Hepatitis C Hope

Unlike alfa and beta interferons, which are naturally occurring interferons, consensus interferon is a recombinant type 1 interferon that was derived by scanning sequences of naturally occurring alfa interferon and adding the most frequently observed amino acid in each corresponding position. As a result CIFN has much higher biological activity than pegIFN so it "adheres to the virus cell more tightly than pegIFN," said Dr. Kaiser.

Daily consensus interferon plus Rebetol (ribavirin) for 72 weeks produced sustained viral response in 70% of patients with chronic hepatitis C who became refractory to Rebetron (pegylated interferon alfa 2a plus ribavirin), according to a pilot study reported here.
CIFN was given as a daily injection (9 ìg) and pegIFN (180 ìg) was given once a week. Patients in both treatment arms received weight-based Rebetol. At the end of 72 weeks the viral response was confirmed in 89% of the patients in the CIFN arm and in 76% of patients treated with pegIFN (NS). Although the CIFN was generally well tolerated, there were more injection site reactions in the CIFN arm and there was slightly higher drop-out rate in the CIFN treatment group, 18% versus 12% for the pegIFN group. When you have this sustained viral response, that's a 99% chance of a cure," Dr. Vierling said. "That's very impressive." The next step, he said, would be to confirm the results in a larger study. http://www.medpagetoday.com/InfectiousDisease/Hepatitis/dh/3357
DDW: Relapsed HCV Patients Achieve Sustained Response with 72-Week Treatment

By Peggy Peck, MedPage Today Staff Writer
Reviewed by Rubeen K. Israni, M.D., Fellow, Renal-Electrolyte and Hypertension Division, University of Pennsylvania School of Medicine
May 22, 2006

MedPage Today Action Points
Explain to interested patients that these results were based on a small study and the findings need to be confirmed in a larger clinical trial. Explain to patients who ask that consensus interferon treatment requires daily injections. This study was published as an abstract and presented in a poster at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication

Review:Stephan Kaiser, M.D.
University of Tuebingen

LOS ANGELES, May 22 — Daily consensus interferon plus Rebetol (ribavirin) for 72 weeks produced sustained viral response in 70% of patients with chronic hepatitis C who became refractory to Rebetron (pegylated interferon alfa 2a plus ribavirin), according to a pilot study reported here. The findings, presented at Digestive Disease Week sessions, compared consensus interferon (CIFN) plus Rebetol with pegylated interferon alfa 2a (pegIFN) plus Rebetol in 81 patients who relapsed after 48 weeks of treatment with Rebetron and found that extending treatment to 72 weeks resulted in good response in both treatment arms, said Stephan Kaiser, M.D., of the University of Tuebingen in Germany. But sustained response was significantly better in the CIFN group with 69% of those patients remaining virus-free for at least four months after completing treatment, versus a 44% sustained viral response rate in the pegIFN arm (P<0.05).>

At the end of 72 weeks the viral response was confirmed in 89% of the patients in the CIFN arm and in 76% of patients treated with pegIFN (NS). Although the CIFN was generally well tolerated, there were more injection site reactions in the CIFN arm and there was slightly higher drop-out rate in the CIFN treatment group, 18% versus 12% for the pegIFN group. John Vierling, M.D., president of the American Association for the Study of Liver Diseases and professor of medicine at Baylor in Houston, was enthusiastic about the results. "When you have this sustained viral response, that's a 99% chance of a cure," Dr. Vierling said. "That's very impressive." The next step, he said, would be to confirm the results in a larger study. Unlike alfa and beta interferons, which are naturally occurring interferons, consensus interferon is a recombinant type 1 interferon that was derived by scanning sequences of naturally occurring alfa interferon and adding the most frequently observed amino acid in each corresponding position. As a result CIFN has much higher biological activity than pegIFN so it "adheres to the virus cell more tightly than pegIFN," said Dr. Kaiser. Dr. Kaiser said the study was investigator initiated and did not receive any industry support.

Primary source: Digestive Disease Week
Source reference: Kaiser, S et al "Comparison of Daily Consensus Interferon versus Peginterferon alfa 2a Extended Therapy of 72 Weeks for Peginterferon / Ribavirin Relapse Patients with Chronic Hepatitis C" Abstract S1060

It's very likely that you have known that something wasn't "right" for a while. Perhaps you thought that you were just run down, out of shape or not eating well. On the other hand, you may have suspected the worst: could your symptoms be due to a tumor, or even cancer? Chances are that if you shared your concerns with family or friends they tried to reassure you. Maybe this helped, or maybe it didn't.
But now you are at the end of an extensive diagnostic process. Maybe you've had bloodwork, an ultrasound, or even a liver biopsy. And now your doctor has told you that you are infected with the Hepatitis C virus (HCV).

How do you feel? How are you supposed to feel? And what do you do now?

Understanding your Reaction...
Your new diagnosis is a life-changing event. You can expect to have a whole range of different feelings about it, feelings that may be uncomfortable and hard to predict. Some healthcare experts have applied Elizabeth Kubler-Ross' theory of grieving to help people understand their own reactions to their HCV diagnosis. Dr. Kubler-Ross' theory about the stages of grief, described in her 1969 book "On Death and Dying," was initially developed through her observations of terminally ill patients and their families. However, many mental health professionals believe that her 5-stage model can be applied to help people understand and possibly predict their emotional reactions to other events involving loss, such as loss of health, loss of relationships, loss of independence or even loss of employment. It's important to note that your progression through these stages is not rigid. People move back and forth between stages, and there's no timetable for how quickly one "should" move through the grieving process. Also, even though you may be the one with HCV, bear in mind that your diagnosis is going to touch the lives of everyone who cares about you. Your family and those close to you are going to have emotional issues to cope with, as well. In the Kubler-Ross model, the five stages of grief are denial, anger, bargaining, depression, and acceptance.

Denial

In the denial stage, one may simply not believe that the diagnosis is true. You may feel numb, or "in shock." Some people feel depersonalized, as though "it's happening to somebody else." You may feel nothing at all - for a while. Denial is not a bad thing - it helps one cope with feelings that may be overwhelming at the time, protecting the person from feeling out of control and helpless. As the shock wears off and you begin to accept the truth of your diagnosis, you will begin to experience other feelings.

Anger

In this stage, you've come to understood that your diagnosis is real and that you really have HCV, and you're angry about it. You may be angry in response to feelings of helplessness, or your anger may come from feelings that your diagnosis is "unfair." You may be angry at your own body or at God for "giving" you hepatitis. You may find yourself preoccupied with what could have been done to prevent the illness. You may also find yourself experiencing strong feelings of guilt as you struggle with the idea that you may have caused the disease can be difficult to cope with strong feelings of anger. You may be prone to lash out, or to "medicate" your feelings with alcohol, drugs or some other behavior. If you are the family member of someone with HCV, you may find the patient directing irrational anger at you.

Bargaining

As the anger subsides, you may find yourself trying to "make deals with God" to make your HCV go away. If this doesn't work, you may find yourself angry again, perhaps questioning and doubting your beliefs or spiritual relationships.

Depression

As bargaining subsides, the truth of your situation begins to "sink in." You may begin to have profound feelings of sadness and loss. Sleep disturbance, loss of appetite, lack of energy, poor concentration, and crying spells are common outward manifestations of depression. It is important to understand that this sort of depression is a normal part of the grieving process. However, depression that significantly interferes with basic activities (eating, bathing, dressing, etc.) or leads the person to thoughts of injuring themselves or others requires immediate (if not emergency) medical care.

