HCV New Drugs

Cell Transplantation Reports A Success In Treating End-Stage Liver Disease
Posted on: Tuesday, 11 January 2011, 14:03 CST
Transplanting their own (autologous) bone marrow-derived stem cells into 48 patients with end-stage liver disease resulted in therapeutic benefit to a high number of the patients, report researchers publishing in the current issue of Cell Transplantation (19:11). Yet, the mechanism by which the infusion of CD34+ stem cells improves liver function remains elusive, they say.
The study, carried out by a team of researchers in California and in Egypt, is now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.

According to the study's corresponding author, Dr. Mark A. Zern of the University of California Davis Medical Center, Sacramento, CA, patients with end-stage liver failure in Egypt have few treatment options but for transplantation. A shortage of donors and cost factors make that strategy unrealistic. Accordingly, this study sought to evaluate the safety and efficacy of transplanting autologous bone marrow-derived CD34+ stem cells in 48 patients, 36 of whom had chronic, end-stage hepatitis C-induced liver disease, and 12 with end-stage autoimmune liver disease.
"For all patients there was a statistically significant decrease in peritoneal cavity fluid, or 'ascites,'" said Dr. Zern. "There was also clinical and biochemical improvement in a large percentage of patients who received the transplantation."

Just In On The Blog: Reality Check: The Outsourcing Of Clinical Trials/Drugs

Social Class And Changes In Mortality From Liver Cirrhosis Over The 20th Century
11 January 2011A paper describing a dramatic change during the 20th century in England and Wales in the association between social class and mortality from liver cirrhosis features in Alcohol and Alcoholism

The Hepatitis C Trust Welcomes New Response To 'The Worst Treatment Disaster In The History Of The NHS'
11 January 2011The review of compensation for people infected with hepatitis C through contaminated NHS blood has been welcomed by The Hepatitis C Trust. Responding to the statement from Health Secretary Andrew Lansley, Charles Gore, Chief

SoCal Health Clinic Patients Possibly Exposed To Hepatitis, HIV
An unidentified nurse is believed to have contaminated the IV line.
SAN PEDRO ( KTLA) -- A contaminated IV line is being blamed for a patient contracting Hepatitis C at a San Pedro health clinic.Officials are urging patients of the Advanced Pain Treatment and Medical Center who were treated between Jan. 16, 2006 and Aug. 18, 2010 to get tested for Hepatitis B, Hepatitis C and HIV.An unidentified nurse is believed to have contaminated the IV line that was improperly administered.The nurse, who is no longer administering IVs, is still working at the clinic.A second case, involving a patient contracting Hepatitis B, has also been linked to the clinic.

Niamh Coyne Home for Christmas, Fourth Birthday After Second Liver Transplant
Niamh Coyne, a 4-year-old from Sheffield, England, survived a rare birth defect and two transplants to make it home from the hospital in time for Christmas and her birthday, reports the Yorkshire Post.When Niamh was born, her bowels were located outside of her body due to a rare condition known as gastroschisis. She underwent an operation to place her bowls back in her abdominal cavity when she was 10 days old, but she spent most of her first two years of life in the hospital.She received an initial liver transplant in February 2009, but the organ soon failed.

A second transplant occurred in October of last year, and thanks to a quick recovery she was able to go home for Christmas and her December 26 birthday."She has recovered really well," Niamh's mother, Hannah Wilkins, told the source. "I am taking down all the Christmas decorations on Christmas night and putting up birthday decorations for her."Despite her legion of health troubles, Niamh is reportedly thriving. Although she could not eat solid food for two and a half years, she now routinely feasts on sausages, eggs and potatoes."When she was really little the doctors said she wouldn't be able to speak, because not eating meant she wasn't exercising her facial muscles," Wilkins added. "But she is the most verbal 4-year-old we have ever met. You cannot keep her quiet.
"According to the Centers for Disease Control and Prevention, approximately one out of every 33 babies born in the United States every year has some kind of birth defect.Parents of babies with birth defects may consult the website of Birth Defect Research for Children for information and resources.

Trial News Make Peregrine Pharmaceuticals Worth Watching
Recently, Peregrine Pharmaceuticals, Inc. (PPHM) announced that it has initiated several trials in oncology and viral infections. They seem poised to garner attention from the Street over the coming months.
Yesterday, we just got news they started another trial, this one is a Phase II clinical trial in patients with previously untreated genotype-1 hepatitis C virus (HCV) infection. Just days earlier, PPHM announced that it has initiated a randomized Phase 2 trial in patients with previously untreated stage IV pancreatic cancer. This is the second trial that PPHM has started since December, the other being a Phase I/II in advanced liver cancer. We like their approach and diversification. We believe this could be a top stock to follow in 2011.
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Big J.P. Morgan Turnout Reason for Optimism and Grumbling
Equally optimistic about the new year was Vertex Pharmaceuticals Inc. CEO, President and Chairman Matt Emmens, who said Vertex entered 2011 with cash and cash equivalents of more than $1 billion.
The Cambridge, Mass.-based company expects to launch telaprevir in hepatitis C this year, he said. Vertex submitted a new drug application for telaprevir to the FDA on Nov. 22 and expects a response this month about its request for priority review. The company said it has hired more than 200 new employees to support the U.S. telaprevir launch.
But the company also expects data from the Phase III registration program of VX-770, which aims to treat the cause of cystic fibrosis, and hopes to submit a new drug application to the FDA in the second half of 2011.
That means that after 22 years without a commercial product, Vertex could come out with two within 12 months, Emmens said.

