December 16^th – “Acupuncture: What’s New? What’s Old!” Includes Hands-on Activity

(Please Note: 3^rd not 2^nd Tuesday – This month only)

Uli Beyendorff^[1] – Acupuncturist, Herbalist – Hennepin Faculty Associates Alternative Medicine Clinic

December 21^st – LiverHope too – By Appointment

December 23^rd – Open Discussion

January 12th – “Benefits of Shiatsu for HCV”

Leslie Kenney – OBT (Oriental Bodywork Therapist) – Hennepin Faculty Associates Alternative Medicine Clinic

January 18th – LiverHope too – By Appointment

January 26th – Open Discussion

liverHope Meetings are:

7:00 - 9:00 PM, 2^nd and 4^th Tuesdays unless otherwise noted.

Shepherd of the Hills Lutheran Church

3920 North Victoria Street, Shoreview, MN

LiverHope Too Meetings are:

7:00 – 9:00 PM, 3^rd Sunday of the Month at Pat’s home:

901 Meadowwood Drive, Brooklyn Park, MN. Please enter the door facing the driveway. Call Pat at (763) 566-3839 for directions.

Are you newly diagnosed or do you want more information about Hepatitis C?

- Attend LiverHope too -

- By Appointment -

- December 21st, 2003 -

Happy Holidays!

In This Issue

Calendar............................................................................................. 1

NEEDLES AND HAYSTACKS...................................................... 1

Many Missed Opportunities for Hepatitis A Vaccination In HCV-Infected Patients 3

Largest Hepatitis A Outbreak in US Leaves Three Dead and is Linked to Green Onions 3

St. Louis University Will Test Hepatitis C Vaccine.................... 4

National Hepatitis C Advocacy Council Advances Hepatitis C Legislative Efforts 4

JOY IN THE JOURNEY.................................................................... 5

NEEDLES AND HAYSTACKS

The Economist – Oct. 30, 2003

Hepatitis C is a dangerous disease. This week delivered mixed news on novel treatments for it.

The world is full of nasty viruses, but the one that causes hepatitis C is particularly tricky. Medical science recognized decades ago that not all cases of hepatitis were caused by the two viruses (A and B) that had already been identified. But hepatitis C virus (HCV), which is spread mainly by contaminated blood from, for example, shared syringes, was not isolated and identified until 1989.

In 1999, the most recent year for which global figures are available, HCV was believed to have infected some 170 million people. Another 3 million join their ranks every year. Fewer than one fifth of those who catch the virus shake it off. In most cases it settles down to form a chronic infection of the liver, which, over the course of several decades, can lead to severe forms of liver damage such as cirrhosis and fibrosis, as well as cancer. According to the World Health Organization (WHO), hepatitis C kills around 500,000 people a year. It is less deadly than AIDS, which claims more than 3 million lives annually. However, its higher prevalence (at the moment, some 42 million people are infected with HIV, the virus that causes AIDS), longer incubation period, and the absence of effective drugs, mean that it is potentially a more lethal epidemic.

News of a way to tackle HCV would therefore be welcome. Hence the enthusiastic headlines, which greeted a report published by researchers from Boehringer Ingelheim, a German drug company, in this week's online issue of NATURE, and also presented at the annual meeting of the American Association for the Study of Liver Diseases, in Boston. Daniel Lamarre and his colleagues have shown that a molecule code-named BILN2061 can block the activity, both in the test tube and in experimental animals, of an HCV protein called NS3 protease, without which the virus cannot go about its business. More significantly, the drug also seems to work in people. Patients infected with HCV who were given four doses of BILN2061 saw their viral burden plummet to almost undetectable levels within two days, although there was a slow rebound over the weeks after the last dose was given.

On the face of it, this is a particularly significant success, since these patients were infected with a strain of HCV called genotype 1, which is common in Europe and America, but which the existing therapy is unable to treat well. That therapy involves two drugs. One is a protein called alpha-interferon, which, as the name suggests, interferes with the virus directly, as well as stimulating the body's immune system to attack the invader. The other is ribavirin, which gums up HCV's ability to replicate. However, only 40% of those infected with genotype 1 respond to this cocktail, for reasons researchers have yet to understand fully.

The bad news is that, whereas BILN2061 looked safe in early animal testing and clinical trials, further experiments in monkeys have shown that, at doses many times higher than those given to patients, the drug can throw the heart seriously out of whack. That result need not, in turn, kill BILN2061. After all, it involves a significant overdose. But it does mean that Boehringer Ingelheim has halted all patient testing with BILN2061, and has returned to the drawing board to work out why BILN2061 has this effect.

(As reported in our July 2003 newsletter:

BREAKING NEWS

The clinical trials and research for Boehringer Ingelheim’s BILN 2061, a protease inhibitor, have been stopped due to cardiac toxicity. It is so disappointing because this drug showed such promise.