Acceptance

Acceptance does not mean happiness. It means that you have allowed enough time and found enough support (from family, friends, or faith) to move forward in your life - your life as it is, not necessarily as you would like it - without suffering crippling emotional reactions or engaging in self-destructive coping behaviors.
Sometimes a "trigger" event will occur that will bring up strong feelings or anger of sadness months or years into the process. This can be something as small as a familiar smell or an old song.

Facilitating the Process

Coming to terms with your diagnosis is not easy, but there are some practical steps you can take to move ahead with your life: Give yourself plenty of time. Don't expect to come to terms with your diagnosis immediately. Learn all you can about HCV. Although Hepatitis C infection isn't rare, most people don't know much about it. As you learn about the disease, you empower yourself to make informed decisions about your care. Participate in a support group. Sharing your feelings and fears with other can decrease your feelings of isolation, and also provide practical advice for day-to-day coping. Use a journal to document your progress. If you tend to be obsessive, capturing your feelings and thoughts on paper can help you to "let go" and decreases anxiety.

If you are compulsively using alcohol, drugs, gambling, sex, or any other pusuit to avoid your emotions, stop. If you can't stop, get help.


Source: Hepatitis Neighborhood

Attention Hepatitis C Advocates,

On June 7, 2006 the fate of hepatitis C prevention funding for 2007 will be decided by the U.S. House Appropriations Labor-HHS-Education Subcommittee. We need your help!

Your Representative needs to hear from YOU that hepatitis C funding is a priority. We cannot afford another year of flat or decreased funding. The House Labor-HHS-Education Appropriations Subcommittee is the panel that will decide funding amounts for hepatitis programs.

On June 7, 2006, the House Labor-HHS-Education Subcommittee is scheduled to decide critical funding needs for health programs - including hepatitis C. Silence on this issue will result in further cuts to an already precariously small hepatitis C allocation of $16.7 million for the Division of Viral Hepatitis (DVH) at the Centers for Disease Control and Prevention (CDC). A small increase of $10 million can make a big difference. The U.S. Senate will work on the their version of the bill in the coming weeks, however, a win now will move us one step closer to securing necessary resources for hepatitis C.

Contact your Representative NOW. We have about 8 days left to educate House Appropriators about the inadequate funding for hepatitis C programs.

WHEN: Right now! Your Representative needs to hear from you by close of business June 6, 2006.


Go to: http://www.democracyinaction.org/dia/organizationsORG/IMPACTC/campaign.jsp?campaign_KEY=4011

Thank you for your support.

Sincerely,

Lorren Sandt
Hepatitis C Caring Ambassadors Program
Managing Ambassador
877-737-4372 toll-free
lorren@hepcchallenge.org
Hepatitis C: Choices now on line at: www.hepcchallenge.org

"We believe strongly in the power of people working together, and that, by doing so, we will make far more significant advances than could be made by any group or discipline working on its own."

Investigative Valopicitabine Shows Promise for Hepatitis C Treatment Non-Responders: Presented at DDW .
By Bruce Sylvester

LOS ANGELES, C.A. -- May 25, 2006 -- A new combination therapy using an investigative antiviral drug, valopicitabine, shows promise for almost half of patients who do not respond to standard interferon therapies for treatment of hepatitis C. Researchers reported this finding in a press briefing here on May 21st at Digestive Diseases Week 2006 (DDW). "This new combination might produce a viable alternative treatment for these challenging patients," said presenting investigator Paul Pockros, MD, division head, division of gastroenterology/hepatology, Scripps Clinic and Research Foundation, San Diego, California. The ongoing phase 2b trial is comparing 5 treatment regimens in nonresponsive patients with HCV (hepatitis C)-genotype 1, who did not respond to 12 weeks or more of pegylated interferon alpha 2a (peg-IFN)/ribavirin (RBV).

Treatment response was defined as negative HCV RNA using polymerase chain reaction (PCR). Subjects were randomized in a 1:2:2:2:2 design to 1 of the following treatment arms: 1) valopicitabine monotherapy 800 mg/day; 2) valopicitabine (400 mg/day, 800 mg/day, or dose-ramping 400-800 mg/day) plus peg-IFN; 3) peg-IFN/RBV retreatment (control). The Peg-IFN dose is 180 mcg subcutaneous injections per week and weight-based RBV is dosed at 1000-1200 mg daily. Virologic response criteria are stipulated for week 4 (>/=0.5log reduction), week 12 (>/=1.0log), and week 24 (>/=2.0log). Subjects who do not achieve these criteria are classified as treatment failures and discontinued from the study.

Among the 162 subjects who have completed 24 weeks, the 2 higher-dose combinations achieved higher response rates than the control group, with an average of 2.5- to 3.0log decrease in hepatitis RNA reductions by week 24. The difference compared to the control group was significant. The investigators have reported no viral breakthrough to date. They reported that the highest dose of valopicitabine (800 mg) was associated with vomiting and dehydration requiring hospitalization. Use of that dosing has been stopped. "Ongoing data from this trial will show us if these notable early results will lead to a sustained response," Dr. Pockros said. [Presentation title: Valopicitabine (NM283), Alone or With Peg-Interferon, Compared to Peg Interferon/Ribavirin (pegIFN/RBV) Retreatment in Hepatitis C Patients With Prior Non-Response to PegIFN/RBV: Week 24 Results. Abstract 4]

http://www.docguide.com/news/content.nsf/news/852571020057CCF685257179006BF65A

Yes, you do it is vital in caring for HCV. Don't worry, I am a chicken and I can tell you, I loved my biopsy... Just ask for a valium drip and you won't care if they take the entire liver out. Liver biopsy—The best way to measure the extent of liver damage is with a liver biopsy. This is a procedure in which a tiny sample of tissue from the liver is removed and examined in a laboratory. Liver biopsies are also important in ruling out any other forms of liver disease.

Today, liver biopsies are performed as outpatient procedures. General anesthesia is not necessary. Patients receive local anesthesia at the area where the needle will be inserted. Although the test itself only takes a few seconds, you may be monitored at the testing facility for several hours. Patients often describe the sensation they experience during the test as a feeling of strong pressure on the spot where the tissue is removed. Patients may feel tired after the test, so it is a good idea to schedule some rest time after having a biopsy.

The degree of liver damage measured from a liver biopsy is scored in stages:

Stage I—In the earliest stage of liver damage, the liver is inflamed (immune cells called lymphocytes are present), but scarring has not yet occurred. There is little damage to the liver at this point.

Stage II—In this early stage of liver damage, the liver is inflamed and scarring (fibrosis) has begun to form in one part of the liver.

Stage III—In this stage, scar tissue from one area of the liver bridges (connects) to scar tissue from other areas, leading to advanced fibrosis. This reduces the liver's ability to circulate blood and remove toxins.

Stage IV—In this advanced stage of liver damage, cirrhosis (advanced scarring) has occurred, which significantly impairs the liver's ability to function properly. At this point, the degree of damage to the liver is very serious.

The goals of therapy for hepatitis C are to delay or halt disease progression by:

delaying the progression of scarring
preventing cirrhosis
preventing liver cancer

In order to track the progression of the disease, your doctor may perform a liver biopsy every 3 to 5 years. A liver biopsy is an essential tool in monitoring hepatitis C. Other Tests—Healthcare professionals may use a variety of other blood tests and noninvasive liver imaging tests to monitor the progression of hepatitis C. Common blood tests include blood chemistry panels, platelet counts, and prothrombin times (PTs). Imaging tests may include ultrasounds and CT scans. MRIs may be ordered to diagnose liver cancer. However, none of these tests alone, or in combination, can fully measure the degree of liver damage, or fibrosis.

