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Week Ending: June 26, 2010
Alan Franciscus
Editor-in-Chief
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This Issue:
June 19, 2010
90% Of HCV Patients to Be Treated with Triple Therapy Regimens, Finds Decision Resources
http://www.news-medical.net
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, based on clinical profiles provided to them, surveyed clinicians estimate that one year after the launch of Vertex Pharmaceuticals/Johnson & Johnson/Mitsubishi Tanabe Pharma's telaprevir and Merck's boceprevir, at least 90 percent of hepatitis C virus (HCV) patients will be treated with triple therapy regimens.
The new Physician & Payer Forum report entitled Hepatitis C: Reimbursement and Uptake of Novel Antivirals Among Payers and Prescribers finds that surveyed physicians expect to treat 71 percent of treatment-naive and 78 percent of nonresponder patients with telaprevir/peg-IFN/ribavirin and 19 percent of treatment-naive and nonresponders with boceprevir/peg-IFN/ribavirin. Similar to clinicians, managed care organizations' (MCO) pharmacy directors are open to reimbursing telaprevir and boceprevir. However, surveyed pharmacy directors do not indicate a clear preference for either one of these protease inhibitors.
"Only 10 percent of the pharmacy directors we surveyed do not expect to add telaprevir or boceprevir to their drug formularies," said Decision Resources Analyst Alexandra Makarova, M.D. Ph.D. "The remaining surveyed pharmacy directors are split regarding the choice of the protease inhibitor for addition to their formularies. Twenty-five percent expect to add both telaprevir and boceprevir, while 15 percent will add only telaprevir and 5 percent will add only boceprevir. Forty percent of pharmacy directors will make their choice based on the relative cost of each agent."
The report also finds that almost half of surveyed clinicians indicate that they will use Roche's Pegasys and Merck's PegIntron interchangeably in combination with an HCV-specific antiviral agent even if this agent was evaluated in clinical trials involving only one of these peg-IFNs. However, one-third of doctors expect to combine a novel HCV-specific antiviral agent only with the peg-IFN that was used with the antiviral agent in clinical trials. These physicians indicate that they will likely use Pegasys in triple therapy regimens as the majority of HCV-specific antiviral agents are being evaluated with Pegasys rather than PegIntron.
Hepatitis C: Reimbursement and Uptake of Novel Antivirals Among Payers and Prescribers is based on a U.S. survey of 74 gastroenterologists, 26 hepatologists and 20 MCO pharmacy directors. Their responses were compared to assess similarities and differences of opinion regarding clinical, economic and scientific factors.
SOURCE Decision Resources
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June 20, 2010
Hepatitis B Screening Serves 180
http://www.journal-news.net/
By Jenni Vincent, Journal staff writer
MARTINSBURG - Approximately 180 individuals attended Thursday's screening clinic held at Martinsburg High School for patients and volunteers from the 2009 Mission of Mercy dental clinic, according to Berkeley County Health Department administrator Bill Kearns.
Kearns said Friday that approximately 200 individuals had telephoned to say they would attend the clinic, so Health Department professionals - as well as other volunteers - were prepared to handle the crowd.
He said more than 2,000 letters were sent to M.O.M. clinic participants and volunteers informing them about the free screening.
"Really, there's no way to speak for the ones who decided not to participate or know what their thinking was," Kearns said.
State and county health officials announced earlier this month that the letters were being sent out as a precautionary measure because five individuals from last year's M.O.M. clinic - which was held at Hedgesville High School - were later identified as having hepatitis B. Among the cases were three patients and two volunteers, officials said.
While health officials stopped short of saying the illness was contracted at the clinic, the did suggest that participants should consider being tested since the "cluster" of hepatitis B cases had seemingly been linked to the event.
Kearns said the blood samples will now be sent for processing to a state laboratory in Charleston.
The results are expected to be ready by mid-July, when they will be made available locally, he said. At that time, individuals will be able to receive their results at the Berkeley County Health Department.
The clinic was an operational success and part of that was due to the help of other agencies' volunteers, Kearns said.
Organizations that assisted with the event included the United Way of the Eastern Panhandle, Eastern Panhandle Medical Reserve Corps and Shepherd University, which provided both nursing students and administrative assistance, he said.
- Staff writer Jenni Vincent can be reached at 304-263-8931, ext. 138, or jvincent@journal-news.net
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Benitec Limited (ASX:BLT) Granted Hepatitis C RNA Interference Patent in US
http://www.pharmalive.com
Benitec Limited (ASX:BLT) (PINK:BNIKF) are pleased to announce that US Patent 7727970 "Multiple promoter expression cassettes for simultaneous delivery of RNAi agents targeted to Hepatitis C virus" has been granted by the United States Patent and Trademark Office (USPTO). The granted claims cover the use of an RNA interference construct (with multiple promoters) to inhibit the level of Hepatitis C virus in animal cells, tissues and organs. Moreover, the USPTO has granted Benitec an additional 805 days patent term in recognition of the delays in examining the patent application. Additional related applications remain pending to extend the scope of protection.
Benitec has licensed the rights to use this patent for Hepatitis C exclusively to Tacere Therapeutics, Inc., who recently announced that Pfizer has exercised its option to further develop and commercialise Tacere's Hepatitis C Virus (HCV) compounds.
Benitec's Chief Scientific Officer, Dr Peter French said, "The grant of this patent is an important further recognition of our dominant global position in the transformational DNA-directed RNA interference field and provides increased depth and breadth to our patent portfolio. Benitec's ddRNAi-related patent estate (solely owned or licensed exclusively for humans from CSIRO) currently comprises over 100 patents and patent applications covering 20 jurisdictions, of which more than 30 are granted, accepted or allowed."
Link: http://www.abnnewswire.net/media/en/docs/
63116-ASX-BLT-596073.pdf
About: Benitec Limited
Benitec Limited (ASX:BLT) (PINK:BNIKF) is an Australian biotechnology company focused on licensing its extensive intellectual property portfolio and developing therapeutics to treat serious diseases using its proprietary ddRNAi technology. For additional information, please visit www.benitec.com.
