Saturday, September 17, 2011

Hepatitis News Ticker- A Practical Guide for the Use of Boceprevir and Telaprevir

Daily news - urban art woman on the street oilpainting by artist Linda Apple

New On The Blog
Telaprevir and Boceprevir
Reference guide highlighting the key elements of care when using boceprevir and telaprevir in clinical practice

More From CCO

A Practical Guide for the Use of Boceprevir and Telaprevir for the Treatment of Hepatitis C
Release Date: 9/15/11
*Free Registration Required

With the advice of a panel of experts, this practical guide has been prepared as a consensus recommendation for how telaprevir and boceprevir should be used in the treatment of patients with HCV infection.

Learning Objectives
Upon completion of this activity, participants should be able to:

Use best practices when integrating boceprevir and telaprevir into treatment of patients with hepatitis C

Use patient-specific factors to determine if an individual with hepatitis C is a candidate for treatment with boceprevir and/or telaprevir

Counsel patients regarding efficacy and safety data with boceprevir and/or telaprevir for the treatment of hepatitis C virus infection

Manage adverse effects of treatment with boceprevir and/or telaprevir in patients with hepatitis C
Provide accurate and appropriate counsel as part of the treatment team
Provide appropriate care and counsel for patients and their families

Slideset: A Practical Guide for the Use of Boceprevir and Telaprevir for the Treatment of Hepatitis C
In this downloadable slideset, a panel of HCV experts outline the optimal use of boceprevir and telaprevir in the treatment of hepatitis C.



A few topics

At the time of writing, the FDA has approved both boceprevir and telaprevir and the EMA has approved boceprevir for the treatment of chronic genotype 1 HCV infection in combination with pegIFN/RBV in adult patients with compensated liver disease, including cirrhosis, who have not been treated for HCV or who have failed previous interferon/RBV therapy for HCV. In July of 2011, the EMA Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for telaprevir in Europe. Phase III registration trials with telaprevir included treatment of previous relapsers, partial responders, and null responders, whereas boceprevir trials did not include previous null responders.
It is the opinion of the panel that triple therapy should be considered the new standard of care in all genotype 1 HCV–infected treatment-naive and treatment-experienced patients wishing to undergo therapy for hepatitis C. Currently, pegIFN/RBV remains the standard treatment for patients infected with non–genotype 1 HCV.

Genotype 1 is the key element of candidacy for boceprevir- or telaprevir-based therapy; other important considerations in evaluating an individual patient’s likelihood of achieving SVR with triple therapy include fibrosis stage and previous treatment experience (Table 1). Fibrosis stage is also important in considering the urgency to treat; for instance, individuals with milder liver histology have a lower urgency for treatment because the risk for disease progression is low. On the other hand, these patients have higher rates of SVR, and all patients without contraindications should be considered candidates for therapy and have a data-driven discussion of the advantages and disadvantages of therapy.

Viral resistance with boceprevir and telaprevir occurs because of the selection of preexisting variants during the course of therapy, as a result of failure to eradicate infection on triple combination treatment.[54] In pooled analyses of subjects who had on-treatment failure or relapse during clinical trials with boceprevir or telaprevir, HCV variants emerged, which have been shown to carry several NS3 amino acid substitutions that reduce viral susceptibility to boceprevir and telaprevir (Table 10).[51,53] Extensive cross-resistance exists between the 2 drugs, one of several reasons why they should never be used together. Patterns of treatment-emergent amino acid substitutions were genotype 1 subtype specific.

Resistance was found to be more frequent among previous null responders and among those with subtype 1a HCV. The emergence of different substitutions among the subtypes can be explained by a different genetic barrier to resistance between subtype 1a and subtype 1b. For example, coding for R155K requires a single-nucleotide change in subtype 1a (AGG → AAG) but 2 nucleotide changes in subtype 1b (CGG → AAG). Thus, R155K is more likely to preexist in subtype 1a than in subtype 1b. The higher failure rates of boceprevir- or telaprevir-based therapy that are observed in treatment-experienced patients are owing to a poorer response to pegIFN/RBV than in treatment-naive patients, resulting in the subsequent outgrowth of resistant variants selected by boceprevir or telaprevir.
*Free Registration Required

From Natap


Egypt's health catastrophe
By Manal Abdul Aziz -
The Egyptian Gazette
Saturday, September 17, 2011 01:35:39 PM

People are calling for questioning ex-president Mubarak over the health disaster that has hit Egyptians, putting them at the top of the world's list of people suffering from liver cancer and diabetes.