Infection with hepatitis C may cause symptoms right away, not for years, or sometimes not at all. With the acute form of the disease, symptoms such as fatigue, nausea, and dark urine typically show up within six months. About one-fourth of patients with acute hepatitis C recover completely with treatment. But according to the National Institute of Diabetes and Digestive and Kidney Diseases, the other estimated 75 percent of these patients will progress eventually to the long-term, or chronic, form of the disease, with detectable HCV in their blood.Chronic hepatitis C, however, varies widely in its severity and outcome. It can lie dormant for 10 years or more before symptoms appear. Some patients will have no symptoms of liver damage, and their liver enzymes will stay at normal levels (elevated enzymes are one indication of liver disease). A liver biopsy, in which the doctor removes a tiny piece of liver with a needle, may show some degree of chronic hepatitis, but it may be mild.Other patients, however, will have severe hepatitis C, with detectable HCV in their blood, liver enzymes elevated as much as 20 times more than normal, and a prognosis of ultimately developing cirrhosis and end-stage liver disease. Another group of patients falls somewhere in the middle, with few or no symptoms, mild- to-moderate elevation of liver enzymes, but with an uncertain prognosis. According to the National Institute of Diabetes and Digestive and Kidney Diseases, at least 20 percent of chronic hepatitis C patients develop cirrhosis, but this process can take 10 to 20 years from the onset of infection. As many as 5 percent of chronic patients, after 20 to 40 years, develop liver cancer. Other studies show that those with cirrhosis develop liver cancer within 17 years.

Patients with no symptoms sometimes learn they have the disease when a routine physical or blood donation shows elevated levels of liver enzymes, which can indicate hepatitis C, as well as other liver disorders.
Other patients, however, have symptoms that prompt them to seek medical attention, including yellowish eyes or skin (jaundice)
fatigue, or an extreme feeling of being tired all the time
pain or tenderness in the right upper quadrant of the body
persistent nausea or pains in the stomach
lingering fever
loss of appetite
diarrhea
dark yellow urine or light-colored stools
If you have any of these symptoms, see a doctor right away.

The most effective medication is the combination of peg-interferon and ribavirin. Treatment with this medication is successful in eradicating HCV in about half of infected patients. This is called a sustained virologic response (SVR).

Current studies suggest that HCV will probably never return in patients with a sustained virologic response unless they are once again exposed to this virus. No vaccine currently exists to prevent infection in an individual that is exposed to HCV. Patients who achieve a SVR following treatment with peg-interferon and ribavirin have an improvement in the degree of liver injury with loss of fibrosis and a return of the liver towards normal.This is called histologic improvement.

Histologic improvement has also been reported to occur in some patients who did not achieve a sustained virologic response following treatment with peginterferon and ribavirin.

The liver is the largest organ in the body. Located in the upper right side of the abdomen, it acts as a filter to remove toxins (harmful substances) and waste products from the blood. A healthy liver filters blood at a rate of about 1.5 quarts per minute. That’s 540 gallons of blood a day! The liver also stores nutrients, such as certain vitamins, minerals, and iron, and plays a role in making and controlling the amounts of certain chemicals and proteins in the body, such as cholesterol, hormones, and sugars. It helps the body digest food by producing a substance called bile, which is stored in the gallbladder. The hep C virus attacks liver cells and uses them as a host to reproduce itself. When the body attempts to fight the virus, it sends lymphocytes (a type of white blood cell) to the liver, which results in inflammation (swelling). This inflammation is a normal response to infection, but over time this process, and certain chemicals released by the lymphocytes, can damage liver cells.

When the liver cells are damaged, they cannot function well and may die. Some of these cells may grow back, but severe injury may lead to fibrosis (a buildup of scar tissue on the liver). Fibrosis slows down the liver's ability to circulate blood and remove toxins.Treatment may help prevent further damage or reduce progression of the condition. However, the longer treatment is delayed, the more likely significant and permanent liver damage will occur. Over time, hardened scar tissue can replace large amounts of normal liver tissue. This condition, called cirrhosis, seriously impairs the liver's ability to function. As a result, blood that cannot pass freely through the liver may back up into the spleen, and this may lead to the destruction of healthy blood cells. In addition, the liver may not be able to produce enough bile to aid in the handling of nutrients, such as vitamins A, D, E, and K, and most fats. If your liver is damaged, there are some important steps you can take to keep the undamaged cells as healthy as possible. You should talk to your doctor or nurse about your specific situation, but, in general, the following measures can help:

Avoid alcohol. The liver treats alcohol as a toxic substance and works to filter it out. In a person with hep C, alcohol significantly increases damage to the liver. It is especially important to avoid combining alcohol with acetaminophen (a nonprescription pain reliever). If taken together, these substances can cause additional damage to your liver. Eat healthy foods. When the liver is damaged, your body may not get all the nutrients it needs, and you may feel weak or tired. You may also lose your appetite. It is important, therefore, to meet your daily nutritional needs so you can maintain your weight and energy levels. Drink plenty of water. Water is a vital substance for all of the body's functions. It helps to remove toxins and process important nutrients. Drinking extra fluids may also help reduce side effects while on therapy. Reduce salt in your diet. When liver disease is severe, signals are sent to the kidneys that cause them to retain both salt and water. The salt acts like a sponge, causing fluid to build up in the body. A low-salt diet can help reduce fluid buildup. Get vaccinations against hepatitis A and hepatitis B. In people with hep C, infection with another strain of hepatitis can cause further damage to the liver. Though there is no vaccine for hep C, a simple series of shots can protect most people from infection with the hepatitis A and hepatitis B viruses. Although hepatitis C can lead to scarring and inflammation of the liver, treatment may help. Even if hep C therapy does not rid your body of the virus completely, it may help reduce inflammation and improve the overall health of your liver.

http://www.helpwithhepc.com/HepC_30.mov

Many Thanks to Willie Nelson.

As May is National Hepatitis Awareness Month, Sierra HOPE will make a limited number of free Hepatitis home testing kits available throughout the month. To find out more about receiving a Hepatitis Home Testing Kit or for more information about Hepatitis C, call Sami Rhodes at Sierra HOPE at 736-6792.

http://www.ledger-dispatch.com/life/lifeview.asp?c=185599
Sierra HOPE to offer free Hepatitis home testing kits

Chronic liver disease is the 10th leading cause of death among adults in the United States and Hepatitis C Virus (HCV) infection is the most common chronic blood-borne infection in the country, affecting more than 5 million Americans. Most people infected don't even know they have it because sometimes it takes 20 or 30 years to become symptomatic.

Studies indicate that 40 to 60 percent of all liver disease is related to Hepatitis C infection. Long term consequences of a Hepatitis C infection include a 75 to 80 percent chronic infection rate, 70 percent chance of chronic liver disease and a 10 to 20 percent chance of developing cirrhosis. Sadly, one out of five of every 100 Hepatitis C infections cases results in death from liver cancer or cirrhosis and Hepatitis C. remains the leading indication for liver transplants in the United States.

