Wednesday, December 21, 2011

Hepatitis C News Ticker-Implications of rapid virological response in hepatitis C therapy in the US veteran population

'Reading Young Man' by Ignat Bednarik.)

Majority of new HIV, tuberculosis and hepatitis B cases are found in immigrants coming to live in Britain

75% of TB cases reported last year were born abroad
Almost two-thirds of HIV cases and 80% of hepatitis B cases were found in immigrants

By Jenny Hope

Last updated at 10:52 AM on 21st December 2011
High rates of tuberculosis, HIV and hepatitis B are found in migrants coming to live as long-term residents in Britain, according to a report.
Three-quarters of tuberculosis cases reported in Britain last year were born abroad, with many diagnosed two or more years after their arrival.
Almost two-thirds of newly diagnosed cases of HIV and 80 per cent of hepatitis B infected blood donors in 2010 were born abroad.....

Implications of rapid virological response in hepatitis C therapy in the US veteran population
The latest Alimentary Pharmacology & Therapeutics investigates the implications of rapid virological response in hepatitis C therapy in the US veteran population.

Implications of rapid virological response in hepatitis C therapy in the US veteran population.

Early predictors of response to hepatitis C virus (HCV) therapy, such as rapid virological response, are valuable for the identification of patients with a higher likelihood of treatment success.

Dr Hwang and colleagues from California, USA identified predictors of rapid virological response in a real world setting.

Using the VA Clinical Case Registry, the researchers identified patients with HCV mono-infection, without liver transplantation, who initiated peginterferon and ribavirin in 2007 or 2008, and had HCV RNA testing for rapid virological response.

Significant baseline characteristics from genotype specific univariate analyses were used in backwards stepwise models to identify significant independent predictors of rapid virological response.

The final cohort consisted of 2424 patients with genotype 1666 patients with genotype 2, and 419 patients with genotype 3.

Sustained virological response rate increased from 40% to 60% in genotype 3
Alimentary Pharmacology & Therapeutics
Rapid virological response rates were 15% for genotype 1, 71% for genotype 2, and 57% for genotype 3.

The team found that sustained virological response rates were significantly higher in patients with rapid virological response than without, increasing from 18% to 52% in genotype 1, 39% to 71% in genotype 2, and 40% to 60% in genotype 3.

A baseline HCV RNA less than 500,000 IU/mL positively predicted rapid virological response across all genotypes studied.

In addition, for G1, the team identified that Black race, Hispanic ethnicity, aspartate aminotransferase/alanine aminotransferase (AST/ALT) 0.6 or more, ferritin 350 ng/mL or more, LDL less than 100 mg/dL and diabetes.

For genotype 2, the team BMI 30 kg/m(2) or more, platelets less than 150 K/μL, LDL less than 100 mg/dL, and the use of PEG-interferon alfa-2b.

For genotype 3, AST/ALT 1.0 or more, all negatively predicted rapid virological response.

Dr Hwang and team commented, "We found several novel independent predictors of rapid virological response, including BMI, AST/ALT ratio, ferritin, platelets, LDL, diabetes and type of PEG-interferon prescribed, which may be useful in guiding treatment decisions in routine medical practice.
Aliment Pharmacol Ther 2012: 35(1): 105-15
21 December 2011

Stem Cells

New discovery of adult stem cells

Researchers a the Victor Chang Cardiac Research Institute in Sydney have discovered new adult stem cells in the heart, which could help people who have suffered a heart attack or heart failure.

Stem cell technology

Stem cell researchers at the University of Glasgow are working on the heart muscle, arteries and blood, to avoid the need to rely so heavily on people donating blood.

The King is Dead, Long Live the King: Entering A New Era of Stem Cell Research and Clinical Development
In mid November the biopharma industry was shocked by the announcement from Geron that they were ending work on embryonic stem cell research and therapy. For more than 10 years the publicimage of all stem cell research has been equated with embryonic stem cells. Unfortunately, a fundamentally important medical and financial fact was being ignored: embryonic stem cell therapy extremely immature..Continue reading..

