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Alan Franciscus
Editor-in-Chief
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In This Issue:
• 1.5 Million Medical Centre to 'Clean Up' Redfern
• BioPartners Submits an Application for Approval of the First Biosimilar Recombinant Interferon alpha for Hepatitis C
• Patients with Hepatitis C with Long-Term Responses to Interferon Have Low Rate of Liver Cancer
• Gangrene Caused Death of Healthy Liver Donor
• Roche and Pharmasset Join Forces to Develop New Generation of Hepatitis C Therapies
• McGreevey Allows Needle Exchanges in 3 Cities for HIV Prevention
• PEG-INTRON Studied in a Wide Range of Hepatitis C Patient Populations
• New Data on Most Prescribed Hepatitis C Therapy Pegasys to Be Presented at American Association for the Study of Liver Diseases Meeting
• Governments Urged to Start Prison Needle Exchanges
• Utah County Considers Hepatitis Shots for Food Workers
• Keeping Organ, Tissue Transplants Safe
• HIV, Hepatitis C Prevalence in Canadian Prisons Presents 'Clear' Health Risk
October 24th, 2004
1.5 Million Medical Centre to 'Clean Up' Redfern
SourceURL:http://www.smh.com.au
$1.5 million medical centre to 'clean up' Redfern
The NSW government's proposal to open a $1.5 million health centre in Redfern would clean up the troubled inner-Sydney suburb, NSW Premier Bob Carr said today.
An existing needle van at The Block in Redfern would be replaced with the new centre on Lawson Street, Mr Carr said.
He said the new centre would also address the critical issue of indigenous health.
"It will deliver a range of health services to this disadvantaged area," Mr Carr said.
"Our goal is to clean up the area to see that it functions better, but to move carefully and carry the support of the community with us."
The move comes eight months after the death of Aboriginal teenager TJ Hickey and ensuing riots on the suburb's streets.
Under the government's plans, drug users would continue to get new syringes and needles, but would also have access to drug and alcohol specialists.
Health Minister Morris Iemma said the new centre would provide mental health services, rehabilitation, counselling, postnatal care and legal support services.
More importantly, it would work to crack down on the spread of HIV and hepatitis, he said.
"All of the international evidence shows that cities that have needle exchange programs have a lower prevalence of HIV and Hepatitis C infections," he said.
Mr Carr said the government had taken into account community concern in Redfern - a known haven for drug dealers and users - about whether needle exchange programs simply led to more people shooting up on the streets.
"While I understand some people's reservation about the needle and syringe program, as a community we must recognise that this has resulted in Australia having some of the lowest HIV and hepatitis C rates in the world," he said.
Mr Carr refused to say if the new centre would reduce the prevalence of heroin on Redfern streets.
"When it comes to heroin I am not confident about anything," he said.
"It's a poisonous addictive substance. We've got to ease the people who are using it off the substance and protect their health in the meantime.
"Don't ask me to make bold predictions when it comes to people who are dependant on this filthy, rotten, white powder."
Mr Iemma said the Health Department was finalising the purchase of the premises and would start consulting the Aboriginal community and Sydney City Council about the issue.
AAP
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October 25th, 2004
BioPartners Submits an Application for Approval of the First Biosimilar Recombinant Interferon alpha for Hepatitis C
SourceURL:http://www.newratings.com
BioPartners Submits an Application for Approval of the First Biosimilar Recombinant Interferon alpha for Hepatitis C
ZUG, Switzerland, October 25 /PRNewswire/ -- BioPartners, a global biopharmaceuticals company and one of the leaders in the emerging field of competitively priced biosimilar products has submitted a marketing authorisation application (MAA) to the European Medicines Evaluation Agency (EMEA) for its interferon alpha product.
The application is currently being evaluated and if approved, BioPartners' interferon alpha may be available for the treatment of Hepatitis C in Europe as early as 2005.
Commenting on the submission, Professor Christian Trepo, Chief of the Hepatogastroenterology Unit at Hotel-Dieu Hospital in Lyon, France said "The incidence of Hepatitis C is growing on a worldwide basis and is increasingly becoming a burden on healthcare systems. The introduction of a cost-effective interferon alpha in the Western world may enable us to treat more patients and thereby reduce the potential deleterious outcomes of this disease"
Hepatitis C is a blood-borne infectious disease of the liver and is transmitted through body fluids, primarily blood or blood products, and by sharing needles. In many patients, the mode of transmission is unknown. Unfortunately, most people infected with hepatitis C are unaware of it because it may take years for symptoms to develop and it is therefore sometimes referred to as the "hidden epidemic". Hepatitis C chronically infects an estimated 170 million people worldwide (three percent of the world's population), with as many as 180,000 new cases occurring each year. It is the leading cause of cirrhosis and liver cancer and one of the most common reasons for liver transplants in Europe and the U.S. The standard treatment for Hepatitis C is recombinant interferon alpha in combination with ribavirin. If left untreated, hepatitis C can be fatal for some patients.
Headquartered in Zug, Switzerland, BioPartners (www.biopartners.com) is a global biopharmaceuticals company and a leader in the emerging field of multi-source biopharmaceuticals. BioPartners' mission is to develop patentable and innovative formulations of "first generation" biopharmaceuticals as well as advanced delivery systems that may improve patient compliance to its product portfolio. BioPartners is developing a comprehensive range of biopharmaceutical products that may offer life-saving therapeutic benefits across many therapeutic areas, including oncology, virology, haematology, endocrinology and neurology.