Contact:
Mel Bridges Executive Director Mob: +61-413-051-600 Email: mbridges@benitec.com
Peter French Chief Executive Officer Mob: +61-412-457-595 Email: pfrench@benitec.com
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North County Hospital Patients Potentially Exposed to Viruses
http://www.gaylesbiantimes.com
by Ivan Garcia, Assistant Editor
Hundreds urged to get tested for hepatitis, HIV
In Escondido, hundreds of patients are being urged to get tested after they were potentially exposed to several serious viruses at two North County hospitals. The hospitals state that the chance of infection is low, but they are offering free blood tests to 3,400 patients who could have been exposed to Hepatitis or HIV due to improperly cleaned equipment.
A letter delivered by certified mail to certain patients at Palomar Health Center and it’s sister hospital at Pomerado said the risk of transmission was low. “It doesn’t say the kind of infection, and I later find out that they’re testing for is Hepatitis B, Hepatitis C, and HIV,” said a patient. The patient, whom wished to not be named, received a letter from Palomar Pomerado’s CEO, Michael Covert, which read:
“As part of our ongoing review process, Palomar Pomerado Health examined the techniques we used to clean and disinfect equipment used in your procedure. As a result, we have found some of the steps we performed were different from the steps the manufacturer recommends.”
The patient said she was shocked. “Especially when the letter said that the issue was they didn’t follow the manufacturer’s instructions,” she said. The procedures in question were colonoscopies and trans-vaginal ultrasounds at Palomar Medical Center, and the letters were sent after the state department of health conducted a full investigation. Palomar Pomerado is now offering the affected patients free blood tests to determine whether they were infected, which does not make matters better for this patient. “It doesn’t set my mind at east at all, it infuriates me,” said the patient. “The whole thing infuriates me.” Palomar Pomerado insisted the chances of infection were very low and to their knowledge, no patients have been infected.
This is not the first time a local hospital has had to warn patients about potential exposure to infection. In 2006, Scripps Green Hospital and Scripps Memorial Hospital issued warnings just months apart. Both cases were due to improper sterilization of instruments, and nearly 400 patients received warnings.
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June 22, 2010
Honda: It’s Time to Get Serious about Viral Hepatitis
http://www.rollcall.com
By Rep. Mike Honda
Special to Roll Call
At a House Oversight and Government Reform Committee hearing last week, I testified to the devastating and deadly impacts of an unsuspecting disease: viral hepatitis. The fact that I was joined by Dr. Howard Koh, assistant secretary for Health, and Dr. John Ward, director of the Viral Hepatitis Program at the Centers for Disease Control and Prevention, underscores the importance of the issue. Government oversight is a good start to getting the American public more informed, but much more is needed, according to the Institute of Medicine’s 2010 report, “Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C.”
Few people realize how highly infectious viral hepatitis is. Hepatitis B is 100 times more infectious than HIV. Few realize that, left untreated, it can cause liver disease, liver cancer and premature death decades after infection. Few realize that roughly 2 billion people worldwide have been infected with hepatitis B, more than 170 million people are chronically infected with hepatitis C, and in this nation alone, an estimated 5.3 million people are infected with either hepatitis B or hepatitis C. Tragically, an average of two-thirds of those infected are unaware of their status.
It is no surprise, then, that some are calling this a silent crisis. However, we cannot afford to be silent anymore. In fact, we will not be silent anymore. Why? Because our countrymen and women are dying daily, needlessly, from a disease that is entirely preventable if detected early. Each year, approximately 15,000 people die from liver cancer or liver diseases related to hepatitis B and hepatitis C. That’s more than 40 Americans dying every day, with no state or district in our nation exempt from its deadly reach.
Beyond the tragic and preventable loss of human life and its subsequent hit to our country’s productivity, the costs to our country are explicitly economic as well. Without effective prevention and vaccination methods in place, chronic hepatitis B and C are expected to cost our country at least $20 billion in treatments alone over the next 10 years. As a result, over the same time frame, commercial and Medicare costs will more than double. Projecting further out, over the next 20 years, total medical costs for patients with hepatitis C infection are expected to increase more than 2.5 times from $30 billion to more than $85 billion.
We must, therefore, change the way hepatitis is diagnosed and treated. With the help of Oversight and Government Reform Chairman Edolphus Towns (D-N.Y.) and Reps. Bill Cassidy (R-La.), Hank Johnson (D-Ga.) and Charlie Dent (R-Pa.), I introduced the Viral Hepatitis and Liver Cancer Control and Prevention Act, H.R. 3974, which provides almost $600 million over the next five years to treat hepatitis. Our legislation focuses federal efforts on a strategy that saves lives and makes our health system more efficient. We bring together the common concerns of the diverse viral hepatitis community to fight chronic viral hepatitis by establishing, promoting and supporting a comprehensive prevention, research and medical management referral program. And we strengthen the ability of the CDC to support state health departments in the prevention, immunization and surveillance efforts.
Through this legislation, and with strategic investments in public health and prevention programs, billions of dollars can be saved, and so can the lives of tens of thousands of people in states and cities all over America. I urge all of you to join me in supporting activities that promote early detection and education. With your help, we can sound the alarm on this silent crisis.
Rep. Mike Honda (D-Calif.) serves on the House Appropriations Subcommittee on Labor, Health and Human Services, and Education.
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Transplanted Organs Are Often Far from Perfect
http://www.suntimes.com
By Monifa Thomas
Staff Reporter/
Donors often have pre-existing conditions
The death of a 28-year-old British woman who contracted pneumonia after receiving a lung transplant from a donor who had smoked for 30 years sparked an uproar.
But the practice of transplanting organs from donors with less-than-ideal medical histories, such as smokers and cancer survivors, isn't unusual and is, in fact, a necessity, given the shortage of donor organs, transplant specialists say.
"In a perfect world, if we were able to build organs from scratch . . . everyone would get a perfect organ," says Dr. Giuliano Testa, director of liver transplantation at the University of Chicago Medical Center. "But those perfect organs in nature are only in a minority of cases."
