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Week Ending: March 1 , 2008
Alan Franciscus
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This Issue:
February 23rd, 2007
Hepatitis C care is one of the best
http://www.thisislancashire.co.uk
By Jane Lavender
CARE for patients in Bolton suffering from the killer disease hepatitis C is among of the best in the country.
A national audit has revealed Bolton Primary Care Trust (PCT) has received one of the highest ratings nationally - scoring nine out of 10.
The PCT has given guidance to GPs in Bolton on how to spot people who could be at risk of the disease, how to test for it and how to counsel patients who have been diagnosed.
Patients with the disease are transferred to either Manchester Royal Infirmary or North Manchester General following an appointment with doctors at the Royal Bolton Hospital and are seen within four weeks.
There are also plans in place to pay for extra medical staff in Bolton to allow patients to be treated within the borough.
Work is also being carried out with the drugs service in Bolton - intravenous drug users are the highest risk group - to ensure staff can warn people of the risks and refer them for treatment.
Graham Munslow, public health specialist at Bolton PCT, said: "I'm glad we have been given such a high rating, but all we've done is follow the recommended guidance from the Department of Health. This is only the tip of the iceberg with hepatitis C.
"There is a real lack of awareness, but we are campaigning to change that because it can affect anyone."
A campaign was launched in Bolton this week, using posters featuring the face of former teacher Susan Wright, aged 50, from Deane, who was left with serious liver damage after contracting the disease.
The high rating Bolton received in the audit, carried out by MPs and Peers, has been praised by Bolton South-east MP Dr Brian Iddon and Gordon Roddick, the husband of the late Dame Anita Roddick - founder of the Body Shop - who died of the disease.
Dr Iddon said: "I'm delighted Bolton PCT is at the top of the league table. There are up to 500,000 people living with hepatitis C in the UK, but only one in eight of these people have been diagnosed."
Mr Roddick said: "I know from experience how important it is for hepatitis C patients to get specialist support, really good information and proper referral to a hospital that can offer prompt treatment, wherever that is appropriate.
"Their families need good information too. I'm delighted that at last a significant number of patients are getting the care they need."
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Hepatitis B sufferers to sue gov't
http://www.japantoday.com
SAPPORO — Hundreds of hepatitis B patients who contracted the virus in their childhood through mandatory vaccinations against diseases will file a series of damages suits against the government from next month, a group of lawyers said Saturday. The move comes after the Diet moved to enact relief measures in January for those people who contracted hepatitis C through tainted blood products and fought their cases against the state in court.
Lawsuits will be filed at a total of 11 district courts across Japan, starting with Sapporo, as the government has presented no concrete measures for redress to other patients following a Supreme Court ruling in 2006 ordering the state to compensate five such victims, the group said after a meeting in the northern Japan city.
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February 25th, 2007
N.S. inmates tested, vaccinated after distribution of dirty razors — report
http://calsun.canoe.ca/
By THE CANADIAN PRESS
HALIFAX — A number of inmates at the Central Nova Scotia Correctional Facility have been tested for various strains of hepatitis after the mistaken distribution of dirty razors.
The Halifax Chronicle Herald reports that inmates at the Dartmouth jail are now receiving vaccinations after being tested last month.
The report says an estimated 36 inmates used the dirty razors in December. On Dec. 29, guards handed out razors to inmates in four sections of the west wing right around shower time.
But they weren’t fresh razors. Two inmates who contacted the Chronicle Herald on Friday said that one of the guards mistakenly picked up a clear plastic bag containing used razors instead of new ones, and sent them around to inmates in those sections.
By the time the inmates noticed the disposable razors weren’t brand new, it was too late.
“Finally, when they got to (the fourth section) . . . people are saying, `These are dirty razors,’ investigating it for a moment and they started to collect them,” one inmate said.
“Meanwhile, people have already used them and they’re coming out with cuts on their faces.
They’re coming out (asking) `What’s wrong?’ And (the guards) are saying, `We’ve got to collect those razors up, they’re dirty razors.’ ”
The provincial Justice Department conducted an investigation and while spokeswoman Sherri Aikenhead had few details, she said: “I think we’re confident it won’t happen again.
“Staff did retrieve them quickly and normal health protocols were followed.”
Vaccinations and testing are part of that procedure, she said.
The Chronicle Herald reported last year that Correctional Service Canada documents showed that about 29 per cent of federal inmates in Atlantic Canada were infected with hepatitis C, a virus that can cause liver failure.
The same story reported that it costs $26,000 annually to treat a prisoner with hepatitis C.
Neither Aikenhead nor a Health Department spokeswoman knew how many provincial inmates have hepatitis C.
In 1997, the provincial government issued a news release with advice on how to avoid contracting hepatitis: don’t share razors or toothbrushes, use clean needles and practise safe sex.
Aikenhead said the Dartmouth jail took “corrective measures” but she didn’t know what those measures were.
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Dong-A PharmTech Co., Ltd. Announces Portal Hypertension Clinical Trial With Udenafil
http://www.earthtimes.org/
SEOUL, South Korea, Feb. 25 /PRNewswire/ -- Dong-A PharmTech Co., Ltd. announced today that its European licensee, Dr. Falk Pharma, has initiated a 200 patient, phase 2 proof of concept clinical study to investigate the use of udenafil, a long acting phosphodiesterase type 5 inhibitor, for portal hypertension, an unmet medical need. The multi-center, European study is designed to investigate the safety and efficacy of udenafil in a study population of patients with portal hypertension resulting from liver disease.
