August 23, 2010

LabCorp Enhances HCV Testing Services with the Launch of IL-28B Test

August 23, 2010 05:05 PM Eastern Daylight Time

Assay is Commercially Available for Patient Testing and Clinical Trials

BURLINGTON, N.C.--(BUSINESS WIRE)--Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) announced today the nationwide availability of a genetic test to detect the presence of a single polymorphism within the IL-28B gene that has been reported to help predict a person’s response to certain hepatitis C virus (HCV) therapies.

“This test represents an important addition to the management and treatment of HCV infections, and complements the current company test portfolio for this disease,” indicated Dr. Mark Brecher, LabCorp’s Chief Medical Officer. “The ability to detect the polymorphism within the IL-28B gene may help predict the response to treatments, leading to an improvement in patient care and a reduction in treatment costs.”

An estimated 3.2 million people in the United States and 170 million people worldwide are infected with HCV. The recommended treatment regimen for chronic infection includes pegylated interferon-based therapies. However, some patients experience limited efficacy, treatment is often poorly tolerated and the side effects prevent some patients from completing therapy. Therefore, identifying patients who may be likely to have a favorable response to treatment is a high priority.

The importance of the IL-28B genetic polymorphism was first reported in the journal Nature (September 2009) by scientific teams from Merck and Duke University. Specific variants in this gene have been associated with an approximately 2-3 fold greater rate of sustained viral suppression in response to treatment with combination pegylated interferon alfa/ribavirin therapy among patients infected with HCV genotype 1 with a CC genotype as compared with either the CT or TT genotypes. HCV genotype 1 is the most common form of the virus, accounting for approximately 70 percent of HCV cases in the U.S.

The test is now available for patient testing through LabCorp’s Centers of Excellence, Monogram Biosciences and The Center for Molecular Biology and Pathology (CMBP). The test is also available through Esoterix Clinical Trials Services for clinical trials. LabCorp has licensed global rights to this marker from Merck.

About LabCorp®

Laboratory Corporation of America® Holdings, an S&P 500 company, is a pioneer in commercializing new diagnostic technologies and the first in its industry to embrace genomic testing. With annual revenues of $4.7 billion in 2009, over 28,000 employees worldwide, and more than 220,000 clients, LabCorp offers clinical assays ranging from routine blood analyses to HIV and genomic testing. LabCorp combines its expertise in innovative clinical testing technology with its Centers of Excellence: The Center for Molecular Biology and Pathology, National Genetics Institute, ViroMed Laboratories, Inc., The Center for Esoteric Testing, Litholink Corporation, DIANON Systems, Inc., US LABS, Monogram Biosciences, Inc. and Esoterix, Inc. and its Colorado Coagulation, Endocrine Sciences, and Cytometry Associates laboratories. LabCorp conducts clinical trials testing through its Esoterix Clinical Trials Services division. LabCorp clients include physicians, government agencies, managed care organizations, hospitals, clinical labs, and pharmaceutical companies. To learn more about our organization, visit our Web site at: www.labcorp.com.

This press release contains forward-looking statements. Each of the forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions in the marketplace and adverse actions of governmental and other third-party payors. Actual results could differ materially from those suggested by these forward-looking statements. Further information on potential factors that could affect LabCorp’s financial results is included in the Company’s Form 10-K for the year ended December 31, 2009, and subsequent SEC filings.

Contacts
Laboratory Corporation of America® Holdings
Stephen Anderson, 336-436-5274
Company Information: http://www.labcorp.com/

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Date Modified: 2010-07-27

Michael Houghton
Canada Excellence Research Chair in Virology
University of Alberta

“Michael Houghton’s discovery of the hepatitis C virus is one of the most significant biomedical breakthroughs in the last 20 years. His work is the foundation of research to improve and save the lives of millions of people around the world. Having him as part of our already impressive team of scientists and the recent establishment of the University of Alberta’s Li Ka Shing Institute of Virology together propel the University of Alberta to the forefront of research into virus-based diseases.”—Indira Samarasekera, president, University of Alberta Breakthroughs in Hepatitis Prevention and Therapy

The hepatitis B and C viruses, particularly as spread through ways other than transfusion, still represent major health problems in Canada and around the world, despite significant advancements in blood-screening techniques. In Canada, it is estimated that there are 300,000 carriers of each hepatitis B (HBV) and C (HCV). Worldwide, these numbers have reached 350 million and 170 million, respectively.

Currently, there is no vaccine for HCV, and existing treatment methods only work for about half of infected patients. While there is a vaccine to prevent HBV, patients with a chronic infection often need to stay on long-term anti-viral treatments that lead to drug-resistance and ultimately end in permanent liver damage.

Building on the knowledge he gained while making his breakthrough discovery of the virus that causes HCV, and his identification of the hepatitis D viral genome, Canada Excellence Research Chair in Virology Michael Houghton will work to develop low-cost prophylactic vaccines against HCV, and therapeutic vaccines against HBV.

Through experimental trials using chimeric mice with human liver, as well as through woodchuck infection models, Houghton hopes to improve current HBV treatment methods and significantly reduce how long treatment takes.

Another major focus of Houghton’s work will be using his experience in virus discovery to investigate a potential infectious basis for various human diseases that have so far remained uncharacterized.

Houghton’s commitment to developing low-cost vaccines could have enormous benefits for hepatitis sufferers across the globe, including in Canada, helping them overcome these diseases and reducing the costs and impacts of HBV and HCV on both sufferers and the health-care system.

Joining a prestigious team of internationally recognized virologists, immunologists and molecular biologists at the University of Alberta, Houghton and his research team will maintain Canada’s pioneering position in biomedicine. His move from industry to academia will also allow him to train a new generation of researchers equipped for careers in academia or the biotechnology industry.