As reported in our April newsletter, BILN 2061 had reduced viral levels by a range of a hundredfold to more than a thousand fold in a small number of patients with chronic Hepatitis C, genotype 1, who took the drug orally for only two days.)

C-ING THE FUTURE

This story illustrates just how difficult it is to come up with effective new treatments for HCV. Matters are complicated by the fact that the virus is hard to grow in the laboratory and, until recently, the only animal "model" of the human disease was the chimpanzee, a species that it is impractical (and many would argue immoral) to use for industrial-scale research. Over the past few years, however, new cell-culture systems and mouse models have opened the way to further drug development, the fruits of which were also presented at the meeting in Boston.

NS3 is a popular target with research groups other than Boehringer Ingelheim's. Scientists at the Schering-Plough Research Institute, in New Jersey, for example, are developing their own inhibitor, and have just begun clinical trials with it. Meanwhile, Vertex Pharmaceuticals, a biotechnology company based in Cambridge, Massachusetts, has another anti-NS3 drug in the works. This substance, called VX-950, has been shown to block its target, at least in mice. The company hopes to test the drug in people next year. As John Thomson, the vice-president of research at Vertex, points out, just because Boehringer Ingelheim's compound has run into difficulties does not automatically dim the prospects of other protease inhibitors.

Meanwhile, others are attacking from different angles. Isis Pharmaceuticals, a biotech company based in Carlsbad, California, has seen encouraging results in patients given its "antisense" compound, which binds to the virus's genetic material and stops it reproducing. Other drugs highlighted in Boston tackle HCV's outer coat in an attempt to stop it binding to liver cells in the first stage of infection.

Among these is a compound from XTL Pharmaceuticals, based in Rehovot, Israel, which has just been tested on 25 chronic sufferers. The drug is a monoclonal antibody designed to lock on to, and block, one of HCV's outer features, called the E2 protein, which it needs to attach to its target cells. Roughly three-quarters of patients who received the compound saw a significant drop in their viral levels, with no serious side effects. As a result, XTL is testing the drug in HCV-related liver-transplant patients, in whom it is hoped that it will prevent the infection of the transplanted organ by hidden reservoirs of the virus. The firm hopes to have the results of the trials before the end of next year.

In practice, it is unlikely that any one medicine will be enough to beat HCV. Just as with HIV--and, indeed, the existing

interferon/ribavirin approach--a combination of drugs, attacking the problem from different angles, will probably be the most potent weapon. And as with AIDS, success in drug making will bring further difficulties. As Daniel Lavanchy, an infectious-disease specialist at the WHO, points out, existing treatments already cost $20,000, which puts them beyond the reach of most of the world's infected in developing countries. How much more will shiny new drugs, and the medical care needed to deliver them, add to the bill? While researchers struggle to find better ways to combat HCV, politicians will have an equally tough task--how to find the money to pay for them when they arrive.

Many Missed Opportunities for Hepatitis A Vaccination In HCV-Infected Patients

Vaccination against hepatitis A virus (HAV) is recommended for all patients with HCV because of the potential for severe, acute HAV infection that may be superimposed on chronic liver disease. Despite these vaccination recommendations, many HCV-infected patients go unvaccinated.

In a study, the proportion of patients diagnosed with HCV infection between January and June of 2000 who were tested for immunity against HAV and vaccinated according to published guidelines was determined. The patient was considered to need HAV vaccination if IgG antibody to HAV was absent. Follow-up was performed through June of 2002.

Of the 4, 322 patients tested for HCV, 743 were positive. After exclusion of 105 HIV+ patients, 638 HCV monoinfected patients were available for the analysis. The median follow-up time for the entire cohort was 630 days and patients were seen by their healthcare providers a median of 10 times during the follow-up period. HAV antibody testing was performed in 305 of the 638 HCV monoinfected patients (47.8%), with 150 (49.2%) found to be HAV IgG positive and 155 (50.8%) HAV IgG negative. Among the 155 HAV IgG negative patients only 40 (25.8%) were vaccinated for HAV; of the remaining 115, 114 were not offered and 1 refused vaccination. Of the 40 patients who were vaccinated, 22 received 1 dose and 18 completed both doses of vaccine. Vaccination for HAV was done in 3 of the 333 patients (0.9%) who did not have HAV antibody ordered; of the remaining 330, 329 were not offered and 1 refused vaccination.

Conclusions: Despite published recommendations for vaccination against HAV in patients with HCV, healthcare providers often do not test or vaccinate susceptible individuals. Future studies to determine barriers to vaccination are warranted. This is clearly an area in need of improvement, and education of primary care providers that may make the initial diagnosis of HCV is desperately needed.