Organ donors who are HIV-positive or who have actively spreading cancer are automatically ruled out for transplants. But transplants involving donors who have just about any other chronic medical condition are still possible, according to the United Network for Organ Sharing.
Transplant centers make decisions on whether to use organs from donors with pre-existing medical conditions based on factors such as how ill the would-be recipient is, how likely it is another organ would be found for that person and whether there's a risk of disease transmission from the donor, says Dr. Michael Ison, a specialist in transplant infections at Northwestern Memorial Hospital who chairs the organ-sharing organization's Ad Hoc Disease Transmission Advisory Committee.
Disease transmission from donated organs is extremely rare, occurring in 0.2 percent of cases, Ison says. The United Network for Organ Sharing requires organ donors to be tested for HIV, hepatitis B and C and the Epstein-Barr virus.
The transmission of HIV and hepatitis C to four transplant recipients in Chicago from a single donor in 2007 was the first known cases in two decades.
A far greater risk for people on the transplant waiting list is dying because they didn't get a transplant. There are currently more than 100,000 people on the waiting list for an organ transplant. About 25,000 people receive transplants each year, while on average 18 people a day die waiting.
"All of transplantation is a cost-benefit ratio," says Dr. Howard Sankary, chief of intra-abdominal transplantation at Loyola University Medical Center in Maywood. "If a liver patient is going to die from their liver disease, and there's no other organ available, you would take the less-than-perfect organ because they have a chance of living."
People in need of organs are usually informed of the potential risk of disease transmission from donors when they join the transplant waiting list, Ison says. If a potential problem with a donor is identified, it's also standard policy for recipients to be notified of these issues at the time an offer is made. Ison says patients usually have one hour to decide if they'll accept the organ, though Testa says he gives his patients longer to decide.
"The majority of patients that are offered this are more than willing to accept that organ, and even in many of the disease transmission cases . . . many people still say they don't regret accepting the organ," says Ison, who is conducting a study on the subject.
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Family Man Leigh Fought Illness with a Smile on His Face
http://www.walesonline.co.uk
Alex Terrell, South Wales Echo
WHEN Leigh David Sugar passed away aged 44, it marked the departure of a beloved husband, a father and a loving son.
An entrepreneur, he established and grew the Tynant Garage in Beddau, near Pontypridd, into a respected business in the community.
It is testament to his positivity that Leigh – a beloved son to parents Margaret and Graham – held the business until recently.
Those closest to Leigh will say that he had the alchemy to make people around him laugh and smile with ease.
He would go out of his way to make a witty remark and it provided family, friends and acquaintances with a unique feeling of assurance.
His wife Barbara and daughters Kayleigh and Jodie have always been Leigh’s muse, a source of love and a reason for action, even when illness took hold. They loved to holiday, jetting off to the sunshine of the Dominican Republic, Mexico and Cuba. Leigh beamed at both his daughters’ ambition at school and university.
A keen horseman, Leigh rode hunts in his youth throughout the Pontypridd area.
It was here that Leigh met his sweetheart Barbara. Her father employed Leigh in their stables and they dated until their marriage in 1990.
Younger cousin David recalled how Leigh would always make him the butt of the jokes, teasing but including those around him in the fun. Leigh once repaired the car of David’s brother in a matter of hours, so nobody could tell that David had earlier driven it into a bollard – such was Leigh’s way with cars and generosity to his family.
A haemophiliac, Leigh died from liver cancer, a complication from Hepatitis C which he was given through contaminated blood products then prescribed to improve his condition. Haemophilia reduces the blood’s ability to clot and can result in internal and external bleeding without warning from a bump or bruise.
Leigh was one of 4,800 haemophiliacs in the UK to be given Hepatitis C through defective blood products, drawn from the blood of American prisoners, prostitutes and homeless patients to fuel a private enterprise.
These were injected into British patients in the 1970s and ’80s, people are still dying as a result.
Aged 26 when he discovered he had Hepatitis C, his relatives remembered how it forced him to seize what was left of his life. He refused to let it stand in the way of securing a future for his family and business. He was still fun to be around, still cracking jokes and lightening the mood, despite the uncomfortable side effects of his treatment plan.
In the pursuit for better treatments, Leigh’s family rallied, searching all over the world for advice. They even managed to get him a pioneering drug from America, and he shared his treatment experiences with other contaminated blood victims.
Barbara told relatives she recently received a letter from an elderly widow, a Tynant Garage customer, thanking Leigh for his fantastic personal service. Nothing was too much trouble for Leigh in his business, nor in his life.
Tainted Blood is a campaign for victims of contaminated blood products. The group will be conducting a protest for the campaign on June 30 in front of Parliament to urge the Government to address the issue and remember those who have passed away.
For more information visit www.taintedblood.info
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Thought Rare, Virus Strikes Twice in S.A.
http://www.mysanantonio.com
By Don Finley - Express-News
Two local cases — one of them fatal — of a form of hepatitis once thought to be rare in the United States have captured the attention of state and local health officials.
Hepatitis E, a viral infection of the liver, was long considered a problem mainly in developing countries — and to a handful of Americans who traveled there — spread by contaminated food and water.
While the infection clears up on its own in most people, it causes severe illness in some and can be fatal in pregnant women.
Large outbreaks of hepatitis E have taken place in Mexico, Asia and Africa.
The Metropolitan Health District was notified late last year that three people in one San Antonio hospital had tested positive for the infection between September and November 2009. A more sophisticated test later found one of the three was not infected.
Of the two others, one was a 21-year-old woman who died while undergoing a liver transplant. An earlier home pregnancy test had been positive, but she wasn't pregnant when admitted to the hospital, health officials said. The other patient, a 44-year-old nurse's aide, had also suffered some liver damage.
“We couldn't figure out how they acquired it,” said Roger Sanchez, senior epidemiologist with Metro Health, who presented a paper on the cases at a public health meeting in Austin recently. “None of them had any (foreign) travel history. They were previously healthy. Which begs the question — how did they get it?”