Udenafil represents a potential new pharmacotherapy in the growing and underserved portal hypertension market which is projected to be 6 million people (US, EU and Japan) by 2010. Portal hypertension is the build-up of pressure in the portal vein (the vein carrying blood from the spleen and digestive tract to the liver). A major complication related to portal hypertension is variceal bleeding, where increased pressure causes veins in the esophagus to rupture and bleed. These episodes are fatal in 30% of patients and reoccurring in 70% of survivors
The most common cause of portal hypertension is cirrhosis of the liver due to alcohol abuse or hepatitis. Cirrhosis from chronic liver disease ranks among the top 15 causes of death worldwide and is expected to increase over the next 20 years due to the prevalence of hepatitis C and hepatitis B, and an increase in non-alcoholic fatty liver disease in development countries.
An estimated 170 million people are infected with hepatitis C and 350 million with hepatitis B globally. It is estimated that up to 25% of those who are chronically infected with hepatitis will develop portal hypertension due to cirrhosis.
The epidemic of obesity in developed countries will lead to a greater incidence of non-alcoholic fatty liver disease (NAFLD), Type II diabetes and high cholesterol which can progress to non-alcoholic steatohepatitis (NASH) and lead to fibrosis and cirrhosis. It is expected that NASH will become the leading cause of chronic liver disease in the next decade yielding 3-5 million patients in developed countries with fibrosis, cirrhosis and portal hypertension.
Currently, there are no approved pharmacological treatments available for portal hypertension, although off-label use of beta-blockers (i.e., propranolol, nadolol, timolol) has exhibited some reduction of bleeding. Beta-blocker therapy, however, is often contraindicated in portal hypertension patients (reported as high as 47% in one clinical trial) and is often not well tolerated leading to discontinuation of therapy (15%), and does not often meet treatment objectives of reducing portal vein pressure sufficiently in as many as 70% of patients treated. An effective long term treatment for life threatening variceal bleeding is thus needed.
Udenafil was approved for the treatment of erectile dysfunction in Korea under the brand name Zydena(R) in late December 2005 and has gained high patient acceptance among ED patients, garnering a market share of approximately 24% by volume during the third quarter of 2007. Udenafil is entering phase 3 clinical development in the USA for erectile dysfunction
Dong Hyun Park, President and CEO of Dong-A PharmTech, stated, "We are pleased to be working with Dr. Falk Pharma on evaluating the potential of our new long acting phosphodiesterase inhibitor, udenafil for treating portal hypertension. Dong-A PharmTech is continuing its development of udenafil for erectile dysfunction in the USA and will develop udenafil for other indications such as benign prostatic hyperplasia and pulmonary hypertension."
Ms. Ursula Falk, Managing Director of Dr. Falk Pharma commented, "Our partnership with Dong-A PharmTech for the development of udenafil for portal hypertension in Europe is extremely important for our company. Successful completion of this study will establish the effectiveness of udenafil as a potential new therapy for the greatly underserved portal hypertension market."
About Dong-A PharmTech Co., Ltd.
Dong-A PharmTech is a late-stage pharmaceutical company incorporated in Korea, focused on the development and commercialization of udenafil worldwide excluding Korea.
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of the Company.
Contact:
Mr. Chan Won OH Director, International Product Development Team 252, Yongdu-Dong, Dongdaemun-Ku Seoul 130-078, Korea Tel: +82 2 920 8220 Fax: +82 2 925 4026 Email: ocw@donga.co.kr
Dong-A PharmTech Co., Ltd.
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Working Toward Effective Treatment for HBV Infection
http://www.sciencedaily.com
ScienceDaily (Feb. 25, 2008) — Despite the existence of safe and efficient vaccines, hepatitis B virus is one of the most deadly viruses in the world, killing about 1.2 million people every year. To better understand the direct liver disease induced by hepatitis B virus, recent research brought us one step closer to an effective treatment for HBV infection.
This dreadful HBV is small in size. The genome of this virus is a partial double stranded circle. When made fully double stranded, this genome carries about 3000 base pairs, compared to 200 kilo base pairs of the genome of the smallpox virus. These 3000 base pairs encode an envelope protein, a core protein, a polymerase essential for virus replication and a very special X protein, named such because its function was not known when it was named.
Dr Dina Kremsdorf of INSERM (Institut National de la Sante et de la Recherche Medicale) and her associates have been trying to elucidate some of the functions of this X protein involved in liver pathogenesis during HBV infection. They first established a system in which the gene for X protein is permanently incorporated into mouse genome. With transgenic mice expressing X protein, they could research many different impacts of the protein on the host.
Their first exciting discovery was the inhibition of liver cell proliferation by X protein. This discovery raised a novel mechanism on how HBV causes liver diseases. Recently, the team further investigated how X protein inhibited the liver cell proliferation. In a new report,* Dr Kremsdorf et al looked at the expression level of 5376 genes in the transgenic mice.
This seemingly daunting work was made possible when Dr Kremsdorf took advantage of the DNA microarray technique, which allowed simultaneous analysis of all 5376 genes. Their results indicated a decreased activity of those genes required for gene transcription and cholesterol metabolic pathway. This not only confirmed the previous observation, but showed how the molecular mechanism of how Hepatitis B virus X protein inhibits the liver regeneration.
