Monday, February 28, 2011

February Ends With A Jolt Of Hepatitis C News Today Folks

In Portsmouth, Ohio parents are engaged in a war void of any sustanial ammunition needed to combat the enemy. OxyContin continues to hold their children hostage in some cases even taking the lives of young and impressionable adolescents. The epidemic is so severe that located in the communities downtown store window is a memorial to those people who have died from prescription drug overdoses. The town is overcome with IV drug use with the cases of hepatitis C reaching new heights. Prescription drug use has become a national crisis, according to a 2010 released White House study detailing that substance abuse treatment admissions for prescription pain relievers increased by 400 percent between 1998 and 2008.

MIAMI, Feb. 28 (UPI) -- A U.S. Army veteran who turned up positive for HIV following a colonoscopy has filed a $20 million suit against the Veterans Administration.

Transmitted resistance to HIV drugs sharply increases the risk that a patient's first anti-retroviral regimen will fail, researchers reported.

CROI: Nurses Can Manage HIV Therapy19 minutes ago BOSTON --
Patients with HIV whose antiretroviral therapy was managed by nurses at regional clinics in South Africa did just as well as those whose care was handled by physicians at larger hospitals, researchers reported here.

By: MARY ANN MOON, Internal Medicine News Digital Network02/24/11A sustained virologic response to antiviral therapy signals a favorable prognosis in patients with decompensated cirrhosis due to chronic hepatitis C, reported Dr. Angelo Iacobellis and his colleagues in the March issue of Clinical Gastroenterology and Hepatology.
The Bristol-Myers Squibb Foundation has awarded four new grants to help improve awareness, prevention and care of hepatitis B (HBV) and hepatitis C (HCV) in China and India. The grants total nearly $1 million USD and bring...

Big Pharma; Johnson & Johnson

Vertex and partner Johnson & Johnson= Telaprevir
Johnson & Johnson=TMC435
Outsourced; Extra Strength Tylenol Rapid Relief Gels
In 2009/2011 Recalled because of safety concerns; Johnson & Johnson’s Children’s Tylenol, Tylenol Arthritis Pain Caplets, Extra Strength Tylenol Rapid Relief Gels. The latter was traced to a fungicide that originated from a Puerto Rican plant.

Food and Drug Administration Commissioner Margaret Hamburg, M. D., said in July 2011, according to The Buffalo News.“Up to 40 percent of the drugs Americans take are imported, and up to 80 percent of the active pharmaceutical ingredients in those drugs come from foreign sources,”

Telaprevir; Vertex, supposedly has hooked up with Shasun chemicals headquartered in India, as noted; Shasun pharmaceutical chemical manufacturer obtained a contract from Vertex Pharma for manufacturing telaprevir. Vertex will source the entire supply from Shasuns UK subsidiary
Feb 25
The lawsuit was filed by Scott Bartz, a New Jersey resident who worked as a sales compensation manager from 1999 until 2007, when he alleges he was terminated in retaliation for repeatedly complaining about illegal marketing practices. His lawsuit also names the Omnicare nursing home operator and McKesson, the pharmaceutical wholesaler.

Feb 25
Here’s a lesson for a board of directors: never let a few setbacks deter you from giving your chief executive a raise, however modest. Consider Johnson & Johnson ceo Bill Weldon. Despite a breathtaking number of recalls spanning nearly every corner of the health care behemoth - over-the-counter meds, contact lenses, syringes, hip replacement devices - he received a 3 percent pay hike. His new base salary is $1.92 million, up from $1.86 million, according to a filing with the US Securities and Exchange Commission.

Feb 25
The health care giant just can’t seem to do anything right. On top of all the quality-control problems that have led to tens of millions of product recalls for over-the-counter meds, syringes, contact lenses and hip replacement devices, now Johnson & Johnson is recalling more than 660,000 Sudafed packages because the labeling has an extra ‘not’ in the instructions. Really.

Hall Of Shame ; Pfizer
Feb 25
Two years ago, Pfizer trumpted a deal in which Aurobindo, a large supplier of active pharmaceutical ingredients that is based in India, would make a few dozen generic meds for the brand-name drugmaker. The move was part of a grand plan to expand into generics with lower manufacturing costs and revive growth as patents on big-selling, brand-name meds began expiring.

