Research & Treatment News
February 23, 2009
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Learn about the eight drug strategies that offer great promise for a new and improved Hepatitis C treatment regimen.
by Nicole Cutler, L.Ac.
Currently, pegylated interferon and ribavirin are the standard of treatment for Hepatitis C. Because these medications only boast an approximate success rate of 50 percent, the pharmaceutical companies are racing to come up with more efficient alternatives.
Even though reports of successful Hepatitis C trials appear to dot the news reels each week, there are a series of hurdles a potential new drug must pass before it is can enter the market. Subsequently, there are just a handful of Hepatitis C drugs that have made it past initial screening processes and are churning out encouraging safety and efficacy data.
Although the listed drugs in development are by no means the only contenders, the following are some of the most promising as of February 2009:
1. Albuferon – Human Genome Sciences and Novartis are studying albuferon, a longer acting form of interferon alfa-2b fused with the human blood protein albumin. While albuferon is in ongoing Phase III clinical trials evaluating safety, tolerability and effectiveness compared to Pegasys, pulmonary complications have required researchers lower the albuferon dosage.
2. R7128 – In a collaborative effort to develop nucleoside polymerase inhibitors for the treatment of chronic Hepatitis C, R7128 is being developed by Pharmasset and Roche. In January 2009, the manufacturers announced launching a large Phase 2b study of varying doses of R7128, in combination with Pegasys and ribavirin. Primary data from the new study is expected to be released late in 2009.
3. ITMN-191 – In January of 2009, InterMune reported on the results from a small Phase I study of protease inhibitor ITMN-191 in combination with Pegasys and ribavirin. While the results from this trial were encouraging, a Phase 2b study of ITMN -191 at various doses, at different intervals with different durations is expected to begin in the second quarter of 2009. Note: ITMN-191 was formerly known as R7227.
4. INFORM-1 – R7128 and ITMN-191, together with ribavirin, are being tested as the first interferon-free combination therapy. Expected to be compiled, analyzed and released in 2009, INFORM-1’s results will yield great understanding into the effectiveness of these polymerase and protease inhibitors as well us divulge any synergistic effects from combining these antiviral compounds.
5. IDX184 – In January of 2009, Idenix Pharmaceuticals announced initiating a small Phase II/III proof-of-concept study of IDX184, a Hepatitis C nucleotide polymerase inhibitor. This will be a small, double-blinded, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and antiviral activity of IDX184 in HCV genotype 1 treatment-naïve patients.
6. Telaprevir – Vertex Pharmaceuticals has several Phase III trials underway to determine safety, tolerability, antiviral activity and dosing guidelines for telaprevir. In 2008, telaprevir demonstrated promising antiviral results in large Phase 2b studies of treatment-naïve and treatment-failure patients, and also demonstrated the potential to be dosed in a twice-daily regimen.
7. Boceprevir – In January 2009, Schering-Plough reported completing patient enrollment in the boceprevir HCV SPRINT-2 study, a pivotal Phase III study in treatment-naïve patients. Together with a previous Phase III study in patients who failed prior treatment, over 1,500 patients are enrolled in Schering-Plough’s lead investigational oral Hepatitis C protease inhibitor.
8. PEG-Interferon Lambda – Bristol-Myers Squibb and ZymoGenetics are co-developing this longer acting form of interferon. Currently in Phase I studies, early data generated by PEG-Interferon lambda suggest the drug might be safer and better tolerated than the current long-acting interferons.
The preceding eight drugs (or drug combinations) are among the most hopeful for improving Hepatitis C treatment. However, this list is not exhaustive, as there are many more substances that scientists are currently examining. Until the FDA concludes that one of these drugs is superior to pegylated interferon and ribavirin for the treatment of Hepatitis C, we’ll have to sit patiently and wait for the next generation of Hepatitis C medications to be approved.
References:
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=364268, Vertex Pharmaceuticals Provides HCV and Cystic Fibrosis Update and Reports 2008 Financial Results, Retrieved February 19, 2009, Vertex Pharmaceuticals, February 2009.
http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle
&ID=1243000&highlight=, InterMune Reports Results from Triple Combination Study of ITMN-191, Retrieved February 19, 2009, InterMune, Inc., 2009.
http://www.hcvadvocate.org/news/newsLetter/2009/advocate0209.html#4, HCV Snapshots – Drugs in Development, Alan Franciscus, Retrieved February 17, 2009, HCV Advocate, Hepatitis C Support Project, February 2009.
http://www.hivandhepatitis.com/hep_c/news/2008/012508_a.html, Albuferon Dose in Ongoing Trials is Lowered Due to Safety Concerns, Retrieved February 19, 2009, hivandhepatitis.com, January 2008.
http://www.hivandhepatitis.com/hep_c/news/2009/012009_b.html, New Hepatitis C Treatment Trials: HCV Polymerase Inhibitor R7128, Nucleotide Prodrug IDX184, and Albumin Interferon (Albuferon), Retrieved February 19, 2009, hivandhepatitis.com, January 2009.
http://www.medicalnewstoday.com/articles/128826.php, Roche, InterMune And Pharmasset Announce Initiation Of INFORM-1, The First Dual-Combination Clinical Trial With Oral Antivirals In Hepatitis C, Retrieved February 19, 2009, MediLexicon International, Ltd, November 2008.
http://www.pharmasset.com/pipeline/R7128.asp, R7128, a prodrug of PSI-6130, Retrieved February 18, 2009, Pharmasset, Inc., 2009.
