Saturday, February 8, 2014

COPD In The Baby Boomer Generation

What a harsh cold winter we're having here in Michigan. I started my weekend with a three mile walk (cut short to 1 mile), cleaned up my humble abode (almost), grabbed a cup of coffee (always do), and started my Saturday ritual of reading the news online.

Poor Justin Beaver, will he ever grow up?

Did you read Clint Eastwood saved a man from choking to death?  He apparently jumped into action, stood behind the man, wrapped his still strong Dirty Harry arms around him and executed a few lifts while preforming the Heimlich maneuver. Wow. 

I guess now that Jay Leno has retired, or forced off "The Tonight Show,"  NBC is already erasing his name off the side of the building where they taped the show.

How I love me some TMZ in the morning.

On a sad note, I ran across an interesting article about Leonard Nimoy, an article unfortunately I can relate to, you may also.

According to CNN, the famous actor known for his work in Star Trek, announced last week he was diagnosed with chronic obstructive pulmonary disease (COPD), after giving up smoking some thirty years ago. On Friday Nimoy sent out a few tweets  to his fans, "I'm doing OK," he tweeted "Just can't walk distances. Love my life, family, friends and followers."


I was diagnosed in 2006 with COPD, after smoking for 25 years. Yep, I quit, but only recently. The reality of the article hit too close to home, like most people with COPD, I wonder to what degree the disease will progress overtime.


Seven years earlier I was diagnosed with hepatitis C, in less then twelve months I went on to treat the virus successfully. I clearly remember a few bothersome and at times frightening side-effects related to my breathing; waking up in the middle of the night gasping for air, shortness of breath while climbing stairs, and that horrible continuous coughing.  Some people treating with interferon and ribavirin experience the same side-effects. However, after learning of my COPD diagnosis, for the most part, I assume my side-effects were possibly more severe due to early COPD. An important point to remember for anyone considering treatment who has a long history of smoking.

To date there have been relatively few studies that have investigated a correlation between the hepatitis C virus and COPD. A study in 2010; Prevalence of hepatitis C virus infection in patients with COPD., published in the journal Epidemiology and Infection, set out to determine the prevalence of HCV infection in a sample of chronic obstructive pulmonary disease (COPD) patients and in a control group of blood donors. The data relieved a significantly greater likelihood of HCV in those with COPD than the general blood donation population, additionally, patients with COPD had more severe lung disease when they also were infected with Hepatitis C.

Obstructive Lung Disease (OLD)
A study entitled; Hepatitis C virus infection is not an independent risk factor for obstructive lung disease, published in the February 2014 issue; COPD: Journal of Chronic Obstructive Pulmonary Disease, reported:
In summary, there was no independent association between markers of HCV exposure, chronicity, viremia, or HCV-associated end-organ damage with OLD. Our findings support the strong correlation between HCV status, injection drug use, and smoking. These data suggest that HCV may not be a sole contributor to the increased prevalence of OLD described in previous studies of HCV-infected individuals.

More than 2 million U.S. baby boomers are infected with hepatitis C, which account for more than 75 percent of all American adults living with the virus. Many of these baby boomers living with hepatitis C are now approaching retirement age, with the oldest of the baby boomers reaching age 68 in 2014,  is COPD an additional disorder baby boomers need to be concerned about?

In theory, the two conditions may co-exist in people living with the virus, chronic hepatitis C infection might function as a trigger for inflammation in the lungs, by either initiating or exacerbating the development of COPD. This means that besides the liver, our lungs might be an additional location the hepatitis C virus infiltrates. Research has suggested the direct effects of HCV on the lung may worsen lung function in some patients with preexisting asthma and/or COPD, according to a 2005 article from: Chest

Recent statistics coming out of Canada has shown a large number of younger baby boomers suffer from COPD. For instance a 2013 research project, entitled Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management, reported the disease is especially prevalent among younger Canadian baby boomers – one in seven Canadians aged 45 to 49 (375,000) may have COPD.

At the other end of the spectrum, a recent study; "The Status of Baby Boomers' Health in the United States: The Healthiest Generation?" in JAMA Internal Medicine, published online Feb. 4, 2013, had some good and bad news for baby boomers. The good news is baby boomers are living longer, the bad news is they are not healthier.  While the boomers were less likely to smoke, have emphysema, or a heart attack, they are more likely to be obese, have diabetes, or high blood pressure than the previous generation at similar ages. However, it's generally accepted that people with hepatitis C are known to smoke, or have smoked more then people without the disease - food for thought. 

COPD Uncovered

COPD Uncovered represents the combined efforts of a multidisciplinary committee of international experts, coming together to explore some of the most important issues in chronic obstructive pulmonary disease (COPD) today. Our aim is to highlight the impact of COPD on active, productive individuals aged from 40–65 years – a population that has been little studied until now, and as a resultis poorly understood.

...26% of people aged between 45 and 67 who were not in work gave up working because of COPD

In 2009, the initial COPD Uncovered report highlighted the serious issues faced by many nations as a result of COPD in the working age population, and raised key questions requiring further evidence and investigation of the disease.

The 2011 COPD Uncovered manuscript, published in the BMC Public Health open access journal, reported findings that significantly advanced our understanding of COPD. The new data included results from an international quantitative survey of more than 2,400 patients with COPD aged 45–67 in six countries, showing the enormous and wide-ranging economic impact of COPD in this group.

This evidence reinforces the original call to action to prioritize the proactive management and early diagnosis of COPD and focuses attention on the benefits of sustaining an active and productive patient population.

Do you have COPD?

If you are over forty and a current or former smoker, visit your doctor if you can answer yes to any of the following questions.

Do you cough regularly?
Do you cough up phlegm regularly?
Do even simple chores make you short of breath?
Do you wheeze when you exert yourself, or at night?
Do you get frequent colds that persist longer than those of other people you know?

