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Week Ending: June 3rd , 2006
Alan Franciscus
Editor-in-Chief
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May 28th, 2006
$90m Sought in Bad Blood Claims
http://www.stuff.co.nz
By IRENE CHAPPLE
As a $10 million bad blood payout inches towards settlement, Budget documents show claims for $90m have been lodged against the government over the hepatitis C scandal.
It is the biggest single legal dispute the state faces. The claim, which has been on the books for several years, reveals the extent of the scandal which blew up more than a decade ago.
Last month the Sunday Star-Times revealed the government was planning a $10m payout to 170 people with haemophilia who were infected with hepatitis C from contaminated blood products.
The deal is expected to include a formal apology from Prime Minister Helen Clark and compensation of up to $60,000 a person.
About 700 people have been infected with hepatitis C, and the Budget figures indicate an average claim of $128,571 each.
But Budget documents show the amount is the "maximum potential cost". It is not "an admission that the claim is valid or an estimation of the possible amount of any award against the Crown".
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Facts on Hepatitis B
SourceURL:http://www.sunstar.com.ph
By Henrylito D. Tacio
IF YOU'VE been feeling out of sorts, have lost your appetite (especially for cigarettes), have a low-grade fever and a yellow hue to your skin and the whites of your eyes, you almost certainly have hepatitis, an infection of the liver.
Medical science has discovered six different kinds of hepatitis and a different virus causes each of these.
Among the six viruses, the most common and more serious disease is hepatitis B. More than two billion individuals alive today have been infected at some time in their lives with the said virus, also known as HBV.
Approximately 350 million people around the world are chronically infected with HBV, according to the Geneva-based World Health Organization (WHO).
In the Philippines, an estimated 1.4 million people are highly infectious carriers of HBV. Every year, at least 1.6 million get sick of the disease. Of this total, two percent do not recover and become chronic carriers. "At the earliest, patients recover after 10 weeks," explains Dr. Ernesto Domingo, head of the Liver Study Group of the University of the Philippines. "Most recover only after six months. If you don't recover after six months, you become a chronic carrier."
My notes said that HBV infection leads to one of three outcomes in man. An infected individual may die of fulminant hepatitis -- a rare form of liver disease that frequently results in death -- within days or weeks after onset of disease, may recover after showing some symptoms (although some sufferers report no symptoms) and develop lifelong immunity, or may develop chronic infection, a persistent infection, which usually lasts for life.
In developing countries like the Philippines, spread of HBV from child-to-child accounts for most HBV infections. Child-to-child spread most likely happens as a result of contact of skin sores, small breaks in the skin, or mucous membranes with blood, skin sores, or perhaps saliva.
Spread from inanimate objects, such as sharing of wash towels or toothbrushes, may also occur because HBV can survive for at least seven days outside the body. Unsafe injection practices, particularly those being employed by drug addicts, are a major source of HBV transmission worldwide.
In addition, blood transfusion can be a major source of HBV transmission in countries where the blood supply is not screened.
Inadequate infection control practices, including reuse of contaminated medical or dental equipment, failure to use appropriate disinfection and sterilization practices for equipment and environmental surfaces, and improper use of multi-dose medication vials, can also result in transmission of HBV.
HBV is efficiently spread by sexual contact, which can account for a high proportion of hepatitis B cases among adolescents and adults in countries with a low and intermediate prevalence of HBV infection.
In countries with a high prevalence of HBV infection, sexual transmission does not account for a high percentage of cases because most persons are already infected during childhood.
Medical experts say that those who are at high risk of the Hepatitis B virus are children below five years old, health care professionals who are usually exposed to blood, blood donors, army personnel, prisoners, homosexuÂals and hospitality girls.
The study conducted by Dr. Domingo has shown commercial sex workers from Cebu and Manila as among the groups with a high numbers of carriers. The lowest numbers of carriers, but also among those at risk, are medical students.
"If you are between the ages of 18 and 34, and are sexually active with more than one partner in a six-month period or if you've been diagnosed with another sexually transmitted disease, you are at a greater risk," claims Dr. Edward Beruff, the American director of vaccine products for SmithKline Beecham Pharmaceuticals in Philadelphia.
"When a person becomes infected by the HBV, the virus travels to the liver where it enters individual liver cells," said Prof. Nancy Leung, consultant and honorary associate professor at the Prince of Wales Hospital in the Chinese University of Hong Kong. "Here, it replicates and may reenter the blood stream or reinfect other liver cells."
Symptoms of initial infection with Hepatitis B result from the body's attempt to defend itself against infection.
"Those individuals with the most severe of symptoms are therefore most likely to eliminate the virus from their body while those with no symptoms or have very mild complaints -- typically children are most likely to retain the virus and become long-term carriers."
Professor Leung added that HBV may remain in some individuals after the initial infection and the patients are said to be chronic hepatitis B carriers when part of the surface of the virus remains in the blood for more than six months.
"The result of long-term carriage of the HBV is continuing inflammation of the liver, which may lead to serious liver damage and cancer," she said.
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VA Hospital Warns of Possible Infection from Prostate Biopsy
SourceURL:http://www.columbiamissourian.com
Potentially unsanitary equipment used during prostate biopsies has prompted the Veterans Administration to encourage patients treated at VA hospitals to be tested for possible infections.
In Columbia, Truman Veterans Hospital sent letters to 263 patients encouraging them to return to the hospital to be tested for hepatitis B, hepatitis C and HIV. The letters were sent to patients who received prostate biopsies between January 2005 and early 2006.
Hospital spokesman Stephen Gaither said another VA medical center recently realized that there was a possibility for infection with a certain piece of equipment used for the exams.
"Once they realized there could be a problem at one VA hospital, they realized any center that has used the equipment could have people at risk," Gaither said.
The Veterans Administration informed 21 of its centers to send letters to patients who received prostate biopsies using the B-K biopsy transducer.
The transducer, manufactured by B-K Medical Systems Inc., had no specific guidelines in its instruction booklet for how to disinfect the device, and VA officials worried that repeated use could transmit diseases from patient to patient, Gaither said. National VA inspectors said that while the equipment was being cleaned and disinfected after each procedure, it was not always scrubbed with a brush, and unscrubbed equipment could still carry the risk of infection.
In Columbia, Gaither said hospital staff were scrubbing the equipment, but the alcohol solution they were using to soak the equipment for four minutes was not as effective as another preferred solution, which is now being used. Gaither did not specify the nature of the new solution.