These new discoveries should improve our knowledge of the implication of the viral proteins in the pathogenesis of HBV infection. This should allow participation in the design of new and more effective treatments for HBV patients.
*Journal reference: Sidorkiewicz M, Jais JP, Tralhao G, Morosan S, Giannini C, Brezillon N, Soussan P, Delpuech O, Kremsdorf D. Gene modulation associated with inhibition of liver regeneration in hepatitis B virus X transgenic mice. World J Gastroenterol 2008; 14(4): 574-581 http://www.wjgnet.com/1007-9327/14/574.asp
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February 26th, 2007
Research results from McGill University update knowledge of hepatitis C virus
http://www.newsrx.com
Hepatitis Weekly
According to recent research from Montreal, Canada, "Recent studies have demonstrated that patients with the hepatitis C virus (HCV) have significant neurocognitive impairment. To assess whether chronic HCV infection impacts on patient marital status, living arrangement and employment."
"The charts of patients with chronic hepatitis C and hepatitis B were reviewed. The mean (+/- SD) age of the 129 patients with the hepatitis B virus (HBV) was 46 +/- 15 years and that of the 428 patients with HCV was 48 +/- 15 years. Sixty-seven per cent of HBV patients were men, compared with 68% of HCV patients. Eighty per cent of HCV patients were Caucasian, compared with 44% of patients with HBV The main modes of transmission were intravenous drug use (37%) and transfusion of blood products (37%) for HCV, compared with country of origin (76%) for HBV There were no differences in marital status rates between HBV- and HCV-infected patients (HBV - married (73%), single (21%) and divorced (6%); and HCV - married (66%), single (23%) and divorced (10%); P=0.20). HCV patients lived alone more often than HBV patients (HBV - 13%, HCV - 22%; P=0.03). There was no difference in overall employment rate between HCV and HBV patients (81% versus 87%; P=0.15). Though there may not have been overall differences between HCV and HBV marital status and employment status, there were differences in the HCV subgroups. These subgroup differences were discovered in the multivariate analysis; mode of transmission was identified as the only predictor of the patients' marital status and employment status," wrote T.P. La and colleagues, McGill University.
The researchers concluded: "The most important determinant of interpersonal relationships was the mode of transmission of the viral hepatitis rather than the type of viral infection: past intravenous drug users had lower level relationships.'."
La and colleagues published their study in Canadian Journal of Gastroenterology (Mode of transmission, rather than the hepatitis C virus, as a major determinant of poor interpersonal relationships in patients with chronic hepatitis C. Canadian Journal of Gastroenterology, 2007;21(12):815-819).
For additional information, contact M. Deschenes, McGill University, Royal Victoria Hospital Site, Dept. of Medical, Health Center, Hepatology Division, Ross Pavil Room R 2-11, 687 Pine Avenue W, Montreal, PQ H3A 1A1, Canada.
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Hepatitis C Danger In Your MD's Office?
http://www.cbsnews.com/
(CBS) During treatment for breast cancer in 2002, Evelyn McKnight was floored to learn that she would have to fight a second serious disease: Hepatitis C, CBS News medical correspondent Dr. Emily Senay reports.
"We were completely confounded," McKnight said. "We had no idea where I could have gotten that."
Soon her husband Tom, a family physician in Fremont, Neb., discovered some of his patients had also been infected.
"The only common denominator was that we were all cancer patients," McKnight said.
And they all were receiving chemotherapy at the same cancer-treatment center.
In the end, 99 people were infected, the largest outbreak of its kind in North American history. The cause: Nurses were discarding used needles, but were reusing the syringes, thereby passing the infection from patient to patient.
"It's a constant worry about am I going to wake up and be jaundiced?" McKnight said. "Is this the day that cirrhosis is going to show up?"
Since 1999, The Centers for Disease Control has tracked 31 outbreaks including Norman Okla., at a pain treatment clinic. In 2002, 71 were infected there. Other outbreaks include:
- Los Angeles, from blood-sugar testing at retirement center (2003-2004).
- Baltimore, Md., at a cardiology center (2004).
- New York City, anesthesia for a colonoscopy (2007).
These known outbreaks could be just the tip of the iceberg.
"There's no excuse for this. It's on the order of driving against traffic on the freeway; it's that reckless," said the Center for Disease Control's Dr. Michael Bell.
He blames these outbreaks on sloppy infection-control practices in out-patient settings, which are not regulated as strictly as hospitals.
"The problem with non-hospital settings, ambulatory settings, is that a lot of times there's less of a framework to make sure people do things right every time," Bell said.
Anesthesiologist Rebecca Twersky of Long Island College Hospital demonstrated one way infection can easily be spread with multi-dose vials designed for use on more than one patient.
"What you shouldn't do is take the same syringe that I just used before go back into that bottle and take out the medication," Twersky said. "Even if you've changed the needle, if you're still using the same syringe."
Then you've contaminated the bottle.
"Then in comes the next patient, and you know you go thru the whole process not realizing that patient A might have put their microscopic blood particles into the multi-dose vial," Twersky said.
Evelyn McKnight founded a patient advocacy group and is now lobbying Capitol Hill to mandate better infection control in outpatient settings.
"You should not feel like seeking healthy care is a high-risk behavior," McKnight said. "Every patient deserves to feel safe when they seek health care."
