Due to overwhelming empirical evidence, some medical circles believe that the symptoms and presenting patterns shared between Hepatitis C and fibromyalgia are beyond coincidental. While Hepatitis C is known to be transmitted through infected blood, authorities are still debating how fibromyalgia is acquired. Due to similarities in manifestation and physiology, there is a possibility that Hepatitis C infection may be one of fibromyalgia syndrome’s triggers. If you suspect having both conditions, awareness of this link can lead you to seek the specialized evaluation and care that may improve your most frustrating symptoms.
Prevalence
Estimates of disease prevalence in the United States approximate the number of people living with fibromyalgia to be around 6 million people, while the number of people known to be living with Hepatitis C hovers just above 4 million. While accurate statistics of the number of people affected by both diagnoses are not currently available, a surprising number of people dually diagnosed with Hepatitis C and fibromyalgia are emerging. However, one study did find the prevalence of fibromyalgia in people with Hepatitis C (15 to 19 percent) to be much higher than the occurrence of fibromyalgia in the general American population (2 percent).
Fibromyalgia
Fibromyalgia is a syndrome causing widespread muscle pain, extreme fatigue and multiple tender points in specific parts of the body. With pain characterized as aching, burning, stabbing and throbbing, its severity can vary widely. While fibromyalgia is a chronic condition, it is not a progressive disease. However, this condition can greatly reduce the quality of life of those affected.
Experts do not agree on what causes fibromyalgia. When trying to determine the etiology of this complex syndrome, it is challenging to discern between cause and effect. The endless cycle of pain, inactivity, insomnia, fatigue and depression typical of fibromyalgia complicates the isolation needed to trace this syndrome’s origins. Although researchers have identified several possible reasons for fibromyalgia, it remains unclear if they are a cause, or part of the problem. Some of the leading contenders for what triggers fibromyalgia include:
· Hormone Imbalance
· Infectious Disease
· Immune System Malfunction
· Sleep Disorder
· Traumatic Event
· Muscle Abnormality
The Hepatitis C Connection
Although not yet confirmed, many experts believe that Hepatitis C may act as a trigger to the onset of fibromyalgia. The documented links between the two conditions include:
· Symptom Specificity – Fibromyalgia and chronic Hepatitis C infection share many clinical features including musculoskeletal pain and fatigue. While the two conditions do not always accompany each other, some symptoms may be unique when a person has both fibromyalgia and Hepatitis C. One study found that people dually diagnosed with fibromyalgia and Hepatitis C exhibit symptoms such as inflammation around a joint, bursa and/or tendon, and vasculitis (blood or lymph vessel inflammation) that are not seen in Hepatitis C negative people with fibromyalgia.
· Immune Proteins – Cytokines are proteins that regulate immune response. Interleukins are a specific type of cytokine that cause a person to feel pain. Several interleukins have been found to be dramatically elevated in fibromyalgia patients. Harvard researchers found those same interleukins increased in production when exposed to the Hepatitis C virus.
· Hepatitis C and Pain – Many people infected with Hepatitis C virus infection complain of myalgias, arthritis and widespread pain. When compared to other liver diseases, the frequency of musculoskeletal pain clearly favors Hepatitis C. The frequencies of musculoskeletal pain for the following isolated conditions are as follows: Alcoholic liver disease = 48 percent, Hepatitis B = 59 percent and Hepatitis C = 91 percent. As fibromyalgia’s most prominent symptom, it is not surprising that musculoskeletal pain may represent the link to Hepatitis C.
Infectious Cause
Certain infections, notably viruses, often occur in the histories of people with fibromyalgia. As these infectious organisms invade the body, scientists think they may cause damage at a cellular level. While fibromyalgia is considered to be non-contagious, it is possible that it may be a manifestation of a viral disease such as Hepatitis C, which is contagious. While many infectious microorganisms have been tied to fibromyalgia, the link with Hepatitis C is becoming increasingly suspect. At this point, there is sufficient evidence linking infectious diseases and fibromyalgia together, but it is unknown if any of these microorganisms are fibromyalgia’s origin, a simultaneous condition or a result.
