Thursday, December 2, 2010

Todays News Dec 2 : Hepatitis



Medivir Announces Positive 24-week Interim Data of TMC435 From the ASPIRE Study (C206) in Treatment-Experienced Prior Non-responders
"The null responder group also demonstrated significant response rates with 38%, 64% and 78% of patients taking TMC435 and Peg-IFN and ribavirin achieving undetectable HCV RNA levels at week 4, week 12 and week 24, respectively" HUDDINGE, Sweden, November 18, 2010 /PRNewswire/ --- Once Daily Novel Therapy in Treatment-Experienced Hepatitis C Patients Highlights of the Study TMC435 Added to Standard of Care: - Increased the response rates and antiviral efficacy, which progressed through to week 24 - Increased the number of patients with undetectable Hepatitis C Virus (HCV) levels through week 4, 12 and 24 - Safe and well tolerated


80% of those infected have no signs or symptoms, expert says.
By Aftab Kazmi, Bureau Chief
Published: 00:00 December 3, 2010
Al Ain: Thinking she is completely healthy and vaccinated against the deadly disease Hepatitis C, an Arab expatriate woman was shocked when she tested positive in a preliminary test.
For Hepatitis C, a silent killer, no vaccination is available and the infected person cannot even notice any significant symptoms for many years. "A wrong assumption for a traceless enemy could be dangerous," said Ahmad Al Za'abi, head of a medical campaign against Hepatitis C.

Hepatitis – cirrhosis – liver between the three is valid and about l0% of viral hepatitis deeds grow into chronic hepatitis and chronic hepatitis in deeds can grow into 50% of cirrhosis. Among them, hepatitis B, followed by the hepatitis C, hepatitis due to rapid recovery, the prognosis is good, do not change lead to cirrhosis.
information overstepped the bounds in recent years, emphasized that hepatitis B virus (HBV) infection of primary liver cancer of at least 80% of hepatocellular carcinoma patients with hepatitis B virus infection. Data confirmed that carriers of chronic hepatitis B antigen profiles of hepatocellular carcinoma patients with negative population risk of 40 times.


Anemona Hartocollis (The New York Times, December 1, 2010)"Some 911 calls in Manhattan will now bring out two ambulances, one hurrying to the scene and one lagging slightly behind. The first one will try to save the patient’s life. The second one will try to save the patient’s kidneys, in case the first ambulance fails. After months of grappling with the ethical and legal implications, New York City medical officials are beginning to test a system that they hope will one day greatly increase the number of organs collected for transplant."


Kounteya Sinha (The Times of India, November 27, 2010)"Indians aren't all that generous when it comes to donating their organs…India's count stands at 0.08 donors per million population. It is estimated that every three minutes, a patient requires an organ transplant. Some experts say more than two lakh Indians require transplantation annually. But, unfortunately, not even 10% get it…Plans are afoot to include a clause on the willingness for organ donation in driving license."


Hepatitis B is an epidemic that is devastating the Asian community. A big problem is that most people don’t know this.
On Sept. 30, the Centers for Disease Control and Prevention (CDC) released its list of priorities. Dubbing them “winnable battles,” Dr. Thomas Friedman, director of the CDC, stated that smoking, AIDS, obesity/nutrition, teen pregnancy, auto injuries, and health care infections are the areas that the CDC are concentrating on most.
Since then, the CDC has gotten a lot of grief for elevating a handful of problems over the dozens that also desperately need attention.
A glaring omission that affects Asian and Pacific Islander (API) populations is hepatitis B and C, both of which many experts say have long been under-recognized by the CDC.


SRC-1 Controls Liver's 'Sweet Spot' For Glucose Production
Posted on: Wednesday, 1 December 2010, 21:15 CST
SRC-1 (steroid receptor coactivator) orchestrates glucose production in the liver, regulating the activity of a cascade of enzymes that turns sugar production on and off in the liver, said Baylor College of Medicine and Duke University Medical Center researchers in a report that appears in the current issue of Cell Metabolism.
"As we achieve a better understanding of gluconeogenesis (production of glucose) in the liver, we can look for new ways to treat metabolic diseases such as type 2 diabetes," said Dr. Jean-Francois Louet, instructor in molecular and cellular biology at BCM and a first author of the report. Dr. Atul R. Chopra, a resident physician at BCM, is the other first author.
SRC-1 is a member of a family of steroid receptor coactivators that control important processes in the body. Dr. Bert O'Malley, chair of molecular and cellular biology at BCM and a senior author of the report, discovered SRC-1 and has been a pioneer in uncovering the role of these molecules as cellular master regulators.Missing control protein


I was taking two blood pressure medicines, had high cholesterol, was diagnosed as pre-diabetic, and had elevated liver enzymes due to a fatty liver. I was seeing my physician every three months and seemed always to be having some sort of test. I had no energy and really just enjoyed sitting around, watching TV and, of course, snacking!
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In case you missed it......
Liver Disease in the News
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Fruit and Vegetables Do Not Reduce Overall Cancer Risk, Review Concludes

Alok Jha (The Guardian, London, December 1, 2010)"Vegetables and fruit are important for a healthy diet but the review says that eating increased amounts does not seem to offer much protection against cancer. 'There's strong scientific evidence to show that, after smoking, being overweight and alcohol are two of the biggest cancer risks,' said Tim Key, an epidemiologist from Oxford University, who wrote the review. In an article published today in the British Journal of Cancer, Key summarised the epidemiological evidence from more than a million people taking part in several dozen long-term research projects looking at the amount of fruit and vegetables people eat and their overall cancer risk."

