Tuesday, March 1, 2011

Hepatitis C News; The Race is On for New Hepatitis C Drugs



by Dr. Joe Galati on February 28, 2011

For those of us that are involved in the care of patients with chronic hepatitis C, the “never too soon” announcement that we will finally have new drugs to treat our hepatitis C patients with cannot come soon enough. There is a real possibility that one and possibly two new agents for hepatitis C will be granted approval by the FDA in the months to come. When that day will be is unknown to me, but I anticipate later this summer at the latest.

There is a frenzy of discussion in the press, as well as the blogosphere on the new drugs, namely Telaprevir, manufactured by Vertex, and Boceprevir, manufactured by Merck. I have had the opportunity to use both of these drugs in clinical studies over the past several years, and understand how they both work, and what patients can expect. Much to everyone’s surprise, patients will still need to take one of the pegylated interferons once weekly, and ribavirin twice daily. The new drugs are added to this backbone of therapy. Besides the expected interferon and ribavirin side effects, the protease inhibitors do add some additional problems, but for the most part, in experienced hands, they can be managed fine. Once these drugs are approved, I anticipate a mad-dash of patients, wanting to get their hands on these therapies.
My advise is to start requesting your old records now if you were previously treated. Knowing exactly how many weeks you were treated, what your response was, and what complications developed, will be important information prior to commencing any sort of new therapy, regardless of which protease inhibitor you are started on. It can take weeks to get these records, so start asking now.

There are hundreds of thousands of patients with hepatitis C that are either naive to therapy (never treated), or previously treated with a partial response (null responder, non-responder, or responder-relapser). All of these individuals should be considered for these new therapies, but you need to be sure you are being seen by a practice that can handle these patients. With the new protease inhibitor drugs, resistance can become an issue, and discontinuing the therapy in a timely fashion is important. The treatment protocols are different from prior therapies, with a lead-in phase with interferon. All of these steps requires careful monitoring and communication with the patient. An experienced staff of nurses will be needed. Prior to being evaluated for these new exciting drugs, you, as a consumer, need to ask these questions to see if your care provider has the necessary experience, as well as a dedicated team to support them once patients are started on therapy.

Besides the two contenders for FDA approval later this summer, the pipeline for additional drugs is incredibly long. We are conducting research studies on an additional 12 drugs, all of which look promising. Some of the protocols are free of the hated interferon. Imagine, HCV therapy without interferon? That day will be here, allbeit several more years. I am currently in Chicago with the HCV team from Abbott, who also has a number of exciting compounds we will start studying soon with our patients in Houston.

So, when will the new hepatitis C drugs be available? My best educated guess will be by Labor Day, but we may all be surprised sooner, based on the chatter in the press and FDA hallways.
I am eager to hear what you think? Comment on your prior experience with hepatitis C therapy.,
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In The News APASL
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Hepatitis-associated aplastic anemia (HAAA) is an uncommon but distinct variant of aplastic anemia in which pancytopenia appears two to three months after an acute attack of hepatitis. HAAA occurs most frequently in young male children and is lethal if leave untreated.The etiology of this syndrome is proposed to be attributed to various hepatitis and non hepatitis viruses. Several hepatitis viruses such as HAV, HBV, HCV, HDV, HEV and HGV have been associated with this set of symptoms.Viruses other than the hepatitis viruses such as parvovirus B19, Cytomegalovirus, Epstein bar virus, Transfusion Transmitted virus (TTV) and non-A-E hepatitis virus (unknown viruses) has also been documented to develop the syndrome. Considerable evidences including the clinical features, severe imbalance of the T cell immune system and effective response to immunosuppressive therapy strongly present HAAA as an immune mediated mechanism.