“Mubarak's regime should be questioned for the crime they committed against Egyptians' health,” said Dr Alaa Eddin Ibrahim, professor of liver diseases at Benha University's School of Medicine. He noted that the catastrophe started, when the Government had a campaign to treat Bilharzia by injections, when the same syringes were used on more than one patient.

This practice led to the spread of infectious liver diseases, especially the hepatitis C virus that, together with Bilharzia, has caused liver cancer cases to rise in number in this country. Endorsing Dr Eddin Ibrahim's words, professor of liver diseases in Al-Azhar University's Faculty of medicine, Dr Adel el-Rakeeb warns of a national health catastrophe caused by the wide spread of hepatitis C virus among the Egyptians, most of whom discover the infection by mere accident.

This can happen, for example, on doing medical tests ahead of getting a work visa for a Gulf state or when serious indications and symptoms of the disease present themselves. “Herein, the patient would have reached an advanced stage of the disease that requires huge sums of money for treatment with a very low rate of survival,” Dr Rakeeb told Radio and TV Arabic magazine.

He added that the Egyptians are a people that resort to the doctor only when pain reaches an unbearable level. We know nothing about periodical check-ups nor routine tests that should be conducted regularly, by which doctors could have saved patients, even if suffering from cancer, through its early detection.

Dr el-Rakeeb also attributes the spread of liver cancer to the carcinogenic wheat that the former regime continued to import and provided to the Egyptians to eat in the form of subsidised bread.
Meanwhile, Dr Inas Shaltout, professor of diabetes in Cairo University's Qasr el-Ainy Faculty of Medicine, has warned of the spread of Diabetes type 2 among the Egyptians, infecting around eight million persons. She says that this is due to citizens' wide dependence on fast food along with the increasing rate of obesity, both of which represent risk factors of heart diseases. The World Health Organisation (WHO) has recently warned that diabetes is turning into an epidemic due to being so widespread in the world. It is also one of four non-infectious diseases that cause 50 per cent of deaths in the world. Dr Gamal Shaaban, cardiac professor at the National Heart Institute has cautioned that the Egyptian nation is in danger because of ousted regime followed wrong health, economic and agriculture polices.

These culminated in an unprecedented rise in the incidence of different diseases such as heart ailments that afflict more than eight million citizens while around 25 per cent of the Egyptian people suffer from high blood pressure. This health problems contribute to the economic crisis because most of the patients are at working age and their ill health affects national production. “It is enough to know that serious diseases such as angina and coronary artery affect Egyptians at the age of 10, lower than in other nations, which is attributed to the widespread disease of diabetes and incidence of hypertension.”

Dr Shaaban cautioned that heart diseases have become the principal cause of death in Egypt: “47 per cent of deaths are caused by heart diseases while the rate was no more than 12.5 per cent n 1970.” Dr Salah el-Messidi, a professor of cancer diseases, presents an even darker picture in suspecting the data given on the number of patients suffering from different diseases. He explains that his suspicions are aroused by “the non-existence of a trusted data base in this country with all the figures given being mere assumptions while the facts are always worse.”

Dr el-Messidi noted, “Cancer diseases have become a chronic problem with some 100,000 cases of cancer being diagnosed every year, which situation exceeds the ability of the Ministry of Health to deal with it, especially with the ministry's limited budget and the high percentage of poor patients.” He believes that carcinogenic pesticides used in agriculture are the main culprits. In addition, professor of chest diseases in Al-Azhar University Dr Mohamed Sedqi focused on the high rate of lung cancer in Cairo and other large Egytian cities that is 20 per cent higher than the median world rate.