Biography

Dr. Michael Houghton is an internationally recognized expert in hepatitis virology. Along with fellow researchers at world-leading blood diagnostics company Chiron (now part of the multinational pharmaceutical company Novartis) and the United States’ Centers for Disease Control and Prevention, he was the first to successfully identify and clone the hepatitis C virus (HCV). The breakthrough allowed him to develop new blood-screening tests able to detect the virus. These techniques are now used worldwide to keep patients safe by ensuring that blood supplies are HCV-free. His work also led to the identification of important new drug targets for hepatitis C, which are being pursued by many groups around the world.

Houghton holds a PhD in biochemistry from King’s College London. Before accepting the position of Canada Excellence Research Chair in Virology at the University of Alberta, he was chief scientific officer at Epiphany Biosciences in California. Previously, he spent 25 years in a distinguished career at Chiron, ultimately serving as vice-president of HCV and virology research. In 2000, Houghton received the enormously prestigious Albert Lasker Clinical Research Award for his work at Chiron.

Houghton’s extensive publishing credits include more than 200 articles spanning topics critical to human health, including gene regulation, human beta interferons (proteins produced to interfere with the spread of viral infections) and hepatitis C and D viruses. He also holds numerous patents on recombinant human interferons, bacterial expression plasmids and on diagnostics, drug targets and vaccines for hepatitis C and D viruses.

His current research interests include developing preventative and therapeutic hepatitis vaccines and exploring an infectious basis for other major human diseases.

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Babool bark extract holds out hope for a liver cancer cure

Vijay Pratap Singh
Posted: Jul 06, 2010 at 0154 hrs IST
 
Allahabad The researchers at Banaras Hindu University claim to have developed a drug that could be a potential cure for liver cancer from the extract of the bark of Acacia nilotica tree, commonly known as babool.
 
The tests on rats have shown encouraging results, said BHU sources.

The medicine is the result of a study funded by the Council of Scientific and Industrial Research (CSIR), New Delhi. The study which has continued for almost four years in the Mycology and Plant Pathology Department of the BHU is supervised by Professor H B Singh. The findings of the study had been published last year in the premier online US journal — Chemico-Biological Interactions.

Dr Brahma Nand Singh, a member of the research team, has now been invited to work with renowned cancer research scientist Professor Shi Wen Jiang at the Department of Bio-medicine (Savannah), USA. He will now embark on research on the role of babool in cancer therapy by reactivating tumor suppressor genes at various stage of the disease.

Singh said they found that Indian Babool can prevent hepatocellular carcinoma, also called liver cancer.

The tree has strong chemo-preventive potential in the form of six compounds present in the methanolic extract of the bark of Acacia nilotica. These compounds play an essential role in prevention and therapy of cancer, cardiovascular diseases, neuro-degenerative diseases and inflammation by inducing antioxidant defense system.

The team inducted liver cancer in rats by injecting them with drugs. One of the drugs they used was N-nitrosodiethylamine, a potent hepatocarcinogenic and is present in tobacco smoke, water, cheese, fried meals and in a number of alcoholic beverages.

The researchers in their tests on rats found that the Indian babool has more cancer preventive phytomolecules (antioxidant polyphenolic compounds) than the Australian babool and that it stabilises and increases all the components of the defense gene pools. The babool extract abolishes the activities of liver injury and tumor markers by decreasing the damage to bio-molecules such as DNA, RNA, lipids and proteins that are essential for life.

H B Singh said, “It’s a path-breaking finding among cancer studies. For the first time, our research has established a link between babool phytomolecules and cancer prevention.”

Source
© 2010 by the American Institute of Ultrasound in Medicine
J Ultrasound Med 29:1353-1356 • 0278-4297

Francesco Giuseppe Foschi, MD, Anna Chiara Dall’Aglio, MD, Giorgio Marano, MD, Arianna Lanzi, MD, Paolo Savini, MD, Fabio Piscaglia, MD, Carla Serra, MD, Carmela Cursaro, MD, Mauro Bernardi, MD, Piero Andreone, MD and Giuseppe Francesco Stefanini, MD

Department of Internal Medicine, Faenza Hospital, Faenza, Italy (F.G.F., A.C.D., G.M., A.L., P.S., G.F.S.); and Departments of Internal Medicine and Gastroenterology (F.P., C.S.) and Clinical Medicine (C.C., M.B., P.A.), Sant’Orsola Malpighi Hospital, University of Bologna, Bologna, Italy.

Address correspondence to Francesco Giuseppe Foschi, MD, Department of Internal Medicine, Faenza Hospital, Via Stradone 9, 48018 Faenza, Italy. E-mail: fg.foschi@ausl.ra.it

Objective. Ultrasonography is the first examination performed for screening of hepatocellular carcinoma (HCC); contrast-enhanced ultrasonography (CEUS) can help discriminate between HCC and other lesions. Primary hepatic lymphoma (PHL), even if rare, should be considered in the differential diagnosis of focal liver lesions (FLLs). Few data are available in the literature about the role of CEUS in the diagnosis of PHL; we tried to determine whether CEUS could have a role in this setting. Methods. we describe 2 cases of primary non-Hodgkin lymphoma of the liver associated with hepatitis B virus (HBV) infection. The first patient was a 62-year-old man who was an HBV-inactive carrier, and the second was a 58-year-old man with type 2 diabetes and chronic HBV hepatitis. Results. in both cases, ultrasonography showed a hypoechoic liver lesion (4 and 3 cm, respectively) with irregular margins in segment 4 of the liver. On CEUS, these lesions were inhomogeneously hyperenhanced in the arterial phase and hypoenhanced in the portal and late phases. Contrast-enhanced computed tomography (CT) in both patients showed slight hyperenhancement in the arterial phase and hypoenhancement in the remaining phases. Needle biopsy showed marginal zone B-cell lymphoma of the mucosa-associated lymphoid tissue type in both patients. Conclusions. Contrast-enhanced ultrasonography and CT did not help us differentiate PHL from HCC; in fact, in both cases we saw the characteristic findings of primary HCC. Primary hepatic lymphoma is a rare condition, but it should always be considered in the differential diagnosis of FLLs. We stress the important role of liver biopsy when imaging indicates HCC in patients without underlying cirrhosis.