Patients with COPD call in sharing their stories 

I leave you with a NPR 2013 broadcast; Fighting To Breathe: Living With COPD, with Grace Anne Dorney Koppel,COPD sufferer and national spokesperson and Dr. Enid Neptune,lung specialist and researcher at Johns Hopkins University School of Medicine. Patients with COPD call in sharing their stories.

Enjoy your family and friends this weekend.
Always Tina

Friday, February 7, 2014

February 2014 Hepatitis Newsletters: Mixing And Matching HCV Drugs

February 2014 

Hepatitis Newsletters

It's almost Valentine's Day folks, will you be purchasing any flowers and candy for that someone special next week? Retailers hope so, the holiday is a billion dollar business, this year consumers will spend close to $1.66 billion on candy, according to an article over at Huffington post.  

The Ten Dollar Liver
Just in time for Valentine's Day, a chocolate liver, waiting to quiver, is available on Craigslist Apparently, the owner went a bit crazy and ordered too many chocolate organs, the site now aspires to sell all fifteen liver looking Valentine treats over the next week. One wonders if all fifteen "Valentine Livers" aren't sold, could they, would they, will they be re-purposed for Easter?

Speaking of chocolate livers, did you see the article published in the January 2014 issue of Journal of HepatologyResearchers suggest drinking more coffee and eating more chocolate - just may be associated with lower levels of liver enzymes in persons living with HIV and hepatitis C.

“Our results provide the first evidence that daily chocolate intake and, more generally, polyphenol rich food intake, may contribute to decreased AST [aspartate aminotransferase] and ALT [alanine aminotransferase] levels and potentially improve liver function in HIV-HCV coinfected patients,” the researchers wrote.  “They also suggest that polyphenols contained in coffee, but also in cocoa, can be involved in the causal process, which leads to reduced inflammation.”

Read a short summary published December 2013 online at Healio, or the full article in the Journal of Hepatology.   

February newsletter Updates
Added February 20, 2014

If you are a baby boomer, you are at risk for hepatitis C. Of the more than 3 million Americans who have hepatitis C, more than 75% were born between 1945 and 1965.

Our core programs are tailored for people of all ages, whether they are living with or at risk for liver disease. The American Liver Foundation® (ALF) implements a variety of education programs about liver health and wellness and ways to prevent, treat and live with liver disease.

Viral Hepatitis Treatment Choices Initiative
Focusing on hepatitis A, hepatitis B and hepatitis C, this program is offered to hospitals, detox centers, prisons and community-based organizations that provide services for addiction and substance abuse. It covers information about the liver, disease risk factors, prevention, coping with the challenges of living with a hepatitis virus and advances in treatment. ALF provides resources and educational materials to help individuals understand how they can go about seeking the treatments they need.

We have many more programs, including those on the local level through ALF’s 16 division offices located throughout the country. For more information about our national and regional programs, call us at 1-800-GO-LIVER (1-800-465-4837).
On January 23, 2014, more than 300 people tuned in to the American Liver Foundation's webinar on hepatic encephalopathy (HE); the first of a four-part webinar series ALF will be presenting on a variety of liver disease topics.
Thirty people from around the country ran nearly 754 miles collectively and raised $106,944 to support the American Liver Foundation®. The ALF Liver Life Challenge®, part of the annual Walt Disney World® Marathon Weekend, took place January 8-12th in Orlando, Florida. Proceeds benefit ALF's national and regional programs.

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Other Updates:

Source - Gastroenterology & Endoscopy News

The combination of daclatasvir plus asunaprevir, both manufactured by Bristol-Myers Squibb (BMS), looks poised to gain approval in Japan for treating patients with hepatitis C virus genotype 1b infection. Experts speculate that BMS will seek approval in the United States for this drug combination at a later date, but with the addition of a third drug, BMS-791325, and for an overall genotype 1 indication. 
Over the next five years, a whirlwind of new direct-acting antiviral agents for hepatitis C are expected to get the green light from the FDA. The recent approval of simeprevir and sofosbuvir–containing regimens is only the tip of the iceberg.

Take your time and browse through this month's informative HCV Newsletters, filled with liver health, research and current news for people treating and living with the hepatitis C virus.

The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education

HCV Advocate Newsletter

In This Issue:

HCV Drug Development News
Alan Franciscus, Editor-in-Chief 
This month's column features the latest information about drugs in development to treat hepatitis C, including impressive results from two articles from the New England Journal of Medicine—AbbVie's interferon-free study and the controversial Gilead and BMS study. Included are pieces about the latest combination trials, and a very interesting drug that may be a one-shot cure—although it is just entering into studies with humans. 

HEALTHWISE: Acetaminophen: Safe or Harmful?
Lucinda K. Porter, RN 
There are two sides to every drug and this applies to acetaminophen, in many ways a wonder drug! 

HCV and Hispanics – Prevalence
Alan Franciscus, Editor-in-Chief 
Finally a study that breaks down the prevalence of HCV in the United States by country of origin instead of lumping everyone under one label—Hispanics.

Jacques Chambers, CLU  
When it comes to disability it is very important to know exactly where you stand especially prior to applying for disability benefits. Jacques outlines the information about presumptive disability programs. 

Lucinda K. Porter, R
In this month's column, Lucinda reviews studies on the prevalence of HCV, a study on the impact of treatment with sofosbuvir/ribavirin on quality of life, as well as an eye-opening study on the manufacturing costs of sofosbuvir, simeprevir, daclatasvir and faldaprevir.
Christine Kukka
In this month's column Chris reviews the following studies that will help you understand the complexities of hepatitis B, including:

Tests for Antigens and Drug-Resistant Virus Emerge as Valuable Diagnostic Tools
Experts Issue a Report Card on Side Effects from Antivirals
Experts Weigh in on Why They Prefer Either Antivirals or Interferon
Doctors Explain Which Medical Guidelines They Follow, Or Ignore
Truvada Effective in Lowering Viral Load in Young Adults with High Viral Load
Hepatitis B Causes Most Liver Cancer Deaths in China
Smoking Shortens Survival after Liver Cancer Surgery

Connect With HCV Advocate

HepCBC Hepatitis C Education and Prevention Society


February Newsletter (PDF)

The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.