Known risk factors include blood transfusions obtained before 1992 or clotting factors before 1987; tattoos or body piercing done with unsterile instruments or common ink wells; having multiple sexual partners or intravenous drug users. Even a single use in the distant past and sharing toothbrushes or razors with someone infected with Hepatitis C can be a risk. As May is National Hepatitis Awareness Month, Sierra HOPE will make a limited number of free Hepatitis home testing kits available throughout the month. To find out more about receiving a Hepatitis Home Testing Kit or for more information about Hepatitis C, call Sami Rhodes at Sierra HOPE at 736-6792.


Bette's Comment: However, as we know there are many other
modes of transmission they are not noted in this article.

InterMune Presents New Preclinical Data on Its HCV Protease Inhibitor at Digestive Disease Week of May, 2006


Strong Potency and Drug Resistance Profile of ITMN-191 Derived From Its Distinct Structure

LOS ANGELES, May 23 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) announced today the presentation of research describing the preclinical characterization of ITMN-191 (previously referred to as ITMN B), its orally available hepatitis C virus (HCV) NS3/4A protease inhibitor. The preclinical findings were presented at the Digestive Disease Week (DDW) meeting in Los Angeles. InterMune expects to submit a European Clinical Trial Authorization for ITMN-191 in the third quarter of 2006. In an oral presentation and Poster of Distinction at DDW, Scott Seiwert, Ph.D., Vice President of Discovery Research at InterMune, described the characterization of ITMN-191 activity against various HCV N3/4A protease variants. ITMN-191 retains activity against variants that exhibit reduced sensitivity to other experimental HCV protease inhibitors in development. A single variant was identified that shows diminished potency to ITMN-191. However, this variant is distinct from variants that have reduced sensitivity to other HCV protease inhibitors. This demonstrates a favorable cross-resistance profile of ITMN-191 with other HCV protease inhibitors currently in development.


Also at DDW, the chemical structure of ITMN-191 was revealed for the first time, demonstrating the distinguishing characteristics between ITMN-191 and other experimental HCV protease inhibitors. InterMune and its collaborators utilized structure-based drug design to optimize drug-target binding interactions. The researchers credit the tight binding between ITMN-191 and the HCV protease for the experimentally observed high potency of ITMN-191 and activity against variants of the protease that are resistant to other HCV protease inhibitors. Structural optimization also enabled InterMune to improve compound exposure to the liver in animal models. Given that viral replication of HCV is reported to occur primarily in hepatocytes, achieving high drug concentrations in liver is believed to be critical to the clinical success of target therapies against HCV. Further in vivo studies reveal favorable high liver exposure of ITMN-191 across multiple species at potentially clinically relevant dosing concentrations. The results continue to support exploration of twice-daily, oral dosing in treatment of chronic HCV.

"Our research team's detailed characterization of ITMN-191 provides important insight regarding how our compound is distinct from other experimental HCV protease inhibitors in development and reinforces our confidence that ITMN-191 has the potential to be a superior drug candidate with favorable cross resistance and potency profiles," said Dan Welch, President and CEO of InterMune.

About HCV and HCV Protease Inhibitors According to the Centers for Disease Control and Prevention (CDC), an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected, and the prevalence of chronic HCV is increasing. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches. HCV protease inhibitors represent a promising class of drugs for HCV, and the HCV NS3/4 protease is an attractive drug target because of its involvement in viral replication and suppressive effects on host response to viral invasion.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes two Phase III programs evaluating possible therapeutic candidates for treatment of patients with IPF: the INSPIRE trial is evaluating Actimmune® (interferon gamma-1b) and the CAPACITY program is evaluating pirfenidone. The hepatology portfolio includes the lead HCV protease inhibitor compound, ITMN-191, a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.

http://www.liverdisease.com/cirrhosis_hepatitis.html

The liver is an incredibly resilient organ, but unfortunately it isn’t indestructible. Sometimes the damage that occurs as a result of excessive alcohol, a virus, or some other chronic disease overwhelms the liver’s capacity to function. Healthy liver cells are destroyed, and scarring occurs. Scarring, known as fibrosis, is the liver’s effort to keep the damage done by alcohol or the hepatitis C virus (HCV), for example, contained. But, scar tissue can block the blood flow through the liver, resulting in an inability of the liver to perform its normal duties. If alcohol, or HCV, is not eliminated from the body, scarring becomes extensive. The liver becomes rock hard and nodular (lumpy). This condition is known as cirrhosis. Although the presence of cirrhosis does not signify that health problems will inevitably develop, a person with cirrhosis should be aware that he is at an increased risk of suffering many serious complications.

Cirrhosis is the end product of any one of a number of different liver diseases. These diseases which will be discussed elsewhere in my book. Regardless of the cause, the potential consequences of cirrhosis are the same. Whereas a healthy liver typically repairs and regenerates itself when injured (see page xx), once cirrhosis has occurred, the damage may never be undone. When I was a student at Mount Sinai Medical School in the early 1980’s, I was taught that cirrhosis was irreversible. In fact, even as recently as the publication of the first edition of this book – the year 2000, it was still the gospel belief among most liver disease experts that while cirrhosis could occasionally be slowed, or even halted, it could never reverse. However, some recent studies have shown that with removal of the cause of the underlying liver disease – alcohol or the hepatitis C virus (HCV) for example, and with effective treatment, cirrhosis can be reversed, - at least in its very early stages, when scarring is minimal. The point at which cirrhosis becomes irreversible is not clear. But, there is a broad consensus among liver disease experts that once cirrhosis has advanced to its late stages -- when complications from extensive scaring have occurred (known as decompensated cirrhosis), it can never be reversed.

Recent progress has made in the control and the reversal of cirrhosis. This is confirmed by the decline in the number of cirrhosis-related death rates in the United States over the last twenty years. Therapies such as interferon and ribavirin for chronic hepatitis C, and Epivir and Hepsera for chronic hepatitis B, have been shown to reverse cirrhosis in its early stages. There have been anecdotal reports of scarring being reversed after treatment in people with autoimmune hepatitis (chapter 14), primary biliary cirrhosis (Chapter 15) and hemochromatosis (chapter 18). Thus, cirrhosis, should no longer be considered as an irreversible condition. Still, cirrhosis continues to be the eighth most common cause of death overall in the United States and the fourth leading cause of death among Americans between the ages of thirty and sixty. But being diagnosed with cirrhosis is not necessarily a death sentence. Usually, when cirrhosis is fatal, it is because it has proceeded unchecked and untreated for many years. If, however, it is caught in its early stages, there will often be steps that the patient and doctor can take to control, and possibly even reverse, its progression. Despite having cirrhosis, many people have lived well past the age of ninety. Of course, prevention remains the best medicine; therefore, most of the treatments doctors prescribe, as well as the nutrition and exercise tips discussed in Chapter 23, are aimed at trying to keep the liver from progressing to cirrhosis in the first place.

LIVER DISEASES THAT CAN LEAD TO CIRRHOSIS
Not all liver diseases cause cirrhosis—only those that cause chronic, ongoing damage to the liver can lead to permanent scarring of liver tissue. For example, someone with hepatitis A will usually recover completely after a few weeks, and as such, will not be at risk for developing cirrhosis. But someone who has lived for decades with a chronic liver condition, such as hepatitis C or hemochromatosis, would be a prime candidate for cirrhosis.

