New On The Website;
Does the hepatitis c virus survive in dried blood
New On The Blog
AASLD-DEB025 potential interferon-free therapy/viral clearance at six wks
Phase 2b PILLAR Study of Once-Daily TMC435
Interim Data for VICTRELIS (boceprevir) in Prior Null Responder
INCIVEK™ / VX-222-Interim Data Showed at 12wk 93% SVR
Santaris Phase 2a Data of Miravirsen Shows Dose-Dependent, Prolonged Viral Reduction of 2-3 Logs HCV RNA After Four-Week
HCV/HIV Incivek-Phase 2 Study Positive Interim Results
PPI-461- Presidio Announces Proof-of-Concept Data And Initiation of Clinical Testing For PPI-668
INX-189 for Chronic Hepatitis C-Inhibitex Reports Corporate Developments
AASLD-Modification of CMS Conditions of Participation to Preserve Access to Liver Life-Saving Liver Transplantations under Less than Optimal Condition
AASLD-Health of Recipients and Quality of Donor are Greater Factors in Survival than Metabolic Factors
Weekend Updates
Hepatitis C transmission via injecting drug use: look beyond needles and syringes
Michael Carter
Does the hepatitis c virus survive in dried blood
New On The Blog
AASLD-DEB025 potential interferon-free therapy/viral clearance at six wks
Phase 2b PILLAR Study of Once-Daily TMC435
Interim Data for VICTRELIS (boceprevir) in Prior Null Responder
INCIVEK™ / VX-222-Interim Data Showed at 12wk 93% SVR
Santaris Phase 2a Data of Miravirsen Shows Dose-Dependent, Prolonged Viral Reduction of 2-3 Logs HCV RNA After Four-Week
HCV/HIV Incivek-Phase 2 Study Positive Interim Results
PPI-461- Presidio Announces Proof-of-Concept Data And Initiation of Clinical Testing For PPI-668
INX-189 for Chronic Hepatitis C-Inhibitex Reports Corporate Developments
AASLD-Modification of CMS Conditions of Participation to Preserve Access to Liver Life-Saving Liver Transplantations under Less than Optimal Condition
AASLD-Health of Recipients and Quality of Donor are Greater Factors in Survival than Metabolic Factors
Weekend Updates
Hepatitis C transmission via injecting drug use: look beyond needles and syringes
Michael Carter
Published: 04 November 2011
Important insights into the continued spread of hepatitis C among injecting drug users are provided by two studies published in the online edition of the Journal of Infectious Diseases.
An international team of investigators showed that infectious quantities of hepatitis C could survive on inanimate surfaces for up to seven days. However, the virus can be rendered inactive by commercially available disinfectants, or heating to a temperature of 65-70° for approximately 90 seconds.
In a separate study, French investigators detected the virus on 80% of alcohol swabs obtained from injecting drug users. They suggest that the swabs may be shared by users, risking the transmission of hepatitis C.
Holly Hagan of the New York University College of Nursing in an accompanying editorial stated: “The studies contribute new knowledge to our understanding of the mechanisms by which HCV [hepatitis C virus] may be transmitted among PWID [people who inject drugs] via injection-related materials.”
There are an estimated 130 million hepatitis C infections worldwide. Hepatitis C is a blood-borne infection and a major mode of transmission is injecting drug use. Needle and syringe exchange programmes have been introduced in many countries to control the epidemic. The have been highly effective at preventing new HIV infections, but hepatitis C transmissions still continue.
This is possibly because viral load tends to be high in individuals with chronic hepatitis C infection, and even small quantities of contaminated blood are potentially infectious.
A team of investigators led by Juliane Doerrbecker wished to establish a clearer understanding of the survival of the virus, and the effectiveness of disinfectants and heat at rendering the virus non-infectious.
Steel discs were contaminated with infectious quantities of hepatitis C which were then allowed to dry. Reassuringly, commercially available disinfectants were also shown to have “a high virucidal efficacy against HCV.”
Tests also showed that infectious quantities of hepatitis C of approximately 30 TCID50/ml could still be detected on inanimate surfaces up to seven days after contamination. However, the investigators emphasised that “all tested biocides were able to inactivate HCV infectivity to undetectable levels.”
The investigators then examined the effect of heat on the virus. Spoons and/or cookers are used to heat diluted heroin into solutions. The liquid is then drawn into a syringe, potentially contaminating the spoon if hepatitis C-infected blood is present in the syringe. The investigators therefore contaminated spoons with the virus, which were then heated to various temperatures using tea candles.
Infectivity started to decrease at temperatures of approximately 50°. Levels of the virus fell below the limit of detection when temperatures reached 67-70°. It generally took between 80 to 95 seconds for heating to produce small bubbles in the spoon.
“Reusing HCV contaminated cookers could lead to infection even if using sterile syringes,” comment the investigators.
Holly Hagan emphasised that injecting drug users rarely heat spoons for more than 15 seconds.
In separate research, Dr Vincent Thibault and his colleagues collected drug-using paraphernalia from individuals known to be infected with hepatitis C. The used paraphernalia included syringes, filters and water cups, swabs for cleaning of skin before injecting and pads employed to stop bleeding after withdrawal of needles. A total of 160 pieces of equipment were collected.
The virus was detected on 44% of the pooled materials.
A further 620 items used by individuals of unknown infection status were also obtained. Approximately 83% of the pools obtained from swabs had detectable hepatitis C. Moreover, viral load was highest (above 3 log10 iu/ml) within these swab pools.
Hepatitis C was also commonly detected in syringes, but viral load tended to be at low levels (12 to 890 iu/ml).
The investigators therefore believe that there is “a higher chance for PWID to be contaminated though sharing of a tainted spoon rather than a tainted syringe.”
