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February 26, 2007
How You Can Stop HCV from Leading to Gallstones
Recent research has shown how Hepatitis C patients have a greater tendency to develop gallstones. Learn how to prevent your diagnosis from leading to one of the 1 million new cases of gallstones reported each year.
by Nicole Culter, L.Ac.
Gallstone disease is the most common disorder affecting the body's biliary system, the network of organs and ducts responsible for creating, transporting, storing and releasing bile. Responsible for the digestion of fat, bile is a fluid produced by the liver and stored in the gallbladder. Bile primarily consists of water, cholesterol, fats, bile salts, proteins and bilirubin. If the chemical balance of bile contains too much of any of these components, particularly cholesterol, crystals form and harden into gallstones.
Gallstones can be as small as a grain of sand or as large as a golf ball. The gallbladder can develop just one large stone, hundreds of tiny stones, or anywhere in between. When gallstones lodge in bile ducts, they can prevent the flow of bile or digestive enzymes or lead to severe abdominal pain, vomiting, inflammation and possible infection.
Symptoms
Symptoms of gallstones are often called a gallstone "attack" because they occur suddenly. A typical attack can cause:
· Steady pain in the upper abdomen that increases rapidly and lasts from 30 minutes to several hours
· Pain in the back between the shoulder blades
· Pain under the right shoulder
· Nausea or vomiting
Gallstone attacks often follow fatty meals, and they may occur during the night. Other gallstone symptoms include:
1. Abdominal bloating
2. Recurring intolerance of fatty foods
3. Belching
4. Gas
5. Indigestion
The Link Between Hepatitis C and Gallstones
Over the years, the medical community has suspected a connection between liver disease and gallbladder disease. Researchers looking to prove this suspicion have shown how people with Hepatitis C have a greater tendency to develop gallstones.
· An Italian study published in the Archives of Internal Medicine in 1999 suggested that cirrhosis represents a major risk factor for gallstones.
· A New York study published in the May 2005 issue of Hepatology concluded that chronic Hepatitis C infection demonstrated a strong association with gallbladder disease and that gallbladder disease was more common in adults with severe liver disease.
· Published in the September 2005 issue of Journal of Gastroenterology and Hepatology, a Taiwanese study involving nearly 30,000 people confirmed that infection with Hepatitis C contributes to gallstone formation.
How This Impacts People with Hepatitis C
Considering the clinical proof that people with chronic Hepatitis C are at a greater risk for developing gallbladder disease, those harboring this virus are strongly encouraged to practice gallstone prevention.
Diet modification is the primary method to prevent gallstones from developing. Increasing consumption of both soluble and insoluble fiber may prevent gallstones. Fiber reduces the absorption of deoxycholic acid by producing a favorable shift in the triad of factors controlling cholesterol's solubility in bile. Soluble fibers that are effective include guar gum and pectin, as well as oat bran, wheat bran, and soy fiber, all of which are found in many fruits and vegetables.
Additionally, regular, vigorous, exercise may decrease gallstone risk. One study, reported by WebMD, found that men who performed endurance activities for 30 minutes, five times a week, experienced a 34 percent reduction in gallbladder disease risk. The benefits derived from exercise were more dependent on intensity than type of exercise. Researchers theorize that exercise helps to normalize blood sugar and insulin levels which may contribute to gallstones when abnormal.
Evidence gathered on gallstone formation clearly points to an increased risk for individuals with the Hepatitis C virus. While people with chronic Hepatitis C likely have plenty of other health concerns, practicing gallstone prevention is easy due to its similarity to liver supportive lifestyle changes. Now there is one more reason for those with liver disease to incorporate healthful habits by increasing the fiber in their diet and getting started on a regular exercise routine.
References:
Bini EJ, McGready J, Prevalence of gallbladder disease among persons with hepatitis C virus infection in the United States, Hepatology, May 2005.
Conte D, et al., Close relation between cirrhosis and gallstones: cross-sectional and longitudinal study, Archives of Internal Medicine, July 1999.