Notes to Editors:
BioPartners was founded by Global Healthcare Partners and Credit Suisse First Boston. Global Health Care Partners currently consists of some of the most respected and recognised figures in the international pharmaceutical industry. These include Henry Wendt, former Chairman of SmithKline Beecham and current Non-Executive Director of BioPartners and Ted Roberts, former Head of Pharmaceuticals of Merck KGaA and current Chairman of BioPartners.
BioPartners has partnered with LG Life Sciences, the leading South Korean manufacturer of biopharmaceuticals and German manufacturer Rentschler Biotechnologie, for the development and manufacture of its portfolio of drugs.
BioPartners GmbH
For further information on BioPartners please contact: Shairose Ebrahim at Zaebra Consulting: Tel: +44-(0)207-536-9833, Mobile: +44-(0)7930-336720, Email: shairose@zaebraconsulting.com
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October 26th, 2004
Patients with Hepatitis C with Long-Term Responses to Interferon Have Low Rate of Liver Cancer
SourceURL:http://www.Cancer
Consultants.com
According to results recently published in the journal Gut, patients with hepatitis C who have long-term responses to treatment with interferon have rates of liver cancer comparable to that of the general public.
Liver cancer is one of the most common types of cancer in the world. However, since its prevalence is much more common in the Eastern world compared to the Western world, most information regarding the disease has been established from studies conducted in that part of the world. The most common type of liver cancer, hepatocellular carcinoma, is characterized by cancer that starts in cells of the liver and can spread through blood and lymph vessels to different parts of the body. The liver is the largest organ in the body and is responsible for over 500 functions, including the secretion of glucose, proteins, vitamins and fats; the production of bile; the processing of hemoglobin; and the detoxification of numerous substances.
Infection with the hepatitis C virus increases a patient s risk of developing hepatocellular cancer. Researchers continue to evaluate optimal management of hepatitis C, in order to reduce the risk of developing hepatocellular cancer, as well as diminish other damage to the liver that is caused by hepatitis C. Long-term treatment with the biologic agent interferon has demonstrated effective control of hepatitis C in patients infected with the virus. However, not all individuals respond to treatment with single-agent interferon. Research has focused not only on different options for treatment of hepatitis C, but also the long-term efficacy of chronic treatment with interferon in infected patients. Furthermore, researchers have begun to evaluate possible differences in treatment outcomes between patients in the Eastern and Western worlds.
A recent multi-institutional study including several countries from Europe evaluated the results of 8 clinical trials evaluating the effectiveness of long-term therapy with interferon in patients diagnosed with hepatitis C and its ability to help prevent hepatocellular cancer. This study included 336 patients who had been diagnosed with hepatitis C and were followed for over 4 years. Patients were treated with single-agent interferon; 286 patients had sustained anti-viral responses to treatment and 50 had detectable virus following treatment, but normal liver enzyme levels that are used to detect liver function (biochemical responders). Among patients who had sustained viral responses, none developed hepatocellular cancer. Among patients who had a biochemical response, the rate of hepatocellular cancer was 7.1%. Survival among patients who had sustained viral responses to interferon was comparable to that of the general population.
The researchers concluded that patients with hepatitis C who have viral responses to long-term therapy with interferon have low rates of hepatocellular cancer and have survival similar to that of the general public. Patients diagnosed with hepatitis C may wish to speak with their physician about their individual risks and benefits of treatment with long-term interferon.
Reference: Veldt B, Saracco G, Boyer N, et al. Long term clinical outcome of chronic hepatitis C patients with sustained virological response to interferon monotherapy. Gut. 2004; 53: 1504-1508.
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Gangrene Caused Death of Healthy Liver Donor
SourceURL:http://www.reutershealth.com
NEW YORK (Reuters Health) - Over two years ago, the case of a man who died at Mount Sinai Hospital in New York after donating a portion of his liver to his brother gained a lot of media attention. According to a report published this month, fulminant gas gangrene of the stomach was the cause of death.
The healthy 57-year-old man volunteered to give the right section of his liver to his brother in January 2002. The operation and the man's recovery were uneventful until the evening of second day after surgery, when he developed nausea and hiccups.
Early the next day, he seemed well and sat in a chair. Within a few hours, however, he developed a rapidly racing heart, plummeting blood pressure, and vomiting of blood.
Despite efforts to resuscitate him, the patient died.
"Autopsy demonstrated gas gangrene of the stomach as the underlying cause of the hemorrhage and numerous colonies of Gram-positive bacilli were identified," the team that cared for the patient reports in the medical journal Liver Transplantation.
Gas gangrene occurs when severe bacterial infection produces gas from fermentation that permeates surrounding tissue, causes widespread tissue damage, and leads to toxic shock.
The lead author of the report, Dr. Charles M. Miller, is now chief of liver transplantation at the Cleveland Clinic Foundation in Ohio.
Miller and his colleagues report that, on the first day after surgery, the patient was feeling so well that he asked his family to bring him takeout food from a local restaurant. The team speculates that "it is most likely that infection resulted from bacteria in the lobster dinner" from the restaurant, based on the type of bacteria identified.
The man's stomach may have been unable to ward off massive infection because of the surgical stress, a drop in blood supply to the stomach because of the diminished liver size, and the fact that he had been given gastric-acid suppressing drugs, the clinicians suggest. Stomach acid usually kills bacteria.