B-K Medical Systems could not be reached for comment.
"I'd like to stress that there is a very remote possibility of infection," Gaither said. "We want to err on the side of caution, though, by doing follow-up tests."
The hospital sent letters to patients explaining the problem and the risks for infection and encouraged them to make appointments for blood tests, Gaither said.
The letter stated that there is no evidence that any patient who had a prostate biopsy with the equipment in question has acquired an infection during the procedure.
"The decision to offer you testing has been made in consultation with the manufacturer of the prostate biopsy device, the Centers for Disease Control and Prevention and the Food and Drug Administration," said the letter, written by Marie Weldon, the hospital's acting director.
The hospital is testing for hepatitis B, hepatitis C and HIV because those are the diseases most likely to have been transmitted, said Gaither.
The letter also stated that patients would not need additional biopsies because the results of the tests had been accurate and that the hospital was taking steps to ensure no similar situation occurs.
Although Gaither said he does not anticipate any infections from the biopsies, if cases are discovered, the VA will start treatment immediately.
"We treat people with those kinds of infections already, so we will just follow usual treatment procedures," he said.
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May 29th, 2006
Fatigue Is a Major Problem After Liver Transplantation
SourceURL:http://www.gastrohep.com
Physical fatigue is a major problem in patients after liver transplantation, and does not appear to improve over time, report researchers in this month's Liver Transplantation.
Fatigue is often experienced after liver transplantation.
Dr Rita van den Berg-Emons and colleagues from the Netherlands assessed the severity of fatigue in liver transplant recipients.
The team explored the nature of fatigue, and factors that may be associated with severity of fatigue after liver transplantation.
The research team included 96 patients up to 15 years after liver transplantation.
Severity of fatigue and nature of fatigue were assessed with the Fatigue Severity Scale, and the Multidimensional Fatigue Inventory, respectively.
66% of were fatigued, and 44% were severely fatigued -- Liver Transplantation
Furthermore, age, gender, indication for transplantation, and time since transplantation were evaluated.
The team also assessed immunosuppressive medication, self-experienced disability, and health-related quality of life as potential associated factors.
The researchers found that 66% of all patients were fatigued, and 44% of all patients were severely fatigued.
Patients experienced physical fatigue with reduced activity rather than mental fatigue and reduced motivation.
Age, gender, self-experienced disabilities, and health related quality of life were factors that correlated with severity of fatigue.
Dr van den Berg-Emons' team concluded, "This study indicates that fatigue is a major problem in patients after liver transplantation, and no indications were found that complaints of fatigue improve over time."
"Liver transplant recipients experience physical fatigue and reduced activity rather than mental fatigue and reduced motivation."
"These findings have implications for the development of interventions needed to rehabilitate persons after liver transplantation."
Liver Transplant 2006: 12(6): 928-33
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Conservative Government Breaks Campaign Promise to Hepatitis C Victims
hepcan@yahoogroups.com
Courtesy of Sue White
(Originally posted by BC Coalition of People with Disabilities, http://health.groups.yahoo.com/group/hepcan/post)
Media Release
May 23, 2006
On Thursday, May 25, Prime Minister Stephen Harper will be at the Vancouver Fairmont Hotel to attend the Farewell Dinner in honour of John Reynolds, former Conservative MP for West Vancouver-Sunshine Coast. There will probably be a number of British Columbians suffering from hepatitis C, several of whom live in Mr. Reynold's former riding, who will take a moment to reflect on the promise made to them by Mr. Harper and his Conservative Party before they were elected in January.
During the federal election, Steven Harper and his Conservatives pledged that, if elected, they would "immediately compensate all individuals who contracted Hepatitis C from tainted blood." Months later, desperately ill victims who were infected with hepatitis C through transfusions from Canada's blood system and then excluded from the compensation fund set up by the Liberal government are still waiting for help.
While in Opposition, the Conservatives were very vocal about this issue. Conservative MPs rose in the House of Commons to describe the plight of hepatitis C victims in their ridings and question the Liberal government about its failure to provide assistance. One year ago, on April 20, 2005, Conservative Health Critic Stephen Fletcher received the unanimous support of all MPs for his motion to extend compensation to the excluded hepatitis C victims. This was followed during the federal election campaign by the promise of immediate assistance.
Since then the silence has been deafening. Neither the Conservative election promise nor the Conservative Health Critic's unanimously supported motion were reflected in the May 2 federal budget. There was nothing for victims of tainted blood products. Health Minister Tony Clement has not spoken on the issue and his Parliamentary Secretary Steven Fletcher is no longer taking a leadership role on behalf of the hepatitis C victims.
Many of the Canadians who contracted hepatitis C through tainted blood transfusions in the 1980s have been very ill for a very long time. As their health deteriorates they struggle to care for themselves and their families and are unable to afford necessary medication.
In March 2006, the Hepatitis C Compassion Umbrella of Canada (HCCUC) sent a letter to Prime Minister Harper and Health Minister Clement requesting an emergency relief fund to provide immediate financial assistance for those suffering from an advanced stage of hepatitis C (the amount to be subtracted from any future settlement). The only response to this request has been a letter from Prime Minister Harper stating that he is "aware of, and sympathetic to, the hardships suffered by these Canadians."
"The lack of action on this issue is shocking given how vocal the Conservatives were in Opposition and the pledge they made during the federal election," says HCCUC spokesperson Jane Dyson. "The Minister of Health has not responded to our proposal for an interim emergency relief fund, the Conservative government has not fulfilled its campaign pledge, and there has been no concrete help for the hepatitis C victims."
The Canadians who put their trust in Canada's blood supply system and were betrayed continue to wait for assistance from their government. For many of the sickest victims, time is running out. They simply cannot afford to wait any longer.
The HCCUC is a coalition of groups that was formed in 2004. By May, 2006, more than 400 community groups across Canada had endorsed the HCCUC recommendation that the excluded hepatitis victims be given immediate access to the existing government fund.
For more information, contact: Jane Dyson, Tel: 604-872-1278.
Read the report "Compassion for all hepatitis C victims" produced by the Hepatitis C Compassion Umbrella of Canada (HCCUC) as part of an ongoing campaign on behalf of the hepatitis C victims of tainted blood transfusions who were excluded from the federal government compensation fund.