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Bill Calls for Routine HIV Testing HIV: Medical Groups Back More Testing - December 02, 2010 (The New York Times News Service) -- Texans having blood drawn as part of any routine medical testing would be screened for the infection that causes AIDS under proposed new state legislation."I'm trying to take the stigma out of HIV-AIDS testing," said Ellis, D-Houston, who timed the filing to coincide with World AIDS Day. "If we can make HIV testing as commonplace as getting a physical or a flu shot, I think we can reduce the toll of this disease in Texas."

Read full article


Abuse of Drugs Complicates South Africa's Fight Against AIDS - December 02, 2010
Cape Town (Deutsche Presse-Agentur - dpa) -- The days when South Africa's president played down the danger of AIDS and the health minister recommended "garlic, beetroot and vitamins" as medicine to fight it are over.


Umesh Isalkar (The Times of India, December 1, 2010)"As India makes steady progress in its battle against HIV, it comes as a setback of sorts that a sizeable chunk of AIDS patients in Maharashtra have given up on treatment after the initial few doses of medication…Labelled as 'lost to follow-up' (LFU) cases, these patients carry a mortality risk that is five times higher than patients who have been taking regular anti-retroviral therapy (ART). Side-effects of the medicines, lack of family support and social stigma are the main reasons why these patients have abandoned the treatment."


Sarah Boseley(The Guardian, London, online, November 30, 2010)"Just half of pregnant women with HIV in developing countries get the drugs necessary to prevent their babies becoming infected at birth, according to a report from Unicef…Low social status, poverty, poor education and living in rural areas are among factors that reduce the chances of millions receiving HIV treatment and prevention. The UN's goal is zero mother-to-child transmissions, but more than 1,000 babies are born with HIV every day. Half of them die before they reach the age of two."


After discovering a potential glitch in the sterilization of surgical instruments and shutting down non-essential procedures, the Charlie Norwood VA Medical Center is slowly building back up its volume of surgeries as it adds new equipment and ensures protocols are followed, officials said.While some surgeries were farmed out into the community, VA officials insist no one was actually put at risk and no one was harmed. Still, it is the second problem with sterilization of reusable medical equipment at the Augusta facility in the last two years. But officials insist the two are not at all related and involve different areas of the reprocessing and sterilization department
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Hepatitis A warning at Jerry's Deli in Westwood
By Alison Hewitt December 02, 2010 Category: Campus News
If you ate at Jerry's Deli in Westwood in November, hopefully you had the soup.
The Los Angeles Department of Public Health (DPH) is warning that people who ate sandwiches at the Jerry's Deli near UCLA on certain days in November may have been exposed to hepatitis A and should get vaccinated.
"Public Health recommends that patrons who ate sandwiches at the restaurant or who ate catered sandwiches from this location on Nov. 18, 21, 23 or 24 should receive an immune globulin (IG) shot or a hepatitis A vaccination no later than 14 days after their exposure to prevent or reduce illness," a DPH notice said. That means today, Dec. 2, is the deadline for anyone who ate their sandwiches on Nov. 18.
Read full article

Stem cells

Published online 1 December 2010
Nature 468, 620-623 (2010) doi:10.1038/468620a
News Feature
Stem cells: The impatient advocate
Bob Klein founded the California Institute for Regenerative Medicine, the biggest state-run research project in US history. What legacy will he leave behind?

James Harrison had just stepped out to grab a sandwich when his mobile phone rang. Bob Klein, chairman of the California Institute for Regenerative Medicine (CIRM), was on the line telling Harrison, the agency's legal counsel, to skip lunch and come back to the office right away. It was 23 August, and a district court judge in Washington DC had just issued an injunction barring the use of federal grant money for human embryonic stem-cell research. At that instant, CIRM became the world's largest funder of such research, and needed to issue a public statement.


Public Release: 2-Dec-2010 Cell Stem Cell
Scripps Research Institute scientists have made a significant leap forward in the drive to find a way to safely reprogram mature human cells and turn them into stem cells, which can then change into other cell types, such as nerve, heart, and liver cells. The ability to transform fully mature adult cells such as skin cells into stem cells has potentially profound implications for treating many diseases.