But some American researchers who study hepatitis E are finding it more common in the U.S. than previously thought. In fact, the infection seems to be everywhere. What remains a mystery is why some people get sick from the virus but most don't.
“It appears to be a relatively common infection. But clinical symptoms following infection appear to be quite rare,” said Mark Kuniholm, an instructor of epidemiology and population health at the Albert Einstein College of Medicine in New York.
In a study published last July in the Journal of Infectious Diseases, Kuniholm and colleagues tested 18,695 blood samples that had been collected across the country through the National Health and Nutrition Examination Survey, which is conducted every few years by the federal government. He found one in every five people had antibodies to hepatitis E, suggesting a previous infection.
Setting aside those born in another country, the highest infection rates were in Anglo men living in the Midwest. Those who ate liver more than once a month were more likely to have antibodies.
Hepatitis E is commonly found in U.S. pigs, with one study showing 63 percent of commercially raised swine carried antibodies to the virus and 35 percent had signs of active infection. Another study found the virus in 11 percent of pig livers sold in a sample of grocery stores.
“But this virus doesn't make pigs very sick,” Kuniholm said. “And for the most part it doesn't make humans very sick. It appears that we get the virus, we develop an immune response, but the vast majority of us never get sick.”
Sanchez and Kuniholm stressed that proper cooking kills the virus.
Of the three common forms of hepatitis in the United States, A, B and C, the infection most resembles hepatitis A — which is also often spread through fecally contaminated food and water. Patients who get sick usually recover without treatment. But it's also different from hepatitis A in that person-to-person transmission isn't common with hepatitis E, and outbreaks are usually linked to water supplies contaminated by sewage. Adults are more likely to get sick from E, while children seem more susceptible to A.
And hepatitis E can be passed from animals to humans. A study found that American veterinarians who specialized in swine had higher rates of hepatitis E exposure. Antibodies also have been found in other animals, including rodents, dogs and cats.
Sanchez said there's too little information about the disease to draw any conclusions about whether more people are getting infected. It might be that the commercially available antibody test is prone to false positives. Hepatitis E isn't part of the standard panel of hepatitis tests given to liver patients. It must be specially ordered from certain labs.
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ASCO: No Evidence to Support Routine Hepatitis B Virus Screening before Chemotherapy
http://www.hemonctoday.com
Newly issued provisional clinical opinion contradicts CDC guidelines.
An American Society of Clinical Oncology ad hoc panel of experts concluded that there is no evidence to support the CDC’s call for routine screening for hepatitis B in all patients undergoing cytotoxic or immunosuppressive therapy.
The CDC issued this recommendation in MMWR: Recommendations and Reports in 2008. ASCO published its opinion last month in the Journal of Clinical Oncology.
At the request of ASCO’s practice guidelines committee, a team from McMaster University used the Rigour of Development subscale of the Appraisal of Guidelines for Research and Evaluation II instrument to assess the quality of the processes the CDC used to gather and synthesize data and the methods used to formulate the guideline. A perfect score is 100%, and a score of 86% is an example of an ASCO-endorsed guideline based on a systematic review of the literature.
Researchers from McMaster gave the guideline an overall score of 24% in terms of methodological quality, with “several serious deviations from the ideal,” such as a lack of systematic methods used to search for evidence and lack of clarity in the description of the criteria for selecting the evidence reviewed. The Rigour of Development score for the guidelines pertaining to testing for hepatitis B among patients receiving cytotoxic or immunosuppressive therapy was only 18%. ASCO said the guideline scored especially low on the item linking the recommendations to the supporting evidence for the cancer-specific section.
“There was little agreement between the published evidence and the recommendation made by the CDC,” said Sandra Wong, MD, assistant professor in the division of surgical oncology with the University of Michigan Health Systems. Wong was co-chair of the practice guidelines committee and one of the authors of the ASCO opinion. “We felt it was our responsibility to point out to ASCO members — practicing clinical oncologists — that while the CDC recommendations are out there, there is little evidence upon which to base those recommendations.”
The CDC recommendation has the potential to change the day-to-day operations for every oncology practice in the country. Considering the potential effect on clinical practice, Wong said panel members were “underwhelmed” by the CDC’s professional outreach efforts.
She said some patients should be screened for hepatitis B surface antigen, antibodies to hepatitis B surface antigen and anti-hepatitis B core antigen. Patients undergoing bone marrow transplantation, those already at-risk for hepatitis B or those assigned to immunosuppressive drugs such as rituximab (Rituxan, Genentech) should be screened before undergoing chemotherapy. However, Wong said the CDC recommendation went too far, especially in light of the scant evidence supporting such a blanket comprehensive program.
“The evidence was insufficient to say that routine screening should be done,” she said. “Physicians have to use clinical decision-making. If the patient may be at risk for hepatitis B de novo, they should be screened. Or if the patient is undergoing immunosuppressive therapy, bone marrow transplant or treatment with rituximab, physicians should consider screening for hepatitis B. However, we don’t think every patient needs screening.” – by Jason Harris
Artz AS. J Clin Oncol. 2010;doi:10.1200/JCO.2010.30.0673.
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Caritas Worries Tension May Derail Korea Aid
http://www.cathnewsindia.com
Caritas Internationalis has called for continued humanitarian aid for North Koreans despite simmering tensions between the two Koreas.
“Caritas is very much concerned about the present high tension between North and South after the sinking of the South Korean warship in late March,” said Caritas secretary general Lesley-Anne Knight.
“This has made it even more difficult to draw the attention of the international public to the ongoing humanitarian crisis in North Korea.”
Knight was speaking to media in Seoul on June 22 after a two-day Caritas Korea Country Group Meeting.
She urged the international community not to forget the plight of many North Koreans who struggle daily to meet basic needs.
The elderly, children and sick people in the North need outside assistance, she said.
Caritas conducted a Hepatitis B vaccination program for North Korean children in February and April this year.
About half a million children aged six to 16 in the Pyongyang area were vaccinated during that program, said Wolfgang Gerstner, a Caritas official.
