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Week Ending: October 8th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• UK Hepatitis C ‘Time Bomb’ Warning
• Call to Save People from Hepatitis-C
• Budget Lacks Hepatitis C Funds for Inmates
• Biomarkers Used to Predict Recurrent Disease in Hepatitis C Transplant Patients
• New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury; VX-950 Clinical Milestones on Track
• Hepatitis C Drug Helping Patients with Treatment-Induced Anemia
• Greasing Interferon's Gears May Pave Way to Greater Therapeutic Benefits, Fewer Side Effects
• Organ Transplant Tolerance Studied
• Genelabs Presents Data on Two Preclinical Candidates at the 12th International Symposium on Hepatitis C and Related Viruses
• Impact of Past Alcohol Use in Treating Hep C
• Hepatitis C Trial Begins
• Hepatitis C Hinders HIV Treatment
• Vertex to Curtail Funding of Two Drugs
• Hepatitis C, the "Hidden Killer" – MP
• Liver Cancer Up, Other Kinds Improving
• Family Talks about Decision to Leave Farming After Father Was Treated for Hepatitis C
• Test Predicts Risk of Liver Scarring After Transplant, Study Shows
• Ulster Company Launches Needlecatcher Safety Product
• Hepatitis C Threat Worried Wife
• CANADA: "Crack Users Say Pipe Program Helps Them Stay Healthy"
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October 3rd, 2005
UK: Hepatitis C "Time Bomb" Warning
SourceURL:http://www.scoopt.org
The report, conducted by the Hepatitis C Trust, compared the UK to France, Germany, Italy and Spain, and found that Britain was at the bottom of each league table when it came to tackling the disease. According to the report, the UK is failing to identify and treat a sufficient number of people infected with the disease. Only 1-2% of hepatitis C sufferers had been identified in the UK and was receiving treatment with approved medication, which could help prevent them developing diseases such as liver cirrhosis and cancer. As a result, the Hepatitis C Trust warned that the prevalence of chronic liver disease in the UK was "set to soar" and could cost the NHS up to £8 billion within 30 years.
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Call to Save People from Hepatitis-C
SourceURL:http://nation.ittefaq.com
Speakers at a seminar in the city yesterday called upon the media to come forward to create mass awareness of Hepatitis-C in Bangladesh in order to save innocent lives of the country from the menace.
Eminent journalists made the call while addressing the seminar on "Role of Media in Creating Hepatitis-C Awareness" held at the auditorium of the Islamic Development Bank (IDB) Bhaban.
Prof Dr Mobin Khan, an eminent liver disease specialist, in his keynote paper revealed that 14 lakh people of the country are infected with Hepatitis-C and most of them are heading towards liver cirrhosis and liver cancer.
The Roche Bangladesh organised the seminar to mark the day yesterday.
Presided over by Prof SAR Chowdhury, an eminent pharmacologist, the seminar was addressed, among others, by Mahbubul Alam, Editor of The Independent, Ataus Samad, Advisory Editor of the daily Amar Desh, M Shafiqul Karim, President of Dhaka reporters' Unity and Dr Rezwan H Siddique, Director General of Press Institute of Bangladesh.
Prof Mobin Khan said people of the country have become aware about Hepatitis-B due to mass awareness programme; as a result mass Hepatitis-B vaccination has got momentum. But most of the people are unaware about Hepatitis-C and they do not take necessary precautionary measures to prevent its spreading.
"Hepatitis-C is emerging as a major health hazard for Bangladesh,"he said adding, though there is no extensive research, preliminary studies show that about one per cent population of our country are infected with Hepatitis-C.
Prof Khan said Hepatitis-C is known for its insidious nature and it is called the silent killer; 85 per cent cases Hepatitis-C becomes chronic.
Mahbubul Alam said it is the duty of the journalist community to project the social problems in front of all so that they can prevent its destructive effects.
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Budget Lacks Hepatitis C Funds for Inmates
SourceURL:http://www.lsj.com
Approved plan cuts $1M to fight virus in prisons
Money to test and treat Michigan prisoners for hepatitis C has been eliminated in the state's new budget, effectively killing a plan to attack the potentially fatal and communicable disease festering inside the state's 42 prisons.
The 2005-06 budget, which was approved by lawmakers and Gov. Jennifer Granholm last week and took effect Saturday, cut $1 million from the corrections department that was set aside for a new hepatitis C program.
The program would have surveyed incoming inmates and tested those most at risk for harboring the blood-borne virus, as is recommended by the U.S. Centers for Disease Control and Prevention. That would have meant more prisoners would have been treated, lowering the risk that they would leave prison unaware they carry the virus and infect others.
Department officials don't know exactly how many prisoners are infected.
A 2003 Lansing State Journal investigative report found that up to 18,000 of Michigan's 48,000 prisoners are believed to harbor the virus. About 55 were being treated.
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Biomarkers Used to Predict Recurrent Disease in Hepatitis C Transplant Patients
SourceURL:http://www.eurekalert.org/
Two new studies on Hepatitis C (HCV) patients who underwent liver transplants examined a potential biomarker that could be used to predict who might develop hepatic fibrosis, a formation of scar-like tissue that can lead to cirrhosis. The studies found that changes in a certain type of liver cell were useful in determining those who were at the greatest risk for developing this serious complication.
The results of these studies appear in the October 2005 issue of Liver Transplantation, the official journal of the American Association for the Study of Liver Diseases (AASLD) and the International Liver Transplantation Society (ILTS). The journal is published on behalf of the societies by John Wiley & Sons, Inc. and is available online via Wiley InterScience at http://www.interscience.wiley.com
/journal/livertransplantation.
Hepatitis C is the leading cause of liver transplants and recurrence of the disease following transplant is a serious problem. It is estimated that up to 20 percent of HCV patients will develop fibrosis or cirrhosis within two years of undergoing a transplant. Antiviral therapy is not highly effective in transplant patients and poses additional problems for these individuals, who may have difficulty tolerating the potent drugs it involves. However, antiviral therapy might be useful for those patients likely to develop fibrosis, if they could somehow be identified. Hepatic stellate cells (HSC) normally store vitamin A in the liver, but in HCV patients these cells produce collagen and other proteins that can lead to fibrosis. Researchers tried to determine if HSC activation could help predict which patients would later develop fibrosis by using laboratory analysis of alpha smooth muscle actin (alpha-SMA), a reliable marker for HSC activation.