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Analyst Bullish on Vertex Hep C Drug
http://www.chron.com
NEW YORK — Shares of Vertex Pharmaceuticals Inc. rose Monday as a Cowen and Co. analyst said upcoming data on Schering-Plough Corp.'s boceprevir oral Hepatitis C drug isn't likely to show a cleaner profile than Vertex's telapravir, nor better sustained viral response.
Shares rose 39 cents, or 2.2 percent, to close at $18.48 on heavy volume.
Investors have been divided over whether or not Schering-Plough's HCV protease inhibitor will be a competitive threat to telaprevir, and are eagerly awaiting data on boceprevir at the annual meeting of the European Association for the Study of the Liver scheduled for April 23rd through 27th.
Abstracts for the April EASL meeting became available this morning, and although no added information was made available by Schering-Plough, Cowen and Co.'s Rachel McMinn said she expects the company to file a late-breaking abstract before March 3rd.
So far, viral load declines demonstrated by a hepatitis C protease inhibitor being developed by Tibotec Pharmaceuticals and Medivir (TMC435350) are comparable or slightly better than the data for telaprevir. However, she said it's still "early days" for TMC435 and more information is needed to draw definitive conclusions about whether or not the product will ultimately be competitive with telaprevir _ especially in regard to safety.
"In October 2007, we downgraded Vertex shares to 'Neutral' based on our loss of conviction that telaprevir would retain its best-in-class profile following interim data for Schering-Plough's boceprevir," she wrote in a note to clients. But McMinn now feels that new boceprevir data to be presented in April is likely to give Vertex investors more comfort in telaprevir's competitive profile.
"Our best guess is that telaprevir will have a cleaner 24-week treatment profile than boceprevir, and that boceprevir is unlikely to show superior sustained virologic response to telaprevir," she added.
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Hepatitis C: a risk factor for lymphoma
http://news.yahoo.com
NEW YORK (Reuters Health) - Canadian researchers have confirmed an association between hepatitis C virus (HCV) infection and an increased risk of non-Hodgkin's lymphoma, according to their report in the International Journal of Cancer.
Dr. John J. Spinelli of the British Columbia Cancer Agency, Vancouver, and colleagues note that studies have indicated HCV infection may double the risk of non-Hodgkin's lymphoma. To investigate this relationship, the researchers conducted a population-based study in British Columbia, involving 795 patients with newly diagnosed lymphoma and 697 subjects without lymphoma.
In 2.4 percent of the patients with non-Hodgkin's lymphoma were also infected with HCV compared with 0.7 percent of the comparison subjects. The greatest non-Hodgkin's lymphoma risk was for diffuse large B-cell lymphoma and marginal zone lymphoma, with 7.3-fold and 6.1-times the risk.
The researchers note that the prevalence of HCV infection in the province, estimated to be about 1.5 percent, is nearly twice the national rate, "likely due to a high rate of injection drug use." Nevertheless, they point out, the non-Hodgkin's lymphoma risk for HCV infection remained after adjusting for injection drug use.
Spinelli told Reuters Health that a possible connection between HCV and non-Hodgkin's lymphoma was first suggested in the 1990s and subsequent investigation has helped to confirm this.
"Our study," he concluded, "provides further evidence that there is indeed an association between HCV infection and the risk of non-Hodgkin's lymphoma."
SOURCE: International Journal of Cancer, February 1, 2008.
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3,859 were not notified they had received tainted blood
http://www.japantoday.com
TOKYO — The health ministry was aware as far back as 2001 that a pharmaceutical company was in possession of detailed data on 3,859 people treated with the tainted blood product that caused hepatitis C, but it did not notify them, sources familiar with the matter said Tuesday.
Of these, 159 people developed acute hepatitis symptoms and the remaining 3,700 people did not develop such symptoms. Hepatitis C patients need to undergo medical checks because some of them could have been infected with the hepatitis C virus even if they do not develop acute symptoms. The Ministry of Health, Labor and Welfare does not know what have become of those patients, officials said.
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February 27th, 2007
Health District notifies patients of potential exposure to hepatitis C – urges testing for approximately 40,000 patients
Southern Nevada Health District:
LAS VEGAS – The Southern Nevada Health District announced it is notifying approximately 40,000 patients of a local medical clinic about potential exposure to hepatitis C following an investigation of several acute cases of the illness. Patients who had procedures requiring injected anesthesia at the Endoscopy Center of Southern Nevada, located at 700 Shadow Lane, Las Vegas will begin to receive letters this week. The health district’s notification includes patients who had procedures at the clinic between March 2004 and January 11, 2008, and recommends they contact their primary care physicians or health care providers to get tested for hepatitis C as well as hepatitis B and HIV.
The health district identified a cluster of three acute cases of hepatitis C in January 2008 and has identified a total of six cases to date. Hepatitis C infections must be reported by medical providers and laboratories in Nevada and the health district typically receives reports of approximately two cases of acute hepatitis C annually. Five of the cases had procedures requiring injected anesthesia on the same day. Following a joint investigation with the Nevada State Bureau of Licensure and Certification (BLC) and with consultation from the Centers for Disease Control and Prevention, the health district determined that unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients. The exposures did not result from the medical procedures performed.
The joint investigation identified the re-use of syringes (not needles) and the use of single dose vials of anesthesia medication on multiple patients as the potential sources of contamination. The clinic took corrective action when notified by staff conducting the investigation.
