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Week Ending: August 4th , 2007
Alan Franciscus
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July 28th, 2007
Visible light pulses to zap HIV, Hepatitis C
http://in.news.yahoo.com
By ANI
London, July 28 (ANI): US scientists have found that an intense pulse of visible light kills viruses lurking in biological samples more effectively and safely than other alternative methods, including therapies with UV irradiation or microwaves.
The researchers say the pulse produces mechanical vibrations in the virus shell, also called capsid, as a result of which, the virus is irreversibly damaged and disintegrated.
They say that the new technique may help destroy human immunodeficiency virus (HIV) and Hepatitis C.
The traditional UV irradiation technique can cause mutations, which eventually make the microorganisms resistant. UV light can also damage the DNA of surrounding healthy cells.
Microwaves, on the other hand, are even less promising as the water surrounding in and around a microorganism absorbs the energy from the radiation, and it does not reach the virus.
But visible light can overcome this problem, Kong-Thon Tsen of Arizona State University and his colleagues at Johns Hopkins School of Medicine have discovered. They say that just a single pulse of light is enough to destroy the viruses completely.
The researchers have already tested the efficacy of the technique in experiments in which they applied pulses of purple-coloured light, lasting just 10-15 seconds, to viruses called M13 bacteriophages.
The "power density" of the laser was just 50 megawatts per square centimetre, low enough to leave surrounding human cells and tissue undamaged, but high enough to produce large-amplitude vibrations in a virus's capsid. It was also too low to cause genetic mutations, meaning the virus would not build up resistant to the treatment over time.
According to researchers, the technique may be used to disinfect blood or other biological samples in hospitals.
"In addition, we believe that the method may be especially important in designing novel treatments for blood-borne viral diseases," the New Scientist quoted Tsen as saying.
"For example blood dialysis allows us to irradiate a patient's blood outside the body and potentially cleanse it of infectious virus particles before reintroducing it into the patient. In this way, we could reduce mortality associated with diseases like hepatitis C and AIDS," he added.
The researchers are now contemplating testing the efficacy of the technique in killing a wide range of deadly viruses including HIV and hepatitis C.
"We also plan to conduct further tests on the effects of the low-power visible laser on mammalian cells to determine any potential side effects and confirm that it selectively kills viruses," said Tsen. (ANI)
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World Hepatitis Day: Endemic health problems preventable and treatable
http://www.dailytimes.com.pk
Staff Report
KARACHI: Combined efforts are needed in order to combat Hepatitis B and C, speakers said at a seminar organized at the Aga Khan University (AKU) Auditorium on the occasion of World Hepatitis Day Saturday.
The programme was organized by the Pakistan Society for the Study of Liver Diseases (PSSLD), in collaboration with the World Congress of Gastroenterology Karachi Training Centre, AKU, and the Pakistan chapter of the international forum Advancing Clinical Treatment of Hepatitis B Virus (ACT-HBV)
Speakers hoped that the PSSLD would provide a platform for a healthier and hepatitis-free Pakistan. They concluded that Pakistan’s endemic health problems, infections in particular, were preventable and treatable.
PSSLD president and the AKU medicine department chairman, Prof. Dr Wasim Jafri, urged physicians and trainee doctors to play their part in preventing, diagnosing and treating liver diseases by keeping themselves updated.
Speakers at the seminar expressed concern that the country lacked adequate sanitation and hygienic water supply in major cities. The rural situation was much worse. Unsatisfactory sanitary conditions, the lack of clean drinking water and a defective sewage disposal contributed towards the spread of hepatitis A and E.
Chronic liver disease due to hepatitis C, B and D viruses is rampant in Pakistan, they said, adding that the prevalence of Hepatitis C and Hepatitis B in the country was six percent and four percent, respectively.
The first session, dedicated to Hepatitis B, was chaired by Dr Wazir Shaikh, a professor of medicine at the Chandka Medical College, Larkana. The government’s perspective was presented by the prime minister’s Hepatitis Control Programme Manager, Dr Sharif Khan, while the prevalence data was presented by Pakistan Medical Research Council (PMRC) executive director, Dr Huma Qureshi. Prof. Dr Jafri presented a liver specialist’s viewpoint in the management of Hepatitis B, and Prof.
Raana Masood from the Dow University of Health Sciences (DUHS) shared the Sarwar Jehan Zuberi Liver Unit’s concept and experience in the public sector.