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Lawsuit Filed Against Scarborough Hospital
http://toronto.ctv.ca/
CTV.ca News Staff
A class-action lawsuit has been filed against the Scarborough Hospital on behalf of dialysis patients who may have been infected with Hepatitis B and C.
About 400 people who received dialysis treatment were notified on May 20 they were at risk of contracting the disease.
The lawsuit alleges the hospital, its staff and employees were negligent because "they failed to disinfect the equipment used in the dialysis unit, and failed to implement adequate infection control and safety measures."
Andrew Nosworthy, of Scarborough, commenced a lawsuit on behalf of all dialysis patients who went to Scarborough Hospital for treatment, but he died last week.
The cause of his death is still unclear, according to the law office of Glyn Hotz, a Toronto lawyer involved in the lawsuit.
Hospital officials said only a small number of people had been infected with Hepatitis.
Hepatitis B and C are viral diseases of the liver spread through contact with blood or body fluids. The disease can cause permanent liver damage.
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Two Families Face a Year of Anguish and Uncertainty
SourceURL:http://www.dailyheraldtribune.com
EDMONTON (CP) - Two families face a year of anguish and uncertainty after a pair of teens were poked with a bloody hypodermic needle stashed in a hotel room pillowcase.
Tony Morrison, 15, and Brandon McGrath, 16, were in Edmonton for a Christian youth conference.
Tony's mother Marty Morrison says her son put the pillow behind and felt something poke him in the back.
Brandon grabbed the pillow from Tony after he complained something had poked him and got pricked in the shoulder. When Brandon reached into the pillowcase to figure out what had hurt him, he got pricked again, this time on his finger. The boys were rushed to hospital Friday night. Doctors have told the boys, who are cousins, that they will have to spend the next year getting their blood monitored for viruses like HIV and hepatitis.
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Hepatitis Cases Up in York County
SourceURL:http://www.eveningsun.com
By JENNIFER NEJMAN
For The Evening Sun
Cases of hepatitis C are increasing in York County, according to the state Department of Health.
Hepatitis C is a virus that occurs when blood from an infected person enters the body of someone who is not infected.
Usually, the virus is spread when people share needles while injecting drugs and through tattoos, even though tattoo businesses have cleaned up their acts, said Kimberly Furman, a physician assistant at Gastroenterology Associates of York in York Township.
The disease progresses slowly over decades, and most people do not know they have the virus, Furman said.
"Most people might have done drugs 20 to 30 years ago," she said. "They are commonly the people we see."
Some tell Furman they experimented with intravenous drugs once or twice.
"All it takes is once with the wrong needle," she said. Some research has found that sharing equipment to snort drugs also can lead to a hepatitis C infection, Furman said.
Hepatitis C can lead to inflammation of the liver and chronic liver disease. The virus is the leading reason for liver transplants in the United States and about one-third of people who have HIV also have hepatitis C, according to the state health department.
Joanne Sullivan, director of public health nursing services at the city bureau, compared those numbers with the goal of Health People 2010, a set of national objectives. The goal is one hepatitis C case per 100,000 people. Today, York city is well over that for its population of about 40,000, she said.
York City Health Bureau officials are working with Owen Simwale, the state's hepatitis C coordinator, to find funding for free hepatitis C screenings.
A small group of people who attended an informational session Simwale held Thursday at the Mental Health-Mental Retardation Center in York told him they believed that, if the barrier of the cost of screening was removed for the patients, they would be able to find resources in the community, including health clinics and a network of providers who would help connect patients with the treatment they would need once diagnosed.
City health bureau officials have wanted to offer free services, Sullivan said.
Simwale said there is little federal and state funding for hepatitis C, but he is working to find outside sources for the city.
The problem of hepatitis C infections exists in York, in Pennsylvania and nationally. Hepatitis C's effects are also the No. 1 cause of death in HIV/AIDS patients, Simwale said.
But the disease has not received the widespread attention HIV/AIDS has, said Mark Wessner, a registered nurse with the state health department.
"It's just not out there. It's not in people's faces," Wessner said. "(Hepatitis C) patients didn't get the public push and public outcry that HIV/AIDS got."
Receiving treatment can help a patient avoid the need for a liver transplant, Furman said.
Treatment cannot eliminate all scarring on a liver, but the earlier treatment is given, the more responsive a person will be, she said. Not everyone progresses to the liver disease cirrhosis or cancer, she said.
Furman said the important message is "if you have a risk factor, ask your doctor to be tested."
HEPATITIS ABCs
The hepatitis viruses are diseases of the liver.
Hepatitis A: found in the feces of people with the virus. Symptoms include jaundice, fatigue and abdominal pain. No long-term infection caused by the virus. It's usually spread by hand-to-mouth contact.
How it's spread: Through household contact, sex with infected people and traveling to countries where the virus is common. Hepatitis A was in the news in 2003 when an outbreak was traced to a western Pennsylvania Chi-Chi's restaurant.
Prevention: The best protection is the hepatitis A vaccine. Wash your hands after using the bathroom, changing a diaper and before preparing and eating food.
Hepatitis B: attacks the liver and can cause lifelong infection; cirrhosis, a chronic liver disease; liver failure; liver cancer; and death. Death from chronic liver disease occurs in 15 to 25 percent of chronically infected people.
How it's spread: When the blood of an infected person enters the body of someone who is not infected -- through sex with an infected person without using a condom (the efficacy of latex condoms is unknown, but proper use may reduce transmission), sharing drug needles or equipment, healthcare workers accidentally sticking themselves with needles and from an infected mother to baby during birth.
Prevention: The hepatitis B vaccine is the best prevention. Use latex condoms if you do not have a steady sex partner. Get a blood test for Hepatitis B if you are pregnant. Do not shoot drugs. If you shoot drugs, never share needles or equipment. Do not share razors or toothbrushes -- they may have blood on them. Consider the risks of a tattoo. If you have Hepatitis B, do not donate blood. If you work in healthcare, get vaccinated and follow procedures for handling needles.
Hepatitis C: a disease of the liver that leads to chronic infections in 55 to 85 percent of people infected and chronic liver disease in 70 percent of chronically infected people. It is the leading reason for liver transplants. It can lead to liver cancer and death.
How it's spread: When the blood of an infected person enters the body of a person who is not infected -- through the sharing of drug needles and equipment, needle-stick exposures on the job and from an infected mother to her baby during birth. Also was spread through blood transfusions or solid organ transplants before July 1992.