“We plan to expand our campaign to 3.7 million children in whole of North Korea by early next year,” Gerstner said.
Caritas was unable to conduct its vaccination program in May as the South Korean government did not give approval for transportation.
The organization has also supplied supplementary food for tuberculosis and hepatitis patients.
Caritas officials from Germany, Japan, South Korea and the United States attended the recent Caritas Korea Country Group Meeting.
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June 23, 2010
New Study Confirms Link between Nonalcoholic Steatohepatitis, Liver Cancer
http://www.docguide.com
HOBOKEN, NJ -- May 25, 2010 -- A study published in the June issue of the journal Hepatology finds that patients suffering from cirrhosis preceded by nonalcoholic steatohepatitis (NASH) are at an equal risk of developing hepatocellular carcinoma than those who develop cirrhosis resulting from hepatitis C virus (HCV).
Nizar N. Zein, MD, Cleveland Clinic, Cleveland, Ohio, evaluated a total of 510 patients, 315 with liver cirrhosis secondary to chronic HCV infection and 195 with NASH-induced cirrhosis, to compare the incidence of NASH-cirrhosis to HCV-cirrhosis, and to identify HCC risk factors in each group.
Over a median follow-up time of 3.2 years after cirrhosis diagnosis, the yearly cumulative incidence of HCC was 2.6% per year in patients with NASH-cirrhosis compared to 4.0% per year in those with HCV-cirrhosis.
These figures suggest that NASH carries a risk of HCC that rivals the risk in patients with HCV-cirrhosis.
Results indicate 3 factors that are statistically significant in the development of HCC within the NASH-cirrhosis group.
An older age at time of cirrhosis diagnosis and a higher body mass index (BMI) were negatively associated with the development of HCC. Among the NASH population, researchers found that patients who reported any lifetime alcohol consumption were 3.6 times more likely to develop HCC than those who had no exposure to alcohol.
"The most significant factor recognised in this study was that of alcohol intake," said Dr. Zein. "Our study supports emerging data that alcohol intake, even in 'social' quantities, may potentially increase the risk of HCC development in NASH- and HCV-cirrhotic patients compared with non-drinkers."
SOURCE: Wiley-Blackwell
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Grant Awarded to Fight Hepatitis C
http://www.chicoer.com
Staff Reports
OROVILLE — The Butte County Public Health Department has received a $25,000 grant to help reduce the spread of hepatitis C.
The department will provide education, testing and support services to high-risk individuals, mainly at drug-rehab centers and homeless shelters.
The money is part of more than $500,000 awarded by the Sierra Health Foundation to agencies in 26 counties.
The Glenn County Human Resources Agency also received a grant.
The Sierra Health Foundation is a private charity that aims to improve health and the quality of life in Northern California.
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Push for Needle Exchange in Jail
http://www.abc.net.au/
Health advocates want a needle exchange at the Alexander Maconochie Centre.
Health reform advocates say it is very unlikely that there has been only one hepatitis C transmission in Canberra's jail.
The advocates have warned the ACT Government it could face costly legal action if it does not provide a needle exchange program in the jail to prevent the further spread of the disease.
The Government recently revealed there has been one probable Hep C transmission there, but health advocates have told a public seminar there have been more.
In the last survey of detainees 65 per cent of those tested for Hepatitis C had the virus.
Public Health Association director Michael Moore says it is time the Government acted by introducing a needle exchange program.
"Is it hard, it's not hard, it has been done before, we're not even inventing the wheel," he said.
The ACT Health Minister Katy Gallagher concedes that a needle exchange program would prevent disease transmission but that corrections staff need to be persuaded.
"There are however in custodial settings other interests that need to be taken into account and historically we haven't had the support of the corrections staff," she said.
Prison officers argue an exchange would put them at risk.
But Stuart Loveday from Hepatitis Australia says the overseas literature shows it would remove stray needles and reduce the risk of officers getting needle stick injuries.
"All the evidence coming out of Europe and elsewhere shows that fear is unfounded and that with a controlled system the occupational health and safety improves," he said.
Opposition Health Spokesman Jeremy Hanson says he remains opposed to a needle exchange.
"My discussion with prison staff, and the evidence I've sought elsewhere is that it does potentially put prison staff and other prisoners at risk," he said.
The Government will revisit the issue after the jail has been open for 18 months.
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Kingston Hospital's Family Birth Place is Honored
http://www.recordonline.com
KINGSTON — The Family Birth Place at Kingston Hospital has received the Certificate of Excellence award for its hepatitis B immunization program. The award, from the New York state Department of Health, recognized efforts to prevent perinatal transmission of the hepatitis B virus, according to hospital officials.
The Family Birth Place, member of HealthAlliance of the Hudson Valley, revealed 100 percent compliance with requirements under public health law mandating testing, reporting and recording of hepatitis B status for all pregnant women, and a minimum 95 percent birth dose rate of hepatitis B vaccine was given to all newborns.
For more information, call 331-3131, ext. 2477, or visit www.hahv.org.
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Study Busts Liver Disease Myth
http://timesofindia.indiatimes.com
Sumati Yengkhom, TNN
KOLKATA: If you had the idea that alcohol and obesity were primarily responsible for fatty liver and other liver diseases, here is a report that turns this theory on its head. Non-obese and non alcoholic people also fall prey to liver diseases, including the cirrhosis of the liver.
A study by a team of Kolkata doctors has revealed a high prevalence rate of non-alcoholic fatty liver (NAFL) and other liver diseases among the non-obese, non-alcoholic people from poor families. The remarkable findings by the team of doctors from SSKM’s School of Digestive & Liver Diseases (SDLD) breaks the myth that NAFL is particular to developed countries that are associated with industrialisation, sedentary lifestyle and obesity.
A sample size of 1,911 adults from Nagari panchayat in Birbhum district were chosen for the study. A majority of them belonged to the below poverty line category and are either agricultural workers or labourers. People from this region and economic background were chosen so that they can be taken as representatives of those living in less developed regions across the country.