T S Chang, et al., Hepatitis C virus infection facilitates gallstone formation, Journal of Gastroenterology and Hepatology, September 20, 2005.
www.digestive.niddk.nih.gov, Gallstones, National Digestive Diseases Information Clearinghouse, November 2004.
www.womenshealth.about.com, Preventing Gallstones, Tracee Cornforth, About, Inc., 2006.
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Genetics May Determine Hepatitis C Treatment Success
New research looks at gene expression as a possible explanation for the significant number of HCV interferon/ribavirin non-responders. In light of the difference in gene expression between responders and non-responders, genetics may play a role in predicting antiviral medication success.
Changes in Gene Expression during Hepatitis C Treatment Distinguish Responders from Non-Responders
www.hivandhepatitis.com
By Liz Highleyman
While treatment of chronic hepatitis C using pegylated interferon plus ribavirin leads to sustained HCV clearance and clinical improvement in approximately half of all patients, response rates are lower in certain "difficult to treat" groups, including patients with genotype 1 HCV and African-Americans.
It is unclear why treatment response rates vary by race/ethnicity, but genetic factors may play a role.
As reported in the January 31, 2007 electronic edition of the Journal of Virology, researchers used DNA micro-arrays to assess gene expression in a group of 33 African-American and 36 Caucasian-American patients with genotype 1 chronic HCV infection during the first 28 days of treatment with pegylated interferon/ribavirin.
Results
• Patients showed a response to treatment at the gene expression level in RNA isolated from peripheral blood mononuclear cells (PBMCs) regardless of degree of decrease in HCV RNA levels.
• Gene expression responses were relatively blunted in patients with poor virological response (< 1.5 log10 IU/mL decrease in HCV RNA at 28 days) compared to those with a marked (> 3.5 log10 decrease) or intermediate (1.5-3.5 log10 decrease) response.
• The number of genes that were up-regulated or down-regulated by pegylated interferon/ribavirin was fewer in patients with a poor virological response compared to those with a marked or intermediate response.
• Induced levels of known interferon-stimulated genes such as OAS, MX1, IRF-7, and the toll-like receptor TLR-7 were lower in poor responders compared to patients with marked or intermediate responses.
• However, African-Americans had stronger interferon responses than Caucasian patients overall.
Conclusion
The authors concluded that, "the relative lack of viral response to interferon therapy of hepatitis C is associated with blunted interferon cell signaling. No specific regulatory gene could be identified as responsible for this global blunting or racial differences."
It remains unclear why African-Americans tend to respond more poorly to interferon-based therapy, given their overall stronger gene expression response to interferon.
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February 21, 2007
Body Shop Founder Living with Hepatitis C
As anyone familiar with the virus knows, Hepatitis C does not discriminate. A highly successful British businesswoman and founder of The Body Shop, has publicly announced that she is living with HCV, which has progressed to cirrhosis of the liver. She has made her health concerns public as a "whistleblower" so Hepatitis C would be taken more seriously as a public health challenge, and would get the attention and resources it needs.
Roddick suffering from Hepatitis C
Wed Feb 14 2007
www.itv.com
Body Shop founder Dame Anita Roddick has revealed she is suffering from Hepatitis C.
The 64-year-old contracted the disease through a blood transfusion while giving birth to her youngest daughter, Sam, in 1971, and is now suffering cirrhosis of the liver, one of its long-term effects.
Dame Anita said: "I have Hepatitis C. It's a bit of a bummer but you groan and move on. I had no idea that I had this virus. I was having routine blood tests when it showed up."
She added: "What I can say is that having Hep C means that I live with a sharp sense of my own mortality, which in many ways makes life more vivid and immediate. It makes me even more determined to just get on with things."
Men are more than twice as likely to be infected with the disease, known as the "silent killer", as women. It is transmitted by infected blood and people who share needles are particularly at risk.
Unprotected sex as well as sharing toothbrushes and razors also carries a small risk.
Dame Anita called for more public money to be spent on raising awareness of the disease, saying: "Well, I've always been a bit of a 'whistleblower' and I'm not going to stop now.
"I want to blow the whistle on the fact that Hep C must be taken seriously as a public health challenge and must get the attention and resources that it needs."