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Aethlon's Hemopurifier® completed a 30-day study on a Hepatitis C patient with end-stage-renal disease. While Aethlon hopes this blood-filtering medical device helps millions reduce Hepatitis C viral load, officials are still waiting for laboratory confirmation.
Aethlon Medical Announces Completion of 30-Day Hepatitis-C Treatment Study
Posted : Wed, 18 Feb 2009
Author : Aethlon Medical, Inc.
SAN DIEGO - (Business Wire) Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it has completed a 30-day treatment case study to further evaluate the safety and efficacy of the Aethlon Hemopurifier® as a candidate treatment for Hepatitis-C Virus (HCV) infection. The Hemopurifier® is a first-in-class medical device that assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins. As in previous studies, which demonstrated robust viral load reductions resulting from three Hemopurifier® treatments administered in a one-week trial, the study enrolled an HCV patient suffering from end-stage renal disease (ESRD) requiring regular kidney dialysis treatment. The study goal was to further demonstrate the Aethlon Hemopurifier® inhibits the progression of HCV in infected ESRD patients. The study protocol provided for 12 Hemopurifier(R) treatments to be administered during the patient’s normally scheduled dialysis treatment. As a result, a 4-hour Hemopurifier® treatment was administered thrice weekly over a period of 30 days. There were no observed adverse events were reported in any of the treatments. The study was conducted at the Fortis Hospital in Delhi, India. Aethlon will disclose viral load and associated data upon receipt from testing laboratories. The insight obtained from the study will help define future clinical protocols and early commercialization strategies. The study data may also be utilized to expand the scope of an IDE submission to the FDA to include the potential use of the Hemopurifier® in the United States as a device designed for the single-use removal of HCV from blood. At present, the focus of Aethlon’s IDE submission has been directed towards high risk bioterror and emerging pandemic threats.
It is estimated that up to 20% of the 1.6 million global ESRD population is infected with HCV. Beyond the treatment of infected ESRD patients, the overall opportunity for the Hemopurifier® is HCV care is significant, as approximately 180 million people worldwide (3% of the world's population) are HCV infected. According to the World Health Organization (WHO), only 30-50% of infected patients will beneficially respond to the 48-week pegylated interferon-ribavirin treatment standard.
“While we still have much work ahead, I am proud that our research and clinical programs allow us the opportunity to expand the therapeutic filtration industry beyond kidney dialysis and into the much larger infectious disease and cancer markets,” stated Aethlon Chairman and CEO, Jim Joyce. “The continued demonstration of Hemopurifier® safety and effectiveness increases the likelihood that our technology will be available to extend and improve the lives of those suffering from these horrific conditions,” concluded Joyce.
In a previous studies conducted the Fortis Hospital, six ESRD patients received a series of three, 4-hour Hemopurifier® treatments every other day during the course of one week. The treatment regimen also mirrored the patient's normal kidney dialysis schedule, allowing for the inclusion of the Hemopurifier® without disrupting dialysis treatment. Robust viral load reductions were observed in three HCV patients who completed the three-treatment protocol. Patient #1 had a 95% reduction three days post treatment and 89% reduction seven days post treatment. Patient #2 had a 85% reduction three days post treatment and 50% reduction seven days post treatment, and patient #3 had a 60% reduction three days post treatment and 83% reduction seven days post treatment.
Aethlon additionally disclosed that it soon expects the receipt of viral load and blood chemistry data resulting from a recently completed 30-day HIV treatment case study. The Hemopurifier® is the first medical device to target the treatment of both HIV and HCV, as well as a broad-spectrum of other infectious viral pathogens.
About Aethlon Medical
Aethlon Medical creates diagnostic and therapeutic filtration devices to improve the health of individuals afflicted with infectious disease and cancer. The Company’s lead product, the Aethlon Hemopurifier®, is a first-in-class artificial adjunct to the immune system proven to capture infectious viruses and immunosuppressive particles from circulation. The device targets to inhibit disease progression of Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus (HIV), and serves as a broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats. The Hemopurifier® also holds promise in cancer care, as research studies verify the Hemopurifier® effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over sixty-five (65) Hemopurifier® treatments (representing approximately 260 hours of treatment time) have been conducted in multi-site studies at the Apollo Hospital, Fortis Hospital, and Sigma New-Life Hospital in India. The studies enrolled end-stage renal disease (ESRD) patients infected with either HCV or HIV. In addition to establishing treatment safety, robust viral load reductions have been reported in HCV-infected patients who completed a three-treatment protocol during the course of one week.
Research studies have also demonstrated the Hemopurifier® is effective in capturing a broad-spectrum of viruses untreatable with drug therapy, including several of world’s deadliest bioterror and pandemic threats. These include: Dengue hemorrhagic fever (DHF), Ebola hemorrhagic fever (EHF), Lassa hemorrhagic fever (LHF), H5N1 avian influenza (Bird Flu), the reconstructed 1918 influenza virus (r1918), West Nile virus (WNV), and Vaccinia and Monkeypox (MPV), which both serve as models for human smallpox infection. The studies were conducted with the assistance of researchers representing: The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID); The Centers for Disease Control and Prevention (CDC); The National Institute of Virology (NIV); The Battelle Biomedical Research Center (BBRC); and The Southwest Foundation for Biomedical Research (SFBR).