None had either hepatitis B or C that can trigger liver ailment. And despite the fact that about 47% of them were malnourished, the most remarkable finding of the study is that about 9% of this sample — who did not consume alcohol and were not obese — had fatty liver.
“Confirmation for NAFL was done by dual radiological screening consisting of ultra sonography and CT scan in order to double check for an absolutely error free result. The study was conducted over a period of two years,” said gastroenterologist Dr Khaunish Das, who was a part of the team.
Because of the significant prevalence of NAFL and higher risks of liver diseases — including cryptogenic cirrhosis — in this non-obese, non-alcoholic, non-affluent population, the researchers believe NAFL will be a major determinant for future liver disease burden in developing economies.
Cirrhosis of the liver is considered the thirteenth most common cause for mortality. So far, chronic viral hepatitis due to hepatitis B and C was known as the most common cause for cirrhosis of the liver.
The study highlights two issues. First, NAFL is prevalent among individuals in developing countries who may not have the typical metabolic risk factors for NAFL and therefore, perceived to be not in the risk category for the condition. Secondly, NAFL in this Birbhum population could be similar to NAFL in other population from similar backgrounds.
“The study has shown that non-obese people who are physically active and without a bulging waistline can also have fatty liver. In fact, this study provides evidence for the first time that NAFL will be an important determinant of liver disease burden even in poor and emerging economies,” said Dr Abhijit Chowdhury who heads SDLD.
The findings of the study have been published recently in two reputable journals — ‘Hepatology, the journal of American Association for the study of the liver’ and Nature Reviews.
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June 24, 2010
Rocker Gregg Allman Has Liver Transplant
http://abcnews.go.com
By Gary Graff
DETROIT (Billboard) - Allman Brothers Band co-founder Gregg Allman underwent liver-transplant surgery on Wednesday, forcing the veteran group to pull out of Eric Clapton's Crossroads Festival on Saturday near Chicago.
Allman, who was diagnosed with hepatitis C in late 2007, underwent the transplant at Mayo Clinic in Jacksonville, Fla.
"I feel pretty good, considering everything that's happened," the 62-year-old keyboardist said in a statement. "Everybody involved here, my doctors and nurses in the hospital and all the Allman Brothers fans, they've just all been great ... All I can say is 'thanks.'"
Shortly after his hepatitis was diagnosed, Allman told Billboard that the disease "was laying dormant for awhile and just kind of crept up on me. I was worn out. I had to sleep 10 or 11 hours a day to play two or three (hours). It's just one of those things that sneaks up on you and will just kind of ride you for as long as you don't know you have it."
Allman, who co-founded the group in 1969 with late brother Duane and remaining original members Butch Trucks and Jai Johanny "Jaimoe" Johanson, added that after being treated, he had "more appreciation for life ... There could be people that are reading this now and they have it and don't know they have it, and all it takes is a blood test. If you catch it early, before you get real fatigued and tired like I did, you can beat it."
There's no word yet on Allman's long-term prognosis or when the band would be able to play live again, although he did say in Wednesday's statement that "I can't wait to get back on the road making music with my friends." The group played its traditional New York City theater residency in March, and the Crossroads Festival was the only show on its summer itinerary. Allmans guitarist Derek Trucks will fill in at Crossroads with his own band, joined by his wife Susan Tedeschi.
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June 25, 2010
Physicians Test for Hepatitis C Based on Risk Factors but Should Expand Screening for High-Prevalence Age Group
www.hivandhepatitis.com
By Liz Highleyman
SUMMARY: Medical providers seeing patients in a high-risk urban setting tend to recommend hepatitis C virus (HCV) testing based on known risk factors such as drug or alcohol use and having symptoms of liver disease such as cirrhosis or elevated ALT, according to an analysis published in the May 20, 2010 advance online edition of the Journal of Viral Hepatitis. Overall prevalence was high, however, and the investigators suggested that broader HCV screening might be useful for people born between 1945 and 1964, even if they do not have other risk factors.
W.N. Southern from Albert Einstein College of Medicine and colleagues examined HCV testing practices to determine which patient characteristics are associated with getting tested and with testing HCV positive. They also sought to determine the prevalence of HCV infection in a high-risk urban population.
Approximately 3.2 million people in the U.S. have chronic hepatitis C, the study authors noted as background, but many are not aware of their infection.
The researchers analyzed all patients seen at the ambulatory care clinic at Montefiore Medical Center in the Bronx, New York City, between January 1 and February 29, 2008. In addition, they extracted demographic information, laboratory data, and ICD-9 diagnostic codes from electronic medical records of patients seen between March 1, 1997 and February 29, 2008. All participants were included in the baseline phase of the Hepatitis C Assessment and Testing Project (HepCAT), a serial cross-sectional study of HCV screening strategies.
Results
- Among the 9579 participants analyzed, 3803 (39.7%) had been tested for HCV.
- Of these, 438 (11.5%) were HCV positive.
- The overall prevalence of HCV infection was estimated to be 7.7%, assuming that untested participants would test positive at the same rate as tested subjects, based on risk-factors.
- The following risk factors were associated with being tested for HCV, and with being HCV positive:
- Being in the high-prevalence birth cohort born during 1945-1964 (roughly age 45 to 65);
- History of drug or alcohol abuse;
- Being HIV positive;
- Diagnosis of cirrhosis;
- Diagnosis of end-stage renal (kidney) disease;
- Elevated alanine transaminase (ALT).
"In a high-risk urban population, a significant proportion of patients were tested for HCV and the prevalence of HCV infection was high," the study authors concluded. The estimated 7.7% prevalence in this group of patients is several times higher than the 1.6% rate for the U.S. general population.
"We found strong evidence that physicians are using a risk-based screening strategy to identify patients with HCV infection, using known risk factors and other conditions associated with HCV to guide testing," they continued in their discussion. However, they added, broader screening may be indicated for people in the high-prevalence birth cohort, even those without behavioral or clinical risk factors.
