Tuesday, August 14, 2012

HCV In The News-Pharmaceuticals,HCV Vaccine,Liver Health And More

Hepatitis C In The News

Liver Health

Common Antibiotics Pose a Risk of Severe Liver Injury in Older Patients

OTTAWA, Ontario -- August 13, 2012 -- The commonly used broad-spectrum antibiotics moxifloxacin and levofloxacin are associated with an increased risk of severe liver injury in older people, according to a study published in the Canadian Medical Association Journal.

Both the European Medicines Agency (EMA) and Health Canada have issued warnings about the risk of liver injury from moxifloxacin, although there are few published studies on the safety of fluoroquinolones, especially related to liver damage.

Researchers examined the risk of acute liver injury in patients taking moxifloxacin compared with those taking other antibiotics commonly used to treat respiratory tract infections. They looked at 9 years of data from Ontario to identify people aged 66 years or older with no history of liver disease who were admitted to hospital for liver injury within 30 days after receiving a prescription for these antibiotics.

Excluding patients admitted for previous liver disease or recent hospitalisation, 144 patients were admitted for acute liver injury, with the median time from the dispensing of the antibiotic to admission to hospital being 9 days. Of the patients admitted for liver injury, 88 (61.1%) died.

"Compared with clarithromycin, moxifloxacin was associated with a more than 2-fold increased risk of admission to hospital for acute liver injury," wrote David Juurlink, MD, Institute for Clinical Evaluative Sciences, Toronto, Ontario, and colleagues. "Levofloxacin was also associated with a statistically significant, but lower risk of hepatotoxicity than…moxifloxacin."

The authors noted that, although these cases are serious, they are relatively rare, with about 6 cases for every 100 000 patients treated with the antibiotics.
The authors believe their findings are an important contribution to the evidence regarding the risks of these antibiotics.

"Despite recent regulatory warnings regarding the hepatic safety of moxifloxacin, there is a lack of controlled studies supporting the notion that moxifloxacin presents a particular risk relative to other broad-spectrum antibiotic agents and, in particular, to other fluoroquinolones," the authors wrote. "Although our results require confirmation in other settings, the findings suggest that both moxifloxacin and levofloxacin be considered for regulatory warnings regarding acute liver injury."

Two Quinolones Linked to Liver Injury in Seniors (CME/CE)
8/13/2012 MedPage Today Gastroenterology
(MedPage Today) -- Two common fluoroquinolones were associated with a greater likelihood of hospitalization for idiosyncratic acute liver injury in older adults, Canadian researchers found.
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Curing Hepatitis C by Gregory T. Everson, M.D - Download Chapter Six

Chapter 6: The Future of HCV Treatment-Beyond Triple Therapy

Download PDF

Chapter six of the new book "Curing Hepatitis C" written by Gregory T. Everson, M.D. is available for downloading.

*Curing Hepatitis C will go on sale August 21, for more information or to pre-order the book click here.

Topics discussed in chapter six

• Status of Clinical Investigation into Future HCV Therapies
• Next Generation Triple Therapy
• Lambda interferon
• Inhibitors of NS3/4A protease
• Inhibitors of NS5B polymerase
• Inhibitors of NS5A protein
• Interferon-Free Regimens
• Mericitabine plus danoprevir
• Daclatasvir plus BMS-650032
• BI-201335 plus BI-207127 ± ribavirin
• GS-7977 plus ribavirin
• Genotype 1b versus 1a
• QUAD Therapy
• Daclatasvir plus BMS-650032 plus peginterferon/ribavirin
• Telaprevir plus VX-222 plus peginterferon/ribavirin
• Host-Acting Antivirals
• Cyclophyllin inhibitors
• Entry blockers
• Micro-RNA inhibitors
• Viral Resistance
• Concluding Remarks
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New Studies Investigate Boceprevir in Null Responders, Versus Telaprevir
Two studies presented at the European Association for the Study of the Liver (EASL)/International Liver Congress meeting in Barcelona, Spain, were the first to explore certain aspects of treatment with boceprevir. One study was the first to show the efficacy of boceprevir in the treatment of null responders with hepatitis C virus (HCV) infection. Another study addressed the absence of head-to-head clinical trials between boceprevir (Victrelis, Merck & Co.) and telaprevir (Incivek, Vertex Pharmaceuticals).
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HCV Vaccine

Major Breakthrough in Hepatitis C Vaccine Development
Researchers at the Burnet Institute have solved a hepatitis C vaccine mystery which, once developed could be the first ever preventative vaccine for the virus.