Contaminated blood compensation 'an insult'
The widow of a man who died after being infected with contaminated blood has described an improved government compensation package as an insult.
Bob Purnell fought for compensation after contracting hepatitis C in the 1970s after a transfusion with contaminated blood from the US.
He died two years ago. The government announced the extra payments on Monday.
Court urges state to pay damages to hepatitis B patients
Wednesday 12th January, 06:34 AM JST
SAPPORO —
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The Sapporo District Court urged the government
Tuesday to pay 500,000 yen each to hepatitis B virus carriers in a lawsuit, issuing the first judicial view on the state compensation scheme for hepatitis B infections believed to have resulted from repeated use of needles in group vaccinations, lawyers of the patients said.
The government had denied that those in the lawsuit—‘‘asymptomatic’’ carriers who do not show symptoms of the disease—have any right to claim compensation on the grounds that the right they once had, which was available to them for 20 years under the Civil Code, had already expired, and instead proposed offering subsidies for medical checkups.
The district court also called on the state to pay from 12.5 million yen to 36 million yen to those who have developed hepatitis B, depending on their condition, according to the lawyers.
Since March 2008, a total of 621 people have filed damages suits over hepatitis B infections with a total of 10 district courts across Japan.
In March 2010, the Sapporo District Court became the first to urge the state and five plaintiffs from Hokkaido to reach a settlement, and the parties entered negotiations two months later.
The state had informed the district court of its plan to pay up to 30 million yen in damages to each of the patients except for asymptomatic ones, while the plaintiffs had demanded damages of up to 40 million yen each—the same amount paid to hepatitis C patients in similar compensation cases.

From HIV and Hepatitis

Anemia during Hepatitis C Treatment Predicts Sustained Response to Pegylated Interferon/ribavirin
SUMMARY: Hepatitis C patients who develop anemia during treatment with pegylated interferon plus ribavirin are more likely to achieve a sustained virological response (SVR), according to data from the IDEAL trial published in the November 2010 issue of Gastroenterology. Both ribavirin dose reduction -- which did not decrease SVR -- and medications that stimulate red blood cell production may be used to manage anemia and help people stay on treatment, the study authors concluded.

Hepatitis B Therapeutic Vaccine Appears Safe and Stimulates Immune Response
SUMMARY: In late December, Dynavax Technologies reported findings from a small early clinical trial showing that its investigational hepatitis B virus (HBV) therapeutic vaccine DV-601 -- intended to help control the virus in people already infected, rather than prevent infection -- was well tolerated and produced immunological and virological responses at all dose levels. Larger studies are needed, however, to show whether the vaccine is clinically effective.

HIV

Why start antiretroviral therapy for people living with HIV so late?
by Bobby Ramakant – CNS
Studies indicate that there are enormous public health benefits of starting antiretroviral therapy (ART) earlier for people living with HIV (PLHIV) then why is ART started so late which severe not only longevity but also considerably reduces quality of life. This was one of the major questions that sparked vibrant academic deliberation at the recently concluded Chennai ART Symposium (CART 2011).

From HIV and Hepatitis

Elevated Triglyceride Level Increases Likelihood of Peripheral Neuropathy
SUMMARY: HIV positive people with higher blood triglyceride levels are more likely to develop peripheral sensory neuropathy, or nerve damage, according to a study described in the January 14, 2011 issue of AIDS. Investigators suggested that the relationship might be due to changes in mitochondria function associated with elevated triglycerides.

Effectiveness of Statins among HIV Positive People on Antiretroviral Therapy
SUMMARY: Atorvastatin (Lipitor) and rosuvastatin (Crestor) may be the best choices for HIV positive people who need a statin drug to control elevated cholesterol, according to a study report in the December 28, 2010 advance online edition of Clinical Infectious Diseases. Researchers found that these 2 medications produced greater decreases in total and LDL cholesterol, with about the same degree of toxicity as pravastatin (Pravachol).

Antiretroviral Zinc Microbicide Gel Protects Monkeys against HIV Infection
SUMMARY: A vaginal microbicide gel containing zinc acetate and a small dose of MIV-150, an investigational NNRTI, protected female macaque monkeys from infection with an HIV-related virus for up to 24 hours, according to a study published this month in the open access online journal PLoS ONE. A gel containing zinc alone provided partial protection.