However, no association of HAAA has been found with blood transfusions, drugs and toxins. Besides hepatitis and non hepatitis viruses and immunopathogenesis phenomenon as causative agents of the disorder, telomerase mutation, a genetic factor has also been predisposed for the development of aplastic anemia.Diagnosis includes clinical manifestations, blood profiling, viral serological markers testing, immune functioning and bone marrow hypocellularity examination. Patients presenting the features of HAAA have been mostly treated with bone marrow or hematopoietic cell transplantation from HLA matched donor, and if not available then by immunosuppressive therapy.New therapeutic approaches involve the administration of steroids especially the glucocorticoids to augment the immunosuppressive therapy response. Pancytopenia following an episode of acute hepatitis response better to hematopoietic cell transplantation than immunosuppressive therapy.Author: Bisma RauffMuhammad IdreesShahida ShahSadia ButtAzeem ButtLiaqat AliAbrar HussainIrshad RehmanMuhammad AliCredits/Source: Virology Journal 2011, 8:87

CROI: HIV-Resistant T Cells on Horizon
BOSTON -- Researchers are cautiously excited about preliminary data showing HIV-resistant T cells can be created in the lab and returned to patients, possibly offering a new approach to therapy.




People With HIV And Hepatitis C May Have Higher Rates Of Osteoporosis Than People With HIV Alone
By Mariana Torrente

Published: Mar 1, 2011 10:40 am
A new study of patients with both HIV and hepatitis C found they had a higher rate of osteoporosis than people in previous studies who had HIV but not hepatitis C. The researchers also found that controlled HIV replication, but not the severity of liver disease, was associated with increased risk of osteoporosis in people with both HIV and hepatitis C.
The study investigators noted that the primarily African-American study participants had a higher rate of osteoporosis than patients in a similar study of Caucasians in Italy. While factors other than race may be involved, the researchers suggested that African-Americans with HIV and hepatitis C virus (HCV) co-infection may be at higher risk of osteoporosis than expected.

Hepatitis B Rates Drop Among Kids Due To Effective Vaccination Programs, More Efforts Needed For Adults
28 February 2011Approximately 5.1% of the American population had been exposed to HBV (Hepatitis B virus) between 1988 and 1994, researchers wrote in Annals of Internal Medicine. Since that date, extensive vaccination campaigns for...

LONDON -- A London borough council confiscated breast milk ice cream being sold in a shop in the city's tourist district over fears it could contain hepatitis viruses and sent it for testing.
"Following two complaints from members of the public and concerns from the Health Protection Agency and Food Standards Agency, our officers visited the premises and removed all ice cream being sold as containing breast milk," council officer Brian Connell told the London Evening Standard newspaper Tuesday. "Selling foodstuffs made from another person's bodily fluids can lead to viruses being passed on and in this case, potentially hepatitis."

Woman Gets New Liver From Church Parishioner
March 1, 2011 7:52 AM
CHICAGO (WBBM) – A 68-year-old local woman has received a liver donation from a member of her Northwest Side church.
Roberta Sturgill contracted hepatitis C from a blood transfusion in 1995. She was in need of a liver transplant, but thought all hope may be lost when her niece’s liver was rejected for being too small.

Wellness

Açaí Juice

In the nutraceutical or nutritional supplements market, there is never any shortage of bandwagons. One of the loudest and largest these days is the açaí bandwagon. Harvested from a Brazilian palm, açaí (ah-SAH-ee) berries are a dietary staple in Brazil and have also been used medicinally by Amazonian tribes. Açaí juice was introduced in the U.S. in 2001, and there are now more than 50 new food and drink products containing açaí. As a juice, pulp, powder, or capsule, it is marketed as a magic path to weight loss, a wrinkle remover, a way to cleanse the body of "toxins," and indeed just a plain old miracle cure. It is often combined with other ingredients, such as glucosamine, so that the claims for benefits multiply exponentially.
Offers for açaí have flooded the nation’s email boxes.

