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November 28, 2008
New Drug Finds Viral Hiding Spots
A new, experimental drug helps the immune system locate a virus by flagging cells that have turned inside out. Hepatitis C is among the viruses that could benefit from bavituximab's unique strategy of exposing a virus in hiding.
Inside-out cells offer target for antiviral drugs
By Julie Steenhuysen
CHICAGO, Nov 23 (Reuters) - An experimental drug cured guinea pigs infected with a fatal hemorrhagic fever virus, raising hope for its use in a broad range of viral diseases including influenza, hepatitis C, HIV, Ebola and others, U.S. researchers said on Sunday.
"This is a whole new strategy for making antiviral drugs," said Dr. Philip Thorpe, professor of pharmacology at the University of Texas Southwestern Medical Center at Dallas, whose research appears in the journal Nature Medicine.
Instead of attacking the virus directly, bavituximab, made by Peregrine Pharmaceuticals Inc (PPHM.O: Quote, Profile, Research, Stock Buzz), takes advantage of a defense mechanism used by the virus to hide from the immune system, Thorpe said.
When cells are under attack by a virus, this stress causes a fat molecule called phosphatidylserine, which normally lines the inside of the cell, to flip to the outside. "It's like wearing your clothes inside out," Thorpe, a scientific adviser to Peregrine, said in a telephone interview.
Bavituximab, a genetically engineered antibody, seeks out and attaches itself to these turncoat cells, flagging them for the immune system, which can then mount an attack,
"When injected into the bloodstream, bavituximab circulates in the body until it finds these inside-out lipids and then binds to them," Thorpe said in a statement.
"In the case of virus infection, the binding raises a red flag to the body's immune system, forcing the deployment of defensive white blood cells to attack the infected cells."
Thorpe said conventional antiviral drugs try to exploit some property of the virus, but these drugs are often quickly defeated as the virus mutates.
By targeting an aspect of infected cells in the host, he thinks bavituximab is less likely to lose effectiveness, which commonly happens when a virus mutates.
In the study, Thorpe and his colleagues tested the compound on guinea pigs in an advanced stage of infection with a form of the Lassa fever virus, a disease that affects parts of West Africa.
Half of the animals treated with the drug alone were cured. When the researchers tested it in combination with the antiviral drug ribavirin, a drug that keeps a virus from replicating, 63 percent of the guinea pigs lived.
Thorpe said the findings suggest the drug might be effective on other types of hemorrhagic viruses, such as Ebola and Marburg. But this lipid flipping also occurs in cells infected with many other viral infections, including influenza, smallpox and rabies.
Peregrine is conducting early phase clinical trials of the drug in people with hepatitis C and human immunodeficiency virus, or HIV, which causes AIDS. And it has more advanced trials under way in cancer.
"We think it has tremendous potential," Steven King, president and chief executive of Peregrine, said in a telephone interview. Peregrine funded the research along with the National Institutes of Health. (Editing by Will Dunham and Todd Eastham)
© Thomson Reuters 2008 All rights reserved
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November 24, 2008
ChronVac-C Reducing HCV Viral Load Up to 99%
Although it is early in the process and only involves a few subjects, interim trial results for ChronVac-C show extremely high percentages of Hepatitis C viral load reduction.
Hepatitis C Therapeutic DNA Vaccine Delivered by Inovio Biomedical's Electroporation Technology Reduces Viral Load by Up to 99.7%
Clinical Data Presented at Annual Scientific Meeting of the American Association for the Study of Liver Diseases
SAN DIEGO, Nov 17, 2008 (BUSINESS WIRE) -- Inovio Biomedical Corporation (INO 0.22, +0.04, +20.2%), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today that its partner, Tripep AB, reported positive additional interim results from its ongoing phase I/II clinical study of its therapeutic DNA vaccine against hepatitis C virus (HCV). This vaccine is being delivered using Inovio's electroporation-based DNA delivery system. In the third and highest dose cohort of the study, two of three subjects demonstrated reductions in viral load of 93% and 99.7%. Previously reported middle dose cohort results demonstrated an 87% and 98% reduction in HCV in two of three subjects, while no anti-viral effect was observed in the low dose cohort. No safety issues have been noted to date in the trial. These data suggest a potential dose response of the vaccine and support the inclusion of three additional subjects in the high dose cohort.
These data were presented by Dr. Matti Sanllberg of Tripep at the recent American Association for the Study of Liver Diseases meeting held in San Francisco.