Liver: Stem Cell Updates and News 2011
Top 10 stem cell predictions for 2012: Science, CIRM, ACT, trends
Stem Cell Awards for 2011

What Organ Shortage? Just Make Your Own! Stem Cells and Organ Engineering
Includes the liver, the history of stem cells, and more.

Healthy You

HCV Management Pearl: Teeth Grinding and Its Aggravator

When under stress, some people grind their teeth. Though, there are several more reasons those with Hep C are vulnerable to and more prone to complications of teeth grinding.

by Nicole Cutler, L.Ac.

A significant percentage of those living with chronic Hepatitis C infection find themselves dealing with an array of oral health challenges. Bruxism, otherwise known as grinding, gnashing or clenching the teeth is a common habit that can be especially problematic for those managing the Hepatitis C virus (HCV). To protect yourself from the potential pitfalls of bruxism, make sure you know what makes it worse, what to look out for and how to put an end to this tension-building, potentially harmful habit...Continue reading..

Is a cure for the common cold on the way?
In the northern hemisphere, cold and flu season is upon us. But the coughing, wheezing and spluttering masses that hit the streets each winter could, some scientists hope, soon be a thing of the past.

The reason for this optimistic thought is the progress being made towards the creation of a drug known as an antiviral.

Just as antibiotics kill many different types of bacteria, antivirals could kill multiple viruses, from the ubiquitous cold and flu to the life-threatening hepatitis virus and HIV. They could even prove crucial in the case of viral epidemics like Sars and bird flu.

Existing antiviral drugs are tailored to specific diseases - HIV, hepatitis and certain types of flu for example. Vaccinations are also very virus-specific and have to be redeveloped at great cost as a virus evolves.

But Todd Rider, a research scientist at the Massachusetts Institute of Technology, is developing an antiviral drug called Draco, which has proven successful against all 15 viruses to which it has been applied in lab trials with human tissue and mice.

These include the common cold, H1N1 or swine flu, a polio virus, dengue fever and the notorious and fatal Ebola virus.

To produce it, Mr Rider took an unusual approach, "wiring together" two natural proteins - one that detects virus entry, and another that acts as a suicide switch that kills the infected cell.

"I studied both biology and engineering back in the dark ages and really wanted to combine those studies," he says.

"Everyone in both departments thought I was crazy."

The dream of a broad-based antiviral drug has for years been a holy grail for microbiologists.

Recent developments in biotechnology - especially the ability of computers to analyse reams of information on DNA and the genetic make-up of viruses - has allowed for great leaps in scientific understanding of how these micro-organisms work.

This has brought a few researchers closer to the goal of a broad-based antiviral, targeting the problem in several different ways.

Last year, a breakthrough study at Cambridge University showed that cells have an internal system which fights and kills viruses. It was previously thought that once a virus succeeded in entering a cell, infection was inevitable.

Dr Leo James, the author of this study, is now working on creating antiviral drugs that can latch on to a virus and destroy it inside the cell.

At Mount Sinai Medical School in New York, Professor Peter Palese has developed an antiviral drug that has so far proven very successful against influenza, though less so against other viruses.

And in a laboratory at the other side of the US, Dr Benhur Lee stumbled across a drug that seemed to be effective against several viruses including various pox viruses and Ebola. He soon realised it only worked against viruses that shared a distinct characteristic, a greasy outer membrane or lipid envelope.

Dr James maintains some scepticism about Mr Rider's study.

"It is potentially very exciting but because the results are so unusual and because it was published in an unusual journal it needs to be proven by others," he says.
PLoS One, the online journal which published the paper, does not have the peer review system used by other journals and encourages ideas that challenge established thinking.

Mediterranean diet gives longer life
A Mediterranean diet with large amounts of vegetables and fish gives a longer life. This is the unanimous result of four studies to be published by the Sahlgrenska Academy at the University of Gothenburg. Research studies ever since the 1950s have shown that a Mediterranean diet, based on a high consumption of fish and vegetables and a low consumption of animal-based products such as meat and milk, leads to better health.

Study on older people

Scientists at the Sahlgrenska Academy have now studied the effects of a Mediterranean diet on older people in Sweden. They have used a unique study known as the "H70 study" to compare 70-year-olds who eat a Mediterranean diet with others who have eaten more meat and animal products. The H70 study has studied thousands of 70-year-olds in the Gothenburg region for more than 40 years.