On the Internet you’ll find a bouquet of endorsements from such celebrities as Oprah, Nicholas Perricone (the TV "skin doctor"), and Rachael Ray (the TV chef), plus statements by these same celebrities denying any such endorsement, or at least any endorsement of a particular brand, except that Dr. Perricone sells a brand of his own. You will also find a war of words among makers of açaí products, each one claiming safety and effectiveness for its particular formulation, and warning of scams by others.
Since açaí came on the market there have been a few studies pointing to potential benefits. Like many other fruits, açaí berries are high in antioxidants (molecules that quell cell-damaging free radicals) and other interesting compounds. But these were lab studies, and the results may not apply to humans. There is no scientific basis for weight-loss claims or any other health claims for açaí. The term "antioxidant" has become a sales tool.

Consumer protection groups such as the Center for Science in the Public Interest (CSPI) and the Better Business Bureau (BBB) have now come out against açaí marketers. "If Bernard Madoff were in the food business," said a CSPI nutritionist, "he’d be offering ‘free’ trials of açaí-based weight-loss products." Online ads regularly promise a free trial, saying that all you have to pay is shipping and handling. The catch is that you must supply your credit card number, and you’ll automatically be signed up for $50 monthly shipments that will prove hard to cancel.
We urge you not to give your credit card number to anybody selling açaí products. Hundreds of complaints have been registered, and you may never get your money back. Beware of web-sites warning you of açaí scams—far from helping you get your money back, most turn out to be just sales pitches for more açaí.

There is no magic berry for weight loss or good health. Açaí berries are no doubt a good food, like other berries, but why pay a fortune for them or supplements containing them?

Liver Cancer


RICHMOND, Va., March 1, 2011 /PRNewswire/ -- Wako Diagnostics, a division of Wako Chemicals USA, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the uTASWako i30 instrument with alpha-fetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP) in vitro diagnostic (IVD) tests in the USA. The AFP-L3 and DCP assays are intended for use by healthcare professionals as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC).

"Wako is very pleased to receive 510(k) clearance for these assays using microfluidic technology," said Peter Panfili Ph.D., General Manager, Wako Diagnostics. "We expect that the adoption of these biomarkers into HCC surveillance programs will complement the use of imaging technologies to bring about the desired earlier detection and treatment of liver cancer."

HCC, primary liver cancer, is currently the fastest growing cause of cancer-related death in the USA. It has been demonstrated that HCC surveillance programs for at-risk patients improves applicability of curative therapies. Incorporating these biomarkers as additional surveillance tools will improve the chance of detecting early stage HCC and improve patient outcomes.
Microfluidics has enabled miniaturization and integration of key analyzer processes for the uTASWako i30: sampling, mixing, separation, and detection on microfluidic chips. The system uses immunochemical and electrophoretic techniques to achieve rapid, accurate, precise and sensitive assay results.
As a bench top automated instrument, the uTASWako i30 is designed for efficiency and ease of use in a clinical chemistry setting. Up to six analytes may be selected per patient sample with the first result reported in nine minutes. With automated calibration and quality control, the uTASWako i30 requires minimal setup time. Reagent usage is tracked using radio frequency identification (RFID) tags.
The uTASWako i30 reports AFP-L3%, total AFP, and DCP values using Wako's unique reagents. This IVD test system is available to hospital laboratories, reference laboratories and tertiary care centers. Wako is the only company that offers 510(k)-cleared AFP-L3 and DCP assays for IVD use.

Hepatitis Awareness: 10 Liver Cancer Risks
Liver cancer rates doubled in the United States between 1976 and 2002, and is one of the most deadly cancers worldwide. A recent review article reported on the risk factors:

1. Hepatitis B or C virus infection. Worldwide, viral liver infections are the most common cause of liver cancer. Rates of hepatitis C infection are on the rise in the United States, and this is one contributing factor to the rising rates of liver cancer.

2. Alcohol. Liver damage is the most familiar hazard of excessive alcohol consumption. Cirrhosis is a common step on the way to liver cancer..............