They note that blood was often visible on swabs. The researchers therefore suggest that transmission of the virus could occur if swabs were being used inappropriately. “The chaotic and rushed atmosphere of the injection setting, where swab sharing and mixing could take place, is…an important factor that should be considered.”
Holly Hagan believes the two studies have important implications for hepatitis C prevention programmes. “Cleaning cookers or perhaps impregnating injection equipment with safe biocides may help reduce the incidence of new infections. Promoting safe swab use to emphasize avoidance of reuse seems a prudent measure.”
Reference
An international team of investigators showed that infectious quantities of hepatitis C could survive on inanimate surfaces for up to seven days. However, the virus can be rendered inactive by commercially available disinfectants, or heating to a temperature of 65-70° for approximately 90 seconds.
In a separate study, French investigators detected the virus on 80% of alcohol swabs obtained from injecting drug users. They suggest that the swabs may be shared by users, risking the transmission of hepatitis C.
Holly Hagan of the New York University College of Nursing in an accompanying editorial stated: “The studies contribute new knowledge to our understanding of the mechanisms by which HCV [hepatitis C virus] may be transmitted among PWID [people who inject drugs] via injection-related materials.”
There are an estimated 130 million hepatitis C infections worldwide. Hepatitis C is a blood-borne infection and a major mode of transmission is injecting drug use. Needle and syringe exchange programmes have been introduced in many countries to control the epidemic. The have been highly effective at preventing new HIV infections, but hepatitis C transmissions still continue.
This is possibly because viral load tends to be high in individuals with chronic hepatitis C infection, and even small quantities of contaminated blood are potentially infectious.
A team of investigators led by Juliane Doerrbecker wished to establish a clearer understanding of the survival of the virus, and the effectiveness of disinfectants and heat at rendering the virus non-infectious.
Steel discs were contaminated with infectious quantities of hepatitis C which were then allowed to dry. Reassuringly, commercially available disinfectants were also shown to have “a high virucidal efficacy against HCV.”
Tests also showed that infectious quantities of hepatitis C of approximately 30 TCID50/ml could still be detected on inanimate surfaces up to seven days after contamination. However, the investigators emphasised that “all tested biocides were able to inactivate HCV infectivity to undetectable levels.”
The investigators then examined the effect of heat on the virus. Spoons and/or cookers are used to heat diluted heroin into solutions. The liquid is then drawn into a syringe, potentially contaminating the spoon if hepatitis C-infected blood is present in the syringe. The investigators therefore contaminated spoons with the virus, which were then heated to various temperatures using tea candles.
Infectivity started to decrease at temperatures of approximately 50°. Levels of the virus fell below the limit of detection when temperatures reached 67-70°. It generally took between 80 to 95 seconds for heating to produce small bubbles in the spoon.
“Reusing HCV contaminated cookers could lead to infection even if using sterile syringes,” comment the investigators.
Holly Hagan emphasised that injecting drug users rarely heat spoons for more than 15 seconds.
In separate research, Dr Vincent Thibault and his colleagues collected drug-using paraphernalia from individuals known to be infected with hepatitis C. The used paraphernalia included syringes, filters and water cups, swabs for cleaning of skin before injecting and pads employed to stop bleeding after withdrawal of needles. A total of 160 pieces of equipment were collected.
The virus was detected on 44% of the pooled materials.
A further 620 items used by individuals of unknown infection status were also obtained. Approximately 83% of the pools obtained from swabs had detectable hepatitis C. Moreover, viral load was highest (above 3 log10 iu/ml) within these swab pools.
Hepatitis C was also commonly detected in syringes, but viral load tended to be at low levels (12 to 890 iu/ml).
The investigators therefore believe that there is “a higher chance for PWID to be contaminated though sharing of a tainted spoon rather than a tainted syringe.”
They note that blood was often visible on swabs. The researchers therefore suggest that transmission of the virus could occur if swabs were being used inappropriately. “The chaotic and rushed atmosphere of the injection setting, where swab sharing and mixing could take place, is…an important factor that should be considered.”
Holly Hagan believes the two studies have important implications for hepatitis C prevention programmes. “Cleaning cookers or perhaps impregnating injection equipment with safe biocides may help reduce the incidence of new infections. Promoting safe swab use to emphasize avoidance of reuse seems a prudent measure.”
Reference
Doerrbecker J et al. Inactivation and survival of hepatitis C virus on inanimate surfaces. J Infect Dis, online edition, doi: 101093/infdis/jir535 (click here for the abstract).
Thibault V et al. Hepatitis C transmission in injecting drug users: could swabs be the main culprit? J Infect Dis, online edition, doi: 101093/infdis/jir650 (click here for the abstract).
Hagan H. Agent, host and environment: hepatitis C virus in people who inject drugs. J Infect Dis, online edition, doi: 101093/infdis/jir654 (click here for a free extract of the text).
November Newsletters
HepC Bull Nov Newsletter
November 2011
News
Research
Foods that Bite, Foods that Fight: Caffeine
Quest: Cross-Border Testing Part II
Hep C on the Internet
Conferences
PegCARE/PegAssist/Neupogen/Compensation
GI & Hepatology News
GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.GI & Hepatology News is published monthly
HCV Advocate Newsletter
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education
See All 2011 Monthly Reviews At CAP Hepatitis C Literature Review
Monthly Pubmed Review of the most relevant research on hepatitis C.
November Pubmed Literature Review
Newswise — In patients with a devastating form of vasculitis who are in remission, stress can be associated with a greater likelihood of the disease flaring, according to a new study by investigators at Hospital for Special Surgery (HSS).
This is the first study to suggest that mental health is a risk factor in patients with vasculitis, a group of autoimmune disorders characterized by the inflammatory destruction of blood vessels. The study, in a form of the disease known as Wegener’s granulomatosis (WG), will be presented on Nov. 8 at the American College of Rheumatology’s annual meeting.