The session on hepatitis C was chaired by Prof Saeed Khokhar of the PGMI Services Hospital, Lahore. Prof. Dr Jafri and Brig. Dr Masood Siddiq (professor and consultant at the Fauji Foundation Hospital, Rawalpindi) he spoke about the national and global burden of Hepatitis C. AKU’s Dr Mohammad Salih highlighted the effect on other organs. A paper on global best practices management of the disease was presented by Dr Muzaffar Gill (a professor at the Shifa International, Islamabad) and AKU’s Dr Zaigham Abbas.
The session on hepatitis A and E was chaired by Prof Saeed Qureshi of DUHS and Dr Muazzamuddin, a consultant gastroenterologist from Quetta. The national Hepatitis A burden was highlighted by AKU’s Dr Uzma Shah, and Dr Sadik Memon of ISRA University, Hyderabad, who presented hepatitis A vaccination data.
Information about Hepatitis E was given by AKU’s Dr Shahab Abid. High maternal mortality in acute hepatitis E was highlighted by Dr Javed Iqbal Farooqi of the PGMI Lady Reading Hospital, Peshawar. AKU’s Dr Ashfaq Ahmed highlighted the development of the hepatitis E vaccination.
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July 29th, 2007
Siemens Medical Solutions Diagnostics Announces Enhanced Liver Fibrosis Test For Europe
http://www.medicalnewstoday.com
Siemens Medical Solutions Diagnostics announced the availability of its Enhanced Liver Fibrosis (ELF) test, the first CE-marked, standardized non-invasive blood test for assessing the status of liver fibrosis. The Siemens ELF test was first validated in an international multicenter cohort study and is now available through iQur, Ltd., Southampton, UK, as a testing service for patient management.
Chronic liver disease, resulting from alcoholic liver disease, fatty liver, or viral hepatitis, is increasingly recognized as a major cause of morbidity and mortality. Standard liver function tests do not accurately reflect the true extent of fibrotic damage or, in many cases, may detect it too late.
Fibrosis is a common outcome in chronic liver disease, with progression to cirrhosis accounting for thousands of deaths each year. Liver biopsies are routinely performed to assess liver damage (fibrosis) and to try to monitor the effectiveness of pharmaceutical drugs in tackling the disease. Performing a liver biopsy is a hazardous, expensive and painful experience for the patient and does not always provide accurate results because of difficulties in sampling and interpretation. Fibrosis is not evenly distributed throughout the liver and because such a small amount of biological material is sampled, 55 percent of 15mm biopsies may be misclassified. Larger biopsies can be performed but even with 25mm sections, 45 percent will be erroneous.
Because ELF uses a blood sample rather than a biopsy, it can be used routinely for the same patient and helps monitor progression of fibrosis in the patient's liver. "The benefit of the Siemens ELF test is that it can be used repeatedly, with minimal patient discomfort, to monitor disease progression and response to therapy," said David Okrongly, senior vice president, Molecular Business Unit, Siemens Medical Solutions Diagnostics. "It's the first standardized laboratory method for assessment of liver fibrosis which requires only a simple sample of blood. We are delighted that iQur now offers this ELF test as an incremental service for physicians managing patients with chronic liver disease."
The ELF test combines three serum biomarkers which have been shown to correlate to the level of liver fibrosis assessed by liver biopsy. These biomarkers include Hyaluronic acid (HA), Procollagen III amino terminal peptide (PIIINP) and Tissue inhibitor of metalloproteinase 1 (TIMP-1). The algorithm measures each of these markers by immunoassay, to create an ELF score. Sampling for the ELF test can be performed in a physician's office or health center, avoiding the need for a patient to travel to a hospital.
iQur® is a specialty pharmaceutical company at the forefront of international breakthroughs in the detection, treatment and monitoring of Hepatitis C and other liver diseases. Founded in 2003 by liver disease specialist Professor William Rosenberg, iQur is based in Southampton General Hospital, Southampton, UK and has a second therapeutics research office at the University of Leeds, UK. To discuss using the ELF Test in your healthcare center, contact Tanya Dominey, Diagnostics Operations - tanya.dominey@iqur.com . Further information about iQur can be found at http://www.iqur.com .