“This is one of the many shortcomings of the former regime that allowed very old vehicles to run in Cairo streets causing the emission of many elements polluting the air.” Dr Sedqi noted that the chest diseases of the Egyptians cost the state some LE five billion per year while just LE one billion could be spent on changing these vehicle, especially public means of transport that could substantially solve the problem.

Pharmaceutical
Science has spoken: the Bay State is the place to be if you want your science career to blossom.
In its 2011 Science Careers Top Employers Survey, which examines companies all over the world, the magazine awarded Cambridge-based, Vertex Pharmaceuticals Incorporated, the #1 spot. Four other companies based in Massachusetts made the coveted 20-company list.
The goal of the Top Employers Survey is to identify the most reputable companies in science; companies that are innovative, socially responsible, that inspire loyalty and that treat their employees with respect. Science calculated its results using a web-based survey, which engaged 3,784 participants.

2011 marks the first year that a Massachusetts-based company has claimed the survey’s top spot. However, the state’s performances in recent years have also been impressive, with companies frequently hovering at the #3 spot.

#1 Vertex Pharmaceuticals Incorporated (Cambridge)
Vertex develops and commercializes medicines that can help people who are suffering from serious diseases. The company recently introduced its first product, Incivek, which treats hepatitis C. Responding to the company’s performance in Science’s recent survey, Vertex’s chief science officer, Peter Mueller, stated, “This recognition is tied directly to the passion and creativity that our 1,800 employees bring to Vertex each day, as we seek to change the lives of people with devastating diseases.”

Doctors Avoid Penalties in Suits Against Medical Firms
Two years ago, drugmaker Eli Lilly pleaded guilty to illegally marketing its blockbuster antipsychotic Zyprexa for elderly patients. Lilly paid $1.4 billion in criminal penalties and settlements in four civil lawsuits. But a doctor named as a co-defendant in one suit - for allegedly taking kickbacks to prescribe the drug extensively at nursing homes - never was pursued. Last year, Alpharma paid $42.5 million to settle federal allegations that it paid kickbacks to doctors to prescribe its painkiller Kadian."Health-care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback," Rod J. Rosenstein, U.S. attorney for the District of Maryland, said in a statement announcing the settlement. But the doctors accused of trading prescriptions for paid speaking gigs faced no consequences...
Continue Reading..

Healthy You

From Medpage
Probiotics Give Sniffles the Heave-Ho
By Crystal Phend, Senior Staff Writer, MedPage Today
Published: September 16, 2011 Reviewed by Zalman S. Agus, MD
Emeritus Professor University of Pennsylvania School of Medicine.

Action Points
Note that acute URTIs are the most common reason for people to seek medical care in the U.S. with up to one billion colds occurring per year.

Point out that the investigators found evidence, albeit weak, that probiotics (live micro-organisms, such as those found in yogurt) may be more beneļ¬cial than placebo for preventing acute URTIs with only minor GI side effects.

Probiotics modestly help stave off colds and the need for antibiotics to treat them, according to a Cochrane review.
Taking prophylactic doses of healthy bacteria in yogurt and supplements was associated with 12% fewer acute upper respiratory tract infections (rate ratio 0.88 versus placebo, 95% confidence interval 0.81 to 0.96), Bi Rong Dong, MD, of Sichuan University in Sichuan, China, and colleagues found.

Antibiotic use to treat these infections was also lower compared with individuals not taking probiotics in the pooled randomized trials (odds ratio 0.67, 95% CI 0.45 to 0.98), the group reported in The Cochrane Library.

"The evidence is weak, but our review shows a benefit in using probiotics to prevent acute upper respiratory tract infections," Dong's group wrote.
Prior reviews have also supported probiotics for treating infectious diarrhea, preventing antibiotic-associated diarrhea, and treating vaginal infections in pregnancy, they noted.
Probiotics, which most commonly include lactic acid bacteria and bifidobacteria, may exert their immune-boosting effect by bolstering gut wall integrity and amping up activity of phagocytes, Dong's group explained.