Key Words: biopsy • contrast-enhanced ultrasonography • focal liver lesions • hepatocellular carcinoma • primary hepatic lymphoma

Abbreviations: CEUS, contrast-enhanced ultrasonography • CT, computed tomography • FLL, focal liver lesion • HBV, hepatitis B virus • HCC, hepatocellular carcinoma • MALT, mucosa-associated lymphoid tissue • MRI, magnetic resonance imaging • PHL, primary hepatic lymphoma

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Choking a Tumor MRI scans show that blood flow [red] decreases in liver tumors after ALN-VSP therapy, which stops cancer cells from making proteins that form blood vessels. Courtesy ALNYLAM

By Corey Binns
Posted 08.23.2010 at 10:21 am
 
Since last April, 19 cancer patients whose liver tumors hadn’t responded to chemotherapy have taken an experimental drug. Within weeks of the first dose, it appeared to work, by preventing tumors from making proteins they need to survive. The results are preliminary yet encouraging. With a slight redesign, the drug might work for hundreds of diseases, fulfilling the promise that wonder cures like stem cells and gene therapy have failed to deliver.

The biotech company Alnylam announced in June that its drug ALN-VSP cut off blood flow to 62 percent of liver-cancer tumors in those 19 patients, by triggering a rarely used defense mechanism in the body to silence cancerous genes. Whereas conventional drugs stop disease-causing proteins, ALN-VSP uses RNA interference (RNAi) therapy to stop cells from making proteins in the first place, a tactic that could work for just about any disease. “Imagine that your kitchen floods,” says biochemist and Alnylam CEO John Maraganore. “Today’s medicines mop it up. RNAi technology turns off the faucet.”

Here’s another analogy: If DNA is the blueprint for proteins, RNA is the contractor. It makes single-stranded copies of DNA’s genes, called mRNA, which tell the cell to produce proteins. In 1998, scientists identified RNAi, a mechanism that primitive organisms use to detect and destroy virus’s double-stranded RNA and any viral mRNA. Mammals’ immune systems made RNAi’s antiviral function irrelevant (although all vertebrates, including humans, still use RNAi to regulate mRNA activity), but researchers found that introducing small segments of double-stranded RNA to cells could trigger the ancient mechanism and selectively halt the production of specific proteins.

That ability makes RNAi a potential fix for many diseases, including cancer, that arise when abnormal cells produce excessive amounts of everyday proteins. In theory, manipulating RNAi to kill proteins is simple. ALN-VSP, for example, consists of synthetic double-stranded RNA designed to match tumor mRNA that codes for two proteins: VEGF, which cancers overproduce to help grow new blood vessels, and KSP, which sets off rapid cell division. The researchers send the synthetic RNA into liver cells, and the body’s RNAi system kills both the synthetic RNA and any matching tumor-grown mRNA. Knock out the mRNAs coding for those proteins—which in the liver are produced only by cancer cells—and the tumor stops growing.

“We can turn off any one of 20,000 genes with RNAi,” says Bruce Sullenger, a molecular biologist researching RNAi at Duke University. “The challenge has been to get a drug into only the desired cells and not harm others.” Researchers have worried that a drug might disrupt normal protein production in a healthy cell, or that the immune system will destroy the drug before it reaches its target.

Alnylam overcame both concerns by packaging the drug in a fatty envelope that is absorbed primarily by the liver. This allowed doctors to administer the drug through the blood, rather than by an injection to one spot, which improves results by ensuring that the entire liver receives an even dose.

The technique’s ability to attack single genes could lead to drugs for the 75 percent of cancer genes that lack any specific treatment, as well as for other illnesses. Alnylam is already testing RNAi therapy for Huntington’s disease and high cholesterol in cell cultures; other researchers are tackling macular degeneration, muscular dystrophy and HIV. The potential has driven nearly every major pharmaceutical company to start an RNAi program.

Because the approach is fundamentally simple, RNAi therapy could be ready within two years, say experts including John Rossi, a molecular geneticist at City of Hope National Medical Center in California. Alnylam plans to enroll an additional 36 patients in the ALN-VSP trial and increase the dosage, but the early results are good enough to suggest that it could be among the first RNAi therapies to hit the market. “I think RNAi could work for anything,” Rossi says. “But even if it only works for liver cancer, it would be pretty good.” For liver-cancer patients who have been failed by chemotherapy and radiation and felt their harsh side effects, that would be wonder drug enough.

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What is a Pre-Existing Condition?

Posted August 18, 2010

By Jay Angoff, Director of the Office of Consumer Information and Insurance Oversight

This is one in a series of Health Care Notes that we’re posting to help respond to the questions and comments consumers are submitting to www.HealthCare.gov.

A number of visitors to http://www.healthcare.gov/ have told us they’d like to know more about pre-existing conditions.

At a very basic level, a pre-existing condition is a physical or mental health condition, disability or illness that you have before you enrolled in a health plan.

I know what you’re thinking: but couldn’t that be almost anything?

There is no one definition of a pre-existing condition. Health insurance issuers and employer plans use different definitions. Depending upon your condition, you may be denied coverage or charged a higher premium.

