Research & Treatment News
January 25, 2011
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Likely due to its ability to dramatically improve the Hepatitis C cure rate, Vertex's telaprevir will get a priority review by the FDA.
FDA awards Vertex speedy review for hepatitis C drug
Boston Business Journal - by Julie M. Donnelly
Thursday, January 20, 2011
Vertex Pharmaceuticals Incorporated says the U.S. Food and Drug Administration has informed the company that it will make an approval decision on its drug target to treat hepatitis C by May 23rd. The FDA decided to give the company a so-called priority review for the drug, because it treats a disease where there is a high unmet medical need. This shortens the review period to six months from the usual 10 months.
Continue reading this entire article:
http://www.bizjournals.com/boston/news/2011/01/20/fda-awards-vertex-speedy-review-for.html
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January 24, 2011
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Two new drugs expected to enter the market soon appear to nearly double the success rate of Hepatitis C treatment. As a result of this therapeutic improvement, the age group most at risk for the Hepatitis C virus may be routinely screened for this infection.
New drugs take aim at hepatitis C, spur debate on whether to test baby boomers
By Lauran Neergaard (CP) - Jan 17, 2011
WASHINGTON -- There's new hope for an overlooked epidemic: Two powerful drugs are nearing the market that promise to help cure many more people of liver-attacking hepatitis C -- even though most who have the simmering infection don't know it yet.
Surprisingly, two-thirds of hepatitis C sufferers are thought to be baby boomers who've harboured since their younger, perhaps wilder, years a virus that can take two or three decades to do its damage.
What could be a treatment revolution is spurring the government to consider if it's time to start screening aging baby boomers for hepatitis C, just like they get various cancer checks.
Continue reading this entire article:
http://www.google.com/hostednews/canadianpress/article/ALeqM5jIimWDRCH6cTQvX2W852dHURUBwA?docId=5676894
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January 20, 2011
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Peregrine Pharmaceuticals, Inc. has started a Phase II clinical trial to determine if bavituximab plus ribavirin elicits an early virologic response in people with previously untreated genotype-1 Hepatitis C.
Peregrine Initiates Randomized Phase II Trial of Bavituximab in Chronic Hepatitis C
Open-Label Trial Evaluating 12 Weeks of Therapy With Novel Targeted Antibody Bavituximab in Combination With Ribavirin Versus Standard of Care
TUSTIN, CA--(Marketwire - January 10, 2011) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that it has initiated a randomized Phase II clinical trial in patients with previously untreated genotype-1 hepatitis C virus (HCV) infection. This open-label trial will determine the early virologic response (EVR) rate of patients after 12 weeks of therapy with Peregrine's bavituximab, a phosphatidylserine (PS)-targeting monoclonal antibody with immune-modulating potential, in combination with the antiviral drug ribavirin versus standard of care, pegylated interferon alpha 2a and ribavirin. Peregrine expects to complete enrollment shortly in an ongoing Phase Ib HCV trial and report data by mid-year.
Continue reading this entire article:
http://www.marketwire.com/press-release/Peregrine-Initiates-Randomized-Phase-II-Trial-of-Bavituximab-in-Chronic-Hepatitis-C-NASDAQ-PPHM-1377628.htm
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January 19, 2011
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Although many have heard of the supplements SAMe and betaine, their potential benefits to those on Hepatitis C treatment are not yet widely known.
by Nicole Cutler, L.Ac.
For the estimated four to five million American adults with chronic Hepatitis C, attempts to conquer the virus can be challenging. This illness' current antiviral treatment, pegylated interferon and ribavirin, is only about 50 percent effective in those infected with the most common strain of Hepatitis C in North America. Thus, investigators are constantly seeking ways to boost the success of these medicines. Building on previous knowledge about S-adenosyl-L-methionine (SAMe) and betaine, researchers from Switzerland have found two potential, seemingly non-toxic contenders for supporting Hepatitis C antiviral therapy.
Those unable to rid themselves of all Hepatitis C genetic material are burdened by the prospect of chronic liver disease progressing, a process that could eventually lead to liver cirrhosis, liver failure or liver cancer. Until better treatment options actualize, people in this situation typically seek experimental, innovative or alternative solutions to preserve their health. There are several ways health professionals attempt to help those who are not responsive to Hepatitis C treatment, such as:
· Developing more potent drugs that have a higher success rate for eliminating the Hepatitis C virus.