Reference: M. Shim and others. SUSCEPTIBILITY TO HEPATITIS A IN PATIENTS WITH HEPATITIS C; MISSED OPPORTUNITIES FOR VACCINATION. DDW 2003, Abstract M1433.

Largest Hepatitis A Outbreak in US Leaves Three Dead and is Linked to Green Onions

November 29, 2003

BEAVER, Pa. (AP) -- A hepatitis A outbreak that has killed three people due to liver failure and sickened more than 600 others who ate at a Chi-Chi's Mexican restaurant was probably caused by green onions from Mexico, CDC officials said Friday, November 21^st. But how the scallions became tainted remains unclear. All the hepatitis A cases at the restaurant 25 miles northwest of Pittsburgh have been linked to green onions, and most of the victims likely contracted it through mild salsa and cheese dip.

The contamination could have been caused by anything from a sewage leak in a farm field to feces in a shipper's truck, health officials said. Contaminated workers or water could have tainted the green onions. The contamination could have occurred during the planting, irrigation, harvesting, processing or shipping of the green onions.

It is the nation's biggest known outbreak of hepatitis A. This outbreak was preceded by similar restaurant-based hepatitis A outbreaks in Tennessee, Georgia and North Carolina in the past two months, which were also linked to green onions. More than 300 people were infected, and there was one hepatitis A-related death in Tennessee.

Health officials in Pennsylvania initially suspected that Chi-Chi's employees had failed to wash their hands after using the bathroom -- another common way that hepatitis A is spread. But suspicion soon fell on the green onions, and the FDA issued a national advisory saying purchased green onions should not be eaten raw.

Chi-Chi's COO Bill Zavertnik said the company was ``gratified'' that state officials traced the outbreak to green onions and not to Chi-Chi's employees. He also noted that state officials confirmed there is no “industry-accepted'' way to test green onions for hepatitis A or to clean them enough to ensure they are safe. If the virus burrows deep into the sleeves of the green onions, restaurants could wash them all day and not be affecting what’s between those sleeves. The hepatitis A virus can remain viable on a piece of food or other inanimate surface for months.

Health officials are particularly concerned about fresh produce, which is often eaten raw or not cooked enough to neutralize germs it may carry. While fresh produce was responsible for only two or three outbreaks a year in the 1970s, that number has now climbed to 15 or 16, says Robert Tauxe, chief of the food-borne diseases at the CDC. For people who eat foods at risk for carrying hepatitis A --raw vegetables, raw fruits and shellfish-- it would be a good thing for them to consider getting the vaccine if they are able said a spokesman for the Georgia Division of Public Health. Though only a fraction of cases are reported, the CDC estimates there were as many as 93,000 cases in 2001.

This infection can be dangerous to people with chronic liver disease or immune disorders because of the possibly of fulminant liver failure. Immunization is strongly recommended. The CDC says about 100 people a year die of liver failure caused by hepatitis A.

It’s no longer necessary to travel to exotic locales to encounter international bugs, says epidemiologist Craig Headberg, professor of public health at the University of Minnesota. “Our produce-distribution systems have created opportunities for exposing people to a lot of organisms that have historically been viewed as being travel-associated infections,” he says.

Hepatitis A is one of the most frequently reported vaccine-preventable diseases in the U.S., but the vaccine, which provides long-term protection and has been available since 1995, isn’t given routinely nationwide. The Pennsylvania outbreak is renewing debate about whether vaccination against the disease should be made routine for children, who are the biggest carriers of the disease but frequently have few symptoms. In parts of the country where hepatitis A vaccine is given as part of childhood immunization programs, infection rates have dropped 86%. The vaccine is an inexpensive way to prevent the deadly and costly outbreaks that do occur.

Sources: Wall Street Journal, New York Times, and the AP.

Editor’s note: If you have hepatitis C, please get vaccinated for hepatitis A.

St. Louis University Will Test Hepatitis C Vaccine

St. Louis Post-Dispatch (11.17.03)--Eli Kintisch

The Center for Vaccine Development at St. Louis University is launching the first US trial of a vaccine that aims to defeat the most common type of hepatitis C, a liver infection whose chronic form affects around 3.7 million Americans.

To be done in conjunction with the Emeryville, Calif.-based pharmaceutical firm Chiron, the SLU trial marks the first attempt to test a preventative vaccine against HCV in people. An ongoing therapeutic vaccine trial by a Belgium firm is focused on curing patients with HCV. "This is the first step on that road towards preventing pain and suffering and death from hepatitis C," said Dr. Adrian Di Bisceglie, a study investigator at the SLU School of Medicine.

The trial is an initial study, mandated by the Food and Drug Administration to test safety and biologic response to the vaccine. Investigators expect to test the vaccine on 45 healthy people, whose blood will be examined for signs of an immune system response. At no stage will patients be purposefully infected with HCV.