Read and Sign the HCV MANIFESTO! 
Show your support for the rights of HCV+ people to live free of discrimination and to access appropriate healthcare.

In This Issue

Gilead Canada's "Momentum" program being set up to enable access to sofosbuvir

In Memorium: Keith Jewell

Mixing and matching HCV drugs from different pharmaceutical companies

Percuro Clinic:Neighbours helping neighbours

Update on "Dale" - patient from rural BC awaiting liver transplant
Preparing for Marathon

Guided Autobiography and Body Mapping Project

Conferences, Medication Assistance, Compensation

HCV Support Groups in Canada


Download February Newsletter Here

Stay Connected


NYC Hep C Task Force
The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community.

NYC Viral Hepatitis Monthly E-Newsletter
February 2014 NYC Hep ABC Newsletter

In This Issue

Hepatitis C: Policy, Action, and What it Means for Communities of Color.
February 13 (3 PM ET)
Presenters: Colleen Flanigan, NYS DOH; Oscar Mairena, NASTAD & Tracie M. Gardner, Legal Action Center.

Improving Health Care of Drug Users
Training (CASAC). February 21st (1-4 pm). Harm Reduction Coalition Training Institute.

Effective Leadership
Training. March 7th.10th. Harm Reduction Coalition Training Institute.
NYS Hep C & Harm Reduction Legislative Advocacy Day.
March 12th, Albany. Get Involved.

International Conference on Viral Hepatitis (ICVH)
(CME). NYC. March 17-18.
NY Hep C ‘Baby Boomer’ Testing Law is in effect!
NYS Hepatitis C Testing Law. 2171 requires healthcare providers to offer hep C test to baby boomers. Requires full diagnostic testing for those who screen anti-body positive and either follow-up health care or referral to a health care provider who can provide follow-up health care.

See new Frequently Asked Questions document from NYS Department of Health.

And more.......

Click here to start reading....

Subscribe to this Newsletter

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Hepatitis Foundation International (HFI)

The Hepatitis Foundation International is dedicated to liver health and the prevention of liver related diseases. We inform and educate by making available reliable and up-to-date facts. We want you to make well-informed decisions for yourself and your loved ones' health and well-being. We are proud to present this website as your personal Internet gateway to hepatitis information and liver care.

The Hepatitis Foundation International is proud to offer this series of very special stories about the people involved in the fight against hepatitis and other liver-related diseases.

You will learn about the courageous lives of people personally affected by the ravages of hepatitis.
You will find uplifting stories of how people engage in the daily fight to bring widespread awareness to the importance of liver health...

Hepatitis Foundation International 


The Liver Lady Speaks...
Feb. 7, 2014 — 

What You Don’t Know CAN Hurt You   

What we don’t know, costs American's billions of dollars and thousands of lives each year.
Billions are being spent caring for chronic liver related diseases that are preventable.  Ignorance about the important role the liver plays in converting the food we eat into hundreds of life sustaining body functions is causing untold suffering and an enormous burden to our national health care system. 

Who is responsible for this lack of basic knowledge?  

Information about the liver has been absent from school curricula for decades. Ignorance is a major contributor to the unintentional development of liver related illnesses later in life. Preventable chronic diseases that depend on healthful selection of foods include: diabetes, obesity, fatty liver, high cholesterol, atherosclerosis, strokes and cardiovascular disease.

We have all heard messages promoting diets that include the basic food groups, vegetables, leaner cuts of meat in smaller portions, and fewer sugary drinks for decades.  Most people are aware that fatty foods can add inches to their waist lines.  What they don’t know is that fatty liver disease is caused by an accumulation of excess fats in liver cells, the chemical converters in their liver.  Fats cause cells to swell up and die.  Dead liver cells are called cirrhosis.  Add a few glasses of wine a day.  Breathe in pollutants and possible exposure to the hepatitis viruses through tattoos or body piercings. Add exposure to hepatitis through unprotected sex, more dead liver cells…more cirrhosis.
However, information to enable everyone to make healthful informed decisions about their own health is missing.  Sadly, individuals unknowingly continue laying the groundwork for future chronic debilitating diseases.

Someone you love could end up with too few healthy liver cells causing the liver to shut down. When your liver shuts down, so do you. Tragically, this can happen without warning of trouble as the liver is a non complaining organ.

How can we expect individuals to make healthful food and lifestyle choices when they are totally unaware of the impact bad choices can have on their future health? We cannot change what we don’t know.

Chubby babies, overweight children and obese adolescents should set off an alarm that liver health education must begin on day one of our lives.  We have made sure our astronauts have a healthy diet while circling the earth.  We need to put as much emphasis on helping children to know why and how to protect their precious liver.  By making healthy food and lifestyle choices as children, many debilitating liver related chronic illnesses could be prevented.

Let’s fill the gap.  Surveys show that individuals who learn about the liver are motivated to avoid liver damaging behaviors. Liver health education is most effective when it begins in pre K and continues through high school.  Where else can we reach a large captive audience when they are receptive to learning?

An investment in prevention through liver health and wellness education can begin saving lives and healthcare dollars today.

For additional information or if you have questions, contact .

Stay Updated

Caring Ambassadors Hepatitis C

The Caring Ambassadors Hepatitis C Program (CAP-Hepatitis C) is a national non-profit organization devoted exclusively to meeting the needs of the hepatitis C community.

The Caring Ambassadors Program mission is to help improve the lives of those affected by long-term diseases through advocacy, information, and support.

Monthly Pubmed Review of the most relevant research on hepatitis C.
View All Monthly Literature Reviews At  CAP Hepatitis C Literature Review 

Hepatitis C news, is an online community for those living with hepatitis C. Join us for news, views and features about hep C, read the real-life experiences of our guest bloggers, and learn about living well with the condition.