· Guiding infected individuals toward herbal supplements and lifestyle choices that strengthen liver cells to better protect them from the virus.
· Adding certain substances to pegylated interferon and ribavirin that enhance their success rate.
While true progress against Hepatitis C is likely to involve all three of these approaches, the research from Switzerland focuses on the latter - enhancing pegylated interferon and ribavirin.
About the Research
A research team from Basel, Switzerland identified viral interference with interferon signal transduction as an important factor explaining the mediocre success of Hepatitis C treatment. Because prior experiments with SAMe and betaine have shown these substances can increase interferon signal strength, the researchers investigated if adding SAMe and betaine to Hepatitis C treatment would increase its efficacy.
As published in a November 2010 edition of the journal PLoS ONE, the researchers tested this concept in Hepatitis C patients who had previously failed antiviral therapy. For their trial, the participants were treated with pegylated interferon, ribavirin, SAMe and betaine.
Compared with their first attempt at antiviral treatment consisting of just pegylated interferon and ribavirin, study participants fared better in their second therapy attempt that included SAMe and betaine. This improvement was measured by a higher percentage of participants achieving an early virological response - undetectable viral load 12 weeks after starting treatment.
The researchers concluded that adding SAMe and betaine to pegylated interferon/ribavirin therapy improves early virological response in chronic Hepatitis C. Based on the fact that the inability to detect Hepatitis C genetic material after 12 weeks increases the chances of treatment success, some clinicians are recognizing the potential therapeutic application of SAMe and betaine.
About SAMe and Betaine
Both considered to be natural substances, SAMe and betaine are nutrients known as methyl donors. Other methyl donors include folic acid and vitamins B6 and B12. These substances carry and donate methyl molecules in the body to help make chemical processes work. Donation of methyl molecules is involved in proper liver function and cellular reproduction.
· SAMe is a synthetic form of a compound formed naturally in the body from the essential amino acid methionine and adenosine triphosphate (ATP), the energy-producing compound found in all cells in the body. Besides studies supporting SAMe's use for relieving the pain of osteoarthritis and helping depression, trials examining this supplement also suggest that it may help to normalize liver enzyme levels.
· Betaine can be obtained in the diet from beets, broccoli, grains, shellfish and spinach. Besides studies supporting betaine's use for heart disease and homocystinuria, there is also evidence that betaine may help protect against fatty deposits in the liver.
The research from Switzerland on these two supplements is encouraging, but there is far more evidence needed to accept SAMe and betaine as worthy and valuable additions to Hepatitis C treatment medications. Although not yet open to participant recruitment, one related follow-up study is being conducted at the University of Nebraska. This pilot study will examine betaine's addition to Hepatitis C antiviral therapy in those who have either not responded to previous treatment or who have relapsed. More information on this study can be found at www.clinicaltrials.gov.
As the quest to help people conquer the Hepatitis C virus intensifies, expect to see more research into substances that aid pegylated interferon/ribavirin efficacy. SAMe and betaine are two such contenders, and the Hepatitis C community will be keeping a close eye on future developments involving these nutrients.
References:
http://altmedicine.about.com/od/treatmentsfromatod/a/SAMe.htm, SAMe, Cathy Wong, Retrieved December 6, 2010.
http://clinicaltrials.gov/ct2/show/study/NCT00882193, Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-Responder/Relapsers, Retrieved December 10, 2010, US National Institutes of Health, 2010.
http://www.ncbi.nlm.nih.gov/pubmed, S-Adenosyl Methionine Improves Early Viral Responses and Interferon-Stimulated Gene Induction in Hepatitis C Nonresponders, Feld JJ, et al, Retrieved December 10, 2010, Gastroenterology, September 2010.
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0015492, S-Adenosyl-Methionine and Betaine Improve Early Virological Response in Chronic Hepatitis C Patients with Previous Nonresponse, Magdalena Filipowicz, Christine Bernsmeier, et al, Retrieved December 6, 2010, PLoS ONE, November 2010.
http://www.umm.edu/altmed/articles/betaine-000287.htm, Betaine, Retrieved December 6, 2010, University of Maryland Medical Center, 2010.
http://www.umm.edu/altmed/articles/cirrhosis-000037.htm, Cirrhosis, Retrieved December 10, 2010, University of Maryland Medical Center, 2010.
