Research & Treatment News
December 31, 2008
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Because the suggested treatment length and success rates vary between genotypes, it is typically one of the first distinctions made after a Hepatitis C diagnosis. In order to assure the correct course of therapy is approved, health insurance companies are demanding to know their members' Hepatitis C genotype.
Genotype Testing Is Crucial to Course of Therapy for Hepatitis C Patients
December 30, 2008
Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.
By Angela Maas, Managing Editor, (amaas@aispub.com)
With hepatitis C patients, the length of treatment depends upon which of the six hepatitis C genotypes the person has. According to Beckie Fenrick, Pharm.D., director of clinical pharmacy at Blue Cross and Blue Shield of Florida, the treatment regimen for genotypes 2 and 3 is generally 24 weeks, while the regimen for 1, 4, 5 and 6 is 48 weeks. The most common genotypes in the U.S. are 1, 2 and 3.
Many health plans require physicians to provide the organization with the genotype information so they can be sure the patient is receiving the appropriate length of therapy. According to Enoch Strollo, vice president of sales and marketing for BioPlus Specialty Pharmacy, genotype testing costs typically between $450 and $600, and health plans typically cover this expense.
Some plans that spoke to SPN say they require genotype testing either before therapy begins or shortly thereafter.
According to Beverly Franklin-Thompson, Northeast regional pharmacy director for BlueCross BlueShield of Tennessee, BCBST allows patients to immediately begin treatment but then requires the physician to follow up with the patient's genotype. "This minimizes impediments to treatment initiation, allowing a patient to immediately fill the prescriptions for the hepatitis C medications," she says. After a physician notifies BCBST of the patient's genotype, "an approval for a specific duration of treatment is granted," she explains. "A nurse contacts the prescriber to assure that certain tests are being performed and to obtain the results of those tests so that the duration of treatment can be determined and authorization loaded. No prior authorization is required to begin therapy; however, to continue treatment beyond the first few months, clinical parameters such as genotyping must be obtained."
The Florida Blues plan requires physicians to determine patients' genotype so it can make sure patients undergo the appropriate length of therapy. The plan also has practitioners notify it of patients' viral loads at the 12-week mark. If there has been "an appropriate reduction, the approval for additional weeks occurs," Fenrick explains. CIGNA HealthCare also requires a follow-up lab test after the first 12 weeks of therapy, says Todd Cooperman, Pharm.D., director of specialty pharmacy clinical program development.
Mark Leeper, vice president of marketing and clinical program development for PrecisionRx Specialty Solutions, WellPoint, Inc.'s specialty pharmacy, says that when a plan does not require genotype testing, "we do highly encourage it." He explains that "a member's hepatitis C genotype will drive treatment and monitoring. Type 1 genotype is more difficult to treat and requires members to stay on the therapy longer. Also, changes in viral load are influenced by genotype. We conduct baseline information on viral load, and then repeat testing for all genotypes at four, 12 and 24 weeks. For Type 1, we continue testing at 36 weeks and 48 weeks. This schedule is important to allow physicians to adjust dosing to respond to the patient's viral load."
He says if those patients with genotype 1 "don't respond by week 12, they are unlikely to respond, and continuing with therapy is not productive."
Sara Deno, Pharm.D., a manager of clinical services for BioScrip, Inc., who also oversees the adherence and therapy optimization program BioScripCare for hepatitis C, says that plans can structure prior authorizations so that patient response is checked at various intervals.
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December 30, 2008
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By utilizing a mathematical formula on the specific genetics of an individual's Hepatitis C infection, doctors may be able to predict whether or not treatment will be successful.
Study may predict if hepatitis C drugs will work
December 23, 2008
By Julie Steenhuysen
CHICAGO (Reuters) - Doctors hope to be able to better predict which patients will respond to traditional treatment for the hepatitis C virus using a new method for identifying slight variances in the virus' genetic makeup.
U.S. researchers said on Monday that the technique may prove useful for other viruses such as HIV as well. The finding could be used to develop a test that would analyze a patient's specific virus strain before treatment was started.