Healthy You

Taking too many dietary supplements
Very little convincing evidence exists that shows supplements are important to slow or prevent illness, said Dr. Ann Zerr, Indiana University School of Medicine physician specializing in women's health.
Calcium and vitamin D are exceptions, and omega-3 fish oil supplements may be worthwhile, she added.
If you don't focus on fruits and vegetables and whole grains in your diet, then a multivitamin is probably a good idea, Zerr said. But taking other vitamin pills is expensive and unnecessary - and those that are fat-soluble can be harmful.

One alcoholic drink a day seems to be beneficial for the heart and for diabetes prevention, Zerr said. Women have less muscle mass than men, so their ability to metabolize alcohol is different, and they can't safely handle as much.

"I see a lot of professional women drink more than one alcoholic drink a day," she said. "More than one seems to increase the risk of head and neck cancers and liver irritation."
Drinks Companies Spread Liver Disease as Surely as Mosquitoes Do Malaria
Opinion Anna Gilmore, professor of public health at the University of Bath and the UK Centre for Tobacco Control Studies, and a Health Foundation clinician scientist; and Jeff Collin, director of the Global Public Health Unit at Edinburgh University (The Guardian, London, online, February 21, 2011)"While the government sees food and alcohol companies as partners in health policy, public health increasingly recognises them as vectors of disease. The vector concept, adapted from infectious disease control, is simple: liver disease and myriad other health and social problems are being spread by alcohol companies just as the mosquito vector spreads malaria. The conduct of these corporate vectors should therefore be studied and where necessary countered."
Complementary Medicine / Alternative Medicine News
Do Home Remedies for Hepatitis C Work?
February 28, 2011
Determining if home remedies for Hepatitis C actually work depends on which remedies are being used and what the treatment goal is.
Off The Cuff

In case you missed it.......

Vertex (Telaprevir) and Merck (Boceprevir) .

In its RESPOND-2 study, Merck defines a null responding patient — someone who is faring the worst under the current standard of care — as a patient whose viral load decreased less than 1 log after four weeks of standard treatment. That's a considerably different criteria from the US Food and Drug Administration, which defines null responders as 'less than a 2 log10 reduction in HCV RNA at week 12'.

Vertex used the FDA's definition of null responder in its study, REALIZE. Since both companies are trying to show that their protease inhibitor works better for patients for whom current options have failed, there is a remote chance that Merck's numbers might paint an artificially rosier picture."The original article from In Vito ; Notes from AASLD: Apples and Oranges and Null Responders
Most Medical Devices Recalled Because of Serious Risks Did Not Undergo Clinical Trials
Most medical devices recently recalled by the Food and Drug Administration because of very serious risks were initially approved through an expedited process or were exempt from regulatory review, ...

Amber Dance(Los Angeles Times, February 21, 2011)
"Heart bypass patients may soon be able to get new arteries without having to sacrifice vessels from other parts of their body, thanks to ready-made, off-the-shelf artificial blood vessels…Artificial vessels could also be useful for people on kidney dialysis machines…There is plenty of testing left to do, in terms of safety and effectiveness of the transplants."

What's the big deal about accepting gifts from drug companies, especially if they are small? Does the medical profession's code of conduct apply to medical students?
Response from Sarah Averill, MD Resident, St. Joseph's Hospital and SUNY Upstate Medical University, Syracuse, New York
When a new pain medication came out last year, the staff in the office where I was rotating discussed how many prescriptions they were writing for that drug and how much they liked the fruit smoothies and gelato that the drug company representatives were bringing. "I don't like gelato," one secretary quipped. "More for us," laughed the physician assistants.
It was weird for me to overhear their conversation, and it made me wonder, did a fruit smoothie actually motivate them to write those prescriptions?

Indeed, evidence suggests that gifts do influence prescribing habits. An article in JAMA, Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?, illustrates the ways in which gifts appear to influence prescribing.[1] A recent radio broadcast, How to Win Doctors and Influence Prescriptions,[2] documented how the pharmaceutical industry promotes their products. Even under new rules, there is strong evidence that the pharmaceutical industry takes a sophisticated approach to "educating" physicians and their staff....