“When this disease flares, people can be really sick. It often affects the lungs, kidneys, sinuses and nerves. It can cause fevers and rashes. People can die from this illness. It is a very robust, active, inflammatory disease when it is active,” said Robert Spiera, M.D., director of the Vasculitis and Scleroderma Program at HSS, who led the study. “When patients are in remission, however, they can do very, very well.”
He says that doctors caring for patients with this disease should be attentive to their psychological health. “This study points out that mental health should be part of your medical assessment,” said Dr. Spiera. “You should pay attention to the patient’s mental well being and be more aggressive about intervening if a patient is in a bad place. Make sure that patients take it seriously.”
Prior to this report, a few small studies had suggested that psychological stress can trigger flares of lupus, another autoimmune disease, and doctors have observed that WG patients often say that stress in their lives, caused by perhaps a death of someone close or losing a job, made their disease flare. To investigate this anecdotal evidence in a more quantifiable way, researchers at HSS conducted a retrospective analysis of data from the Wegener’s Granulomatosis Etanercept Trial (WGET). The primary objective of this randomized, placebo-controlled clinical trial was to evaluate the safety and efficacy of using etanercept (Enbrel; Immunex Corporation) to get patients with WG into remission and maintain that remission.
All patients in this multicenter trial had active disease at the beginning of the study and most patients went into remission. Checkups occurred every three months. “We assessed their disease activity at defined time intervals, in terms of how active their vasculitis was or whether they were in remission, and we also collected information at every visit regarding the patient’s physical and mental health,” Dr. Spiera said. Investigators measured disease activity using the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis, a validated tool. At every visit, patients also filled out the Short Form 36 Health Survey, which includes a physical and mental component. Summary scores for each component are measured on a scale of 0 to 100, with 100 being the healthiest.
For their retrospective analysis of WGET, HSS investigators reviewed records of all patients who had a sustained remission of at least six months (143 patients). They then reviewed data from all checkups after the time of sustained remission to assess the relationship between flare status and the physical and mental health scores from the previous visit. They found that patients were 19 percent more likely to experience a disease flare if they had a five point lower mental health score (P<0.01) at the checkup immediately prior to the flare. The physical component score did not predict an activation of the disease.
“If you looked at patients who were in remission for six months or longer and assessed their mental health as captured by this mental health score, those with a lower mental health score at a given point in time would be more likely to be flaring at the next visit, within three months,” Dr. Spiera said. “This is the first time that as an independent variable, stress seemed to predict a greater likelihood of flaring.”
The study suggests that doctors need to be attentive to a patient’s psychological state and be proactive about interventions to help them manage stress. “There are a lot of things that can be done proactively in stress management on the patient’s side outside of seeing a psychiatrist,” Dr. Spiera said. For example, exercise and yoga have been shown to be effective stress relievers.
The HSS researchers next hope to prospectively examine the association between psychological state and flares in upcoming trials of vasculitis and other autoimmune diseases. Some investigators have hypothesized that stress-related hormones lead to immune dysregulation, but research is needed to tease out the mechanisms.
“Going forward, we can even think of trials where you would take patients who have declined in their mental component score and randomize half of them to receive some sort of stress management program and half of them not to receive it, to see if it changes their outcomes,” Dr. Spiera said.
Wegener’s granulomatosis was recently renamed granulomatosis with polyangiitis. The rare disease, in which inflamed blood vessels interfere with blood circulation, mainly affects vessels in the nose, sinuses, ears, lungs and kidneys, although other areas may be involved. It is most common in middle-aged adults.
Other authors of the study are Morgana Davids and Huong Do at HSS; Gunnar Tomasson, M.D., Boston University School of Medicine; John Davis Jr., M.D., MPH, Genentech; Gary Hoffman, M.D., Cleveland Clinic; W. Joseph McCune, M.D., University of Michigan; Ulrich Specks, M.D., Mayo Clinic; E. William St Clair, M.D., Duke University Medical Center; John Stone, M.D., MPH, Massachusetts General Hospital; and Peter Merkel, M.D., Ph.D., Boston University.
About Hospital for Special Surgery
Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked No. 1 in orthopedics, No. 2 in rheumatology, No. 19 in neurology and No. 16 in geriatrics by U.S. News & World Report (2011-12), has received Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center, and has one of the lowest infection rates in the country. From 2007 to 2011, HSS has been a recipient of the HealthGrades Joint Replacement Excellence Award. A member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Cornell Medical College, HSS provides orthopedic and rheumatologic patient care at NewYork-Presbyterian Hospital at New York Weill Cornell Medical Center. All Hospital for Special Surgery medical staff are on the faculty of Weill Cornell Medical College. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at www.hss.edu.
(The Philadelphia Inquirer, November 4, 2011)
"It used to be that you picked a hospital based on the recommendation of your doctor, perhaps your spouse or neighbor. Location was certainly a factor, particularly in an emergency. But increasingly, consumers have had access to hard data on how well hospitals actually heal the sick. This year, for example, the federal government publicized figures for eight serious, generally preventable conditions such as bedsores and certain infections. Are consumers using this information to make health-care decisions? And should they? So far, there is limited evidence that consumers consult a computer screen full of numbers before choosing where to get a hip replacement. Experts on health-care quality expect that to change as more information becomes available, but they urge caution."....
Canadian Health Care
Canada: We Need a Health Plan for Boomers Now
"The aging population and the concomitant rise in people living with chronic illnesses pose many public policy challenges. The response to this demographic reality has largely been apocalyptic defeatism…This alarmist view of our aging society is challenged in a...report from the Institute for Research on Public Policy...Stated simply: We need a plan…The most shocking reality is not that the population is aging but that we have done virtually nothing to understand or prepare for this change…There have been, of late, a number of studies debunking the notion that seniors are principally to blame for spiralling health costs.