Currently undergoing formal preclinical studies, the vaccine is the result of breakthrough work done by Associate Professor Heidi Drummer with her team from the Institute's Centre for Virology.
Hepatitis C affects around 200 million people around the world - a preventative vaccine has the potential to have a significant global health impact.

Associate Professor Drummer and her team have overcome a major hurdle in HCV vaccine research, developing a vaccine candidate that protects against a number of different HCV strains.
"Hepatitis C has a great ability to change its structure and evade the immune response. This makes vaccine development challenging," Associate Professor Drummer said.

"Our vaccine is unique as it contains only the most essential, conserved parts of the major viral surface protein, eliciting antibodies that prevent both closely and distantly related hepatitis C viruses from entering cells, thereby preventing infection."

Associate Professor Drummer unveiled the details about her HCV vaccine project at the prestigious Immunotherapeutics and Vaccine Summit (ImVacS) in Cambridge, Massachussets on August 13.
To arrange an interview with Associate Professor Heidi Drummer please contact: Catherine Somerville Media and Communications Officer Burnet Institute Tel: +61-(0)-422-043-498 or Email:

Read more here: http://www.sacbee.com/2012/08/13/4722020/major-breakthrough-in-hepatitis.html#storylink=cpy

Big Pharma

New at NATAP

HCV Update Selected Highlights: key new HCV drugs, timelines & recent news developments

Currently approved are 2 protease inhibitors telaprevir & boceprevir. In phase 3 now are 4 drugs: 2 proteases TMC435 & BI1335; nucleotide GS7977; and NS5A BMS052. Also in phase 3 is Peg Lambda, a peginterferon that has showed in trials similar efficacy to current Peginterferons with little of the side effect. Phase 3 for these drugs should be finished in about one year with varying finish timelines between these drugs. Abbott is about to start phase 3 studies, they have 4 drugs in 3 classes: protease, NS5A, HCV polymerase nonnucleoside inhibitors (NNIs). Gilead has drugs in 4 classes: nucleotide, protease, HCV polymerase nonnucleoside inhibitors (NNIs), NS5A. BMS has drugs in 4 clases: NS5A, HCV polymerase nonnucleoside inhibitors (NNIs), nucleotide (trial just suspended, evaluating), protease; Roche/Genentech has drugs in 3 classes: protease, nuke, HCV polymerase nonnucleoside inhibitors (NNIs). Vertex has drugs in 3 classes: protease, nucleotide, HCV polymerase nonnucleoside inhibitors (NNIs). Merck has drugs in 2 classes: protease in development in addition to boceprevir, NS5A. Tibotec has protease TMC435 in phase 3 now with other drugs further back in development.
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Gilead: A Stock For The Future
Edited By Kate Boehme
Gilead Sciences (GILD) is a biopharmaceutical company involved in discovering, developing and commercializing medicines. Gilead's key areas of focus are HIV/AIDS, liver diseases - such as hepatitis B and C - and cardiovascular/metabolic and respiratory conditions. This company operates in North America, Asia Pacific, and Europe. Gilead is a leader in the biopharmaceutical industry, with a portfolio of 14 marketed products, as well as a growing pipeline of investigational drugs and 4,600 employees.

Idenix To Forge Ahead On HCV Combo After Novartis' Departure
Thursday, August 09, 2012
Idenix Pharmaceuticals has been quite busy of late, on the fundraising front and elsewhere. A clinical-stage biotech with a market cap of nearly $900 million and no marketed products, the virology-focused firm has just exited a long-term collaboration with Novartis, raised $191 million in a registered direct offering, and previewed preclinical data for a hepatitis C candidate that it says appears to offer greater antiviral activity than any other clinical compound in its class.

Also of note, with IDX184, Idenix owns one of four nucleoside polymerase inhibitors still in clinical development for HCV, and that class widely is seen as the backbone for future combinations of all-oral, direct-acting antivirals that could transform a burgeoning market highlighted by millions of warehoused and potentially tens of millions of undiagnosed patients. The peak annual market for HCV drugs has been estimated as high as $20 billion worldwide, and Idenix, while trailing clear leader Gilead Sciences, is positioned as well or better than many more established and deep-pocketed companies racing to grab a significant chunk of that market.