A team at Saint Louis University in Missouri analyzed genetic patterns of the virus in patients infected with Hepatitis C to see if they could tell why many patients fail to respond to standard treatment with pegylated-interferon and ribavirin.
The year-long therapy activates the body's natural defenses against viruses, but patients often feel as though they have a bad case of influenza. Only about half of the people who suffer through the treatment actually respond.
"This is a very difficult therapy to take. It's really hard on the patient," said John Tavis, a professor of molecular and microbiology at Saint Louis University, whose study appears in the Journal of Clinical Investigation.
"If you can identify those patients who aren't going to respond anyways because they've got a strain that is highly resistant to the drug, then you just don't treat those patients and you save them $20,000 to $30,000 in medical bills just from drugs alone -- not to mention the side effects," Tavis said in a telephone interview.
He and colleagues studied the ribonucleic acid or RNA chains of the hepatitis C virus, looking for patterns that would explain why some people responded to the treatment while others did not.
Using a math formula, they zeroed in on a specific pattern of changes called "covariance networks" that differed depending on whether the drug worked. And these patterns proved to be a strong indicator of whether the virus was especially resistant to therapy.
"What we found will allow a doctor to predict whether or not a medication will work in a patient," Tavis said in a statement.
The finding also may have implications for other types of RNA viruses, such as human immunodeficiency virus or HIV or the influenza virus.
"It's a pretty easy process. The algorithm can be applied fairly quickly," he said. Whether or not it turns up a pattern that will be useful is less clear, he said.
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.
Pegylated interferon brands include Roche Holding AG's Pegasys and Schering-Plough Corp's Pegintron.
(Editing by Cynthia Osterman)
© Thomson Reuters 2008 All rights reserved.
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December 18, 2008
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Instead of prescribing the drugs for "off-label use," pediatricians can now feel more confident when treating children with Hepatitis C. Schering-Plough's Rebetol and PEG-Intron have been officially approved by the FDA for treating Hepatitis C in kids aged 3 to 17.
Schering-Plough hepatitis C drug approved for kids
By LINDA A. JOHNSON
TRENTON, N.J. (AP) — The first high-tech, long-acting treatment for hepatitis C in children, a two-drug combination from Schering-Plough Corp., has been approved by the Food and Drug Administration.
Schering-Plough said Friday that FDA had approved sales of a treatment combining its antiviral pill, Rebetol, with its PEG-Intron, an advanced, genetically engineered version of the immune system protein interferon, for children age 3 to 17 infected with the hepatitis C virus.
An estimated 130,000 American children are infected with hepatitis C, with most of them acquiring it from an infected mother while in the womb. Some adolescents are infected with the liver-destroying virus through illegal drug use that involves sharing contaminated needles or by getting tattoos or body piercings at establishments with poor hygiene.
Many adults and even some children don't know they are infected because hepatitis C can display no obvious symptoms for years, but it often is spotted when a patient has blood testing for something else.
Earlier versions of interferon drugs, which are widely used in adults to treat chronic hepatitis C, had to be injected three times a week. PEG-Intron, available for several years now, has a technology called pegylation that allows the drug to circulate in the bloodstream much longer.
"This treatment is a little more effective than (the older one) and only involves one shot a week," said Dr. Jean P. Molleston, a pediatric hepatitis C expert at Indiana University School of Medicine who has participated in industry-funded research.
She said FDA approval is important because while some hepatitis specialists have prescribed the pegylated interferon to children and adolescents off label — without official approval, which is legal — many more doctors will feel comfortable doing so now, given the potentially serious side effects of the drugs.
Until now, only Schering-Plough's older interferon drug, Intron A, was officially approved for children in this country. The new approval includes a liquid version of ribavirin for younger children.
Patient testing that led to the approval showed the virus was cleared from 55 percent of the children with the most difficult-to-treat strains of hepatitis C, most of whom had a strain called genotype 1, the type carried by about 70 percent of U.S. hepatitis C patients. Children in that arm of the study were treated for just under a year. In children with less-common, less-resistant strains, 96 percent had the virus cleared from their blood; they were treated for six months.
The study, which included a total of 107 children, was funded by Schering-Plough, which is based in Kenilworth, N.J.