In one study, led by Samer Gawrieh of the Division of Gastroenterology and Hepatology at the Mayo Clinic College of Medicine in Rochester, MN, 26 patients who underwent HCV-related liver transplants at the Mayo Clinic between April 1993 and July 1999 were included. Biopsies obtained 4 months and 1 year post-transplant were evaluated and given a score for alpha-SMA. The results showed that HSC activation of one particular type of cell (mesenchymal cells, which give rise to connective tissue) was highly reliable in predicting the development of fibrosis. "Staining early post-LT liver biopsies for alpha-SMA may help identify patients with hepatitis C at risk for severe recurrence who may benefit from early anti-HCV or anti-fibrotic therapy," the authors conclude.
In another study, led by Mark W. Russo, M.D., M.P.H. of the Division of Gastroenterology and Hepatology of the University of North Carolina in Chapel Hill, 46 patients who underwent HCV-related liver transplants at the University of Florida between 1997 and 2001 were included. Patients were divided into two groups: those who developed advanced fibrosis within 2 years of liver transplant and those who developed mild or no fibrosis in the same period. Biopsies from 4 months, 1 year and 2 years post-transplant were scored for alpha-SMA. The results showed that HSC activation was significantly higher in the 4 month biopsies for those who developed advanced fibrosis within 2 years. The authors note that alpha-SMA "is an attractive biomarker because it is determined from the organ of interest and there is biological plausibility for why increased stellate cell activity would lead to advanced fibrosis."
In an accompanying editorial by A.J Demetris and J.G. Lunz III of the Thomas E. Starzl Transplantation Institute at the University of Pittsburgh Medical Center in Pittsburgh, the authors note that the ability of alpha-SMA to predict disease at 4 months after transplant suggests that something triggers a chain of events that begins with mesenchymal and/or HSC activation and leads to the development of fibrosis. They speculate as to what the trigger might be and how it might explain the mechanism of liver disease, examining risk factors for recurrent HCV that might offer clues, as well as substances such as viral proteins and proteins secreted by liver cells. In particular, they cite their research on p21, a protein made in the liver, which showed that progression of fibrosis was related to the effect of p21 on liver cell proliferation. "This model better fits observations about disease pathogenesis," they conclude. "It explains why any hepatocyte stressors, such as steatosis [accumulation of fat in the liver], iron, inflammation, HCV replication or spontaneously increased 21 expression, such as occurs with aging, can accelerate liver disease progression."
References
Article: "Early Hepatic Stellate Cell Activation Predicts Severe Hepatitis C Recurrence After Liver Transplantation," Samer Gawrieh, Bettina G. Papouchado, Lawrence J. Burgart, Shogo Kobayashi, Michael R. Charlton, Gregory J. Gores, Liver Transplantation; October 2005 (DOI: 10.1002/lt.20455).
Article: "Early Hepatic Stellate Cell Activation is Associated with Advanced Fibrosis After Liver Transplantation in Recipients with Hepatitis C," Mark Russo, Roberto Firpi, David Nelson, Robert Schoonhoven, Roshan Shrestha, Michael Fried, Liver Transplantation; October 2005 (DOI: 10.1002/lt.20432).
Editorial: "Early HCV-Associated Stellate Cell Activation in Aggressive Recurrent HCV: What Can Liver Allografts Teach About HCV Pathogenesis?" A.J. Demetris, J.G. Lunz III, Liver Transplantation; October 2005 (DOI: 10.1002/lt.20506).
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New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury; VX-950 Clinical Milestones on Track
SourceURL:http://www.newswire.ca
MONTREAL, Oct. 3 /CNW/ -- New data show that patients with genotype 1 hepatitis C virus (HCV) infection treated with VX-950, an investigational oral HCV protease inhibitor being developed by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX), rapidly achieved substantial reductions in alanine aminotransferase (ALT) levels after 14 days of treatment. The findings were presented today by researchers at the 12th International Symposium on Hepatitis C and Related Viruses (HCV 2005) in Montreal, Canada. Vertex also provided an update on clinical development of VX-950, which is one of the most advanced of a new class of medicines in development for the treatment of chronic hepatitis C infection.
Data from a 14-day clinical study demonstrated that treatment with any one of three doses of VX-950 resulted in median serum ALT declines of 25-32 U/L in all dose groups. In the placebo group, a median 8 U/L increase was observed. Prior to treatment with VX-950, serum ALT levels were elevated in approximately 70 percent of patients in the study. In the VX-950 dose groups, 83 percent (15 of 18) of patients with elevated ALT levels at baseline (prior to treatment) had achieved normalization of ALT levels at day 14, compared to 0 percent (0 of 6) in the placebo group. Elevated ALT levels are common in HCV patients and are considered to be a marker of liver injury due to HCV infection. Mean levels of serum neopterin also were observed to decrease with VX-950 treatment in the study. Decreased neopterin levels may be a further signal of a reduction in inflammation associated with HCV infection.(1)
A study of viral isolates from patients at baseline in a 14-day clinical study, also presented at the conference, found heterogeneity among viral sequences in the HCV protease domain. In vitro analysis indicated that all baseline viral isolates were sensitive to VX-950.(2)
"To date, data from early clinical studies have suggested that VX-950 is well-tolerated and can rapidly reduce HCV viral levels in patients over a short treatment period," said John Alam, M.D., Senior Vice President of Drug Evaluation and Approval at Vertex. "In addition, we now have evidence that treatment with VX-950 appeared to lead to a dramatic decline in markers of liver injury associated with viral infection."
Clinical Update
Vertex affirmed today that it remains on track to achieve key milestones in its VX-950 clinical program in the fourth quarter of 2005, including initiation of a 14-day Phase Ib combination study of VX-950 and pegylated interferon in Europe and filing of an investigational new drug (IND) application in the United States to support Phase II development of VX-950. Vertex anticipates that it will initiate a 28-day, Phase II combination study of VX-950 and pegylated interferon by year-end. Vertex expects to present additional VX-950 clinical data at two more medical conferences in the fourth quarter of 2005.
Clinical Need and Market Opportunity in HCV Infection
Chronic hepatitis C virus (HCV) infection is a serious public health concern affecting approximately 2.7 million people in the United States. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer, and ultimately, liver failure. Cirrhosis of the liver resulting from chronic HCV infection is the leading reason for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Worldwide, the disease afflicts as many as 170 million people. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV infection.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes the HIV protease inhibitor, Lexiva(R), with GlaxoSmithKline.