Recall

12/2/2010
WASHINGTON -- Johnson & Johnson-Merck Pharmaceuticals is recalling 12 Mylanta products and 12-oz AlternaGEL because the product label does not list the alcohol content of flavoring agents.

Hall Of Shame
Comedian not laughing at doc’s wrong diagnosis
by ROB SMYTH
A COMEDIAN who was told he had three months to live by doctors started living out his dreams — before being told doctors had got his diagnosis wrong.
Dave Ismay, 64, of Ashby, was told alcohol had left him with liver cirrhosis and that he had just months to live.
But faced with the diagnosis, the former TV comic — who performed for 20 years with Bob Monkhouse — decided there was still much he had left to do.
He immediately started a ‘bucket list’ — a list of things to do before he died — only to find that 10 weeks later doctors had got his diagnosis very wrong.
Dave did not have cirrhosis of the liver caused by alcohol, but in fact was suffering from a treatable hereditary condition called haemochromatosis; an overload of iron in his blood.

Wednesday, December 1, 2010

RDA : Researchers Increase Vitamin D and calcium.

Related Reading : "Low Vitamin D Ups Mortality Risk in Patients With Diabetes

Low Vitamin D Not Linked to Bone Density or Liver Fibrosis in HIV/HCV Group

What about Vitamin D and HCV ?


Researchers Increase Vitamin D RDA

RTTNews) - An increase in the recommended dietary allowance of vitamin D has been called for in new guidelines issued by the Institute of Medicine.


The new recommendations call for 699 international units (IU) daily, with 800 IU recommended for the elderly. The researchers note, however, that most Americans receive the necessary amount of vitamin D already and that taking more is not necessarily better.


Guideline researcher Clifford J. Rosen, MD, senior scientist at the Maine Medical Center Research Institute in Scarborough, says: "We believe that taking in amounts larger than 600 to 800 IU a day has no extra benefit for bones."


The vitamin, which helps the body absorb calcium and strengthens bones, has also been linked to reduced heart disease, diabetes and cancer risks, though further investigation is needed.
The guidelines also raised the recommended daily allowance of calcium.

New Protease blockers that irreversibly inhibit the HCV protease enzyme

Sticking Fast To Foil Hepatitis C

Biochemistry:
Aiming beyond the active site of a virus's key protease yields selective blockers
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Hanging Tough A covalent inhibitor (blue) binds irreversibly to a cysteine in the substrate-binding site of hepatitis C protease (green). The active site serine is shown in red.


By targeting a noncatalytic cysteine, researchers have designed selective irreversible blockers of a protease enzyme essential for hepatitis C virus replication (Nat. Chem. Biol., DOI: 10.1038/nchembio.492).

The work is the first demonstration that steering clear of the active site is a viable design strategy for drugs that react to form a covalent bond to proteases, a broad class of proteins that includes many drug targets. This strategy has already proven useful for blocking other proteins such as kinases.

A team from the biotechnology company Avila Therapeutics developed the new protease blockers, which covalently bind to a cysteine in hepatitis C protease's substrate-binding site. In contrast, most other hepatitis C protease inhibitors in development reversibly bind to a catalytic amino acid common to proteases in human hosts as well as in viruses. Avila's published inhibitor structures are prototypes, but the company hopes to begin human clinical trials with optimized compounds in 2011. The team says its comprehensive structural analysis of hundreds of proteases suggests this strategy can be applied broadly
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However, it's not clear how applicable the team's strategy will be to all proteases, says Matthew S. Bogyo of Stanford University, who develops chemical tools to study the roles of proteases in disease. Nevertheless, "covalent inhibitors benefit from a long duration of action, and when used for clearing pathogens such as hepatitis C virus, they may make more sense than classical reversible inhibitors," Bogyo says. Covalent inhibitors can also make several aspects of drug development more straightforward because it's easier to monitor their target selectivity and distribution throughout the body compared with reversible inhibitors, he adds
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Organizational culture as barriers to Hepatitis C treatment delivery


Perceptions of Hep C treatment in opiate substitution treatment

The latest issue of the Journal of Viral Hepatitis investigates perceptions of clients and health professionals and hepatitis C treatment in opiate substitution treatment.
Uptake of treatment for hepatitis C virus infection is very low particularly among people who have injected drugs.

Opiate substitution treatment programs, with a high prevalence of people living with hepatitis C, have been a site of growing interest in the delivery of hepatitis C treatment.
There has been no exploration of OST clients’ and health professionals’ perceptions of the barriers and facilitators to uptake and delivery of Hepatitis C treatment in OST clinics from personal and organizational perspectives.

Organizational culture as barriers to Hepatitis C treatment delivery
Journal of Viral Hepatitis

Dr Treloar and colleagues from Australia completed a qualitative study involving interviews with 27 opiate substitution treatment clients in New South Wales, and a focus group and interviews with 22 Australian opiate substitution treatment health professionals.
Clients and health professionals viewed hepatitis C treatment in opiate substitution treatment as a ‘one-stop-shop’ model which could increase access to and uptake of treatment and build on existing relationships of trust between opiate substitution treatment client and health professional.