While 55 percent seems disappointing, Molleston noted that the first interferon drugs helped only 15 of patients.
Testing of the older Intron A found it worked in only 36 percent of children with the toughest strain and in 81 percent with easier-to-treat strains.
Children with hepatitis C should be treated by doctors familiar with these drugs because of their serious side effects, some of which require dose adjustments, and very young children should not get them, Molleston said.
She previously participated in research for Schering-Plough and recently participated in a hepatitis C study of a rival drug for children, not yet approved, from the Roche Group.
Ribavirin causes anemia and can cause birth defects or kill a fetus, so pregnancy must be avoided in both female patients and female partners of male patients taking it.
PEG-Intron's side effects include weight loss and stunted growth, which can persist for months after treatments, as well as fever, vomiting, headaches, anorexia, fatigue and a drop in infection-fighting white blood cells.
Even so, "children tolerate these drugs much better than adults," Molleston noted.
According to Schering-Plough, only 2 percent of children in the study stopped treatment early.
Schering-Plough shares rose 83 cents, or 5.2 percent, to close at $16.89 Friday. The company's shares are set be added to the S&P 100 Index after trading closes.
Copyright © 2008 The Associated Press. All rights reserved.
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December 16, 2008
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A potential alternative to liver transplant surgery, stem cells from umbilical cord blood may be the solution that those living with chronic hepatitis have been looking for.
by Nicole Cutler, L.Ac.
Once chronic hepatitis has progressed to the end stages of liver disease, there is only one medically accepted option for a person’s recovery. Despite organ transplantation currently being the only choice for helping someone with a non-functioning liver, researchers from Spain are bringing another avenue of hope to those with end stage liver disease. By finding that umbilical cord blood may offer an effective alternative to liver transplants and a potential strategy to treat chronic hepatitis, Spanish scientists could have forever changed the outlook of chronic hepatitis.
About Umbilical Cord Blood
Harvested from the umbilical cord right after a baby is born, stem-cell containing umbilical cord blood is retrieved after the cord has been clamped and cut. Highly coveted by modern medicine, stem cells have the ability to grow into any one of the body’s specialized cells.
Although they are concentrated in cord blood, few stem cells are collected from this source because the total amount of blood from an umbilical cord is small. Despite the challenge of obtaining the quantity needed, stem cells from the umbilical cord have exceptional applications because they are unlikely to cause a graft-versus-host disease after a transplant.
Cord blood cell transplants are already becoming common as a therapy for diseases of the blood. While stem cells from umbilical cord blood appear to be a medicinal panacea, obstacles ranging from possible side effects to political opposition have thwarted their full therapeutic potential.
Cord Blood Stem Cells for the Liver
Fueled by encouraging research that surfaced five years ago, a recently conducted study has demonstrated that stem cells obtained from umbilical cord blood offer real hope for those with chronic hepatitis.
· The Earlier Research – Appearing in the journal Blood in 2003, Xiuli Wang and coworkers transplanted specialized stem cells obtained from umbilical cord and bone marrow into immuno-deficient mice to evaluate a stem cell-based treatment strategy for liver disease. Based on their expression following liver damage, the researchers concluded that bone marrow and umbilical cord stem cells should be considered as an effective treatment strategy for liver diseases.
· Recent Research – To be published in an upcoming issue of Cell Transplantation, a collaborative study conducted by Spanish scientists concluded that mononuclear blood cells derived from the human umbilical cord blood may be useful in the treatment of liver disease, such as hepatitis. The researchers introduced human umbilical cord blood cells through the hepatic portal vein of mice with induced hepatitis. Subsequently, they found a significant improvement in both histological damage and the hepatic function of the animals following cell transplantation.
Today, the need for donor livers far outpaces the supply as more people with chronic hepatitis reach the end stages of liver disease. If future studies using stem cells from umbilical cord blood continue to prove their effectiveness against liver disease, the Spanish research results announced in July of 2008 will be heralded as a major advancement in the field of regenerative hepatic medicine. In addition to the prestige this success could bring, stem cells from umbilical cord blood could become the victor over chronic hepatitis that we’ve all been waiting for.