In the year following this patient's catastrophic death the number of living donor liver transplants in the United States fell by 30 percent compared with the year before, as a result of "national and international media furor, and the rumors and speculations generated in the medical community and the general public."
Now, "We have presented the facts," Miller and his colleagues write.
"Whether or not this death was preventable will remain unknown," they conclude.
Nevertheless, they say it is "reasonable" to avoid oral intake of food for living partial-liver donors immediately after surgery, and to discontinue acid-blocking medications before resuming a regular diet.
SOURCE: Liver Transplantation, October 2004.
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October 27th, 2004
Roche and Pharmasset Join Forces to Develop New Generation of Hepatitis C Therapies
SourceURL:http://www.prnewswire.com
Collaboration Exploring Compounds for Use in Combination with Roche's Hep C Product Pegasys(R)
NUTLEY, N.J. and ATLANTA, Oct. 27 /PRNewswire/ -- Roche and Pharmasset today announced a partnership to develop nucleoside polymerase inhibitors for the treatment of chronic hepatitis C virus (HCV) infections. Pharmasset will receive an upfront fee, research and development support, and milestone payments that could total $168 million for PSI-6130, the lead nucleoside compound of the partnership. In addition, Pharmasset will receive royalties on product sales and retain certain co-promotion rights in the U.S.
PSI-6130 may have the potential to offer greater efficacy and activity against the hepatitis C virus, especially in combination with Roche's Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin, USP). For patients who do not respond to current therapy, the addition of nucleoside polymerase inhibitors to the treatment regimen may offer benefit.
"Pharmasset's expertise in nucleoside drug discovery and early stage clinical development, combined with Roche's proven track record in bringing new and improved hepatitis C therapies to market is a formula for success," stated Schaefer Price, Pharmasset's President and CEO. "The economics of this deal are significant. In addition, this partnership will support Pharmasset's activities toward establishing a commercial infrastructure for our HIV and HCV clinical candidates."
"Roche has already established itself in hepatitis C with Pegasys, the most prescribed hepatitis C medication in the U.S. This collaboration with Pharmasset demonstrates our ongoing commitment to advancing therapy for hepatitis C patients with unmet needs," said George Abercrombie, President and CEO, Hoffmann-La Roche Inc. "We hope that further research and development will show that PSI-6130 is an important new hepatitis C treatment option that complements Pegasys and Copegus."
Under the terms of the agreement, Roche will gain the worldwide rights, excluding Latin America and Korea, to Pharmasset's PSI-6130 and its prodrugs. Pharmasset will be responsible for preclinical work, investigational new drug (IND) filings, and phase I proof of concept studies, with Roche managing other preclinical studies and clinical development. Roche will also receive options to related nucleoside polymerase inhibitors, which, if exercised, could result in Pharmasset receiving in excess of $300 million in total milestones under the agreement. Pharmasset will continue to develop and retain worldwide rights to ongoing and future hepatitis C programs unrelated to the PSI-6130 series of nucleoside polymerase inhibitors. In addition, the Roche Venture Fund has made a $4 million investment in Pharmasset and has received warrants to purchase an additional $6 million in shares within the next two years at a premium price.
About HCV
Hepatitis C is a blood-borne infectious disease of the liver and the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S. An estimated 2.7 million Americans are chronically infected with hepatitis C.
About Pegasys
Pegasys, the most prescribed pegylated alpha interferon in the U.S., and Copegus were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.
Please see attached additional important information about Pegasys indication and safety.
About Pharmasset
Pharmasset, Inc., is an emerging pharmaceutical company committed to the discovery, development, and commercialization of novel antiviral drugs. The company leverages its expertise in nucleoside chemistry to develop therapeutics to combat infections caused by drug-resistant human immunodeficiency virus (HIV) and hepatitis viruses. Pharmasset has two drugs in Phase II clinical trials, Reverset(TM) and Racivir(R), and several other antiviral compounds in advanced preclinical studies. In September 2003, Pharmasset entered into a collaborative licensing agreement with Incyte Corporation for the development and commercialization of Reverset in certain territories. Pharmasset retains proprietary development and commercialization rights to the balance of its clinical and preclinical pipeline. Pharmasset's expanding portfolio of antiviral therapeutics aims to improve the lives of individuals around the world.
About Roche as a Partner
Roche is a valued partner to over 50 companies worldwide. In 2003, Roche led the pharmaceutical industry in the number of product deals signed, bringing 10 potential products into the company, including a new antibiotic, a novel treatment for rheumatoid arthritis, and an exciting cardiovascular compound. Roche's alliance strategy is to enable our partners to grow through a flexible and collaborative approach.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals and diagnostics. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C. For more information on the Roche pharmaceuticals business in the United States, visit the company's web site at: http://www.rocheusa.com
Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus
Indication
* Pegasys(R), a pegylated alpha interferon, alone or in combination with Copegus(R) (ribavirin, USP) is indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
Dosing and Administration
Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous injection once a week. Copegus, available as a 200mg tablet, is administered at 800 to 1200mg taken twice daily as a split dose. The two products are sold separately.