Siemens Medical Solutions Diagnostics offers a broad portfolio of performance-driven diagnostic solutions that assist in the diagnosis, monitoring and management of disease. Products and services bring together the right balance of science, technology, and practicality across the healthcare continuum to empower medical professionals with the vital information they need to deliver better, more personalized healthcare to patients around the globe. Visit us at http://www.siemens.com/diagnostics
Siemens Medical Solutions is one of the world's largest suppliers to the healthcare industry. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. Recent acquisitions in the area of in-vitro diagnostics - such as Diagnostic Products Corporation and Bayer Diagnostics - mark a significant milestone for Siemens as it becomes the first full service diagnostics company. Employing more than 41,000 people worldwide and operating in over 130 countries, Siemens Medical Solutions reported sales of 8.23 billion EUR, orders of 9.33 billion EUR and group profit of 1.06 billion EUR for fiscal 2006 (Sept. 30). Further information can be found by visiting http://www.siemens.com/medical
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Palm Beach County high school students do research with biotech giant
http://www.sun-sentinel.com
By Rhonda J. Miller | South Florida Sun-Sentinel
Jupiter They're working on research to help discover cures for cancer, Alzheimer's disease, hepatitis C, depression and other ills.
But they're student and teacher summer interns at Scripps Florida, so the day-to-day reality is more about putting on gloves, goggles and white lab coats and learning to use state-of-the-art equipment. The opportunity brings scientific excitement to Palm Beach County classrooms and awakens students to career possibilities.
"I've been teaching for 15 years and teaching is very rewarding, but when I first crystallized a protein two weeks ago, it was an incredible experience," said Fred Hock, who teaches biology in the International Baccalaureate program at Atlantic High School in Delray Beach. "I didn't realize how exciting it would be just to see this tiny little crystal of protein that hadn't been crystallized before."
Hock is one of three teachers and nine students who completed a six-week summer internship at Scripps Florida on Friday. Thepartnership with the Palm Beach County School District began in 2003. Officials developed an aggressive plan to meet with leaders of The Scripps Research Institute in La Jolla, Calif., as soon as the renowned biotechnology center announced plans to locate a branch in South Florida, said School District Science Administrator Fred Barch.
The Scripps leading-edge environment gives hands-on practice to students and teachers.
"Before Scripps came to South Florida, there really was no way to have a laboratory experience like this," Hock said Thursday as interns prepared scientific presentations.
Two Palm Beach County teachers got a taste of the internship program in La Jolla in June 2004. After Scripps located in South Florida, the student and teacher internship program expanded each summer.
The biotech initiative with a world-class partner such as Scripps added force and direction to Barch's vision.
"I think that life sciences will dominate this century, and we're right on the cutting edge when it comes to our students and bioscience," Barch told the School Board at a meeting Wednesday. "I believe we have a national model in our biotech academies."
The district has 450 students in high school biotech academies at Seminole Ridge in Loxahatchee, Spanish River in Boca Raton and Palm Beach Lakes in West Palm Beach.
"There are 10 or 15 hot spots in the country where biotechnology is flourishing, and Florida is one of the fastest-growing. Scripps is one of the reasons," said Jeff Ghannam, spokesman for The Biotechnology Institute, which works from its headquarters in Arlington, Va., to educate the public about the science that works with organisms and its potential to solve health, food and environmental problems.
"When there's a research facility, like Scripps, what happens is that companies tend to cluster and education institutions want to work together to develop that work force," Ghannam said.
Ariel Abovich, 16, an 11th-grader at Suncoast High School in Riviera Beach, worked with experiments on bacteria that are resistant to antibiotics.
"Working in the lab has been one of the greatest experiences I've ever had," Abovich said. "I learned that science is almost never-ending and that it reassured me that I definitely want to pursue a career in science."
Ross Einsteder, 17, an 11th-grader in the Seminole Ridge biotech academy, got familiar with some career possibilities.
"I worked in infectology, doing research on hepatitis C," Einsteder said. "Basically, we took different combinations of drugs and dropped them on cells to see the reactions. It gave me an open door to learn about something I might want to do."
That's exactly the point.
"We give students and teachers an opportunity to work in a contemporary research laboratory," said Deborah Leach-Scampavia, Education and Outreach Administrator for Scripps Florida.
"It's a bit self-serving," said Leach-Scampavia, who said the 80 student applicants for nine spots created a highly competitive pool. "We're looking for future scientists to work at the bench toward new discoveries."
The process for discovering treatments became clearer for the interns.
"It's different from labs in school, because [here] you're doing experiments that could become very useful to the general public," said Hock, who will pass along his hands-on lab experiences to his students this fall. "Drug discovery, in the long run, could mean treatments for things such as I've been working on, which is cancer biology.