References:
http://bloodjournal.hematologylibrary.org/cgi/content/abstract/2002-05-1338v1, Albumin expressing hepatocyte-like cells develop in the livers of immune-deficient mice transmitted with highly purified human hematopoietic stem cells, Xiuli Want, et al., Retrieved July 20, 2008, Blood, American Society of Hematology, December 2002.
http://ngm.nationalgeographic.com/ngm/0507/feature1/, The Power to Divide: Stem Cells, Rick Weiss, Retrieved July 20, 2008, National Geographic Society, 2008.
http://news.nationalgeographic.com/news/pf/96995126.html, Umbilical Cord Blood: The Future of Stem Cell Research?, Erica Lloyd, Retrieved July 20, 2008, National Geographic Society, April 2006.
http://prensa.ugr.es/prensa/research/verNota/prensa.php?nota=552, Scientists use stem cells from the umbilical cord to treat hepatic diseases, Luis G Fontana, Retrieved July 17, 2008, University of Granada, 2008.
http://www.bchealthguide.org/kbase/topic/special/uq1027spec/sec1.htm, Umbilical Cord Blood Stem Cells, Retrieved July 20, 2008, Healthwise, Incorporated, 2008.
http://www.medinewsdirect.com/?p=533, Umbilical Cord Blood Derived Stem Cells Used to Treat Liver Disease, Retrieved July 17, 2008, MediNEWS.Direct!, July 2008.
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December 15, 2008
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The relationship between drinking alcohol and developing alcoholic hepatitis is not necessarily linear. Aside from consuming alcohol, learn which other factors – such as obesity and malnutrition – can play a role in developing this potentially life-threatening liver disease.
by Nicole Cutler, L.Ac.
As the second of the three stages of alcoholic liver disease, alcoholic hepatitis is striking a growing number of people worldwide. With potentially fatal consequences, being able to recognize what predisposes someone to develop this disease may help prompt its early discovery and appropriate action. Since alcohol is the culprit of liver inflammation in alcoholic hepatitis, it may be reversible through abstinence when detected early enough. Unfortunately, when chronic hepatitis is caused by a virus, it is much harder to turn around.
The 3 Stages
There are three primary stages of alcoholic liver disease, although the progression through each stage can vary. Only through a liver biopsy (or comparable method) can the degree of liver damage be evaluated.
· Stage 1 – In the first stage of alcoholic liver disease, the person develops a fatty liver where there is minimal change to liver tissue. While a fatty liver is not linked to deterioration in liver function, abnormalities may be seen in some of the liver function tests. Even though fatty liver is reversible with alcohol abstinence, it is also the first step in progressing toward cirrhosis.
· Stage 2 – As fatty liver worsens, the liver becomes inflamed. Alcoholic hepatitis is the liver inflammation that ensues during the second step in alcoholic liver disease. Alcoholic hepatitis can range from mild to life-threatening, and may be present with or without liver inflammation symptoms. Similar to a fatty liver, abstinence from alcohol can reverse the effects of alcoholic hepatitis, but those who continue to drink heavily have a high risk of developing cirrhosis.
· Stage 3 – The final, irreversible stage of alcoholic liver disease is cirrhosis. Characterized by scarring and nodules on the liver, cirrhosis severely inhibits liver function, reduces life expectancy and increases the likelihood of developing liver cancer or liver failure.
If caught early on, fatty liver or mild alcoholic hepatitis can be mitigated by abstaining from drinking alcohol. However, advanced cases of alcoholic liver disease – whether severe alcoholic hepatitis or cirrhosis – renders the remaining liver capacity insufficient for carrying out normal, body functions.
Susceptibility
The relationship between drinking alcohol and developing alcoholic hepatitis is not necessarily linear. Only a small percentage of heavy drinkers develop alcoholic hepatitis, yet the disease can occur in people who drink only moderately or binge just once.
While the liver damage from alcoholic hepatitis has the potential to be reversed in people who stop drinking, this dangerous disease is likely to progress to cirrhosis and liver failure in those continuing to indulge. Because many people who drink heavily or binge drink never develop alcoholic liver disease, it’s likely that factors other than alcohol play a role:
· Genetic factors – Genetic mutations affecting alcohol metabolism may increase the risk of alcoholic liver disease as well as of alcohol-associated cancers. Genetic factors may account for half of any person’s susceptibility to alcohol-related disease.