In additional to therapeutic market opportunities, Aethlon is leveraging principles underlying the Hemopurifier® technology platform to establish a pipeline of clinical and research diagnostic products and services. Additional information regarding Aethlon Medical can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the Company’s ability to raise capital when needed, the Company’s ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company’s ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company’s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company’s Securities and Exchange Commission filings.
Aethlon Medical, Inc.
Prashant Mehta, Ph.D.
Director of Business Development
858.459.7800 x303
pmehta@aethlonmedical.com
or
Jim Frakes
Senior VP Finance
858.459.7800 x300
jfrakes@aethlonmedical.com
or
Jim Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
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URL for Article Source:
http://www.earthtimes.org/articles/show/aethlon-medical-announces-
completion-of-30-day-hepatitis-c-treatment-study,720986.shtml
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February 20, 2009
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Enabling poorer countries to screen their blood banks for the virus, researchers have developed a blood test for Hepatitis C that is high in specificity and low in cost.
Novel Economical Blood Test For Hepatitis C
ScienceDaily (Feb. 19, 2009) — A novel blood test could bring a breakthrough in the battle against the dangerous hepatitis-C virus. This procedure offers a considerably cheaper alternative to the normal commercial tests, whilst maintaining equal sensitivity. So now, for the first time, poorer countries will also have the opportunity to monitor their entire blood banks for the hepatitis C virus using optimum methods.
This procedure has been developed by researchers at Bonn University and the Bernhard-Nocht Institute for Tropical Medicine in Hamburg. Scientists from Brazil, Singapore, South Africa and England were also engaged in this research.
170 million people worldwide have already become infected with the hepatitis C virus. The early stages of the disease often go unnoticed. However, later symptoms include liver cancer and mortally dangerous liver cirrhosis. One of the chief sources of infection lies in contaminated blood banks, which is why all the bloodbanks in Europe or the USA are routinely tested for the hepatitis C virus. However, the poorer countries cannot afford this, or they have to rely on out-dated tests of inadequate sensitivity. The new procedure could change all this. “In Brazil, a standard hepatitis C test costs over 100 dollars a sample – for us, in contrast, the cost lies at just under 19 dollars”, declares Dr. Jan Felix Drexler. 10 dollars of this are licence fees – several major pharmaceutical companies hold patents for the genome of the hepatitis C virus.
Dr. Drexler, who has been engaged in the development of this new test procedure, has just removed from the Bernhard-Nocht Institute in Hamburg to Bonn University. The procedure functions, in principle, in exactly the same way as most of the commercial tests hitherto available on the market: all these procedures recognise genotype sequences in the blood, which originate from the hepatitis C virus. However, the problem is that various types of pathogen exist, whose genotypes are sometimes very different. A good blood test ought to raise the alarm equally well for each of these types. “In Asia, for example, we often find different hepatitis C viruses from ours”, says Dr. Drexler. “But when a tourist becomes infected in Thailand and subsequently donates blood in Germany, we must be able to diagnose these blood samples without fail, too”.
600 Blood Samples examined
At many points, however, the genotypes of diverse pathogens are to a great extent identical. Genetisists speak here of conserved regions, and all commercial tests have been “specialised” with respect to one of these points. The new procedure, in contrast, reacts when it detects sequences from a different conserved region which has not so far been used for HCV diagnosis. Working on the basis of just under 600 blood samples from five different countries, researchers were able to demonstrate just how well this functions. “We are, at least, just as sensitive as the two best standard procedures”, emphasises Professor Dr. Christian Drosten, a virologist from Bonn University. “This is true for all types of virus”.
Passes Practical Test in Brazil
So now, for the first time, poorer countries also have the chance to test their blood banks, and at comparatively small cost. “This would be a significant breakthrough for containing the disease”, Dr. Drexler stresses. “After all, transfusions are a major source of propagation“. In one Brazilian laboratory the new blood test has already been given trials on 127 patients – with outstanding success. In this latest publication, the researchers reveal every detail of their methods. “For anyone wishing to use this test we can also supply the control reagents”, Dr. Drexler declares. Commercial suppliers, in contrast, maintain the strictest secrecy regarding the precise data of their tests.
But this procedure will not only detect the presence of an infection with hepatitis C viruses. Doctors can also determine the total concentration of the viruses in the blood. Hence this blood test can also be used, for example, for monitoring therapeutic success. According to Dr. Drexler, “In this way we could spare many patients months of expensive treatment, and the unpleasant side-effects, too”.
Journal reference:
1. Drexler et al. A Novel Diagnostic Target in the Hepatitis C Virus Genome. PLoS Medicine, 2009; 6 (2): e31 DOI: 10.1371/journal.pmed.1000031
Adapted from materials provided by University of Bonn, via AlphaGalileo.
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URL for Article Source:
http://www.sciencedaily.com/releases/2009/02/090210134744.htm
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February 19, 2009
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Upon studying inflammatory markers in those with cirrhosis, researchers found that the degree of systemic inflammation is directly related to the common cirrhosis complications of diminished mental and cardiac function.
Inflammation May Be Common Thread Behind Nervous And Heart Rhythm Problems In Cirrhosis
ScienceDaily (Feb. 17, 2009) — Liver cirrhosis is the seventh leading cause of death in the United States, taking 25,000 lives per year. It is often the result of alcohol over-consumption or exposure to hepatitis C, either of which can damage the liver and prevent it from filtering toxins. These toxins then accumulate in the blood stream and eventually reach the brain where they disrupt neurological and mental performance, a condition known as hepatic encephalopathy.