"To say we're going to cure cancer isn't right," Hock said. "But we're contributing in some small way in the search to find a drug that will work."
Rhonda J. Miller can be reached at rjmiller@sun-sentinel.com or 561-243-6605.
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July 30th, 2007
Injection drug use and HIV and HCV infections among Ontario prison inmates
http://www.eurekalert.org
In this issue of CMAJ, 2 research groups report on the prevalence of HIV and hepatitis C virus (HCV) infections in different inmate populations: people in provincial prisons in Quebec, and adult and young offenders admitted to remand facilities (jails, detention centres and youth centres) in Ontario. The Ontario study is highlighted below; the Quebec study appears in a separate release posted on EurekAlert today. In both studies, injection drug use was the most important risk factor, and the prevalence of hepatitis C virus (HCV) infection was much higher than that of HIV infection. Given the high rates of recidivism and the short stays in remand facilities and provincial prisons, the results of these studies have important public health implications and point to the need for preventive measures.
In this Ontario study, Dr. Liviana Calzavara and colleagues assessed data from 1877 adult and young offenders admitted to 13 remand facilities between Feb. 1, 2003, and June 20, 2004. Among the adult offenders, the rate of HIV infection was 11 times higher and the rate of HCV infection 22 times higher than those in the general population. Rates were highest among inmates aged 30 or more and those who reported a history of injection drug use. A history of injection drug use was reported by 30.3% (477/1576) of the adults and 4.7% (14/299) of the young offenders. Two percent of the adults tested positive for HIV antibodies and 17.6% tested positive for HCV antibodies. None of the 299 young offenders tested positive for HIV antibodies, and 1 tested positive for HCV antibodies. Based on these results, the researcher estimated that 1079 HIV-positive adults and 9208 HCV-positive adults were admitted to Ontario remand facilities from Apr. 1, 2003, to Mar. 31, 2004. They recommend targeted education and prevention efforts.
In a related commentary, Richard Elliott, deputy director of the Canadian HIV/AIDS Legal Network, comments on the continued refusal by federal and provincial governments to implement evidence-based harm reduction measures to prevent HIV and HCV infections in prisons. He postulates that it may be time to put the evidence of this ongoing denial of human rights before the courts.
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July 31st, 2007
Japanese government, drug makers lose another blood suit
http://www.japantimes.co.jp
The Japan Times
NAGOYA (Kyodo) The Nagoya District Court on Tuesday ordered the government and three drug makers to pay a total of ¥132 million in damages to eight of the nine plaintiffs infected with the hepatitis C virus after being treated with tainted blood products.
Presiding Judge Shigeo Matsunami issued the order against the government, Mitsubishi Pharma Corp., its subsidiary Benesis Corp., and Nihon Pharmaceutical Co.
Mitsubishi Pharma is the successor to the now-defunct major blood product maker Green Cross Corp.
Hepatitis C is a blood-borne, infectious viral disease. The hepatitis C virus can cause liver inflammation that is often asymptomatic, but ensuing chronic hepatitis can result later in cirrhosis and liver cancer. An estimated 2 million people have been infected with the hepatitis C virus.
Tuesday's decision is the fourth in a series of damages suits involving hepatitis C virus infections, following ones in June 2006 at the Osaka District Court, in August 2006 at the Fukuoka District Court and this March at the Tokyo District Court.
All four courts found the government and drug makers responsible for the infections.
The plaintiffs at the Nagoya District Court were two men and seven women in their 20s to 70s from Gifu, Shizuoka and Aichi prefectures. They sought a total of ¥650 million in damages from the government and the drug makers.
The plaintiffs argued they were infected with the hepatitis C virus after being given virus-tainted blood products – fibrinogen, christmassin or PPSB-Nichiyaku – from 1981 to 1987 to sttop bleeding when they underwent surgical operations or gave birth.
They said they have been suffering from chronic hepatitis or liver cirrhosis.
They also insisted that the drug makers produced and sold the tainted blood products without confirming their safety, and the government acted irresponsibly by approving the production.
The government maintained that its approval was adequate, saying the products were effective in treatment.
The drug makers argued they had taken sufficient safety measures at the time of production.
A total of 172 people have filed damages suits against the government and drug makers at the Tokyo, Osaka, Nagoya, Fukuoka and Sendai district courts since October 2002, seeking a combined ¥10.6 billion.