· Other types of hepatitis – Long-term alcohol abuse worsens the liver damage caused by other types of hepatitis, especially Hepatitis C. If you have Hepatitis C and also drink (even moderately), the likelihood of developing cirrhosis is much greater than in someone who doesn’t drink.
· Other diseases – People who drink alcohol are more likely to develop alcoholic hepatitis if they also have another disease affecting the liver, such as diabetes or hemochromatosis.
· Obesity – Although most researchers agree that obesity makes alcoholic liver disease worse, the reasons are unclear. A likely cause is that alcohol causes fatty tissue to produce certain hormones and cytokines responsible for increasing inflammation throughout the body.
· Malnutrition – For one or both of the following reasons, many people who drink heavily are malnourished:
1. Because alcohol is often substituted for food, nutritional habits may be poor.
2. Because alcohol and its toxic byproducts prevent the body from properly absorbing and metabolizing nutrients, substances such as protein, vitamins and essential fats never make it to the body’s blood circulation.
In both cases, the lack of absorbed and metabolized nutrients contributes to liver cell damage. While it was previously thought that malnutrition – rather than alcohol – caused alcoholic liver disease, the relationship between the two appears more complicated.
· Alcohol use – Consistent heavy drinking or binge drinking is the primary risk factor for alcoholic hepatitis, though it’s hard to precisely define heavy drinking. Some experts believe that four or more drinks a day for men and two or more a day for women greatly increase the risk of liver damage. Moderate drinking is usually defined as no more than two drinks a day for men and one for women. However, because people vary greatly in their sensitivity to alcohol, these amounts can vary dramatically.
· Age – The effects of alcoholic hepatitis are likely cumulative, showing up after years of heavy drinking. However, symptoms of this disease can develop in people as young as 20.
· Gender – Women are two to three times as likely to develop alcoholic liver disease as men are. Experts believe this inequality is because it takes less alcohol to harm the liver in women, and liver disease progresses more quickly in women than in men. This disparity may result from genetic differences in the way alcohol is absorbed and broken down. Because women tend to metabolize alcohol more slowly, their livers are exposed to higher blood concentrations of alcohol for longer periods of time – with potentially greater toxicity. The slow rate of alcohol metabolism in women may be due to:
1. lower levels of stomach enzymes to break down alcohol
2. the effects of the female hormone estrogen
3. the typically smaller size of a woman’s liver
According to medical experts, even an occasional drinker is susceptible to developing alcoholic hepatitis. Since so many factors can contribute to the development of alcoholic liver disease, there is only one way to eliminate this threat. Making the monumental effort to quit drinking alcohol can return a liver to its pre-alcohol, healthy state. As long as abstinence occurs before the last stage of alcoholic liver disease begins, there is great hope for eradicating the perils of alcoholic hepatitis.
References:
Lederer, Sharon L., et al, Distinct cellular responses differentiating alcohol- and hepatitis C virus-induced liver cirrhosis, Virology Journal, November 2006.
www.gastroresource.com, Alcoholic Liver Disease, F. Wong, L. Blendis, First Principles of Gastroenterology, AstraZeneca Canada Inc., 2000.
www.hepatitis.org, Acute Alcoholic Hepatitis, Dr. Langlet Philippe, hepatitis.org, 2007.
www.mayoclinic.com, Alcoholic Hepatitis, Mayo Foundation for Medical Education and Research, 2007.
www.montana.edu, Alcohol and Liver Disease, Montana State University, 2007.
www.netdoctor.co.uk, Alcoholic Liver Disease, Dr. Matthew Warren, Professor Christopher P. Day, Netdoctor.co.uk, 2007.
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December 11, 2008
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In response to a large, Roche-sponsored study, the European Commission approved Pegasys and Copegus for re-treating Hepatitis C non-responders.
Roche wins European approval for hepatitis drug
5th December 2008
By Staff Writer
Roche has announced that the European Commission has approved Pegasys plus Copegus for the re-treatment of hepatitis C patients who were not successfully treated with an initial course of interferon alpha, either alone or in combination with ribavirin.
