to develop cirrhosis and other complications of the infection. This risk will increase even more over the next 10 to 20 years," said Dr. Davis.

In a study published by Dr. Davis in Liver Transplantation in April 2003, he emphasized that while the number of people with the disease is large, the U.S. health system can manage the current volume. But as these infected patients age and their disease progresses, he expects a large proportion of patients will develop liver failure, liver cancer and cirrhosis; the incidence of these complications may double by 2020. As a result, the burden on the health care system will increase substantially.

"Despite the effectiveness of current antiviral treatments, our study model clearly shows that the majority of cases of advanced liver disease are not currently preventable," said Dr. Davis. "Today, there are not enough organs for all of the patients who need transplants. We need for greater access to transplantation through increased organ donation and the use of living donor liver transplants. Future research into xenotransplantation (animal to human transplants), artificial liver support devices, and stem cell technology also may offer options for these patients."

Baylor University Medical Center at Dallas, a not-for-profit medical center, is a major patient care, teaching and research center for the Southwest. The nationally acclaimed Baylor University Medical Center serves as flagship hospital for Baylor Health Care System. The 2004 U.S. News & World Report "America's Best Hospitals" guide marked the 12th consecutive year Baylor University Medical Center at Dallas was ranked. For more information, call 1-800-4BAYLOR or visit http://www.baylorhealth.com/. Baylor University Medical Center at Dallas

CONTACT: Wendy Walker of Baylor University Medical Center at Dallas, +1-214-820-4581, or wendyw@baylorhealth.edu

Web site: http://www.baylorhealth.com/

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January 6th, 2005

Elevated Prevalence of Hepatitis C in United States Veterans
SourceURL:http://www.gastrohep.com

The prevalence of hepatitis C in users of veterans' medical centers exceeds the estimate from the general US population by more than 2-fold, likely reflecting more exposure to traditional risk factors among these veterans, finds a report in January's Hepatology.

Several studies suggest veterans have a higher prevalence of hepatitis C virus infection than nonveterans, possibly because of military exposures.

Dr Dominitz and colleagues from Seattle, Washington undertook a study in order to estimate the prevalence of anti-hepatitis C antibody and evaluate factors associated with infection among users of Department of Veterans Affairs medical centers.

The researchers collected 1,288 completed surveys out of 3,863 that were given to randomly selected veterans.

Veterans had also undergone home-based phlebotomy for serological testing.

The research team used administrative and clinical data to correct the prevalence estimate for nonparticipation.

The researchers found that the prevalence of anti-hepatitis C antibody among serology participants was 4%.

At least 1 traditional risk factor (transfusion or intravenous drug use) was reported by 30% of all subjects—Hepatology

The research team noted that the estimated prevalence in the population of Veterans Affairs medical center users was 5% after correction for sociodemographic and clinical differences between participants and nonparticipants.

The researchers found that significant predictors of seropositivity included demographic factors, period of military service (e.g., Vietnam era), prior diagnoses, health care use, and lifestyle factors.

At least 1 traditional risk factor (transfusion or intravenous drug use) was reported by 30% of all subjects.

The investigators found that among those testing positive for hepatitis C antibody, 78% either had a transfusion or had used injection drugs.

When the team had adjusted for injection drug use and nonparticipation, they found that seropositivity was associated with tattoos and incarceration.

Military-related exposures were not found to be associated with infection in the adjusted analysis.

Dr Dominitz concluded, "The prevalence of hepatitis C in these subjects exceeds the estimate from the general US population by more than 2-fold, likely reflecting more exposure to traditional risk factors among these veterans."

Hepatology; 2005: 41:88-96

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Coley Reports Results from Phase I Studies of Actilon(TM) for Hepatitis C
SourceURL:http://press.arrivenet.com

Antiviral Activity Demonstrated in Interim Phase Ib and Consistent with Phase Ia Dose Tolerance, Pharmacokinetics and Immune Response Findings

WELLESLEY, Mass., Jan. 6 /PRNewswire/ -- Coley Pharmaceutical Group, Inc. today announced results from the company's Phase Ia study in normal volunteers and Phase Ib dosing of Hepatitis C patients with Actilon(TM) (CPG10101), the company's lead antiviral TLR Therapeutic(TM). Actilon is a first-in-class Toll-like receptor 9 (TLR9) agonist initially being developed for the treatment of Hepatitis C.