In June 2006, the Osaka District Court ordered the government and drug makers to pay a total of ¥256 million in damages to nine out of 13 plaintiffs.
Two months later, the Fukuoka District Court ordered the defendants to pay a combined ¥168 million in damages to 11 of 18 plaintiffs.
In March, the Tokyo District Court ordered the defendants to pay a total of ¥259 million to 13 out of 21 plaintiffs.
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August 1st, 2007
Anadys to cut jobs, end hepatitis B drug development
http://asia.news.yahoo.com
Aug 1 (Reuters) - Anadys Pharmaceuticals Inc. said it was cutting its workforce by a third and discontinuing further development of ANA380, its drug to treat hepatitis B virus infection.
Anadys said it was halting all work on early discovery projects and will incur a charge of about $0.8 million related to the workforce reduction.
In a filing with U.S. regulators, the company said it was terminating its employment agreement with Chief Scientific Officer Devron Averett, effective Aug. 17. Averett will assume a consultancy role, it added.
Anadys expects the 33 percent workforce reduction to result in annual savings of between $4 million and $5 million.
The company said it would return all rights of the ANA380 compound to Korean pharmaceutical company LG Life Sciences Ltd. .
Anadys and LG Life Sciences had entered into a joint development program in April 2004, under which Anadys had marketing rights to the compound in North America, Europe, Japan and some other countries.
Last week, the company said it was discontinuing development of ANA975, its drug to treat hepatitis C virus infection, on safety concerns. It was developing the drug with Swiss drug-maker Novartis .
Anadys said it will focus its resources on two drug candidates, ANA598 for hepatitis C and ANA773 for cancer. With a cash balance of about $69 million, it believes it can carry development of the two drugs forward.
The company posted a second-quarter loss of $7 million, or 24 cents a share, on revenue of $1.3 million. Analysts on average were expecting a loss of 29 cents a share, on revenue of $1.34 million, according to Reuters Estimates. (Reporting by Jennifer Robin Raj in Bangalore).
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Crack pipe program not proven to reduce HIV, hep C: councillor
http://www.cbc.ca
CBC News
There's not enough evidence that an Ottawa program that provides free crack pipes to drug users has directly resulted in lower rates of HIV and hepatitis C infection, says the Ottawa councillor who initiated the program's cancellation.
"We need to have very solid evidence before council endorses any kind of program that sends that kind of mixed message," said Coun. Rick Chiarelli in an interview Tuesday, adding that residents have complained that it encourages illegal drug use.
Councillors voted in favour of Chiarelli's motion in July to end the program at the end of the month.
Chiarelli said the program's cancellation came amid requests from advocates for $500,000 to study how effective the program was at reducing the spread of disease, "which means there is no conclusive evidence one way or the other," he said.
He argued the controversy over the program erodes support for the city's overall strategy to fight drug addiction and accompanying social problems.
Program reduces risk: doctor
Meanwhile, advocates of the program said there is plenty of evidence that distributing free crack pipes reduces the risk of disease transmission, even if transmission rates haven't been measured in relation to the program.
"We know that when folks share drug paraphernalia, that's when they are at risk of transmitting those diseases," said Dr. Dona Bowers, a family physician at the Somerset West Community Health Centre at a news conference held by a group of community agencies Tuesday.
The 10 agencies were announcing their intention to continue the program until the end of the year using their own funding.
Bowers said the program reduces the sharing of homemade crack pipes, which can cause cuts or burns.
She also cited a University of Ottawa study by epidemiology professor Lynne Leonard that showed the program resulted in drug users switching from riskier injection drug use to smoking crack.
"We know that among the IV drug users in our community, there are enormous rates of disease," she said, adding that a fifth of IV drug users are infected with HIV and more than 75 per cent are infected with hepatitis C.
Finally, she added, the program helps drug users develop a relationship with the health and social workers who distribute the crack pipes.
In January, the city's chief medical officer of health, Dr. David Salisbury, told reporters that that the city's HIV infection rate fell from 39 cases in a year to 12 after the program was introduced in 2005.
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Couple takes the ride of a lifetime for organ donation
http://www.insidetoronto.ca/
BY CARRIE BRUNET
Two years ago, Robert Crawford and his sister-in-law Marilyn Olivo-Crawford laid in their respective hospital beds at Toronto General Hospital, contemplating a bike tour across the country.