Individuals with cirrhosis are also susceptible to a change in heart rhythm (decreased heart rate variability). Since cirrhosis, hepatic encephalopathy and heart rate variability are known to be associated with inflammation, researchers have examined what role cytokines (inflammatory molecules) play.
A new study from The American Physiological Society suggests that these cytokines can lead to both the neurological and cognitive abnormalities and changes in heart rhythm in patients with cirrhosis. The results of the study may also apply to other conditions where heart rate variability is also decreased, such as bipolar disorder and post-menopausal depression.
The study, “Decreased heart rate variability in patients with cirrhosis relates to the presence and severity of hepatic encephalopathy,” was carried out by Ali R. Mani, Sara Montagnese, Clive D. Jackson, Christopher W. Jenkins, Ian M. Head, Robert C. Stephens, Kevin P. Moore and Dr. Morgan. All are affiliated with the University College London Medical School, with the exception of Mr. Jackson, who is with the Royal Free Hospital, London. The study appears in The American Journal of Physiology-Gastrointestinal and Liver Physiology.
Three measurements
The study involved 80 patients suffering cirrhosis of the liver. Sixty-five (81%) of the patients had cirrhosis because of chronic alcohol abuse, although none had abused alcohol within three months of the study. Of the remaining 15 participants, seven had developed cirrhosis from chronic hepatitis while the remaining eight had developed the disease in various other ways. The participants were compared to a control group of 11 healthy people.
First, the researchers tested for the presence of hepatic encephalopathy by examining the patient’s mental state. They conducted various cognitive tests and obtained an electroencephalogram (EEG). After examination, the study participants were classified as having either overt hepatic encephalopathy, minimal hepatic encephalopathy or no encephalopathy.
Second, they measured heart rate variability using an electrocardiogram. A healthy heart varies the rate at which it beats depending upon a variety of factors. For example, the heartbeat accelerates when inhaling and decelerates when exhaling. Reduced heart rate variability -- that is, a more regular heartbeat -- has been associated with systemic inflammation and with various neuropsychiatric conditions, such as bipolar disorder.
Third, in a subgroup of 18 patients, the researchers also measured for cytokines, which circulate in the blood as part of the inflammation. Among these cytokines was interleukin-6, a substance that plays a role in cell signaling as part of the body’s response to inflammation.
Connected to inflammation
When the researchers began the study, they knew that cirrhosis of the liver leads to hepatic encephalopathy, systemic inflammation and reduced heart rate variability. It was not known whether and how they were related.
Their first major finding was that reduced heart rate variability and the presence of hepatic encephalopathy were very strongly connected. The second major finding was that blood levels of the inflammatory cytokines (including interleukin-6 levels) closely paralleled both the degree of neuropsychiatric impairment and reduced heart rate variability. This suggests that inflammatory response plays a role in these impairments.
Additional Findings
The researchers also found that:
* In patients with cirrhosis, there were significant concentrations of cytokines. By contrast, concentrations were below the level of detection among healthy volunteers.
* There was no significant differences in heart rate variability between patients with alcohol-related cirrhosis and patients with cirrhosis due to other reasons, such as chronic viral hepatitis.
* The risk of death increased as heart rate variability decreased.
The authors concluded that inflammation plays a role in both the reduction in heart rate variability and the development of hepatic encephalopathy in patients with cirrhosis. In subsequent, yet unpublished research, they have found that treatment for hepatic encephalopathy not only improves mental function but also improves heart rate variability. This treatment also reduces blood levels of cytokines providing further evidence of a link between systemic inflammation, mental and cardiac function in this patient group.
Adapted from materials provided by American Physiological Society.
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URL for Article Source:
http://www.sciencedaily.com/releases/2009/02/090210092728.htm
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February 11, 2009
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Hepatitis C survivor Natalie Cole may receive a much needed kidney transplant from her son.
Natalie Cole's Son to Donate Kidney to Mom
BY: Actress Archives | Thursday, February 5, 2009
Proving that he's a son that really knows how to step up to the plate for his mom, it's been reported that Natalie Cole's son may give her one of his kidneys. Cole was diagnosed with Hepatitis C about a year ago and now it seems she might need a kidney transplant, which would finally put an end to the dialysis treatments she goes through three times a week.
Speaking to Entertainment Tonight at the Grammy Salute to Jazz on Tuesday (Cole is nominated for three Grammys for her 2008 album "Still Unforgettable") she said, "My son [Robert,] may be a possible match. It's very sweet and kind of strange to have people offer something like that." Cole explained that while does not look forward to the recuperation time she'll need to take after the surgery, "in the end it'll be worth it." Her son Robert is 31 years old.
In September of last year, Natalie Cole spoke openly about her struggle with Hepatitis C, which doctors told her she contracted from sharing needles in the eighties when she was a heroin addict. Shedding light on her new health routine, Cole said, "I give myself a weekly injection of chemotherapy in my thigh. When I started in May, I thought I was dying. I couldn't get out of bed for three weeks - literally. I was nauseous every day. I lost 15 pounds from not eating."
Upon learning about the illness, which remained dormant in her body for twenty-five years, Cole says, "My life crumbled before my eyes." She added, "I've learned a lot of lessons. Yes, I could have handled some things better. But they've also made me who I am today."