The research team noted elements of the organizational culture as barriers to Hepatitis C treatment delivery.

The team found that confidentiality, lack of discussion of hepatitis C treatment and that hepatitis C treatment was not perceived by clinicians as a legitimate activity of opiate substitution treatment clinics.

Opiate substitution treatment client participants also reported a number of personal barriers to engaging with Hepatitis C treatment including family responsibilities, unstable housing, comorbidities and perceptions of the unsatisfactory level of treatment efficacy.
Dr Treloar's team concludes, "These findings emphasize the need for future research and delivery of services which addresses the complexity of care and treatment for people in marginalized social circumstances."
01 December 2010
Uptake and delivery of hepatitis C treatment in opiate substitution treatment: perceptions of clients and health professionals (pages 839–844)
C. Treloar, J. Newland, J. Rance and M. Hopwood
Article first published online: 10 NOV 2010 DOI: 10.1111/j.1365-2893.2009.01250.x
Abstract

Liver Cancer: Microwave ablation (MWA) or RFA ?

Hello Folks, today Medgadget added a video (see below) presentation on "Microsulis microwave ablation (MWA) system" which is used to destroy liver tumors by heat generated microwave energy. The device is beneficial when liver tumors can not be removed surgically. The advantages of MWA over RFA (Radiofrequency Ablation) are highlighted below

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***Update Dec 6th
Liver Cancer:First U.S. Patient Treated with the Accu2i Percutaneous Microwave Tissue Ablation Device

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What Is Primary Liver Cancer?

Microwave ablation (MWA) is used to treat inoperable liver tumors.

These include hepatocellular carcinoma or (primary liver cancer) that originates in the liver.

HCC (hepatocellular carcinoma) is a disease associated with cirrhosis and hepatitis B and C .

What Is Secondary Liver Cancer ?

Metastatic or secondary liver cancer results through the spread of cancer from another organ in the body, Because the liver has two blood supplies and a ready store of growth factors, it is a fertile site for liver metastases, liver tumors originating elsewhere in the body. Abdominal cancers, and especially colorectal cancer, frequently metastasize to the liver.

What Is Microwave ablation (MWA) ?

A new technology, microwave ablation (MWA), destroys liver tumors using heat generated by microwave energy. With microwave ablation, the surgeon inserts a small laparoscopic port or open incision to access the tumor. A CT scan or ultrasonic guidance is used to pinpoint the exact location of the tumor. A thin antenna, which emits microwaves, is then inserted into the tumor. The probe produces intense heat that ablates (destroys) tumor tissue, often within 10 minutes.

,What Are The Advantages Over Traditional RFA= Radiofrequency Ablation ?

"According to the American Cancer Society, more than 450,000 Americans suffer from lung and liver cancer annually. Historically treatment options for these types of cancer have included one or a combination of treatments including surgical removal of the cancer, chemotherapy, radiofrequency ablation (RFA), or radiation therapy. Ablative therapies which aim to destroy tumors in-situ are limited by the number and size of the tumors that can be targeted and so it’s not an option in many cases due to the limited performance of existing RFA and microwave systems. However the Acculis Accu2i pMTA system is the first high power 2.45 GHz system that enables larger and faster ablations to be performed. This means that ablative therapy will now be available as an option for many more patients".

Microwave ablation has a number advantages when compared to traditional RFA, which is a standard method for ablating liver tumors

These include:

Speed - Microwave ablation (MWA) is faster than RFA, destroying tumors more efficiently, and reducing the time patients remain under general anesthesia.

Simultaneous Tumor Ablation - With MWA, surgeons can ablate multiple liver tumors at the same time.

Larger Tumor Size - MWA can ablate larger tumors than are possible with RFA.

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What Is Radiofrequency Ablation (RFA) Therapy ?

How is RFA done and how does it work?
In RFA, heat is generated locally by a high frequency, alternating current that flows from the electrodes. A probe is inserted into the center of the tumor and the non-insulated electrodes, which are shaped like prongs, are projected into the tumor. The local heat that is generated melts the tissue (coagulative necrosis) that is adjacent to the probe. The probe is left in place for about 10 to 15 minutes.

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***Up***Update Dec 6thdate Dec 6th
Liver Cancer:First U.S. Patient Treated with the Accu2i Percutaneous Microwave Tissue Ablation Device,

Microsulis Reports Comprehensive Global Electrical Safety Standards for Powerful Accu2i Percutaneous Microwave Tissue Ablation System

Nov 11 2010

“Increasing numbers of clinicians around the world are adopting the radically improved performance and ease of use of the Acculis system, moving away from older radiofrequency ablation systems. The groundbreaking performance of the device reflects the extensive testing the device has undergone to the highest standards around the world.”