Posted by Editors at 12:32 PM --- Printer-friendly version
January 14, 2011
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Interim data from a Phase 1b trial of Inhibitex's INX-189 demonstrates potent antiviral activity against the Hepatitis C virus.
Inhibitex Reports Positive Data From Ongoing Phase 1b Clinical Trial Of INX-189
1/9/2011
(RTTNews) - Inhibitex, Inc. (INHX: News ) reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus or HCV.
The company added that the trial, which is being conducted under an IND in the United States, is a double-blind, placebo-controlled, dose escalation study, administered orally once-daily for seven days, for the treatment of HCV genotype 1 treatment naïve patients. Each treatment cohort in the study is comprised of 10 patients, eight that receive INX-189 and two that receive placebo.
Continue reading this entire article:
http://www.rttnews.com/Content/QuickFacts.aspx?Id=1522611&SM=1
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January 12, 2011
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In the U.S. and Europe, Boceprevir's entrance into the market is being accelerated due to its effectiveness against Hepatitis C.
Merck's new oral hepatitis C drug boceprevir will receive fast track reviews from both the FDA and the EMA after the regulators decided it marked a major advance in treatment.
01/07/11
The FDA has granted Merck's investigational protease inhibitor priority review status, a move that could see the drug on the market within six months.
The US regulator's European counterpart the EMA has also accepted the marketing Merck's boceprevir application for accelerated assessment.
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http://www.inpharm.com/news/110107/merck-hepatitis-c-drug-boceprevir-fast-tracked
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January 11, 2011
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Investigators have discovered that blood levels of a specific protein appear to foretell of Hepatitis C treatment success or failure.
Investigators Identify Prognostic Marker for Treating Hep C with Peg-Interferon and Ribavirin
Jan 6, 2011
Plasma levels of the protein IP-10 predict , prior to therapy initiation, the efficacy of treating chronic hepatitis C infection with pegylated-interferon and ribavirin, according to scientists at Inserm and Institut Pasteur. They say that they have developed a prognostic test for hepatitis C based on these results and anticipate commercialization this year.
The study, published in the Journal of Clinical Investigation, was conducted in the research lab of Matthew Albert, Ph.D. Dr. Albert's team found IP-10 elevated in those patients for whom treatment was ineffective. This observation was paradoxical as IP-10 is considered a pro-inflammatory molecule, which should have facilitated migration of activated T cells to the liver, the exact cell types responsible for viral immunity.
Continue reading this entire article:
http://www.genengnews.com/gen-news-highlights/investigators-identify-prognostic-marker-for-treating-hep-c-with-peg-interferon-and-ribavirin/81244482/
Posted by Editors at 10:06 AM --- Printer-friendly version
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Pharmasset has released interim study results for several of its Hepatitis C drugs that are in different stages of testing.
Pharmasset Reports Interim Study Results For Its Hepatitis C Drugs
Thursday, January 06, 2011
Pharmasset (NASDAQ:VRUS) announced today interim results for the Phase 2b study for its PSI-7977 drug and the Phase 1 study for its PSI-938 drug. Both drugs are designed to treat Hepatitis C.
The Phase 2b study consisted of evaluating the effects of various PSI-7977 dosages in patients with Hepatitis C genotype 1, 2 or 3. The patients also received antiviral drugs commonly used to fight Hepatitis C.
Continue reading this entire article:
http://www.proactiveinvestors.com/companies/news/11228/pharmasset-reports-interim-study-results-for-its-hepatitis-c-drugs--11228.html
Posted by Editors at 10:01 AM --- Printer-friendly version
January 10, 2011
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Along with Health Canada, the United States Food and Drug Administration has cleared the protocol for Anadys' Phase IIb Hepatitis C study of ANA598 in combination with pegylated interferon and ribavirin.