From The Big Guys At Wall street

Question: What does silver mining have to do with selling plane and hotel tickets online? What do either of these activities have in common with the treatment of hepatitis C? Answer: Companies behind these endeavors boast some of the hottest stocks on the market today. Over the past year, priceline's share price has doubled, while shares of InterMune and Silver Wheaton have both gained roughly 170%.
In Closing
Members of the Peer Education Project in Fife talking about the impact it has had on their life and dealing with Hepatitis C. The project is run by the Hepatitis C Resource centre -


Sunday, February 27, 2011

Decompensated Cirrhosis Due to HCV:SVR Signals Good Prognosis

SVR Signals Good Prognosis in Decompensated Cirrhosis Due to HCV

By: MARY ANN MOON, Internal Medicine News Digital Network

A sustained virologic response to antiviral therapy signals a favorable prognosis in patients with decompensated cirrhosis due to chronic hepatitis C, reported Dr. Angelo Iacobellis and his colleagues in the March issue of Clinical Gastroenterology and Hepatology.

Mean survival was 20 months longer in patients who achieved a sustained virologic response (SVR) with antiviral therapy than in patients who did not achieve SVR (73 vs. 53 months; P = .004). Thus, antiviral therapy "might represent a life-sparing intervention" for patients who have progressed to the stage of liver decompensation and who aren’t eligible for liver transplant, said Dr. Iacobellis and his associates at Casa Sollievo della Sofferenza in San Giovanni Rotondo, Italy.

The authors previously reported on the short-term benefits of pegylated interferon alfa-2b plus ribavirin in patients whose cirrhosis had caused at least one episode of decompensation, as evidenced by esophageal bleeding, ascites, or hepatic encephalopathy. However, "for cirrhotic patients with advanced disease, achieving a sustained virologic response might be only a cosmetic goal of low clinical relevance if it does not guarantee a positive impact on their poor prognosis."

Therefore, Dr. Iacobellis and his colleagues studied the survival rates after 5-year follow-up in 75 patients (mean follow-up, 51 months; range, 3-78 months). A total of 24 patients achieved an SVR with either standard dosing (13 patients) or a low-dose regimen (11 patients).

"The main finding of our study was the improved survival of patients who attained a sustained virologic response." Mean survival was 73 months in patients who achieved an SVR, compared with 53 months in those who did not (Clin. Gastroenterol. Hepatol. 2011 March [doi:10.1016/j.cgh.2010.10.036]).

In all, 25 patients died during follow-up. Only two patients (8%) who had achieved SVR died, both of them from liver disease. In contrast, 23 of the 51 patients (43%) who had not achieved a sustained virologic response died – all but one of them from liver disease.

During follow-up, only 8 of the 24 treatment responders (33%) experienced further decompensation events such as bleeding, ascites, sepsis, or development of hepatocellular carcinoma. In contrast, 49 of the 51 treatment nonresponders (96%) experienced further decompensation events; this was a highly significant difference (P less than .0001).

There were 20 adverse events requiring hospitalization among the treatment responders, compared with 137 in treatment nonresponders. Readmission rates were eight times higher among nonresponders: 56 per 1,000 person-months, compared with 7 per 1,000 person-months for responders.

However, the achievement of SVR did not appear to affect the development of hepatocellular carcinoma. The malignancy developed in 21% of patients who had achieved an SVR and 22% of those who had not. The incidence rates were 3.7 per 1,000 person-months and 4.5 per 1,000 person-months, respectively, which was not a significant difference.

"This finding reinforces the concept that decompensated cirrhosis is a unique step of liver disease, in which derangement of liver architecture assumes a negative prognostic role on the probability of developing hepatocellular carcinoma," the investigators said.

"It is also worth noting that only 1 patient who attained a sustained virologic response was transplanted for hepatocellular cancer development, without a reinfection of the liver graft. In contrast, of the 7 patients without a sustained virologic response [who were approved for a liver transplant], 6 died while on the waiting list and 1 grafted patient had immediate [HCV] reinfection of the graft," they added.

This study received no industry support. Dr. Iacobellis and his associates reported no financial conflicts of interest.

Videos; Hepatitis C Quick View

What is hepatitis C?

To what extent is hepatitis C an economical problem?

How common is hepatitis C?