Cole's illness didn't stop her from touring the world last year. Said Cole, "I've never been through anything like this. I love what I do so much. I just keep going. Nothing can bring me down."
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URL for Article Source:
http://www.actressarchives.com/news.php?id=14562
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Whether undergoing treatment or just managing Hepatitis C, hunger and digestive problems can interfere with good eating habits. Compiled from experts in liver disease, Hepatitis C and nutrition, discover 17 tips that can help improve a person’s ability to fulfill their nutritional needs despite having Hepatitis C.
by Nicole Cutler, L.Ac.
Experiencing the symptoms of liver disease and enduring antiviral treatment can present many eating challenges to those with Hepatitis C. Eliminating morsels that are harmful to the liver and choosing foods that are beneficial to hepatic health are crucial to a successful Hepatitis C eating plan. However, the reality of living with chronic liver disease can easily throw additional food concerns into the mix.
Whether a consequence of liver disease or accompanying medications, those with Hepatitis C face several potential barriers to eating well. At the center of the body’s detoxification responsibilities, the liver purifies unwanted substances from the blood. Chronic liver disease puts a strain on this toxin elimination system. Thus, those with chronic Hepatitis C who have sustained liver damage are likely to have excessive toxicity in their bloodstream. When waste is not effectively removed from a person’s body, their hunger and reaction to food are often altered. In addition, fighting chronic Hepatitis C infection leaves many too exhausted to prepare healthful meals.
As the current standard of treatment for Hepatitis C, antiviral therapy has a wide range of severe side affects. Aside from zapping people of their energy, the antiviral drugs frequently interfere with a person’s desire for food, ability to keep food down and they can distort taste and smell.
Because eating healthy food is the most revered way to fuel the body in its quest for wellness, the following tips can help those with Hepatitis C overcome their food obstacles:
When you have no desire to eat:
1. Consume small portions
2. Do some mild exercise to stimulate the appetite
3. Use liquid nutrition supplements if needed
4. Take advantage of when you are hungry
5. Make the most of each mouthful (choose nutritionally dense foods)
If foods you once enjoyed don’t taste or smell appealing:
6. Since red meat can taste bitter when on antiviral drugs, choose other sources of protein like chicken, fish, beans, cheese, yogurt and eggs
7. Since heat can intensify flavors, opt for foods cold or at room temperature
8. Turn on a fan or open the windows while cooking and eating
9. Cook outside or in the microwave
If fatigue is overwhelming:
10. Ask friends and family members to help prepare meals
11. Have liquid nutrition supplements or prepared snacks ready
12. When you have enough energy to cook, prepare extra food and freeze it
When nausea or vomiting interferes with eating:
13. Stay hydrated by sucking on ice chips or taking small sips of non-citrus, clear fluids
14. Choose bland foods because they are easier to digest and keep down
15. Eat small bits every few hours to prevent an empty stomach
16. Avoid foods that trigger your nausea (spicy, greasy and fatty foods are common triggers)
17. Try ginger ale, ginger tea or other products containing ginger to settle your stomach
Eating nutritious food is crucial to living a long life, especially with chronic liver disease. Unfortunately, the obstacles associated with food present an additional daily challenge to managing Hepatitis C. However, this challenge can be overcome by experimenting with the suggestions listed above. By minimizing the difficulties related to food preparation, hunger and digestion, these tips will help those with Hepatitis C get closer to their health and nutrition goals.
References:
http://books.google.com/books?id=Pf5j8RgzkRMC&pg=PA386&lpg=PA386&dq
=eating+tips+with+liver+disease&source=web&ots=Jscacb6ry5&sig=
-FakX8uqvgDI3JHCA-quiCtgOJU&hl=en&sa=X&oi=book_result&resnum=9&ct=
result#PPA407,M1, Dr. Melissa Palmer’s Guide to Hepatitis & Liver Disease, Melissa Palmer, MD, Avery, 2004; 407.
http://www.allabouthepatitisc.com/readytolearn/living/slowing/eating_healthy.jsp, Eating Healthy, Schering Corporation, 2009.
http://www.dietitians.ca/resources/HepC_Guidelines_enC.pdf, Hepatitis C Nutrition Care, Retrieved January 22, 2009, Dieticians of Canada, 2009.
http://www.hepatitisc.org.au/resources/documents/Food03.pdf, Hepatitis C and Food, Retrieved January 21, 2009, Hepatitis C Council of NSW, November 2003.
http://www.mayoclinic.com/health/nausea/DG00019, Nausea and Vomiting, January 21, 2009, Mayo Foundation for Medical Education and Research, 2009.
Posted by Editors at 2:44 PM --- Printer-friendly version
February 6, 2009
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Schering-Plough's lead Hepatitis C protease inhibitor has finished enrollment in a pivotal Phase III study. The completion of this study in 2010 could lead to boceprevir being approved for Hepatitis C treatment.
Schering-Plough completes enrollment in registration studies of hepatitis drug
Published: 02-February-2009
By Datamonitor staff writer
Schering-Plough has completed patient enrollment in the boceprevir hepatitis C virus Sprint-2 study, a pivotal Phase III study in treatment-naive patients.