Larger Viral Decline during Hepatitis C Treatment in HIV/HCV Coinfected People with Favorable IL28B Pattern
SUMMARY: HIV/HCV coinfected patients with the C/C IL28B gene pattern experience larger decreases in hepatitis C virus (HCV) levels during the first phase of viral decline after starting treatment with pegylated interferon plus ribavirin, and were more likely to achieve virological response, researchers reported in the December 19, 2010 advance online edition of the Journal of Acquired Immune Deficiency Syndromes. A similar effect was seen for second-phase viral decline in people with HCV genotype 1, but not genotype 3.

Healthy You

Hep C Advisory: Where Salt Hides
Also known as salt, sodium is overly abundant in many common foods - an abundance that could put someone with advanced Hepatitis C infection in peril.

Recalls, Market Withdrawals, & Safety Alerts
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January 10, 2011 -
Surtex Foods Recalls “Oaxaca String Cheese La Original” Because Of Possible Health Risk12
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January 07, 2011 -
La Placita Botanas Mexicanas, Inc. Recalls Wheat Snacks with Chile, Potato Chips with Chile, and Corn Churritos with Chile Because of Possible Contamination with Salmonella13

Off The Cuff

Dyslexic comic waitress from Tulsa makes racing reality show pilot
A dyslexic comic waitress from Tulsa says her car-racing family is a reality show, so she made a pilot.
“Livin' 4 Racin' Time” will run one time this Saturday on a Tulsa TV station, and Susan has been contacted by several cable channels about the show. “I'm hoping one of the major networks sees it. Stirred into “Livin' 4 Racin' Time” is the Dales' promotion of awareness of hepatitis C, a disease that Allen highlighted by stenciling “GET TESTED, Hepatitus C” on the brothers' race cars. Yep, he misspelled it. And Susan, dutiful sis that she is, was right there to point it out.

Most Consumers Want Predictive Tests to Learn If a Disease Is in Their Future
Consumers may place a high value on information to predict their future health, and may be willing to pay out of pocket to get it. In a national survey, roughly 76 percent of people indicated that ...

January 10, 2011
How far do your sneeze and cough go? Experts study

SINGAPORE (Reuters) - Ever wondered how far your sneeze goes? Or if you can stop germs from spreading by cupping your mouth with your hand when you cough?

With a giant mirror and high-speed camera, scientists in Singapore are trying to find out how airborne transmission of flu viruses takes place, or if it happens at all.

The equipment allows them to observe real-time a person's spray of minute liquid droplets when coughing, sneezing, laughing and talking, and they hope the results can be used to make better guidelines for infection control.

"It's really to inform infection control teams, because there is controversy now about which pathogens, e.g. flu, are airborne and if so, how significant this route is compared to others, such as direct contact," said team leader Julian Tang, a virologist and consultant with Singapore's National University Hospital.

While it is likely a flu sufferer can infect others by coughing or sneezing, little is known about the distances a cough or sneeze travels and the volume of air - and viruses - packed into it.

Are flu viruses transmitted whilst airborne? Which is more dangerous: coughing or sneezing, or even laughing?

Infection control guidelines are mostly based on modeling studies and expert estimates, not hard scientific data.

In their S$1.08 million ($833,000) study, funded by the National Medical Research Council of Singapore, Tang and colleagues designed a large concave mirror, akin to those used in astronomical telescopes.

Along with a camera that can capture up to 250,000 frames per second, the scientists can observe the aerosol, or spray, produced by a cough or sneeze across the mirror.

BEWARE LAUGHING, SINGING

Using volunteers, Tang and his colleagues will study the velocity and distance of exhaled airflows, or plumes, produced by coughs and sneezes, and even laughing, crying, singing, whistling, talking, snoring and breathing.

"We will be studying these other forms of plumes, where possible, as all forms of exhaled jets have the potential to carry infectious agents over greater distances," Tang said.

They will evaluate interventions such as coughing into a loosely clenched fist, a tissue and different types of face masks to see how effective they are in containing airflows.

"What people do every day, we can visualize in real-time. Studying intervention is very important because we want to know how effective they are," Tang said.

"This may have budgetary implications when planning for the next pandemic."

With better knowledge of airflows, the scientists hope to make improved recommendations for infection control, such as how far apart to place hospital beds and quarantine measures to be taken in a place found to be housing a person with an airborne infection, such as measles, flu and drug-resistant tuberculosis.

From images seen so far, whistling and laughing appear to spread infection very effectively.

"Laughing produces a surprisingly strong, diffuse, exhaled plume, and I suspect that singing (especially trained operatic singing) will produce an even stronger, more penetrating plume," Tang said.

"However, whether they will lead to infection and disease depends on many other factors, such as virus survival and host immune responses - which other teams are studying."