When cases were identified the health district notified the Nevada State Health Division, Bureau of Licensure and Certification. The endoscopy center holds an ambulatory surgical center license with the state and licensing regulations require a surgical center to maintain systems for quality assurance and for the governing body to oversee the effectiveness of those systems. The licensing inspection focused on rapid identification of deficient regulatory practices that were brought to the immediate attention of the center for correction. The surgical center has been issued a formal Statement of Deficiencies relating to both state licensing requirements and federal regulations for Medicare certification. The center has responded with a written Plan of Correction. The bureau will conduct additional on-site inspections to determine that the center continues to implant and maintain its corrective action plan.
“Based on the information we discovered during our investigation it appears the injection practices that can lead to the transmission of hepatitis C and other bloodborne infections have been occurring at this clinic for several years. We are recommending all patients during this timeframe to get tested because we cannot determine which patients may have been exposed,” said Dr. Lawrence Sands, chief health officer. “Hepatitis C is a serious medical condition and infected patients may not have outward symptoms of the disease for many years. As a precaution, and in order to take appropriate steps to protect their health, it is important for these patients to get tested and for anyone with the illness to seek medical treatment,” Sands said.
The health district is also recommending patients get tested for hepatitis B and HIV, as both of these diseases can be transmitted through the same unsafe injection practices identified as the likely source of transmission. However, the risk of transmission of hepatitis B and HIV is lower, and no associated cases of hepatitis B or HIV have yet been identified. The prompt identification of these infections is important, as there are treatment and/or medical management options available.
Eighty percent of people infected with hepatitis C will have no signs or symptoms. In acute cases, there is a clearly defined onset of symptoms, that may include loss of appetite, stomach pain, nausea, vomiting and sometimes jaundice (a yellowing of the skin or the whites of the eyes). Individuals with chronic hepatitis C virus and HIV infections typically are asymptomatic for many years and are often not aware they are infected. Persons with chronic hepatitis C infection may have the disease for many years without symptoms before more severe liver disease develops.
Approximately 2 percent of the general population will test positive for hepatitis C and based on the average age of the patients at the clinic, it is expected that approximately four percent will test positive as many people have contracted the virus through other sources. Hepatitis C is more common among people who received blood transfusions or organ transplants prior to 1992 and intravenous drug users therefore, it will not be possible to determine if patients who test positive were infected at the clinic.
The risk to the general population is very low as hepatitis C is not spread by casual contact or in typical school, work or food service settings. It is not spread by coughing or sneezing or by drinking from the same glass used by someone who is infected. The role of person-to-person contact or sexual activity is not well understood at this time.
The Southern Nevada Health District has posted additional information on its website at www.SouthernNevadaHealthDistrict.org . In addition, the health district has set up a hotline at
(702) 759-4636 (INFO) for people with questions about this notification or hepatitis C.
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FDA MedWatch - Tysabri (natalizumab) - Reports Of Clinically Significant Liver Injury
http://pharmalive.com
ROCKVILLE, Md., Feb. 27, 2008-Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.
Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and prescribing information for Tysabri attached.
Downloads
Tysabri_dhcp_letter.pdf
Tysabri_PI.pdf
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Clean needle program gets thumbs-up
http://www.record-bee.com
By Tiffany Revelle--Record-Bee staff
LAKEPORT -- A legal needle exchange program is closer to becoming a reality after the Lake County Board of Supervisors authorized such a program Tuesday. The vote was unanimous, with supervisor Anthony Farrington absent.
The board adopted a resolution that authorizes a clean needle and syringe exchange program under Assembly Bill 547, signed into law Jan. 1, 2006. In 2000, AB 136 set up a provision that protected government organizations and employees from criminal prosecution for giving hypodermic needles to injection drug users during a planned exchange, provided that a state of health emergency was declared first. AB 547 streamlined the needle exchange process by removing the requirement that a state of emergency be declared.
"This will protect the future, not just the present, but the future of Lake County residents," Glenhaven resident Jeff Ott said. Ott told the board that he had used injection drugs for 11 years, and was lucky to not be infected with hepatitis C or the human immunodeficiency virus (HIV). He was one of eight speakers who came forward in favor of authorizing the needle exchange.
"I am not intending for this to be a platform to condone or condemn drug use or the laws pertaining to it," Lake
County Public Health director Jim Brown told the board. "It is our feeling that an SEP (syringe exchange program) would be an effective measure to gain some control over and reduce the spread of HIV, AIDS (acquired immune deficiency syndrome) and hepatitis C in the county."
The speakers and approximately 50 audience members wore pins with red and yellow ribbons to symbolize HIV and hepatitis C. A small syringe was attached to the ribbons, without an actual needle under each orange cap.
"What if a child was stuck with a needle on a playground? What would it cost to take care of that child for the rest of its life, as opposed to the cost of prevention," Mendocino Community Health Clinic board chairman Tom Jordan said.
Supervisor Rob Brown noted that possession of a hypodermic needle is a misdemeanor. He voted in favor of the resolution supporting the exchange after expressing his misgivings about his vote.
"I have to look at it from the perspective of the facts, and I'm still conflicted, unfortunately, because I have not heard from law enforcement," supervisor Rob Brown said.
"If this just saves one person from getting accidentally stuck, if this stops one child or one police officer from accidentally being stuck because needles are lying around, then we've done right thing," supervisor Jeff Smith said.
Public health director Jim Brown said he will do research in the next 60 days into how to implement the exchange. "I don't anticipate that public health will do a syringe exchange, but we're going to see if we can possibly interest clinics or someone else who might be interested in providing those services," he said.