Together with the hepatitis C virus (HCV) Respond-2 study, a pivotal Phase III study in patients who failed prior treatment that completed enrollment in November 2008, the company has fully enrolled its registration studies for boceprevir, its lead investigational oral hepatitis C protease inhibitor. A total of more than 1,500 patients were enrolled in these studies at US and international sites.
The HCV Sprint-2 study evaluates the efficacy of 28- and 48-week regimens of boceprevir (800mg TID) in combination with Pegintron (1.5mcg/kg/week) and Rebetol (600-1,400mg/day) compared to a control of Pegintron and Rebetol alone for 48 weeks in treatment-naive adult patients with chronic HCV genotype 1. The study enrolled a total of 1,099 patients, including 158 African-American or black patients.
The HCV Respond-2 study evaluates 36- and 48-week regimens of boceprevir in combination with Pegintron and Rebetol at the same doses as described above compared to a control of Pegintron and Rebetol alone for 48 weeks in adult patients with chronic HCV genotype 1 who failed prior treatment (relapsers and nonresponders) with peginterferon and ribavirin combination therapy. The study enrolled a total of 404 patients.
In both studies, RVR criteria at four weeks of boceprevir treatment (treatment week eight) is used to determine which boceprevir patients can stop all treatment at 28 weeks (HCV Sprint-2) or 36 weeks (HCV Respond-2). The company expects to complete the studies in mid-2010.
Thomas Koestler, executive vice president and president of Schering-Plough Research Institute, said: "We believe boceprevir has the potential to be a first-in-class and best-in-class protease inhibitor for treating chronic hepatitis C. We are very encouraged by the boceprevir study results reported to date and look forward to the completion of these registration studies."
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URL for Article Source:
http://drugdiscovery.pharmaceutical-business-review.com/news/schering_
plough_completes_enrollment_in_registration_studies_of_hepatitis_drug_
020209
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February 3, 2009
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Learn why Rockefeller University scientists' recent discovery on how to infect mice with Hepatitis C could lead to a necessary HCV vaccine.
Discovery Could Lead To A New Animal Model For Hepatitis C
ScienceDaily (Jan. 28, 2009) — During its career, the potentially fatal hepatitis C virus has banked its success on a rather unusual strategy: its limitations. Its inability to infect animals other than humans and chimpanzees has severely hampered scientists in developing a useful small animal model for the disease.
But now, in a breakthrough published in the journal Nature, Rockefeller University scientists have identified a protein that allows the virus to enter mouse cells, a finding that represents the clearest path yet for developing a much-needed vaccine as well as tailored treatments for the 170 million people across the globe living with the tenacious, insidious and rapidly changing virus.
By using a genetic screen, the group, led by Charles M. Rice, head of the Laboratory of Virology and Infectious Disease, identified a human protein, called occludin, that makes mouse cells susceptible to the virus. The discovery means that scientists now have the complete list of cellular factors — a total of four — that are required for the virus to enter nonhuman cells.
The hepatitis C virus exclusively targets human liver cells, suggesting that these cells express genes that allow uptake of the virus, genes that are not expressed in other human and nonhuman cells, explains Rice. In past years, three proteins — CD81, CLDN1 and SR-BI — were identified as having key roles in shuttling the virus into cells, but something was clearly missing. Rice’s group found that even when they engineered mouse cells to overexpress all three proteins, the cells still denied the virus entry.
The discovery of occludin, however, has changed that. When Rice and his colleagues engineered mouse and human cell lines to express all four proteins, they showed that each cell line became infectible with the virus. To further establish occludin’s role as a required entry factor, the group showed that human liver cells naturally express high levels of occludin, and that by silencing its expression, they could give these once highly susceptible liver cells the ability to completely block infection.
“You know, you sort of have to get lucky,” says Rice, who is also Maurice R. and Corinne P. Greenberg Professor at Rockefeller. “You’ve got these three factors you know are important, but you could have 10 other human factors that could have been necessary for hepatitis C virus entry. This work shows that’s not the case.”
In their DNA screen, the team, including Alexander Ploss, a research associate in the lab, and Matthew J. Evans, currently at Mount Sinai School of Medicine in New York, first cloned all the genes that were expressed in liver cells and then delivered them to mouse cells. “Then, going through an iterative screening process, we honed in on the genes that made the mouse cells permissive,” says Ploss, who spearheaded the project with Evans.
Since mice and humans each have a species-specific version of the four factors, the group used hamster cells to see which combination of factors did the best job at making the cells infectible. They found that in the case of two of the proteins, occludin and CD81, only the human versions worked; for SR-BI and CLDN1, the human and mouse versions did an equally good job. These experiments not only suggest that there may be more than one potential animal model, but also that there are several specific combinations of entry factors that could generate them.
“This work provides a clear foundation upon which we can now begin to construct an animal model for the uniquely human pathogen,” says Rice. “This is only a first step but in terms of creating an animal model for hepatitis C, it’s a big leap forward.”
Journal reference:
1. Ploss et al. Human occludin is a hepatitis C virus entry factor required for infection of mouse cells. Nature, January 28, 2009; DOI: 10.1038/nature07684
Adapted from materials provided by Rockefeller University.
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URL for Article Source:
http://www.sciencedaily.com/releases/2009/01/090128183934.htm
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February 2, 2009
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Discover the importance of consuming whey protein and artichokes, and how these and four other key foods can help your liver resist damage from Hepatitis C infection. This is the first installment of this invaluable 2-part article.
By Nicole Cutler, L.Ac.