The Phase Ia trial of Actilon in forty healthy volunteers demonstrated that the compound is well tolerated over a wide dose range, and that small subcutaneous doses induce measurable, dose-related immune responses consistent with the known pharmacologic mechanisms of this new class of antiviral activity drugs. The same range of doses were administrated twice weekly for four weeks to adults with chronic Hepatitis C virus (HCV) infection who had relapsed after, or were intolerant of, prior interferon therapy. One-third of these patients showed at least a 1.0 log reduction in HCV RNA (range 1.0 to 2.6).

"Coley staff is very pleased by the consistent and clear results in these randomized Phase I studies. The data confirm our expectations regarding Actilon's TLR9-mediated antiviral activity which was observed over a wide range of tolerable dose levels," said John Whisnant, M.D., Coley's Senior Vice President, Drug Development. "I am also encouraged by the fact that Actilon demonstrated antiviral activity even among patients with genotype 1 HCV, the viral genotype which is most difficult to treat. These results provide us with important insights on dosing regimens for further development."

"Actilon showed the predicted two phases of drug activity now characteristic of TLR9 Therapeutics. The early phase helps restore innate immune functions which are commonly dysfunctional in Hepatitis C infected hosts. This occurs through TLR9 activation of dendritic cells, leading to early antiviral cytokine and cellular changes. Actilon is designed then to drive long-term adaptive immune response, also through TLR9 and dendritic cells, to sustain the virus reduction," Dr. Whisnant added.

Detailed Study Results

The Phase Ia study, designed to assess the compound's safety, dose tolerability and immunological activity, randomized forty healthy volunteers within five sequential dosing cohorts (0.25, 1, 4, 10, or 20 mg). Two subcutaneous injections were administered double-blind fourteen days apart and subjects were evaluated for a total of 29 days. Researchers observed an immune system response demonstrating drug-related increases in interferon alpha (IFN-alpha) levels and other markers indicative of antiviral activity. Volunteers had no drug-related serious adverse events or dose-limiting toxicities. Mild injection site reactions and mild-to-moderate flu-like symptoms were consistent with the pharmacological mode of action of Actilon.

The ongoing Phase Ib study is evaluating anti-viral responses among chronic Hepatitis C patients as well as the safety and tolerability of twice weekly Actilon over the same dose range (0.25, 1, 4, 10, and 20 mg). Adult patients, who had relapsed after or were intolerant of prior IFN-alpha therapy were randomized to receive Actilon or a placebo two times weekly for four weeks with monitoring for up to four additional weeks (eight weeks total). Of 18 patients evaluated to date at the 1, 4, and 10 mg dose levels, six (33 percent) have demonstrated early viral level reduction equal to or better than 1.0 log decrease (or 90 percent) during the four weeks of treatment. The viral level reduction observed was consistent with the elevation of IFN-alpha and other markers associated with an antiviral immune response. Dose tolerance and laboratory safety were the same in HCV patients as in normal volunteers.

Both the Phase Ia and interim Phase Ib data were presented at national scientific meetings last fall. Phase Ia dose tolerance, pharmacokinetic (PK) and immune response data were presented at the 44th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in Washington DC., USA. Phase Ib data, including antiviral response, were reported at The American Association of Liver Disease (AASLD) meeting (November 2004) in a poster entitled "Human Pharmacologic Activity of a New TLR9 Agonist Antiviral, CPG 10101" in Boston, MA, USA.

About Actilon

Actilon is one of Coley's TLR Therapeutic(TM) family of compounds, a new class of investigational pharmaceutical products which activate and direct the immune system. Actilon is designed to act through the toll-like receptor 9 (TLR9) found in dendritic cells and B cells to induce a durable and natural immune response against the Hepatitis C virus. The compound is also designed to not only stimulate the body's own production of anti-viral interferons, but to also drive both early and sustained virus-specific memory immune responses to help clear the viral infection.

About Hepatitis C

According to the Center for Disease Control (CDC), approximately 200 million people worldwide are infected with the Hepatitis C virus (HCV), a blood-borne infectious disease of the liver and the leading cause of cirrhosis and a cause of liver cancer. An estimated four million people in the United States carry the Hepatitis C virus, and approximately 85 percent of those infected with the virus will progress to chronic infection. Further, 70 percent of those who are infected will develop chronic liver disease, making HCV the leading cause of liver transplants in the U.S. Currently, the most common treatments for Hepatitis C are recombinant forms of interferon alpha (IFN-alpha) intended to mimic the body's natural immune response in suppressing the virus. These therapies may be limited by toxicities and by viral resistance among some patients.