* Combination Therapy Clinical Studies
- The two combination therapy pivotal study findings:
- Study 5, published in the March 2, 2004 Annals of Internal Medicine, including 1,284 patients receiving medication, showed that patients with certain genotypes (strains) of the hepatitis C virus should be treated with different dosing regimens of Pegasys and Copegus. The treatment regimens and resulting sustained virological response rates for these groups treated with Pegasys and Copegus therapy were:
-- Genotype 1: 48 week duration with 1000 - 1200mg Copegus: 51 percent
-- Genotype non-1: 24 week duration with 800mg Copegus: 82 percent
* Study 4, published in the September 26, 2002 New England Journal of Medicine, including 1,121 patients receiving medication, showed that Pegasys and Copegus combination therapy is a more effective treatment for chronic hepatitis C than interferon alfa-2b and ribavirin. The sustained virological response rate in the Pegasys and Copegus treated patients was 53 percent compared to 44 percent in the interferon alfa-2b and ribavirin group. Sustained virological response refers to a patient's continued undetectable serum hepatitis C RNA levels 24 weeks after finishing a course of treatment.
Adverse Events
Alpha interferons, including Pegasys, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping Pegasys therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE EVENTS in complete product information).
* Use with Ribavirin. Ribavirin, including Copegus may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease. Ribavirin is genotoxic, mutagenic, and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE EVENTS in complete product information).
* Pegasys is contraindicated in patients with hypersensitivity to Pegasys or any of its components, autoimmune hepatitis, and decompensated hepatic disease (Child-Pugh class B and C) before or during treatment with Pegasys. Pegasys is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal.
Pegasys and Copegus therapy is additionally contraindicated in patients with a hypersensitivity to Copegus or any of its components, women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
* COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the six months after treatment has concluded. Routine monthly pregnancy test must be performed during this time. If pregnancy should occur during treatment or during six months post-therapy, the patient must be advised of the significant teratogenic risk of Copegus therapy to the fetus.
Physicians and patients are strongly encouraged to report any pregnancies that do occur to Roche by calling 1-800-526-6367.
* The most common adverse events reported for Pegasys and Copegus combination therapy, observed in clinical trials (n=451), were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability /anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%).
* Serious adverse events include neuropsychiatric disorders (suicidal ideation and suicide attempt), serious and severe bacterial infections, bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including psoriasis and lupus), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis ulcerative and hemorrhagic/ischemiccolitis), pancreatitis, and opthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema).
* The complete package inserts for Pegasys and Copegus are available at http://www.pegasys.com , or by calling 1-877-PEGASYS.
SOURCE Roche; Pharmasset, Inc.
Web Site: http://www.rocheusa.com http://www.pegasys.com
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McGreevey Allows Needle Exchanges in 3 Cities for HIV Prevention
New York Times
Damien Cave
On Tuesday, Gov. James McGreevey signed an executive order authorizing the New Jersey Department of Health and Senior Services (DHSS) to oversee needle exchange programs in as many as three municipalities. The order covers only cities that have high HIV prevalence due to intravenous drug-use and that have ordinances allowing needle exchange programs. Camden and Atlantic City fit both criteria and are expected to make clean syringes available within weeks. A third city has not yet qualified.
To support his contention that HIV constitutes an emergency in New Jersey, McGreevey cited statistical evidence and referenced a study showing that HIV prevalence decreased by 29 percent in cities with needle exchanges, while prevalence increased by 5 percent in cities without the programs. The evidence is incontrovertible. We have resisted the evidence at a high cost, he said. The goal of the executive order is to demonstrate that the science works and to move forward, McGreevey said, even as he acknowledged the state's lack of political consensus on the issue.
McGreevey resigns his office on Nov. 15, when Senate President Richard J. Codey (D) will replace him.
We will review the order once we receive it, said State Attorney General Peter Harvey's office. Codey's office said he wants to take a look at it and work with the other legislative leaders. Republican state Sens. Robert Singer and Thomas H. Kean questioned both McGreevey's declaration of an emergency and the constitutionality of the order. Sen. Ronald Rice (D) said he hoped the order would be quickly challenged.
Needle-exchange programs are a very effective gateway to engage drug users into health and social services, and into drug treatment, DHSS Commissioner Dr. Clifton Lacy said. Regular visits to these syringe-exchange sites create an opportunity for referrals.
A future governor can rescind the executive order. McGreevey's action leaves Delaware as the only state that bars needle-exchange programs and criminalizes possession of syringes without a prescription.
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PEG-INTRON Studied in a Wide Range of Hepatitis C Patient Populations
SourceURL:http://www.medadnews.com
Researchers Present 44 Abstracts on PEG-INTRON at Annual Meeting Of The American Association for The Study Of Liver Diseases (AASLD)
KENILWORTH, N.J., October 27, 2004 /PRNewswire-FirstCall/ -- Important new data investigating PEG-INTRON(R) (peginterferon alfa-2b), both as monotherapy and in combination with REBETOL(R) (ribavirin, USP), will be presented at the 55th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) at the John B. Hynes Convention Center in Boston, Oct. 29 - Nov. 2. Researchers will report on the investigative use of PEG-INTRON in treating a variety of hepatitis C patient populations, including patients who failed previous therapies, African-American patients, patients with fibrosis and those with acute hepatitis C infection. Clinical studies evaluating treatment duration in patients with specific genotypes and studies examining liver disease progression in patients with advanced hepatitis C also will be presented.
Hepatitis C virus (HCV) is the most common blood-borne infection in America and the most common form of liver disease, affecting nearly 4 million people -- or one in 50 adults -- in the United States and 200 million people worldwide.