The Health Protection Agency (HPA) said the number of adults infected with Hepatitis C in England was around 231,000 in 2003 and those living with serious liver disease caused by the virus could more than double by 2015.
An estimated 4,855 people are living with cirrhosis of the liver or serious liver failure in 2005. That figure is expected to rise to 10,090 by 2015.
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February 20, 2007
New Approach Shifts Focus on HCV Treatment
New HCV drug treatments are now primarily focusing on inhibiting Hepatitis C viral replication by targeting a particular viral protein. Based on preliminary clinical findings, one treatment option in development has been discontinued, in favor of another lead contender as a breakthrough Hepatitis C treatment.
Gilead and Achillion Announce Positive Antiviral Activity of NS4A Antagonist in HCV, But Discontinue GS 9132 (ACH-806) Development
From the PharmaLive.com News Archive - Feb. 09, 2007
HCV Collaboration to Continue With Potential New Development Candidates
FOSTER CITY, Calif. and NEW HAVEN, Conn., Feb. 8, 2007 /PRNewswire-FirstCall/ -- Gilead Sciences (Nasdaq: GILD) and Achillion Pharmaceuticals (Nasdaq: ACHN) today announced their decision to discontinue the development of GS 9132, also known as ACH-806, for the treatment of hepatitis C viral (HCV) infection, based upon preliminary data from a Phase 1b/2 trial. Preliminary data from the first cohort of the Phase 1b/2 trial indicated that the compound demonstrated antiviral activity, validating the novel anti-HCV mechanism that involves inhibition of a viral protein called NS4A, which binds to a portion of HCV protease. However, based on small elevations of serum creatinine (a marker of kidney function), which were reversible after completion of dosing, Gilead and Achillion have elected to shift their focus to the evaluation of other NS4A antagonists developed by Achillion to identify a lead candidate for development.
"GS 9132 has demonstrated antiviral activity in patients with genotype 1 HCV infection. Even at the low dose studied, we observed significant reductions in hepatitis C viral load. This validation of the mechanism of action is encouraging as we evaluate next-generation compounds for potential development," said Norbert Bischofberger, Ph.D., Executive Vice President, Research and Development, Gilead Sciences. "We look forward to our continued collaboration with Achillion."
"As part of our collaboration with Gilead, we have worked diligently to generate a number of compounds belonging to a different chemical class that demonstrate the same mechanism of action and similar in vitro potency to GS 9132. One of the most promising of these has been designated by Achillion as ACH-1095, and we are evaluating this and other compounds in preclinical studies to determine if one has the right profile to advance into clinical development," stated Milind Deshpande, Ph.D., Chief Scientific Officer of Achillion. "Our goal is to develop a novel, efficacious and safe therapeutic for HCV, and the data indicate that candidates with this mechanism may be complementary to both protease and polymerase inhibitors, as well as interferon therapies."
The GS 9132 Phase 1b/2 trial was a double-blind, randomized, placebo-controlled dose-escalation study initiated in 2006. The goal of the trial was to evaluate the antiviral activity, safety and pharmacokinetics of GS 9132 in patients with HCV genotype 1 infection. Gilead and Achillion are continuing to analyze the data from this trial. Following completion of analysis, these data will be submitted for possible presentation at an upcoming scientific conference.
In November 2004, Gilead and Achillion established an agreement granting Gilead worldwide rights for the research, development and commercialization of certain Achillion compounds for the treatment of hepatitis C. GS 9132 and ACH-1095 are small molecule inhibitors of HCV replication, which target a viral protein called NS4A. NS4A antagonism is a novel mechanism of action for HCV treatment distinct from that of protease or polymerase inhibitors currently in development. GS 9132 and ACH-1095 were discovered by Achillion, and the company completed the initial work necessary to move GS 9132 into clinical development.
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February 19, 2007
Why Antioxidants are Important for Hepatitis C Patients
The goal of those currently undergoing treatment for chronic Hepatitis C is to prevent further liver damage from the Hepatitis C virus. Read this exclusive article to learn how to incorporate antioxidants into your lifestyle. Here is a simple, reputable and reasonably priced way to support your liver.
by Nicole Cutler, L.Ac.