Avtar Dhillon, MD, Inovio's president and CEO, stated: "We continue to be encouraged by the data flowing out of the ChronVac-C study. This promising DNA vaccine candidate, in which Inovio has an ownership position, is one of the more advanced clinical vaccine candidates in the HCV field. ChronVac-C was designed to play a role as a first-line therapy or as an adjunct to existing therapies."
About ChronVac-C
ChronVac-C(R) is a therapeutic DNA-based vaccine given to individuals already infected with the hepatitis C virus with the aim of clearing the infection from the liver by boosting the body's immune response against the virus. Inovio's electroporation technology is being used to deliver the vaccine and is intended to enhance the potency of the DNA vaccine. This clinical study is being conducted at the Infectious Disease Clinic and Center for Gastroenterology at the Karolinska University Hospital in Huddinge and Solna, respectively, in Sweden. The intended enrollment of 12 patients is being divided into four groups, three with increasing doses of ChronVac-C and the fourth at the maximum tolerable dose. Each patient receives four vaccinations one month apart. After the last vaccination, patients are followed for another six months. The study's main purpose is to assess safety. It is also testing whether the treatment boosts the immune response (immunogenicity) to HCV and its effect on virus replication in the liver.
About Inovio Biomedical Corporation
Inovio Biomedical is focused on developing DNA vaccines for cancers and infectious diseases using its novel method for DNA delivery -- electroporation -- which uses brief, controlled electrical pulses to increase cellular uptake of useful biopharmaceuticals. Initial human data has shown that Inovio's electroporation-based DNA delivery technology can significantly increase gene expression and immune responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer Institute, and International Aids Vaccine Initiative. Inovio's technology is protected by an extensive patent portfolio covering in vivo electroporation. The company has entered into a definitive merger agreement with VGX Pharmaceuticals. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications and that results from one study may not necessarily be reflected or supported by the results of other similar studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2007, our 10-Q for the nine months ended September 30, 2008 and other regulatory filings from time to time. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proved accurate.
SOURCE: Inovio Biomedical Corporation
Investors:
Inovio Biomedical
Bernie Hertel, 858-410-3101
or
Media:
Ronald Trahan Associates Inc.
Ron Trahan, 508-359-4005, x108
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Posted by Editors at 11:25 AM --- Printer-friendly version
November 21, 2008
Hepatitis C Patients: Drink More Coffee for a Healthier Liver
Demonstrating a hepatoprotective effect against Hepatitis C, the world's number one morning beverage lands a victory in the debate over its healthfulness.
by Nicole Cutler, L.Ac.
People living with Hepatitis C have had just about every aspect of their lifestyle analyzed to determine what could facilitate or impede the progression of liver disease. While most indulgences have been implicated in a worsening of Hepatitis C, drinking coffee may be an exception to this trend.
Over the past few years, several studies have encouraged people with chronic liver disease to be faithful to their preferred morning beverage. Research into its health benefits has revealed some surprising associations with coffee consumption including decreased risks of:
· alcoholic cirrhosis
· type 2 diabetes
· gallstone development
· liver damage in those with liver disease
· liver cancer
While the studies bearing such conclusions were encouraging to coffee drinkers with liver disease, there had been little evidence specific to advanced cases of Hepatitis C – until now. As reported at the 59th Annual Meeting of the American Association for the Study of Liver Diseases in November 2008, an increase in coffee consumption may slow the progression of liver damage caused by Hepatitis C. Pertinent details of the reported study are listed below:
· Over 800 people participated in this observational study
· Participants had Hepatitis C with an Ishak fibrosis score of 3 or higher
· Participants were unresponsive to standard drug therapies
· 88 percent of participants drank zero to two cups of coffee a day
· 12 percent of participants drank three or more cups of coffee daily
· Those who drank the most coffee also consumed the most alcohol and cigarettes
Considering the known dangers that drinking alcohol and smoking cigarettes pose to a person with Hepatitis C, one would expect those with the highest consumption rates to also have the most advanced cases of liver disease. However, this study found the reverse to be true. Compared to those who drank zero to two cups of coffee per day, the coffee drinkers who consumed three or more cups of coffee showed the following indicators of liver health:
· Less steatosis as determined by liver biopsy
· Lower bilirubin levels
· Lower α-fetoprotein levels
· Lower aspartate aminotransferase/alanine aminotransferase ratios
The calculations of liver damage in these Hepatitis C participants support the idea that consuming three or more cups of coffee per day may protect against the progression of liver disease.