In fact, it is new technologies, new drugs and higher wages for health professionals...that are pushing up costs...disability tends to affect the 'old elderly' -- those over 80. Ill health is not evenly distributed either: It disproportionately affects those who are poor, female and socially isolated. It is members of those groups that require the most care and assistance, and also to whom prevention efforts should be targeted."...
The Food and Drug Administration is warning people not to eat frozen oysters sold under the ASSI brand name.
FDA NEWS RELEASE
For Immediate Release: November 4, 2011
Media Inquiries: Doug Karas, 301-796-2805, douglas.karas@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA
FDA warns consumers not to eat certain ASSI Brand frozen oysters
Oysters linked to norovirus cases in Washington state
Fast Facts
• The U.S. Food and Drug Administration is warning consumers not to eat certain ASSI Brand frozen oysters from Korea following an outbreak of illness in Washington state caused by norovirus.
• The frozen oyster meat (shucked; not in shell), is packed in 3-lb bags . Each bag is labeled ASSI Brand “INDIVIDUALLY QUICK FROZEN OYSTER” with a “Better if Used By” date of “2013.02.232.” Each bag identifies Central Fisheries Co. Ltd., as the packer and Korean Farms of Santa Fe Springs, Calif., as the distributor. Korean Farms has voluntarily agreed to recall these oysters.
• The individual bags are shipped in boxes of 10 bags each with the lot number C-110223, appearing on each shipping carton , along with a “SHUCKED DATE: 2011.02.24.
• These oysters, which were served in a Washington state restaurant and were eaten by three people who became ill, have been sampled and tested positive by FDA for norovirus genotypes I and II.
• There have been no reports of hospitalizations or deaths resulting from consuming the frozen oysters.
• Records indicate that this product was shipped to the states of Washington, California, Texas, Colorado, Arizona, Alaska, Idaho, and Utah.
• Those who have recently purchased oysters should not eat them and should safely dispose of them in the trash or garbage disposal.
What is the problem?
Certain ASSI Brand frozen oysters from Korea have been linked to an outbreak of illness in Washington state caused by norovirus. These oysters, which were served in a Washington state restaurant and eaten by three people who became ill, have been sampled and tested positive by FDA for norovirus genotypes I and II. The frozen oyster meat (shucked; not in shell), is packed in 3-lb bags. Each bag is labeled ASSI Brand “INDIVIDUALLY QUICK FROZEN OYSTER” with a “Better if Used By” date of 2013.02.232. Each bag identifies Central Fisheries Co. Ltd., as the packer and Korean Farms of Santa Fe Springs, Calif., as the distributor. The individual bags are shipped in boxes of 10 bags each with the lot number C-110223, appearing on each shipping carton, along with a “SHUCKED DATE: 2011.02.24.” Korean Farms has voluntarily agreed to recall these oysters.
What are the symptoms of Norovirus?
Norovirus causes acute gastroenteritis (inflammation of the stomach and intestines). The most common symptoms are nausea, diarrhea, vomiting, and stomach pain. The illness often begins suddenly and norovirus can make people feel extremely ill with frequent vomiting and diarrhea. Most people get better within 1 to 2 days. Dehydration can be a problem among some people with norovirus infection, especially the very young, the elderly, and people with other illnesses.
Who is at risk?
Anyone can get norovirus, and can have the illness multiple times during their lifetime. Norovirus is highly contagious. People with norovirus are contagious from the moment they begin feeling ill to at least 3 days and perhaps for as long as 2 weeks after recovery, making control of this disease difficult. Norovirus can spread quickly in settings such as day care centers or nursing homes.
What Do Consumers Need To Do?
Those who have recently purchased the frozen oysters should not eat them and should dispose of them in the trash or garbage disposal. If the oysters were already consumed and no one became ill, no action is needed. If you develop illness within several days after consuming these Korean frozen oysters, consult your health care provider and inform the provider of your exposure to this product.
Where Were the Oysters Distributed?
Records indicate that the identified lot of oysters was shipped to the states of Washington, California, Texas, Colorado, Arizona, Alaska, Idaho, and Utah.
What is Being Done about the Problem?
Under the provisions of the National Shellfish Sanitation Program, the state of California is working with the company that distributed the frozen oysters to recall the product.
Who Should be Contacted?
Consumers with questions about the recalled oysters should call Korean Farms Inc. at 1-562-789-9988.
Consumers who show any signs of illness after eating the frozen oysters should consult their health care provider. FDA encourages consumers with questions about seafood safety to call 1-888-SAFEFOOD or consult the fda.gov website.
The information in this press release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
For more information:
FDA: Fresh and Frozen Seafood: Selecting and Serving it Safely1
CDC: Norovirus Illness – Key Facts
2
Thibault V et al. Hepatitis C transmission in injecting drug users: could swabs be the main culprit? J Infect Dis, online edition, doi: 101093/infdis/jir650 (click here for the abstract).
Hagan H. Agent, host and environment: hepatitis C virus in people who inject drugs. J Infect Dis, online edition, doi: 101093/infdis/jir654 (click here for a free extract of the text).
NAFLD Linked to Cardiovascular Risk
BY SARA FREEMAN
BY SARA FREEMAN
Elsevier Global Medical NewsLISBON –
Accumulation offat in the liver, along with inflammationand fibrosis, appears linked to corresponding increases in cardiovascular risk,especially in patients with diabetes, a small study suggests.
“We are realizing that increasing severity of nonalcoholic fatty liver disease [NAFLD] is adding extra cardiovascular riskin the population,” investigator Dr. Christopher D. Byrne said in an interview.
Patients who have more severe NAFLD may require more aggressive therapies to address their additional risk, and such therapies need to target the heart as much as the liver, said Dr. Byrne, professor of endocrinology and metabolism at the University of Southampton (England).