Anadys Pharmaceuticals Initiates Phase IIb Study of ANA598 in HCV Patients
SAN DIEGO, Jan. 4, 2011 /PRNewswire/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that it has initiated the planned Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin. The protocol for the study has been cleared by the United States Food and Drug Administration (FDA) and Health Canada. Patient screening has begun and patient dosing is expected to commence within the next several weeks. In the study ANA598 will be tested in both treatment-naive patients and treatment-experienced patients who failed a prior course of therapy with interferon and ribavirin. ANA598 is the Company's direct-acting antiviral, or DAA, being developed for the treatment of hepatitis C.
"We are excited to initiate this Phase IIb study of ANA598," said James L. Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer. "By establishing safety and efficacy in a greater number of patients, including those who have failed prior HCV treatment, we hope to position ANA598 as a highly attractive HCV agent ready for Phase III development."
Continue reading this entire article:
http://www.prnewswire.com/news-releases/anadys-pharmaceuticals-initiates-phase-iib-study-of-ana598-in-hcv-patients-112891599.html
Posted by Editors at 10:21 AM --- Printer-friendly version
January 7, 2011
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Also known as salt, sodium is overly abundant in many common foods - an abundance that could put someone with advanced Hepatitis C infection in peril.
by Nicole Cutler, L.Ac.
Hepatitis C has been dubbed a "silent epidemic," because symptoms rarely surface until the virus has caused irreversible liver damage. Unfortunately, a large percentage of Americans infected only find out about their illness after Hepatitis C has severely scarred their liver. Known clinically as cirrhosis, living with this severe liver scarring requires additional cognizance of its aggravating factors. Besides complete elimination of alcohol, curbing sodium intake is one of the first things someone with cirrhosis must learn to do. Many people may consider the table salt shaker as their primary source of sodium; however, there are many food sources that secretly contain astronomical amounts of salt.
An estimated four to five million Americans are currently infected with Hepatitis C, a liver infection that becomes a lifelong illness for a majority of people. If those with chronic Hepatitis C are unable to eliminate the virus from their body, progressive damage to the liver can ensue. When the rate of liver cell injury outpaces the body's ability to regenerate new liver cells, scar tissue accumulates. Over the course of many years, this leads to cirrhosis, the accumulation of scar tissue that changes the liver's topography - into a hardened, shrunken organ, that functions sub-optimally.
The primary reason someone with cirrhosis should avoid salt has to do how much fluid is retained in the body:
· Due to the principle of osmosis, salt in the blood draws water out of the surrounding cells.
· This drawing out of water is the body's way of equalizing the salt concentration on either side of the cell.
· Equalization occurs from drawing water out of the cell instead of pulling salt into the cell, because water flows much more readily across the cell's membrane than salt does.
Thus, the more salt in a person's diet, the more fluid the body retains in an effort to dilute the salt. Unfortunately, those with cirrhosis are more vulnerable to being harmed by high sodium consumption and its resulting fluid retention.
Also known as ascites, fluid accumulation in the abdomen is the most common consequence of cirrhosis. Ascites is the result of several mechanisms:
1. Blood Pressure - As cirrhosis progressively scars the liver, its ability to effectively filter blood is reduced. This reduction lowers blood volume, which also lowers blood pressure. When blood pressure is low, signals are sent to the kidneys instructing the body to retain salt and fluids.
2. Albumin - The liver produces albumin, a protein responsible for holding fluid inside the blood vessels. Cirrhosis lowers blood albumin levels, resulting in fluids seeping out of the leg and abdomen tissues.
3. Portal Hypertension - When cirrhosis causes unfiltered blood to back up, the pressure inside liver blood vessels rises (portal hypertension). Consequently, some of the fluid inside the highly pressurized portal vein leaks out to prevent the blood vessel from bursting.
Besides expanding abdominal girth, ascites can cause several complications, such as abdominal pain and discomfort, difficulty breathing, infection (bacterial peritonitis), hernia, fluid filling the lungs and heart failure. Because every gram of sodium consumed typically results in the accumulation of 200 milliliters of fluid, salt restricted diets are essential for those with cirrhosis.
Salt can be sneaky, abundant in curious places. Thus, identifying the following sodium-hiding spots can help with salt minimization. For those with cirrhosis from Hepatitis C, health professionals typically advise restricting sodium intake to 500 to 1,000 milligrams per day.