Although many are convinced of the importance of food in both causing and relieving health problems, a substantial percentage of physicians fail to utilize nutrition for guiding their patients back to wellness. This is unfortunate, especially when their patients have chronic ailments like Hepatitis C. Regardless of the involvement of their doctor or their stage of liver disease, the food eaten by people with Hepatitis C can either make their bodies feel better or worse.
Our fixit fast culture has developed a higher level of comfort with drugs rather than foods; thus food as medicine has been largely neglected. Circa 400 B.C., the father of modern medicine, Hippocrates, said: “Let your food be your medicine and your medicine, your food.” In the eighteenth century, one of the greatest gastronomes of the world, Jean Anthelme Brillat-Savarin proclaimed: “Tell me what you eat, and I will tell you what you are.” Still popular today, Brillat-Savarin's The Physiology of Taste is a treatise on the relation between man’s joy and survival with his ability to know and experience the pleasures of taste.
In lieu of continually being advised to avoid foods that assault the liver, many with chronic Hepatitis C are left wondering what they should eat. For a clear understanding of six ideal foods for the liver, the following tips are given:
1. Drink Whey Protein – Add whey protein when making a smoothie because it contains lactoferrin and builds glutathione levels. While glutathione is the main antioxidant found inside liver cells, lactoferrin stimulates the immune system and has a direct antiviral property that hampers the Hepatitis C virus from attacking liver cells.
2. Cook Mung Beans – Used by practitioners of Traditional Chinese Medicine to detoxify poisons in the body, mung beans contain a natural protease inhibitor. High in Vitamin B and C, potassium, magnesium, iron, phosphorous, copper, fiber and protein, mung beans’ ability to help a Hepatitis C-laden liver flush out toxins are worth the effort to find and prepare.
3. Eat Shitake – Shitake Mushrooms contain lentinan, a beta-glucan with powerful effects on hepatitis and many other diseases, including cancer. According to the Sloan Kettering Cancer Center, lentinan is used for cancer, high cholesterol, strengthening the immune system and treating infections. These specialty mushrooms also raise white blood cell counts and increase helper t-cells.
4. Love Artichokes – A member of the milk thistle family that helps control blood sugar levels, artichokes are known to support liver health. This fibrous, green veggie contains cynarin, which promotes the flow of bile from the liver to the gallbladder. This is very important because if the bile is not transported adequately to the gallbladder, the liver has an increased risk of being damaged.
5. Munch on Dandelion Greens – By stimulating the flow of bile, dandelion helps both the liver and gallbladder break down fat, prevent gallstones and aid in detoxification. In addition, dandelion greens have mild diuretic properties, which may help relieve ascites, a common consequence of liver cirrhosis.
6. Pick Foods Rich in Selenium – Because Hepatitis C encodes selenoproteins, the virus depletes cells of selenium. Thus, those with Hepatitis C need more selenium than the average person. Researchers hypothesize that when cells are drained of selenium, the Hepatitis C virus will spread from cell to cell looking for more. Thus, supply as much selenium to your cells as possible with the following selenium-rich foods: brazil nuts, broccoli, onions, leeks and garlic.
Using food to guide our health is not a new concept. While awareness of how unhealthy food can damage our bodies has recently grown, much of our medication-oriented society has forgotten about food’s therapeutic potential. Luckily, you needn’t be a certified nutritionist to know what choices to make in the grocery store. By including whey protein, mung beans, shitake mushrooms, artichokes, dandelion greens and selenium-rich foods into your diet, you can help your body feel well despite being infected with Hepatitis C.
References:
http://ayurwhat.blogspot.com/2007/11/mung-beans.html, Mung Beans, Julia Australia, Retrieved January 17, 2009, Ayurwhat?, 2009.
http://www.alchemistlab.com/newsletter11.htm, Top Ten Foods For Treating Chronic Hepatitis, Steven Finkbine, L.Ac., Retrieved January 16, 2009, Alchemist Lab Newsletter # 11, Alchemist Lab, LLC, September 2008.
http://www.allabouthepatitisc.com/readytolearn/living/slowing/eating_
healthy.jsp, Eating Healthy, Schering Corporation, 2009.
http://www.atihealthnet.com/pages/diethiv.html, Diet and Hepatitis C, Retrieved January 16, 2009, AIE Pharmaceuticals, 2009.
http://www.bmj.com/cgi/content/full/328/7433/0-g, “Let Food Be Thy Medicine…”, Richard Smith, Retrieved January 16, 2009, British Medical Journal, January 2004.
http://www.dietblog.com/archives/2007/05/02/10_reasons_to_choose_
food_as_medicine.php, 10 Reasons to Choose Food as Medicine, J. Foster, Retrieved January 16, 2009, Diet-Blog, 2009.
http://www.kitchenproject.com/history/Brillat_Savarin.htm, The Gastronomic Servings of Brillat-Savarin, Amanda Watson Schnetzer, Retrieved January 16, 2009, The Washington Times, July 1999.
http://wwwhealthfreedomcoachcom.blogspot.com/2008/03/dandelion-herbal
-liver-cleanse-better.html, Dandelion: Herbal Liver Cleanse, Better Digestion, and More!, Ellen Landauer, Retrieved January 17, 2009, Health Freedom Coaching, 2009.
http://www.hepccouncilsa.asn.au/factsheets/lifestyle/herbs/theraputicherbs.html, Herbs – Therapeutic and Toxic, Retrieved January 17, 2009, Hepatitis C Council of SA, 2009.