In the study of 112 patients with biopsy-proven NAFLD,the Kleiner scores – a histologic measure of NAFLD severity– were highly correlated with both Framingham Risk Score(FRS) and QRISK2 score, two estimates of cardiovascular risk.“[NAFLD] represents a spectrum off at-mediated liver conditions causing progressive hepatocellular damage,” said Sarah Hudson, a fifth-year medical student at the University of Southampton, who presented the work at the annual meeting of the European Association for the Study of Diabetes.
The aim of the study was to determine whether a histopathologic marker– the Kleiner score – correlated with two cardiovascular risk scores, and if Kleiner scores were higher in people already known to have elevated cardiovascular risk, namely those with diabetes.
The Kleiner score assesses the degree of steatosis, lobular inflammation, hepatocyte “ballooning,” and fibrosis, with higher scores indicating more severe liver disease. The mean Kleiner score was5.3, and mean body mass index (BMI) was34 kg/m2. The median FRS was 13 and the median QRISK2 score was 8.
Kleiner scores were highly correlated with both cardiovascular risk models used,and were also higher in a subgroup of 32 patients with diabetes, compared to nondiabetics (6.4 vs. 4.7, P less than .001).
The increased risk of cardiovascular disease in correlation with higher NAFLD severity was found to be independent of both hyperglycemia and body weight.
“We know that losing weight and increasing activity levels are very effective at decreasing liver fat, but what we don’t know is whether those lifestyle changes are good at decreasing liver inflammation,or decreasing liver fibrosis,” he said.
Treatment to decrease liver fat and prevent progression to fibrosis is urgently needed, and Dr. Byrne is part of a team now looking at use of a high concentration of highly purified omega-3 fatty acid ethyl esters in the treatment of NAFLD. For now, clinicians need to optimize the available treatments, including antihypertensive and lipid-lowering medicines in conjunction with lifestyle modifications.
The study was funded by the National Institute for Health Research and Diabetes UK and is supported by the Southampton Biomedical Research Unit in Nutrition, Diet & Lifestyle. Dr. Byrne and Ms. Hudson had no relevant disclosures.
Dr. Byrne said he has given lectures on behalf of pharmaceutical companies in the past, including Pfizer.
■In a study recently presented at the European Association for the Study of Diabetes, Hudson and colleagues found that the severity of NAFLD was independently associated with increased10-year risk of an adverse cardiovascular event.
As the authors point out, epidemiological studies have shown that cardiovascular disease is the most common cause of death in patients with NAFLD. However,until recently, this was thought to be due to the high prevalence of cardiovascular risk factors in such patients.There is a growing body of literature supporting the notion that NAFLD is an independent predictor of cardiovascular disease.
The presence of fatty liver has been associated with subclinical manifestations of coronary artery disease as well as impaired endothelial function.
The findings of this study have important public health implications. NAFLD is the most common cause of abnormal liver chemistry tests and will be the leading cause of liver failure necessitating liver transplantation in the ensuing decade. While this is a relatively small retrospective study, it emphasizes the concept that NAFLD and NASH [nonalcoholic steato hepatitis] severity could help to predict adverse cardiovascular events, independent of traditional risk factors.
The findings of this study have important public health implications. NAFLD is the most common cause of abnormal liver chemistry tests and will be the leading cause of liver failure necessitating liver transplantation in the ensuing decade. While this is a relatively small retrospective study, it emphasizes the concept that NAFLD and NASH [nonalcoholic steato hepatitis] severity could help to predict adverse cardiovascular events, independent of traditional risk factors.
More data are anxiously awaited to better u nderstand the pathophysiology of this association,and to be able to predict outcomes in our patients with fatty liver disease.
MARY E. RINELLA, M.D., is Associate Professor of Medicine,Department of Medicine,Division of Hepatology, Northwestern University Feinberg School of Medicine, Chicago.
Solid organ recipients at increased risk for a range of cancers
“What’s new about this study is that it’s the largest study in the world to date, and it includes people who got a whole range of organ transplants, not just kidney, but also liver, heart, and lung,” lead author Dr. Eric Engels, from the NCI in Rockville, Maryland, told Reuters Health.
Solid organ recipients at increased risk for a range of cancers
“What’s new about this study is that it’s the largest study in the world to date, and it includes people who got a whole range of organ transplants, not just kidney, but also liver, heart, and lung,” lead author Dr. Eric Engels, from the NCI in Rockville, Maryland, told Reuters Health.
NEW YORK (Reuters Health) – After organ transplantation, the overall risk of any new malignancy doubles, according to a new report from the U.S. National Cancer Institute.The NCI study, reported online today in the Journal of the American Medical Association, found that transplant recipients have an elevated risk of 32 different types of cancers, including those closely tied to infection and the loss of immunologic control of oncogenic viruses, and others with no known infection link.
It’s “actually pretty shocking when presented like this how many different kinds of cancers transplant patients are (at) risk for and how high the magnitude of risk is compared to general population,” said Dr. Scott Palmer, Scientific Director of the Lung Transplant Program at Duke University Medical Center, Durham, North Carolina, in an email to Reuters Health.
The findings “reinforce that all of our patients ought to (undergo) more frequent and more vigorous cancer screening,” said Dr. Palmer, who was not involved in the new report. “Population based recommendations don’t apply to transplant patients and screening should be more aggressive in these patients given their higher risk.” Increased cancer risks after transplant have been reported before, but most studies have been relatively small and limited to kidney recipients, according to the authors of the new report.
“What’s new about this study is that it’s the largest study in the world to date, and it includes people who got a whole range of organ transplants, not just kidney, but also liver, heart, and lung,” lead author Dr. Eric Engels, from the NCI in Rockville, Maryland, told Reuters Health. Using linked data for 1987-2008 from the U.S. Scientific Registry of Transplant Recipients and cancer registries in 13 states and regions, his team analyzed recipients of 175,732 solid organ transplants (which account for 39.7% of all transplants done in the U.S. over that period).