Prevention: There is no vaccine. Same prevention as hepatitis B regarding drug use and tattoos.
Unlike hepatitis B, hepatitis C is rarely spread through sex. If you have more than one sex partner, it is still recommended that you use latex condoms. York County
Hepatitis C in York County, confirmed reported new cases:
2003: 168 cases
2004: 230 cases
2005: 236 cases
2006: 86 cases so far
Of those, 456 are men and 266 are women.
Sources: state Department of Health, York City Health Bureau, Centers for Disease Control
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May 30th, 2006
Nabi Biopharmaceuticals Provides Regulatory Update on Hepatitis B Liver Transplant Programs
SourceURL:http://www.finanznachrichten.de
ROCKVILLE, Md., May 30 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nachrichten) provided updates today on its progress with regulators toward the licensure of its antibody product to prevent re-infection with hepatitis B in liver transplant patients in the U.S. and Europe.
U.S. Update: Nabi-HB(TM) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous]
The company announced that its Biologic License Application (BLA) for Nabi-HB Intravenous will be reviewed and discussed by the Food and Drug Administration's (FDA) Blood Products Advisory Committee (BPAC) at a meeting scheduled for July 13, 2006 in Gaithersburg, Maryland. The BPAC meeting represents the culmination of lengthy discussions between the FDA and Nabi Biopharmaceuticals concerning the data that might be accepted to support the BLA. BPAC is expected to render its view as to whether the BLA for Nabi-HB Intravenous for the prevention of recurrence of hepatitis B after liver transplant should be approved based on a combination of prospective and retrospective clinical data. Nabi Biopharmaceuticals believes that such data should be sufficient for approval given Nabi-HB's widely accepted off-label use in liver transplant patients.
Currently, Nabi-HB(R) [Hepatitis B Immune Globulin (Human)] is licensed in the U.S. to provide protection from infection after accidental exposure to the hepatitis B virus. However, it is acknowledged as a standard-of-care in liver transplant patients at risk for re-infection. Because this use of the product is off-label, there are no FDA-approved guidelines for how such a product should be dosed to optimize patient outcomes. If approved, the intravenous formulation of Nabi-HB would be the only product in the U.S. indicated for preventing re-infection of the transplanted liver in HBV-positive patients. Previously, the FDA granted orphan drug designation to Nabi-HB Intravenous. Nabi Biopharmaceuticals believes the BPAC meeting will not only advance a thorough consideration of the relevant clinical data, it will also provide the opportunity to establish clear standards for how the product should be used in liver transplant patients. The company is particularly encouraged about the outcome for this meeting because the same clinical data set was acceptable for licensure in Europe.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "We believe the benefits from using Nabi-HB in liver transplant patients have been amply demonstrated in thousands of liver transplant patients. The clinical data we have compiled supports using Nabi-HB at the time of transplant, a time when no other drugs can be used effectively. The data also demonstrate the importance of using Nabi-HB in combination with anti-virals on a long-term maintenance basis to prevent re-infection. If they approve the product's use in these patients, the FDA would be providing physicians with the information they need to make the best treatment and dosing decisions for their patients. In addition, we believe this indication will build physician awareness and understanding about the positive long-term prognosis for liver transplants in hepatitis B-positive patients. That in turn may help to increase the numbers of patients helped each year."
EU Update: HEBIG(TM) [Hepatitis B Immune Globulin (Human) Intravenous]
The company also announced that as a result of discussions about its Marketing Authorization Application (MAA) for HEBIG with regulators of the Reference Member State (RMS), it has made certain improvements in the formulation of the product to comply with EU standards. As a result of this agreement with regulators of the RMS, the company has voluntarily withdrawn its MAA in Europe while it compiles 12 months of stability data for the reformulated product. Nabi Biopharmaceuticals expects to resubmit its MAA with this data during the first half of 2007. It is important to emphasize that all other pieces of the MAA have already been reviewed and accepted by the RMS and that the RMS has committed to an accelerated turn-around upon re- submission of the MAA. The company believes that this new formulation will yield several benefits for the intravenous product in Europe and the U.S. These improvements will increase the product's shelf-life, benefiting hospital pharmacies and product distributors. In addition, the formulation changes are designed to enhance the product's safety profile by providing additional viral inactivation benefits and further differentiating HEBIG from other hepatitis B immune globulin products. Finally, these changes are a first step in the company's 2006 program to capture yield improvements in the production of polyclonal antibody products and product candidates like Nabi-HB, Civacir(R) [Hepatitis C Immune Globulin (Human)], Altastaph(R) [Staphylococcus aureus Immune Globulin Intravenous (Human)] and IVIG in its biological manufacturing facility in Florida. When fully implemented, these improvements are intended to leverage the value of the full supply chain within Nabi Biopharmaceuticals, from sourcing plasma at its antibody collection centers, through production in its plant, and finally to the distribution of final products to hospitals and distributors in the U.S. using its sales force.
Dr. Rasmussen continued, "The intravenous formulation of HEBIG will provide competitive differentiation from other licensed products approved in the European market today. Its launch in Europe will increase the opportunity to leverage our integrated manufacturing platform. We are encouraged that European regulators have offered that, upon this resubmission, the MAA will be granted an immediate and accelerated review, as the other components of the application, that is the preclinical, toxicological and clinical pieces, as well as other parts of the quality dossier, have been reviewed and accepted by the regulators. We are particularly pleased that the RMS agrees that the clinical data are acceptable for licensure."
A Significant Medical Need
Nabi-HB Intravenous (U.S.) and HEBIG (Europe) are being developed to prevent hepatitis B disease in HBV-positive liver transplant patients. According to the World Health Organization (WHO), of the two billion people who have been infected with HBV, more than 350 million have chronic infections and are at high risk of death from cirrhosis of the liver and liver cancer; and as a result, many of these patients are in need of a liver transplant. Recurrence of HBV infection following liver transplant is almost universal if left untreated, and most often leads to rapid deterioration of liver function, often resulting in death or the need for re-transplantation. The U.S. Centers for Disease Control (CDC) currently estimates that in the U.S. alone there are approximately 1.2 million chronic hepatitis B carriers, 8,500 new hepatitis B infections per year, and 5,000 individuals who die annually from hepatitis B or its complications.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Hepatitis B remains a serious, global healthcare threat. The commitments from regulators that we have announced today significantly advance our efforts to make this safe and efficacious product available to patients in the U.S. and Europe. We believe that the steps we will undertake for HEBIG will also build added value in this important and highly needed product, and may even contribute to an increased number of transplants that take place because of the benefits it can provide to patients. In addition, the formulation enhancements will advance our efforts to build the value of our integrated supply chain for the manufacture and distribution of not only Nabi-HB and HEBIG, but also our portfolio of high- value products including Civacir and Altastaph, as well as IVIG."