Although this data is exciting for the coffee loving crowd, there are some uncertainties associated with this report. According to Neal D. Freedman, M.D., of the National Cancer Institute at the National Institutes of Health, Department of Health and Human Services, in Rockville, Maryland, “This is an observational study, so it may be that coffee is a marker for some other activity. It may be that people who are feeling sicker don’t drink as much coffee.” In addition, there were many details of coffee consumption omitted from the participants’ questionnaires such as:
· Coffee strength and preparation technique
· Caffeinated or decaffeinated
· Coffee additives like milk or sugar
The reason this study is so compelling is because the heavy coffee drinkers who consumed the most alcohol and cigarettes, both known liver toxins, had the least amount of liver damage. Likely due to the 1000-plus compounds in coffee, the jury is still out on why coffee appears to act as a liver protector. There is not enough evidence to conclude that drinking more than two cups of coffee a day fights Hepatitis C. However, there is sufficient proof that Hepatitis C on its own is not reason to abandon a daily coffee habit.
References:
http://www.liversupport.com/wordpress/2006/06/coffees-liver-benefits/, Coffee’s Liver Benefits, Nicole Cutler, Retrieved November 16, 2008, Natural Wellness, June 2006.
http://www.medscape.com/viewarticle/583121, AASLD 2008: High Coffee Consumption May Slow Hepatitis C Progression, Laurie Bouck, Retrieved November 16, 2008, Medscape, November 2008.
http://www.natap.org/2006/AASLD/AASLD_08.htm, Coffee Appears to Reduce Risk of Fibrosis in HCV+, Jules Levin, Retrieved November 16, 2008, AASLD, The Liver Meeting, October 2006.
Posted by Editors at 03:08 PM --- Printer-friendly version
November 14, 2008
Who Will Respond to Hepatitis C Treatment
The relatively new field of proteomics may be able to predict who will respond to Hepatitis C therapy - before treatment even begins.
by Nicole Cutler, L.Ac.
Of the approximately four million Americans infected with chronic Hepatitis C, only about half will benefit from Hepatitis C’s current standard of therapy – interferon and ribavirin. Considering the enormous health and financial tolls this treatment takes on its recipients, clinicians are finding it increasingly important to identify who will respond to the medications early into the treatment regime. However, a new field on the cutting edge of medical technology may have discovered a way to predict who will respond to standard Hepatitis C therapy before the drugs are even started.
Researchers from the Duke University Clinical Research Institute found a similarity among those with Hepatitis C who are among the 50 percent who do not respond to interferon-ribavirin combination therapy. Presented October 31, 2008 at the annual meeting of the American Association for the Study of Liver Disease, the Duke researchers used proteomics to identify specific proteins that foretold the likelihood of Hepatitis C treatment success. The data for this research was derived from the following:
· Blood samples from 30 patients with Hepatitis C were examined.
· Ten of the samples had genotype I and were cured with the standard therapy.
· Ten of the samples had genotype I and did not respond to standard therapy.
· Ten of the samples had genotype 2 or 3 and were cured with the standard therapy.
With 90 percent accuracy, three clusters of proteins in the blood samples were found to predict who would respond to therapy and who would not. Dubbed a ‘protein signature,’ those with the cluster of proteins indicative of non-responders could be directed towards other treatment approaches. Thus, individuals with this non-responder protein signature could be saved from many months of side-effect ridden and costly treatment with interferon and ribavirin.
The importance of this research is summed up by senior study author Dr. John McHutchison, “Those of us who treat patients with Hepatitis C know that treatment can be very difficult, in terms of side effects, and most patients need to be in therapy for almost a year. When treatment demands this much commitment, it would be nice if we had something to help us – and our patients – decide in advance who is most likely to benefit, and who should try other options.”
Art Moseley, director of the proteomics laboratory in the Duke Institute for Genome Science & Policy gives those who have or treat Hepatitis C even more to look forward to, “We still have to figure out which protein pathways these clusters are associated with. That, in turn, may yield information that could lead to new treatment options or more informed treatment decisions using current therapies.”
Background on Proteomics
The completed human genome published in 2003 contained between 30,000 and 35,000 genes, far fewer than the 100,000 genes predicted by scientists when the project began in the mid-1990s. Those genes contain the recipes for between one million and five million proteins. While the genes that compose the human genome provide the building blocks for who we are, the gene’s proteins directly regulate all of our cell’s functions.