A total of 44 PEG-INTRON abstracts will be presented at AASLD, including nine oral presentations:
1. Comparison of Peginterferon alfa-2a and Peginterferon alfa-2b Pharmacokinetics and Pharmacodynamic in COMPARE, a Randomized, Prospective, Blinded Trial, Silva M, et al. Parallel Session 10, Sunday, Oct. 31, 5:00 PM, Hynes Memorial Auditorium.
This study has been selected for inclusion in the AASLD HOT TOPICS press conference on Saturday, Oct. 30, 5:30 PM, room 108, at the Haynes Convention Center. The study investigates the in vivo pharmacokinetic attributes of the molecular differences between PEG-INTRON and PEGASYS (peginterferon alfa-2a, Hoffmann-La Roche, Inc.) in a randomized, third-party blind, parallel-group trial.
2. Weight-Based Ribavirin Dosing in HCV-Infected Genotype 1 African- Americans (AA) Compared to Flat Dose Ribavirin with Peginterferon alfa-2b Combination Therapy Jacobson I, et al. Presidential Plenary Session 4, Monday, Nov. 1, 12:00 PM, Hynes Memorial Auditorium.
The presentation reports on the WIN-R study, a multicenter community-based study evaluating weight-based PEG-INTRON in combination with fixed or weight- based REBETOL in a diverse patient population, including the largest number of African-American patients in any study to date.
3. Evaluation of Early Viral Response with PEG-INTRON/REBETOL Weight-Based Dosing in Previous Interferon/Ribavirin HCV Treatment Failures; Early Results of the EPIC3 Trial Poynard T, et al. Parallel Session 25, Monday, Nov. 1, 3:15 PM, Hynes Memorial Auditorium.
Researchers report an evaluation of early virologic response (EVR) data with PEG-INTRON and REBETOL from the first treatment phase of the EPIC3 (Evaluation of PEG-INTRON in Control of Hepatitis C Cirrhosis) study, a large multicenter global clinical study involving approximately 2,200 patients at approximately 140 sites worldwide. The EPIC3 study also investigates maintenance therapy with weight-based low-dose PEG-INTRON in patients who either did not respond in the initial treatment phase and/or have cirrhosis.
4. Colchicine versus PEG-INTRON Long Term (COPILOT) Trial: Interim Analysis of Clinical Outcomes at Year Two Afdhal N, et al. Parallel Session 25, Monday, Nov. 1, 3:30 PM, Hynes Memorial Auditorium.
This study evaluates long-term maintenance therapy with weight-based low- dose PEG-INTRON vs. colchicine in delaying or preventing progression of liver disease in patients with advanced chronic hepatitis C (fibrosis or cirrhosis) who failed previous interferon-based therapies.
5. Peginterferon alfa Compared with Conventional Interferon alfa and Ribavirin Combination Therapy in Asymptomatic Acute Hepatitis C: A Randomized Trial of Treatment Onset, Duration and Cost-Effectiveness Kamal S, et al. Parallel Session 5, Sunday, Oct. 31, 3:00 PM, Hynes Ballroom C.
6. Three Months' Course Of Peg-Interferon a-2b in Acute HCV Hepatitis Calleri G, et al. Parallel Session 5, Sunday, Oct. 31, 3:15 PM, Hynes Ballroom C.
7. Kinetics of HCV-Specific CD4+ and CD8+ T Cell Responses During and After Therapy with Pegylated Interferon alfa-2b in Patients with Acute Hepatitis C Wiegand J, et al. Parallel Session 31, Monday, Nov. 1, 5:30 PM, Hynes Ballroom A.
The above three oral presentations report on studies evaluating the use of PEG-INTRON monotherapy in the treatment of acute hepatitis C, an area of unmet medical need. Currently, there are no therapies approved for treating acute hepatitis C infection.
8. Evaluation of Antiviral Therapy on Hepatic Venous Pressure Gradient in Patients with Chronic Hepatitis C and Fibrosis Stage 3 or 4 Rincon D, et al. Parallel Session 28, Monday, Nov. 1, 5:15 PM, Hynes Ballroom C.
Major complications of liver cirrhosis are due to portal hypertension. This study evaluates the effect of PEG-INTRON and REBETOL combination therapy on liver histology and portal pressure.
9. Evaluation of Short (14 Weeks) Treatment with Pegylated Interferon alfa-2b and Ribavirin in Patients with Hepatitis C Genotype 2/3 Virus Infection Dalgard O, et al. Parallel Session 29, Monday, Nov. 1, 5:45 PM, Hynes Memorial Auditorium.
This multicenter study evaluates a short 14-week course of weight-based PEG-INTRON and REBETOL combination therapy in previously untreated patients with HCV genotypes 2 or 3.
PEG-INTRON and REBETOL Combination Therapy
PEG-INTRON and REBETOL combination therapy is indicated for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.
WARNING
Alpha interferons, including PEG-INTRON, cause or aggravate fatal or life- threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-INTRON therapy.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
PEG-INTRON
There are no new adverse events specific to PEG-INTRON as compared to INTRON A (interferon alfa-2b, recombinant) for Injection, however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEG-INTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEG-INTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON, but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEG-INTRON.
PEG-INTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
The following serious or clinically significant adverse events have been reported at a frequency less than 1% with PEG-INTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG- INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5 mcg/kg)/ REBETOL and in 34% of those receiving INTRON A/REBETOL.
REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
INTRON A
All patients receiving INTRON A therapy experienced mild-to-moderate side effects. Some patients experienced more severe side effects, including neutropenia, fatigue, myalgia, headache, fever, chills and increased SGOT. Other frequently occurring side effects were nausea, vomiting, depression, alopecia, diarrhea and thrombocytopenia. DEPRESSION AND SUICIDAL BEHAVIOR, INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALFA INTERFERONS, INCLUDING INTRON A THERAPY.
Please see full prescribing information available at http://www.schering-plough.com/.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., USA, and its Web site is http://www.schering-plough.com/.
SCHERING-PLOUGH DISCLOSURE NOTICE: This media alert contains "forward- looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including the market for PEG-INTRON and REBETOL combination therapy and the market for drugs to treat hepatitis C. Forward-looking statements relate to expectations or forecasts of future events and not to historical information. Schering-Plough does not assume the obligation to update any forward-looking statement. There are no guarantees about the market performance of PEG-INTRON and REBETOL combination therapy, Schering-Plough stock or Schering-Plough's business. Actual results may vary materially from forward-looking statements made here or in other Schering-Plough written or spoken communications due to many factors and uncertainties, which include the market acceptance of PEG-INTRON and REBETOL combination therapy, trade buying patterns, the introduction and performance of competitive products in the market, legislation that may impact the pricing/availability of PEG-INTRON and REBETOL combination therapy and other items discussed in Schering-Plough's Securities and Exchange Commission filings, including the 8-K filed October 21, 2004.
CONTACT: Media - Robert J. Consalvo, +1-908-298-7409, or Investors - AlexKelly, +1-908-298-7450, or Janet M. Barth, +1-908-298-7417, all of Schering-Plough Corporation
Web site: http://www.schering-plough.com/
Company News On-Call: http://www.prnewswire.com/comp
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New Data on Most Prescribed Hepatitis C Therapy Pegasys to Be Presented at American Association for the Study of Liver Diseases Meeting
SourceURL:http://www.medadnews.com
- Studies Evaluate Treatment in Special Populations, Such as Non-Responders to Other Therapies and Patients Co-Infected With HIV -
BOSTON, October 27, 2004 /PRNewswire/ -- New studies evaluating the hepatitis C treatment Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin, USP), including Roche's head-to-head study evaluating the impact of Pegasys versus Peg-Intron(R) on patients' hepatitis C virus levels up to the eighth week of therapy, will be presented at the 55th American Association for the Study of Liver Diseases Annual Meeting, October 29 - November 2 in Boston, Mass. The meeting will bring together leading hepatologists and gastroenterologists to discuss the latest clinical research about hepatitis C and liver disease.
Hepatitis C is a blood-borne virus that chronically infects an estimated 2.7 million Americans. The virus is a leading cause of cirrhosis and liver cancer and is the number-one reason for liver transplants in the U.S.
Roche has backed Pegasys with the most extensive development program ever undertaken in hepatitis C, including major studies initiated to advance treatment for hepatitis C patients with unmet needs, such as African Americans, patients co-infected with HIV and hepatitis C, patients with cirrhosis and patients who have failed to respond to previous therapy.
Data from several Pegasys studies will be presented and discussed at the meeting, including:
1. Pharmacokinetics and Pharmacodynamics of Pegylated Interferon Alfa-2a Or Alfa-2b with Ribavirin in Treatment Naive Patients with Genotype 1 Chronic Hepatitis C
Interim data from this head-to-head viral kinetics study will compare the impact of Pegasys versus Peg-Intron on early viral clearance. Data from a subset of patients who have completed eight weeks of treatment will be presented.
2. Safety and Efficacy of Peginterferon Alfa-2a (40kd) (Pegasys) Plus Ribavirin (Copegus) in HIV-HCV Co-Infected Patients with Cirrhosis/Bridging Fibrosis: Results of the AIDS Pegasys Ribavirin International Co-Infection Trial (APRICOT)
This sub-analysis of the international APRICOT trial investigates the efficacy and safety of Pegasys plus Copegus in hepatitis C patients co- infected with HIV with cirrhosis or bridging fibrosis.
3. Sustained Viral Response (SVR) with Peginterferon Alfa-2a and Ribavirin in Patients with Chronic Hepatitis C (CHC) Who Were Non-Responders (NR) to Peginterferon Alfa-2b and Ribavirin
This study examines efficacy of retreatment with Pegasys and Copegus in patients who did not respond to initial treatment with Peg-Intron and ribavirin.
4. Natural History of Chronic Hepatitis C (CHC) in Patients With Persistently Normal ALT Levels in the Multinational Peginterferon Alfa-2a (40kd) (Pegasys) Plus Ribavirin (Copegus) Study: Comparison of Baseline Histology with Baseline Data from Patients with Elevated ALT Levels Enrolled in Phase III Studies
The study compares the histologic characteristics of chronic hepatitis C patients with persistently normal ALT levels with those of patients with elevated ALT levels.
5. Durability of Sustained Virological Response (SVR) After Treatment with Peginterferon Alfa-2a (40kd) (Pegasys) Alone or in Combination with Ribavirin (Copegus): Results of an Ongoing Long-Term Follow-Up Study
This study examines the long-term durability of a sustained virologic response achieved with Pegasys monotherapy or Pegasys/Copegus combination therapy for up to five years post-treatment.
About Pegasys
Pegasys, a pegylated alpha interferon, and Copegus were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha.
Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.
Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week. Copegus is available as a 200mg tablet, and is administered orally two times a day as a split dose.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals and diagnostics. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life.
Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.