Contact Tiffany Revelle at trevelle@record-bee.com.
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February 28th, 2007
Insulin resistance tied to hepatitis C infection
http://in.reuters.com
By Michelle Rizzo
NEW YORK (Reuters Health) - Insulin resistance, a "prediabetic" abnormality of blood sugar, is a specific feature of chronic hepatitis C virus (HCV) infection, independent of the severity of HCV or the presence of other metabolic factors, French investigators report.
HCV infection is now recognized as a system-wide disease, Dr. Rami Moucari, of Université Denis Diderot-Paris, and colleagues note in a report in the journal Gastroenterology. Some previous studies have linked HCV infection to an increased risk of insulin resistance or full-blown diabetes.
Insulin is the body's key blood sugar-regulating hormone. Normally, insulin is secreted to clear glucose (sugar) from the blood and deposit into cells to use as fuel. Insulin resistance occurs when cells become desensitized to insulin.
In their study, Moucari's team found that 150 (32.4 percent) of 462 chronic HCV patients who did not have diabetes were insulin resistant. In this group, insulin resistance was associated with the metabolic syndrome (a cluster of heart disease and diabetes risk factors), as well as HCV genotypes 1 and 4, significant liver scarring or "fibrosis," severe fatty liver disease, and being older than age 40.
Among 145 chronically HCV infected patients without metabolic syndrome or significant fibrosis, insulin resistance was diagnosed in 22 (15 percent). Insulin resistance in this population was also associated with infection with HCV genotypes 1 and 4, high blood levels of HCV, and moderate-to-severe liver inflammation.
"Insulin resistance should be assessed in the routine management of patients with chronic hepatitis C," Moucari noted in an interview with Reuters Health.
SOURCE: Gastroenterology, February 2008.
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Slow Growth Seen in Hepatitis C Market
http://biz.yahoo.com
Jefferies Sees Slower Than Expected Growth in the Hepatitis C Drug Market
NEW YORK (AP) -- The market for oral hepatitis C treatments could be smaller than Wall Street expects, according to Jefferies & Co., possibly leaving sales forecasts too high.
Analyst Eun K. Yang, following a discussion with experts, said the market will likely increase between 20 percent and 30 percent through 2015. There are currently about 80,000 patients being treated in the U.S.
Hepatitis C is a liver disease caused by the HCV virus and is spread though direct contact with the blood of an infected person.
Specifically, Yang said, the market potential for oral therapies is about $2 billion between 2011 and 2015, and $9 billion after 2015, in a best case scenario. The market will initially be modest, she said, citing side effects of current sexually transmitted disease treatments, an aging hepatitis population, co-morbidity rates with conditions such as HIV, and patient motivation for treatment.
"Long-term, larger potential for oral antivirals is likely to occur in 2015 or beyond," she said. "This market potential will depend on the availability of a combination of two to three oral antivirals demonstrating a high success rate."
Meanwhile, most products are in early development and the competitive outlook is still very fluid, she added.
One exception is Cambridge, Mass.-based Vertex Pharmaceuticals Inc., which plans on starting a late-stage study for its hepatitis C drug candidate telaprevir in March, with its partner Johnson & Johnson. Vertex shares fell 19 cents to $18.43, while Johnson & Johnson shares fell 52 cents to $62.52.
Vertex could face competition from Kenilworth, N.J.-based Schering-Plough Corp., which is conducting midstage studies on its oral treatment boceprevir and already sells the injectible treatment Pegintron. Schering shares fell 43 cents to $21.67.
Brisbane, Calif.-based InterMune Inc., working with Roche, is developing ITMN-191 as a hepatitis C treatment. Its stock fell 10 cents to $14.36.
Other companies developing hepatitis C treatments include Human Genome Sciences Inc., Rockville, Md.-based Human Genome Sciences Inc., and Cambridge, Mass.-based Idera Pharmaceuticals Inc.
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What Safety Measures Are Being Taken After Hepatitis C Outbreak?
http://www.ktnv.com
Action News has received dozens of emails from viewers, who are both concerned and scared about possibly being exposed to Hepatitis C and other diseases.
The wife of a viewer named Robert says she recently had a procedure done at the Endoscopy Center of Southern Nevada.
Robert wrote, "It is a very scary thought, that she could have contracted this through a health care provider."
In an email to Action News a viewer named Jessica wrote, "I was scared out of my mind. How does this happen? I have two small children and a husband."
Right now many questions remain, including: who is to blame and who is going to foot the bill?
Action News spoke with many among the medical community along with a personal injury attorney who says the domino effect from this could become a catastrophe.
"According to the news reports these were re-used on patients."
They say it is medical training 101, to use proper sterilization techniques.
Doctor David Gremse says, "It is something that is engrained in you from the start of your medical education and training."
Syringes were reportedly reused at the Endoscopy Center of Southern Nevada possibly exposing thousands of patients to Hepatitis B & C , not to mention HIV.
The medical community is outraged.
Dr. Gremse says, "You can not relax your standards you should follow the best practices for every patient."
There are certain types of syringes in question.
They come in sterile packages from the company, but once they are used on a patient they are supposed to be discarded in medical waste receptacles.
The question is, why would any health official re-use a syringe?
Attorney Rob Murdock says, "It all goes back to the mighty dollar ."
Murdock adds, "There is something even scarier to think about. If they did this, if they would reuse syringes and not clean equipment properly, what else are they doing? I will tell you what I would not go there!"