Defined in 1994 by the Australian postdoctoral fellow Marc Wilkins, a proteome includes all the proteins being expressed in a given cell at a given time. Wilkins called the study of the proteome, proteomics. According to Raj K. Puri, M.D., Ph.D., director of the Division of Cellular and Gene Therapies at the FDA’s Center for Biologics Evaluation and Research Proteomics, “Proteomics provides the opportunity for researchers to get a global view of the communications and always-changing events within a cell, instead of focusing on the more static singular gene.”
Researchers are learning that analyzing patterns of proteins, rather than identifying every active protein, may be sufficient for diagnosing disease. However, as the Duke researchers have found, a protein signature can also reveal how a person with Hepatitis C will respond to treatment.
There are many more stages of testing to go before hepatologists around the world use proteomics to screen patients for interferon-ribavirin therapy. However, this innovative application of a relatively new science is already getting people excited. Because of its potential to help physicians and their patients make better informed treatment decisions, testing patients for the non-responder protein signature might become routine when determining who is a candidate for interferon-ribavirin therapy.
References:
http://www.dukehealth.org/HealthLibrary/News/protein_signature_may
_predict_who_responds_to_hepatitis_c_treatment, Protein Signature May Predict Who Responds to Hepatitis C Treatment, Duke Medicine News and Communications, Retrieved November 2, 2008, Duke University Health System, November 1, 2008.
http://www.expasy.ch/proteomics_def.html, What is Proteomics?, Retrieved November 2, 2008, ExPASy, 2008.
http://www.fda.gov/fdac/features/2005/605_proteomics.html, Proteomics: Moving Beyond the Human Genome, Raymond Formanek Jr., Retrieved November 2, 2008, FDA Consumer Magazine, November/December 2005.
http://www.wisegeek.com/what-is-proteomics.htm, What is Proteomics?, J.S. Petersen, Retrieved November 2, 2008, WiseGeek, 2008.
Posted by Editors at 11:48 AM --- Printer-friendly version
November 12, 2008
Antivirals Combined Without Interferon: New Trial
Three companies unite to begin an innovative Hepatitis C trial, where two oral antiviral drugs will be combined in the absence of interferon.
Pharmasset Announces Initiation of Hepatitis Antiviral Combination Study
Tuesday, 11 November 2008
Pharmasset, a clinical-stage pharmaceutical company, Roche and InterMune, a biotechnology company, have announced that the first patients have been dosed in an innovative clinical trial in patients chronically infected with the hepatitis C virus.
The trial is said to be the first to investigate the combination of two oral antiviral molecules in the absence of interferon. The initial study will evaluate the safety and combined antiviral activity of R7227 (ITMN-191), a protease inhibitor, and R7128, a polymerase inhibitor, in 14 days of combination therapy in treatment-naive patients infected with hepatitis C virus (HCV) genotype 1.
This direct antiviral combination study represents an important first step in evaluating the therapeutic potential of an all-oral, interferon-free combination treatment for HCV, the three companies said.
Dan Welch, chairman, CEO and president of InterMune, said: "The goal is to develop a treatment regimen that is better tolerated, shorter in duration and delivers higher sustained viral response rates. We are pleased to participate in the first clinical exploration of an all-oral, direct antiviral regimen towards that goal."
Source: Datamonitor
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initiation_of_hepatitis_antiviral_combination_study/
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HCV May Be Able to Be Cleared from Both Blood and Liver
Viral clearance doubled in a Hepatitis C Phase II trial during standard therapy when coupled with GlobeImmune's GI-5005. Because Hepatitis C must be eradicated not just from the blood, but also the liver, GI-5005's ability to speed the clearance rate of infected cells from the liver shows great therapeutic promise.
GlobeImmune Hepatitis C Therapeutic Vaccine, GI-5005, Doubles Viral Clearance and Increases RVR Rates in Phase 2 Clinical Trial
Four-Week Data Comparing GI-5005 Plus Standard of Care vs. Standard of Care to Be Presented Next Week in Late-Breaking Poster at AASLD Meeting; AASLD President Will Highlight Data at President's Press Conference
LOUISVILLE, CO, Nov 01, 2008 (MARKET WIRE via COMTEX) -- Four-week Phase 2 clinical trial data show that GI-5005, GlobeImmune's hepatitis C virus (HCV) targeted molecular immunogen (Tarmogen(R)), doubled viral clearance overall and in all major subgroups and doubled the rapid virologic response (RVR) rate in naive patients with high viral load. The study compared GI-5005 plus standard of care (SOC) -- pegylated-interferon plus ribavirin -- versus SOC alone in patients with chronic genotype 1 hepatitis C infection.