For more information on the Roche pharmaceuticals business in the United States, visit the company's web site at: http://www.rocheusa.com/
Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus
Indication
* Pegasys(R), a pegylated alpha interferon, alone or in combination with Copegus(R) (ribavirin, USP) is indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
Dosing and Administration
* Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous injection once a week. Copegus, available as a 200mg tablet, is administered at 800 to 1200mg taken twice daily as a split dose. The two products are sold separately.
Combination Therapy Clinical Studies
* The two combination therapy pivotal study findings:
* Study 5, published in the March 2, 2004 Annals of Internal Medicine, including 1,284 patients receiving medication, showed that patients with certain genotypes (strains) of the hepatitis C virus should be treated with different dosing regimens of Pegasys and Copegus. The treatment regimens and resulting sustained virological response rates for these groups treated with Pegasys and Copegus therapy were:
* Genotype 1: 48 week duration with 1000 - 1200mg Copegus: 51 percent
* Genotype non-1: 24 week duration with 800mg Copegus: 82 percent
* Study 4, published in the September 26, 2002 New England Journal of Medicine , including 1,121 patients receiving medication, showed that Pegasys and Copegus combination therapy is a more effective treatment for chronic hepatitis C than interferon alfa-2b and ribavirin. The sustained virological response rate in the Pegasys and Copegus treated patients was 53 percent compared to 44 percent in the interferon alfa-2b and ribavirin group. Sustained virological response refers to a patient's continued undetectable serum hepatitis C RNA levels 24 weeks after finishing a course of treatment.
Adverse Events
* Alpha interferons, including Pegasys, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping Pegasys therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE EVENTS in complete product information).
* Use with Ribavirin. Ribavirin, including Copegus may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease. Ribavirin is genotoxic, mutagenic, and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE EVENTS in complete product information).
* Pegasys is contraindicated in patients with hypersensitivity to Pegasys or any of its components, autoimmune hepatitis, and decompensated hepatic disease (Child-Pugh class B and C) before or during treatment with Pegasys. Pegasys is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal.
Pegasys and Copegus therapy is additionally contraindicated in patients with a hypersensitivity to Copegus or any of its components, women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
* COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the six months after treatment has concluded. Routine monthly pregnancy test must be performed during this time. If pregnancy should occur during treatment or during six months post-therapy, the patient must be advised of the significant teratogenic risk of Copegus therapy to the fetus.
Physicians and patients are strongly encouraged to report any pregnancies that do occur to Roche by calling 1-800-526-6367.
* The most common adverse events reported for Pegasys and Copegus combination therapy, observed in clinical trials (n=451), were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%).
* Serious adverse events include neuropsychiatric disorders (suicidal ideation and suicide attempt), serious and severe bacterial infections, bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including psoriasis and lupus), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemiccolitis), pancreatitis, and opthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema).
* The complete package inserts for Pegasys and Copegus are available at http://www.pegasys.com/, or by calling 1-877-PEGASYS.
Contacts: Pamela VanHouten
Roche (973) 562-2231
Sarah Gudema
Manning Selvage & Lee (617) 937-2590
CONTACT: Pamela VanHouten, Roche, +1-973-562-2231,; or Sarah Gudema, Manning Selvage & Lee,+1-617-937-2590, , for Roche
pamela.vanhouten@roche.com sarah.gudema@mslpr.com
Web site: http://www.rocheusa.com/
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Governments Urged to Start Prison Needle Exchanges
SourceURL:http://www.theglobeand
mail.com
DARREN YOURK
Federal and provincial governments were called on Wednesday to establish needle-exchange programs in Canadian prisons to combat escalating rates of HIV and hepatitis C among prisoners.
The Canadian HIV/AIDS Legal Network and the Ontario Medical Association (OMA) both spoke out on the issue, warning that the general population is being put at risk when prisoners infected with blood borne illnesses are released from jail.
"Prisoners come from the community and most return to it," Canadian HIV/AIDS Legal Network executive director Ralf Jurgens said in a release. "What is done -- or not done -- in prisons with regard to HIV/AIDS, hepatitis and drug use therefore has an impact on the health of all Canadians."
The OMA released a position paper on the issue Wednesday, saying that recent statistics -- showing that the rate of HIV infection among prisoners is 10 times higher than the general population and 29 times higher for hepatitis C -- prove that programs to prevent disease transmission in prisons are not working.
"The frequent movement of individuals between prisons and the community means that any transmission of disease within prisons will increase the risk of disease transmission in the community," said Dr. John Rapin, president of the OMA. "We should all be concerned about disease spreading through our prison systems because we are at risk."
According to the Legal Network's findings , there were 14 known cases of HIV/AIDS in federal prisons in 1989. That number rose to 251 in 2002. The hepatitis C numbers paint an even more grim picture.
"Approximately 0.8 per cent of Canadians are living with hepatitis C, but studies have shown rates of 20 to 80 per cent among prisoners," Mr. Jurgens said.
Both organizations suggest that all levels of government work together to launch needle-exchange programs in prisons as soon as possible.
Thomas Kerr, a Research Associate with the British Columbia Centre for Excellence in HIV/AIDS, noted effective needle exchange programs have been operating with government funding throughout Canada since the late 1980s.
"They are generally regarded as one of the most important factors in preventing HIV epidemics among injection drug users," Mr. Kerr said. "Despite this, and although Canadian and international experts have been calling for prison needle exchange programs for over ten years, no Canadian prison has thus far introduced and evaluated this pragmatic public health measure."