The Accu2i pMTA is the most powerful tumour ablation system currently available, combining extreme ease of use with the widest range of clinical applications. The device is a single high power high frequency 2.45GHz microwave needle that can address tumours over 5cm in size in just 6 minutes, and is therefore between 3 to 10 times faster than other systems. Its launch followed two years of extensive clinical use and evaluation in major centres around the world mainly treating liver and lung cancers





Acculis Microwave Thermal Ablation Demo at RSNA 2010


Press Release In August

Microsulis Medical Limited Receives FDA 510(k) Clearance of Accu2i Percutaneous Microwave Tissue Ablation Device

*** August

High Power Microwave Tissue Ablation System Used to Destroy Liver and Lung Tumors
DENMEAD, England--(BUSINESS WIRE)--Microsulis Medical Limited, the leading company in microwave technology for medical devices, today announced that the U.S. Food and Drug Administration (FDA) has provided the company 510(k) clearance to market the Acculis Accu2i percutaneous microwave tissue ablation (pMTA) system for the coagulation of soft tissue during surgical procedures. This innovative treatment allows physicians to apply precise microwave energy to ablate unwanted tissue masses. The system has already been in use in Europe treating liver and lung tumors via a small 1.8 mm needle puncture of the skin. By providing an alternative to “open surgery” patients avoid the risks associated with longer, more invasive surgical interventions.

“If the clinical performance of the system confirms the early promise of this technology, this advancement will lead to new treatment options for lung and liver cancer patients”
“We are delighted to receive this clearance from the FDA and are looking forward to introducing the pMTA product to the U.S. market after seeing its success throughout Europe. Having transferred the product to the manufacturer in Europe we now have a system that we know is market-ready and tested,” said Stuart McIntyre, CEO of Microsulis Medical Limited. “Moreover this is the first high power 2.45 GHz system available and sets a new benchmark for such devices.”

According to the American Cancer Society, more than 450,000 Americans suffer from lung and liver cancer annually. Historically treatment options for these types of cancer have included one or a combination of treatments including surgical removal of the cancer, chemotherapy, radiofrequency ablation (RFA), or radiation therapy. Ablative therapies which aim to destroy tumors in-situ are limited by the number and size of the tumors that can be targeted and so it’s not an option in many cases due to the limited performance of existing RFA and microwave systems. However the Acculis Accu2i pMTA system is the first high power 2.45 GHz system that enables larger and faster ablations to be performed. This means that ablative therapy will now be available as an option for many more patients.

“If the clinical performance of the system confirms the early promise of this technology, this advancement will lead to new treatment options for lung and liver cancer patients,” said Dr. William Scott Helton, Chairman, Department of Surgery at Hospital of Saint Raphael, New Haven, Conn. “The Accu2i pMTA system allows physicians to deliver precise microwave energy to treat tumors up to 5cm in size in a very short period of time. It will add a significant additional tool into the armamentarium of oncologists, surgeons and radiologists treating patients with this illness.”

For more information about the Acculis Accu2i pMTA system, visit About Microsulis Medical Limited
Founded in 1997, Microsulis Medical Ltd is a UK-based medical device company that exploits specialist intellectual property in medical microwave design to create therapeutic devices. The company was initially formed following research collaboration between Chemring and the University of Bath in 1993. The company leads the field in microwave technology for endometrial ablation, tumour ablation and venous occlusion. Part of MML, Acculis specialises in devices for oncology applications.

Information On This Blog For

HCV And HCC Updates: ThermoDox® To Treat Primary Liver Cancer

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Dec 1st Hepatitis C News :Phase I/II Investigator-Sponsored Trial in Liver Cancer

Investigators Evaluating Novel Monoclonal Antibody Bavituximab in Combination With Sorafenib "Our research has demonstrated that sorafenib increases the exposure of the highly immunosuppressive molecule phosphatidylserine (PS) on tumor vasculature, providing more of a specific target for bavituximab," said Adam C. Yopp, M.D., lead investigator of this trial and assistant professor of surgery at the University of Texas Southwestern Medical Center. "We are eager to determine if combining the growth-blocking mechanisms of sorafenib with the vascular-targeting and immune-reactivation mechanisms of bavituximab offers additive anti-tumor effects for patients with HCC." Currently, Peregrine's bavituximab is being evaluated in combination with chemotherapy in multiple Phase II trials in non-small cell lung cancer and advanced breast cancer, as well as a Phase Ib trial for hepatitis C virus (HCV) and HIV coinfection. Continue Reading........