The study data will be presented by principal investigator John G. McHutchison, M.D., of Duke University, in a late-breaking poster next week at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Treatment-naive patients with high viral loads at baseline ( > 600,000 IU/mL) saw a 2.6-fold improvement in RVR, which is defined as undetectable HCV RNA levels ( < 25 IU/ml) by four weeks. Treatment-naive patients with a high viral load at baseline are particularly difficult to treat to an RVR. RVR is highly predictive of whether a patient will achieve a sustained virologic response (SVR), or "cure," which is defined as undetectable HCV RNA at six months post-treatment. A significant improvement was also noted in the rate of viral reduction in the peripheral blood using viral kinetic analysis in all patients, with a 2-fold improved slope (0.32 log10/month difference, p=0.02) for patients receiving GI-5005 in addition to SOC. Comparable magnitude of increased viral clearance in GI-5005 treated patients was noted in all patient subgroups including prior non-responders and patients with high viral load at baseline.
"These data represent early but important evidence that a patient's natural immune response can be harnessed to positively influence important virologic endpoints with the potential to impact the course of chronic HCV infection," said Dr. McHutchison. "The rational combination of novel immune approaches such as GI-5005 with IFN-based standard of care or with novel direct acting antiviral agents holds promise in terms of ultimately improving clinical outcomes, shortening the exposure to toxic therapies, or both."
David Apelian, M.D., Ph.D., GlobeImmune Chief Medical Officer, said, "These data indicate that GI-5005 can increase the rate of clearance of infected cells from the liver, something that interferon-based therapies and antivirals are not designed to do. Direct acting antivirals act primarily by inhibiting viral replication, an important step, but they have not been shown to speed the immune clearance of infected cells from the liver. Ultimately, to achieve sustained virologic response, HCV must be eradicated not just from the blood, but also the liver. GI-5005 may improve this critical part of the treatment and healing process in a way that is complementary to standard of care and the new direct acting antivirals."
An HCV-targeted cellular immune response is essential to curing a patient with hepatitis C. Twenty percent of patients infected with hepatitis C have immune responses strong enough to clear the virus on their own, without medical intervention. However, for the remaining 80 percent who go on to develop chronic infection, it takes the immune system six to twelve months to eliminate the infection, even with SOC and the best antivirals. Improving the rate of viral clearance may ultimately lead to a decrease in the time needed for therapy.
"The role of the immune response in combating hepatitis C infection is often overlooked," added Apelian. "Most of the recent development interest has been focused on new direct-acting antivirals, which inhibit viral replication. However, to improve the rate of viral clearance from the liver, it is necessary to stimulate an HCV targeted cellular immune response. We believe that the Phase 2 data to date demonstrate the potential of GI-5005 to be an important and complementary part of the treatment of hepatitis C."
The GI-5005-02 clinical trial is a randomized, multi-center, Phase 2 study evaluating 140 patients, all with genotype 1 HCV infection. In the trial, 74 percent of the patients had never received prior treatment, and the remaining 26 percent experienced prior treatment failures.
GlobeImmune's GI-5005 is a targeted molecular immunogen (Tarmogen(R)) designed to elicit an HCV-specific T-cell response. Tarmogens are whole, heat-killed recombinant S. cerevisiae yeast that express antigens from one or more disease-related proteins.
About GlobeImmune
GlobeImmune Inc. is a private company developing targeted molecular immunogens, Tarmogens(R), for the treatment of cancer and infectious diseases. The company's lead product candidate, GI-5005, is a Tarmogen for the treatment of chronic hepatitis C infection (HCV). GI-5005 is designed to complement both the current standard of care and emerging novel therapies for HCV. The company's lead oncology program, GI-4000, targets mutated versions of the Ras oncoprotein for the treatment of pancreas cancer as well as other cancers that contain mutated Ras, including non-small cell lung cancer and colorectal cancer.
For additional information, please visit the company's Web site at www.globeimmune.com.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the preliminary results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.
SOURCE: GlobeImmune, Inc.
Copyright 2008 Market Wire, All rights reserved.