New In February @ Hepatitis C News

Hep C and Liver Transplants
February 5th, 2014 For patients with advanced hepatitis C-related liver disease, liver transplants can offer a second chance of recovery for people whose condition has significantly deteriorated.

News Video
Published on Jan 27, 2014
Another monthly dose of all things hep C! This time around we take a look at new legislation in New York that legalizes the use of marijuana for chronic hep C, the growing craze of tattoo parties and the realities of sex and dating with the virus.

Check out
Hepatitis C News YouTube Channel

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Canadian Liver Foundation

News Updates

Canadian Liver Foundation’s Newsroom

Livewell is our e-newsletter exclusively for friends and donors of the Canadian Liver Foundation. Each issue highlights liver health issues, exciting research projects, upcoming events and includes profiles of our outstanding volunteers and donors.

The Livewell newsletter is distributed 4x per year. Please click here to fill in the form and we will be happy to add you to our subscriber list!

CLF updates you and interacts with you on all things liver

Stay Updated

GI & Hepatology News
GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.

January Issue - Please Check Back

Stay connected

Bloggers Corner

Hepatitis C News -Bloggers
Hear from our community of bloggers
Our growing team of contributors from around the world who share their experiences of hep C is a really valuable part of our online community.

Hepatitis C and Exercise
January 31, 2014 8:38 PM
Hepatitis C and Exercise, What are the recommendations? Dr. Joseph Galati M.D. a Hepatologist from Houston, Texas shares valuable information on how we can improve our health and take care of our liver through proper exercise.

Dark chocolate benefits for the liver 
Chocolate has been known uplift the spirit – but what great news that it’s good for our liver too! Dark chocolate, in particular, contains rich antioxidants that help cleanse the liver and control blood pressure, which is important for people suffering liver cirrhosis

Opening Doors to the Latest Hepatitis C Drugs 
 Lucinda K. Porter, RN
Recommendations for "Testing, Managing, and Treating Hepatitis C" carry huge weight, as many medical providers use this expert advice in their own practices. The Recommendations offer all-oral interferon-free alternatives for all genotypes except genotype 5 and 6 hepatitis C patients.

Of Interest

Genotype: Hepatitis C Treatment
News and research is offered on this page with a focus on treatment options for HCV genotypes 1-6 , including FDA approved drugs, and investigational agents currently in clinical trials. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, research manuscripts and interactive learning activities

Hepatitis C Guidelines: The Right Treatment, For the Right Person, For The Right Amount Of Time
Dr Michael Charlton, medical director of Intermountain Medical Center's Transplant Program  talks about the new national guidelines issued this week to manage and treat the hepatitis C virus The new guidelines will have a complex algorithm for practitioners around the country to follow and see whats the right right treatment, for the right patients, for the right about of time.

The Mediterranean Diet For Liver Disease 
There are few things about which I am obsessive, one is bedbugs, the other is dieting.
Clinical research has demonstrated adhering to a diet plan with foods named in the Mediterranean diet may help preserve memory as we age, reduced both liver fat and inflammation, help protect against liver cancer, may have potential benefits for people chronically infected with hepatitis, reduce the risk for diabetes, heart attack and stroke  

Healthy Liver - Healthy Digestion
Did you know in the absence of severe liver damage - no diet for people living with hepatitis C is recommended. However, eating the right foods, careful weight management including exercise can improve overall liver health and aid in digestion. This section of the website offers a quick glance at the above topics with a focus on digestion and a somewhat familiar disorder called Functional Dyspepsia (FD). The medical term simply means - bad digestion, the symptoms vary but are frequently described as a full or bloated feeling after eating. An article provided below about managing FD from Harvard Health offers insight into the uncomfortable disorder which apparently has no clear identifiable cause, or cure.

Health Sites Worth The Click

A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services

In This Issue

February Features

Illustration of a woman clutching a tissue near her face while talking with her doctor, who has a prescription pad handy.
Stop the Spread of Superbugs
Antibiotics can destroy many types of bacteria that can make us sick. Sadly, our overuse of antibiotics is helping to create new drug-resistant “superbugs” that are difficult to defeat.  
 Read more about drug-resistant bacteria.
Illustration of an older man sitting on the edge of his bed and gripping his foot that has a painful swelling at the base of the big toe.

Gripped by Gout Avoiding the Ache and Agony
Sudden, painful swelling at the base of the big toe is often the first warning sign of gout. It can affect other joints as well. The good news is, most types of gout are treatable, especially if caught early.   
Read more about gout.

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ACP Internist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP

Current Issue - February 2014

Look for reasons if patients refuse advicePatient Communication  
Look for reasons if patients refuse advice
By Terri D’Arrigo
Refusal can be frustrating for physicians, who likely see their medical advice as contributing toward healing and improving quality of life. But patients reserve the right to make informed decisions about their care, even if these decisions run counter to what’s been recommended.

Psoriasis symptoms can be tough to address
By Charlotte Huff
A recent survey showed that many psoriasis patients are not satisfied with their care, reporting inadequate relief from such symptoms as itching and scaling. Learn more about clues to diagnosis and suggestions on treating and managing symptoms of both mild and more severe disease.

Home stool test will detect most colorectal cancers
Fecal immunochemical tests (FITs) have high accuracy, high specificity and moderately high sensitivity and can detect about 4 out of 5 colorectal cancers, according to an evidence review.

Washington Perspective
Why 2014 may be a make-or-break year for health reform
By Robert B. Doherty
2014 is shaping up to be a critically important year in determining whether the country moves forward or backward on expanding health insurance to 30 million uninsured persons and providing better consumer protections for many millions more.

Follow ACP On Twitter

Stay safe and healthy, see you soon.