Who is at risk of having hepatitis C?

What are the health consequences of chronic hepatitis C?

What is the goal of hepatitis C treatment?

What is the impact of not treating?

How can hepatitis C treatment be improved?

What does the future hold?

Pulmonary hypertension

'Pulmonary hypertension... A breathtaking disease'

European awareness campaign launched on Rare Disease Day

"Although it can occur alone, PAH is often associated with other diseases such as congenital heart diseases, chronic liver disease or connective tissue diseases."

Little-known but life-threatening condition literally takes the breath away from several million people globally1

Brussels (Belgium), Vienna (Austria), 28th February 2011 /PRNewswire/ — Events taking place today in Brussels and Vienna mark the launch of a new European campaign to raise awareness of pulmonary hypertension (PH), a condition characterized by high blood pressure in the arteries of the lungs which can affect anyone at any age and can kill.2 Improved diagnosis and awareness of PH are urgently needed to increase understanding and help to support those living with the serious condition, which can severely restrict a person's ability to carry out normal daily activities,3,4 and can lead to heart failure and death.2 The mortality rate of pulmonary arterial hypertension (PAH), the more rare form of PH, can be higher than that of certain forms of cancer including breast and colorectal cancers.5,6

The Breathtaking campaign is being led by the Pulmonary Hypertension Association Europe (PHA Europe) and supported by Bayer HealthCare. The events in two European cities will be followed by a range of awareness-raising activities in countries across Europe*. The events are taking place in Brussels Central Station and Schwedenplatz, Vienna. Thought provoking activities in both locations reflect the difficulties that patients with PAH face on a daily basis.

"Most people have not heard of the rare disease pulmonary arterial hypertension let alone know the symptoms or understand the huge struggle that patients living with the disease face every day such as simply climbing stairs", said Gerry Fischer, President, PHA Europe. "Even though PAH is a rare disease with a prevalence of about 50 cases per million, awareness and early diagnosis are relevant issues. This is an important campaign for PHA Europe which aims to boost awareness and provide a greater understanding of the deadly disease, as we work towards providing better support and a brighter future for patients and their families."

PAH is a rare but progressive disease which affects the lungs and heart.2 The extreme and often unexpected breathlessness, weakness and fatigue which can be caused by PAH, have a dramatic impact on a patient's quality of life, making simple everyday tasks, such as climbing the stairs, walking short distances and getting dressed, difficult.7,8 With earlier diagnosis and treatment, almost two-thirds of PAH patients can survive for longer than five years,5,7 but in spite of this, diagnosis is often delayed by up to two years.9

"The early symptoms of pulmonary arterial hypertension can be vague and unspecific; people may feel breathless, weak and tired," said Dr Nazzareno Galiè, Associate Professor of Cardiology, University of Bologna. "Currently the knowledge of the differences between the various types of PH in the medical community appears to be insufficient, and the lack of accurate differential diagnosis can lead to inappropriate, off-label use of drugs which are specifically approved for the more rare form of PH, PAH. This may lead to increased risks for the patients rather than the expected benefits of the medical therapy. The strict observation of the joint Guidelines of the European Society of Cardiology and the European Respiratory Society on PH diagnosis and treatment is relevant in optimizing patient management."10

Although it can occur alone, PAH is often associated with other diseases such as congenital heart diseases, chronic liver disease or connective tissue diseases. In most cases PAH has no known cause and in rare cases it can be inherited.2

There are five main types of PH, all of which affect people in different ways.11 PAH is the more rare type of PH (with a prevalence of approximately 50 cases per million)12 and the only type for which effective and approved medications currently exist.13 However, currently available medications for PAH all have significant limitations and no approved medications exist for the other types of PH.13,14 As a result, there is a need for more research to improve understanding of how all five types of PH can be diagnosed and treated effectively.9,13


About the Breathtaking campaign
The objective of the Breathtaking campaign is to increase awareness of PH among the general public and the medical community with the aim of creating an environment in which better care, earlier and more accurate diagnosis and more research can become a reality. Activities to launch the campaign include events in:

Vienna: Commuters passing through busy Schwedenplatz on the morning of the 28th February will have their attention grabbed by a Breathtaking branded bus. Representatives of PHA Europe will be in attendance to educate people about PH, answer their questions and hand out leaflets and themed give-aways.
Brussels: Commuters travelling through Brussels Central Station on the morning of the 28th February will have the opportunity to learn more about PH, and PAH particularly, as they climb the station stairs on the way to work. Representatives of PHA Europe, Pulmonary Arterial Hypertension Belgium and Pulmonary Hypertension Belgium, will be on hand to inform people about PH and hand out leaflets and give-aways.
*Awareness activity will also take place in: Bulgaria, Czech Republic, Germany, Hungary, Norway, Poland, Portugal, Spain, Italy and finally outside of Europe in Latin America.
As well as the on-the-ground activity, a virtual campaign will take place:

Facebook application
Facebook users can support the Breathtaking campaign by downloading an application (app). The app allows users to send their friends a 'blue kiss' to raise awareness of PH. The 'blue kiss' was developed to represent the blue lips characteristic of the disease. Visit to send your 'blue kisses'.
YouTube patient video diary
Visit to view a video diary revealing what it is like to live with PH on a day-to-day basis.


About Rare Disease Day
The 28th of February 2011 marks the fourth International Rare Disease Day coordinated by the European Organization for Rare Diseases (EURORDIS) with the support of rare disease national alliances in 25 countries. Rare Disease Day is an annual awareness-raising event coordinated at an international level by EURORDIS and driven at a national level by National Alliances of Patient Organisations. Every year Rare Disease Day aims to remind people of the importance of rare diseases and the particular challenges faced by those who live with them. Please visit the Rare Disease Day website for more information about the event:

About Pulmonary Hypertension Association Europe
Pulmonary Hypertension Association Europe (PHA Europe) is an umbrella association of national patient organizations working in the field of pulmonary hypertension. The primary objective of PHA Europe is to establish a narrow cooperation between the members, the European institutions, international organizations and public institutions worldwide. For more information about PHA Europe, please visit:

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 15,988 million (2009), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 53,400 employees and is represented in more than 100 countries. Find more information at:

For more information:
Gemma Pritchard
Ketchum Pleon
+ 44 207 611 3641

PHA Europe
Pisana Ferrari
Vice President
+39 3484023432

PHA Europe
Gerry Fischer
+43 14023725


BSP data on file.
McLaughlin, VV et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension. J Am Coll Cardiol 2009 28;53(17):1573-619.
Chen, H et al. Health-related Quality of Life and Patient-reported Outcomes in Pulmonary Arterial Hypertension. Proc Am Thorac Soc 2008;5:623-630.
McKenna, S et al. The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR): A measure of health-related quality of life and quality of life for patients with pulmonary hypertension. Quality of life Research 2006;15:103-115.
Ruiz-Cano, M et al. Comparison of Baseline Characteristics and Survival between Patients with Idiopathic and Connective Tissue Disease-related Pulmonary Arterial Hypertension. J Heart Lung Transplant 2009;28:621-627.
Verdecchia, A et al. Recent cancer survival in Europe: a 2000-02 period analysis of EUROCARE-4 data. Lancet Oncol 2007;8:784–96.
PuckerUp4PH website Accessed: January 2010.
PHA UK website. Available from: Accessed: January 2010.
Peacock, A. Treatment of Pulmonary Hypertension. BMJ 2003;326;853-836.
Galiè, N et al. Guidelines on diagnosis and treatment of pulmonary hypertension: The Task Force on Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology and of the European Respiratory Society. Eur Heart J 2009;30:2493-2537.
Rosenkranz, S. Pulmonary hypertension: current diagnosis and treatment. Clin Res Cardiol 2007; 96(8):527–41.
Peacock, AJ et al. An epidemiological study of pulmonary arterial hypertension. Eur Respir J 2007;30:104–109.
Galiè, N et al. Pulmonary hypertension and pulmonary arterial hypertension: a clarification is needed. Eur Respir J 2010 Nov;36(5):986-90.
Girgis, RE. Emerging drugs for pulmonary hypertension. Expert Opin Emerg Drugs 2010; 15:71–85.