By Jessica Wapner
Infectious Curiosity


The course of virologist Charlie Rices career changed with one phone call in 1989. Then at Washington University in St. Louis, Rice was the country's leading yellow fever expert. The voice on the other end of the line belonged to Stephen Feinstone, an FDA scientist asking about a vaccine for the disease that had just won agency approval. Yellow fever virus is a flavivirus. Feinstone wanted to know if Rice could help develop a vaccine to protect against another flavivirus: hepatitis C. “I can get interested in pretty much anything, I guess,” says Rice.
Today, more than 20 years after Rice took that call, hepatitis C virus (HCV) infects about 170 million people worldwide, but those statistics may soon take a downward turn. Two protease inhibitors that recently completed late-stage clinical trials—telaprevir and boceprevir—are curing significant numbers of patients who may otherwise have suffered a lifetime of liver problems. Published studies reported profound responses to treatment with either of these drugs when used in combination with pegylated interferon (PegIFN) and ribavirin—the current standard, but often ineffective, therapy (J.G. McHutchison et al., NEJM, 360:1827-38, 2009 and P.Y. Kwo et al., Lancet, 376:705-16, 2010).
Continue reading............


Hepatitis C GI-5005 Vaccine Elicits Immune Response in Some Patients
In the proof-of-concept trial, 133 patients infected with hepatitis C virus (HCV) genotype 1 were randomized to either triple therapy comprising the experimental GI-5005 vaccine, which is designed to elicit a T-cell response specific to HCV, along with pegylated interferon alfa-2b plus ribavirin (P/R), or the standard P/R therapy alone.

Sticking Fast To Foil Hepatitis C
Biochemistry: Aiming beyond the active site of a virus's key protease yields selective blockers
Carmen Drahl
By targeting a noncatalytic cysteine, researchers have designed selective irreversible blockers of a protease enzyme essential for hepatitis C virus replication (Nat. Chem. Biol., DOI: 10.1038/nchembio.492).
The work is the first demonstration that steering clear of the active site is a viable design strategy for drugs that react to form a covalent bond to proteases, a broad class of proteins that includes many drug targets. This strategy has already proven useful for blocking other proteins such as kinases.
Continue reading...........

Hepatitis fears for hundreds of Scots after Spanish outbreak
Matthew Holehouse
1 Dec 2010
Hundreds of dialysis patients in Scotland are being called in for screening amid fears they could have contracted the hepatitus C virus from two Scottish holidaymakers who became infected while undergoing treatment at a clinic in Spain.
The male Scottish victims, one from the NHS Greater Glasgow and Clyde board area and one from the NHS Forth Valley board area, are understood to have received dialysis in September at the Centro Hemodiálisis Nefdial on Majorca.
They returned to Britain unknowingly carrying the blood-borne disease – which can cause liver failure – and continued their treatment in Scotland.
Health experts say they could have passed it to other dialysis patients in Scottish hospitals. Health Protection Scotland said the threat was “extremely low” because of the robust infection control measures in place in Scotland.
However, 245 people who may have been treated in the same units as the two people in Scotland are being offered extra screening for hepatitis C.
Continue Reading........

Pharmasset Initiates Dosing In A Combination Study Of PSI-7977 And PSI-938 For Chronic Hepatitis C
01 December 2010Pharmasset, Inc. (Nasdaq: VRUS) announced that dosing has begun in Part 2 of a Phase 1 study. This is the first clinical study combining a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for HCV, and is...
[read article]

Ikaria® Begins Enrollment Of Pivotal Trial For LUCASSIN®
01 December 2010Ikaria, Inc. announced that it has enrolled the first patients in its pivotal Phase III trial for LUCASSIN® (terlipressin). The multi-center, randomized, placebo-controlled, double-blind trial is known as the REVERSE Trial...
[read article]

Scoring System Is 93% Accurate For Diagnosing Wilson's Disease In Pediatric Patients
01 December 2010An Italian research team confirmed that the scoring system for Wilson's disease (WD) provides good diagnostic accuracy with 93% positive and 92% negative predictive values, respectively in children with mild liver disease...
[read article]

Merck's Frazier Stresses Science, Innovation For Future
By Thomas Gryta
Published December 01, 2010
Dow Jones Newswires
On Wednesday, Frazier highlighted anti-clotting drug vorapaxar that will have late-stage data in mid-2011 and "could have a significant impact on cardiovascular health."
"We believe this could be a very important contributor," he said.
He also talked about hepatitis C drug boceprevir, which has shown success in late-stage trials and may hit the market next year, as being an important new product. He noted that 170 million people world-wide have the liver disease and current treatments are toxic and less effective than boceprevir.
But in order to get new products to the market, Merck will have to work with the Food and Drug Administration.
Frazier praised the agency, noting that it needs more resources in the form of staffing and funding, but he also hinted that the drug review process is becoming a bit too cautious.
Continue reading................

Ex-model loses Hep C payout action
(UKPA) – 5 hours ago
A former model who was infected with hepatitis C after being given a blood transfusion more than 20 years ago has lost her High Court bid to challenge the legality of a Government compensation scheme.
A QC for Sharon Moore said at a recent hearing in London that it appeared the Department of Health was "looking for ways of not making payments" to a whole category of people accidentally given contaminated blood in the mid-1980s during "the worst treatment disaster in the history of the NHS".
Continue reading...........