NPR - Maker Of $1,000 Hepatitis C Pill Looks To Cut Its Cost Overseas

Maker Of $1,000 Hepatitis C Pill Looks To Cut Its Cost Overseas

It's not yet clear whether the pricing deal would include middle-income countries, such as India, China and Egypt, which have particularly heavy burdens of hepatitis C.
And activists say that $2,000 is unaffordable to all but the wealthy in most low- and middle-income countries, where governments, insurers or global payers aren't covering hepatitis C treatment.
"We think a $2,000 price tag, although a discount from U.S. prices, is not going to get the job done," says , a policy director of Doctors Without Borders. "It's a discount from a price we think is absolutely outrageous. The way we look at it is, how much does this drug cost to make and what is patients' ability to pay?"
Solvadi can be , Malpani and other critics say, perhaps $68 to $136 for a 12-week treatment course.
Continue reading......... 

Thursday, February 6, 2014

Hepatitis C - Big Pharma pushes for U.S. action against India over patent worries

Big Pharma pushes for U.S. action against India over patent worries

February 6, 2014 4:49 AM ET

By Sumeet Chatterjee and Ben Hirschler
MUMBAI/LONDON (Reuters) - Global pharmaceutical firms are pressuring the United States to act against India to stop more local companies producing up to a dozen new varieties of cheap generic drugs still on-patent, sources with direct knowledge of the matter said.

An Indian government committee is reviewing patented drugs of foreign firms to see if so-called compulsory licenses, which in effect break exclusivity rights, can be issued for some of them to bring down costs, two senior government officials told Reuters.

The drugs that are part of the review process are used for treating cancer, diabetes, hepatitis and HIV, said the sources, declining to give details. No timeline has been given for completion of the review process.

Emerging markets, from South Africa to China and India, are battling to bring down healthcare costs and boost access to drugs to treat diseases such as cancer, HIV/AIDS and hepatitis.
Western drugmakers, including Pfizer Inc, Novartis AG, Roche Holding AG and Sanofi SA, covet a bigger share of the fast-growing drugs market in India.

But they have been frustrated by a series of decisions on patents and pricing, as part of New Delhi's push to increase access to life-saving treatments where only 15 percent of 1.2 billion people are covered by health insurance.
Read More.............

Gilead In The News

Gilead to license hepatitis C drug to lower-cost manufacturers in India
Thu Feb 6, 2014 4:28am IST

(Reuters) - Gilead Sciences plans to license its breakthrough hepatitis C drug Sovaldi to a number of Indian generic pharmaceutical manufacturers, allowing for lower-priced sales of the medication in that developing nation, according to the company.

Although prices for the drug have not been set, company spokesman Nick Francis said in an emailed statement on Wednesday that Gilead aims to establish "tiered pricing."

For example, the price discussed for 24 weeks of Sovaldi therapy would run about $2,500 for certain patients at public hospitals, community clinics and non-governmental agencies in India, the Hindu Business Line reported earlier this week.

"Providing treatment in resource-limited settings presents complex challenges, and we will work with partners in multiple sectors around the world to ensure our access program reaches as many patients as possible," Francis said.
Read More.........

Sovaldi sales help push revenue increases for Gilead Sciences
Boosted by a 15% increase in 2013 antiviral product sales over the previous year, Gilead Sciences announced fourth-quarter sales were up 21% from 2012 and full-year revenues improved by 15%, according to a company press release.

Gilead’s annual product sales climbed to $10.8 billion, up 15% from $9.4 billion in 2012, and the release said the company’s newest product, Sovaldi (sofosbuvir) 400 mg tablets, played a significant role in sales increases. Approved by the FDA in December, Sovaldi is indicated for use in combination with other agents for patients with chronic hepatitis C virus.

The company said Sovaldi sales were “driven by initial inventory stocking, patient demand and a clinical trial order.” Sovaldi is a once-daily oral nucleotide analog polymerase inhibitor for treating patients with HCV genotypes 1, 2, 3 or 4 infection; patients with hepatocellular carcinoma, awaiting liver transplantation; and patients coinfected with HCV/HIV-1.
Read More.........

Tuesday, February 4, 2014

Hepatitis C Guidelines: The Right Treatment, For the Right Person, For The Right Amount Of Time

Dr Michael Charlton, medical director of Intermountain Medical Center's Transplant Program  talks about the new national guidelines issued this week to manage and treat the hepatitis C virus The new guidelines will have a complex algorithm for practitioners around the country to follow and see whats the right right treatment, for the right patients, for the right about of time.

AASLD/IDSA Launches up-to-date guidance for the treatment of hepatitis C

Online Expert Advice for Clinicians Treating Hepatitis C Now Available at

Last week the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society- USA (IAS-USA), announced the launch of a new website,, that will offer up- to-date guidance for the treatment of hepatitis C virus (HCV) infection.

It is estimated that between 3 and 4 million Americans are infected with HCV and have chronic liver disease as a result. The most recent generation of direct-acting antivirals has the potential to cure most patients with HCV. However, the rapid pace of drug development has left medical providers and insurance companies unsure what the optimal treatments are. The guidance provided through will assist clinicians in using these and other treatments in the care of their patients. is the result of an ongoing collaboration between the two medical professional societies and IAS-USA.

New sections will be added, and the recommendations will be updated on a regular basis as new information becomes available. An ongoing summary of "recent changes" will also be available for readers who want to be directed to updates and changes.

ArQule Announces Commencement of Phase 3 Clinical Trial with Tivantinib in Hepatocellular Carcinoma by Partner Kyowa Hakko Kirin in Japan .

WOBURN, Mass.--(BUSINESS WIRE)--February 04, 2014--

ArQule, Inc. (Nasdaq: ARQL) today reported the announcement by its partner, Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151) of the initiation of a Phase 3 clinical trial evaluating tivantinib (ARQ 197) in Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma treated with one prior sorafenib therapy.

The trial is a randomized, double-blind placebo-controlled study to compare progression-free survival (PFS) in patients treated with tivantinib with those treated with placebo. Kyowa Hakko Kirin plans to enroll approximately 160 patients in this study.