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Posted by Editors at 04:15 PM --- Printer-friendly version
November 10, 2008
How to Afford HCV Treatment
Some Hepatitis C patients may choose not to attempt antiviral therapy for many different reasons. However, with the resources available today, financial reasons can be excluded from deciding whether or not to receive treatment.
by Nicole Cutler, L.Ac.
Some people are lucky enough to receive their Hepatitis C diagnosis while there is still time to do something about it. While absorbing the news that you are chronically infected with the Hepatitis C virus (HCV) may initially feel devastating, it beats not finding out until your liver is ready to shut down. Once a person discovers this virus lurking in their body, it is time to make decisions about receiving treatment. While many factors go into choosing whether or not to undergo antiviral therapy, its high cost may be less of an obstacle than most people think.
Choosing Anti-Viral Treatment
Aside from the financial burden, opting for the standard Western medical treatment consisting of pegylated interferon and ribavirin primarily hinges on two things: your state of health and your likelihood of progressing to cirrhosis or liver cancer in the future.
Anti-viral therapy is typically recommended if a person:
· Is at increased risk of developing cirrhosis due to elevated enzyme levels for over six months
· Has a high level of the virus in their blood, indicating an active infection
· Has had a liver biopsy which shows significant liver damage
Anti-viral therapy is typically NOT recommended if a person:
· Is not likely to develop cirrhosis, due to normal or only slightly elevated liver enzyme levels, and a liver biopsy showing little or no significant liver damage
· Has another serious medical condition such as diabetes, an autoimmune disease, depression, heart disease or active substance abuse
· Is pregnant
Best done in concert with your physician, deciding to try antiviral therapy for HCV involves many considerations. Some of the pros for this treatment are:
· Antiviral medicine is currently the only approved treatment for chronic HCV.
· The newer pegylated interferon medicine (combined with oral ribavirin) only needs to be injected once a week, rather than 3 times a week as is needed for standard interferon treatment.
· Research has shown that those who complete treatment and have no detectable virus in their blood six months following treatment appear to be “cured.”
· Approximately 50 percent of those with the most common HCV genotype in the United States, genotype 1, are able to achieve treatment success.
Some of the cons for this treatment are:
· Approximately 50 percent of those on the medicines develop significant side effects including fever, fatigue, muscle-aches, anemia and depression.
· Those who discontinue the treatment due to the side effects have a lower chance of treatment success.
· Studies on the effectiveness of anti-viral treatment have not been done on people who have other serious conditions.
· You will not be able to perform your job or take time off if you have significant side effects from the medicines.
· Approximately 50 percent of those with the most common HCV genotype in the United States, genotype 1, are able to achieve treatment success.
After weighing the treatment’s pros and cons, a decision to proceed is often met with concerns about how to pay for the high-priced medications. As it turns out, there is a way for most people who need and want the treatment to financially afford it.
Affording Treatment
Proper physician care and the cost of medications for HCV can both cost a lot of money. A representative from the pharmaceutical company Schering-Plough estimated the cost of antiviral medication averaged between $2,000 and $3,500 per month. While health insurance offsets this burden, data from the 2006 U.S. National Health Interview Survey show that 14.8 percent of Americans, or 43.6 million, do not have health insurance. Whether you do or do not have health insurance, there are many resources available in the United States for helping people afford HCV therapy. The more common options are listed below:
1. Private Health Insurance – Most private insurers provide coverage for all necessary care and medications. Depending on the company and plan, co-pays or deductibles may be necessary out-of-pocket expenses. Please note, if you must pay for a portion of your medication costs, shop around between pharmacies. The price of these drugs can vary widely between mail order companies, small pharmacies and big chain stores.
2. Medicaid – The federal and state public insurance program for low-income people meeting eligibility requirements, Medicaid programs cover HCV treatment in every state. However, the enrollment criteria, amount that you pay for prescription drugs, the number of drugs you can get in one month and the requirements to get drugs usually differ between states.
3. ADAP – For those co-infected with HCV and HIV, the AIDS Drug Assistance Program (ADAP) is a state and federal program that serves people living with HIV who are uninsured or underinsured. While eligibility criteria varies state to state, ten ADAPs provide access to both ribavirin and peg-interferon for those co-infected with HIV and HCV.
4. State Programs – Many states have HCV assistance for those in financial need. While it may take a bit of investigative work, a simple phone call to your state’s Department of Health and Human Services Department can reveal programs for helping afford the cost of physician care and HCV antiviral medications.