This press release may contain forward-looking statements, including statements that (i) VX-950 is well-tolerated, can dramatically reduce HCV viral levels over short treatment periods, and can lead to a reduction in liver injury associated with viral infection; (ii) Vertex is on track to achieve milestones in its VX-950 clinical program in the fourth quarter of 2005, including the initiation of a Phase Ib clinical trial in Europe, the filing of an IND in the U.S. and commencement of a Phase II clinical trial in the U.S.; and (iii) Vertex expects to present additional VX-950 clinical data at one or more medical conferences in the fourth quarter of 2005. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause Vertex's actual results to vary materially. These risks and uncertainties include, among other things, the risks that early clinical trial results will not be duplicated in later, larger trials, that planned clinical trials for VX-950 may not proceed as expected due to technical, scientific, or patient enrollment issues, that the planned IND filing will be delayed due to operational issues or the unavailability of required clinical data, or that, when filed, the IND will not be allowed by the FDA to open without additional studies or data which may not be readily available, and other risks listed under Risk Factors in Vertex's form 10-K filed with the Securities and Exchange Commission on March 16, 2005.
Lexiva(R) is a registered trademark of the GlaxoSmithKline group of companies.
(1) H Gelderblom et al, "Decline in Serum Neopterin Concentration Correlates with HCV RNA Decline During Administration of VX-950, a Hepatitis C Virus Protease Inhibitor," 12th Annual International Symposium on Hepatitis C and Related Viruses, Montreal Canada.
2) T Kieffer et al, "Genetic Heterogeneity in the HCV NS3 Protease of Untreated Genotype 1 Patients Has Little Effect on the Sensitivity to VX-950," 12th Annual International Symposium on Hepatitis C and Related Viruses, Montreal Canada.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Lynne Brum, Vice President, Corporate Communications and Financial Planning, (617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Media Relations Specialist, (617) 444-6470
For further information: Lynne Brum, Vice President, Corporate Communications and Financial Planning, +1-617-444-6614, or Michael Partridge, Director, Corporate Communications, +1-617-444-6108, or Lora Pike, Manager, Investor Relations, +1-617-444-6755, or Zachry Barber, Media Relations Specialist, +1-617-444-6470 all of Vertex
Company News On-Call: http://www.prnewswire.com/comp/938395.html
Web site: http://www.vrtx.com
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Hepatitis C Drug Helping Patients with Treatment-Induced Anemia
SourceURL:http://www.newswise.com
FINDINGS: A UCLA/VA study found that for Hepatitis C patients who develop treatment-induced anemia due to a key medication, it is more cost-effective to take an additional drug to help prevent anemia, rather than reducing or stopping treatment altogether, which had been the standard approach.
IMPACT: The study may lead to a new treatment standard for the one-third of Hepatitis C patients who develop treatment-induced anemia as a result of taking a key medication called ribavirin. Over 4 million Americans are infected with Hepatitis C.
AUTHORS: Dr. Brennan M.R. Spiegel, director, UCLA/VA Center for Outcomes Research and Education (CORE) and assistant professor of medicine, David Geffen School of Medicine at UCLA and VA Greater Los Angeles Healthcare System, is available for interviews.
JOURNAL: The research will appear in the Oct. 1 edition of the peer reviewed Clinical Gastroenterology and Hepatology. A PDF of the full study is available.
FUNDING: Spiegel is supported with funding by a VA HSR&D Research Career Development Award. The research was also funded by Amgen Inc. Global Health Outcomes. Dr. Spiegel has received research funding from Amgen and has served as a consultant.
BACKGROUND: Ribarvin, a common medication used in treating Hepatitis C, can cause anemia, which traditionally leads to dosage reduction and diminished treatment compliance by patients. Practice guidelines suggest that patients with anemia receive a drug called erythropoietin, which helps prevent treatment-induced anemia by increasing the number of red blood cells in the body. Erythropoietin has been proven to help patients maintain a full dose therapy of ribarvin, thus improving rates of complete cure from Hepatitis C. However, the drug is expensive, so it is unclear whether its benefits outweigh its cost.
UCLA researchers conducted a cost-effectiveness analysis and found that despite the high cost, co-therapy with erythropoietin proved more cost-effective compared to using the standard treatment in patients who experience treatment-induced anemia. Spiegel notes that a general cost-effectiveness standard accepted by society and many insurers for treating a chronic condition like Hepatitis C is roughly $50,000 per quality-adjusted life-year (QALY) gained. The study found that erythropoietin would cost an additional $16,443 per QALY gained for these patients, which is well in the acceptable cost level.
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Greasing Interferon's Gears May Pave Way to Greater Therapeutic Benefits, Fewer Side Effects
SourceURL:http://www.sciencedaily.com
Source: Washington University School of Medicine
Interferon -- a critical protein that mediates the body's defense against a wide variety of infectious agents and tumors -- may soon have greater therapeutic value as the result of a new study by researchers at Washington University School of Medicine in St. Louis.
"Essentially, we found a way to grease the gears that drive the interferon signal," says Michael J. Holtzman, M.D., the Selma and Herman Seldin Professor of Medicine and director of the Division of Pulmonary and Critical Care Medicine.
The researchers modified the structure of a protein called Stat1, which relays signals from interferon at the cell surface to genes in the cell nucleus. The modification up shifted Stat1's response to interferon.
The study will appear in the October 7, 2005 issue of the Journal of Biological Chemistry and was selected as the journal's Paper of the Week, which recognizes the top one percent of the journal's papers in significance and overall importance.
The development of a mechanism to tweak Stat1's responsiveness may prove particularly useful for patients with such disorders as hepatitis C, multiple sclerosis and many types of systemic cancer, who currently benefit from interferon treatment, but sometimes find it difficult to tolerate the side effects of the high doses required.
"We reasoned that if we could enhance the way interferon produces its beneficial defensive effects, the body could respond to its normal level of interferon and receive enhanced benefit without side effects," Holtzman says.
The group engineered a mutant Stat1 protein in which the identities of two amino acids were switched. Investigations conducted on cells growing in culture showed that the altered Stat1 proteins reacted more efficiently to the presence of both type I and type II interferons. Further tests revealed that the souped-up Stat1 recruited more of a specific protein it needs to pass on the interferon signal, essentially raising the speed limit on signal transmission.
"Ordinarily, the interferon signaling system's rate may be slowed because this helper protein interacts with Stat1 at less than the maximum amount," Holtzman says. "It's possible that the maximal setting would be harmful in the long term, because too much interferon could lead to inflammatory diseases. But we may find advantages to increasing Stat1 action in the short term using drug treatments."
Such therapies could allow physicians to turn up the effect of interferon temporarily to treat infections or other disorders and then to turn it back down to normal levels when the patient is cured.
"The potential for this 'rheo-Stat' strategy is exciting," Holtzman says. "As an example, one could improve Stat1 efficiency during the winter months in patients at risk of developing serious viral infections, including children with asthma, heart disease or compromised immune systems."