Cellular oxidation occurs when oxygen or disease excessively breaks down a substance, producing free radicals. As negatively charged electrons no longer attached to their atoms, free radicals create chemical instability. This instability invites another atom or molecule to easily bond with the free radical, resulting in a cellular-altering chemical reaction capable of damaging cell walls, cellular structures and the genetic material inside cells. This process is readily seen in Hepatitis C’s deterioration of liver tissue. Antioxidants reduce, neutralize, and prevent the damage inflicted by free radicals.
Research illustrating the role of oxidation in advancing liver disease has consistently been produced over the years:
· 2006 – The Journal of Translational Medicine published a Turkish study whose aim was to determine oxidant/antioxidant status of patients with chronic Hepatitis C and the effect of combination therapy (pegylated interferon alfa-2b plus ribavirin) on oxidative stress. Researchers reported that patients with chronic HCV infection are under the influence of oxidative stress associated with lower levels of antioxidant enzymes. These impairments return to healthy levels following combination therapy. Although interferon and ribavirin are not antioxidants, their antiviral capacity might reduce viral load and inflammation, allowing for a reduction in virus-induced oxidative stress. Therefore, antioxidants can reduce the oxidative stress of Hepatitis C and make combination therapy more successful.
· 2005 - An Israeli study published in the Journal of Clinical Gastroenterology observed that oxidative stress in the liver is associated with chronic Hepatitis C infection. Researchers concluded that treatment with multiple antioxidants for people with chronic HCV was well tolerated and has a therapeutic benefit for hepatic inflammation and liver cell death. Therefore, antioxidant therapy can reduce liver inflammation and cell death.
· 2002 – A study published in the Journal of Hepatology measured levels of fibrosis and corresponding levels of oxidative stress in Hepatitis C patients. The authors found oxidative stress to be a significant feature of HCV infection. Although more severe in those with cirrhosis, there was clear evidence of oxidative stress in non-cirrhotic patients with the virus. The authors concluded that antioxidant therapy may have a role in slowing disease progression to cirrhosis.
· 1999 – A University of New Mexico study combined three potent antioxidants (alpha-lipoic acid, silymarin, and selenium) for administration to patients with cirrhosis, portal hypertension and esophageal varices secondary to chronic Hepatitis C infection. Those on the triple antioxidant program recovered quickly from HCV and their laboratory values remarkably improved. Furthermore, liver transplantation was avoided and the patients returned to work, carried out their normal activities, and reported feeling healthy. Therefore, antioxidants can help people improve their quality of life and recover more rapidly from Hepatitis C.
The overwhelming evidence suggests that antioxidants may hinder the Hepatitis C virus in the following ways:
· Impairs HCV replication
· Improves liver enzyme levels
· Protects against liver cell damage
· Renders interferon anti-viral therapy more effective
Dietary Sources of Antioxidants
A simple way to add antioxidants to your life is to seek them in food sources. Found in fruits and vegetables rich in Vitamins C and E, selenium, carotenoids and anthocyanins, antioxidants are optimally absorbed from whole food sources. Since antioxidants are the substances responsible for color, brightly colored produce represent the sources highest in free radical fighting power. Some examples of foods high in antioxidants are:
· Cabbage, broccoli, spinach and kale (Note to Hepatitis C patients: both spinach and kale are high in iron; check with your doctor before including in your regular diet.)
· Citrus fruits, strawberries, melons, apricots and mangos
· Sweet potatoes, tomatoes, corn, eggplant
· Romaine lettuce, avocadoes, carrots
· Blueberries, cranberries, red grapes
Additionally, antioxidants are widely available in supplement form. A refined milk thistle extract is a highly trusted antioxidant supplement that demonstrates tremendous benefits to the liver.
Whether you intend to improve the outcome of combination therapy, or simply wish to halt the progression of cirrhosis, remember the research demonstrating the benefits of antioxidants. Including antioxidant-rich foods and supplements into a daily routine can provide enormous protective benefit to those with chronic Hepatitis C.