The OMA says more than 50 needle-exchange programs have been successfully implemented around the world and extensive research shows that syringe exchange does not pose any safety concerns to either prison staff or prisoners nor does it lead to an increase in intravenous drug use among prisoners.
"In light of this evidence," Mr. Jurgens said, "There no longer are any good reasons to deny prisoners who inject drugs access to clean needles. This does not condone their drug use.
"Rather, it is a pragmatic public health measure that should accompany other efforts to reduce harms related to drug use, such as drug-treatment programs, including methadone maintenance."
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Utah County Considers Hepatitis Shots for Food Workers
SourceURL:http://tv.ksl.com
PROVO, Utah (AP) -- A Utah County push to vaccinate all food workers with Hepatitis A shots is leaving a bad taste in the mouths of some restaurant owners.
The virus is spread hand-to-mouth after exposure to contaminated feces. The vaccine calls for three shots over six months -- but even the initial dose can be effective.
However, some say the disease isn't spread through restaurants, and food workers shouldn't have to bear the 25 dollar expense of each shot, which is not covered by all insurance providers.
Critics also argue that it would be a tough measure to enforce because of turnover in the industry.
However, proponents say it's a no-brainer, because an outbreak would devastate any restaurant.
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October 29th, 2004
Keeping Organ, Tissue Transplants Safe
SourceURL:http://www.forbes.com
Robert Preid,
FRIDAY, Oct. 29 (HealthDayNews) -- Routine screening for viral RNA in blood samples from tissue and organ donors could help reduce the risk of transmission of viral diseases such as HIV and hepatitis C, says a study in this week's issue of The Lancet.
Checking for the presence of blood antibodies to these viral diseases is the conventional way of determining whether a person is a safe tissue or organ donor. But this method has drawbacks. For example, some infected donors may not be seroconverted -- even though they're infected, they don't yet show a full immune response to viral infection by producing antibodies.
In this study, French researchers examined whether nucleic acid testing (NAT) could detect HIV and hepatitis C (HCV) RNA. The study included 2,236 organ donors, 636 tissue donors, and 177 cornea donors.
Using NAT, the researchers identified five HCV RNA-positive donors in 2,119 HCV-seronegative organ donors and one HCV RNA-positive donor in 631 HCV-seronegative tissue donors. They did not find any HIV RNA-positive donors.
"Our data, together with reported cases of HCV transmission to recipients from a seronegative HCV RNA-positive donor, suggest that routine NAT screening of organ and tissue donors might increase viral safety in the transplantation setting," researcher Jean-Michel Pawlotsky said in a prepared statement.
"Implementation of systematic NAT screening of tissue (and cell) donors is highly feasible because viral testing can be done every day and can be based on standardized, partly automated, commercial techniques and procedures," Pawlotsky said.
More information: The United Network for Organ Sharing has more about organ transplantation.
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HIV, Hepatitis C Prevalence in Canadian Prisons Presents 'Clear' Health Risk
SourceURL:http://www.medicalnews
today.com/
HIV and hepatitis C infections are "[r]ampant" in Canadian prisons and present a "clear and present health risk" to inmate populations, prison guards and the general public, according to a report released Wednesday by the Ontario Medical Association, Toronto's Globe and Mail reports (Blatchford, Globe and Mail, 10/28).
Correctional Service Canada -- which oversees the prison system -- reports that in 2002, HIV prevalence among prison populations was seven to 10 times higher than in the general population and hepatitis C prevalence was 30 times higher among inmates than in the general population, according to Reuters.
"We have an epidemic in the prison system," Peter Ford, head of OMA's HIV and hepatitis C committee, said, adding, "What we've seen in our studies is people getting infected in prison with HIV and hepatitis C, and then obviously those people are capable of taking this out (into the community)." Michele Pilon-Santilli, a spokesperson for CSC, said that 80% of inmates in the federal prison system have a "substance abuse problem," according to Reuters. There are no needle-exchange programs in Canadian prisons, but prisons provide inmates with bleach kits. However, Ford said that the bleach the prisons give the inmates is so dilute, "it certainly has no effect on hepatitis C, and may not have much effect on HIV" (Reuters, 10/27).
Needle-Exchange Report
The Canadian HIV/AIDS Legal Network on Wednesday released a report that was the "most comprehensive" study of prison needle-exchange programs ever published, according to a CHALN release. The report, titled "Prison Needle Exchange: Lessons from a Comprehensive Review of International Evidence and Experience," focuses on six countries that currently operate prison needle-exchange programs (CHALN release, 10/27).
According to the report, prison needle-exchange programs "make prisons safer" and do not increase drug use among inmates, the Toronto Star reports.
CHALN called on the Canadian government to initiate prison needle-exchange programs within 18 months. CHALN Executive Director Ralf Jurgens said that the prison needle-exchange issue is a public health issue for "all Canadians," adding, "Prisoners come from the community, and they return to the community. Most prisoners are in prison for very short periods of time, they have families and loved ones outside and they deserve to have the same access to preventative measures that people outside prisons have."
Federal Health Minister Ujjal Dosanjh said that he had not read the report but the government will consider its recommendations, according to the Star.
Public Safety and Emergency Preparedness Minister Anne McLellan said that CSC will work with Canada's public health officer, David Butler-Jones, to make recommendations on the issue, according to the Star (Gordon, Toronto Star, 10/28).
http://www.kaisernetwork.org
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