The European approval provides a significantly broader indication for peginterferon alfa-2a and establishes a new standard of care for treatment-experienced patients with the most difficult-to-treat virus, the company said.
A large, Roche-sponsored study called REPEAT demonstrated that 72 weeks of re-treatment with peginterferon alfa-2a plus ribavirin doubled the chance of achieving a cure, compared to 48 weeks, in patients who were prior non-responders to PegIntron (peginterferon alfa-2b) and ribavirin. Furthermore, the study showed that 57% of patients who responded by week 12 (defined as HCV RNA levels of less than 50 IU/mL) went on to achieve a cure with 72 total weeks of re-treatment.
William Burns, CEO of Roche's pharmaceuticals division, said: "This new indication for Pegasys plus Copegus is another demonstration of Roche's commitment to extend the promise of a cure to as many chronic hepatitis C patients as possible.
"Our approach is to optimize and individualize treatment to increase patients' chance of success with Pegasys and Copegus, while establishing them as the backbone for combination with novel agents in development, both by Roche and through external partnerships and collaborations."
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December 8, 2008
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The results are in from a 3-1/2 year study of long-term interferon treatment against the Hepatitis C virus. By examining clinical outcomes, researchers evaluated whether or not long-term use of interferon would be helpful or even appropriate for HCV patients.
Interferon As Long-term Treatment For Hepatitis C Not Effective
ScienceDaily (Dec. 8, 2008) — Use of the drug interferon as a long-term maintenance strategy to slow the progression of liver disease associated with the hepatitis C virus is ineffective, UT Southwestern Medical Center researchers and their colleagues from nine other institutions have found in a multicenter study.
Results of the 3½-year study, called the HALT-C (Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis) Trial, appear in today's issue of The New England Journal of Medicine. The researchers found no difference in the rate of progression of liver disease among patients who received interferon and those who did not.
"It wasn't that there was an insignificant difference; there was absolutely no difference whatsoever in the progression to cirrhosis and other disease complications," said Dr. William M. Lee, professor of internal medicine at UT Southwestern and a principal investigator for the study. "It is a negative study but an important one."
Dr. Lee said physicians should not expect any benefit from the long-term use of interferon by itself in slowing disease progression. By contrast, use of interferon with other drugs such as ribavirin can lead to viral eradication, or complete clearance of hepatitis C virus, a result that will "stop the disease in its tracks," Dr. Lee said.
Hepatitis C is a viral infection that causes liver inflammation and can progress over many years to cirrhosis, liver cancer, liver failure and death. The disease affects more than 3 million people in the United States and 170 million people worldwide. It is the most common reason for liver transplantation in the U.S.
There is no vaccine to prevent hepatitis C virus infection. The combination of interferon and ribavirin works for about 40 percent to 50 percent of people with the virus, while the other 50 percent to 60 percent of patients will continue to progress to later states of liver disease, Dr. Lee said.
In addition to interferon and ribavirin, new drug agents such as protease and polymerase inhibitors are being used in clinical studies at UT Southwestern to improve rates of virus eradication. Food and Drug Administration approval of these agents is likely to be three years away, Dr. Lee said.
In the HALT-C Trial, conducted between August 2000 and June 2007, 1,050 people with hepatitis C who did not respond to initial antiviral treatment were assigned randomly to either a group that received treatment with a type of interferon called peginterferon or to a group that did not. About 120 patients were enrolled at UT Southwestern.
Participants were monitored every three months and underwent liver scans and biopsies at specified intervals through the study period. Researchers found that although the level of hepatitis C virus in blood and certain enzymes in the liver decreased significantly with treatment, there was not a significant difference in ultimate clinical outcome.
"Currently, we use interferon only to clear the virus," said Dr. Lee. "If you cannot clear the virus with treatment, the idea that struggling long term through the side effects of interferon is somehow going to help you rid yourself of cirrhosis is just not plausible any longer."
Some patients cannot tolerate the side effects of the different types of interferon medication, which can cause extreme flu-like symptoms, such as fever, chills, fatigue, depression, muscle aches, chest pain, difficulty breathing, nausea, vomiting, and weight and hair loss.