References:
Jain SK, Pemberton PW, Smith A, et al, Oxidative stress in chronic hepatitis C: not just a feature of late stage disease, Journal of Hepatology, 2002.
Levent G, Ali A, Ahmet A, et al., Oxidative stress and antioxidant defense in patients with chronic hepatitis C before and after pegylated interferon alfa-2b plus ribavirin therapy, Journal of Translational Medicine, June 2006.
Melhem A, Stern M, Shibolet O, et al, Treatment of chronic hepatitis C virus infection via antioxidants: results of a phase I clinical trial, Journal of Clinical Gastroenterology, September 2005.
www.deliciousorganics.com, Antioxidants, Delicious Organics, Inc., 2004.
www.healthyhepper.com, Antioxidants, Free Radicals and Your Liver, healthyhepper.com, 2004.
www.integrative-healthcare.com/mt, Anti-Inflammatory Foods, Natural Wellness, 9/22/05.
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February 06, 2007
Controlled Release Drug for Hepatitis C Being Tested
Marked by less frequent dosing, higher patient compliance and reduced side effects, OctoPlus Pharmaceuticals is now in Phase IIa testing with LocteronTM. A controlled release version of alfa-interferon, Locteron may end up being the preferred medical treatment for Hepatitis C.
Market Wire - Jan. 30, 2007
LEIDEN, NETHERLANDS, January 30 / MARKET WIRE/ --
OctoPlus N.V. (Euronext: OCTO), the drug delivery and development company, announces today the commencement of a Phase IIa study with LocteronTM, its controlled release formulation of alfa interferon for treatment of chronic hepatitis C. The Phase IIa study is designed to evaluate Locteron in combination with the anti-viral drug ribavirin in previously untreated chronic hepatitis C patients. Recruitment of patients is ongoing and dosing has started.
Locteron is designed to be a best-in-class therapeutic for patients with chronic hepatitis C, with the potential to induce less side effects, improve patient compliance and provide a more convenient once every two week dosing schedule compared with current therapies. Results from the Phase I study, which was completed in April last year, showed that Locteron is both safe and successful in producing a gradual release over two weeks of alfa interferon after a single injection.
Locteron combines OctoPlus' proprietary PolyActive(TM) drug delivery technology with BLX-883, a recombinant alfa interferon produced by OctoPlus' co-development partner Biolex Therapeutics in its patented LEX SystemSM. Locteron is produced in OctoPlus' cGMP manufacturing facilities in Leiden, the Netherlands.
Design of the Phase IIa study
The Phase IIa study, known as SELECT-1 (Safety and Efficacy of Locteron: European Clinical Trial 1) is a European multi-center, randomized, open- label trial. SELECT-1 will evaluate a range of up to four doses of Locteron administered every two weeks in combination with ribavirin. A total of 32 treatment-naïve hepatitis C genotype I patients will receive this treatment during the 12 week study.
The study will assess viral response, safety and tolerability of Locteron. Results from this study are expected mid-2007 and will be used to select the optimal dose range to be tested in a subsequent Phase IIb study.
"The start of our lead product in its Phase IIa study is a major milestone for OctoPlus," says Joost Holthuis, CEO of OctoPlus. "We believe that Locteron has the potential to be the future treatment of choice for chronic hepatitis C, with less frequent administration and fewer side effects compared to currrent therapies."
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February 05, 2007
Announcing: New Liver Transplant Option on the Horizon
Two pharmaceutical companies are taking a similar approach in helping those facing acute liver failure. Recognizing both the ability of healthy liver cells to replicate and the difficulties involved in liver transplantation, the collaboration between Vesta and Cytonet is based on transplanting healthy liver cells to those in need.
Ex-rivals tackle acute liver disease - Vesta to produce cells for Cytonet
www.newsobserver.com
Sabine Vollmer, Staff Writer
Vesta Therapeutics, a small Durham company that is working on an alternative to liver transplants, announced Tuesday that it has gotten a contract to produce liver cells for German competitor Cytonet.
The therapies that Vesta and Cytonet are developing differ slightly. But both essentially target healthy liver cells for transplantation into patients with acute liver failure. The cells come from donated livers that were unsuitable as transplants.