Crawford had just given his sister-in-law the gift of life, two-thirds of his liver. The two motorcycle enthusiasts needed something to look forward to as they spent their days in the hospital.
So it was only fitting that the hospital be a stop on Crawford and sister in-law Marilyn Olivo-Crawford's cross-country motorcycle tour, as they promote organ donation and the importance of signing one's organ donor card.
"I could have waited with a pager in hand up to three years," said Olivo-Crawford. Today the wait can be as long as six years for a liver transplant.
For Crawford, the decision was simple.
"She needed a liver transplant," he said, explaining that Olivo-Crawford had been diagnosed with Hepatitis C. "I knew if it wasn't done, she'd probably be dead."
Crawford did research the living donor option and discussed it with his wife before making his decision. But in the end, he knew he couldn't sit idly by as his brother's wife took her chances on a donor waiting list.
"She's like my sister," he said. "How could I not?"
The first in his family to step up, Crawford knew his blood type, O negative, was a universal donor type, meanwhile Olivo-Crawford's type AB positive is a universal recipient type, lowering the odds of incompatibility.
Live donors are growing in frequency, especially at Toronto General, where last year 50 live liver donations were made.
The hospital hopes that this year 75 such procedures will happen.
"We have been highly innovative in trying to solve the donor shortage problem," said Dr. Gary Levy, director of the Multi-Organ Transplant Program at the University Health Network.
Levy explained that in most cases live donors are family members, or friends. On rare occasions though, strangers offer to donate part of their liver or one of their kidneys to save a life.
"All of us can be organ donors," said Levy.
According to the Trillium Gift of Life Network, it takes a donor up to 10 weeks to recover from the eight to 10 hour surgery during which 60 to 70 per cent of the liver is removed.
In about three months, the liver will regenerate itself to its original size.
"He saved my life," said Olivo-Crawford of her brother-in-law. "And I'm cured."
Crawford's son Jacob, who has joined the pair on their cross-country tour, had a few words to say about his dad going under the knife.
"I'm very proud that my dad was able to donate part of his liver to my Aunt Marilyn," said the 10-year-old, adding that he was anxious to get back on the road to tell more people to sign their donor cards. During their tour, which started July 23 in Newfoundland and is sponsored in part by the Rotary Clubs of Canada, they hope to collect $100,000 to help fund major transplant centres while raising awareness about the urgency of organ donation.
Today in Ontario, there are more than 1,700 people on the waiting list for organ donation.
While live donors are an option for some surgeries, most donations are still made by deceased donors and their families.
A deceased donor recipient, Rob Kolatschek made the case for people to talk to their loved ones about whether or not they would like to be an organ donor today.
"I can accept if they have thought about it and they have decided against it," said Kolatschek, but he said that too often families are reluctant to choose for their deceased loved ones because they haven't been made aware of their wishes.
"I only spent nine months on the waiting list," said Kolatschek, who had been diagnosed with a liver disease at the age of 22. Today he is a newlywed, and an avid sports competitor in dragon boating and running.
"Discuss your wishes with your family," he said.
Visit the Crawford and Olivo-Crawford team online to find out how to make a donation at cross_canada_ride@yahoo.ca , or make a donation directly at any TD Canada Trust, Branch No. 2456 and account No. 307093.
Sponsors for the ride and donors to the cause are being sought.
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August 2nd, 2007
Coffee Drinking Related To Reduced Risk Of Liver Cancer
http://www.sciencedaily.com
Science Daily — After lung and stomach cancer, liver cancer is the third largest cause of cancer deaths in the world. A new study on the relationship between coffee drinking and the risk of hepatocellular carcinoma (HCC) confirmed that there is an inverse association between coffee consumption and HCC, although the reasons for this relationship are still unresolved.
At least eleven studies conducted in southern Europe and Japan have examined the relationship between coffee drinking and the risk of primary liver cancer. The current study, led by Francesca Bravi of the Istituto di Ricerche Farmacologiche Mario Negri in Milan, Italy, was a meta-analysis of published studies on HCC that included how much coffee patients had consumed. Researchers combined all published data to obtain an overall quantitative estimate of the association between coffee consumption and HCC.
The results showed a 41 percent reduction of HCC risk among coffee drinkers compared to those who never drank coffee. "Moreover, the apparent favorable effect of coffee drinking was found both in studies from southern Europe, where coffee is widely consumed, and from Japan, where coffee consumption is less frequent, and in subjects with chronic liver diseases," the researchers state.