5. Patient Assistance Programs – If unable to access care through the previously described routes, both the manufacturers of the peg-interferon (Schering-Plough) and ribavirin (Roche Pharmaceuticals) have patient assistance programs. If a person meets these programs’ eligibility requirements, they may be able to receive the medications at a low-cost or for free. If in need, call the Schering-Plough Patient Assistance Program at 1-800-521-7157 and/or the Roche Patient Assistance Program at 1-877-757-6243.
Determining eligibility for one of the many programs will definitely involve paperwork. However, it can exclude financial need as a criterion for choosing to begin HCV antiviral treatment. Although antiviral treatment may not cure someone of the Hepatitis C virus, it proves worthy to some of those who can endure it.
Learning you have HCV before it progresses to the end stages of liver disease affords someone the option of choosing anti-viral therapy. If this route is chosen, there are many ways to finance the medications. Whether a person with HCV is insured, underinsured or uninsured – investigative effort, follow-up and filling out paperwork are sure to erase money from the anti-viral therapy pros and cons list.
References:
www.cdc.gov, Uninsured Americans: Newly Released Health Insurance Statistics, Center for Disease Control and Prevention, 2007.
www.schering-plough.com, Patient Assistance and Support Programs, Schering-Plough Corporation, 2007.
www.thebody.com, Access to Care and Treatment for HCV, WISE Words, The Body, August 2003.
www.webmd.com, Should I take antiviral therapy for hepatitis C?, WebMD, Inc., 2007.
Posted by Editors at 03:22 PM --- Printer-friendly version
November 06, 2008
FDA Approves Roche's Hep C Viral Load Measurements Test
Roche's COBAS® AmpliPrep / COBAS® TaqMan® Test brings improved ease, speed and accuracy to Hepatitis C viral load measurements, and was just approved by the FDA.
Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform
Improved laboratory efficiencies and standardization to personalize patient care
PLEASANTON, Calif., Oct 30, 2008 /PRNewswire via COMTEX/ -- Roche Molecular Diagnostics today announced that the U.S. Food & Drug Administration (FDA) has approved the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test for use in the United States. The test uses Roche's proprietary real-time PCR technology to quantify the amount of Hepatitis C RNA in a patient's blood. Physicians use Hepatitis C viral load testing results to establish a baseline level of hepatitis C infection and to serially monitor viral load levels and treatment effectiveness in patients on therapy.
"This new Roche test enables laboratories to deliver reliable healthcare information with ease and allows physicians to more efficiently monitor their patients and improve treatment outcomes," said Daniel O'Day, President and CEO of Roche Molecular Diagnostics. "We are pleased to offer this new solution for laboratories and physicians to optimize their turnaround time, workflow and patient care with simultaneous processing of HIV and HCV patient samples."
The new test offers a broad dynamic range from high levels of virus in a patients blood to the "undetectable" low levels of viremia -- the goal of therapy. To ensure accurate quantification, the test has been calibrated to World Health Organization (WHO) traceable standards and can detect down to 18 IU/mL with 100% certainty. In a 1,281 patient clinical trial, the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test confirmed the importance of viral load testing to personalize Hepatitis C patient care by accurately predicting treatment response, from onset of therapy through end of treatment.
About the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) System
The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Viral Load Test is designed for use on the first fully automated, FDA approved, real-time PCR platform, providing sample-in/results-out capability. The platform is flexible and customizable to meet the space and workflow needs of any laboratory. In the United States, more than 130 laboratories already utilize this fully automated platform for HIV testing.
The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test is the third Roche COBAS(R) TaqMan(R) real-time PCR test approved by the FDA in the last eighteen months. The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System menu includes an FDA approved HIV viral load test, with continuous loading of samples in addition to parallel processing of HIV and HCV tests. In September 2008, Roche received FDA approval of the COBAS(R) TaqMan(R) HBV Test to monitor Hepatitis B viral load in patients on therapy.
About Hepatitis C
According to the Centers for Disease Control and Prevention, each year in the U.S. approximately 8,000-10,000 people die from hepatitis C-related liver disease.
An estimated 3.2 million persons in the United States have chronic hepatitis C virus infection. Most people do not know they are infected because they don't look or feel sick. However, approximately 75%-85% of people who become infected with hepatitis C virus develop chronic infection. (1)
Hepatitis C infections can range in severity from a mild or "acute" illness lasting a few weeks to a serious, lifelong or "chronic" illness. For most people, acute infection leads to chronic infection. Chronic hepatitis C infection is a serious disease that can result in long-term health problems, including liver damage, liver failure, liver cancer, or even death. Hepatitis C is the leading cause of cirrhosis and liver cancer and the most common reason for liver transplantation in the United States.