Chance of living longer

The results show that those who eat a Mediterranean diet have a 20% higher chance of living longer. "This means in practice that older people who eat a Mediterranean diet live an estimated 2 3 years longer than those who don't", says Gianluca Tognon, scientist at the Sahlgrenska Academy, University of Gothenburg.

Support in other studies

These results are supported by three further as yet unpublished studies into Mediterranean diets and their health effects: one carried out on people in Denmark, the second on people in northern Sweden, and the third on children.

"The conclusion we can draw from these studies is that there is no doubt that a Mediterranean diet is linked to better health, not only for the elderly but also for youngsters", says Gianluca Tognon.

Italian background

Gianluca Tognon himself is from Italy, but moved to Sweden and Gothenburg specifically to collaborate with Lauren Lissner's research group at the Sahlgrenska Academy, and develop research into the Mediterranean diet.

UNESCO has recognised the Mediterranean diet as an intangible cultural heritage. UNESCO states that the Mediterranean diet is based on such items as fish, vegetables, nuts and fruit, but the concept includes also a structure of traditional customs in which knowledge is transferred between generations, giving a feeling of communal identity and continuity to the local population.

Related-AASLD-The Mediterranean Diet Improves Liver Health

Big Pharma

Health Care's Hottest Duo

The following video is part of our "Motley Fool Conversations" series, in which Brendan Byrnes, industrials editor and analyst, and David Williamson, health-care editor and analyst, discuss topics around the investing world.

In today's edition, they discuss the two performers in health care for 2011. Both companies have exciting hepatitis C drug candidates catching the attention of Big Pharma. Gilead purchased Pharmasset for $11 billion, a 59% premuim over the company's all-time high.

There's a race among major drugmakers to obtain the most effective next-gen combo drug treatment to eliminate hep-C. Investors are looking for more M&A, as shares of Inhibtex and Achillion have been bid up recently.

View Video here

Doctor, salesman sentenced in US insider cases


"The tip Benhamou gave Skowron helped his funds avoid $30 million of losses because they sold their Human Genome stake before the company revealed problems with its experimental hepatitis C treatment in January 2008."

NEW YORK, Dec 21 (Reuters) - A French doctor and a California sales manager were the latest to be sentenced following convictions in a recent U.S. government crackdown on insider trading at hedge funds.

Yves Benhamou, was sentenced to time served and three years supervised release on Wednesday after he cooperated with an insider trading probe and pleaded guilty to leaking secrets to a hedge fund manager about biotech company Human Genome Sciences Inc. Benhamou served as an adviser on a clinical drug trial.

And in a separate case, a former Silicon Valley sales manager, James Fleishman, was sentenced to 2-1/2 years imprisonment and two years supervised release for helping to ferry leaks to hedge funds. That included confidential information such as revenues or margins from executives at companies, including Advanced Micro Devices Inc and Dell Inc.

In imposing Fleishman's sentence, U.S. District Judge Jed Rakoff emphasized the need for deterrence. He said prosecutors in New York had been bringing insider trading cases for 30 to 40 years "and yet the prosecutions have not done enough to deter this serious and sophisticated crime."

Fleishman, 42, used to work for Primary Global Research, a so-called expert networking firm. He was convicted by a jury at trial in September on charges of conspiracy to commit securities fraud and conspiracy to commit wire fraud. He did not testify and he did not address the court at sentencing.

In the last two years, dozens of people have been charged in New York with crimes related to insider trading, pleaded guilty or been convicted at trial.

The stiffest prison term handed down so far was 11 years for Galleon hedge fund founder Raj Rajaratnam in October. Rajaratnam was the principal figure charged by federal prosecutors. Another principal defendant, former trader Zvi Goffer was sentenced to 10 years imprisonment.

Benhamou, an infectious diseases expert, was credited during his sentencing in Manhattan federal court with being crucial to the prosecution of one of the most prominent hedge fund managers to become embroiled in an investigation of illegal stock tips solicited from consultants.