During follow-up, 10,656 cancers were diagnosed in organ recipients, for an overall incidence of 1375 per 100,000 person-years -- twice as high as the adjusted rate of cancer diagnoses in the general population (standard incidence ratio, 2.10). The excess absolute risk attributable to transplantation is approximately 0.7% per year, the researchers said.
The most common cancers that occurred more frequently in transplant recipients were non-Hodgkin’s lymphoma (SIR, 7.54) and cancers of the lung (SIR, 1.97), liver (SIR, 11.56), and kidney (SIR, 4.65).
The risk of liver cancer was only elevated in liver recipients. However, lung cancer risks were higher than expected in lung, kidney, liver, and heart recipients, and kidney cancer risks were was elevated among kidney, liver, and heart transplant patients. There are likely multiple mechanisms behind the elevated cancer risks, Dr. Engels said, including immunosuppressant medications and underlying medical conditions -- including smoking damage in the case of lung and heart recipients and hepatitis C in liver recipients.
He did not say that all transplant recipients should necessarily be screened more frequently than general-population guidelines recommend -- but he does hope that the findings will help inform future guidelines specific for these patients. For now, Dr. Engels said, transplant physicians “should carefully evaluate transplant candidates for cancer risk factors, and after transplant consider those factors in managing transplant recipients.” Physicians should help recipients quit smoking, Dr. Engels emphasized, and encourage them to avoid unnecessary sun exposure.
The SIR for nonmelanoma, nonepithelial skin cancer in recipients was 13.85. He and his colleagues will continue to analyze the linked transplant and cancer registry data, he said, in an effort to identify specific cancer risk factors for certain types of transplant patients. The research team admits that “patterns of cancer risk in transplant recipients may partly reflect artifacts of cancer screening. For example, decreased breast and prostate cancer risk may arise from screening before transplant, leading to removal of prevalent cancers or deferral of transplant in candidates with cancer.
Additionally, transplant recipients may appear to have elevated risk for some cancers (e.g., melanoma, cancers of the kidney or thyroid) because of heightened medical surveillance.” “In the long run themost important message is how imperfect our current immunosuppression really is for our patients,” Dr. Palmer concluded in his email. “We have drugs that reduce the risk of rejection and allow patients to successfully undergo solid organ transplant but they pay a price in terms of significant toxicity including a higher risk for many cancers. It should reinforce the need to develop new innovative ways to prevent rejection that don’t have such a high price to pay in terms of side effects.” Reference: JAMA 2011.
It’s “actually pretty shocking when presented like this how many different kinds of cancers transplant patients are (at) risk for and how high the magnitude of risk is compared to general population,” said Dr. Scott Palmer, Scientific Director of the Lung Transplant Program at Duke University Medical Center, Durham, North Carolina, in an email to Reuters Health.
The findings “reinforce that all of our patients ought to (undergo) more frequent and more vigorous cancer screening,” said Dr. Palmer, who was not involved in the new report. “Population based recommendations don’t apply to transplant patients and screening should be more aggressive in these patients given their higher risk.” Increased cancer risks after transplant have been reported before, but most studies have been relatively small and limited to kidney recipients, according to the authors of the new report.
“What’s new about this study is that it’s the largest study in the world to date, and it includes people who got a whole range of organ transplants, not just kidney, but also liver, heart, and lung,” lead author Dr. Eric Engels, from the NCI in Rockville, Maryland, told Reuters Health. Using linked data for 1987-2008 from the U.S. Scientific Registry of Transplant Recipients and cancer registries in 13 states and regions, his team analyzed recipients of 175,732 solid organ transplants (which account for 39.7% of all transplants done in the U.S. over that period).
During follow-up, 10,656 cancers were diagnosed in organ recipients, for an overall incidence of 1375 per 100,000 person-years -- twice as high as the adjusted rate of cancer diagnoses in the general population (standard incidence ratio, 2.10). The excess absolute risk attributable to transplantation is approximately 0.7% per year, the researchers said.
The most common cancers that occurred more frequently in transplant recipients were non-Hodgkin’s lymphoma (SIR, 7.54) and cancers of the lung (SIR, 1.97), liver (SIR, 11.56), and kidney (SIR, 4.65).
The risk of liver cancer was only elevated in liver recipients. However, lung cancer risks were higher than expected in lung, kidney, liver, and heart recipients, and kidney cancer risks were was elevated among kidney, liver, and heart transplant patients. There are likely multiple mechanisms behind the elevated cancer risks, Dr. Engels said, including immunosuppressant medications and underlying medical conditions -- including smoking damage in the case of lung and heart recipients and hepatitis C in liver recipients.
He did not say that all transplant recipients should necessarily be screened more frequently than general-population guidelines recommend -- but he does hope that the findings will help inform future guidelines specific for these patients. For now, Dr. Engels said, transplant physicians “should carefully evaluate transplant candidates for cancer risk factors, and after transplant consider those factors in managing transplant recipients.” Physicians should help recipients quit smoking, Dr. Engels emphasized, and encourage them to avoid unnecessary sun exposure.
The SIR for nonmelanoma, nonepithelial skin cancer in recipients was 13.85. He and his colleagues will continue to analyze the linked transplant and cancer registry data, he said, in an effort to identify specific cancer risk factors for certain types of transplant patients. The research team admits that “patterns of cancer risk in transplant recipients may partly reflect artifacts of cancer screening. For example, decreased breast and prostate cancer risk may arise from screening before transplant, leading to removal of prevalent cancers or deferral of transplant in candidates with cancer.