They pooled results of 10 randomized controlled trials in 3,451 participants across varying ages -- from infants to adults in their 40s -- aimed at prevention of upper respiratory tract infections with probiotics taken for more than a week, compared with a placebo or no treatment.
Probiotics reduced the number of individuals who had at least one acute upper respiratory tract infection by 42% (odds ratio 0.58, 95% CI 0.36 to 0.92).

Among the three trials that also reported on the proportion of participants who had three or more such acute infections, probiotics had a similar benefit (OR 0.53, 95% CI 0.36 to 0.80).
Mean duration of the infections wasn't significantly reduced in pooled results from the two studies that reported this outcome (0.29 days less than among controls, 95% CI -3.71 to 3.13).

Adverse events reported with probiotics largely fell under the gastrointestinal category, such as vomiting and flatulence, but weren't more common than among controls (OR 0.92, 95% CI 0.37 to 2.28).
The researchers cautioned, though, that these results were limited by a high level of heterogeneity, only one or two studies for some outcome measures, and no data regarding use among older people.

Three studies have been done in older adults -- an important population since the immune system weakens with age, Dong and colleagues pointed out.

While not specifically targeted to upper respiratory tract infections, those studies found:
Lower duration, but no reduction in incidence of winter infections
Lower duration of common infectious diseases, particularly upper respiratory tract infections
A 3.4-fold reduction in risk of coming down with the common cold or influenza virus infection
The study was supported by the Chinese Cochrane Center at Sichuan University and by the Cochrane ARI Group in Australia.

The researchers reported having no conflicts of interest to disclose.
Primary source:
The Cochrane LibrarySource reference:
Hao Q, et al "Probiotics for preventing acute upper respiratory tract infections" Cochrane Database of Syst Rev 2011; 9: CD006895.

From WebMD

What are probiotics?

Probiotics are bacteria that help maintain the natural balance of organisms (microflora) in the intestines . The normal human digestive tract contains about 400 types of probiotic bacteria that reduce the growth of harmful bacteria and promote a healthy digestive system. The largest group of probiotic bacteria in the intestine is lactic acid bacteria, of which Lactobacillus acidophilus, found in yogurt with live cultures, is the best known. Yeast is also a probiotic substance. Probiotics are also available as dietary supplements. It has been suggested that probiotics be used to treat problems in the stomach and intestines. But only certain types of bacteria or yeast (called strains) have been shown to work in the digestive tract. It still needs to be proved which probiotics (alone or in combination) work to treat diseases. At this point, even the strains of probiotics that have been proved to work for a specific disease are not widely available....Continue Reading..

Stem Cells
Ramya Kannan
It is imperative that any application of stem cells in people is driven by firm scientific evidence. Any activity without such evidence must be strictly condoned and prevented, says Sanjeev Gupta, who holds the Eleazar and Feige Reicher Chair in Translational Medicine, Albert Einstein College of Medicine, US.

Dr. Gupta is one of the authorities on stem cell research, with particular interest in regeneration of the liver through stem cells. In Chennai recently, on the invitation of the Institute of Gastrointestinal Surgery, Government Stanley Hospital, he said it was particularly important that false hope was not generated through inappropriate, premature or unwise use of stem cells.
“These areas of activity, it seems to me, have not been appropriately regulated, permitting many unscrupulous individuals to take steps for financial gain, not for benefitting people,” he stressed.

Appropriate measures must be taken at multiple levels – at the medical and political establishment levels to ensure that this is controlled. Only with the right type of scientific evidence and validation, will treatments be effective over the long run.
“Right now,” Dr. Gupta explained, “there is an enormous amount of good and bad information about stem cells. On the one hand, people believe that stem cells will cure everything, and on the other hand, that they have failed to make an impact so far.” The truth, is somewhere in between, he contended.

There is increasing information now, on stem cells. The major emphasis is on identifying the biological components of stem cells and how they could be harnessed for repairing organs. There is also great interest in liver-directed stem cell therapy, as this has the potential to impact on the condition of other organs as well. That makes the liver the most attractive, single target for stem cell therapy.