Roche Worker Sues For Whistleblowing & Firing
A former senior clinical program manager at the Genentech unit of Roche has filed a lawsuit against the drugmaker after claiming she suffered retaliation for effectively blowing the whistle on clinical trial practices that she alleged jeopardized patient safety.

Drugs Companies Putting Profit Ahead of Medical Discoveries, Warn Scientists
Jeremy Laurance
(The Independent, London, August 8, 2012)

"The multi-billion pound pharmaceutical industry has spent the last decade developing new drugs which have produced little benefit and caused considerable harm, experts say...Counter to drug industry claims that the pipeline of new drugs is running dry, the number of new drugs being licensed each year has remained at between 15 and 25. But most involve minor tweaks to existing drugs, designed to grab a slice of an existing market rather than offering genuine therapeutic innovation. Independent reviews suggest that 85 to 90 per cent provide little benefit over existing treatments with some...causing serious side effects which led to their withdrawal."

Liver Cancer

Celsion Corporation Reports Second Quarter 2012 Financial Results and Business Update
8/14/2012 8:53:39 AM

LAWRENCEVILLE, NJ--(Marketwire - August 14, 2012) - Celsion Corporation a leading oncology drug development company, today announced financial results for the second quarter ended June 30, 2012 and provided a business update including development progress with ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. ThermoDox® is currently being evaluated under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA) in a global, multi-center, randomized, pivotal Phase III trial (the HEAT Study) in patients with non-resectable primary liver cancer. The HEAT Study has been designated as a Priority Trial for liver cancer by the National Institutes of Health, has received Fast Track Designation from the FDA and has received Orphan Drug Designation in both the U.S. and Europe. ThermoDox® is also being evaluated in two Phase II trials for patients with recurrent chest wall breast cancer and colorectal liver metastases.

"Celsion has had a productive, if not pivotal, quarter in its development program for ThermoDox®, an investigational drug with the potential to provide a first line therapy for patients with HCC, the largest unmet need in oncology. Having successfully completed patient enrollment in the HEAT Study, secured a commercial supply agreement for ThermoDox® in China, entered into a $10 million loan agreement which strengthens our balance sheet well beyond data, and advanced several important collaborations with leading industry and academic players, we are well positioned for success," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Our continued progress underscores the momentum and enthusiasm behind our ThermoDox® program, and its advancement toward the key clinical, regulatory and commercial milestones ahead. Among the most important of these near-term milestones, we look forward to top line results from the pivotal HEAT Study."

A total of 380 events of progression are required to reach the planned final analysis of the HEAT Study, which are projected to occur in late 2012. Top line results will be announced following review by the study's independent Data Monitoring Committee.

Mr. Tardugno added, "Beyond the HEAT Study, we are very encouraged by the progress being made with ThermoDox® in multiple indications using a variety of heat-based modalities in collaboration with some of the top names in science and healthcare, including Royal Philips Electronics, Oxford University and the University of Washington. These collaborations, along with our own clinical programs, we believe will bear out ThermoDox®'s significant clinical potential as it progresses through the commercialization process."

Exeter Hospital Hepatitis C Outbreak

Lies, lack of reporting helped suspected hepatitis C infector slip through cracks

AP IMPACT: Med tech's arrest shows flaws in system
CONCORD, N.H. (AP) -- Radiology technician David Kwiatkowski was a few weeks into a temporary job at the University of Pittsburgh Medical Center-Presbyterian in 2008 when a co-worker accused him of lifting a syringe containing an addictive painkiller from an operating room and sticking it down his pants....
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Possible new hepatitis C infections in other states
In addition to the 31 patients he allegedly infected with hepatitis C in Exeter Hospital's cardiac catheterization laboratory, patients of at least two other hospitals where Kwiatkowski worked recently tested positive for hepatitis C. Positive test results were returned for a patient at Johns Hopkins Hospital in Baltimore, Md., but it's not clear ...
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Hep. C test results pending
Nearly 1,000 attend clinic after Exeter Hospital outbreak
STRATHAM — More than 900 people were tested on Friday and Saturday during the first state-run hepatitis C testing clinic at the Cooperative Middle School.