Fortunately, in most cases, cirrhosis takes many years to develop. Therefore, just because a person is at risk for cirrhosis, it doesn’t necessarily mean that he will definitely develop this condition over the course of a normal life span. Also, the slow pace at which cirrhosis develops allows a person to obtain treatment from a liver specialist before cirrhosis occurs.
Alcoholic liver disease and chronic hepatitis C are the two most common causes of cirrhosis in the United States. However, there are other circumstances that can give rise to permanent liver damage. Even some herbal remedies and medications can trigger massive scarring of the liver (see Chapters 21 and 24 respectively). Although a discussion of every condition that has the potential to cause cirrhosis is beyond the scope of this book, some causes include the following:

• Viral hepatitis—hepatitis B, C, and D
• Autoimmune hepatitis
• Primary biliary cirrhosis
• Nonalcoholic fatty liver disease
• Excess alcohol consumption
• Hemochromatosis
• Excessive intake of vitamins, such as vitamin A
• Certain herbal remedies, such as comfrey
• Certain medications, such as methotrexate, isoniazid, Aldomet
• Primary sclerosing cholangitis
• Vascular anomalies—for example, Budd-Chiari syndrome
• Congestive heart failure (see your doctor for more information).
• Wilson’s disease, a genetic disorder of copper overload

Findings could influence approaches to treatment and outcome
The study was published in an advance online edition of the Proceedings of the National Academy of Sciences on May 17.

Hepatitis C virus (HCV) is a worldwide public health problem. The World Health Organization estimates that 170 million people worldwide are chronically infected and that between 3-4 million are newly infected annually. HCV is the leading cause of chronic liver disease including hepatic fibrosis, end-stage cirrhosis, and hepatocellular carcinoma. There is no vaccine available to prevent HCV, and current therapies are costly, have serious side effects and are curative in only a fraction of patients. According to the World Health Organization, the major causes of HCV infection are use of unscreened blood transfusions, and re-use of needles and syringes that have not been adequately sterilized.

Viral infections like hepatitis C often trigger an immediate innate immune response involving release of type 1 interferon (IFN-? and IFN-?). In turn, type 1 interferon stimulates the production of a family of what are known as IFN stimulated genes that have a multitude of inhibitory effects on viral replication in infected and neighboring uninfected cells. While interferon production and other immune responses can greatly influence the course of a number of different viral infections, many human pathogenic viruses have evolved distinct strategies to inhibit the early signaling events leading to interferon production. HCV is no different.

"We have previously demonstrated that many interferon stimulated genes with antiviral activity are induced in the liver during HCV infection," said Francis V. Chisari, M.D., a Scripps Research professor whose laboratory conducted the study. "Despite their induction, the virus can persist indefinitely, indicating that it is resistant to their antiviral effects."

The current study sheds light on one strategy the hepatitis C virus uses to resist the immune system. The findings suggest that the hepatitis C virus inhibits the activity of naturally occurring interferon by shutting down a key antiviral signaling protein.

Early after HCV infection, the immune system responds to viral RNA by activating a signaling cascade in the infected cells that results in the production of type 1 interferon. One of the intermediaries in that cascade is a mitochondrial antiviral signaling protein (MAVS). HCV blocks the production of type1 interferon by using its protease activity to destroy MAVS. By preventing infected cells from producing interferon, the virus inhibits the body's immune response against HCV, enabling it to persist.

"Our new work shows that HCV does not induce interferon-? or antiviral interferon stimulated genes in the infected cells," Chisari said. "This means that the antiviral interferon stimulated genes expressed in the HCV-infected liver are likely produced by uninfected cells in some novel fashion and that the virus has other tricks up its sleeve that makes it resistant to their antiviral effects. Further study is needed to understand which cells in the liver produce the interferon and how the virus can resist the broad spectrum of these antiviral effects."

The knowledge gained from fundamental studies such as these could lay the groundwork for the development of potential new treatment strategies for this devastating global disease.

Please take a few moments from your busy day to pause, reflect, and thank those who have served and are serving our country. Although this page is dedicated to veterans of our Armed Services, almost every American family, many without donning a uniform, has contributed to the preservation of the ideals of the United States of America. "Rosie the Riveter" serves as a symbol of all those who stayed behind during World War II.

Mom may have helped at the Red Cross or USO, and rolled bandages at home. School girls and boys knit scarves, socks, and mittens for the men on the front, and collected milkweed pods for life jacket fill. From the American Revolution to today's War on Terrorism, many are the untold stories and many are the unsung heroes.
Today we ask that you remember all those currently in the service of the United States and all her allies. While military conflicts are never easy to accept, neither are the denial of basic human rights. Whatever your opinions or beliefs, RESPECT and HONOR those who are answering the call to serve their country.

NEW YORK (Reuters) - Viropharma Inc on Sunday said its experimental drug, being developed with Wyeth Inc., cut levels of the hepatitis C virus by up to 97 percent in a small 14-day clinical trial.

The drug was given for 14 days by itself to patients infected with the virus who had not been previously treated with other medicines. The drug is designed to block an enzyme called polymerase that the virus, which can cause fatal liver damage, needs to replicate itself.

Patients in the Phase I trial twice daily received 50 milligram, 100 milligram, 250 milligram, 500 milligram, 1000 milligram, or 1500 milligram oral doses of the medicine, called HCV-796, or received placebos.

"Peak antiviral response was achieved at doses of 500 twice daily and higher," Viropharma said in a release, and the medicine was well tolerated. Mean virus levels were cut by 1.4 log to 1.5 log -- or 96 to 97 percent -- in patient groups receiving the three highest doses of the drug.

The amount of viral reduction, however, is less than the greater than 99 percent reduction that has been shown in previous clinical trials of another experimental drug being developed by Vertex Pharmaceuticals Inc..

http://news.yahoo.com/s/nm/20060521/sc_nm/viropharma_wyeth_dc

Schering-Plough Initiates PEG-INTRON 'PROTECT' Study in Liver Transplant Patients with Recurrent Hepatitis C


KENILWORTH, N.J., May 23 /PRNewswire-FirstCall/ -- Schering-Plough today announced the initiation of a large multicenter clinical trial in the United States to evaluate the safety and efficacy of PEG-INTRON(R) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy in liver transplant recipients with recurrent hepatitis C virus (HCV) infection. Known as the PROTECT study, the trial is targeted to enroll 125 HCV patients at approximately 28 liver transplant centers nationwide.

Hepatitis C is currently the leading indication for liver transplantation in the United States,(1) and more than 17,000 Americans are awaiting liver transplants for all diagnoses.(2) Long-term mortality rates are higher in liver transplant recipients with HCV compared to those without HCV,(3,4) and the majority of patients who receive liver transplants for hepatitis C disease will be reinfected after transplant, most likely from virus sanctuaries in the body.(5,6) Without treatment, these patients will not eradicate their virus and are prone to faster progression of their hepatitis C disease.

To date, only a few small studies have been conducted in this patient population using pegylated interferon and ribavirin, the current standard of care in treating HCV, and results of these small studies have varied widely. (7-9) It is unclear what virologic response rates can be expected in the post-liver transplant setting.

"A large multicenter study in liver transplant recipients with recurrent HCV is needed to better understand how to maximize treatment outcomes for these patients," said Fred Gordon, M.D., Division of Gastroenterology and Hepatology, Lahey Clinic, Burlington, Mass., and lead investigator for the PROTECT study. "Given the potential for diminished long-term survival and the shortage of available resources for liver transplant patients with HCV recurrence, viral eradication is an important goal of treatment and would benefit both patients and society."