About Coley Pharmaceutical Group

Coley Pharmaceutical is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of drugs that direct the human immune system to treat cancers, infectious diseases, asthma and allergy. Coley has partnered programs with Sanofi-Aventis, Chiron, GlaxoSmithKline and the United States Government. For further information please visit http://www.coleypharma.com/.

Coley Pharmaceutical Group

CONTACT: Charles Abdalian, Senior Vice President and CFO of Coley

Pharmaceutical Group, +1-781-431-9000, Ext. 1244, cabdalian@coleypharma.com; or Karen L. Bergman, +1-650-575-1509, kbergman@bccpartners.com, or Michelle Corral, +1-415-794-8662, mcorral@bccpartners.com, both of BCC Partners (US)

Web site: http://www.coleypharma.com/

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ViroPharma Announces Submission of Investigational New Drug Application for HCV-796
SourceURL:http://www.primezone.com

EXTON, Pa., Jan. 6, 2005 (PRIMEZONE) -- ViroPharma Incorporated (Nasdaq:VPHM) today announced that its partner in the development of antiviral compounds targeting hepatitis C (HCV), Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE) has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration to evaluate ViroPharma's compound HCV-796, a novel polymerase inhibitor, as a potential new product to treat hepatitis C. Under this IND, a protocol has been prepared to assess the safety and tolerability of HCV-796 in healthy adult volunteers, as well as to gather pharmacokinetic data. Preclinical studies have shown HCV-796 may be more potent than other anti-HCV compounds developed to date between the two companies.

"The filing of this IND represents an additional step in our goal to identify new drugs to combat hepatitis C and we are excited to kick off the development of this promising molecule," said Dr. Colin Broom, ViroPharma's chief scientific officer. "We now have two anti-HCV compounds in development. We expect to begin dosing patients in the HCV-796 trial later this quarter, and hope to initiate proof of concept studies with the compound during the second quarter of 2005. In addition, our proof of concept trial with HCV-086 is moving forward expeditiously, and we continue to expect to have the data from the trial available later this quarter. It is our hope that we may one day offer patients suffering from hepatitis C an efficacious and well-tolerated option to the currently available therapies."

ViroPharma and Wyeth are engaged in a collaboration to develop and commercialize antiviral compounds to treat HCV.

About hepatitis C

Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.

About ViroPharma Incorporated

ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R) Pulvules(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/Vancocin_PI.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at www.viropharma.com

Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties, including those relating to the company's anticipated schedule relating to its HCV clinical development schedule as well as its ability to find an effective small molecule antiviral treatment for HCV disease. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. Conducting clinical trials for investigational pharmaceutical products is subject to risks and uncertainties. There can be no assurance that ViroPharma's studies as part of the HCV program can be conducted within the timeframe that the company expects, that such studies will yield positive results, or that ViroPharma will be successful in gaining regulatory approval of any of its HCV product candidates. These factors, and other factors, including, but not limited to those described in ViroPharma's quarterly report on Form 10-Q for the quarter ended September 30, 2004 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.

CONTACT: ViroPharma Incorporated

Will Roberts

Director, Corporate Communications

Phone (610) 321-6288

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Penal Reform Trust Slams Mandatory Drug Tests for Prisoners
Source: Ireland Online

The Irish Penal Reform Trust has criticised Justice Minister Michael McDowell's plans to introduce mandatory drug testing in all Irish prisons.

The trust said today that the plan would have no impact on drug abuse among inmates and could even make the problem worse.

It said a comprehensive drug treatment programme to help reduce the spread of HIV and Hepatitis C in prisons would be a better use of resources.

IPRT director Rick Lines said evidence from other countries showed that mandatory testing was ineffective and counterproductive.

"It has, in fact, had an influence in encouraging people to switch their drug of choice and their method of drug use from smoking cannabis to injecting heroin," he said.

"This is specifically because injecting heroin is less easily detected by drug-screening kits. As a result, you have a situation where you're increasing the risk of transmission of HIV and Hepatitis C in prisons while not making a significant dent in the overall levels of drug use."

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January 7th, 2005

Schering-Plough's Pegintron Also Effective in Hepatitis B
SourceURL:http://uk.biz.yahoo.com

Results from a large international clinical study have shown that Schering-Plough's hepatitis C therapy PegIntron produced sustained responses in patients with chronic hepatitis B.

Results from a large international clinical study have shown that Schering-Plough's hepatitis C therapy PegIntron produced sustained responses in patients with chronic hepatitis B.

