Friday, October 7, 2011

HCV News Ticker; Hepatitis C Virus May Increase The Risk Of Brain Disorders And Death In People With HIV

Hepatitis News Ticker

AngioDynamics Completes Enrollment

Therapeutic and diagnostic devices maker AngioDynamics reported that it has completed the patient enrollment for the European clinical trial of its popular tumor-zapping NanoKnife system for the treatment of hepatocellular carcinoma (“HCC”), the most common type of liver cancer.

The European trial has been designed to assess the safety and efficacy of the NanoKnife System in treating early-stage HCC. The multi-center, company-sponsored trial includes 26 patients from 5 European sites.

Patients with one-to-three tumors with sizes not more than 3 centimeters (or roughly 1.18 inches) have been considered eligible for the study. These patients are allowed one re-treatment with the NanoKnife System.

Hepatocellular carcinoma affects more than 500,000 people globally every year. Major risk factors for the condition includes infection with hepatitis B (“HBV”) and hepatitis C (“HCV”). Despite advancements in therapy, one-year survival rates remain below 50%.

AngioDynamics is a leader in therapeutic and diagnostic devices for treating peripheral vascular and other non-coronary diseases. It has market leading positions in several of its operating segments including angiographic products and thrombolytic catheters.

The company’s focus on interventional peripheral products has allowed it to expand its share as the market continues to shift from open surgery to less invasive interventional procedures.

NanoKnife remains the life blood for AngioDynamics and it is seeking to expand the label to broaden its commercial opportunity. The company is ramping up R&D investments to support the ongoing clinical studies of NanoKnife and vascular product development programs.

However, AngioDynamics is exposed to pricing headwinds, stemming from lower selling prices of some access and peripheral vascular products. Moreover, its product lines face strong challenges from the competitive offerings of its larger rivals such as Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR). We are also cognizant about the dilutive impact of higher R&D spending on the company’s bottom line. We are currently Neutral on the stock.

New clues to how body fights viruses

Researchers have determined the structure of a protein that is the first line of defense in fighting viral infections, including influenza, hepatitis C, West Nile, rabies, and measles.

The finding is key to developing broad-based drug therapies to combat viral infections, say author of the study published in the journal Nature.

“Understanding innate immunity to viral infections is crucial to developing drugs that can fight viruses or control inflammation,” says Joseph Marcotrigiano, assistant professor of chemistry and chemical biology at Rutgers. “Having this foundation is extremely important.”

Read the original study

DOI: 10.1038/nature10537

Marcotrigiano and Smita Patel, professor of biochemistry at Robert Wood Johnson Medical School, are principal investigators on the study.

RIG-I is a receptor protein that recognizes differences in molecular patterns in order to differentiate viral RNA—the process during which virus particles makes new copies of themselves within a host cell and can then infect other cells—from cellular RNA.

Scientists discovered that viral RNA, as opposed to single-stranded cellular RNA, is a double-stranded structure. This double-stranded difference is the reason the RIG-I protein recognizes it and initiates a signal to induce anti-immune and anti-inflammatory defenses within the cell.

Prior to this research, there was little understanding on how RIG-I protein recognized the viral infections, says Patel. Knowing that it is due to the double-stranded molecular structure of the viral RNA is critical because, he says, “a failure of RIG-I to identify viral RNA can lead to alterations of the cell, including cell death, inflammation, autoimmune diseases, and cancer.”

This is a first step, the scientists say, in helping to develop therapies that interfere with a broad variety of viral infections—a major breakthrough for millions of people who get sick from viruses which cannot be treated effectively by current medication.

“This work provides unprecedented insights on the molecular mechanism of viral RNA recognition by RIG-I,” says Barbara Gerratana, who oversees enzyme catalysis grants at the National Institute of General Medical Sciences of the National Institutes of Health. “As a result, we have a deeper understanding of how the human body fights viral infections and a structural basis of the development of new anti-viral therapeutics.”

More news from Rutgers:


CCO offers insight to patients who are embarking on HCV therapies. The format is an interactive CME "CME stands for Continuing Medical Education" and requires free registration. Other topics at Clinical Care Options -CCO can be found here.


Strategies to Maintain Quality of Life and Minimize Adverse Events in Patients Receiving Hepatitis C Therapy

Topics covered include:
  • Impact of HCV on Health-Related Quality of Life
  • Clinical Trial Results With Telaprevir or Boceprevir Plus Peginterferon and Ribavirin
  • Drug-Drug Interactions
  • Strategies for Preparing Patients for Treatment and the Challenge of Adherence
  • Strategies for Management of Adverse Effects and Quality-of-Life Issues

Chronic Liver Disease in the Hispanic Population of the US
What types of liver diseases are more common in the Hispanic population of the US, and is there an explanation for their prevalence?
Clinical Gastroenterology and Hepatology
, October 2011


Study uncovers why anti-rejection drugs for transplant patients cause hypertension

A group of researchers led by scientists at Oregon Health & Science University has discovered the process that may be causing side effects caused by the anti-rejection drugs given to organ transplant patients. The discovery means those side effects likely can be dealt with much more cheaply and easily....
National Institutes of Health, US Department of Veterans Affairs, Dutch Kidney Foundation, Erasmus University

Lifetime probabilities of needing an organ transplant vs donating an organ
A study in the most recent issue of the American Journal of Transplantation investigates lifetime probabilities of needing an organ transplant vs donating an organ after death.
The lifetime probabilities of becoming a deceased organ donor and requiring or receiving an organ transplant are unknown.