"With the commencement of this study, two Phase 3 trials are now ongoing worldwide to evaluate the impact of tivantinib therapy in second line HCC," said Brian Schwartz, M.D., chief medical officer of ArQule. "We are also enrolling patients in the ongoing pivotal, randomized, double-blind METIV-HCC trial, being conducted in the West by ArQule and our partner, Daiichi Sankyo Co., Ltd., under a Special Protocol Assessment (SPA) agreement."

About MET and Tivantinib (ARQ 197)

Tivantinib is an orally administered, selective inhibitor of MET, a receptor tyrosine kinase, which is currently in Phase 2 and 3 clinical trials. In certain healthy adult cells, MET is present in low to normal levels to support natural cellular function, but in some cancer cells, MET is inappropriately and continuously activated. When abnormally activated, c-Met plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. The activation of certain cell signaling pathways, including MET, has also been associated with the development of resistance to EGFR inhibitors such as cetuximab.

Pre-clinical data have demonstrated that tivantinib inhibits MET activation in a range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in the tumors studied. Tivantinib has not yet been approved for any indication in any country.

About ArQule, Inc. and its Partners for the Development of Tivantinib

On December 19, 2008, ArQule and Daiichi Sankyo Co., Ltd. signed a license, co-development and co-commercialization agreement to co-develop tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, areas for which Kyowa Hakko Kirin has exclusive rights for development and commercialization under an exclusive license agreement signed with ArQule in 2007.

About ArQule

ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company's targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule's lead product, in Phase 2 and Phase 3 clinical development, is tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase. The Company's pipeline includes: ARQ 092, designed to inhibit the AKT serine/threonine kinase and ARQ 087, designed to inhibit fibroblast growth factor receptor (FGFR). ArQule's current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP(TM)), are focused on the identification of novel kinase inhibitors that are potent and selective against their targets.

This press release contains forward-looking statements regarding the METIV-HCC clinical trial with tivantinib in hepatocellular carcinoma (HCC) conducted with Daiichi Sankyo and the Phase 3 clinical trial with tivantinib in HCC conducted by Kyowa Hakko Kirin as well as the Company's agreements with both Daiichi Sankyo and Kyowa Hakko Kirin. These statements are based on the Company's current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that tivantinib alone or in a combination therapy will demonstrate promising therapeutic effects in pivotal or other trials; in addition, tivantinib may ultimately not demonstrate an appropriate safety profile in later stage or larger scale clinical trials, such as METIV-HCC or the Kyowa Phase 3 trial in HCC, including among patients with underlying cirrhosis and compromised liver function, as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing tivantinib that could lead the Company, Daiichi Sankyo or Kyowa Hakko Kirin to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from analyses of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities, and regulatory authorities may disagree with the Company's view of the data or require additional data or information or additional studies. In addition, the planned timing of completion of clinical trials like METIV-HCC or the Phase 3 HCC trial conducted by Kyowa Hakko Kirin is subject to the ability of the Company or its partners to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome ongoing or emergent regulatory issues and address other technical hurdles and issues related to the conduct of the trials for which each of them is responsible that may not be resolved promptly, or at all. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. Moreover, Daiichi Sankyo and Kyowa Hakko Kirin have certain rights to unilaterally terminate the tivantinib license agreement with the Company. If it were to do so, the Company might not be able to complete development and commercialization of tivantinib on its own. For more detailed information on the risks and uncertainties associated with the Company's drug development and other activities, see the Company's periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements. CONTACT: ArQule, Inc.

William B. Boni, 781-994-0300

Monday, February 3, 2014

Hepatitis C: Gilead, in talks to bring Sovald (sofosbuvir) into India

Mumbai, February 3:

Gilead, local generic players in talks to bring hepatitis C drug into India
PT Jyothi Datta

California-based drug-maker Gilead Sciences Inc is in discussions with a handful of local pharmaceutical companies to bring its much anticipated oral Hepatitis C drug Sovaldi (sofosbuvir) into India.

“We are going to give licence to Indian companies, so there will be Indian production of our hepatitis C product. We are in discussions right now. We hope to announce those in the next couple of months,” Gregg H Alton, Gilead’s Executive Vice- President, Corporate and Medical Affairs, told Business Line.

Gilead’s move comes at a time when the patent on sofosbuvir is being contested at the Kolkata patent office. The opposition was filed late last year by US-based legal group I-MAK (Initiative for Medicines, Access & Knowledge).

On how the drug would be priced, Alton said the imported and locally-made versions would be pegged lower than the current standard of care with existing generic products, estimated at $2,500 (around ₹1.5 lakh) for six months.

Gilead proposes to peg its imported branded product at about $2,000, he indicated, adding discussions were under way with patient-groups before the price is finalised. “We’ll be substantially less than that (current standards of care), and we’ll be more effective, less toxic and easier to use and without side-effects… We leave it up to the Indian companies to bring the price down – should they choose to do that,” he added.

You need three or more companies to compete against each other to truly get the cost down, and “so, we’ll be working probably with three-to-five different companies”, he said. In the US, Gilead’s drug is priced at $84,000 for 12 weeks.

Gilead’s soon-to-be sealed deal will include royalty payments and cover about 60 low and middle-income countries, he said, adding details were discussed during their latest visit to India.

Without getting into details on the patent case, Alton said: “We will defend the patents, but at the same time, we are going to be pushing very hard to enable generic production in India with multiple companies.”

By traditional timelines, it would take at least two years before the product is available in India, said Alton.

Clinical trials to test the drug on the local population have been approved and efforts are on to fast-track this process, he added.

About 15 sites have been identified to run Phase III trials on the drug, involving about 120 people.

Touted to be among “the biggest breakthroughs in medicine in the last 10 years”, Alton said the drug was launched in the US last December, and Gilead and its partners were working to bring it to India soon.