Comparison of hepatitis drugs zeros in on null responders/ Merck,Vertex

Good Sunday afternoon folks,
I am a bit late bringing this to you, I posted a link to the original article from In Vivo when it was published back in November. However, I did not follow up the article reiterating the point of interest until today. You may have already read the piece but I wanted to make sure it wasn't missed. A few weeks ago I mentioned as a great source for hepatitis c information. While making my rounds at Nature I was reminded of the importance of the "In Vivo" article .

Vertex (Telaprevir) and Merck (Boceprevir) .

Excerpt From Nature; Comparison of hepatitis drugs zeros in on null responders

"But when comparing the two companies' compounds, the devil is in the details. An 'apples and oranges' problem was highlighted on the pharmaceutical blog In Vivo.
In its RESPOND-2 study, Merck defines a null responding patient — someone who is faring the worst under the current standard of care — as a patient whose viral load decreased less than 1 log after four weeks of standard treatment. That's a considerably different criteria from the US Food and Drug Administration, which defines null responders as 'less than a 2 log10 reduction in HCV RNA at week 12'.
Vertex used the FDA's definition of null responder in its study, REALIZE. Since both companies are trying to show that their protease inhibitor works better for patients for whom current options have failed, there is a remote chance that Merck's numbers might paint an artificially rosier picture."

The original article from In Vito ; Notes from AASLD: Apples and Oranges and Null Responders


Hepatitis C; Weekend Update

Over at HCV Advocate the very handsome Mr. Alan Franciscus has updated the HCV Drug Pipeline.
The HCV Advocate is looking for people who are interested in telling their stories.
.,. .
We are particularly interested in people who have been treated with the combination of pegylated interferon, ribavirin and an HCV protease inhibitor. If you are interested in writing about your experience to help others learn more about the treatment experience with the new triple combination, please drop me a note and I can send you the basic guidelines. Thank You, Alan.
Click here to email Alan
This was another incredible week with news about hepatitis C. The most important news item was the press release from Tibotec announcing the start of phase III studies of their once-a-day dose of TMC-435—an HCV protease inhibitor. Stay tuned for information about this drug – in addition to the once-a-day dosing the preliminary data from the phase II studies looks very promising.
2. In addition to the Tibotec news you might want to check out what others are reading about hepatitis B and hepatitis C. The Top Ten English and Spanish fact sheets include Acetaminophen and Your Liver, Short Term Disability, and more. On the HBV Advocate the Top Ten includes How to Interpret Hepatitis B Antibody and Viral Tests, Hepatitis B Antigen and Antibody Tests and many more.
3. Jacques Chambers monthly column is on “Taxation of Disability Benefits” – a must read if you are paying into disability and want to make sure you are reporting the income correctly.
4. Centerforce in cooperation with San Quentin and prison peer educators have produced three videos titled “Mythbusters, which you can find on our Patient Education page under streaming videos.” Feel free to pass these around to other prisons that are educating peers about hepatitis C.
5. Our HCSP Training Calendar has been updated through April 2011. If you are interested in attending one of our trainings the flyers will soon be available for the confirmed dates and locations so that you can find out more information on how to register.
6. Lastly, the CDC in cooperation with AASLD is sponsoring a Hepatitis Single Topic Conference on June 4-5, 2011 in Atlanta, GA. The conference topic is “Chronic Viral Hepatitis Strategies to Improve Effectiveness of Screening and Treatment.”

Don’t forget to keep checking out our blog for more about the most recent news stories.
The 21st Conference of the Asian Pacific Association for the Study of the Liver APASL Feb 17-20, 2011
Bangkok, Thailand

Reported by Jules Levin;


Intensified peginterferon alfa-2a (40KD) dosing increases sustained virological response rates in genotype 1 hepatitis C patients with elevated low-density lipoprotein


Efficacy and Safety of Entecavir Treatment in a Heterogeneous CHB Population in a Real-Life Setting in China

Efficacy and Safety of Entecavir Versus Adefovir in Chronic Hepatitis B Patients with Evidence of Hepatic Decompensation: Week 96 Results


In The News
The House, The Senate, The President, The Budget…This is Not a Love Story!
By Lyle Dennis, Cavarocci – Ruscio – Dennis Associates, LLC, Consultants to AASLD
Even in the best of times, the machinations of Washington DC can be confusing (bordering on unintelligible) to the casual observer. And these are not the best of times!
For AASLD members, there are aspects of the current budget debate in Washington that could be very beneficial to your research and your practice. But there are other factors that could have a deleterious impact. We will touch on some of these aspects here but, trust me when I tell you, this is the “Reader’s Digest” version because you are..
Continue Reading