Nabi-HB Intravenous and HEBIG are purified human polyclonal antibody products manufactured using plasma collected from donors who have been previously vaccinated with a hepatitis B vaccine. This plasma is sourced at Nabi Biopharmaceuticals' antibody collection centers and the product is manufactured at the company's state-of-the-art fractionation facility in Florida. When administered, the anti-hepatitis B antibodies contained in Nabi-HB Intravenous and HEBIG bind to the hepatitis B virus and trigger its clearance by the body's immune system.
Nabi-HB, currently marketed in the U.S., provides passive immunization, or short-term protection, following exposure to the hepatitis B virus. Nabi-HB is indicated for the treatment of:
* acute exposure to blood containing hepatitis B surface antigen (HBsAg)
* perinatal exposure of infants born to HBsAg-positive mothers
* sexual exposure to HBsAg-positive persons
* household exposure to persons with acute HBV infection
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo(R) (calcium acetate), Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in our core business areas: Gram-positive bacterial infections, hepatitis and transplant, kidney disease (nephrology) and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php . The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit our Website at: http://www.nabi.com/ .
Forward-Looking Statement
Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements about our products in development, the market for such products, and regulatory approval of our product candidates. You can identify these forward-looking statements because they involve our expectations, beliefs, intentions, plans, projections, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to the company's ability to advance the development of products currently in the pipeline or in clinical trials; maintain the human and financial resources to commercialize current products and bring to market products in development; obtain regulatory approval for its products in the U.S., Europe or other markets; successfully develop, manufacture and market its products; successfully partner with other companies; realize future sales growth for its biopharmaceutical products; maintain sufficient intellectual property protection; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and Quarterly Report on Form 10-Q for the Quarter ended April 1, 2006 filed with the Securities and Exchange Commission.
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Woman Graduates from College, Gets Liver Transplant
SourceURL:http://www.idahostatesman.com/
LEWISTON -- A 53-year-old Lewiston woman graduated from college and received a liver transplant just days apart this month, marking what she hopes will be the end of Hepatitis C-induced lethargy that left her unable to work.
Mollie Flerchinger was featured in a May 10 article in the Lewiston Tribune focusing on her impending graduation from Boise State University with a nursing degree -- something she'd been working on for 30 years, in part because of her illness -- and her agonizing wait for a new liver.
A person who hasn't yet been identified by the newspaper sent the article to a transplant surgeon at Portland's Oregon Health & Science University. The surgeon helped expedite her transplant, moving her up on a waiting list.
After the May 18 transplant, Flerchinger is staying in Portland for up to two months. She's receiving medication to prevent her body from rejecting the new organ.
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May 31st, 2006
Hepatitis Scare for 5,000 Patients
SourceURL:http://icnorthwales.icnetwork.co.uk
FIVE thousand patients of a Gwynedd health worker diagnosed with hepatitis C were today receiving letters offering blood tests.
At risk patients were given a helpline number to book an appointment at one of 47 special clinics in the county.
The tests cover hepatitis B, hepatitis C and HIV.
The clinics start on Monday, June 5 and remain open until July 17.
Public health director Dr Sandra Payne said: "The risk of a health care worker passing on the hepatitis C virus is very low indeed.
"It can only happen if the health care worker's blood gets into the patient's bloodstream."
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June 1st, 2006
New Findings in Hepatitis C Virus Described from the United States, Canada and Germany
SourceURL:http://www.therapeuticsdaily.com
Data on hepatitis C virus are outlined in reports from the United States, Canada and Germany.
Study 1: According to recent research from the United States, early interferon therapy produces sustained hepatitis C virus (HCV) virologic response.
"Pegylated interferon therapy has not been adequately evaluated in acute HCV infection. This randomized trial assessed the efficacy, safety, and timing of pegylated interferon alfa-2b for treatment of acute hepatitis C," wrote S.M. Kamal and colleagues, Harvard University.
They explained, "One hundred seventy-five patients acutely infected with HCV were screened. Patients whose infection did not spontaneously resolve by week 8 were randomized to once weekly peginterferon alfa-2b monotherapy (1.5 mcg/kg per week) started at weeks 8, 12, or 20 for a duration of 12 weeks. The primary endpoint was undetectable HCV RNA 24 weeks after the end of treatment (sustained virologic response [SVR])."
"All patients were followed for 48 weeks after cessation of therapy. One hundred twenty-nine subjects started treatment at week 8 (group A, n=43), week 12 (group B, n=43), or week 20 (group C, n=43). By using an intent-to-treat analysis, the overall SVR rate was 87%. The SVR rates were 95%, 92%, and 76% with treatment onset at 8, 12, and 20 weeks, respectively. Overall, SVR rates were better for patients infected with genotypes 2, 3, and 4 than those infected with genotype 1.
"Earlier initiation of therapy improved SVR rates for patients infected with genotype 1 with high viral load. Peginterferon alfa-2b was well tolerated. Subjects with SVR maintained undetectable HCV RNA 48 weeks after therapy," wrote the researchers.
The scientists concluded, "Peginterferon alfa-2b monotherapy in acute hepatitis C induces high sustained virologic response rates, prevents chronic evolution, and is well tolerated. Initiation of treatment at week 8 or 12 results in higher sustained virologic rates than initiation at week 20."
Kamal and colleagues published their study in Gastroenterology (Peginterferon alfa-2b therapy in acute hepatitis C: Impact of onset of therapy on sustained virologic response. Gastroenterology, 2006;130(3):632-638).
For additional information, contact S.M. Kamal, Harvard University, Beth Israel Deaconess Medical Center, School of Medicine, Liver Diseases Center, 4 Blackfan Circle, Boston, MA 02115, USA.
Study 2: According to scientists from Canada, hepatitis C virus treatment efficacy can be predicted.