Reading all food labels is necessary to circumvent excess salt consumption. In the real world, we are sometimes lax in our label reading routine. Nonetheless, the following four food groups require this practice to avoid consuming unnecessarily high amounts of sodium:
1. Soda - Whether diet or regular, many sodas have a surprising amount of sodium. An investigation of one popular soda manufacturer's website revealed several of their products contained between 40 and 65 milligrams of sodium per serving. Considering many people consume several sodas per day, that can add up to a lot of excess sodium.
2. Soup - Canned soups contain extremely high amounts of sodium for a supposedly healthful meal. Make sure to check soup labels, because just one cup of soup can harbor close to or over 1,000 milligrams of salt. While reduced sodium soups are better, they can still have more sodium than most people realize. Always check the sodium content in canned soup.
3. Beans - Loaded with fiber and protein while low in fat and cholesterol, beans are a staple for many health conscious folk. However, the canned versions often have extraordinary amounts of salt. One cup of plain baked beans can have over 1,000 milligrams of sodium, while ½ cup of black beans can have nearly 500 milligrams. Despite being less convenient, cooking dried beans is a great option. Otherwise, seek out low sodium beans, restrict serving sizes and always check the label.
4. Condiments and Sauces - While some condiments and sauces are obviously salty, the amount of sodium hiding in these refrigerator staples is surprising. For example, a leading brand of soy sauce contains 920 milligrams of sodium in just one tablespoon and ½ cup of some marinara sauces has upwards of 500 milligrams. The problem is that most of us go far beyond the serving size quoted on the label.
The four food categories listed above pose a problem to anyone who must restrict their salt intake. Representing the need for vigilance in reading nutrition labels, these foods are not the only high sodium consumables. Living with Hepatitis C that has progressed to cirrhosis is far from easy, but reducing sodium amounts will eventually become second nature. To minimize complications from ascites, ease the pressure in your blood vessels and keep a damaged liver from wrecking more havoc, avoid (or at least reduce) your inclusion of foods that pack loads of salt into your body.
References:
http://productnutrition.thecoca-colacompany.com/welcome, Nutrition: Connection, Retrieved November 21, 2010, The Coca-Cola Company, 2010.
http://www.everydayhealth.com/diet-and-nutrition-pictures/uncovering-hidden-salt-in-food-1028.aspx?xid=nl_EverydayHealthDietandNutrition_20101109&xid=nl_EverydayHealthHealthyAging_20101116, Sneaky High-Salt Foods, Jennifer Acosta Scott, Retrieved November 17, 2010, Everyday Health Inc., 2010.
http://www.liverdisease.com/diet.html, Diet and Hepatitis C, Retrieved November 17, 2010, Melissa Palmer, MD, 2010.
http://www.liversupport.com/wordpress/2009/08/important-facts-about-salt-and-cirrhosis/, Important Facts About Salt and Cirrhosis, Nicole Cutler, L.Ac., Retrieved November 17, 2010, Natural Wellness, 2010.
Posted by Editors at 9:42 AM --- Printer-friendly version
January 5, 2011
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Scripps researchers have identified a protein that interacts with the Hepatitis C virus to enable replication. Since blocking this interaction could impair the virus' ability to reproduce, Scripps' discovery could lead to a new focus for the next generation of Hepatitis C drugs.
Scripps Research scientists identify key interaction in hepatitis C virus
Findings point toward a novel therapeutic target for antiviral drugs
JUPITER, FL, December 28, 2010 - Scientists from the Florida campus of The Scripps Research Institute have identified a molecular interaction between a structural hepatitis C virus protein (HCV) and a protein critical to viral replication. This new finding strongly suggests a novel method of inhibiting the production of the virus and a potential new therapeutic target for hepatitis C drug development.
The study was published in the January 2010 issue (Volume 92, Part 1) of the Journal of General Virology.
These new data underline the essential role of the viral protein known as "core" as a primary organizer of the infectious HCV particle assembly and support a new molecular understanding of the formation of the viral particle itself.
Continue reading this entire article:
http://www.eurekalert.org/pub_releases/2010-12/sri-srs122810.php
Contact: Mika Ono
mikaono@scripps.edu
858-784-2052
Scripps Research Institute
Posted by Editors at 9:34 AM --- Printer-friendly version