It may be possible, as well, to screen patients for levels of Stat1 responsiveness and use the same treatment strategy to correct low levels of response, according to Holtzman. The researchers are currently screening newborn infants for levels of Stat1 action and tracking their susceptibility to viral infection.
In addition, the group is studying transgenic mice engineered to carry the same Stat1 mutations that were examined in cells. In this way, the researchers can investigate the benefits of hyper-responsive Stat1 for infection control and cancer treatment in a living organism. These studies lay the foundation for the development of human treatments that use drugs that increase Stat1 responsiveness and consequently enhance the benefits of interferon produced naturally in the body or given as treatment.
Reference:
Zhang Y, Takami K, Lo MS, Huang G, Yu Q, Roswit WT, Holtzman MJ. Modification of the Stat1 SH2 domain broadly improves interferon efficacy in proportion to p300/CREB-binding protein coactivator recruitment. Journal of Biological Chemistry, October 7, 2005.
Funding from the National Institutes of Health, the Martin Schaeffer Fund and the Alan A. and Edith L. Wolff Charitable trust supported this research.
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Organ Transplant Tolerance Studied
SourceURL:http://www.dfw.com
By JAN JARVIS
Star-Telegram Staff Writer
Josie Hatch hates taking any kind of drug. But after a liver transplant in August 2003, she figured she had no choice but to take anti-rejection medication.
Through a clinical trial conducted by Baylor Institute for Immunology Research in Dallas, Hatch has dramatically reduced the number of drugs she takes.
"Now I take two pills instead of up in the hundreds," said Hatch, of North Richland Hills. "And I feel absolutely great."
Hatch is among the few transplant recipients participating in the trial that is examining ways of developing organ tolerance without immunosuppressant drugs.
Researchers want to know why some patients survive with a few drugs while others need many more. They are also studying ways to manipulate the immune system to induce greater tolerance.
A third of transplant patients do well without anti-rejection drugs, but the rest require medication, said Dr. Goran Klintmalm, chief and chairman of the Baylor Regional Transplant Institute.
"We know this because patients have stopped taking their medications on their own and about one-third are OK," he said.
Doctors can't predict who will need anti-rejection drugs, so they usually prescribe them for all transplant patients. The study aims to help doctors identify which patients can forgo medications.
"We may not be able to get all of the patients off the drugs, but even if we reduced them from two to one once a day or every other day, that is a huge advance," Klintmalm said.
Side effects associated with immunosuppressant drugs include hand tremors, high blood pressure, decreased kidney function and weakening of bones. The cost can surpass $10,000 annually. For some patients, the expense leads them to abruptly stop taking the drugs, which can lead to complications.
Researchers hope that by reducing transplant rejection, more organs will become available to the many patients on waiting lists.
In Texas, 1,434 people are waiting for liver transplants, according to the United Network for Organ Sharing in Richmond, Va.
More than 4,500 liver transplants have been performed since Baylor's liver transplant program debuted in 1985.
Hatch, 53, needed a new liver after she was diagnosed with hepatitis C. She believes she contracted the disease from a blood transfusion in the 1980s. She has been participating in the trial since 2003.
But to look at her now, she said, "you'd never know I had a liver transplant."
Liver transplant trial
The study is open only to patients about to receive transplants. For information, call (800) 4BAYLOR or (800) 422-9567.
SOURCE: Baylor University Medical Center at Dallas
ONLINE: www.baylorhealth.com
www.unos.org
Jan Jarvis, (817) 548-5423
jjarvis@star-telegram.com
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Genelabs Presents Data on Two Preclinical Candidates at the 12th International Symposium on Hepatitis C and Related Viruses
SourceURL:http://biz.yahoo.com
REDWOOD CITY, Calif., Oct. 3 /PRNewswire-FirstCall/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB - News) announced the presentation of data on two internally-developed hepatitis C virus (HCV) preclinical development candidates at the 12th International Symposium on Hepatitis C and Related Viruses in Montreal. Genelabs preclinical development candidates GL59728 (728) and GL60667 (667) are highly potent inhibitors of the hepatitis C replicon, demonstrating inhibitory concentrations of 170 and 37 nanomolar, respectively, and 16 and 28 nanomolar for inhibition of the HCV polymerase. Compounds 728 and 667 are both non-nucleoside HCV polymerase inhibitors, although the discovery of each resulted from optimization of distinctly different chemotypes. Because of this structural distinction, as well as certain advantages inherent to each, Genelabs believes that both merit further development. Compound 667, in particular, is a member of a large class of closely related compounds discovered by Genelabs, a number of which appear to be among the most potent inhibitors of the HCV polymerase yet described.
In addition to the potency data presented at the symposium in Montreal, Genelabs presentation also noted that the compounds have demonstrated good DMPK (drug metabolism and pharmacokinetic) properties in multiple species -- mice, rats, monkeys and dogs. For example, the canine data showed that the compounds had half-lives of 5.1 and 3.2 hours, with oral bioavailability of 56% and 47% for compounds 728 and 667, respectively. Based on this data, Genelabs believes that these compounds may be suitable for once-a-day dosing, which would provide a competitive advantage over other published compounds currently in development as inhibitors of the hepatitis C virus polymerase.
Recently, Genelabs completed 1-day and 7-day sub-acute toxicity studies in two different species. Based on the safety profile for both compounds from interim data from these studies, and their favorable potency and DMPK attributes, both compounds have thus far met Genelabs' criteria for advancement into IND-enabling preclinical studies. Genelabs retains all rights to both of the preclinical development candidates presented.
About Hepatitis C
The Hepatitis C virus is an infectious and potentially fatal virus that can be contracted through blood and bodily fluid contact. The virus attacks the liver and can cause liver inflammation, liver scarring, liver failure and liver cancer. In most cases, the body is not able to fight off the infection and the infected individual becomes a chronic carrier of HCV. According to the World Health Organization, as many as 170 million people worldwide have chronic HCV infection. The United States Centers for Disease Control and Prevention estimates that approximately 2.7 million people in the United States are chronically infected with HCV and that each year there are approximately 25,000 new cases of HCV infection and approximately 8,000 to 10,000 deaths from hepatitis C complications. Liver failure resulting from chronic HCV infection is now recognized as the leading cause of liver transplantation in the United States. The current standard of care for treatment of HCV is a combination of pegylated interferon alpha and the nucleoside analogue ribavirin, typically given over a number of months, with interferon injected once weekly and ribavirin given orally once daily. This treatment regimen is effective only in approximately 50% of patients infected with HCV genotype 1, the genotype most prevalent in the United States. The interferon/ribavirin treatment has significant toxicities, most importantly severe anemia and psychiatric effects. There are no other drugs or biologics approved by the FDA for treatment of HCV. As a consequence, the pool of patients continues to grow.