The investigator-initiated study, which was published in medical journal The Lancet, is the largest clinical trial to date with peginterferon alfa-2b therapy (PegIntron) for chronic hepatitis B.

"Our study showed that patients with chronic hepatitis B responded to peginterferon alfa-2b, and achieved higher sustained response rates than is typically seen with any other antiviral treatment," said lead investigator Dr Harry Janssen, from the Erasmus Medical Center in Rotterdam, The Netherlands.

"Based on our findings with peginterferon alfa-2b, it is appropriate to consider this therapy as a first-line treatment for HBeAg-positive chronic hepatitis B," he continued.

The findings of this study are significant as chronic hepatitis B currently affects an estimated 400 million people worldwide, making it one of the most common infectious diseases and one of the ten leading causes of death. Current antiviral therapies, such as the nucleoside analogues lamivudine (GlaxoSmithKline (LSE: GSK.L - news - msgs) 's Zeffix) and adefovir, do not achieve a durable response.

The study, organized and sponsored by the Foundation for Liver Research (SLO), is the first to assess whether prolonged treatment with peginterferon alfa-2b, alone or in combination with lamivudine improves sustained treatment response in patients with HBeAg-positive chronic hepatitis B. HBeAg indicates that the virus is actively replicating and the infected person is highly infectious.

In the study, more patients in the lamivudine combination group had a response to therapy at the end of treatment, but the response was not sustained during the follow-up period. There is growing evidence that only a complete and vigorous hepatitis B virus (HBV)-specific immune response is capable of achieving control and elimination of the virus, preventing disease progression.

"This suggests that induction of a host immune response is necessary for sustained response to hepatitis B treatment, which can only be reached by immunomodulatory therapy, such as peginterferon alfa-2b," Janssen said.

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Noninvasive Assessment of Liver Fibrosis
SourceURL:http://www.gastrohep.com

Noninvasive assessment of liver stiffness with transient elastography appears a reliable tool to detect significant fibrosis or cirrhosis in patients with chronic hepatitis C, reports January's issue of Hepatology.

Liver fibrosis is the main predictor of the progression of chronic hepatitis C, and its assessment by liver biopsy can help determine therapy.

However, biopsy is an invasive procedure with several limitations.

A new, noninvasive medical device based on transient elastography has been designed to measure liver stiffness.

Dr Beaugrand and colleagues from France undertook a study in order to investigate the use of liver stiffness measurement (LSM) in the evaluation of liver fibrosis in patients with chronic hepatitis C.

The researchers enrolled 327 patients with chronic hepatitis C prospectively in a multicenter study.

Patients underwent liver biopsy and LSM. 2 pathologists then assessed METAVIR liver fibrosis stages on biopsy specimens.

Liver stiffness measurement was well correlated with fibrosis stage—Hepatology

LSM was performed by transient elastography.

The research team determined the efficiency of LSM and optimal cutoff values for fibrosis stage assessment using a receiver-operating characteristics (ROC) curve analysis and cross-validated by the jack-knife method.

The researchers found that liver stiffness measurement was well correlated with fibrosis stage.

The research team noted that the areas under ROC curves were 0.79 for F=2, 0.91 for F=3, and 0.97 for F = 4; for larger biopsies, these values were, respectively, 0.81, 0.95, and 0.99.

Optimal stiffness cutoff values of 8.7 and 14.5 kPa showed F=2 and F = 4, respectively.

Dr Beaugrand concluded, "Noninvasive assessment of liver stiffness with transient elastography appears as a reliable tool to detect significant fibrosis or cirrhosis in patients with chronic hepatitis C."

Hepatology; 2005: 41:48-54

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Cardiac Alterations in Cirrhosis: Reversible after Liver Transplant
SourceURL:http://www.gastrohep.com

Researchers report in January's Journal of Hepatology that cardiac alterations in cirrhosis presenting with mild increases in ventricular wall thickness, and diastolic dysfunction that worsens with ascites and physical stress, can be reversed by liver transplantation.

Liver cirrhosis induces cardiac alterations.

Dr Genescaa and colleagues from Barcelona, Spain undertook a study in order to define these alterations and assess their reversibility after transplantation.

The researchers oversaw echocardiography and stress ventriculography for 40 cirrhotic patients and 15 controls.

The research team reevaluated 15 cirrhotics 6–12 months after transplantation.

The researchers found that cirrhotics had higher left ventricular wall thickness and ejection fraction than controls.

Basal diastolic function was similar.