Other researchers from UT Southwestern involved in the study were Dr. Thomas Rogers, professor of pathology, and Dr. Peter Malet, professor of internal medicine.
Also involved in the study were researchers from Saint Louis University School of Medicine; Virginia Commonwealth University Medical Center; University of Colorado School of Medicine; University of Southern California; National Institute of Diabetes and Digestive and Kidney Diseases; University of Michigan Medical Center; University of Connecticut Health Center; University of California, Irvine, and VA Long Beach Healthcare System; and University of Washington.
The study was funded by the National Institutes of Health. Pharmaceutical manufacturer Hoffman-LaRoche, through an agreement with the NIH, also provided funding.
Dr. Lee has received consulting fees from Eli Lilly, Fibrogen and Astra Zeneca, and grant support from Hoffmann-LaRoche, Schering-Plough, Vertex Pharmaceuticals, GlaxoSmithKline, Siemens, Globelmmune and Bristol-Myers Squibb.
Adapted from materials provided by UT Southwestern Medical Center.
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December 4, 2008
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At the end of a 48-week, Phase IIb study, taribavirin shows similar effectiveness as ribavirin in reducing Hepatitis C viral load. However, participants taking taribavirin had a significantly lower rate of anemia.
Valeant reports encouraging results from Phase IIb hepatitis study
25th November 2008
By Staff Writer
Valeant Pharmaceuticals, a multinational specialty pharmaceutical company, has reported promising results at end of treatment, week 48 analysis point in the Phase IIb clinical trial for its antiviral compound, taribavirin, a prodrug of ribavirin in development for the treatment of chronic hepatitis C in conjunction with a pegylated interferon.
Similar to the treatment week 12 results reported earlier in 2008, the 48-week viral response data continue to show comparable reductions in viral load for weight-based doses of taribavirin and ribavirin. The anemia rate was statistically significantly lower for patients receiving taribavirin in the 20mg/kg and 25mg/kg arms versus the ribavirin control arm.
The Phase IIb trial is a US multi-center, randomized, parallel, open-label study in 278 treatment-naive, genotype 1 patients evaluating taribavirin at 20 mg/kg, 25 mg/kg, and 30 mg/kg per day in combination with pegylated interferon alfa-2b. The control group is being administered weight-based dose ribavirin (800/1000/1200/1400mg daily) and pegylated interferon alfa-2b. Overall treatment duration is 48 weeks with a post-treatment follow-up period of 24 weeks.
Michael Pearson, chairman and CEO of Valeant, said: "We believe that taribavirin will be a promising alternative to ribavirin in the treatment of chronic hepatitis C and, with Valeant's strategic shift away from the infectious disease market, we plan to out-license this compound in order to maximize its potential for these patients."
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An ongoing Phase IIa study on Schering-Plough's next generation Hepatitis C protease inhibitor is encouraging. According to the company, SCH 900518 is 10 times more potent than other medications in this class and is active against highly resistant Hepatitis C strains.
Schering-Plough to develop new oral hepatitis drug
25th November 2008
By Staff Writer
Schering-Plough, a science-based healthcare company, has announced that it is developing a highly potent next-generation oral hepatitis C protease inhibitor that has future best-in-class potential.
As part of its long-term commitment to hepatitis C therapy, Schering-Plough is developing SCH 900518 (518), a next-generation hepatitis C virus (HCV) protease inhibitor. A Phase IIa study with 518, known as the Next-1 study, is currently ongoing.
The company said that 518 has been shown to be 10 times more potent in-vitro than other protease inhibitors currently in Phase III development and has the potential for once daily dosing. The protease inhibitor also has shown decreased emergence of resistance in vitro. Given its pharmacokinetic profile, the company anticipates that 518 may be active against some HCV strains that are resistant to other protease inhibitors.
Phase I proof of concept studies with 518 in treatment-naive patients and those who failed prior treatment, both as monotherapy and in combination with peginterferon, demonstrated enhanced antiviral activity, with up to 4log10 and 5log10 decreases in circulating HCV, respectively, the company said.
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