About Genelabs
Genelabs Technologies, Inc. is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. We have built drug discovery and clinical development capabilities that can support various research and development projects. Genelabs is currently concentrating its capabilities on developing a late-stage product for lupus, discovering novel compounds that selectively inhibit replication of the hepatitis C virus and advancing preclinical development of compounds from this hepatitis C virus drug discovery program. We believe that these high-risk, potentially high reward programs focus our research and development expertise in areas where we have the opportunity to generate either first-in-class or best-in-class products that will address diseases for which current therapies are inadequate. For more information, please visit www.genelabs.com.
NOTE: Genelabs® and the Genelabs logo are registered trademarks of Genelabs Technologies, Inc.
NOTE ON FORWARD LOOKING STATEMENTS AND RISKS:
Genelabs cautions that compounds in preclinical studies are at an early stage of development and there is no assurance that any of these compounds will successfully pass all the requirements necessary for studies in humans. This press release contains forward-looking statements including statements regarding the progress of Genelabs' hepatitis C virus research programs, the potency of compounds being developed by Genelabs and elsewhere, and the potential future properties of the compounds. These forward-looking statements are based on Genelabs' current expectations and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation, failures or setbacks in our HCV research programs or in our collaboration with Gilead Sciences, Inc.; progress and announcements by competitors regarding their HCV programs; de-listing from the Nasdaq National Market; fluctuations in Genelabs' stock price; events which reduce Genelabs' future prospects; unexpected expenses and Genelabs' capital requirements and history of operating losses. Please see the information appearing in the Genelabs' filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, under the captions "Risk Factors" and "Forward- Looking Statements," for more discussion regarding these uncertainties and risks and others associated with the company's research programs, early stage of development and other risks which may affect the company or cause actual results to differ from those included in the forward-looking statements. Genelabs does not undertake any obligation to update these forward-looking statements or risks to reflect events or circumstances after the date of this release.
Source: Genelabs Technologies, Inc.
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October 4th, 2005
Impact of Past Alcohol Use in Treating Hep C
SourceURL:http://www.gastrohep.com
Median daily alcohol use more than 30 g/day is associated with failure to respond to pegylated interferon and ribavirin for treatment of Hepatitis C, finds the most recent issue of Alimentary Pharmacology & Therapeutics.
Studies have shown that past alcohol consumption reduces response rates in patients with chronic Hepatitis C treated with interferon monotherapy.
Dr Chang and colleagues conducted a single center study in patients undergoing treatment with pegylated interferon and ribavirin.
The research team clarified the importance of alcohol consumption on response rates in these patients.
The team calculated the median daily alcohol consumption, determined by previously validated method, as well as quartiles of alcohol consumption.
Univariate and binary logistic regression analyses were performed using treatment response status as the dependent variable.
Predictors of response by regression analysis included non-genotype 1 status – Alimentary Pharmacology & Therapeutics
The researchers reported that overall, in an intention-to-treat analysis, 34 of 115 patients responded to treatment.
Black patients, especially those with Hepatitis C virus genotype 1, high viral load and low alanine aminotransferase were significantly less likely to respond.
The team noted that predictors of response by regression analysis included alcohol less than 30 g/day, non-genotype 1 status and non-black race.
Dr Chang's team concluded, "Median daily alcohol use more than 30 g/day is associated with failure to respond to pegylated interferon and ribavirin for treatment of Hepatitis C."
"Past alcohol use should be evaluated when considering treatment for Hepatitis C."
Aliment Pharmacol Ther 2005: 22(8): 701
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Hepatitis C Trial Begins
SourceURL:http://www.fremontneb.com
Beverly J. Lydick/Tribune Staff
Robert Ridder bounced back from cancer but was never the same after contracting hepatitis C, his daughter testified Monday during the opening day of the first trial stemming from the nation's largest outbreak of the disease.
Ridder and his wife, Verena, of Fremont are suing former Fremont oncologist Tahir Javed and his nurse, Linda Prochaska, claiming their unsanitary medical practices resulted in Robert Ridders' contraction of hepatitis C in 2002. The Ridders are seeking unspecified damages due to damage to their marriage and loss of quality of life.
Cheryl Ridder Sudbeck, the eldest of the Ridders' four children and publisher of newspapers in Howells and North Bend, said her father farmed near Dodge until 2003, farrowing hogs, feeding cattle and raising corn and soybeans. In July 2000, Ridder was diagnosed with non-Hodgkins leukemia, received chemotherapy at the Fremont Cancer Clinic run by Javed, and was declared cancer-free.
A divorced mother of two at the time of her father's cancer treatment, Sudbeck called him her "knight in shining armor."
"He was the same man he was before (the chemotherapy)," she said. "The same guy I needed when I needed someone as a single parent."
In October 2002, Ridder was among 612 Fremont Cancer Clinic patients to receive letters from the Nebraska Department of Health recommending a screening test for the hepatitis C virus. Ridder learned he had the virus in November 2002.
Sudbeck said the hepatitis C infection and treatments have changed her father.
"After the hepatitis C, he got weaker, he got tired," she said. "The hepatitis C robbed me of the ability to watch my dad grow old gracefully. He aged 10 years in that one year. He's never come back."
Sudbeck said the diagnosis angered the whole family.
"At first, we blamed the nurse," she said. "But that nurse has to answer to someone, someone you trust to cure you, not send you home with something else."
In January 2003, Ridder began taking treatments to counteract the disease. The treatments, which involved injections and oral medications, lasted six months and were directed by Omaha hepatologist Mark Mailliard.
While Ridder is considered a sustained responder, indicating the absence of live hepatitis C virus in his system, Sudbeck said Verena Ridder still worries about contracting the disease through marital relations, even though physicians agree such a transmission, although possible, is unlikely, especially with the use of a condom.
"No one can tell us she absolutely will not catch hepatitis C," Sudbeck said. "She'd rather die than expose any of us."
The Ridders' family practitioner, Dr. Jeffry R. Rapp, also testified during the trial's first day.
Rapp, the Ridders' primary care physician since 1997, talked to Ridder about the virus shortly after he received the health department's letter in 2002.
"I told him the hepatitis C virus would not go away on its own, that it could result in death, and that he had a long life ahead of him and should go in for treatment," Rapp said.
Ronald J. Palagi, the Ridders' attorney, claimed in opening statements they face medical bills, emotional stress and "the anguish of having friends and neighbors look at you and not knowing what to do."