He is Joseph "Chip" Skowron, who ran healthcare funds at FrontPoint Partners. Skowron was sentenced to five years imprisonment in November. Skowron, 42, a doctor-turned-stock picker, pleaded guilty to trading in the stock of HGSI on nonpublic information he received from Benhamou.

"I can't find the words to express how sorry I am and how much regret I feel," Benhamou, 51, told U.S. District Judge George Daniels as his wife, brother and other relatives looked on.

Benhamou said his crime had "devastating consequences" for his family and compromised the health of his patients at a public hospital in Paris, some of whom have HIV or AIDS.

Benhamou spent 24 days in jail after his November 2010 arrest. He also spent about nine months confined to an apartment in New York separated from his wife, two daughters, parents and siblings in France, his lawyer, David Zornow, told the court.

The judge said he would have sent Benhamou to prison if it had not been for his extensive cooperation in prosecuting Skowron. He ordered Benhamou to forfeit $52,138 and ordered him to pay $5.9 million in restitution.

According to court records, Skowron bribed Benhamou. The men met at a hotel in Barcelona in April 2007 and Skowron gave him an envelope with about 5,000 euros in cash. A few months later, he paid for a $4,624 hotel stay for Benhamou and his wife in New York.

After getting the tip about Human Genome and telling Benhamou to lie to regulators probing the sale, Skowron passed on an envelope with at least $10,000 in cash when the men met in a hotel bar in Milan in April 2008, prosecutors said.

The case is USA v Benhamou, U.S. District Court for the Southern District of New York, No. 11-00336.

For USA: David Massey of the U.S. Attorney's Office.

For Benhamou: David Zornow of Skadden, Arps, Slate, Meagher & Flom.

(Reporting by Grant McCool)

Follow us on Twitter: @ReutersLegal

Interview: Vertex CEO concerned about investors' 'hyper-focus' on hep C

On the heels of Vertex Pharmaceuticals' ($VRTX) big news last week about changing CEOs next year, FierceBiotech chatted with both current chief executive Matt Emmens and his successor Dr. Jeffrey Leiden. Both Emmens and Leiden are heavyweights in the biopharma industry, with hugely successful drug launches under their belts.

Here's an edited version of FierceBiotech's conversation with Emmens and Leiden on Tuesday:

FierceBiotech: What has been your biggest mistake as CEO of Vertex?

Emmens: You ask tough questions, you know that [laughing]. I don't see any mistakes. I don't know if I'd do anything different. People are going to second-guess a lot of things. But when you look retrospectively at things, without all the information, that's easy to do. When you're there, the decisions that you have to make at the time have quite a different face on them. I don't think I would have done anything differently knowing what I knew then. Knowing what I know now, yeah, in the drug industry I think I would have gone back and bought Genentech when it was three people.

FierceBiotech: What's your biggest concern about Vertex's business heading into 2012?

Emmens: My biggest concern is the way it's perceived by some in the investment community. I think you have a company here that has the best pipeline that I've ever seen in any company in terms of numbers of projects that are successfully proven in man and in a time frame that's not 15 years out. You see, basically, 8 projects here that could all be on the market by [2017], and you see three or four that could be on the market by [2015]. That's very nice, I think. The hyper-focus on hepatitis C has taken people's focus away from that. And I think on top of that, in hepatitis C, we've got a number of projects that could put us in an all-oral regimen in the time frame of [2014]. That's being overlooked.

FierceBiotech: Do you see yourself being a biopharma CEO again after you leave your executive role at Vertex in May?

Emmens: No. I've been working since I was 11 years old. I retired once from Shire, as you probably know. I was on the board here at Vertex and I saw a unique opportunity to use my skill set at a time that the company needed it. I would not be willing to do that for the long term again. I'll be happy to be on boards and advise and help people who are earlier in their career be successful... Continue reading .......

Massachusetts recovers $24 million from Merck, in its largest Medicaid fraud settlement ever

Merck & Co. has agreed to pay $24 million to the state Medicaid program to settle long-running civil charges that it charged too much for some drugs, in the largest single-case Medicaid fraud settlement in Massachusetts history.

The agreement, unveiled yesterday by Attorney General Martha Coakley’s office, closes out a 2003 lawsuit filed against 13 drug makers over inflated prices for medicines that were sold in pharmacies...Continue reading..

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