Study Design

PROTECT is single-arm, multicenter, open-label Phase IV study evaluating the efficacy and safety of PEG-INTRON (1.5 mcg/kg once weekly) and REBETOL (400-1,200 mg daily) in patients after orthotopic liver transplantation with chronic hepatitis C recurrence. All patients will be enrolled within the first 12 months of this 72-week study, and will be treated with up to 48 weeks of PEG-INTRON and REBETOL therapy.

Sustained virologic response (SVR),(10) the standard measure of successful response to HCV therapy, will be determined at 24 weeks following treatment. Written informed consent will be obtained and all other regulatory requirements adhered to for all patients participating in the study.

"The PROTECT study continues Schering-Plough's research strategy to conduct and support clinical studies with PEG-INTRON therapy to explore new approaches to treatment, particularly for hepatitis patients with difficult-to-treat forms of the disease," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "These research efforts underscore our long-term commitment to this therapeutic area and the hepatitis community."

About PEG-INTRON

PEG-INTRON is approved in the United States as monotherapy and for use in combination therapy with REBETOL for the treatment of chronic hepatitis C in previously untreated patients with compensated liver disease who are at least 18 years of age. The recommended dose in the United States for combination therapy is PEG-INTRON 1.5 mcg/kg once weekly plus REBETOL 800 mg daily for up to 48 weeks.

Important Safety Information Regarding U.S. Labeling for PEG-INTRON and REBETOL

WARNING

Alpha interferons, including PEG-INTRON, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-INTRON therapy.

Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.

REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6-month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.

PEG-INTRON

There are no new adverse events specific to PEG-INTRON as compared to INTRON(R) A (interferon alfa-2b, recombinant) for Injection, however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEG-INTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEG-INTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON.

Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON, but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEG-INTRON.

PEG-INTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).

The following serious or clinically significant adverse events have been reported at a frequency less than or equal to 1% with PEG-INTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.

In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG-INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5 mcg/kg)/ REBETOL and in 34% of those receiving INTRON A/REBETOL.

REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs.

Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to PEG-INTRON and REBETOL and the company's strategy. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's 2005 10-K.

References
1. U.S. Centers for Disease Control and Prevention; http://www.cdc.gov/ncidod/diseases/hepatitis/c/fact.htm

2. U.S. Organ Procurement and Transplantation Network (OPTN) data as of May 2006; www.OPTN.org

3. Forman LM, Lewis JD, Berlin JA, et al. The association between hepatitis C infection and survival after liver transplantation. Gastroenterol 2002;122(4):889-96.

4. Mazzaferro V., Regalia E., Pulvirenti A., et al. Prophylaxis against HCV recurrence after liver transplantation; effect of interferon and ribavirin combination. Transpl Proc. 1997; 29:519-521.

5. Wright TL, Donegan E, Hsu HH, et al. Recurrent and acquired hepatitis C viral infection in liver transplant recipients. Gastroenterol 1992;103(1):317-322.

6. Gane EJ, Portmann BC, Naoumov NV, et al. Long-term outcome of hepatitis C infection after liver transplantation. N Eng J Med 1996;334:815-20.

7. Ghalib R, Levine C, McClelland T et al. Factors Predictive of 24 Week Viral Response to PEG IFN alfa-2b plus Ribavirin in Subjects with Recurrent Hepatitis C after Liver Transplantation. Abstract. AASLD Boston, 2004

8. Rodriguez-Luna H, Khatib A, Sharma A, et al. Treatment of recurrent hepatitis C infection after liver transplantation with combination of pegylated interferon alpha 2b and ribavirin: an open-label series. Transplantation 2004 Jan 27;77(2):190-4.

9. Gordon FD, Morin D, Davis C, et al. High sustained virologic response (SVR) in HCV treatment with Peginterferon-alpha 2B (PEG) and Ribavirin (RBV) after Liver Transplantation (LT). AM J Transpl 2005; 5 (Suppl 11): 181.

10. Sustained Virologic Response (SVR) is defined as undetectable virus (HCV RNA) 24 weeks after the end of treatment.

NOTE TO EDITORS: Schering-Plough press releases are available on the company's Web site at http://www.schering-plough.com. Schering-Plough press releases are also available on PRNewswire's Web site at http://www.prnewswire.com/comp/777050.html/

SOURCE Schering-Plough
05/23/2006

CONTACT: Media: Robert J. Consalvo, +1-908-298-7409, or Investors: Alex Kelly, +1-908-298-7436, both of Schering-Plough

Web site: http://www.schering-plough.com
(SGP)

Press Contact: Lenore Neier
212-668-1000 x137
lneier@liverfoundation.org

More Than 500 Million People Worldwide Are Infected by These Killer Viruses...

New York, NY. The threat of avian flu may dominate the media, but its impact on human lives is miniscule compared to the reality of hepatitis B and C, the two most common forms of chronic liver disease. Together, they infect nearly five million people in the United States and, according to a World Health Organization estimate, more than 500 million people around the world. Without global intervention, the U.S. Centers for Disease Control and Prevention predicts that the impact of the disease will double over the next ten years. Yet these viruses, which are one of the top ten causes of death nationwide, are often preventable. Although a vaccine is available for hepatitis B, few people get the vaccination. Fewer still are aware that the vaccine exists.

As for Hepatitis C considered a silent killer because it often produces no symptoms during its long incubation period there is no vaccine, but infection can be avoided through common-sense precautions such as using sterile needles for tattoos or body piercing, not injecting drugs, and practicing safer sex. It is imperative that patients speak with their doctor about getting tested for hepatitis B and C and consider treatment options that will help preserve liver health, said James L. Boyer, MD, who is Chairman of the Board of Directors of the American Liver Foundation, a nonprofit organization founded 30 years ago in order to promote liver health and disease prevention. Although many people shy away from it, testing can allow for early diagnosis and treatment, preventing the virus from developing into cirrhosis of the liver or cancer.

Too often, Dr. Boyer explained, people are ashamed to be tested because of long ago drug habits or sexual activities. But shame is a terrible reason for dying an unnecessary and a painful death. Shame and ignorance go hand in hand, according to Frederick G. Thompson, President and Chief Executive Officer of the American Liver Foundation. He pointed to a recent survey conducted by the organization, which revealed that half the US. population did not even know that hepatitis was a liver disease.

In order to heighten understanding of the illness and its causes, volunteers from the 25 local chapters will present special programs during the month of May for the annual Hepatitis Awareness Month. A key weapon in this years Hepatitis Awareness Month is a Liver Wellness Toolkit. The kit consists of a professional slide presentation, complete with handouts and instructions, for use by medical and nursing staff, volunteers and healthcare educators. For more information about this presentation, call 1-800-GO-LIVER.

I grew up in the sixties and by the grace of God I did not get involved with hard drugs as many of my friends and family members did. I once posted this on some HCV forums and they thought I was putting down people who were infected because of the present or past drug use and thought I thought I was an elitist. Trust me there is nothing elite about having HCV. This is not the case and hope that those who read this, do not walk away thinking that. My beef is that if the CDC and other HCV organizations mainly focus that IV Drugs users are the main source of infection, hundreds of thousands out there will not get tested.

I guess a good example would be if a heterosexual was infected by HIV and his doctor told him, the virus is contained solely to the gay community, he would not like to be labeled and would be utterly confused how he was infected. When I go to a new doctor and informed them that I had HCV, I’m still asked well, how did you get it, were you a drug user? I simply rely, how do people get cancer? The rate of sporadic (unknown origin) infections has risen from 15% since 1995 to 30% and climbing. Most importantly, in 1995 when my first dr. told me there were only two ways of getting it blood transfusions or drug use. I truly believe that I had been misdiagnosed. He insisted and all the tests proved that I had it.