Some plans consider acne, asthma or high blood pressure a pre-existing condition. Others narrow the definition of pre-existing conditions to cancer or diabetes. Sometimes you might have totally recovered from a condition – like a past bout with depression – and it will still count against you. While some States limit how far back an insurer can look for a pre-existing condition, some States have no limit.

Private insurance companies may choose to deny your application for health coverage because of a pre-existing condition, or agree to sell you a policy, but exclude coverage for benefits associated with certain pre-existing conditions. Or the insurance company may charge you more because of a pre-existing condition.

What this means is that if you have a pre-existing condition, you may have been unable to obtain coverage or afford coverage.

The good news is that, under the Affordable Care Act, denying coverage or excluding benefits due to a pre-existing condition will no longer be allowed. For children under 19, this new protection applies for plan years beginning this fall. For everyone else, this protection will be in place by 2014. After 2014, insurers also will no longer be able to charge higher premiums based on a pre-existing condition. (Note: the exception to this is grandfathered individual family policies.)

For individuals with a pre-existing condition, the new Pre-Existing Condition Insurance Plan (PCIP) program will help to bridge the gap until 2014. Specifically, the PCIP program will make health coverage available to people with a pre-existing condition who have had no health insurance for at least the last 6 months and who have been unable to obtain insurance from private insurance companies because of a pre-existing condition.

Under the PCIP, such individuals will be able to obtain coverage at the same price as would be paid by individuals of average health in their state. And, under the new PCIP program, that coverage will include immediate coverage of health care services linked to your pre-existing condition.

A PCIP is available in every state—but the exact nature of the plan offered by the PCIP, and how eligibility based on a pre-existing condition is to be demonstrated, may vary depending on your state:

◦ In some states, the U.S. Department of Health and Human Services is operating the program. If this is the case in your state and you have been denied enrollment or coverage of specific benefits due to a health condition, you have a pre-existing condition that makes you eligible.

Some states are running their own programs. Different states may use different methods of determining whether you have a pre-existing condition.

The key takeaway here is that if you are interested in the Pre-Existing Condition Insurance Plan, you should contact the program in your state.

Note: Even if you have a pre-existing condition, the PCIP may not be the best insurance option for you. For example, if you already have insurance you would not be eligible to join the PCIP in your state, or you might be eligible for another program like Medicaid which might be a better fit for you.

In general, make sure you check out the Insurance Finder to find out what options are available for you and your family.

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A national short film competition has been launched by actor Tom Hardy and Sadie Frost in partnership with Steel Mill Pictures and The Hepatitis C Trust, to challenge current misconceptions of hepatitis C.

FOR IMMEDIATE RELEASE

PRLog (Press Release) – Aug 23, 2010 – A national short film competition launches today in partnership with Steel Mill Pictures and The Hepatitis C Trust. Students and graduates are invited to submit a film concept to Chooselife@virgohealth.com, that challenges current misconceptions of hepatitis C, and ensures it is recognised as a national health priority by policy makers and healthcare professionals. The deadline for submission is 17 September 2010.

Hepatitis C, which damages the liver, may affect as many as half a million people in the UK [1] although 80% of people with the condition are unaware that they have it.[2] It is often thought that hepatitis C is only an issue amongst drug users, who contract the virus through unsterilised needle sharing. In fact, there are many more ways the virus can be passed on including:[3]

· The use of unsterilised tattoo, piercing or barber equipment
· Sharing of razors or toothbrushes with an infected person
· Sharing rolled banknotes or straws to snort drugs such as cocaine
· Blood transfusions prior to 1991 when screening was introduced
· Receiving medical/dental treatment abroad

The competition called Choose Life is supported by funding from Roche Products Ltd and aims to uncover the best in up-and-coming British film talent whilst helping to make hepatitis C a national health priority. The judging panel includes actor Tom Hardy, Sadie Frost, Charles Gore (CEO of The Hepatitis C Trust), Mat Whitecross (Director of the 2010 award-winning film, Sex & Drugs & Rock & Roll starring Andy Serkis), Paul Andrew Williams (2007 BAFTA nominee for ‘London to Brighton’) and Jo Sweby (E1 Entertainment, distributors of The Twilight Saga). The winning team will receive mentoring and production support to make their film from Steel Mill’s critically acclaimed writer director Paul Andrew Williams.

Paul Andrew Williams comments: “The Choose Life competition provides students with an exciting opportunity to get involved in a worthwhile and challenging project whilst providing a platform to showcase their work to film industry professionals. Film is a great way to make hard-hitting health messages accessible and relevant to the public, and we are looking forward to mentoring and working with new film making talent.”

Charles Gore, Chief Executive of The Hepatitis C Trust said, “Hepatitis C awareness and diagnosis is astoundingly low in the UK, even though it is a cancer-causing virus. There are many people living with this life-threatening disease who do not even know it. Furthermore, many people don't know that hepatitis C can actually be treated and the virus completely eradicated. The aim of this competition is to bring hepatitis C to the forefront of people’s minds, to help improve awareness and make it a national health priority, so people that think they may be at risk get tested and treated.”