Why it Is Important
A high prevalence of fibromyalgia has been found in patients infected with Hepatitis C, especially women. According to Israeli researchers, recognizing fibromyalgia in people with Hepatitis C will prevent misinterpretation of fibromyalgia symptoms as part of the liver disease and enable physicians to correctly focus on alleviating these symptoms.
A doctor well versed in fibromyalgia should be consulted if this syndrome is suspected. Because its diagnosis is not simple and symptoms often overlap with other conditions, a proper evaluation will test for fibromyalgia while ruling out other diseases. Doctors who are familiar with fibromyalgia typically make a diagnosis based on criteria established by the American College of Rheumatology (ACR). Those criteria are:
1. Widespread pain (right and left side body pain, above and below the waist) that lasts for more than 3 months.
2. Eleven or more tender points present at 18 specific sites on the body.
Whenever there is a profound crossover in a disease’s symptoms, we can learn from their parallels. Although many questions shroud the connection between fibromyalgia and Hepatitis C, their relationship exists in many people with either condition. With their comparable symptoms, similar immune biochemistry and irrefutable statistics of simultaneous presentation, exposure to the Hepatitis C virus may be one of fibromyalgia’s triggers.
Understanding this connection may prompt a person with fibromyalgia to get tested for Hepatitis C or it may help a person with Hepatitis C seek evaluation for fibromyalgia. If you think you might be burdened with both conditions, discuss your thoughts with your primary healthcare provider. By taking this proactive stance, you may open yourself up to new ways of reducing Hepatitis C’s challenging symptoms of pain and fatigue.
References:
www.archinte.ama-assn.org, Fibromyalgia in hepatitis C virus infection. Another infectious disease relationship, Buskila D., et al, Archives of Internal Medicine, November 1997.
www.cdc.gov, Viral Hepatitis C Fact Sheet, US Department of Health and Human Services, 2007.
www.hcvadvocate.org, Extrahepatic Manifestations: Hepatitis C and Fibromyalgia, Alan Franciscus, HCV Advocate, July 2006, Hepatitis C Support Project, 2007.
www.ihop-net.org, Fibromyalgia, hepatitis C infection and the Cytokine connection, Thompson ME, Barkhuizen A, Current Pain and Headache Reports, 2003.
www.medscape.com, Fibromyalgia Pain: Do We Know the Source?, Roland Staud, Current Opinion In Rheumatology, April 2004.
www.rheumatology-oxfordjournals.org, Fibromyalgia-associated hepatitis C virus infection, Rivera J, et al., The British Journal of Rheumatology, 1997.
www.vir.sgmjournals.org, Structural proteins of Hepatitis C virus induce interleukin 8 production and apoptosis in human endothelial cells, Anuradha Balasubramanian,, et al., Journal of General Virology, 2005.
]]>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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URL for Article Source:
http://www.aishealth.com/Bnow/hbd123008.html
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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URL for Article Source:
http://uk.reuters.com/article/healthNewsMolt/idUKTRE4BM00020081223
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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URL for Article Source:
http://www.google.com/hostednews/ap/article/ALeqM5hGR26NvNp0mBpQa79Z
_JNiPu0kkgD951F3180
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.
]]>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.
]]>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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URL for Article Source:
http://www.pharmaceutical-business-review.com/article_news.asp?guid=
7098C11A-1C5D-4247-81E7-554B6D4A2C0D
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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URL for Article Source:
http://www.sciencedaily.com/releases/2008/12/081204133645.htm
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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URL for Article Source:
http://www.pharmaceutical-business-review.com/article_news.asp?guid=
02C2D191-166C-4F5C-AA9E-CAEE307BE5B6
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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URL for Article Source:
http://www.pharmaceutical-business-review.com/article_news.asp?guid=
FA09E462-E62D-4F09-88CF-D00C4AAE4B8A
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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URL for Article Source:
http://www.reuters.com/article/marketsNews/idUSN2149745020081123
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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URL for Article Source: http://www.marketwatch.com/news/story/Hepatitis-C-Therapeutic
-DNA-Vaccine/story.aspx?guid=%7B50998DF9-516F-4207-84D6-1948D
197794D%7D
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.
]]>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.
]]>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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URL for Article Source:
http://www.redorbit.com/news/health/1599470/pharmasset_announces_
initiation_of_hepatitis_antiviral_combination_study/