However, once on TX, paranoia, would come to mind from time to time and I would think OMG, I might being doing the God awful tx for no reason. I just want the accurate ways of transmissions to reach the general population so they too will get tested. We are all in this together and I do not care how someone was infection, I just care that someone was infected.

Love Always,

The Be In Charge® Program* offers you information and support to allow you to deal with the concerns you face as a hepatitis C patient.

Be In Charge is a Free Service. Be In Charge is a free service of Schering Corporation for people considering treatment.

Be In Charge is designed to help you: Choose a treatment that is right for you. Cope with the side effects that often accompany interferon treatment. Understand and talk more easily with your doctor about hepatitis C . Feel confident about your therapy for hepatitis C.

Variety of Support Materials. The program also offers you support materials to help you get through therapy and adjust to living with chronic hepatitis C. The Be In Charge program support materials offered to you are based on where you are in therapy and include:

Personal Nurse Counselor - You will be teamed with your own Nurse Counselor, who will answer your questions by telephone. Plus, you can call our Nurse Counseling service toll-free, 24 hours-a-day, 7 days-a-week to speak with a nurse.

Patient Therapy Management Binder - This one-stop reference guide helps you progress through your therapy more easily.

The Hepatitis Workbook: A Guide to Living with Chronic Hepatitis B and C - This comprehensive reference book offers detailed information about hepatitis and treatment options.

Coaching Booklet - This booklet is intended for family members, close friends, or coworkers, explaining chronic hepatitis C, your therapy, and how to offer you better support. Other Educational Materials - These include educational reference materials about chronic hepatitis C and its treatment.

If you have been diagnosed with chronic hepatitis C, and are on either PEG-INTRON® (Peginterferon alfa-2b) Powder for Injection alone or in combination with REBETOL® (Ribavirin, USP) Capsules; REBETRON® Combination Therapy containing REBETOL® and INTRON® A (Interferon alfa-2b, recombinant) Injection; or INTRON® A for Injection therapy, contact Be In Charge today.

Other Available Resources

Be In Charge can Help Explore Reimbursement Options. Schering's COMMITMENT TO CARE® has been designed to aid eligible patients in receiving therapy with Schering products by exploring reimbursement options. This is available to all eligible patients taking either PEG-INTRON® alone or in combination with REBETOL®, REBETRON® Combination Therapy containing REBETOL® and INTRON® A, or INTRON® A for Injection Therapy.

This COMMITMENT TO CARE® reimbursement assistance is available to eligible patients whether you enroll in the Be In Charge program or not. Since its inception in September 1995, COMMITMENT TO CARE® has helped over 6,000 patients by providing reimbursement assistance for their medication. For information and enrollment,
call 1-800-521-7157.

To be eligible for the Be In Charge program, you must be diagnosed with chronic
hepatitis B or C, be 18 years of age or older, and be living in the U.S.

* Note: If you or someone you know may be at risk for hepatitis C, please visit

www.peg-intron.com

Written by:
Karen Barrow
Published on: May 16, 2006

Currently, patients with hepatitis C face a long road of expensive treatments, but a new test may make sorting out who needs this treatment a little easier.
A genetic test has been developed to predict which patients with hepatitis C will develop cirrhosis, or scarring, of the liver, a serious side effect of the disease that often leads to the need for a liver transplant. Since treatment for hepatitis C is costly and comes with serious side effects, this screening test may allow doctors to sort out who is most in need of immediate treatment and who can wait.

"Use of this information to select and treat the patients at highest risk for progression earlier may help prevent irreversible liver damage," said Kathy Ordonez, president of Celera Genomics, the company that developed the test.

In many patients, hepatitis C causes no symptoms and may never cause any liver damage. However, the disease can also cause a chronic liver disease, including cirrhosis, liver failure and liver cancer. Of the estimated 4 million Americans with hepatitis C, 70 percent will develop chronic liver disease and 5 to 20 percent will develop cirrhosis, a leading cause of death in hepatitis C patients.

Determining which patients will end up at this dangerous end of the spectrum is key in preventing liver damage.

According to Dr. David Speechly, determining which patient will develop liver damage as a result of hepatitis C is basically a "flip of a coin." Doctors will look at several factors to try to determine a patient's risk of developing liver disease, including age, gender and alcohol consumption. Liver biopsies, too, are often done to determine the current amount of damage done to the liver, but it cannot predict how much damage will occur in the future.

Celera's test checks for seven genetic variations that seem to increase a patient's risk of developing cirrhosis. In a study, researchers found that those with these genetic variations and particular lifestyle factors, like alcohol consumption, are more than eight times as likely to develop cirrhosis than a patient without either. The results of the study were presented at the annual meeting of The European Association for the Study of the Liver.

Currently, if a doctor does suspect that a patient will develop cirrhosis, he will likely prescribe a combination of medications that can top $30,000 a year and cause major side effects, including chronic flu-like symptoms and nausea. Therefore, if a genetic test can pinpoint which patients truly need treatment, it could prevent unnecessary pain and expense.

"This study confirms that the genetic makeup of each patient is the most important factor in determining which patients are likely to develop [cirrhosis of the liver]," said Dr. Mitchell L. Schiffman, study author and chief of hepatology of the liver transplant program at Virginia Commonwealth University Medical Center.

Celera Genomics is currently seeking FDA approval for this test, which is estimated to cost around $1,000.

© 2006 Healthology, Inc.

This is my real passion regarding HCV. I went to Capital Hill a couple of years ago with a HCV group. I presented members of both houses with a report on this. None of them had been aware of this. I continue to apply pressure on the NY elected officials that I know and won't stop until they do.

I had stumbled upon this information by trying to find out how I had contracted HCV. My first doc had told me that I either contracted it from IV drugs or a blood transfusion which did not apply to me.. He gave me an evil smirk and said, well, that's the only way you could have gotten HCV. As fate would have it, my first Dr. from hell who's name is Dr. Rovito while performing endoscopies and colonoscopies had a wonderful Anesthesiologist who infected 19 patients with HCV by reusing IV needles.

A close friend that I grew up with, was one of them, who received a letter from the NYC health Dept, stating she needed to be tested for HIV & HCV. She had stomach cancer at the time; had surgery and chemo when she was done with that she was diagnosed with breast cancer. After treating that she found out she had HCV, gee isn't the medical filed thoughtful to give 42 patients such a lovely gift as HCV. At the present time does not feel emotionally physically
up to doing treatment.

Surgical saw blade, drill, stapler, scissors and forceps were all sold in packages clearly labeled as single-use devices. That means the manufacturer designed the device as a throwaway. Use on one patient, and then discard. So are the surgical gowns, elastic bandage, the catheter used for balloon angioplasty, the mask used for anesthesia, and plenty of other common medical equipment used in hospitals and doctors' offices.

How many times has that "non-reusable" medical device actually been reused? Is a balloon angioplasty catheter, used to treat blockages in coronary arteries, just as flexible, safe and effective the second time around? Or the third?

Does your kid care if those metal braces had a previous home in a mouth or two before they were glued to her teeth? After all, everything has been carefully sterilized. But will the metal in those used braces be more likely to break in the middle of a vacation or another inconvenient time?