Expanded testing might be useful given that a considerable proportion of people with HCV do not know how they became infected. Furthermore, sexual transmission of HCV is a growing concern among HIV positive gay men, but sexual behavior is not commonly regarded as a hepatitis C risk factor. At a recent hepatitis C forum attended by gay men in San Francisco, several participants said their providers had refused to test them for HCV because they did not have a history of injection drug use or other traditional risk factors.
Investigator affiliations: Albert Einstein College of Medicine, Montefiore Medical Center, New York, NY; School of Public Health, Boston University, Boston, MA; VA QUERI-HIV/Hepatitis Program, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA; Division of Viral Hepatitis, Centers for Disease Control and Prevention, National Center for HIV/Viral Hepatitis/STD/TB Prevention, Atlanta, GA.
6/22/10
Reference
WN Southern, M-L Drainoni, BD Smith, and others. Hepatitis C testing practices and prevalence in a high-risk urban ambulatory care setting. Journal of Viral Hepatitis (Abstract). May 20, 2010 (Epub ahead of print).
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OraSure Technologies Receives FDA Approval for OraQuick(R) HCV Rapid Test, the First Rapid HCV Test Approved for Sale in the U.S.
www.marketwatch.com
BETHLEHEM, Pa., Jun 25, 2010 (GlobeNewswire via COMTEX) -- OraSure Technologies, Inc. /quotes/comstock/15*!osur/quotes/nls/osur (OSUR 5.10, +0.25, +5.16%) announced today that its OraQuick(R) Hepatitis C ("HCV") Rapid Antibody Test has been approved by the U.S. Food and Drug Administration ("FDA") for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States.
"The OraQuick HCV test efficiently identifies previously undiagnosed HCV infected individuals who are at risk," said Eugene R. Schiff, MD, MACP, FRCP, MACG, AGAF, University of Miami School of Medicine. "We at the University of Miami found this test to be user-friendly, practical and an important tool for rapid HCV antibody detection."
"We believe that the OraQuick(R) HCV Rapid Antibody Test, with its simplicity and speed, will be a critical tool in identifying more at risk individuals infected with hepatitis C in the U.S., and thus represents a significant market opportunity," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "Obtaining FDA approval of our OraQuick(R) HCV Rapid Antibody Test for venous whole blood represents a major milestone for our Company."
OraQuick(R) HCV is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus in venous whole blood specimens that is approved by the FDA. The test, which utilizes the OraQuick(R) technology platform, provides results in 20 minutes. The OraQuick(R) HCV Rapid Antibody Test is the latest rapid test manufactured by OraSure to receive FDA approval. OraSure had previously received FDA approval for its OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test for use with oral fluid, fingerstick and venous whole blood and plasma samples.
In the U.S., there are an estimated 4.1 million Americans, or 1.6 percent of the population, that are or have been infected with HCV. According to the Centers for Disease Control and Prevention ("CDC"), new infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.
According to the World Health Organization, most cases of HCV infection are currently undiagnosed and up to 80 percent of HCV-positive individuals show no signs or symptoms.
In December 2009, the Company received the CE mark for its OraQuick HCV Rapid Antibody Test for use with oral fluid, whole blood, serum and plasma specimens. The CE mark was required in order to sell the product in the European Union.
As previously announced, OraSure has entered into agreements with Merck & Co. (through its predecessor Schering Plough Corporation) to collaborate on the development and promotion of the OraQuick(R) HCV test. Under the terms of these agreements, the Company has been and will be reimbursed by Merck for a portion of its costs to develop the test and obtain regulatory approvals. Additionally, Merck will provide promotional support, including detailing the test in the physicians' office market in those countries in which the Company has obtained approval.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of antibodies to HIV.
For more information on the Company, please go to www.orasure.com.
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Screening Cancer Patients for Hepatitis B: Should it Be Routine?
www.medscape.com
Zosia Chustecka
June 24, 2010 — Chemotherapy and immunosuppressive drugs, including high-dose steroids, can cause the reactivation of hepatitis B in people who are carrying the virus, with potentially fatal results.
Hence, cancer patients who are about to undergo such treatment should be screened for hepatitis B virus (HBV), and treated prophylactically with an antiviral if they are found to be positive, according to a new protocol recently put into place at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City.
The new protocol was outlined at the recent American Society of Clinical Oncology (ASCO) 2010 Annual Meeting (abstract 9009) by Emmy Ludwig MD, an MSKCC gastroenterologist, who explained that it was set up after a retrospective review found deaths from liver failure, resulting from hepatitis B activation, in patients who had potentially been cured of their cancer.
This new protocol is in line with recommendations issued in 2008 by the Centers for Disease Control and Prevention, together with the American Association for the Study of Liver Diseases, which recommends screening for HBV in several groups of people, including those about to undergo immunosuppressive therapy.
But this is directly at odds with a new provisional clinical opinion just issued by ASCO, which concludes that there is no need to screen all cancer patients prior to chemotherapy and immunosuppressive drugs, only those considered to be at high risk.
The ASCO provisional opinion, published online June 1 in the Journal of Clinical Oncology, states that the "evidence is insufficient to determine the net benefits and harms of routine screening for chronic HBV infection in individuals with cancer who are about to receive cytotoxic or immunosuppressive therapy or who are already receiving therapy."
Instead of being carried out routinely, it suggests that HBV screening in cancer patients requires "clinical judgment." Physicians can consider screening patients belonging to groups at heightened risk for chronic HBV infections if highly immunosuppressive therapy is planned, the document states.
At the meeting, Dr. Ludwig said she was "surprised" by this.
New Protocol at MSKCC
The new protocol at MSKCC, introduced just over a year ago, recommends screening all patients who will receive anticancer therapy, including hormonal therapy and high-dose steroids (equivalent to a cumulative dose of prednisolone of >80 mg).
“The cases who died were cured patients.”
The action was prompted by a retrospective review of the MSKCC experience, which found 23 documented cases of hepatitis B reactivation in cancer patients on immunosuppressive therapy in the previous 3 years. Four patients died, 3 of whom had solid tumors. "The cases who died were cured patients — one was a 35-year-old with early breast cancer," Dr. Ludwig said. Nineteen patients were hospitalized, 1 required a liver transplant, and 4 had a "clinically significant delay" in treatment with curative chemotherapy or surgery, she said.