State officials said the first day of the clinic was rough, with long lines and delays, but the second day of the clinic went well.

"We got backed up for long periods of time on Friday. but we had no backups on Saturday," said Rick Cricenti, director of emergency management at the state Department of Health and Human Services.

Cricenti said as of Monday afternoon he had only received one written complaint about the two-day clinic, a letter from a recently formed patient advocacy group, The Patients Speak, on behalf of one of the patients that was tested over the two days. The complaints included long lines, lack of seating and a lack of privacy at the blood-draw stations.

On Friday, some patients were at the clinic for as long as three hours, according to Cricenti. By Saturday, most were out of the clinic in under an hour. Issues with long lines and lack of seating were remedied by Saturday.
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Unsafe Injections: More Preventive Action Needed, GAO Says
From Medscape Medical News
Emma Hitt, PhDAugust 13, 2012

The extent of unsafe injection practices may be underestimated because of a lack of proper documentation, according to a new report from the Government Accountability Office (GAO).

"Data on the extent and cost of blood-borne pathogen outbreaks related to unsafe injection practices in ambulatory care settings are limited and likely underestimate the full extent of such outbreaks," the authors write.

Two agencies, the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), both part of the Department of Health and Human Services (HHS), need to improve their efforts in this area, the report notes.

The CMS took steps to expand oversight of unsafe injection practices in ambulatory care settings in 2009 by requiring surveyors to use an Infection Control Surveyor Worksheet for documentation. However, the agency stopped collecting data from surveyor worksheets after fiscal year 2011.
"CMS may be undermining its efforts by stopping data collection after fiscal year 2011, in part because of concerns that the time and effort required in collecting the data placed a burden on surveyors," the report states.

The authors also suggest that the absence of comprehensive data underestimates outbreaks of blood-borne pathogens (hepatitis B and C) linked to a specific healthcare facility or clinician that uses unsafe injection practices.

Likewise, data from the CDC indicate that from 2001 through 2011, at least 18 outbreaks of viral hepatitis associated with unsafe injection practices in ambulatory settings, such as physician offices or ambulatory surgical centers, were reported.

Unsafe injection practices that led to outbreaks included syringe reuse, mishandling of medication vials, failure to prepare and store intravenous infusions under aseptic conditions, and medication preparation in a contaminated environment.

The GAO now recommends that HHS do the following: "(1) resume collecting data on unsafe injection practices that will permit continued monitoring of such practices, (2) use those data for continued monitoring of [ambulatory surgical centers], and (3) strengthen the targeting efforts of the One and Only Campaign for health care settings."

The One and Only Campaign is a program designed to educate both clinicians and patients about safe injection practices.

According to the report, HHS concurred with the above GAO recommendations and stated that the CMS intends to resume collection of the Infection Control Surveyor Worksheet data beginning in fiscal year 2013 for a state-stratified, randomly selected subset of ambulatory surgical centers surveyed in that year, and that the agency will repeat this sampling and data collection approximately every 3 years thereafter.

In addition, HHS said that the CDC supports targeting the outreach of the One and Only Campaign toward specific clinician groups and setting types, "though the agency further noted that broad outreach also remains critical as demonstrated by the wide variety of settings where blood-borne pathogen outbreaks and unsafe injection practices have been identified."
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CDC Recommendation: Dual Treatment to Curb Tide of Drug-Resistant Gonorrhea
Increasing fears about the emergence of antibiotic resistant gonorrhea in the U.S. have prompted new treatment and surveillance recommendations from the Centers for Disease Control and Prevention (CDC). Gail Bolan, director of the agency's Division of STD Prevention, called the move "a critical pre-emptive strike to preserve the last effective treatment option."
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Engineered Pancreatic Tissues Could Lead to Better Transplants for Diabetics
Released:8/14/2012 11:00 AM EDT
Source:American Technion Society
Newswise — Technion researchers have built pancreatic tissue with insulin-secreting cells, surrounded by a three-dimensional network of blood vessels. The engineered tissue could pave the way for improved tissue transplants to treat diabetes.