Additionally, transplant recipients may appear to have elevated risk for some cancers (e.g., melanoma, cancers of the kidney or thyroid) because of heightened medical surveillance.” “In the long run themost important message is how imperfect our current immunosuppression really is for our patients,” Dr. Palmer concluded in his email. “We have drugs that reduce the risk of rejection and allow patients to successfully undergo solid organ transplant but they pay a price in terms of significant toxicity including a higher risk for many cancers. It should reinforce the need to develop new innovative ways to prevent rejection that don’t have such a high price to pay in terms of side effects.” Reference: JAMA 2011.
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Healthy You
Related 2011- Hepatitis C-related vasculitis
Study Shows Psychological Health Important to Controlling Wegener’s GranulomatosisNewswise — In patients with a devastating form of vasculitis who are in remission, stress can be associated with a greater likelihood of the disease flaring, according to a new study by investigators at Hospital for Special Surgery (HSS).
This is the first study to suggest that mental health is a risk factor in patients with vasculitis, a group of autoimmune disorders characterized by the inflammatory destruction of blood vessels. The study, in a form of the disease known as Wegener’s granulomatosis (WG), will be presented on Nov. 8 at the American College of Rheumatology’s annual meeting.
“When this disease flares, people can be really sick. It often affects the lungs, kidneys, sinuses and nerves. It can cause fevers and rashes. People can die from this illness. It is a very robust, active, inflammatory disease when it is active,” said Robert Spiera, M.D., director of the Vasculitis and Scleroderma Program at HSS, who led the study. “When patients are in remission, however, they can do very, very well.”
He says that doctors caring for patients with this disease should be attentive to their psychological health. “This study points out that mental health should be part of your medical assessment,” said Dr. Spiera. “You should pay attention to the patient’s mental well being and be more aggressive about intervening if a patient is in a bad place. Make sure that patients take it seriously.”
Prior to this report, a few small studies had suggested that psychological stress can trigger flares of lupus, another autoimmune disease, and doctors have observed that WG patients often say that stress in their lives, caused by perhaps a death of someone close or losing a job, made their disease flare. To investigate this anecdotal evidence in a more quantifiable way, researchers at HSS conducted a retrospective analysis of data from the Wegener’s Granulomatosis Etanercept Trial (WGET). The primary objective of this randomized, placebo-controlled clinical trial was to evaluate the safety and efficacy of using etanercept (Enbrel; Immunex Corporation) to get patients with WG into remission and maintain that remission.
All patients in this multicenter trial had active disease at the beginning of the study and most patients went into remission. Checkups occurred every three months. “We assessed their disease activity at defined time intervals, in terms of how active their vasculitis was or whether they were in remission, and we also collected information at every visit regarding the patient’s physical and mental health,” Dr. Spiera said. Investigators measured disease activity using the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis, a validated tool. At every visit, patients also filled out the Short Form 36 Health Survey, which includes a physical and mental component. Summary scores for each component are measured on a scale of 0 to 100, with 100 being the healthiest.
For their retrospective analysis of WGET, HSS investigators reviewed records of all patients who had a sustained remission of at least six months (143 patients). They then reviewed data from all checkups after the time of sustained remission to assess the relationship between flare status and the physical and mental health scores from the previous visit. They found that patients were 19 percent more likely to experience a disease flare if they had a five point lower mental health score (P<0.01) at the checkup immediately prior to the flare. The physical component score did not predict an activation of the disease.
“If you looked at patients who were in remission for six months or longer and assessed their mental health as captured by this mental health score, those with a lower mental health score at a given point in time would be more likely to be flaring at the next visit, within three months,” Dr. Spiera said. “This is the first time that as an independent variable, stress seemed to predict a greater likelihood of flaring.”
The study suggests that doctors need to be attentive to a patient’s psychological state and be proactive about interventions to help them manage stress. “There are a lot of things that can be done proactively in stress management on the patient’s side outside of seeing a psychiatrist,” Dr. Spiera said. For example, exercise and yoga have been shown to be effective stress relievers.
The HSS researchers next hope to prospectively examine the association between psychological state and flares in upcoming trials of vasculitis and other autoimmune diseases. Some investigators have hypothesized that stress-related hormones lead to immune dysregulation, but research is needed to tease out the mechanisms.
“Going forward, we can even think of trials where you would take patients who have declined in their mental component score and randomize half of them to receive some sort of stress management program and half of them not to receive it, to see if it changes their outcomes,” Dr. Spiera said.
Wegener’s granulomatosis was recently renamed granulomatosis with polyangiitis. The rare disease, in which inflamed blood vessels interfere with blood circulation, mainly affects vessels in the nose, sinuses, ears, lungs and kidneys, although other areas may be involved. It is most common in middle-aged adults.
Other authors of the study are Morgana Davids and Huong Do at HSS; Gunnar Tomasson, M.D., Boston University School of Medicine; John Davis Jr., M.D., MPH, Genentech; Gary Hoffman, M.D., Cleveland Clinic; W. Joseph McCune, M.D., University of Michigan; Ulrich Specks, M.D., Mayo Clinic; E. William St Clair, M.D., Duke University Medical Center; John Stone, M.D., MPH, Massachusetts General Hospital; and Peter Merkel, M.D., Ph.D., Boston University.
About Hospital for Special Surgery
Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked No. 1 in orthopedics, No. 2 in rheumatology, No. 19 in neurology and No. 16 in geriatrics by U.S. News & World Report (2011-12), has received Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center, and has one of the lowest infection rates in the country. From 2007 to 2011, HSS has been a recipient of the HealthGrades Joint Replacement Excellence Award. A member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Cornell Medical College, HSS provides orthopedic and rheumatologic patient care at NewYork-Presbyterian Hospital at New York Weill Cornell Medical Center. All Hospital for Special Surgery medical staff are on the faculty of Weill Cornell Medical College. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at www.hss.edu.