During stress, cirrhotics presented lower increases of heart rate, left ventricular ejection fraction, stroke volume and cardiac index, and diastolic dysfunction with lower ventricular peak filling rate.

Ascitic patients exhibited more diastolic dysfunction at rest and during stress compared to non-ascitic patients—Journal of Hepatology

The researchers noted that exercise capacity was reduced and ascitic patients exhibited more diastolic dysfunction at rest and during stress compared to non-ascitic patients.

Liver transplantation caused regression of ventricular wall thickness and improvement of diastolic function.

The researchers also noted normalization of systolic response and exercise capacity during stress (significant increases in heart rate, ventricular ejection fraction, stroke volume and cardiac index).

Dr Genescaa concluded, "Cardiac alterations in cirrhosis present with mild increases in ventricular wall thickness, diastolic dysfunction that worsens with ascites and physical stress, and abnormal systolic response to stress limiting exercise capacity."

"Liver transplantation reverses these alterations."

Journal of Hepatology; 2005: 42 (1): 68-74

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Caffeine Reduces Risk of Elevated Alanine Aminotransferase
SourceURL:http://www.gastrohep.com

In a large study including persons at high risk for liver injury, consumption of coffee and especially caffeine has been found, in the most recent issue of Gastroenterology, to be associated with lower risk of elevated alanine aminotransferase activity.

Dr Ruhl and colleagues from Maryland in America designed a study to investigate whether coffee and caffeine consumption reduced the risk of elevated alanine aminotransferase (ALT) activity in persons at high risk for liver injury.

In this national, population-based study the researchers recruited a total of 5944 adult participants from the Third US National Health and Nutrition Examination Survey, 1988–1994.

The participants exhibited excessive alcohol consumption, viral hepatitis, iron overload, overweight, or impaired glucose metabolism.

Liver injury was indicated by abnormal serum ALT activity (>43 U/L).

The researchers found elevated ALT activity in 8.7% of this high-risk population.

In unadjusted analysis, the research team noted that lower ALT activity was associated with increasing consumption of coffee and caffeine.

Relationships were relatively unchanged when analyses included the entire population —Gastroenterology

The researchers performed multivariate logistic regression analyses in order to show that risk of elevated ALT activity declined with increasing intake of coffee and caffeine.

The research team found that on comparing persons who drank more than 2 cups per day with noncoffee drinkers, the odds ratio was .56.

Comparing persons in the highest caffeine quintile with the lowest, the odds ratio was .31.

The researchers found that these relationships were consistent across subgroups at risk for liver injury.

Relationships were relatively unchanged when analyses included the entire population or when limited to persons without impaired liver function or right upper quadrant pain.

Fasting insulin concentrations did not mediate the effects.

Dr Ruhl concluded, "In this large, national, population-based study, among persons at high risk for liver injury, consumption of coffee and especially caffeine was associated with lower risk of elevated ALT activity."

Gastroenterology; 2005: 128 (1)

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Mouse to Help Fight Hepatitis-C
Source: Indo-Asian News Service

[Health India]: Ahmedabad, Jan 7 : A genetically engineered mouse will soon be used in a new initiative by Indian and German scientists to prevent hepatitis and other communicable diseases.

Under an agreement to be signed in March by the German Research Centre for Biotechnology (GBF) and the Indian Council of Medical Research, scientists will develop a mouse that would be infected with the hepatitis-C virus, said Rudi Balling, GBF's director.

"So far, it has been impossible to create a study model for the disease. But we are trying our best since a mouse in many cases behaves like humans," Balling told IANS on the sidelines of the Indian Science Congress here.

The mouse would receive human immune cells derived from the umbilical cord of a foetus and be infected with the "hepatocides" that cause the Hepatitis-C disease.

"It would help in our study to a great extent," said Balling, whose organisation does a lot of work with "mouse genetics".

The hepatitis-C virus is transmitted in humans by sexual contact and there is currently no vaccine for it.

The study with the mouse would be the first initiative of the new agreement.

Later, Indian and German scientists would focus on government-sponsored studies on rheumatoid heart diseases and communicable diseases.

"Diseases in Germany were very different from those in India sometime ago," noted Balling.

"But things are changing. Pathogens such as viruses and bacteria need no passport to cross boundaries.

"People in Germany are becoming increasingly susceptible to diseases found in this part of the world, because immunity levels have been decreased by the large number of surgeries and chemotherapies conducted there.

"Also people live longer, and generally get vulnerable as they grow old," said Balling, who has tied up with doctors in Delhi and plans to meet researchers in Pune.