(This article was published on February 3, 2014)

Sunday, February 2, 2014

The Mediterranean Diet For Liver Disease

The Mediterranean Diet 

There are few things about which I am obsessive, one is bedbugs, the other is dieting.

For decades advertisements have inspired or tricked us, me mostly, into trying a number of crazy diets. 

For whatever reason folks, years ago, I never met a diet I didn't try.

In my twenties I inhaled the cabbage soup diet, gave up eating anything white during Christmas, even juiced for a few days, and really committed to that cookie diet.  

In my thirties I embraced Dr. Atkins’ Diet Revolution, eggs became my dinner, bacon became my steak, and the water weight I lost impressed my scale.

In my late thirties at a Weight Watchers meeting I met a handsome vegetarian, I dumped the meat, he dumped me, and I moved on to Jenny Craig. Such is life.

In any event, with age comes wisdom. One day, I sat down and looked at my own medical history along with my families, took a few notes to present to my physician. At my very next appointment we discussed any risk factors for disease, such as heart disease and diabetes. Long story short, in the end because of my history of HCV and high risk for diabetes he suggested I try the Mediterranean diet, I took his advice. 

The Mediterranean Way Of Eating - My First Non-Diet Approach To Eating Right

For the last fifteen years I have adopted the Mediterranean way of eating, commonly referred to as the Mediterranean diet. Although, it isn't really a diet, the name evolved as a way to reference a group of healthy foods, or a diet pattern used by people whose countries border the Mediterranean Sea. In these countries, especially Greece, people eat a lot of fruits, vegetables, legumes fish and olive oil.  According to years of research, people living in this region suffer less than most Americans from cancer and cardiovascular disease. 

Everyone should eat a healthy, balanced diet to maintain their health, especially people living with chronic illness. Maintaining a healthy weight is especially important if you have HCV, the risk for developing scarring of the liver; fibrosis and cirrhosis is higher in people who are obese and living with the virus.

Diets come and go, as do hot vegetarians, but for people with liver disease eating foods proven to help preserve, or even improve overall liver health is worth the effort.

Today close to 30% of American adults have nonalcoholic fatty liver disease (NAFLD). In people living with hepatitis C it rises to around 40% and even higher in people with genotype 3. Often referred to in the medical world as HCV-induced steatosis, 60% to 80% people with genotype 3 have moderate or severe steatosis.

So What Is HCV-induced Steatosis?

Fatty liver disease (steatosis) is a build-up of excess fat in the liver cells, and in some cases may trigger inflammation of the liver.  HCV-induced steatosis develops due to a combination of viral and host factors. Viral factors are genotype specific, with genotype 3 viral-induced steatosis the most common, up to 80% of people with genotype 3 have moderate to severe steatosis. Chronic hepatitis C also alters glucose metabolism resulting in insulin resistance (IR), further promoting hepatic steatosis, which outside of genotype 3 infection has been associated with more advanced liver disease, according to a review published in last months issue of the Journal of Viral Hepatitis. 

Another study published in Nutrition 2013, found HCV patients who participated in a diet and exercise program lowered their grade of steatosis and remarkably, their fibrosis score.

For most people, I raise my hand in shame,  diets are something we jump on and jump off, but eating right is better accomplished when we make it more of a lifestyle. Rather it originated on the boarder of the Mediterranean Sea, or here in the U.S., it only works when we embrace it as a way of life. 

America - Suggested Nutrition Guidelines

In the United States the USDA Dietary Guidelines for Americans, is intended to help people choose an overall healthy diet, based on five food groups. The dietary guide is put together jointly by the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA). A committee of scientific experts review the guide which is  incorporated into a scientific evidence-based report, the next edition will be released in 2015.

The dietary recommendations are aimed at preventing two major health problems in the U.S., which are obesity and heart attacks. Obesity can sneak up on us overtime, the older we get the more calories we consume, more than the body burns. Obesity in turn can cause numerous health problems, such as heart disease, stroke, liver disease, arthritis, high blood pressure, gout, gallstones, and even certain cancers.

In June 2011, the USDA launched a visual guideline depicting a place setting using the five food groups, called  MyPlate. It proved successful and replaced our some twenty year old food pyramid.

Check out this interactive website; ChooseMyPlate, find tons of advice on nutrition, watch a few videos, grab a recipe or take part in an educational program.

 Follow MyPlate on twitter for daily tips.

Cooking according to MyPlate guidelines is possible in any culture, rather you come from Europe, Asian or American. In the video Cris Comerford, prepares an authentic Filipino dish following the MyPlate guidelines and portion size.

For Chef Comerford's recipes, go here:

Healthy and Traditional Asian American and Pacific Islander Cuisine

Shrimp, Chicken and Vegetable Fried Rice

Links: features practical information and tips to help Americans build healthier diets

The Mediterranean Diet
As previously mentioned, this is my preferred way of eating. The program includes a high consumption of olive oil, legumes, unrefined cereals, bread, pasta, rice, nuts with less red meat and dairy products than many other diets. Although, red wine is used in moderation, it has never been advisable for people living with hepatitis C, or advanced liver disease. Other food choices are lots of fresh fruit, vegetables and moderate consumption of fish. Fish is rich in omega-3 fatty acids and low in saturated fats. Omega-3 fatty acids can help lower triglycerides and blood pressure.

Clinical research has demonstrated adhering to a diet plan with foods named in the Mediterranean diet may help preserve memory as we age, reduced both liver fat and inflammation, help protect against liver cancer, may have potential benefits for people chronically infected with hepatitis, reduce the risk for diabetes, heart attack and stroke - Whew!  Provided a research summary of the above mentioned health benefits, followed up with a link to each original article and research.

Mediterranean Diet and Memory

Omega-3 fatty acids are also known to benefit the brain and nervous system. A study in the journal Neurology, January 2013, reported adhering to a Mediterranean diet may help to preserve memory.

U.S. researchers studied 17,478 people with an average age of 64 by monitoring their eating habits, and testing their mental ability over a four year period. In that time, 7% developed problems with their memory and ability to think. Those who ate a Mediterranean diet had a 19% reduced risk of mental impairment. 