The tissue created by Professor Shulamit Levenberg of the Technion-Israel Institute of Technology and her colleagues has some significant advantages over traditional transplant material that has been harvested from healthy pancreatic tissue.

The insulin-producing cells survive longer in the engineered tissue, and produce more insulin and other essential hormones, Levenberg and colleagues said. When they transplanted the tissue into diabetic mice, the cells began functioning well enough to lower blood sugar levels in the mice.
Transplantation of islets, the pancreatic tissue that contains hormone-producing cells, is one therapy considered for people with type 1 diabetes, who produce little or no insulin because their islets are destroyed by their own immune systems. But as with many tissue and organ transplants, donors are scarce, and there is a strong possibility that the transplantation will fail.

The well-developed blood vessel network built into the engineered tissue is key to its success, the researchers concluded. The blood vessels encourage cell-to-cell communication, by secreting growth hormones and other molecules, that significantly improve the odds that transplanted tissue will survive and function normally.

The findings confirm that the blood vessel network “provides key survival signals to pancreatic, hormone-producing cells even in the absence of blood flow,” Levenberg and colleagues concluded in their study published in the journal PLoS One.

One reason transplants fail, Levenberg said, “is that the islets are usually transplanted without any accompanying blood vessels.” Until the islets begin to connect with a person’s own vascular system, they are vulnerable to starvation.

The 3-D system developed by the Technion researchers tackled this challenge by bringing together several different cell types to form a new transplantable tissue. Using a porous plastic material as the scaffold for the new tissue, the scientists seeded the scaffold with mouse islets, tiny blood vessel cells taken from human umbilical veins, and human foreskin cells that encouraged the blood vessels to develop a tube-like structure.

“The advantages provided by this type of environment are really profound,” said Xunrong Luo, an islet transplantation specialist at the Northwestern University Feinberg School of Medicine. She noted that the number of islets used to lower blood sugar levels in the mice was nearly half the number used in a typical islet transplant.

Islets grown in these rich, multicellular environments lived three times as long on average as islets grown by themselves, Levenberg and colleagues found.

The technology “is still far from tests in humans,” Levenberg said, but she noted that she and her colleagues are beginning to test the 3-D tissue scaffolds using human instead of mouse islets.
According to Northwestern’s Luo, the 3-D model demonstrated in the study “will have important and rapid clinical implications” if the same results can be replicated with human cells. “This model system also provides a good platform to study the details and mechanisms that underlie successful transplantation.”

The Technion-Israel Institute of Technology is a major source of the innovation and brainpower that drives the Israeli economy, and a key to Israel’s renown as the world’s “Start-Up Nation.” Its three Nobel Prize winners exemplify academic excellence. Technion people, ideas and inventions make immeasurable contributions to the world including life-saving medicine, sustainable energy, computer science, water conservation and nanotechnology.

American Technion Society (ATS) donors provide critical support for the Technion—more than $1.7 billion since its inception in 1940. Based in New York City, the ATS and its network of chapters across the U.S. provide funds for scholarships, fellowships, faculty recruitment and chairs, research, buildings, laboratories, classrooms and dormitories, and more.
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Around The World

China: Experts Call to Improve Monitoring of Organ Trade
Cao Yin
(China Daily, August 6, 2012)
"[A]bout 1.5 million Chinese need organ transplants every year, but only around 10,000 transplants are performed annually due to a lack of donors. The huge gap has led to a thriving illegal market for human organs, although the government has repeatedly pledged to improve regulations on organ transplants and increase the supply. China's central government issued its first national level regulations on human organ transplants in 2007, banning organizations and individuals from trading human organs...To increase the supply of legally harvested organs, Chinese health authorities are building an official network to facilitate organ donations."
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Just For Fun

Triple Hep C Therapy - Using Facebook Under The Influence
Establishing connections online is a highly beneficial experience to those who are newly diagnosed with hepatitis C. Although, when in the throes of HCV triple therapy it can be a challenge using a social site like Facebook.

To put it gently, comprehension is somewhat limited during therapy, additional side effects include fatigue, depression, anxiety, insomnia, spelling and impaired typing skills. The last two debilitating side effects have never been acknowledged in a peer-reviewed journal, but I'm thinking they should be.
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Healthy You

Hot Cocoa May Boost Seniors' Brain Power

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