They point out that animal and laboratory studies have indicated that certain compounds found in coffee may act as blocking agents by reacting with enzymes involved in carcinogenic detoxification. Other components, including caffeine, have been shown to have favorable effects on liver enzymes. Coffee has also been related to a reduced risk of liver diseases and cirrhosis, which can lead to liver cancer.
"Despite the consistency of these results, it is difficult to derive a causal inference on the basis of the observational studies alone," the authors note. It may be that patients with digestive tract diseases, including liver disorders, naturally reduce their coffee consumption, even though avoidance of coffee is not routinely recommended.
Also, they note that the assessment of coffee intake was based on patients' self-reporting, although recall of coffee drinking has been shown to be accurate. The fact that the inverse relationship between coffee drinking and HCC was shown in both southern Europe and Japan suggests a lack of bias in these studies. Allowance for other confounding factors, such as hepatitis B and C, cirrhosis, social class indicators, alcohol use and smoking, also suggests that such factors did not influence the results.
"In conclusion, the results from this meta-analysis provide quantitative evidence of an inverse relation between coffee drinking and liver cancer," the authors state. "The interpretation of this association remains, however, unclear and the consequent inference on causality and worldwide public health implications is still open for discussion."
The results of this study appear in the August 2007 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD).
Article: "Coffee Drinking and Hepatocellular Carcinoma Risk: A Meta-Analysis," Francesca Bravi, Cristina Bosetti, Alessandra Tavani, Vincenzo Bagnardi, Silvano Gallus, Eva Negri, Silvia Franceschi, Carlo La Vecchia, Hepatology; August 2007; (DOI: 10.1002/hep.21708).
Note: This story has been adapted from a news release issued by John Wiley & Sons, Inc.
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Pharmasset Completes Enrollment of Phase 1 Study of R7128 for HCV
http://biz.yahoo.com
- Anticipate Preliminary 14-day Multiple Ascending Dose Efficacy Data in September 2007 -
PRINCETON, N.J., Aug. 2 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) has completed patient enrollment of the ongoing multiple ascending dose study of R7128 for the treatment of hepatitis C virus (HCV). R7128, a nucleoside polymerase inhibitor of HCV, is currently being evaluated in a Phase 1 clinical trial as part of Pharmasset's collaboration with Roche. The primary objective of the multiple ascending dose study is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice- daily dosing for 14 days in up to 40 patients chronically infected with HCV genotype 1 who have previously failed interferon therapy. The secondary objective is to assess antiviral efficacy by measuring the change in HCV RNA in these patients.
Pharmasset expects to release preliminary 14-day safety and efficacy treatment data from the multiple ascending dose study in September 2007. Results for the entire Phase 1 single ascending and multiple ascending dose study are expected to be presented at various scientific conferences throughout the remainder of 2007. As recently announced, Roche has initiated long-term chronic toxicology studies in support of the potential advancement of R7128 into Phase 2 clinical trials.
About R7128
R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This Phase 1 study is comprised of two parts:
* Part 1 is a single ascending dose study conducted in 38 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability and pharmacokinetics of R7128 following single ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128.
* Preliminary data from the single ascending dose portion of the study
indicate:
- All doses of R7128 studied were generally well-tolerated.
- All patients completed the study with no gastrointestinal adverse events or serious adverse events reported during the study.
- No hematological or laboratory abnormalities of clinical significance were noted.
* Part 2 is a multiple ascending dose study being conducted in up to 40 patients chronically infected with HCV genotype 1 who have previously failed interferon therapy. The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy by measuring the change in HCV RNA.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates: Clevudine for the treatment of chronic HBV infection, which is expected to enter US, European and South American Phase 3 registration clinical trials and is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals under the brand name Levovir; R7128, an oral treatment for HCV, in a Phase 1 clinical trial through a strategic collaboration with Roche; and Racivir for the treatment of HIV in combination with other approved HIV drugs, which has completed a Phase 2 clinical trial.
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Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that there will be a delay in the release of the preliminary 14-day safety and efficacy treatment data from the multiple ascending dose study or in the results from the entire Phase 1 single ascending and multiple ascending dose study, the risk that our collaboration with Roche will not continue or will not be successful, the risk that the on-going clinical trial or the toxicology studies of R7128 will not be successful or that R7128 will not be successfully developed and commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2007 filed with the Securities and Exchange Commission entitled "Risk Factors" and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.