Mediterranean Diet and Liver Disease

Previous studies have suggested the Mediterranean Diet has additional benefits for people with liver disease, for instance a study published in the July 2013 issue of the Journal of Hepatology demonstrated patients with nonalcoholic fatty liver disease who followed the diet for six weeks not only significantly improved insulin sensitivity, but reduced both liver fat and inflammation.

Mediterranean Diet, Hepatocellular Carcinoma and Viral Hepatitis

This is exciting, according to a study found in the Journal of Hepatology, November 2013;
A closer adherence to the Mediterranean diet appears to be protective against HCC (liver cancer). Our results also point to potential benefits from adhering to a Mediterranean dietary pattern for patients chronically infected with hepatitis viruses. 

Read the full article over at NATAP, abstract here.

Mediterranean Diet and Diabetes

A recent study found patients at high risk for diabetes due to pre-existing cardiovascular conditions reduced the risk for diabetes by 40% by adhering to the traditional Mediterranean diet high in extra-virgin olive oil intake. View the study; Prevention of Diabetes With Mediterranean Diets: A Subgroup Analysis of a Randomized Trial, published in Annals of Internal Medicine -  

Mediterranean diet  and Heart Attack and Stroke

2013-Mediterranean diet  and Heart Attack and Stroke:

Published in the February 2013 online issue of the New England Journal of Medicine, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events (heart attack, stroke, cardiovascular death) by close to 30%, among people with high cardiovascular risk.

A total of 7447 persons were in the study (age range, 55 to 80 years); 57% were women. None had cardiovascular disease when they enrolled in the study, but they did have a high cardiovascular risk.
The participants were broken down into three cohorts. The first group followed a Mediterranean diet with extra-virgin olive oil, the second a Mediterranean diet supplemented with nuts, and the last group (control) followed a low-fat diet. Statistical analysis showed that compared to those following the control (low-fat) diet, participants on the Mediterranean diet with extra-virgin olive oil were 30% less likely to experience a cardiovascular event, and those on the Mediterranean diet with nuts were 28% less likely. Researchers reported on the importance of the results  "... the results of the PREDIMED trial are of utmost importance because they convincingly demonstrate that a high vegetable fat dietary pattern is superior to a low-fat diet for cardiovascular prevention."

Read the article, here 

2014-Mediterranean diet: lower risk of peripheral artery disease (PAD):

A multicenter study that previously reported a reduction in heart attack and stroke with a Mediterranean diet supplemented with extra-virgin olive oil or with nuts now also reports a lower risk of peripheral artery disease (PAD), according to a study in the January 22/29 issue of JAMA.

"To our knowledge, this is the first randomized primary prevention trial to suggest an association between a dietary intervention and [reduction in] PAD. These results are consistent with previous observational studies and relevant from a public health perspective," the authors write.
Read the article here..........

****Related- Feb 2014:Increased prevalence of coronary artery disease risk markers in patients with chronic hepatitis C – a cross-sectional study
Chronic hepatitis C is a global health problem and has been associated with coronary artery disease. Our aim was to examine the prevalence of coronary artery disease risk markers including endothelial biomarkers in patients with chronic hepatitis C and matched comparisons without manifest cardiovascular disease or diabetes in a cross-sectional design.
Mediterranean Diet and Longevity 

A few months ago, an observational study published in the Annals of Internal Medicine , November 2013 issue, suggested middle-aged women who follow a Mediterranean diet may live longer.

The 15 year study primarily funded by the National Cancer Institute, National Institutes of Health, examined 10,670 women aged late 50s and early 60s.

The purpose of the study was to examine the association between dietary patterns in midlife and prevalence of healthy aging.

In the end, after 15 years, middle-aged women who followed the Mediterranean diet had a 40% more chance to live up to age 70, then those who followed a different eating style.

Read more about the history of the diet, here.  

What Is the Mediterranean Diet?

Excerpt: The Mediterranean Diet and Good Health
There is no one typical Mediterranean diet. Many countries border the Mediterranean Sea and variations in the Mediterranean diet exist between these countries. However, according to the American Heart Association, traditional Mediterranean diets have the following characteristics in common:

An abundance of plant foods:
Breads and cereals
Beans, nuts, and seeds

Olive oil used as a common monounsaturated fat source
Low-to-moderate amounts of fish and poultry
Small amounts of red meat
Low-to-moderate amounts of dairy products (mostly cheese and yogurt)
Low-to-moderate amounts of eggs (zero to four times per week)
Low-to-moderate amounts of wine (one to two glasses of wine per day), normally consumed with meals

* Skip the wine if you hepatitis C or advanced liver disease 

Comparison With the American Diet

 The American diet is characterized by:

Animal products daily, as main source of protein
White starches, predominantly
Moderate to low in fruits and vegetables
High in saturated and trans fats

Unlike the typical American diet, the traditional Mediterranean diet is high in fiber and low in saturated fat. However, the Mediterranean diet is not necessarily low in total fat. But, the types of fats emphasized in the Mediterranean diet are "healthy" monounsaturated fats, like those found in olive oil, which do not raise cholesterol levels.
Read more here........ 

Mediterranean diet: A heart-healthy eating plan
Mayo Clinic Staff
How to Follow the Mediterranean Diet
Offers a quick guide
The Mediterranean diet: 4 recipes to try  
You've heard the health benefits of the fruit & fish-packed Mediterranean diet, now it's time to test it out in the kitchen. We turned to ‘Cook Yourself Sexy’ chef Candice Kumai for these delicious recipes, loaded with omega-3s and nutrients.

The goal of healthy eating is to develop a plan that you can maintain for life. For people living with hepatitis C,  keeping your weight under control can lower your risk for developing fibrosis, liver cancer, and diabetes.

Whatever healthy plan you try, or use now, may you remain safe, healthy and happy.

Until next time, Tina