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Most people with liver disease are aware of being careful when considering taking acetaminophen for pain and fever relief. However, because new evidence now points to a higher risk of liver toxicity when mixing acetaminophen with caffeine, even further caution is warranted.
by Nicole Cutler, L.Ac.
Just when those with chronic hepatitis thought they had a handle on what to eat and what to avoid, new research has emerged complicating their previously memorized liver health consumption list. Keeping up with science’s discoveries has never been more important, as researchers demonstrate that pairing two common items can have devastating consequences to someone with an already compromised liver. Even though most people with chronic hepatitis know that too much acetaminophen can cause liver failure, few are aware that even small amounts can be dangerous when paired with a habitual cup of coffee.
The Warning
As published in an October 2007 issue of Chemical Research in Toxicology, University of Washington researchers reported that those who consume caffeine with acetaminophen could be at a higher risk of liver damage. Acetaminophen often has caffeine added because it enhances the effects of the painkiller. Although previous studies have linked alcohol consumption and acetaminophen use to liver damage, this is the first study to link caffeine to the danger.
The University of Washington team found that caffeine can triple the amount of a toxic byproduct, N-acetyl-p-benzoquinone imine (NAPQI), an enzyme produced while breaking down acetaminophen. This enzyme is also responsible for the liver damage and failure in most toxic alcohol-acetaminophen interactions. Even though the researchers conducted their testing using E. coli bacteria, they confidently conclude that the peril of combining caffeine with acetaminophen also applies to humans.
According to lead researcher Sid Nelson, M.D., “The bottom line is that you don’t have to stop taking acetaminophen or stop taking caffeine products, but you do need to monitor your intake more carefully when taking them together, especially if you drink alcohol.” While this warning appears mild, gambling with these two simultaneously is just too risky for those already living with chronic hepatitis.
Acetaminophen
One of the most popular over-the-counter medications for pain and fever relief is acetaminophen. Although sold over-the-counter, this drug is far from safe for those with liver disease. Capable of causing liver damage or even acute liver failure, acetaminophen poisoning accounts for over 56,000 emergency room visits in the United States each year.
Though most people are only at risk for liver toxicity if they take more than the normal recommended dose, living with chronic hepatitis can render someone more susceptible to acetaminophen toxicity. In fact, a study by the U.S. Food and Drug Administration (FDA) showed that about 20 percent of people with acetaminophen-related liver toxicity had taken less than the recommended daily amount.
Acetaminophen (paracetamol) can be found in the following drugs:
· Tylenol
· Excedrin
· Midol
· NyQuil
· Sudafed
· Vicodin
Acetaminophen with Hepatitis
Despite the plentitude of discomfort it can cause, interferon therapy is the most likely route chosen for those battling chronic hepatitis. Physicians often recommend acetaminophen to relieve the most common side effects of interferon therapy, such as body aches and fever. Even though it can cause liver damage, acetaminophen in restricted dosages and under doctor supervision is often the best choice for pain and fever relief for those with chronic hepatitis. Because the other choices (aspirin and non-steroidal anti-inflammatories) can cause gastrointestinal upset or even stomach bleeding, acetaminophen remains a strong over-the-counter contender.
Caffeine
When it comes to caffeine consumption, the general consensus seems to be opposite that of acetaminophen. A United States population study of nearly 6,000 adults was conducted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2004. This study divulged a strong association between coffee drinking and a lowered risk of liver injury in those at high risk for liver disease. In this NIDDK report, liver injury was defined as serum alanine aminotransferase (ALT) levels over 43 U/L and the high-risk population was defined as:
· being heavy drinkers of alcohol
· having Hepatitis B or C
· having an iron overload
· being obese
· having impaired glucose metabolism
The researchers concluded that the greater the coffee consumption, the greater the association with liver protection. Upon learning of this coffee advantage, many people with chronic hepatitis heaved a sigh of relief as they continued their relationship with caffeinated beverages.
Bad Combo
Even though you may take doctor-recommended acetaminophen for symptom relief and drink coffee to help protect your liver, those with chronic hepatitis must be careful to separate the two. If caffeine can multiply acetaminophen’s potential toxicity by three, it may not be safe to take Tylenol to relieve those body aches. Until further confirmation arrives on exactly how much you can take of what, at exactly which time intervals, those living with chronic hepatitis are hereby warned to separate their caffeine fix with as much time as possible from a dose of acetaminophen.
References:
www.foxnews.com, Mixing Tylenol with Caffeine May Increase the Risk of Liver Damage, Study Finds, Tina Benitez, Fox News Network, LLC, September 2007.
www.hcvadvocate.org, Acetaminophen and Your Liver, Liz Highleyman, Hepatitis C Support Project, January 2005.
www.medicalnewstoday.com, Combining Acetaminophen with Caffeine Might Cause Liver Damage, Christian Nordqvist, Medical News Today, September 2007.
www.medicinenet.com, Caffeine Plus Acetaminophen Toxic for Some, Steven Reinberg, MedicineNet Inc., September 2007.
www.medscape.com, Coffee, Caffeine Consumption Associated With Reduced Liver Disease, Karla Harby, Medscape, 2007.
www.sciencedaily.com, Acetaminophen, Caffeine Shouldn’t be Mixed, ScienceDaily LLC, September 2007.
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