Source: Pharmasset, Inc.
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August 3rd, 2007
IAS: Rectal trauma and drug use key in sexual transmission of HCV
http://www.aidsmap.com
Michael Carter, Friday
The factors involved in the sexual transmission of hepatitis C virus amongst HIV-positive gay men may be more complex than previously thought, according to German research presented to the recent 4th International AIDS Society Conference in Sydney.
Investigators from Bonn initially found, in common with several other recent studies, that unprotected anal intercourse was associated with a risk of hepatitis C. But in subsequent statistical analysis, only snorting drugs and rectal bleeding after sex were risk factors for infection with hepatitis C. The study’s researchers fear that hepatitis C prevention that focuses only on consistent condom use could be too narrow in its cope and overlook potentially more important risk behaviours.
Doctors from across Europe have been observing mini-epidemics of hepatitis C virus in HIV-positive gay men. Several studies have implicated unprotected anal sex as a significant risk factor for the sexual transmission of hepatitis C, with other research showing an association with fisting, drug use and some sexually transmitted infections.
Although few would seriously doubt that hepatitis C is being sexually transmitted between HIV-positive gay men, there is, nevertheless, very little evidence of sexual transmission of the virus in HIV-negative gay men, or in HIV-positive heterosexual couples. Although one study found that hepatitis C was more likely to be found in the semen of those with HIV, therefore explaining transmission of the virus via unprotected sex, some investigators believe that the factors involved in the sexual transmission of hepatitis C may be much more complex.
To try and obtain a better understanding of the sexual, behavioural and social risk factors for the sexual transmission of hepatitis C amongst HIV-positive gay men, investigators in Germany conducted a case-controlled study in late 2006. Each HIV-positive gay man diagnosed with hepatitis C was matched with two HIV-positive, but hepatitis C-uninfected gay men.
The investigators then obtained demographic data as well as information on sexual behaviour and the use of recreational drugs. Men were also asked to say if they had received blood products or had had an invasive medical procedure, a tattoo or body piercing, as these are possible modes of hepatitis C transmission if screening and sterilisation procedures are not adhered to.
A total of 22 cases and 44 controls were recruited to the study. In bivariate analysis, snorting drugs (OR = 10.5), a history of major surgery (OR = 9.1), unprotected anal sex with more than five men in the previous year (OR = 7.5), bleeding from the rectum after sex (OR = 7.1), fisting (OR = 5.9), and use of erectile dysfunction drugs (OR = 4.1) were all significantly associated with an increased risk of being infected with hepatitis C.
But in subsequent multivariate analysis, most of these factors ceased to be significant. Only snorting drugs (OR = 13.5, p < 0.005) and bleeding from the rectum after sex (OR = 7.7, p< 0.005) remained significantly associated with a risk of infection with hepatitis C.
“Unprotected anal intercourse per se does not sufficiently explain hepatitis C transmission among HIV-positive men who have sex with men”, write the investigators.
They add, “the possibility of hepatitis C coinfection is frequently used to encourage HIV-positive men who have sex with men to consistently use condoms, and condom use seems to be the predominant focus in hepatitis C prevention messages for men who have sex with men. We fear in this narrow perspective, other and possibly more effective hepatitis C prevention messages could be neglected.”
Group sex and anal trauma are highlighted by the investigators as factors potentially implicated in the sexual transmission of hepatitis C. They note that 46% of cases, but only 10% of controls, reported group sex, and that anal bleeding after sex was much more common in cases than controls (27% versus 5%). The use of sex toys, fisting, or longer duration and frequency of anal intercourse due to the use of erectile dysfunction drugs could all, the researchers believe, contribute to an increased risk of anal bleeding.
The investigators also believe that there is an important role for recreational drug use in the sexual transmission of hepatitis C. They note that nasal and rectal administration of drugs can cause ulceration that can facilitate the transmission and acquisition of hepatitis C. Furthermore, drug use can increase the duration and intensity of sex, meaning there is a greater risk of rectal injury.
“Prevention efforts are needed to communicate sexual or sex-associated routes of transmission for hepatitis C that cannot be prevented by condoms alone”, conclude the investigators.
Reference
Schmidt AJ et al. Risk factors for hepatitis C in HIV-positive MSM. A preliminary evaluation of a case control study. Fourth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, abstract MOPEB037, Sydney, 2007.
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