Attorneys Mark Christensen and Greg Thomas represent Javed and Prochaska, respectively. Javed left the United States in July 2002 and now resides in Pakistan. Prochaska attended Monday's proceedings. Both have lost their licenses to practice in Nebraska.
Christensen cautioned the jury to be sensible in their deliberations.
"(Palagi) wants you to be emotional about this case, to decide with your emotions rather than logic," he said.
Christensen questioned whether the effects of that treatment resulted in Ridder's inability to maintain his farming operation, noting the farrowing operation had closed and the auction planned well in advance of the 2002 diagnosis. The Ridders sold their farm home and the surrounding 10 acres in 2003 and built another home in Fremont.
The trial continues today.
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Hepatitis C Hinders HIV Treatment
SourceURL:http://www.rednova.com
By Bowden, Rachel
Antiretroviral treatment to restore the immune function of patients with HIV is less effective if they also have hepatitis C, according to a US study.
Infection with hepatitis C reduces the effectiveness of highly active antiretroviral therapy (HAART) by around a fifth, the study showed.
The researchers carried out a meta-analysis of eight trials that studied how HIV patients responded to at least 12 months of HAART.
They looked at data from 2,179 patients with HIV and hepatitis C and 4,037 patients with HIV only. The patients' response to HAART was expressed as an increase in CD4 cell count.
The researchers found that although the CD4 cell count of patients infected with both hepatitis C and HIV did increase after 48 weeks of HAART, this increase was around a fifth lower than that seen in patients with HIV only.
They concluded that HIV-infected patients were likely to have a better immunological response to antiretroviral therapy if they were not co-infected with hepatitis C.
They added that this finding could have implications for how HIV is treated in patients who are also infected with hepatitis C.
They suggested that HAART should be initiated earlier in patients who had hepatitis C as well as HIV because of their reduced immune response. The findings could also prompt earlier treatment of hepatitis C in these patients.
Around 30 per cent of patients with HIV in the US are also infected with hepatitis C.
Clin InfectDis2005; 41: 713-20
racket.bowden@haynet.com
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Vertex to Curtail Funding of Two Drugs
SourceURL:http://biz.yahoo.com
Vertex Pharmaceuticals to Refocus Clinical Program, Sharply Reducing Investment in Two Drugs
CAMBRIDGE, Mass. (AP) -- Biotech firm Vertex Pharmaceuticals Inc. said Tuesday that it plans to sharply reduce its investment in two clinical-stage treatments -- one aimed at improving hepatitis C therapies and another at psoriasis -- to marshall its funds for more commercially promising drugs.
Vertex said it will instead concentrate its resources in 2006 on mid-stage trials of its direct hepatitis C drug and its rheumatoid arthritis therapy. In addition, the company plans to start clinical studies for a drug to treat cystic fibrosis.
The pharmaceutical firm added that it will continue to collaborate with other companies to develop small molecule drugs for cancer and HIV, the virus that causes AIDS.
Both the drugs for which Vertex is curtailing funding are currently in Phase II trials. The company said it plans to complete two current studies on merimepodib -- the drug to enhance the effectiveness of hepatitis treatments -- but does not plan any further trials.
Vertex said it has completed dosing for a mid-stage trial of the psoriasis drug, but did not provide other details in a news release.
The company's shares rose 30 cents, or 1.2 percent, to $24.68 in recent after-hours trading.
Vertex's Clinical Pipeline
VX-950:
VX-950 is an investigational oral HCV protease inhibitor and is one of the most advanced in a new class of medicines for the treatment of chronic HCV infection. In a 14-day, Phase 1b study concluded earlier in 2005, VX-950, administered as a single agent, produced a rapid and dramatic reduction in HCV-RNA in HCV patients.
Vertex is on track to expand its clinical program in the fourth quarter of 2005 and to conduct a variety of key clinical studies with VX-950 in 2006, including a one-month study in combination with pegylated interferon, and a three-month study in combination with pegylated interferon that will be designed to evaluate sustained viral responses in HCV-infected patients.
Merimepodib (MMPD):
Vertex is conducting two Phase II clinical studies with MMPD. Vertex is continuing to conduct the ongoing METRO study, a triple combination, Phase II trial that has enrolled 356 patients who were non-responsive to a combination of pegylated interferon and ribavirin, as well as a 28-day viral kinetic study of MMPD in combination with ribavirin only. Vertex plans to complete the METRO study in 2006 and is on track to complete the Phase II, 28-day viral kinetic study in the fourth quarter of 2005. The company does not currently plan to conduct additional MMPD clinical studies after these two ongoing clinical trials are completed.
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October 5th, 2005
Hepatitis C, the "Hidden Killer" - MP
SourceURL:http://www.pioneernow.co.uk
LABOUR MP Betty Williams has supported calls for improved diagnosis and treatment for people living with Hepatitis C.
Speaking before International Hepatitis C Awareness Day, Betty Williams said: "Hepatitis C is a hidden killer which destroys lives and leads to cirrhosis and cancer if left undetected.
"I support calls to improve the diagnosis of this killer condition and want to add my voice to those of patients and doctors throughout the UK and Europe, calling for better testing and treatment for people living with Hepatitis C.
"I will be showing my support for International Hepatitis C Awareness Day by writing to UK Ministers calling for more action to tackle this chronic condition."
Hepatitis C is a hidden killer, affecting around half a million people throughout the UK, many of whom are unaware that they are carrying this potentially fatal virus. That's around 840 per constituency.
The Hep C virus is contracted by blood to blood transfer and can be passed on through un-screened blood transfusions, insufficiently sterilised medical and dental equipment, drug paraphernalia such as needles, straws and rolled-up notes used to inhale powder, and tattoo-needles.
If caught in time, treatment can often prevent the virus doing irreparable damage to the liver and leading to further complications.
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Liver Cancer Up, Other Kinds Improving
SourceURL:http://www.omaha.com
Liver cancer seems to be on the rise, a blip of bad news in the nation's otherwise optimistic annual report on cancer that shows survival continuing to improve.
Overall, Americans' death rates from cancer have dropped 1.1 percent a year since 1993, a trend that continued in 2002 - the most recent figures available - researchers reported Tuesday in the Journal of the National Cancer Institute.
Rates of new cases are holding steady for men. But a small but stubborn increase in female diagnoses continues - 0.3 percent a year since 1987 - fueled mostly by steadily rising rates of breast and thyroid cancer, melanoma and lymphoma.