Early diagnosis and treatment of Hepatitis C is important to help reduce the risk of disease progression, [2] including cirrhosis, liver disease, and liver failure which can lead to death.[4]

Show your support for the campaign and share the competition with friends on Facebook www.facebook.com/chooselifefilmcomp

-Ends-

For more information or to request an interview contact:

Katy Mortimer or Kam Pearce
Tel: 020 8939 2450
Katy.Mortimer@virgohealth.com or Kam.Pearce@virgohealth.com

About The Hepatitis C Trust

The Hepatitis C Trust is the national UK charity for hepatitis C and has been operating since 2001. It is predominantly a patient-led and patient-run organisation: the majority of its staff, both paid and voluntary, either have hepatitis C or have had it and have cleared it after treatment. More information: http://www.hepctrust.org.uk/

About Steel Mill Pictures

Steel Mill Pictures produced the award-winning ‘London to Brighton’ and ‘The Cottage’, and their third feature film ‘Cherry Tree Lane’ will get a theatrical release in the UK on 3rd September 2010. Steel Mill has several projects in development with Paul Andrew Williams, including genre project ‘Salvage’ with Warp X and bittersweet road movie ‘Wisdom's Last Legs’. They are closing the financing on the tender comedy ‘Song For Marion’, to be written and directed by Paul Andrew Williams in the summer 2011. The team is also working with a number of new writers and directors, developing projects that include an adaptation of Filth by Irvine Welsh and ‘Last Will’, a hard-hitting love story written by BAFTA-winning writer Geoff Thompson with Paddy Considine attached to play the lead role. Steel Mill also produces music promos and short films.

About Roche in the UK

Roche is a leader in research-focused healthcare and in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. Find out more at http://www.rocheuk.com

References:

1. NICE. Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C. Technology Appraisal 75. January 2004

2. Health Protection Agency. Hepatitis C in the UK 2009 Report. Available from: http://www.hpa.org.uk/hepC2009. Last accessed [8 June 2010]

3. Hepatitis C Trust Organisation. Risk Factors. Available from: http://www.hepctrust.org.uk/hepatitis-c/Risk+factors. Last accessed [13 July 2010]

4. Net Doctor. 2005. Cirrhosis of the Liver. Available from: http://www.netdoctor.co.uk/diseases/facts/cirrhosisliver.htm. Last accessed [16 July 2010]

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Source
Posted on August 23, 2010, 9:42 am

HIV-infected drug users have increased age-matched morbidity and mortality compared with HIV-infected people who do not use drugs. This includes an increased risk of viral hepatitis, tuberculosis (TB), bacterial infections, and mental illness. In a new paper in The Lancet Series on HIV in people who use drugs, Professor Frederick L Altice, Yale University, New Haven, CT, USA, and colleagues show that there are evidence based treatments for both HIV and these co-morbidities, and that antiretroviral treatment (ART) for HIV can improve not only the course of HIV infection but also these other conditions.

The authors say: “Evidence-based treatment for substance-use disorders improves the psychological and physiological disruptions that perpetuate the often unstable life of HIV-infected drug-dependent individuals. Treatment of HIV infection, substance-use disorders, and comorbidities in HIV-infected drug users is improved by comprehensive and multidisciplinary management of these disorders.”

If appropriately dosed, medication-assisted therapies for opioid and alcohol dependence, such as methadone, buprenorphine and injectable naltrexone, enhance adherence to ART in patients with HIV, as well as treatment for the above mentioned co-morbidities. Furthermore, they improve retention in HIV care and decrease HIV risk behaviours.

The authors note that as and when ART becomes universally available to drug users with HIV, and their health status improves, so their other health problems will take on increased prominence, such as non-AIDS related comorbitities and TB, all of which will come with their own treatment priorities. HIV infected drug users with TB co-infection creates various clinical challenges since TB can be difficult to diagnose in HIV patients due to atypical chest radiographs, high-rates of TB in parts of the body outside the usual setting of the lungs, and the reduced sensitivity of skin tests used to diagnose TB in HIV patients. While people with latent TB but not HIV infection have a roughly 1 in 11 lifetime risk of having their TB develop into full blown disease, it becomes a 1 in 11 annual risk in patients with HIV co-infection. Concentration of people with HIV and substance use disorders behind bars facilitates transmission of TB, including multidrug resistant strains, due to overcrowding and increased numbers of people who are immunosuppressed. Despite available treatments for HIV and substance use disorders, little treatment is available within these settings.

Due to common routes of transmission, between 60% and 90% of HIV infected IDUs have hepatitis C, and few receive treatment for reasons including cost, physician reluctance, concern about poor treatment adherence, and misperception about potential harm of hepatitis C. Though effective treatments are available, treatment resources are limited due to expense and availability; if the person has hepatitis B, however, they can be treated with other oral antiviral agents that are also effective against HIV.

Mental illness and substance-use disorders are closely inter-related with HIV infection and concentrated especially among prison populations. If drug treatments such as antidepressants are warranted, then care must be taken in the selection of the medication. Some common antidepressants are associated with decreased metabolism of methadone in patients on OST, yet most are safe and effective.

“The concentration of HIV behind bars is a result of society’s punitive rather than treatment-oriented approach to drug use,” says Professor Altice*. “Despite society’s failed policy of mass incarceration of drug users, many of whom are HIV-infected, these sites may be seminal places for the identification and treatment of HIV, but requires sufficient resources to continue care, not only for HIV but for the myriad of substance use disorders, mental illness and other complications, after release.”

The authors conclude: “HIV-infected drug users have substantial HIV-related and non-HIV-related medical and psychiatric comorbidities. As a result, care is often complicated for the individual and for the health-care system. Several evidence-based interventions are available to improve treatment outcomes for this vulnerable population, but parity in treatment outcomes to reduce morbidity and mortality in HIV-infected drug users will be achieved only with further resources, expertise, political will, and commitment by the health-care establishment.”