Serious efforts have been made towards understanding how a liver fails, and treating the liver with transplantation of healthy stem cells, to see if they can correct the disorders. Trying to make liver cells from stem cells is one way. Simultaneously, there has been a lot of interest in using cells from other parts of the body, such as bone marrow or the peripheral vascular system, with the consideration that those cells will convert themselves to the damaged organ, and start the process of repair.

“There is as yet no compelling scientific evidence that blood-derived cells can replace tissue cells elsewhere – such as the liver,” he said. However, there is definitely the possibility that these cells can be extracted, as also cells from the skin, intestinal tract, or eye, and converted to stem cells.

“At the moment, it requires manipulation, insertion of multiple genes that could cause cancers. There is a lot of work to do in the field,” Dr. Gupta explained.

There is another component of stem cells that has not received as much attention in the public mind, he said. This is the activation of one's own endogenous stem cells, or of one's own resident stem cells in every organ. “If there is damage to the organ, why can't we activate our own residual stem cells so that they can repair through appropriate signals?” he asks.

“The million dollar question is why those cells are not getting activated. Much work is being done to understand the biology of signals and cues that may coax these cells to become active again, and begin regeneration of various tissues in the body. However, this work is in its infancy,” Dr. Gupta added.

Once we understand these mechanisms, we may be able to develop new drugs that can activate these stem cells and we may not even need to transplant anything, he said.
Further important advances will come in our understanding of immunological mechanisms by which rejection of transplanted cells derived from stem cells can be prevented, and identification of the early stage where stem cells begin to get depleted, to fashion treatments that will prevent the onset of certain diseases.

Cash backing for stem cell research
A new fund to pay for stem cell research has been launched.
The money will support the work of researchers and clinicians in Scotland to find treatments for illnesses including diabetes, multiple sclerosis, strokes, blindness, liver disease and Alzheimer's.
Medical research charity the UK Stem Cell Foundation (UKSCF) hopes to raise £5 million towards stem cell research over the next three years.

It is also being supported by Scottish Enterprise with a £300,000 grant.
The UKSCF has already backed a number of stem cell research projects in Scotland in collaboration with Scottish Enterprise. These have focused on treatments for liver disease, corneal blindness and bone and cartilage repair.

UKSCF chairman Sir Richard Sykes said: "Scotland is home to some of world's leading stem cell researchers and scientists. However, with ongoing pressure on budgets, it is becoming increasingly difficult to access funding for this exciting area of research.
"We will be focusing on raising funding for research projects from a range of sources, and would encourage everyone with an interest in this exciting area of work to get involved."

Andrew Henderson, life sciences manager at Scottish Enterprise, added: "Major opportunities exist for cell therapies in heart disease, stroke, diabetes and liver failure.

"We already have over 20 Scottish companies involved in stem cell activity, and I believe this new fund has the potential to help turn our world-leading science into real commercial success."
Copyright © 2011 The Press Association. All rights reserved.

AASLD 2011

The 62nd Annual Meeting of the American Association for the Study of Liver Diseases

San Francisco, CA - Moscone Convention Center November 5 - 8, 2011
SAN FRANCISCO, Sept. 15, 2011 /PRNewswire/ -- The Liver Meeting® is the premier meeting in the science and practice of hepatology, including the latest findings on new drugs, novel treatments, and the results from pilot and multicenter studies.
Approximately 10 percent of Americans have some form of liver disease, but fortunately, the research community has made great strides in recent years in developing new treatments for patients.

At this year's meeting, 2312 abstracts addressing these issues that will be presented, including 276 abstracts that will be presented in oral sessions. Those abstracts are available to members of the press at our website (http://www.aasld.org/%29.

San Francisco, CA: November 5 – 8, 2011
Poster Presentations: November 5 – 8
Oral Presentations: November 6 – 8

An AASLD President's press conference highlighting key abstracts and issues presented at the Liver Meeting® is scheduled for Saturday, November 5 at 4:00 pm.
Two of this year's programs deal directly with the direct-acting antiviral agents that were recently approved by the FDA.