Surprisingly, another fairly rare malignancy is becoming more common: liver cancer. The report found annual increases of 3 percent among white men, 4.5 percent among black men, 3.7 percent among white women and 5 percent among Hispanic women.
It's not clear what's spurring the rise; one factor may be hepatitis infections.
"It's a concern worldwide," said Brenda Edwards of the NCI, who co-wrote the report with scientists from the Centers for Disease Control and Prevention, American Cancer Society and North American Association of Central Cancer Registries.
Another concern is ensuring that patients receive care based on the latest expert guidelines. The report shows growing numbers of patients do, which is considered a significant reason why deaths are dropping. But there are gaps, including:
More breast cancer patients are getting just the tumor removed instead of the entire breast, but a significant number skip the follow-up radiation recommended to kill any leftover cancer cells.
Patients 65 or older are less likely to receive recommended chemotherapy after surgery for advanced colorectal cancer.
Only 34 percent of female Medicare beneficiaries had their ovarian cancer removed by a gynecologist oncologist, a specialist considered to have better outcomes than more general surgeons.
While there is a dispute over what is the most appropriate prostate cancer treatment, in general black men receive less aggressive care than white men.
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Family Talks about Decision to Leave Farming After Father Was Treated for Hepatitis C
SourceURL:http://www.fremontneb.com
By Beverly J. Lydick/Tribune Staff
Robert and Verena Ridder no longer farm.
Whether their decision to stop was a business move or the result of hepatitis C was debated Tuesday as the first trial stemming from the 2002 outbreak of the virus continued in Dodge County District Court.
The Ridders are suing former Fremont oncologist Tahir Javed and his nurse, Linda Prochaska, claiming the hepatitis C infection Robert Ridder contracted at Javed's cancer clinic damaged their quality of life.
Susan Ridder, a psychiatric nurse at Immanuel Hospital, testified her father was "ridiculously healthy" prior to a diagnosis of non-Hodgkin's lymphoma in July 2000.
She said her father handled the subsequent chemotherapy at the Fremont Cancer Clinic without complaint.
"He worked really hard to reassure us that it was no big deal," she said. "That's the Ridder way. If they're your problems, you have to deal with them."
Robert Ridder learned he had hepatitis C in November 2002.
Susan Ridder confirmed her parents, who farmed near Dodge, already had sold their hogs by then and were arranging a sale of some farm equipment, keeping a tractor, loader and other items to feed their cattle. She said her parents did not discuss selling the homestead at that time. David Ridder, 34, of Fremont testified that prior to the hepatitis C treatments, his parents had walked for exercise, averaging three or four miles a day.
"I expected (the cancer chemotherapy) to really slow (Robert) down," David Ridder said. "It just didn't."
David Ridder said his father didn't handle the hepatitis C treatments as well, noting what were "inconvenient" headaches prior to the treatments later became "debilitating."
Talk of selling the farm home started in late February or early March of 2003, after the treatments began, David Ridder said.
His parents' house and the surrounding 10 acres sold a month after being listed, he said.
Robert and Verena Ridder now live in Fremont. A relative farms the 350-400 acres they still own, David Ridder said.
Mark Christensen, Javed's attorney, asked Mike Coday Jr. of Howells about Robert Ridder's employment at Howell Fab Inc.
Coday is co-owner of the plant where Ridder has worked as a pipe threader since January 2002.
Coday said he hired Ridder the day he applied.
"He would come to work, sick or not sick," Coday said. "He'd come in early and stay late if he had to."
After beginning the hepatitis C treatments in January 2003, Ridder began napping over the noon hour and sometimes left work early, Coday said.
But Christensen said annual summaries of Ridder's work show an steady increase in overtime hours.
"He's on a pace to exceed even 2004 this year," Christensen said.
Dr. Stephen Skulsky, a clinical psychologist from Omaha, evaluated the Ridders in June.
The psychologist said Tuesday that Robert Ridder told him dealing with hepatitis C had made him "stronger."
"Someone who is trying to make a case that he'd been damaged would not say he's been made stronger by it," Skulsky said.
No amount in damages has been specified in the lawsuit. According to a Feb. 9 story issued by The Associated Press, Javed's malpractice insurance policy has set limits of $200,000 per claim and an annual aggregate of $600,000.
Nebraska has a $1.75 million cap on medical malpractice claims.
The trial continues today.
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October 6th, 2005
Test Predicts Risk of Liver Scarring After Transplant, Study Shows
http://www.sciencedaily.com/
CHAPEL HILL -- An estimated 20 percent of people with chronic hepatitis C who receive a liver transplant will develop advanced cirrhosis, scarring of the new organ severe enough to impair its ability to function normally within five years of transplantation.
A new study from the University of North Carolina at Chapel Hill School of Medicine may have found a way to identify those at greatest risk, thereby allowing doctors to decide who should receive treatment that could save the transplanted organ. The new findings appear in the October issue of the journal Liver Transplantation.
The research found a laboratory test that shows activation of a certain type of liver cell -- hepatic stellate cells -- to be useful in determining high risk for developing cirrhosis.
"Right now, there are no reliable tests for identifying the group that's at high risk," said lead author Dr. Mark W. Russo, assistant professor of medicine in the Division of Gastroenterology and Hepatology at UNC. "The reason you want to identify that group is because there are some people who will not go on to develop cirrhosis from hepatitis C after liver transplant and the therapy has a lot of side effects and is also very expensive."
This antiviral drug therapy is effective in only 10 percent to 30 percent of liver transplant recipients, the research team reported. Moreover, side effects, including anemia, cause roughly the same percentage of patients to stop the treatment.
Russo and collaborators from UNC and the University of Florida focused on hepatic stellate cells (HSCs), which normally store vitamin A in the liver. But they produce collagen and other proteins that can lead to fibrosis, or scarring, in patients infected with hepatitis C virus.
The research team hypothesized that a known valid biomarker of HSC activation -- alpha smooth muscle actin (alpha-SMA) -- could predict which patients would later develop fibrosis.
The study involved 46 patients with hepatitis C virus who received liver transplants between 1997 and 2001. The patients were divided into two groups: those who developed advanced fibrosis within two years of liver transplant and those who developed mild or no fibrosis in the same period.
Liver tissue samples from four months, one year and two years post-transplant were scored in the laboratory for alpha-SMA. The results showed HSC activation to be significantly higher in the four-month biopsies for those who developed advanced fibrosis within two years. "These results are exciting because they suggest for the first time that this biomarker could help us identify liver transplant recipients with hepatitis C who are at high risk for progressing to advanced fibrosis. But it would be important to confirm this in a larger independent, prospective study," Russo said.