Indo-Asian News Service

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January 8th, 2005

Hepatitis C Poses Threat of Big Crisis
www.newsday.com
BY DELTHIA RICKS
STAFF WRITER

The prevalence of hepatitis C is growing citywide and could spawn an epidemic of staggering proportions unless steps are taken now, health experts said Friday.

Doctors, researchers, community activists and people with the infection testified in Manhattan before members of two state Assembly committees asking legislators to take action to prevent an unprecedented increase in the blood-borne disease within a decade. The infection can cause irrevocable liver damage. Experts say an epidemic could overwhelm public and private health systems and overload waiting lists for transplantable livers.

"This is just the start of a tidal wave that is going to hit in 2015 to 2020," said Dr. Alain Litwin, an infectious-disease expert from Albert Einstein School of Medicine in the Bronx. Litwin and other doctors said they know an epidemic is in the making because hepatitis C is being diagnosed with increasing frequency, and is the No. 1 opportunistic infection causing death in people with AIDS throughout the city.

An estimated 200,000 to 300,000 people in the city may be infected, experts said, and many may be unaware because of the disorder's long latency. Symptoms can take up to 20 years to manifest.

"There is potential for a crisis in the city and the state," said Dr. Isaac Weisfuse, deputy commissioner of infectious disease control of the New York City Department of Health and Mental Hygiene. Weisfuse attributed the growing problem to an increasing use of the street-drug crystal methamphetamine. Sharing needles and other drug paraphernalia is spreading the virus at an alarming rate, he said.

Experts Friday argued that, statewide, hundreds of thousands of other cases of hepatitis C are probably going undiagnosed, and that legislators should put strong outreach plans in place to provide drug counseling and treatment. The infection can be effectively controlled with medications when caught early.

Weisfuse said the rising number of cases in New York mirrors a national trend. The Centers for Disease Control and Prevention estimates within a decade there will be a 279 percent increase in the incidence of liver damage nationwide due to hepatitis C, a 528 percent increase in the need for transplantation, and a 223 percent increase in the liver-related death rate.

Hepatitis C is one in a family of infectious viruses that attack the liver. Hepatitis A and B, whose prevalence also is rising in New York, are preventable through vaccines. All three can be transmitted through blood, by sharing needles, for example. Hepatitis C and B also can be transmitted sexually. Hepatitis A is noteworthy as a contaminant of food and water.

Community activists Friday called on state legislators to increase funding for vaccine programs to aid the uninsured. But while they sought greater access to vaccinations, they sounded their strongest pleas for help with hepatitis C.

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Health Worker May Be Source of Hepatitis C
Tammy Fonce-Olivas
El Paso Times

A health-care worker at Sierra Medical Center, who also worked at Beaumont Army Medical Center, might have exposed patients to the hepatitis C virus, officials of Sierra Medical said Friday in a written statement to the news media.

Beaumont last month confirmed that eight people had contracted the virus at the hospital. Hepatitis C is a blood-borne infection typically passed through contact with blood of the infected person.

About 200 people who came in contact with the infected people have since been tested, and an additional six cases of hepatitis C have been confirmed, Beaumont spokesman Clarence Davis III said.

In those six cases, further testing is being done to determine whether they came from the same source.

The only Beaumont patients who risked exposure were those who had surgery between July and October 2004, he said.

Officials of Sierra could not be reached for comment Friday. However, the Sierra Providence Health Network issued a statement Friday confirming that it had only one known case of hepatitis C -- that of the health-care worker.

"During September and October 2004, this individual worked a limited number of shifts on a part-time basis and had contact with a small number of patients, which the hospital has confirmed to be less than two dozen," the statement read.

Patients who might have come into contact with the health-care worker have been notified, according to the statement.

Officials at Beaumont said all precautions have been taken to prevent another incident.

"I want to reassure patients that we are safe. Patients can rest assured that we have done everything to prevent this outbreak from occurring again," Davis said.

Of the five types of hepatitis, an inflammation of the liver, hepatitis C is the most serious, according to the U.S. Centers for Disease Control and Prevention. Though it can be fatal, most people infected suffer only chronic infection or liver disease.

Most people who have the hepatitis C virus don't show any symptoms. Symptoms include jaundice, fatigue, dark urine, abdominal pain, loss of appetite and nausea, according to the Centers for Disease Control and Prevention.

Tammy Fonce-Olivas may be reached at tfonce@elpasotimes.com; 546-6362.

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