Murdock says it is time for those responsible to step up.
"I can't believe that the doctors who own this clinic are not out there saying we will pay for this right now."
In the meantime, a spokesperson for the Nevada Center for Ethics and Health Policy tells Action News that a situation like this is "A violation of trust and standard practice and that further investigation could result in severe sanctions against those responsible."
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Free hepatitis B tests offered on campus
http://xpress.sfsu.edu
by Eric Gneckow, staff writer
Free hepatitis B screenings at SF State next month are the latest effort to stop the spread of the cancer-causing liver disease among San Francisco’s Asian population, according to information from a “Pre-Kick Off” event held at the student center this Monday.
One in 10 Asians living in the United States has the life-long hepatitis B infection, and the effects are most catastrophic in areas with high-density Asian populations like San Francisco, said Meredith Bergin, special projects coordinator at Stanford’s Asian Liver Center. Non-Asians can also contract the disease, but the current number of those infected is much lower.
At SF State, where Asian students number almost 10,000, approximately 1,000 Asian and students are expected to have the disease. The number climbs to 24,000 people citywide, according to 2007 school enrollment data, the 2000 Census and the Department of Public Health.
Of those infected, one in four will die from the resulting liver damage, Bergin said.
“Because it’s asymptomatic, many people don’t know until it’s too late,” she said.
Many parents of Asian Americans come from countries with high rates of hepatitis B infection, and the most lasting version of the disease is usually passed from mother to child during birth. For those unaware of their own infection, measures to protect their children from the disease are never taken, said Erin Bachus of the San Francisco Department of Public Health.
“My dad almost died from it last year,” said Kohei Nishida, a 24-year-old Cinema major. To be safe, he said he plans to participate in the free testing.
To be screened and vaccinated as an adult typically costs around $170, but the California Pacific Medical Center will be offering them for free to anyone from March third to seventh on and around the campus, said SF State health educator Ingrid Ochoa.
Screeners will take blood samples to test for the virus, and 30 to 40 percent of those present are expected to need the vaccine, said Jackson Wong, main coordinator of the CPMC.
“Nobody will be turned down,” Ochoa said, though Asian students are the targets of the provided treatment.
Despite mandatory and free hepatitis B vaccinations for minors in the United States, some still manage to avoid the procedure. In California, many public and private schools are lax in ensuring that students receive their vaccinations in either kindergarten or seventh grade, Bachus said.
“All my life, I thought I was invincible,” said 67-year-old hepatitis B carrier Bok Pon. “Then they said, ‘Stop everything—you’ve got six months.”
Commander of his American Legion post, Pon said he felt perfectly healthy when he was diagnosed with hepatitis B and liver cancer one year ago. He bragged that he can still do 100 pushups at a health center seminar earlier this month, but it has been painful chemotherapy that helped him survive for a year longer than expected.
“It’s like your whole body goes into a microwave,” Pon said of the treatments he has received.
Awaiting a liver transplant, the last chance for those with tough liver cancer, Pon said he spends his time helping to organize Chinatown-area meetings to educate others about the disease.
In China, one of the countries most affected by the spread of hepatitis B, the disease is often poorly understood, Bergin said. Those who are infected face discrimination and are sometimes barred from jobs.
“There’s a certain amount of discrimination against carriers in China,” she said.
In the United States, attitudes are better, yet misconceptions persist within Chinese and other Asian communities, according to a 2007 study by the Asian Liver Center.
“Hepatitis B is endemic to Asians as HIV is endemic to Africa,” Bergin said, adding that the disease affects Asians not because of their genetics or habits but because of the disease’s centralization in Asia.
While hepatitis C is arguably worse than B, the “B” strain is 100 times more contagious than HIV and has taken root and spread among Asian populations. “A,” another common strain, is the only version that can be transmitted by casual contact but is much less severe. The “A” variant is rarely seen in the United States due to modern sanitation systems, Ochoa said.
Last year, state Assemblywoman Fiona Ma went public about her own hepatitis B infection and announced a bill that would allocate state funding to treating those with the disease. Currently, the State Assembly’s Committee on Health is analyzing the bill.
At SF State, the California Pacific Medical Center is fronting $100,000 for the March vaccinations, providing its own clinical staff and equipment for the tests, said Health Center Director Dr. Alastair K. Smith.
The SF State Medical Center, providing services from optometry to HIV screening, is paid for entirely by the $108 included with regular student fees, Smith said.
“A lot of people don’t even know where the health center is!” said Ochoa, an SF State alumnus with a master’s degree in public health.
The screenings will begin on Monday, March 3, in the Health Center. Treatments will continue throughout the week, alternating daily between the center and the Tower Conference Hall, Ochoa said.
E-mail Eric Gneckow@egneckow@sfsu.edu
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Interferon Is Effective in Hemodialysis Patients With Hepatitis C
www.medscape.com
By Michelle Rizzo
NEW YORK (Reuters Health) Feb 29 - A paper in the February issue of the American Journal of Kidney Diseases suggests that in hemodialysis patients with hepatitis C virus (HCV) infection, interferon (IFN) therapy achieves good rates of sustained virological response.
Dr. Craig E. Gordon and colleagues at Tufts-New England Medical Center in Boston conducted a meta-analysis and meta-regression of randomized controlled trials, uncontrolled trials, and prospective observational studies in order to assess the risks and benefits of using IFN and pegylated IFN (PEG-IFN), with and without ribavirin, to treat hemodialysis patients who have chronic HCV infection. To be included, studies had to report on virological response at least 5 months after treatment.