UNC co-authors along with Russo include Dr. Michael Fried and Dr. Roshan Shrestha, professors of medicine within the Division of Gastroenterology and Hepatology; and Robert Schoonhoven, laboratory research specialist in the UNC School of Public Health's department of environmental sciences and engineering. Co-authors from the University of Florida include Dr. Roberto Firpi, clinical assistant professor of medicine, and Dr. David Nelson, assistant professor of medicine.
Support for the research came from the National Institute of Environmental Health Sciences, a component of the National Institutes of Health.
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Ulster Company Launches Needlecatcher Safety Product
http://www.belfasttelegraph.co.uk/
By Andrea Clements
A new device has been developed by a Warrenpoint company in a bid to protect surgeons from needlestick injuries which could cause HIV and hepatitis.
Clonallon Laboratories is to launch its Needlecatcher device internationally at Medica - a large scale medical/healthcare exhibition - in Dusseldorf next month.
The single use device helps medical staff manipulate the needle and covers and holds it securely for safe disposal.
Devised by Northern Ireland consultant surgeon Dermot Dempster, Needlecatcher, which has been approved by European and US regulatory authorities, will form part of a sterile procedure pack with surgical items including scissors, forceps, drapes and swabs.
Clonallon is the only company in Northern Ireland to provide the packs.
Mr Dempster said: "Our market research has established that Needlecatcher is the only device of its type in the world.
"It offers surgeons, doctors and medical students an extremely effective means of protecting themselves from blood borne conditions such as HIV and Hepatitis when suturing patients during and after surgery.
"The new device is a perfect fit for our existing product range of surgical packs."
Its clients include hospitals in Northern Ireland and the Republic.
Alan Hingston, Invest NI's trade director, said Medica was the best international platform for Northern Ireland companies wishing to reach potential customers in life sciences, healthcare and medical devices.
Clonallon will display its new product on an Invest NI capability stand at Medica.
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Hepatitis C Threat Worried Wife
http://www.fremontneb.com
By Beverly J. Lydick/Tribune Staff
An Omaha physician specializing in the treatment of hepatitis C testified Wednesday in Dodge County District that sexual transmission of the virus is very unlikely, but possible.
Dr. Mark Mailliard said he has treated hundreds of patients with hepatitis C, including approximately 100 infected with genotype 3A, the particular strain identified in a 2002 hepatitis outbreak in Dodge County.
One of Mailliard’s patients is Robert Ridder of Fremont. Ridder, 62, and his wife, Verena, 59, are suing former Fremont oncologist Tahir Javed and his head nurse, Linda Prochaska, for damages, including loss of consortium, resulting from Robert Ridder’s contraction of hepatitis C at the Fremont Cancer Clinic in 2000.
Unsanitary medical practices performed there during Robert’s chemotherapy treatments caused the infection.
Robert and Verena both testified Wednesday they no longer engage in martial relations due to fear of transmitting the hepatitis C virus. The couple has been married nearly 40 years.
“Our marriage is still good,” said Verena, “but not in every way it should be.”
Robert said the absence of physical contact with his wife is his greatest loss since learning in 2002 that he’d contracted the virus.
Mailliard testified he’d never seen a transmission of hepatitis C in a monogamous relationship and that he told the couple it would be “very unlikely any transmission would occur” as long as Robert Ridder remained a sustained responder, or one with no detectable virus after six months.
“If the hepatitis C should come back,” Mailliard said, “there’s a possibility.”
The physician said Robert Ridder has a four percent chance of a reoccurrence.
That is enough to worry Verena, who twice tested negative for the virus before telling her husband, “I can’t do this anymore.”
Confirming Wednesday she’d been told the chances of contracting the virus are remote, she said, “There’s always still that chance. I work in a daycare. I work with babies. It’s a contagious disease.”
Verena said her husband changed during his six-month treatment for hepatitis C in 2003.
“He was cold all the time,” said Verena. “He found it hard to eat, he was short-tempered, he wanted to be by himself. I didn’t feel he wanted me around. When he was done, he looked like a very old man.”
Robert said he’d been warned by his family practitioner, Dr. Jeffrey Rapp, that the treatments were going to be rough.
“I thought they couldn’t be any worse than the cancer treatments,” Robert said. “I was pretty much wrong.”
The couple, who lived near Dodge at the time, had already sold their livestock and rented their farm ground to a relative. In March 2003, they decided to sell their rural home.
“The treatments were so bad, I though I was going to die,” Robert said. “We decided it would be better to sell the 10 acres and move to Fremont … I was in no shape to take care of the place. If the hepatitis C treatments didn’t work, Verena couldn’t take care of it.”
Attorneys for the plaintiffs rested their case Wednesday. The defense will begin its case when the trial continues Friday.
Tribune reporter Don Bowen contributed to this story.
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CANADA : "Crack Users Say Pipe Program Helps Them Stay Healthy"
Ottawa Citizen
Raina Delisle
Nearly a year ago, the city of Ottawa augmented its needle-exchange program, which began in 1991, with a controversial safer-inhalation initiative to distribute clean pipe kits to crack cocaine users. Ottawa adopted the program based on a report that former medical officer of health, Dr. Robert Cushman, presented to the city.
Cushman advocated the distribution of crack pipes, tourniquets and other drug paraphernalia to Ottawa drug users to curb the spread of HIV and hepatitis C. The city estimates there are between 3,000-5,000 injection drug users in town, about 80 percent of whom have smoked crack cocaine. Roughly 75-80 percent of drug users have hepatitis C, and approximately 20 percent have HIV.
Ottawa has 12 partner agencies providing needle-exchange services, but not all health and community centers have joined the pipe-distribution effort. According to Cushman's report, "crack smokers are at increased risk for blood-borne infections and sexually transmitted diseases. Sharing of contaminated equipment increases risk of transmission" because hot pipes burn and split users' lips, allowing infected blood to be transferred when the next smoker uses the pipe.
Since April, the city has distributed about 1,500 pipe kits that include condoms, lip balm, chewing gum, a pipe-disposal mechanism and information on drug use and prevention. Dr. David Salisbury, Ottawa 's current medical officer of health, said a Health Canada study showed users enrolled in needle-exchange programs are less likely to acquire HIV. A similar study is assessing the safer-inhalation program.
Ottawa 's Site Program, based at the Sexuality Center at 179 Clarence St. , dispenses clean needles and crack kits. The center also has a mobile van, which travels from 6 p.m. - midnight , and outreach workers who visit drop-in centers and patrol the Byward Market area. The safer-inhalation program has an estimated annual cost of $2,500 Canadian ($2,129 US), according to Cushman.
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