"In the past, antiviral therapy has been given to 15% to 30% of patients infected with hepatitis C virus (HCV). The efficacy of therapy has recently improved with the addition of ribavirin and pegylated interferon. The aim of the present study was to identify the clinical, socioeconomic and health-system predictors of antiviral treatment for HCV," wrote M. Witkos and colleagues, University of Toronto. "A retrospective analysis of compensation claims data of patients who acquired HCV through blood transfusions between 1986 and 1990 was performed. The patients consisted of 2456 Canadian HCV-positive individuals."
The researchers wrote, "The authors reviewed narrative comments from physicians, and constructed univariate and multivariate logistic regression models, using receipt of antiviral therapy with interferon or interferon/ribavirin as the primary outcome. Of the 2456 patients, approximately 30% appeared to be eligible, but only 16% received treatment.
"Univariate analyses suggested that the disease severity, age, HIV status and province of residence were associated with the likelihood of receiving treatment (p<.01). The final, multivariable model indicated that in patients with HCV. Intermediate disease severity (eg, fibrosis, p<.0001); middle age (p<.0001); HIV-negative status (p<.0001); and province of residence (Quebec, p<.0001; and Saskatchewan, p<.0001) were independent predictors of treatment."
"Narrative comments of physicians emphasized the importance of age, HIV status and patient preferences in clinical decision-making. Given the efficacy and cost-effectiveness of current antiviral therapy, treatment rates of HCV patients may be suboptimal," reported the authors.
They concluded, "Further work is required to understand barriers to treatment related to geography, organization of medical care, age, medical provider and patient preferences."
Witkos and colleagues published their study in Canadian Journal of Gastroenterology (Predictors of antiviral therapy in a post-transfusion cohort of hepatitis C patients. Can J Gastroenterol, 2006;20(2):107-111).
For additional information, contact M.D. Krahn, University of Toronto, Toronto General Hospital, Department of Health Policy Management & Evaluation, 200 Elizabeth St., EN 14-207, Toronto, ON M5G 2C4, Canada.
Study 3: A study from Germany has reported that early monotherapy with pegylated interferon alpha-2b for acute hepatitis C infection leads to high virological response rates.
"Early treatment of acute hepatitis C with interferon alpha-2b for 24 weeks prevents chronic infection in almost all patients. Because pegylated interferons have replaced conventional interferon in the therapy of chronic hepatitis C, the aim of this study was to analyze the efficacy of an early treatment of acute hepatitis C with peginterferon alpha-2b," wrote J. Wiegand and colleagues, Hannover Medical School.
They continued, "Between February 2001 and February 2004, 89 individuals with acute HCV infection were recruited at 53 different centers in Germany. Patients received 1.5 mcg/kg peginterferon alpha-2b for 24 weeks; treatment was initiated after a median of 76 days after infection (range 14-150)."
The researchers explained, "End-of-treatment response and sustained virological response were defined as undetectable HCV RNA at the end of therapy and after 24 weeks of follow-up, respectively.
"In the total study population, virological response was 82% at the end of treatment and 71% at the end of follow-up. Of 89 individuals, 65 (73%) were adherent to therapy, receiving 80% of the interferon dosage within 80% of the scheduled treatment duration. End-of-treatment and sustained virological response rates in this subpopulation. were 94% and 89%, respectively."
"A maximum Ala aminotransferase level of more than 500 U/L prior to therapy was the only factor associated with successful treatment," the scientists explained.
"In acute HCV infection, early treatment with peginterferon alpha 2b leads to high virological response rates in individuals who are adherent to treatment. The high number of dropouts underlines the importance of thorough patient selection and dose monitoring during therapy," concluded the authors.
"Thus," they further noted, "future studies should identify factors predicting spontaneous viral clearance to avoid unnecessary therapy."
Wiegand and colleagues published their study in Hepatology (Early monotherapy with pegylated interferon alpha-2b for acute hepatitis C infection: the HEP-NET Acute-HCV-II Study. Hepatology, 2006;43(2):250-256).
Additional information can be obtained by contacting M.P. Manns, Hannover Medical School, Department of Gastroenterology, Hepatology & Endocrinology, Carl Neuberg Str 1, D-30625 Hannover, Germany.
This article was prepared by World Disease Weekly editors from staff and other reports.
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June 2nd, 2006
Treating Obesity May Improve the Efficacy of Therapy for Hepatitis C
http://www.interscience.wiley.com
/journal/hepatology
According to a new study, obese patients chronically infected with the hepatitis C virus (HCV) and treated with combination drug therapy may have better outcomes if the underlying abnormalities caused by excessive fat tissue are corrected. Weight loss, medications to decrease insulin resistance and extending duration or dosage of therapy are strategies that may improve the efficacy of therapy.
The results of this study appear in the June 2006 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at www.interscience.wiley.com/journal/hepatology.
HCV is one of the leading causes of chronic liver disease worldwide, affecting 3 percent of the world’s population. In the U.S. alone 4.1 million people have been infected with HCV, and up to 85 percent of those are chronic carriers of the virus. Up to 70 percent of chronic carriers will go on to develop some other form of chronic liver disease, from mild liver enzyme abnormalities to cirrhosis and liver cancer. While there is no vaccine for HCV, the current optimal treatment is combination therapy with peginterferon alfa (an immune stimulant) and ribavirin (an inhibitor of viral replication). However, this will cure only 55 percent of patients. One of the risk factors for treatment failure is obesity.
Obesity itself is linked to the disruption of hormone signaling pathways that affect cell function and to abnormal levels of circulating proteins and sugars. In other words, obesity is associated with a wide range of metabolic changes that affect multiple cellular and organ functions. This biochemical disregulation is linked to serious chronic medical conditions, such as heart disease, diabetes, and non-alcoholic fatty liver disease.
Given the association between obesity and metabolic abnormalities, Michael R. Charlton, M.D. of the Division of Gastroenterology and Hepatology at the Mayo Clinic and Foundation in Rochester, MN and coauthors reviewed several mechanisms by which obesity may interfere with the treatment of chronic HCV and recommend management strategies for obese patients.
The authors identify three possible ways by which obesity may interfere with peginterferon alpha and ribavirin activity. First, fat tissue actively secretes hormones that can modulate the immune system. Increases in fat tissue may disregulate immune pathways peginterferon targets, rendering the drug ineffective. Second, obesity causes insulin resistance which itself leads to the accumulation of fat in the liver. The greater the accumulation of fat in the liver, the greater the risk of fibrosis, or scar tissue formation, that alters liver function and blood flow, often permanently. Because HCV also causes liver cells to not respond to insulin, obesity may simply compound the problem and worsen liver disease. Third, fat tissue reduces the amount of peginterferon circulating in the body. The decreased circulation of the drug may also weaken peginterferon’s stimulation of the immune system against HCV.