The studies included 20 in which a total of 459 patients were given IFN, 3 in which 38 patients were treated with PEG-IFN, and 2 in which 49 patients received PEG-IFN and ribavirin.
Overall in the 25 studies, the sustained viral response to IFN was 41%. For PEG-IFN, the overall sustained viral response was 37%. The authors report that viral response rates were higher when the dose of IFN was at least 3 million units. Sustained viral response was also higher with lower mean HCV RNA levels and with lower rates of cirrhosis, HCV genotype 1 or elevated transaminase, but not to a statistically significant degree.
Frequently reported adverse events included influenza-like illness, anemia, symptomatic rejection of a nonfunctioning kidney graft, depression, leukopenia, confusion, diarrhea, thrombocytopenia, and seizures. Combined treatment discontinuation rates were 26% for IFN and 28% for PEG-IFN.
"The sustained virological response of 41% to interferon in dialysis patients is nearly as high as that seen with pegylated-interferon and ribavirin combination therapy in the general population of patients who are not on dialysis," Dr. Gordon said in an interview with Reuters Health. "This is important because dialysis patients cannot receive ribavirin because of a high rate of side effects," he explained. "We think the higher response to interferon is because of fixed dosage in patients with impaired kidney function resulting in higher drug levels leading to greater efficacy but also a higher rate of side effects, although this is not yet proven."
"Most physicians would expect that the treatment of hepatitis C virus would be less successful in hemodialysis patients," Dr. Gordon said. "We found the opposite, and in fact the treatment was more successful in hemodialysis patients, suggesting that perhaps more patients should be considered for treatment."
The author noted that there is a high risk of side effects from interferon, so patients need to be selected carefully. "For instance, hemodialysis patients with untreated depression would not be good candidates for treatment because interferon can worse depression," he said. "So there are several reasons to be cautious with treatment," he added.
Am J Kidney Dis 2008;51:263-277.
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Survival rates exceed national averages for UCSF heart, liver and lung transplant programs
http://pub.ucsf.edu
One-year survival rates for patients receiving heart, liver and lung transplants at UCSF Medical Center exceed national averages at statistically significant levels, according to new data compiled by the Scientific Registry of Transplant Recipients (SRTR).
Released on January 11, the report measures performance and characteristics of each transplant program at all facilities in the United States, including waiting list outcomes, post-transplant survival rates, and organ recovery and transplantation rates. Reported statistics can be found on the SRTR website (http://www.ustransplant.org).
“The registry collects data from the nation’s transplant programs and uses an algorithm they created to standardize calculations across facilities, looking at such information as how sick patients are in each program and then assigning an expected survival rate,” explained John P. Roberts, MD, chief of the UCSF Medical Center Transplant Service.
According to the report, the one-year survival rate for the UCSF Heart Transplant Program was 100 percent, compared to an expected survival rate of 87 percent. The UCSF Liver Transplant Program produced a one-year survival rate of 92 percent compared to an expected 88 percent, and the Lung Transplant Program generated a one-year survival rate of 90 percent compared to an expected 80 percent. The expected survival rates reflect the health condition of each program’s transplant patients.
UCSF is recognized for tackling the most complex transplant surgeries, including multiple organ transplants, and is the only hospital among the U.S. News & World Report top 18 hospitals with these three programs that exceeds the national averages for expected survival rates at significant levels.
UCSF transplant teams include a full range of patient care and support personnel, and all are committed to achieving better-than-expected survival rates, according to Roberts and also emphasized by Teresa De Marco, MD, medical director of the UCSF Heart Transplant Program.
Many audiences, such as patients and families looking to select a transplant program, use the SRTR data. Transplant surgeons use it to explain a patient’s prospects for recovery, as do administrators addressing quality control for transplant programs, insurance companies and payers, and federal regulatory bodies charged with protecting patients.
Transplants are the most advanced treatment for patients with severe, end-stage disease with no other effective, available medical or surgical treatments, according to clinicians.
The Heart Transplant Program at UCSF began in 1989 and is expected to soon perform its 500th procedure. The program focuses on pulmonary hypertension and right ventricular failure, combined heart-kidney transplant, transplant for Chagas disease, transplant for congenital heart disease, transplant for HIV, and research on the genomics of heart failure and allograft loss (rejection of donor organ).
Since it began in 1988, the Liver Transplant Program has performed more than 2,100 liver transplants for adults and children. The program is designated as a Center of Excellence by the U.S. Department of Health and Human Services and performs more liver transplants than any other hospital in Northern California. Program specialists are currently conducting research in the areas of living donor transplantation, liver cancer, clinical therapeutics in liver transplantation, transplantation in HIV-infected patients, hepatitis C antiviral therapy, and recurrent viral disease.
The UCSF Lung Transplant Program has performed more than 250 transplants since the program began in 1991, and it is a specialized center of excellence for treating cystic fibrosis and pulmonary hypertension. The program also focuses on ECMO (extracorporeal membrane oxygenation) as a bridge to transplant for acute respiratory failure, the role of transplant in malignancy (bronchoalveolar carcinoma), and transplant for HIV patients. Current research includes the genomics of transplant rejection, acute lung injury and fungal infections.
Information about all of UCSF’s transplant programs can be found at: http://www.ucsfhealth.org/adult/medical_services/ organ_transplants/.
UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.
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