Provided by Lancet

View the Original article

Source
The Lancet, Early Online Publication, 23 August 2010
doi:10.1016/S0140-6736(10)61030-6

Feng-Cai Zhu MSc a, Prof Jun Zhang MD b, Xue-Feng Zhang MSc a, Cheng Zhou MD c, Zhong-Ze Wang MD d, Shou-Jie Huang MD b, Hua Wang MD a, Chang-Lin Yang BSc d, Han-Min Jiang BSc d, Jia-Ping Cai BSc d, Yi-Jun Wang BSc d, Xing Ai MSc a, Yue-Mei Hu MD a, Quan Tang MD a, Xin Yao MSc c, Qiang Yan MSc b, Yang-Ling Xian BSc e, Prof Ting Wu PhD b, Yi-Min Li MD e, Prof Ji Miao PhD b, Prof Mun-Hon Ng PhD b, Prof James Wai-Kuo Shih PhD b, Prof, Dr Ning-Shao Xia MD b

Summary

Background
Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial.

Methods
Healthy adults aged 16—65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 μg of purified recombinant hepatitis E antigen adsorbed to 0·8 mg aluminium hydroxide suspended in 0·5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov, number NCT01014845.

Findings
11 165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56 302) or placebo (n=56 302). 48 693 (86%) participants in the vaccine group and 48 663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100·0% (95% CI 72·1—100·0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted.

Interpretation
HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16—65 years.

Funding
Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars.
 
Source

HIV virus hides in the brain

23 August 2010 University of Gothenburg

Studies of the spinal fluid of patients given anti-HIV drugs have resulted in new findings suggesting that the brain can act as a hiding place for the HIV virus. Around 10% of patients showed traces of the virus in their spinal fluid but not in their blood – a larger proportion than previously realised, reveals a thesis from the University of Gothenburg, Sweden.

We now have effective anti-HIV drugs that can stop the immune system from being compromised and prevent AIDS. Although these drugs effectively prevent the virus from multiplying, the HIV virus also infects the brain and can cause damage if the infection is not treated.

“Antiviral treatment in the brain is complicated by a number of factors, partly because it is surrounded by a protective barrier that affects how well medicines get in,” says Arvid Edén, doctor and researcher at the Institute of Biomedicine at the Sahlgrenska Academy. “This means that the brain can act as a reservoir where treatment of the virus may be less effective.”

The thesis includes a study of 15 patients who had been effectively medicated for several years. 60% of them showed signs of inflammation in their spinal fluid, albeit at lower levels than without treatment.

“In another study of around 70 patients who had also received anti-HIV drugs, we found HIV in the spinal fluid of around 10% of the patients, even though the virus was not measurable in the blood, which is a significantly higher proportion than previously realised,” explains Edén.

The results of both studies would suggest that current HIV treatment cannot entirely suppress the effects of the virus in the brain, although it is not clear whether the residual inflammation or small quantities of virus in the spinal fluid in some of the patients entail a risk of future complications.

“In my opinion, we need to take into account the effects in the brain when developing new drugs and treatment strategies for HIV infection,” says Edén.

HIV
HIV, human immunodeficiency virus, belongs to the retrovirus family and takes two forms, HIV-1 and HIV-2, which can be transmitted through blood, semen and other secretions and bodily fluids. In the acute phase, patients suffer from fever, swollen lymph glands and rashes. These symptoms do recede, but AIDS develops after a long period of infection. Attempts to produce an HIV vaccine have been ongoing since the 1980s, but have yet to be successful.

http://hdl.handle.net/2077/22187

Source
August 23, 2010 09:12 AM Eastern Daylight Time

Swiss Scientists Prove Stem Cells Can Be Reprogrammed without Genetic Modification

HOUSTON--(BUSINESS WIRE)--Cindy Morrissey, President and CEO of Emerging Healthcare Solutions, Inc. (Pink Sheets: EHSI), called the results of a recent study on Friday an ‘encouraging step’ towards the use of stem cells to regenerate human organs.

The research, published in the journal Nature, shows that it is possible to convert one stem cell type to another, without the need for genetic modification.

“This is really a key discovery in the race to make stem-cell tissue regeneration therapy a reality,” Morrissey said. “These scientists have shown that triggers from surrounding tissue can reprogram stem cells to become tissues they do no not normally generate. It’s an encouraging step that may open the door for additional research on stem-cell therapies,” she said.

Using rat models, researchers completed the study by growing stem cells from the thymus in a laboratory using conditions for growing hair follicle skin stem cells. According to the study, when these cells were transplanted into developing skin, they were able to maintain skin and hair for more than a year. The experimental follicles outperformed naturally-produced hair follicle stem cells, which are only able to heal and repair skin for three weeks.

Once they were transplanted, the genetic markers of the stem cells changed to be more similar to those of hair follicle stem cells. Previously, it was believed that germ layer boundaries could not be crossed. This new research indicates that the regeneration of other organs may be possible, as well.

That’s good news for EHSI, which is in the midst of a Due Diligence period with Regenevita, an international company working on a unique, sustainable cellular banking model that could facilitate the widespread use of regenerative cell therapy. Regenevita plans to collect and store stem cell-rich umbilical cord blood and to replicate those cells into the larger quantities necessary for stem cell treatment. The replication and storage process is designed to make stem cells more readily available and effective for research and treatment applications than current supplies allow.

Emerging Healthcare Solutions focuses on the development of profitable emerging medical technology, a sector that also includes Gilead Sciences, Inc. (NASDAQ: GILD), Genzyme Corporation (NASDAQ: GENZ), Celgene Corporation (NASDAQ: CELG) and Biogen Idec, Inc. (NASDAQ: BIIB).

About Emerging Healthcare Solutions, Inc.

Emerging Healthcare Solutions, Inc. is a medical technology company that works to bring new and innovative medical technologies to the market. The Company’s model is to engage a technology prior to its inflection point in order to maximize the profits available to EHSI as that new technology is adopted. Our common stock is traded under the symbol EHSI.