"Two of these patients were only on steroids," she noted.
"We think this is a vast underestimation," she said, and her team suspects that many more cases, maybe even hundreds of cases, went undocumented.
Under the new protocol, cancer patients are screened for hepatitis surface antigen (HBsAg), which indicates a chronic infection, and also for hepatitis B core antibody (HBcAb), which indicates a previous infection. If either or both are positive, then patients also undergo a reflexive HBV DNA polymerase chain reaction (PCR).
Patients who test positive for HBsAg and for HBV DNA PCR are started on prophylactic antiviral therapy with entecavir 0.5 mg orally once daily, which is continued throughout their cancer therapy and for 6 months after it ends.
Patients who test negative for HBsAg and for HBV DNA PCR but test positive for HBcAb are not given prophylactic antiviral therapy, but are followed and retested with PCR every 3 months, unless they are slated for a bone marrow transplant or rituximab therapy, in which case they receive entecavir.
This protocol has been in place for just under a year, and so far there have been no cases of reactivation, Dr. Ludwig noted. She also said that there have been no adverse reactions reported with entecavir: "We have seen absolutely no toxicity."
In the time that the protocol has been in place, just more than half of the cancer patients have been screened (1720 of 3309 patients, 53%).
“This is another thing to add to very busy oncologists' lives.”
This is an increase in what was happening previously, when about 10% of cancer patients were screened for HBV, she noted, but added that "this is another thing to add to very busy oncologists' lives, and some people have responded better than others."
Of the 1720 cancer patients who were screened, 18 patients (1.1%) tested positive for HBsAg, of whom 91% had solid tumors and 46% were Asian.
There were also 155 patients (9.2%) who tested positive for HBcAb, of whom 76% had solid tumors and 19% were Asian.
Profiling patients by country of birth, cancer diagnosis, or planned treatment will miss a lot of patients who test positive, Dr. Ludwig said.
"The screening is straightforward, and the most exciting thing is that prophylaxis has been 100% effective," she concluded.
Inability to Select High-Risk Patients
In a discussion of this presentation, Sandra Wong, MD, MS, from the University of Michigan in Ann Arbor, said that the finding that 91% of patients who tested positive for HBsAg had solid tumors was "a very surprising and unanticipated result."
Dr. Wong, who was a coauthor of the recent ASCO Provisional Clinical Opinion that recommended screening for HBV only for high-risk patients, rather than routinely, pointed out that "this experience highlights the inability to select high-risk patients for screening for HBV."
She commended the MSKCC team for putting this protocol in place, but added that the short experience so far "limits interpretation, especially as prophylaxis will be continued for 6 months after cancer treatment and the protocol has been in place for less than a year."
"There is no doubt that increased awareness of this issue is important," Dr. Wong concluded. "There may be a lot of benefit, but it is not based on strong evidence at this time"
In addition, Dr. Wong raised a question about the choice of antiviral for prophylaxis. "Lamivudine is really the accepted drug and has been used in many randomized trials, although entecavir is being increasingly used," she said.
Dr. Ludwig explained that her team chose entecavir because of documented cases of resistance with lamivudine.
In another presentation at the meeting, Gretchen Genevieve Kimmick, MD, from Duke University in Durham, North Carolina, included this work in her overview of Highlights of the Day. She noted that she had found, in a review publication, data to show that prophylaxis with lamivudine had a "number needed to treat to prevent reactivation of HBV of only 3, so it is certainly worth considering."
Dr. Ludwig and Dr. Wong have disclosed no relevant financial relationships.
J Clin Oncol. Published online June 1, 2010. Abstract
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Silencing Hepatitis B Virus Prevent Recurrence of Liver Cancer
www.eurikalert.org
(PHILADELPHIA) Previous studies have shown that antiviral treatment reduces the incidence of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). But now, researchers from the Division of Gastroenterology and Hepatology at Thomas Jefferson University are reporting that the antiviral therapy also prevents recurrence of HCC and extends patients' lives.
The standard of care for patients with HCC is local ablation of the tumor, unless it is large or has metastasized. However, HCC tumors often recur, or new lesions develop. In the International Journal of Cancer, Hie-Won Hann, M.D., professor of Medicine at Jefferson Medical College of Thomas Jefferson University, and colleagues reported that the median survival in patients who received antiviral therapy after HCC diagnosis was 60 months in patients. In those who did not receive antiviral therapy, the median survival was 12.5 months.
"Before the antiviral drugs were developed, patients would often develop new lesions within a few months of tumor ablation because we were not treating the underlying virus that is causing the liver cancer," Dr. Hann said. "The virus drives the cancer, and by suppressing the virus and making it undetectable we can extend the survival for these patients."
The small study included 15 CHB patients who received local ablation of a single HCC tumor that was less than four cm. The first six patients were diagnosed between 1991 and 1997, prior to the development of antiviral therapy. These patients were considered historical controls.
The other nine patients were diagnosed between 2000 and 2004. These patients began ongoing antiviral therapy with lamivudine immediately after HCC diagnosis. Other antiviral medications, such as tenofovir and adefovir were added to the regimen if resistance to lamivudine developed, or even without drug resistance.
All patients who received the antiviral therapy maintained undetectable hepatitis B virus in serum and continued the therapy. Seven of the nine patients have not developed a new HCC or recurrence. The longest survivors are the two patients who came with HCC in 2000. They are doing well, free of caner for more than 10 years. All patients continue with the antiviral therapy and are followed at three to four month intervals.
"The other option for these patients is liver transplantation, which carries its own risks," said Robert Coben, M.D., associate professor of Medicine at Jefferson Medical College of Thomas Jefferson University, who was involved in the study. "This is an attractive alternative for this patient population."
Other researchers include Anthony J. DiMarino, M.D., William Rorer Professor of Medicine at Jefferson Medical College of Thomas Jefferson University, and Diane Bergin, M.D., who is now at the University Hospital Galway in Ireland.
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