An actuarial analysis was performed in a representative Canadian sample.
Dr Sam Shemie and colleagues from Canada used Canadian organ donation data from 1999 to 2007, provincial waiting list and population census data, actuarial rates were produced that provide the probabilities, by age band and gender, of becoming a deceased organ donor, needing an organ transplant, and receiving all organs needed.
Regardless of age, the lifetime probability of needing a transplant for males is approximately twice that of females.

Depending on age, Canadians are 5 to 6 times more likely to need an organ transplant than to become a deceased organ donor.

The lifetime probabilities of not receiving a required organ transplant, expressed as a percentage of individuals on the waiting list, ranges from approximately 30% at birth, 20 years and 40 years to approximately 40% at 60 years.

Across provinces and genders, Canadians at all ages are much more likely to need an organ transplant than to become an organ donor.
Approximately one-third of those in need of a transplant will never receive one. How this information may influence organ donation decisions is currently under study.
Am J Transplant 2011: 11(10): 2085–2092 07 October 2011

Presumed Consent Plan: Wales Supplies More Organ Donors
(BBC News, online, October 4, 2011)
"A University of Ulster team has found Wales consistently supplies more donors and donations than other UK nations. But they say that laws on presumed consent across Europe show mixed results and need further research…The Ulster team analysed data from NHS Blood & Transplant for all four UK countries between 1990 to 2009, and compared data on registration and donation from other European countries…The authors recommended more research on the issue of presumed consent, which would mean people would have to opt out of becoming donor, or their organs may be used. The Welsh government is proposing to introduce the system with a proviso that family members should be consulted…Spain was found to have doubled organ donation rates with a such a system of 'soft' presumed consent, but Sweden -- which presumes consent -- had a similar rate to Germany and Denmark where informed consent operates, as in the UK."....

Cord blood transplants

Better Cord-Blood Match Improves Transplant Survival

By Michael Smith, North American Correspondent, MedPage Today
Published: October 07, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.
Transplant-related deaths can be markedly reduced if recipients and donors of umbilical cord blood are better matched than they currently are, researchers reported...


Hepatitis C Virus May Increase The Risk Of Brain Disorders And Death In People With HIV

Results from a recent study indicate that brain disorders, particularly epilepsy and seizures, are more common in HIV-positive patients with hepatitis C virus than in patients with HIV alone. The risk of death was also higher for these individuals.

However, the researchers noted that the use of illegal drugs, which was more common in participants with hepatitis C and is linked to increased seizure risk, could have affected the study results. They suggested that studies of patients with hepatitis C only and hepatitis C patients without past illegal drug use would help determine the impact of the virus on the nervous system....


Association between tamoxifen treatment and diabetes

View abstract here

Breast cancer drug tied to diabetes in older women

NEW YORK | Thu Oct 6, 2011 1:27pm EDT

NEW YORK (Reuters Health) - Older women taking the breast cancer drug tamoxifen may have an increased risk of developing diabetes, a new study suggests.

The findings, reported in the journal Cancer, do not prove that tamoxifen directly leads to diabetes in some women.

But researchers say it is plausible that in women with known risk factors for diabetes -- like obesity or family history of the disease -- tamoxifen furthers the risk somewhat.

The study, of more than 14,000 breast cancer survivors age 65 and up, found that 10 percent were diagnosed with diabetes over five years.

Those odds were one quarter higher among women who were currently on tamoxifen, versus those who were not. (Women prescribed tamoxifen for breast cancer typically take it for five years.)

That increase is small and the findings should not "alarm" women taking tamoxifen, said study leader Lorraine L. Lipscombe, of Women's College Hospital and the University of Toronto in Canada.

"Tamoxifen is a very important drug," Lipscombe said in an interview. "I don't want women to think they should stop taking it."

And if tamoxifen does affect the odds of developing diabetes, it may only do so in certain women, according to Lipscombe.

She and her colleagues speculate that tamoxifen may boost diabetes risk in women already predisposed to the disease.

Tamoxifen, sold in the U.S. as Nolvadex and Soltamox, works by inhibiting the hormone estrogen. And animal research suggests that estrogen plays a role in blood sugar control. Adult-onset, or type 2, diabetes arises when the body can no longer properly use the hormone insulin, which regulates blood sugar.

So in theory, tamoxifen's effects on estrogen may add to any problems in blood sugar regulation.

Still, this is the first study to show a link between tamoxifen and diabetes. "So we definitely recommend that more studies be done," Lipscombe said.

And that, she noted, should include studies of younger women to see if the same association exists for them.

For now, she said, women on tamoxifen may want to pay particular attention to controlling any of the established diabetes risk factors they may have. That includes maintaining a healthy weight through a balanced diet and exercise -- "just like any other woman should," Lipscombe noted.