Researchers Report Surprising AIDS-Treatment Benefits, Prevention Strategy in Epidemic Regions of Africa
Two teams of researchers at UC San Diego and other U.S. and African universities and the World Bank have documented significant spillover benefits of a drug therapy to combat AIDS symptoms and a novel prevention strategy that focuses on girls in Sub-Saharan Africa, an area with two-thirds of the world’s HIV infections.


In Case You Missed It

HCV Advocate Newsletter, December 2010

Messages From Joe:Walkin To Boston from Santa Cruz,Ca. Hepatitis C Awareness/Nov 30th Update

Vertex Completes FDA Submission of Telaprevir New Drug Application

Interim Results Show TMC435 Works Well in Treatment-experienced Hepatitis C Patients

Liver Cancer: Video Understanding SIR-Spheres microspheres - Whats Being Discussed ?

Pharmasset Initiates Dosing in a Combination Study of PSI-7977 and PSI-938 for Chronic Hepatitis C


Top News Headlines

Anti-Microbials Are a Common Cause of Drug-Induced Liver Injury and Failure, Study Suggests
ScienceDaily (Nov. 30, 2010) —
New research shows that anti-microbial medications are a common cause of drug-induced liver injury (DILI) leading to acute liver failure (ALF), with women and minorities disproportionately affected. While ALF evolves slowly, once it does occur a spontaneous recovery is unlikely; however liver transplantation offers an excellent survival rate. Full findings of this ten-year prospective study are published in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases.


Health Forum Sees Sacrifices for Doctors, Insurers - December 01, 2010
(The New York Times News Service) -- Health care costs can't continue to rise rapidly without crippling the state's economy and public services. But efforts to rein them in will require new team-based health care payment and delivery approaches, which would demand sacrifices from hospitals, doctors, and insurers.

Foods May Help Ward Off Cold, Flu - December 01, 2010
(The Atlanta Journal-Constitution) -- The holiday season is upon us, and along with the festive lights and music, we often encounter the not-so-welcome sounds of coughing and sneezing.

Calcium, Vitamin D Changes Suggested - November 30, 2010
(The New York Times News Service) -- A long-awaited report from a panel of independent scientists recommends tripling the amount of vitamin D most Americans should take and small increases in calcium levels for children to build and maintain strong bones, but some specialists warned that the recommendations were flawed.

Public Release: 1-Dec-2010
Journal of Virology
BUSM researchers show an oncolytic virus switches off cancer cell surival signal
Researchers from Boston University School of Medicine have identified a mechanism by which specific viruses acting as oncolytic agents can enter and kill cancer cells. This finding, which is currently featured in an online edition of the Journal of Virology, could help lead to the development of more targeted treatments against many types of cancer. National Institutes of Health

Beyond Stem Cells: Scientists Transform Skin Cells to Nerve, Heart, Blood Cells - November 30, 2010
NEW YORK, N.Y. (Canadian Press) -- Suppose you could repair tissue damaged by a heart attack by magically turning other cells into heart muscle, so the organ could pump effectively again.

Public Release: 1-Dec-2010 American Journal of Human GeneticsResearchers identify gene tied to extremely rare disorder that causes inflammation and loss of fatUT Southwestern Medical Center researchers have identified a gene responsible for a rare disease that results in severe joint stiffness, muscle loss, anemia and panniculitis-induced lipodystrophy, or JMP syndrome. National Institutes of Health

Public Release: 1-Dec-2010 Physics World
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Hepatitis C GI-5005 Vaccine Elicits Immune Response in Some Patients

Hepatitis C Vaccine Elicits Immune Response in Some Patients


By: DIANA MAHONEY, Internal Medicine News Digital Network

BOSTON – A therapeutic vaccine against the hepatitis C virus was associated with a significantly higher sustained virologic response rate when added to standard-of-care treatment, and the findings justify further development of the vaccine, Dr. Paul Pockros reported at the annual meeting of the American Association for the Study of Liver Diseases.
Dr. Paul J. Pockros

In the proof-of-concept trial, 133 patients infected with hepatitis C virus (HCV) genotype 1 were randomized to either triple therapy comprising the experimental GI-5005 vaccine, which is designed to elicit a T-cell response specific to HCV, along with pegylated interferon alfa-2b plus ribavirin (P/R), or the standard P/R therapy alone.


The primary outcome measure was sustained virologic response (SVR), defined as undetectable HCV RNA at 6 months after treatment, said Dr. Pockros of the Scripps Clinic in La Jolla, Calif.
The 68 patients in the experimental group initially received monotherapy with the vaccine, consisting of five weekly injections followed by two monthly injections for a 12-week lead-in period, before progressing to the standard-of-care P/R treatment and once-monthly injections. The 65 patients in the control group received standard-of-care P/R treatment alone.