The Hepatitis C Symposium is designed to educate the provider on newly approved and anticipated therapies for HCV and how these should be integrated into clinical practice.
The Hepatitis Debrief is designed to rapidly synthesize and summarize the new data presented at the Liver Meeting® in such a way that the information will be meaningful and useful.
Founded in 1950, AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD has grown into an international society responsible for all aspects of hepatology, and our annual meeting attracts more than 8,000 physicians, surgeons, researchers, and allied health professionals from around the world.
Please contact AASLD at 703-299-9766 for information about the above presentations, or to receive any additional information about The Liver Meeting® – or visit our website at http://www.aasld.org/.

Please contact Gregory Bologna to register as press for the meeting: 703-299-9766 or gbologna@aasld.org.

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.xpresspress.com/

SOURCE American Association for the Study of Liver Diseases (AASLD)

RELATED LINKS http://www.aasld.org/

Off The Cuff

Sanford Guide Introduces New Hepatitis Guide
September 17, 2011
The mobile app for this Guide is available on Apple’s App Store and the Android Market


Sanford Guide Introduces New Hepatitis Guide

CHICAGO, Sept. 17, 2011 /PRNewswire/ — The Sanford Guide, recognized as the essential reference for infectious disease treatment, announced the release of the Sanford Guide to Hepatitis Diagnosis and Treatment today at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). This is the first mobile app of its kind for Hepatitis treatment, making it easy for healthcare professionals anywhere in the world to find the latest treatment guidelines instantly.

Hepatitis was recently identified by the World Health Organization (WHO) as a matter of global concern, affecting nearly one of every three people in the world. WHO held a World Hepatitis Day in August to highlight the worldwide scope of this increasingly prevalent disease. The new Sanford Guide, whose editors are among the world’s foremost infectious disease experts, assists health care professionals who specialize in the care and management of patients with Hepatitis or whose practice in this area is growing, by providing convenient access to critical information at the point of care.

“A revolution is occurring in the treatment of Hepatitis C virus infections, similar in magnitude to the rapid change in HIV therapy in the mid-1990s,” said Jeb Sanford, managing editor. “A major difference between HIV therapy and Hepatitis C therapy is that patients can be cured of Hepatitis C infections. New drugs approved in 2011 are transforming therapeutic approaches to Hepatitis C treatment and many more new drugs are in development.”

The Sanford Guide to Hepatitis Diagnosis and Treatment covers:
Hepatitis C diagnosis, epidemiology, natural history, clinical presentation, treatment setting and treatment Hepatitis A treatment of acute infections
Hepatitis B treatment of chronic infections, management of exposure, prophylaxis in transplant patients
Hepatitis immunization recommendations
Comprehensive drug information for anti-Hepatitis agents, including usage, dosage, dose adjustments, adverse effects, pharmacology and major interactions with other drugs

The mobile app for this Guide is available on Apple’s App Store and the Android Market. Advantages to using a mobile application rather than a printed booklet include easy navigation and search tools and links to related material and source references. Regular updates will reflect new drugs, shifting response patterns, and the changing availability and efficacy of anti-infective therapies. The expanded Hepatitis coverage is also included in the Sanford Guide Web Edition and in the upcoming 20th edition of The Sanford Guide to HIV/AIDS Therapy.

About Sanford Guide
Sanford Guide provides the leading authoritative reference guides for the treatment of infectious diseases to health care providers at the “point of care.” The Sanford Guide delivers convenient, comprehensive recommendations for treatment and prevention of bacterial, fungal, viral, retroviral, parasitic and mycobacterial infections. It provides recommendations for surgical prophylaxis, and comprehensive anti-infective drug information, all supported by expert commentary and evidence-based references. Antimicrobial Therapy, Inc., publisher of the Sanford Guides, has been owned and operated by the Sanford family since 1969. More information is available at http://www.sanfordguide.com/.
Source: PR Newswire

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