Both companies hope that the contract is a step toward getting a therapy to market more quickly.
"Sometimes competitors get together and become friends," said Christian Tidona, Cytonet's head of business development.
Financial details were not disclosed.
Cytonet wants to explore whether a U.S. location makes sense, Tidona said. The deal could expand into a partnership or might even lead to Cytonet acquiring Vesta, he said.
Spun off by Swiss pharmaceutical company Roche in 2000, Cytonet is testing its therapy in humans. The company has about 50 employees.
The liver cells that Cytonet expects to receive from its contractor starting midyear will be used to determine how well Cytonet's therapy works in patients.
Development of Vesta's therapy isn't as far along. Mark Johnston, Vesta's president, said testing in patients is planned to begin this year.
Vesta is the Triangle remnant of Incara Pharmaceuticals, a once-promising Research Triangle Park company that held an initial public offering of stock in 1996. In 2002, cash-strapped Incara sold its liver cell therapy to Vesta. Incara changed its name to Aeolus Pharmaceuticals two years ago and moved its corporate headquarters to Laguna Niguel, Calif.
Since its inception, Vesta has raised more than $5 million in venture capital and research grants, Johnston said.
The contract with Cytonet provides revenue and allows Vesta to hire two lab technicians, increasing its work force to 14.
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February 02, 2007
New Virus Culture System for Hepatitis C
A new culture method greatly improves researchers' ability to study the Hepatitis C virus. Experts believe this breakthrough may enhance our knowledge of HCV, eventually contributing to enhanced treatment options.
New Culture Method For Hepatitis C Virus Uses Primary Hepatocytes And Patient Serum
medicalnewstoday.com
January 25, 2007
Researchers open the way for improved study of hepatitis C virus by devising a novel virus culture system that allows replication of patient-isolated virus in nontransformed hepatocytes, instead of culture-adapted virus strains in transformed cell lines. The related report by Lázaro et al, "Hepatitis C virus replication in transfected and serum-infected cultured human fetal hepatocytes," appears in the February issue of The American Journal of Pathology.
Hepatitis C virus (HCV) infection affects approximately 170,000,000 people worldwide. HCV liver disease, which may induce liver inflammation, cirrhosis, and/or hepatocellular carcinoma, represents the foremost reason for liver transplantation in much of the U.S.
Study of HCV replication within liver cells, or hepatocytes, has been hampered by a lack of adequate virus culture systems. Some systems allow the virus to infect cells but do not permit prolonged replication and production of virus, while other systems rely on derivatives of permissive virus isolates for efficient replication in transformed (mutated) cell lines. Still lacking has been a system to sustain replication of novel virus isolates from patients using nontransformed hepatocytes.
Nelson Fausto of the University of Washington School of Medicine has crossed this hurdle using a human fetal hepatocyte culture system that was previously developed in his lab. Using this system, his group has demonstrated sustained replication and production of virus particles for at least 2 months, with these virus particles able to infect new cells.
In their first experiments, Fausto and colleagues transfected hepatocyte cultures with HCV genomic RNA and found replication of HCV RNA genomes and production of core protein (for virus particle formation). Release of infectious virus particles was confirmed, as media from these cells were able to infect naive hepatocytes. Finally, virus particles were examined by electron microscopy and shown to possess the expected size and shape of HCV virus particles.
Once the system was established, the group examined whether sera from patients carrying HCV could infect the human fetal hepatocytes. When sera from patients infected with different HCV strains were added to the hepatocyte culture system, viral replication occurred and new virus particles were produced.
In both transfection and infection models, virus particles were released in a cyclical manner, with bursts of virus produced every 10-14 days. This is similar to what has been reported during clinical HCV infection, possibly due to the host's natural defenses. Interestingly, cultured hepatocytes responded to viral replication by displaying signs of distress and cell death and by expressing interferon-beta, a cellular antiviral, in an effort to control the infection.
This culture system provides a breakthrough in studying HCV replication in nontransformed hepatocytes, the natural target of the virus. By allowing infection by patient serum containing a wide array of virus strains, this system may allow better understanding of the differences between different strains, further improving treatment strategies.
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