In both groups, the treatment duration was 48 weeks for treatment-naive patients and 72 weeks for those who had a poor or partial response to prior P/R treatment, said Dr. Pockros. Patients in whom prior P/R therapy induced no notable decrease in HCV viral load, as well as those in whom prior treatment initially resulted in undetectable HCV RNA followed by a viral rebound, were excluded from the analysis.


Among the study’s treatment-naive patients, 58% of those who received the vaccine achieved SVR, compared with 48% of those who received P/R alone. Among the prior poor and partial responders, the respective SVR rates in the vaccine and control groups were 17% and 5%, Dr. Pockros reported.


"There was a slight benefit in the treatment-naive and nonresponders, [but] this was numerical only and was not statistically significant," he said. However, the overall benefit in the vaccine vs. control groups was statistically significant, with respective SVR rates of 47% and 35%, he noted.
The vaccine strategy appears to be safe. "The most common associated adverse events were mild, transient injection-site reactions," said Dr. Pockros. Additionally, he stated, "the discontinuation rates due to adverse events were comparable [13%] in both the triple-therapy and standard-of-care arms."


Of particular interest, Dr. Pockros noted, was the T-cell response in a subgroup of difficult-to-treat patients receiving the vaccine. Previous studies have suggested that patients carrying the T allele of the IL28 gene are at high risk of treatment failure with the standard interferon-based therapy. The T-cell response in vaccine-treated patients, as measured by interferon-gamma enzyme-linked ImmunoSpot assay, "mimicked what we saw with a virologic response," he said.
"Four of five T/T allele patients had a T-cell response – one did not actually get treated – but none of the patients who received standard of care had a T-cell response."


This finding is consistent with the hypothesis that the GI-5005 vaccine corrects a fundamental deficit in cellular immunity in IL28B T/T genotype patients, he said. Although the findings need to be confirmed in additional studies with larger patient populations, the vaccine will likely be genotype specific, he noted.


Because the immune response is similar to that observed in HCV-infected patients who are able to clear the virus without treatment, future studies will evaluate the efficacy of monotherapy with the vaccine in genotype-specific patients, Dr. Pockros said.
The proof-of-concept study was funded by GlobeImmune, manufacturer of the vaccine. Dr. Pockros disclosed financial relationships with GlobeImmune, Genentech, Vertex, Merck, Gilead, Abbott, Pfizer, Phenomix, Tibotec, Pharmasset, 3RT, Novartis, Johnson & Johnson, Achillon, Regulus, Debio, Zymogenetics, and Human Genome Sciences.

http://www.internalmedicinenews.com/news/infectious-diseases/single-article/hepatitis-c-vaccine-elicits-immune-response-in-some-patients/4f49d68bff.html

Compare drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma

Also See Hepatitis C News: FDA Approves Merit Phase 3 clinical trial protocol to treat primary liver cancer

Recently, Merit Medical Systems (MMSI) received approval from the US Food and Drug Administration (FDA) for the phase III clinical trial protocol to treat primary liver cancer with QuadraSphere microsphere for delivery of doxorubicin.

The approval is significant since the late-stage study in the US will be the first to compare drug-eluting microspheres to conventional chemoembolization (cTACE) in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. At present, according to Merit Medical, there is no FDA-approved embolic for the treatment of liver cancer in the US.
QuadraSphere is indicated for embolization of hypervascular tumors and peripheral arteriovenous malformations. While QuadraSphere has a long way to go before receiving the US approval, a similar product, HepaSphere is marketed in Europe since 2007 for embolization of HCC and hepatic metastases.

The phase III study is aimed at investigating HepaSphere/QuadraSphere microspheres for delivery of doxorubicin to treat HCC. While survival is the primary end-point of the study, secondary end-points include tumor response by mRECIST criteria, safety, resource utilization and adverse events. Approximately 500 patients are expected to be enrolled for the study at clinical sites across the US, Europe and South America.

Merit Medical had included microsphere products to its line of tumor treatment options with the acquisition of BioSphere Medical which was completed in September 2010. Through this acquisition, the company gained access to BioSphere's embolotherapy technology platform. This technology finds applications in treating uterine fibroids and primary liver cancer, representing a global market potential of $650 million and $380 million, respectively.

Viewing the untapped potential in the liver cancer market, it is expected that successful commercialization of microspheres in the US will be beneficial to Merit Medical over the long term. While liver cancer is the third leading cause of cancer deaths globally, its occurrence has increased with rise in hepatitis C infections, alcohol consumption and obesity.
Although liver transplantation or tumor resection is considered a curative treatment; only 25% of liver cancers are diagnosed when they can be treated surgically. It has been witnessed that in cases where surgery is not a viable option, TACE has shown promising results.

Read more: http://www.benzinga.com/10/11/654602/good-news-for-merit-medical-analyst-blog#ixzz16q5PxdFI