For more information, visit http://www.emerginghealthcaresolutionsinc.com/.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipate" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements. In addition, description of anyone's past success, either financial or strategic, is no guarantee of future success. This news release speaks as of the date first set forth above and the company assumes no responsibility to update the information included herein for events occurring after the date hereof.

Contacts
Emerging Healthcare Solutions, Inc.
Cindy Morrissey, 713-821-1486

Source
J. de Bruijne 1,†, J.F. Bergmann 2,†, H.W. Reesink 1,*,‡, C.J. Weegink 1, R. Molenkamp 3, J. Schinkel 3, X. Tong 4, J. Li 4, M.A. Treitel 4, E.A. Hughes 4, J.J. van Lier 5, A.A. van Vliet 5, H.L.A. Janssen 2, R.J. de Knegt 2

Hepatology
DOI: 10.1002/hep.23899
Accepted Article (Accepted, unedited articles published online for future issues)
Copyright © 2010 American Association for the Study of Liver Diseases

Author Information
1 Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, Department of Gastroenterology and Hepatology, The Netherlands
2 Erasmus MC University Hospital, 's-Gravendijkwal 230, 3015 CE Rotterdam, Department of Gastroenterology and Hepatology, The Netherlandz
3 Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, Department of Medical Microbiology, The Netherlands
4 Schering-Plough Research Institute, Kenilworth, NJ, USA
5 PRA International EDS, Stationsweg 163, 9471 GP Zuidlaren, The Netherlands

Email: H.W. Reesink (H.W.Reesink@amc.nl)
*Correspondence: H.W. Reesink, Department of Hepatology, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

These authors contributed equally to this study
Ph: +31205667863; Fax: +31205669582

Publication History
Accepted manuscript online: 19 AUG 2010 08:52AM EST
Manuscript Accepted: 30 JUL 2010
Manuscript Revised: 29 JUN 2010
Manuscript Received: 19 APR 2010

Funded by
Schering-Plough and designed by Schering-Plough employees and H.W. Reesink

Abstract
Narlaprevir (SCH 900518) is a potent inhibitor of the HCV NS3 serine protease that is primarily metabolized by the cytochrome P450-3A4 system (CYP3A4). In order to explore the use of ritonavir-based pharmacokinetic enhancement of an HCV protease inhibitor, this study investigated the safety, tolerability, pharmacokinetics and antiviral activity of narlaprevir (with or without ritonavir) administered as monotherapy and combination therapy with pegylated interferon-α-2b to HCV genotype 1 infected patients. This was a randomized, placebo-controlled, two period, blinded study in 40 HCV genotype 1 infected patients (naïve and treatment-experienced). In Period 1, narlaprevir was administered for 7 days as 800 mg TID without ritonavir or 400 mg BID with 200 mg ritonavir BID. In Period 2, after a 4 week washout, the same dose and regimen of narlaprevir was administered in combination with pegylated interferon-α-2b for 14 days. Upon completion of Period 2, all patients initiated pegylated interferon-α-2b and ribavirin treatment. A rapid and persistent decline in plasma HCV RNA was observed in both treatment-experienced and -naive patients during Period 1, with a mean viral load decline of at least 4 log10 in all treatment groups. A high percentage of both treatment-experienced (50% and 50%) and naïve (75% and 63%) patients had undetectable HCV RNA (<25 IU/mL) after Period 2. Standard of care resulted in SVR rates of 38% and 81% in treatment-experienced and treatment–naïve patients, respectively. Narlaprevir (with or without ritonavir) alone or in combination with pegylated interferon-α-2b was safe and well tolerated.

Conclusion:
Narlaprevir administration resulted in a robust HCV RNA decline and high SVR rates when followed by standard of care in both treatment-experienced and treatment-naïve HCV genotype 1-infected patients. (HEPATOLOGY 2010.)

Source

HIV transmitted during sex may hold clues to infection

An archive photo of a volunteer dressed as a condom during a 2003 AIDS awareness event in Bulgaria. Photo: Julia Lazarova
 
Mon, Aug 23 2010 13:02 CET
by Joe DeCapua
 
A new study finds the AIDS virus circulating in the blood may be very different from the virus that’s transmitted during sex. And this could have implications in the search for an effective vaccine or microbicide.

University of North Carolina School of Medicine researchers at Chapel Hill say HIV may undergo changes in the genital tract of men. As a result, the virus contained in semen could hold clues about how to block infection. More research is needed, however.

Why important

"Most of what we know about HIV is based on analysis of virus that’s in the blood. And much of the transmission that goes on goes from men to women or men to men. But the male genital tract, male seminal tract, is involved in those transmissions," says Ron Swanstrom, professor of biochemistry at UNC and the senior author of the study.

"Anything that makes the virus different in semen, which is the site of the transmitted virus, becomes important to understand just to find out if it’s relevant to the transmission event," he adds.

Do researchers know why HIV can change in the seminal tract? "That’s the big question for us," he says, "and no."

It could be one of two reasons.

Swanstrom says, "There’s a phenomenon known called the founder’s effect where…by chance it’s one thing that gets started and it grows from that…. So it could be just by luck that one or a few viruses get established in the seminal tract and grow out . In which case presumably there won’t be any differences in terms of the biology of the virus compared to what’s in the blood."

On the other hand, there’s another, more important possibility.

"There could be some selective pressure. That the virus that grows in the seminal tract has some other different set of circumstances that it deals with and has to adapt to that environment. And therefore, it’s a little bit different than what’s in the blood," he says.

What’s the difference?

Much of the time HIV in the semen and HIV in the blood may not differ at all. But other times there may be two different scenarios.