Pharmaceuticals

Pharma jobs outlook bleak as European sites axed

Tue Mar 1, 2011 5:50am EST
* Pfizer, Merck, AstraZeneca sites in Europe face closure

Drug industry moving to "fragmented" model of research
* 6,000 pharmaceutical jobs gone in UK in last 12 months
By Ben Hirschler

LONDON, March 1 (Reuters) - Drug companies are pulling down the shutters on major European research laboratories, posing a serious challenge to the region's ambitions for creating new high-tech jobs.

Nowhere is the problem more acute than in Britain, where Prime Minister David Cameron named pharmaceuticals as one of five "industries of the future" in early January -- only to have the rug pulled from under his feet two weeks later.
Pfizer's (PFE.N) new CEO Ian Read told Cameron on Jan. 24 the world's biggest drugmaker's was closing its Sandwich site in southern England with the loss of up to 2,400 jobs.
Company executives said on Monday they had been discussing the possibility of shutting Sandwich as early as last November, when site head Ruth McKernan started to wind down recruitment for the flagship research centre.
Pfizer, facing massive revenue losses from drugs whose patents are expiring, is exiting Sandwich as part of a drive to cut 2012 research and development (R&D) spending by as much as $2 billion from an originally planned $8.0-8.5 billion.
The group is talking to a number of companies interested in using part of Sandwich, and McKernan said it was encouraging staff hoping to form spin-outs or management buy-outs.
But she acknowledged finding a single occupier for the 3 million square feet available at Sandwich "would be a real challenge".
"This is really an evolution of the industry to a more fragmented model," McKernan told a parliamentary committee probing Pfizer's plans to quit Sandwich within 18-24 months.
NEW TENANTS?
Pfizer's site is the biggest casualty of the current round of drug industry retrenchment but it is not alone -- and the flood of specialist lab-equipped real estate now hitting the market makes it doubly tough to find new occupiers.

From Pharmalot

Abbott & Glaxo Go To Court Over AIDS Drug Price
By Ed Silverman // March 1st, 2011 /
8:39 am
Abbott sells a combo pill called Kaletra that includes Norvir and its own protease inhibitor. The lawsuit claims Abbott raised Norvir’s price - but not the Kaletra price - in order to boost Kaletra sales at the expense of other protease inhibitors that require Norvir as a booster. In other words, Abbott allegedly tried to use Norvir to create an illegal monopoly over the market for protease inhibitors. The stakes are high, though, because the damages can be tripled


Off The Cuff

From Celebrity Dianosis;

Recently, radio/TV personality, internist and host of Celebrity Rehab Dr. Drew Pinsky was asked to comment on one of Charlie Sheen's recent public statements and said, "He's in an acute manic state now ... whether it's drug-induced or drug-withdrawal or he has bipolar disorder, I don't know but right now he's manic and that's an acute psychiatric emergency. Bipolar patients who are manic are more likely to kill themselves or hurt themselves than when they're depressed. So this is somebody ...........

21st Century Medicine, 19th Century Practices
8:19 AM Friday February 25, 2011

Editor's note: This post is part of a three-week series examining innovation in health care, published in partnership with the Advanced Leadership Initiative at Harvard University.

By the time I saw Mr. Johnson (not his real name), he had received three CT scans in less than 24 hours — and we had done nothing to make him feel better or cure his clinical problem. The day prior, he had seen his primary care physician in rural Maine for fever and belly pain, and had a CT scan which showed an abscess in his abdomen. At the nearby emergency room, where he went next, another physician, unable to obtain the original films, reordered the CT scan. The ER physician was about to hospitalize the patient when Mr. Johnson reported being a veteran and was promptly transferred to the Boston VA. The films were misplaced during his transfer to Boston and after arriving, he had — you guessed it — yet another CT scan confirming the abscess. All that diagnosing and still no treatment! Although this true story is alarming, it's hardly atypical for our $2.5 trillion healthcare system.........


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