Vaccines work by training the body's immune system to recognize and defeat viruses or bacteria. But round, spiky HCV has eluded vaccine developers for decades because it has been so hard to grow. In addition, HCV mutates quickly - sometimes causing the disturbing phenomenon of reinfection by a second strain of the virus. "That made us despondent about the prospect of developing a vaccine," Di Bisceglie noted.

But Chiron's scientists made a breakthrough this year when a new vaccine showed promise: A trial in chimpanzees showed those vaccinated could eventually fight off HCV infection. "In chimpanzees, the vaccine may not prevent infection, though it may prevent the virus from taking hold," said Di Bisceglie.

There are six main HCV types, with dozens of variants of each type. Though the vaccine is designed to attack the most common type, it is unclear how it will perform against other strains. "This is not likely to be the final vaccine for all hepatitis C viruses, though it is an important step," noted SLU Vaccine Center Director Dr. Robert Belshe.

National Hepatitis C Advocacy Council Advances Hepatitis C Legislative Efforts

WASHINGTON--(BUSINESS WIRE)--Nov. 20, 2003 Representatives Heather Wilson (R-NM) and Edolphus Towns (D-NY) yesterday filed The Hepatitis C Epidemic Control and Prevention Act in the House, announced the National Hepatitis C Advocacy Council.

This landmark proposal represents the first coordinated federal response to the prevention and control of hepatitis C, the most common blood-borne viral infection in the United States. The bill (not yet numbered) is a companion to the Senate Bill of the same name (S.1143) introduced earlier this year by Senators Kay Bailey Hutchison (R-TX) and Edward Kennedy (D-MA).

It is estimated that nearly 2% of all Americans, about four million people, have been infected with the hepatitis C virus (HCV). Nearly 10,000 Americans die each year of HCV-related liver disease. Without a timely intervention, the annual death toll is expected to triple in the next ten to fifteen years.

The Hepatitis C Epidemic Control and Prevention Act mandates a federal hepatitis C program under the HHS, to conduct public education, counseling and screening, surveillance, training, and to monitor research. Financial support will be provided for state and local agencies to implement these activities.

The Hepatitis C Epidemic Control and Prevention Act is the result of a grass roots effort spearheaded by the National Hepatitis C Advocacy Council (NHCAC), a coalition of hepatitis C advocacy organizations from across the nation.

NHCAC Founder Lorren Sandt of Oregon City, OR, commented: "The most powerful component about this legislation is the testing - identifying people who are already infected and getting them to care. Unless someone knows they have the disease, they can't change their outcome. We can really make a difference."

The NHCAC lauds the bipartisan efforts of Representatives Wilson and Towns for introducing legislation aimed at bringing the currently unchecked HCV epidemic under control.

Additional information about The Hepatitis C Epidemic Control and Prevention Act is available at http://www.hepcnetwork.org or by calling:

National Hepatitis C Advocacy Council
Lorren Sandt, 877/737-4372
Sharon Phillips, 903/291-9700
Michael Ninburg, 206/732-0311

(Editor’s Note: LiverHope is a member of the National Hepatitis C Advocacy Council.)

JOY IN THE JOURNEY

If you have ever been discouraged because of failure, please read on.

Far often, achieving what you set out to do is not the important thing. Let me explain.

Two brothers decided to dig a deep hole behind their house. As they were working, a couple of older boys stopped by to watch.

"What are you doing?" asked one of the visitors.

"We plan to dig a hole all the way through the earth!" one of the brothers volunteered excitedly.

The older boys began to laugh; telling the younger ones that digging a hole all the way through the earth was impossible.

After a long silence, one of the diggers picked up a jar full of spiders, worms and a wide assortment of insects. He removed the lid and showed the wonderful contents to the scoffing visitors.

Then he said quietly and confidently, "Even if we don't dig all the way through the earth, look what we found along the way!"

Their goal was far too ambitious, but it did cause them to dig. And that is what a goal is for - to cause us to move in the direction we have chosen; in other words, to set us to digging!

But not every goal will be fully achieved. Not every job will end successfully. Not every relationship will endure. Not every hope will come to pass. Not every love will last. Not every endeavor will be completed. Not every dream will be realized.

But when you fall short of your aim, perhaps you can say, "Yes, but look at what I found along the way! Look at the wonderful things which have come into my life because I tried to do something!"

LiverHope Support Group

Helen Clark & Pat Buchanan

Co-Facilitators

16807 Canterbury Drive

Minnetonka, MN 55345-2621

Voicemail: (763) 780-0108

Email: info@liverhope.com

Fax: (763) 566-0589

Website: www.liverhope.com

Helen: (952) 933-0932 – helen@liverhope.com

Pat: (763) 566-3839 – pat@liverhope.com