The researchers did find that women who had used tamoxifen in the past, but not currently, were at no increased risk of diabetes.

"We did not see the risk persist after women stopped taking the drug," Lipscombe said.

Nor did the researchers see a connection between diabetes and another class of breast cancer drugs called aromatase inhibitors -- which also inhibit estrogen, though by a different mechanism than tamoxifen.

Lipscombe said it's possible that the lack of a link is due to the fact that few women in the study were using an aromatase inhibitor. More studies are needed to answer that question too, she said.

If tamoxifen does increase the risk of diabetes, it would not be the only side effect of the drug. It is known to carry small risks of blood clots, stroke, uterine cancer and cataracts, according to the U.S. National Cancer Institute.

However, the agency says, the benefits of tamoxifen in treating breast cancer are "firmly established and far outweigh the potential risks."

Tamoxifen is the drug of choice for women with early-stage breast tumors that are estrogen-receptor-positive -- meaning the hormone fuels their growth. Those tumors account for about 70 percent of breast cancer cases.

Along with treating cancer, tamoxifen is sometimes prescribed to lower breast cancer risk in women at higher-than-average risk of the disease.

FDA approves Merck's new diabetes therapy combo
By Alina Selyukh
Fri Oct 7, 2011 1:23pm EDT
Reuters - U.S. health regulators approved a new combination therapy for type 2 diabetes from Merck & Co, the first to combine a diabetes drug with cholesterol-lowering medicine in one tablet.
Merck's new drug Juvisync combines the drugmaker's diabetes medicine Januvia, which helps lower high blood sugar levels, with simvastatin, a commonly prescribed statin that helps lower cholesterol alongside diet and exercise.
About 20 million Americans have type 2 diabetes, and many of them also have high cholesterol levels. The conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, especially if left untreated or poorly treated, the Food and Drug Association said.
For Merck, this is a chance to boost sales of Januvia, generically known as sitagliptin, whose sales rose 30 percent to $779 million in the second quarter.

The American Diabetes Association guidelines recommend statin therapy for anyone who has both diabetes and cardiovascular disease, regardless of cholesterol levels. They also recommend statins for anyone older than 40 with diabetes and with cardiovascular disease risk factors, such as high blood pressure.
Merck's experts have estimated that 6 million to 8 million of the type 2 diabetics who should be on a statin have not been receiving that therapy -- a gap that the company hopes to fill with the single-tablet Juvisync.
"Although clinical guidelines put people with diabetes at the same risk level as those with coronary heart disease, nearly 40 percent of eligible patients do not receive statin treatment," Dr. Barry Goldstein, Merck's vice president for diabetes and endocrinology, said in a statement. "We are proud to bring forward a treatment option that can help address this important health issue."
The FDA on Friday approved the combination in several dosage strengths.
The most common side effects of Juvisync include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation and nausea, regulators said.

Merck will now have to conduct a post-marketing clinical trial to compare how Januvia lowers glucose alone compared to its combination with simvastatin, the FDA said.
Merck's shares were up 1.5 percent at $31.88 in afternoon trading on the New York Stock Exchange.

Approved in 2006, Januvia was the first FDA-backed member of a new class of drugs called DPP-4 inhibitors that enhance the body's ability to lower elevated blood sugar. It has previously been coupled with another diabetes drug, metformin, and sold under the brand name Janumet. Merck's second-quarter sales of Janumet reached $321 million.
(Reporting by Alina Selyukh in Washington; additional reporting by Ransdell Pierson in New York and Anna Yukhananov in Washington; editing by John Wallace and Matthew Lewis)


Drugmakers Lose Another Hepatitis C Trial
For the second time in a year and a half, Teva Pharmaceuticals and Baxter Healthcare have a lost a trial in which a jury determined they contributed to a 2008 hepatitis outbreak in Nevada due to the way the Propofol medication was marketed. Another defendant was McKesson, the big distributor. The jury awarded three people a total of $20 million, although punitive damages are not yet decided...

Consumer & Food Safety

Long Road from Farm to Fork Worsens Food Outbreak

(The Associated Press, October 3, 2011)
"The recent listeria outbreak from cantaloupe demonstrates one likely cause of large-scale occurrences of serious illnesses linked to tainted food: the long and winding road what we eat takes from farm to fork. A cantaloupe grown on a Colorado field may make four or five stops before it reaches the dinner table. There's the packing house...then the distributor...A processor...The retail distribution center...Finally it's stacked on display at the grocery store. Imported fruits and vegetables, which make up almost two-thirds of the produce consumed in the United States, have an even longer journey…'The food chain is very complex,' says Sherri McGarry, a senior adviser in the Food and Drug Administration's Office of Foods. 'There are many steps, and the more steps there are the harder it can be to link up each step to identify what the common source' of an outbreak is."...

New On The Blog

Published in the Aug edition of Modern Medicine

Treatment of chronic hepatitis C: The new standard of care for the future

Published @J Gastrointestin Liver Dis. 2011 Sep;20(3):293-8.
Response to Standard of Care Antiviral Treatment in Patients with HCV Liver Cirrhosis – a Systematic Review

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