To address all of these mechanisms, the authors make three treatment recommendations. First, weight loss to reduce fat tissue would address all three hypothesized mechanisms. Weight loss in obese HCV patients is already associated with improved liver biopsy results and liver enzyme levels. Second, treatment with drugs that improve cellular sensitivity to insulin, such as the diabetes drugs metformin or pioglitazone, would lead to reduced fat accumulation in liver cells and might reverse disease progression. Third, increasing the dosages or the duration of combination therapy may increase circulating drug levels and improve drug efficacy.
“Treatment strategies that focus on improving underlying metabolic factors associated with poor response to combination therapy are thus more likely to overcome the low sustained viral response rates often observed in obese patients infected with HCV,” conclude the authors.
Article: “Impact of Obesity on Treatment of Chronic Hepatitis C,” Michael R. Charlton, Paul J. Pockros, Stephen A. Harrison, Hepatology; June 2006 (DOI: 10.1002/hep.21239).
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Education and Guidelines Needed for Genetic Testing in Liver Disease
http://www.interscience.wiley.com
/journal/hepatology
A new commentary on genetic testing suggests that professional organizations and physicians involved in liver diseases should be actively engaged in developing evidence-based genetic testing guidelines, community education programs, and clinical practice recommendations. Professional and popular understanding of assessing risks for genetic diseases has not kept pace with epidemiological and biomedical advances. Furthermore, misinterpretation of results poses clear dangers to individual human rights, patient management and research.
The commentary is published in the June 2006 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at www.interscience.wiley.com/journal/hepatology.
Conventional medical ethics is based on doctor-patient confidentiality of existing medical conditions. That is, no medical information can be released by the physician unless required by law, including public health reporting requirements, or released with permission from the patient. With increasing epidemiological study of inherited diseases, an emergent ethical and legal principle, “the duty to warn,” has been gaining acceptance in medical, labor management and legal circles. For example, medical malpractice suits in the U.S. have been won on this tenet and, though rare, people have been turned away from employment because of their test results.
The recent proliferation of inexpensive, commercial blood tests to identify disease-associated genes has made a powerful risk assessment tool accessible to physicians, employers, and individual patients. However, few necessarily understand its benefits and limitations to interpret the test results appropriately.
According to the authors of the commentary, Dirk J. van Leeuwen, M.D., Ph.D. and James L. Bernat, M.D. of the Dartmouth Medical School/Dartmouth Hitchcock-Medical Center in Lebanon, NH, the combination of availability, misunderstanding the genetic tests’ limitations, and societal fears undermine patient benefits of testing. However, mistrust is not necessarily misplaced. Individuals and societies unhindered by ethical guidelines and driven by quasi-scientific prejudices have long used genetic traits to abuse, enslave, and commit genocide. Mistrust is so entrenched, that the U.S. Centers for Disease Control reports that 21 percent of potential research subjects refuse to donate blood or tissue for future medical research.
Sequencing the human genome has also changed the genetics debate from issues such as disease screening, individual discrimination, and group prejudice to include the ethics of gene manipulation, cloning, embryonic genetic diagnosis and gene banking.
At a more practical level, the authors ask, how different from other medically sensitive information, such as laboratory tests or diagnosis, is genetic data. “The novel feature of genetic information is the increased potential that the person carrying a specific gene (mutation) may develop a health problem that can be identified prior to any other test abnormality or clinical symptom,” the authors write. It is this “potential” which is open to interpretation and misinterpretation. The authors add that “the disease manifestation (phenotypic expression, penetrance) is much less predictable than generally assumed.”
To address these shortcomings in the science and society’s understanding of the science, the authors propose that professional organizations, such as the AASLD, collaborate with patient advocacy groups, to develop and deliver comprehensible educational messages about genetic testing based on facts. “The impact of such an agenda could be considerable,” they write. “Education on the applications of genetic information should start with a focus on current and future generations of scientists and clinicians,” conclude Drs. van Leeuwen and Bernat. Ultimately, the target audience should not just be physicians and hospitals, but also the public at large.
Article: “Ethical, Social and Legal Implications of Genetic Testing in Liver Disease,” Dirk J. van Leeuwen, James L. Bernat, Hepatology; June 2006 (DOI: 10.1002/hep.21206).
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Compensation Said to Be Close for 'Forgotten Victims' of Tainted Blood
http://www.canada.com/
Canadian Press
OTTAWA (CP) - The federal government may be close to announcing a compensation package for the so-called forgotten victims of tainted blood.
A source close to the talks says funding could be in the same range as a separate package announced in 1998 for other victims, or about $1.1 billion.
About 5,500 people who were infected with hepatitis C through blood transfusions before 1986 or after 1990 are expected to receive substantial payments under the new deal.
The original deal was restricted to people infected between 1986 and 1990, since the government of the day claimed it could not have prevented infections outside that period.
That argument was refuted as documents surfaced showing that screening tests available before 1986 could have prevented many infections.
In opposition, the Tories pressed the government to provide equal compensation for all victims, regardless of when they were infected.
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Help Coming for Hep C Victims: Sources
DENNIS BUECKERT
CANADIAN PRESS
OTTAWA — The federal government is close to announcing a compensation package for the "forgotten victims" of tainted blood, sources say.
Approximately 5,500 people who were infected with hepatitis C before 1986 or after 1990 are expected to receive substantial payments under the deal.
Funding could be in the same range as the original $1.1-billion federal-provincial package announced in 1998, said one source, speaking on condition of anonymity.
The original deal was restricted to people infected between 1986 and 1990, since the government of the day claimed it could have done nothing to prevent infections outside that period.
That argument was refuted as documents surfaced showing that screening tests available before 1986 could have prevented many if not most of the infections.
In opposition, the Conservatives pressed the government to provide equal compensation for all victims, regardless of when they were infected. The new package is expected give the excluded victims at least as much as those in the 1986-1990 group.
"I think we'll probably have good news within the next week or so," said a source in the hepatitis C community, who praised the Conservative government for moving on the issue.
"They've really done their job this time. I want to give them kudos for working diligently to ensure we're going to get help to people as soon as possible."
A $3.8-billion class-action lawsuit against the federal government will be dropped when the package is announced, said the source.