Patients should be asking those questions because disposable medical devices are reused all the time. In addition, nobody knows how well devices made for one use stand up to repeated use. The practice of reprocessed and reusing "single-use devices" has become common during the last few years. The 2000 congressional study concluded that at least one-third of American hospitals reuse some disposable medical devices. Experts believe the trend is growing.

Cost-cutting efforts are one factor. A hospital or clinic can save money by reusing disposable medical devices. Sales of these devices totaled $56 billion in 1999. Use a disposable umbilical scissors to cut the cord on one newborn baby, for instance, and pay full price. Use it on two newborns, and the hospital's costs drop by 50 percent.

Advances in plastics and other materials used to make the 80,000 to 100,000 different kinds and brands of medical devices are another factor. Single-use devices are made from sturdier materials, and it seems reasonable that such material can be reprocessed and safely reused. However, few studies have been done to verify that belief. In order to get U.S. Food and Drug Administration (FDA) approval to sell a single-use device, manufacturers must prove only that it is safe and effective for one use.

Manufacturers need not do studies proving that the device can be reprocessed and used multiple times just as safely and effectively as the first.
reprocessed usually means that the device is carefully cleaned, inspected, refurbished and sterilized before use on the next patient. Some hospitals reprocessed single-use devices themselves. Others send used devices to companies that reprocessed them. Cleaning and sterilizing medical devices made for one-time use may be more difficult than sterilizing devices manufactured for multiple use, according to the FDA.

FDA studies identified several theoretical problems with reused medical devices. These include possible increased risk of infection if devices are not properly sterilized before reuse, possible increased risk of failure in orthodontic products, possible loss of elasticity and durability in balloon catheter devices and possible loss of original lubricants. Studies, however, find little evidence of widespread health problems from recycling single-use devices. Only 245 "adverse events" were linked to reuse of such devices during the last three years of the 1990s, according to the FDA. Manufacturers reported seven patient deaths, 72 injuries and 147 device malfunctions. I think these numbers are bullshit, how does one know when they went for a flu years ago, that needle wasn't reused, or went to a dentist, or had a medical procedure. These numbers are the ones that were caught!

The FDA decided on stricter regulation and monitoring of single-use-device reprocessed by third-party companies and hospitals. It hinted that more regulation may be on the horizon. Patients may want to talk with their doctors about recycled medical devices before undergoing procedures and ask, too, whether such devices could have been a factor if a procedure goes bad.


Some Commonly Reprocessed Single-Use Devices
Surgical saw blade
Surgical drill
Surgical stapler
Laparoscopy scissors
Orthodontic (metal) braces
Electrophysiology catheter
Electrosurgical electrodes and pencils
Endotracheal tube
Balloon angioplasty catheter
Biopsy forceps
Umbilical scissors
Gas mask
Ophthalmic knife
Irrigating syringe
Surgical gown
needles

MAY-2006

Hepatitis C Virus Infection Increases Risk Of Type 2 Diabetes

NEW YORK (Reuters Health) - Patients with hepatitis C virus (HCV) infection who are 40 years of age or older have three times the risk of developing type 2 diabetes compared with their uninfected counterparts, according to a report in the May issue of Diabetes Care.

"HCV is a diabetogenic agent that by means of increasing insulin resistance strongly predisposes infected patients to type 2 diabetes," Dr. Rafael Simo from Hospital Vall d'Hebron, Barcelona, Spain told Reuters Health. Dr. Simo and colleagues reviewed the available evidence concerning the epidemiological association between HCV infection and diabetes.
In all studies that contained a control group, there was a higher prevalence of HCV antibodies among patients with type 2 diabetes than among nondiabetic patients, the authors report. This was not the case for patients with type 1 diabetes.

Similarly, data from the Third National Health and Nutrition Examination Survey (NHANES III) confirmed a three-fold increased risk of type 2 diabetes in patients who were at least 40 years old and infected with HCV. Again, the results indicate, there was no association between HCV infection and type 1 diabetes.

In other studies, HCV-positive patients with chronic hepatitis were three times as likely to have glucose abnormalities, compared with HCV-negative subjects with other liver diseases. Diabetes and impaired fasting glucose were also more common among patients with anti-HCV antibodies.
Research examining the mechanisms linking HCV infection and type 2 diabetes effectively ruled out autoimmunity, iron overload, and direct damage to pancreatic beta cells. Instead, insulin resistance mediated by proinflammatory cytokines appears to be the main pathogenic mechanism.

"Taking into account the clear association between HCV infection and the development of diabetes, and given that HCV is a very prevalent disease affecting approximately 3% of the world's population, it is possible that HCV infection is contributing to the increasing prevalence of type 2 diabetes," Dr. Simo said. Because HCV infection can be considered a risk factor for diabetes, screening to detect diabetes and pre-diabetic conditions (impaired fasting glucose or impaired glucose tolerance) should be done at least every 3 years.
Dr. Simo also cited results of recent studies by his group indicating that successful treatment of HCV infection can prevent the subsequent development of type 2 diabetes.
Diabetes Care 2006;29:1140-1146.

2006 Reuters Health

Thou shalt regard the word, "Hepatitis", as exactly that: a word. Nothing more, nothing less. For its original meaning has changed mightily over the years, as have such words as Smallpox, TB, and Polio, all once dreaded ailments, now non-existent as maladies. And thus shalt go thy Hepatitis. The answer shall come to those who shall be present to hear it. Be present when it comes.

Thou shalt love thy interferon, and thy other treatments even as thyself, for they are thy friends and champions. Although they exact a toll for their endeavors, they are oft most generous in the favors they bestow.

Thou shalt participate fully in thy recovery. Thou shalt learn all the details of thy ailment, its diagnosis, its prognosis, its treatments, conventional and alternate. Thou shalt discuss them openly and candidly with thy hepatologist and shalt question all thou do not comprehend. Then, thou shalt cooperate intelligently and knowledgeably with thy doctor.

Thou shalt regard thy ailment as a temporary detour in thy life and shalt plan thy future as though this detour had not occurred. Thou shalt never, at no time, no how, regard thy temporary ailment as permanent. Thou shalt set long-term goals for thyself. For thou WILL verily recover and thy believing so will contribute mightily to thy recovery.

Thou shalt express thy feelings candidly and openly to thy loved ones for they, too, are stricken. Thou shalt comfort and reassure them for they, too, needest comforting and reassurance, even as thou doest.

Thou shalt be a comfort to thy fellow brothers and sisters, providing knowledge, encouragement, understanding and love. Thou shalt give them hope where there may be none, for only in hope lies their salvation. And by doing so, thou providest comfort for thyself, as well.

Thou shalt never relinquish hope, no matter how thou may feelest at that moment, for thou knowest, in the deep recesses of thy heart, that your discouragement is but fleeting and that a better day awaits thee.

Thou shalt not regard thy ailment as the sum total of thy life but as merely a part of it. Fill your life with other diversions, be they mundane, daring, altruistic, or merely amusing. To fill your life with your ailment is to surrender to it.

Thou shalt maintain, at all times and in all circumstances, thy sense of humor, for laughter lightens thy heart and hastens thy recovery. This is not an easy task, sometimes seemingly impossible, but it is a goal well worth the endeavor.

Thou shalt have enduring and unassailable faith, whether thy faith be in a Supreme Being, in Medical Science, in Thy Future, in Thyself, or in Whatever. Steadfastly sustain thy faith for it shall sustain thee. The wit makes fun of other persons; the satirist makes fun of the world; the humorist makes fun of himself.