U.S. Health Care
A New Tool To Compare Hospital Performance(The Philadelphia Inquirer, November 4, 2011)
"It used to be that you picked a hospital based on the recommendation of your doctor, perhaps your spouse or neighbor. Location was certainly a factor, particularly in an emergency. But increasingly, consumers have had access to hard data on how well hospitals actually heal the sick. This year, for example, the federal government publicized figures for eight serious, generally preventable conditions such as bedsores and certain infections. Are consumers using this information to make health-care decisions? And should they? So far, there is limited evidence that consumers consult a computer screen full of numbers before choosing where to get a hip replacement. Experts on health-care quality expect that to change as more information becomes available, but they urge caution."....
Canadian Health Care
Canada: We Need a Health Plan for Boomers Now
"The aging population and the concomitant rise in people living with chronic illnesses pose many public policy challenges. The response to this demographic reality has largely been apocalyptic defeatism…This alarmist view of our aging society is challenged in a...report from the Institute for Research on Public Policy...Stated simply: We need a plan…The most shocking reality is not that the population is aging but that we have done virtually nothing to understand or prepare for this change…There have been, of late, a number of studies debunking the notion that seniors are principally to blame for spiralling health costs.
In fact, it is new technologies, new drugs and higher wages for health professionals...that are pushing up costs...disability tends to affect the 'old elderly' -- those over 80. Ill health is not evenly distributed either: It disproportionately affects those who are poor, female and socially isolated. It is members of those groups that require the most care and assistance, and also to whom prevention efforts should be targeted."...
FDA Recalled
FDA Recalls Frozen Oysters The Food and Drug Administration is warning people not to eat frozen oysters sold under the ASSI brand name.
FDA NEWS RELEASE
For Immediate Release: November 4, 2011
Media Inquiries: Doug Karas, 301-796-2805, douglas.karas@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA
FDA warns consumers not to eat certain ASSI Brand frozen oysters
Oysters linked to norovirus cases in Washington state
Fast Facts
• The U.S. Food and Drug Administration is warning consumers not to eat certain ASSI Brand frozen oysters from Korea following an outbreak of illness in Washington state caused by norovirus.
• The frozen oyster meat (shucked; not in shell), is packed in 3-lb bags . Each bag is labeled ASSI Brand “INDIVIDUALLY QUICK FROZEN OYSTER” with a “Better if Used By” date of “2013.02.232.” Each bag identifies Central Fisheries Co. Ltd., as the packer and Korean Farms of Santa Fe Springs, Calif., as the distributor. Korean Farms has voluntarily agreed to recall these oysters.
• The individual bags are shipped in boxes of 10 bags each with the lot number C-110223, appearing on each shipping carton , along with a “SHUCKED DATE: 2011.02.24.
• These oysters, which were served in a Washington state restaurant and were eaten by three people who became ill, have been sampled and tested positive by FDA for norovirus genotypes I and II.
• There have been no reports of hospitalizations or deaths resulting from consuming the frozen oysters.
• Records indicate that this product was shipped to the states of Washington, California, Texas, Colorado, Arizona, Alaska, Idaho, and Utah.
• Those who have recently purchased oysters should not eat them and should safely dispose of them in the trash or garbage disposal.
What is the problem?
Certain ASSI Brand frozen oysters from Korea have been linked to an outbreak of illness in Washington state caused by norovirus. These oysters, which were served in a Washington state restaurant and eaten by three people who became ill, have been sampled and tested positive by FDA for norovirus genotypes I and II. The frozen oyster meat (shucked; not in shell), is packed in 3-lb bags. Each bag is labeled ASSI Brand “INDIVIDUALLY QUICK FROZEN OYSTER” with a “Better if Used By” date of 2013.02.232. Each bag identifies Central Fisheries Co. Ltd., as the packer and Korean Farms of Santa Fe Springs, Calif., as the distributor. The individual bags are shipped in boxes of 10 bags each with the lot number C-110223, appearing on each shipping carton, along with a “SHUCKED DATE: 2011.02.24.” Korean Farms has voluntarily agreed to recall these oysters.
What are the symptoms of Norovirus?
Norovirus causes acute gastroenteritis (inflammation of the stomach and intestines). The most common symptoms are nausea, diarrhea, vomiting, and stomach pain. The illness often begins suddenly and norovirus can make people feel extremely ill with frequent vomiting and diarrhea. Most people get better within 1 to 2 days. Dehydration can be a problem among some people with norovirus infection, especially the very young, the elderly, and people with other illnesses.
Who is at risk?
Anyone can get norovirus, and can have the illness multiple times during their lifetime. Norovirus is highly contagious. People with norovirus are contagious from the moment they begin feeling ill to at least 3 days and perhaps for as long as 2 weeks after recovery, making control of this disease difficult. Norovirus can spread quickly in settings such as day care centers or nursing homes.
What Do Consumers Need To Do?
Those who have recently purchased the frozen oysters should not eat them and should dispose of them in the trash or garbage disposal. If the oysters were already consumed and no one became ill, no action is needed. If you develop illness within several days after consuming these Korean frozen oysters, consult your health care provider and inform the provider of your exposure to this product.
Where Were the Oysters Distributed?
Records indicate that the identified lot of oysters was shipped to the states of Washington, California, Texas, Colorado, Arizona, Alaska, Idaho, and Utah.
What is Being Done about the Problem?
Under the provisions of the National Shellfish Sanitation Program, the state of California is working with the company that distributed the frozen oysters to recall the product.
Who Should be Contacted?
Consumers with questions about the recalled oysters should call Korean Farms Inc. at 1-562-789-9988.
Consumers who show any signs of illness after eating the frozen oysters should consult their health care provider. FDA encourages consumers with questions about seafood safety to call 1-888-SAFEFOOD or consult the fda.gov website.
The information in this press release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
For more information:
FDA: Fresh and Frozen Seafood: Selecting and Serving it Safely1
CDC: Norovirus Illness – Key Facts
2
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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