Hepatitis C virus is passed from person to person when infected blood enters the body of someone who is not infected. Different ways people can be infected with the hepatitis C virus include sharing contaminated needles, high risk sex with an infected partner, and from an infected mother to her infant during pregnancy and childbirth.
About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at http://www.roche.com.
All trademarks used or mentioned in this release are legally protected by law.
(1) U.S. Centers for Disease Control. http://www.cdc.gov
For further information please contact:
Jessica E. Brillant
Molecular Diagnostics Communications
925.730.8503
Melinda Baker
Molecular Diagnostics Communications
925.730.8379
SOURCE Roche Molecular Diagnostics: http://www.roche.com
Copyright (C) 2008 PR Newswire. All rights reserved
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November 03, 2008
Vertex Treatment May Also Help Non-Responders
Here's some news to be announced at next week's meeting of the American Association for the Study of Liver Diseases. Vertex Pharmaceuticals will release mid-stage study results indicating the effectiveness of its experimental drug, telaprevir. This recent study, known as Prove 3, focused on 453 patients who had failed previous treatment with pegylated-interferon and ribavirin. The exciting news is that 52 percent of them saw the virus fall to undetectable levels for a 12-week period following treatment. In this article you'll learn how telaprevir might shorten treatment time by half, whether reducing dosage frequency could affect its safety, and how sustained viral response rate is determined.
Impressive Vertex hepatitis C drug data unveiled
By Bill Berkrot
NEW YORK, Nov 1 (Reuters) - A closely watched hepatitis C treatment being developed by Vertex Pharmaceuticals Inc showed an impressive ability to knock out the virus in patients who failed other treatments and those not previously treated for the serious liver disease, data from mid-stage studies show.
As it has in earlier studies, the experimental Vertex drug, telaprevir, when combined with standard treatments, showed the potential to cut in half the 48 weeks of treatment needed with the current standard of care and with greater efficacy.
In a study known as Prove 3 with 453 patients who had failed previous treatment with pegylated-interferon and ribavirin, 52 percent of those who received telaprevir saw the virus fall to undetectable levels and remain there 12 weeks after stopping treatment, according to interim analysis of data to be presented at the American Association for the Study of Liver Diseases meeting in San Francisco next week.
The percentage with undetectable virus 24 weeks after stopping treatment will yield the critical measure known as sustained viral response (SVR).
Within the 52 percent result, the virus was undetectable in 41 percent of patients who had not responded to previous treatment and 73 percent of those who had relapsed after previous treatment.
The Prove 3 result "is noteworthy as patients who have failed therapy are very difficult to manage due to limited available treatment options and are at greater risk for developing progressive liver disease," Dr. John McHutchinson, lead investigator of the Vertex-sponsored study, said in a statement.
Hepatitis C is a blood-borne liver disease that can lead to chronic liver disease, liver cancer, cirrhosis and death. The virus affects an estimated 3.2 million people in the United States alone and some 170 million worldwide.
Vertex also released final results from an earlier study called Prove 2 involving 323 hepatitis C patients who had not received prior treatment for the virus.
A higher SVR rate is expected in that patient population and telaprevir delivered on that.
In that study, 69 percent of patients in the telaprevir combination group had the virus fall to undetectable levels following 24 weeks of treatment, compared with a 46 percent SVR rate after 48 weeks of standard treatment.
A third study tested whether telaprevir might be as effective when given twice a day rather than three times per day as it has been in clinical trials.
The twice daily dosing, which could prove to be a more attractive option for patients, demonstrated similar efficacy and turned up no additional safety concerns, according to interim results, the company said.
The most common adverse side effects seen with telaprevir patients in the Prove studies were gastrointestinal problems, skin rash and anemia. Fourteen percent of telaprevir patients discontinued treatment due to adverse events in Prove 2 and 16 percent in Prove 3, Vertex said. That compared with 4 percent and 7 percent dropout rates in the control arms.
Vertex is set to begin pivotal late stage trials of telaprevir along with partner Johnson & Johnson.
Several companies are developing potential rival medicines, including boceprevir from Schering-Plough Corp, but telaprevir is widely expected to be the first in its class to reach the market.
(Reporting by Bill Berkrot, editing by Richard Chang)
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