Unlike the 1998 compensation package, there is no provincial participation. Legal action is expected to continue against some provinces that have not compensated all victims.
The new fund will be structured differently from the 1998 deal, which resulted in much of the money going to legal fees.
Other fallout from the tainted-blood scandal will continue, including criminal trials of officials involved in managing the blood system, and a $1-billion suit over the distribution of contaminated blood from an Arkansas prison.
An RCMP investigation into the Arkansas blood is also continuing.
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Largest U.S. Hepatitis C Trial Provides Insight Into Optimizing Treatment
http://www.endonurse.com/
LOS ANGELES -- Researchers who participated in the WIN-R trial, the largest hepatitis C study ever conducted in U.S. patients, reported key factors affecting treatment outcomes in five data presentations at the Digestive Disease Week (DDW) annual meeting, and provided important insights for optimizing treatment with PEG-INTRON® (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) combination therapy for patients with chronic hepatitis C virus (HCV) infection, a potentially deadly liver disease. WIN-R (Weight-Based Dosing of PEG-INTRON and REBETOL), a community-based trial, involved more than 4,900 patients at 225 centers across the United States.
In the WIN-R study, patients achieved significantly better outcomes overall with weight-based dosing of ribavirin in combination with PEG-INTRON as compared to the combination using a flat dose of ribavirin. These results included significantly higher rates of sustained virologic response (SVR),1 the standard measure of treatment success, for patients overall (44 percent vs. 41 percent; p=0.01), and for patients with HCV genotype 1, the most difficult type to treat (34 percent vs. 29 percent; p=0.004). The study also showed that, for patients infected with HCV genotype 2 or 3, a shorter, 24-week course of therapy was as effective as the standard 48-week course, with better tolerability.2
Researchers presenting WIN-R data at DDW examined the effect specific predictive factors had on the likelihood of patients achieving an SVR, including factors such as HCV genotype and pretreatment viral load, degree of fibrosis or cirrhosis, cigarette smoking and prior HCV treatment experience at the study sites.
"These WIN-R findings help us better understand how to optimize hepatitis C treatment for our patients and how certain patient characteristics affect response to therapy in real-world community settings," said principal investigator Ira M. Jacobson, MD, Vincent Astor professor of Clinical Medicine at Weill Medical College of Cornell University, and Chief of the Division of Gastroenterology and Hepatology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City. "These results, in the large number of patients who participated in this study, provide a wealth of information that not only help confirm what many treating physicians have come to know in their everyday practice, but also add exciting new information that gives physicians added confidence that they can optimize the chance for cure in their hepatitis C patients."
Treating U.S. HCV patients can be especially challenging as they tend to have disease characteristics associated with poor treatment response, including a high prevalence of HCV genotype 1, high viral load and advanced liver fibrosis (scar tissue). Other factors such as age, high body weight and African-American ethnicity also have been shown to be associated with poor response to treatment.
In the WIN-R study, 4913 patients were randomized to receive weight-based PEG-INTRON (1.5 mcg/kg weekly) in combination with REBETOL given either as a flat dose (800 mg daily) or a weight-based dose (800 mg, 1,000 mg, 1,200 mg or 1,400 mg daily for body weights of less than 65 kg, 65 to 85 kg, 86 to 105 kg, or 106 to 125 kg, respectively). Patients with HCV genotype 1 were treated for 48 weeks; those with genotype 2 or 3 were treated for 48 weeks or 24 weeks. Patients in the treatment arms were evenly matched for gender, age, body weight, genotype, viral load and stage of liver fibrosis.
Serving with Jacobson as co-principal investigator of the WIN-R study is Robert S. Brown Jr., MD, MPH, associate professor of Medicine and Surgery at Columbia University College of Physicians and Surgeons, and chief of Clinical Hepatology and Medical Director of the Center of Liver Disease and Transplantation at New York-Presbyterian Hospital/Columbia University Medical Center. Drs. Jacobson and Brown are also co-directors of New York-Presbyterian Healthcare System's Liver Clinical Trials Network (LCTN).
Jacobson also is medical director of the Center for the Study of Hepatitis C, a unique interdisciplinary center established jointly by The Rockefeller University, New York-Presbyterian Hospital and Weill Cornell Medical College in New York City.
WIN-R is an investigator-initiated clinical study supported by Schering-Plough Corporation and monitored by Schering-Plough Research Institute as part of a post-marketing commitment to the U.S. Food and Drug Administration (FDA). PEG-INTRON and REBETOL are registered trademarks of Schering-Plough.
Hepatitis C is the most common blood-borne infection in America, affecting approximately 4 million people or about one in every 50 adults. Chronic hepatitis C can cause cirrhosis, liver failure and liver cancer. It has been estimated that at least 20 percent of patients with chronic hepatitis C develop cirrhosis, and a smaller percentage of patients with chronic disease develop liver cancer. Patients with chronic hepatitis C and related cirrhosis are 100 times more likely to develop liver cancer than uninfected persons.3 About half of all cases of primary liver cancer in the developed world are caused by hepatitis C, and hepatitis C related liver disease is now the leading cause for liver transplants.4
References
1) Sustained virologic response (SVR) is defined as undetectable virus (HCV-RNA) levels in the blood at 6 months after the end of therapy.
2) Jacobson I, Brown Jr. R, Freilich B, Afdahl N, Kwo P, Santoro J, Becker S, Wakil A, Pound D, Godofsky E, Strauss R, Bernstein D, Flamm S, Bala N, Araya V, Davis M, Monsour H, Vierling J, Regenstein F, Balan V, Dragutsky M, Epstein M,. Herring RW, Rubin R, Galler G, Pauly MP, Griffel LH, Brass CA, the WIN-R Study Group. Weight based ribavirin dosing (WBD) increases sustained viral response (SVR) in patients with chronic hepatitis C (CHC): final results of the WIN-R study, a U.S. community-based trial. Oral presentation at: 56th Annual Meeting of the American Association for the Study of Liver Diseases, San Francisco, CA, Nov 11-15, 2005.
3) Ince N, Wands JR. The increasing incidence of hepatocellular carcinoma. N Engl J Med 1999 March 11;340:10.
4) Centers for Disease Control and Prevention. Recommendations for prevention and treatment of hepatitis C virus (HCV) and HCV-related chronic disease. MMWR Weekly Report 1998 Oct. 16;1.
Source: New York-Presbyterian Hospital/Weill Cornell Medical Center
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