"One virus or a couple of viruses seem to take off over a very short period of time and represent a significant fraction of the virus in the semen. We don’t know why that happens, but it’ll be a much less complex population. The population of the blood is very complex genetically. The viruses are all kind of different from each other. Suddenly the semen looks much more homogeneous," he says.

Those particular viruses, however, disappear fairly quickly. Another possibility, he says, is that the virus gets established in the seminal tract and eventually becomes separated from the HIV population in the blood.

"That’s when we see this strong compartmentalization where the virus is very different. But again, we don’t know what that difference is at this time," he says.

Vaccines, microbicides

At this stage, it’s unclear whether the finding will affect vaccine and microbicide research. But Swanstrom says, "If this is the pool of viruses that are being transmitted, then it’s really the virus that we want to understand the most about."

He cautions that while the differences can be seen at the genome level, they may not have any biological difference from the HIV in the blood and therefore won’t behave any differently.

"But if they do confer some special property, then we certainly need to know about that. If we were really lucky, it might help inform us on either a vaccine or a more efficacious microbicide," he says.

It’s just a different kind of virus

"I think that’s fair to say. I’ve been a virologist for a long time and probably what’s different about HIV is that it grows constantly in the host. And this is also true for HCV (Hepatitis C Virus)."

The biochemistry professor says these are special viruses in that "they know how to survive in the face of our immune system. For HIV it’s always evolving. The virus is growing every day."

The HIV lifecycle is only about a day long. "So 365 times a year it divides. It grows. If you think about that in terms of generations and how long it would be to have 365 generations of a person, that gets compressed into every year for HIV. And whatever the host is able to throw at it, it evolves away from it. And so there’s this titanic battle that goes on constantly between the virus and the host," he says.

The next step is to clone the HIV found in the semen and study it further to learn whether its difference will make a difference in the search for better treatment or a cure.

Source: VOANews.com
 
Source
 
Also See: AIDS virus changes in semen make it different than in blood

Egypt rejects estimates of high hepatitis C levels

23 Aug 2010 09:41:00 GMT
Source: SciDev.Net
Ola Al-Ghazawy
Website: http://www.scidev.net/

Reuters and AlertNet are not responsible for the content of this article or for any external internet sites. The views expressed are the author's alone.

[CAIRO] A new study estimates that around half a million people in Egypt are infected annually with hepatitis C virus (HCV)-far more than any country in the world-and that one in every ten people in Egypt is a HCV carrier.

An important reason for the high incidence rate is the huge level of infection in the blood supply in Egypt, suggested Laith Abu-Raddad, a co-author of the study. "Much more transmission is likely to happen in Egypt because the background prevalence is about 20 times higher [than other countries]," he said.

However, the study's findings have been rejected by the country's Ministry of Health.

Wahid Doss, director of the Egyptian National Committee on Viral Hepatitis said the figure published in the Proceedings of the National Academy of Sciences online last week (9 August) was highly exaggerated.

"According to our most recent survey, there are only some 100,000 new cases of hepatitis C every year," he told local newspaper Al-Masry Al-Youm.

But Abu-Raddad, who is an assistant professor in public health at Weill Cornell Medical College, Qatar, said he had anticipated the government's rejection of the study's conclusions.

"Usually whenever a result is politically sensitive, the study is rejected," he said.

However, Mohammed Ezz Al-Arab, head of the Oncology Unit at the National Hepatology and Tropical Medicine institute said that "these [high] numbers might have been true ten years ago".

"After all the government's efforts, such as launching new programs for infection control targeting healthcare providers and blood banks in Egypt, new HCV infections decreased considerably," Ezz Al- Arab said.

He said that most infected people are over 45 years old, as they were exposed to the contaminated intravenous injection during Egypt's anti-Bilharzia treatment campaign in the 1960s, which spread HCV. "Under the age of 15 the rates are really low because of a higher awareness nowadays due to the constant campaigns."

Alaa Ismail, head of the liver research unit at the faculty of medicine at Ain Shams University, Cairo, said there were many indicators suggesting a decrease in HCV infections, such as a decrease in the number of reported cases from blood banks.

But he added that even 100,000 would still be a high number, caused by a lack of disposable medical technologies and poor hygiene habits.

Egyptian officials admitted that country-wide field studies had not been conducted as they would require huge human resources.

Link to article in Al-Masry Al-Youm

Link to full article in Proceedings of the National Academy of Sciences*
 
Source

Hepatitis C – Not just a celebrity disease


23rd August 2010

Everyone seems to know that Pamela Anderson has Hep C. They even know that Keith Richards, Anthony Kiedis and Marianne Faithful suffer from the disease and Body Shop founder - Anita Roddick also had the disease. But did you know that if you have ever shared your partner’s toothbrush or borrowed your friend’s razor you could be at risk too?

There are estimated to be over half a million people in the UK living with hepatitis B or C without knowing it. The Hepatitis C Trust is calling on health services to introduce testing in pharmacies to ensure the early diagnosis of the disease which could save thousands of lives each year.

You can contract Hepatitis C the following ways:

- Regularly shared razors or toothbrushes with a person who is known to have hepatitis C

- Contact sports, fights and a human bite (where they may have come in contact with another person’s blood)

- Tattoos / piercings/ Acupuncture (in unregistered premises or with possibly unsterile equipment or with needles that were not new)

- Current sniffing cocaine / past sniffing cocaine (sharing pipes, notes or straws with a person who is known to have hepatitis C or may have been at risk)

- Receiving a blood transfusion / blood products / organ transplantation prior to 1991

- Current IV drug use / past IV drug use (including steroids, sharing any injecting equipment)

To find out more about the disease and how you can get tested, watch our video, or log on to: hepctrust.org.uk
 
Source

Also See: Campaign for Hepatitis Tests in Pharmacies as Deaths Rise