Best Weekend Reading
Grand Rounds
Grand Rounds is a weekly summary of the best health blog posts on the Internet. Each week a different blogger takes turns hosting Grand Rounds, and summarizing the best submissions for the week. The schedule for Grand Rounds is available at the Better Health Blog and at Both Dr. Val Jones and Dr. Nick Genes coordinate the schedule and identify appropriate hosts for Grand Rounds. features weekly interviews with new hosts of Grand Rounds. MedPage Today powers the Grand Rounds newsletter. .
This weeks host...........
DrRich February 22nd, 2011 - 6:02 am
Especially since the events of last week, it would be absurd for DrRich to think that everybody is out to get him. Still, it seems plain that, of late, not all individuals enjoy his efforts here at the Covert Rationing Blog.
Two years ago, for instance, DrRich was “invited” to testify as a witness before a federal grand jury in a matter involving one of his consulting clients. While under oath, DrRich was caused to understand that the Feds (at least certain members of the DOJ) are well aware of this blog, and of the general tenor of its content. The impression left by this experience makes DrRich doubt whether many of his fans come from that particular precinct.
Further, the CRB has been the victim of two targeted denial-of-service attacks just in the last several months. Perhaps this is a common experience for healthcare bloggers, but then again, perhaps not. Finally, there’s the fact that last May (some readers may recall) a nasty hacking exploit completely trashed the CRB at the server level, resulting in the loss of the first three years of DrRich’s endeavors here (which, some have said, is the greatest tragedy to befall posterity since the burning of the Library at Alexandria).
And so, Dear Reader, while DrRich is certainly happy to be hosting Grand Rounds for the fourth time, and is particularly delighted with the quality of postings which he has the honor of featuring this week, it occurs to him that hosting an event with such high (and well-deserved) visibility might draw certain “extra attention” here. So perhaps you had better read this quickly.
We begin with HealthAGEnda, the John A. Hartford Foundation blog, which is posting a remarkable series of articles by Amy Berman, a senior program officer at that foundation, who has recently been diagnosed with an incurable form of breast cancer. Ms. Berman discusses very openly and frankly both the good and the bad aspects of the American healthcare system she is encountering as she deals with this likely fatal illness. In this post, the second in a series, Ms. Berman talks about her ordeal in confirming what she already strongly suspected was a very bad diagnosis, .....Continue Reading.......
Healthy You
If I had Video
Once a week this blog will post a video in a series deemed "If I Had."
These videos cover numerous disorders and diseases.
Physicians share what they would do "IF they Had..." the disease in the topic video.
These videos are available at Insider Medicine
This weeks topic is; If I Had Psoriasis

In this video, Dr. Ronald Prussick from George Washington University discusses what he would do if he had psoriasis.

Arnon D. Cohena, b, Dahlia Weitzmanc, Shlomo Birkenfelda, Jacob Dreihera, b
“This association is biologically plausible as systemic inflammation plays an important role in both psoriasis and hepatitis C,” they add.
The researchers compared the prevalence of viral hepatitis in 12,502 patients with psoriasis older than 20 years of age and 24,287 individuals without the condition matched for age and gender.
The prevalence of hepatitis C was 1.03% among patients with psoriasis compared with 0.56% among individuals without the condition.

Univariate analysis showed that the risk for hepatitis C was greater for psoriasis patients who were older (65–110 years) obese, and non-smokers, compared with others.
There was a significant interaction with smoking, although the strength of the association between psoriasis and hepatitis C did not differ significantly between smokers and non-smokers in multivariate analysis, with odds ratios of 2.22 for non-smokers and 1.93 for smokers.
Cohen et al also point out in the journal Dermatology that, although the recommended hepatitis C treatment interferon-α has previously been reported to trigger or exacerbate psoriasis, most hepatitis C patients in their study were not taking the drug, and the association with psoriasis was strongly evident among patients not taking it.

The prevalence of hepatitis B was also higher in patients with psoriasis than in controls, at 0.74% versus 0.56%. But in multivariate analysis the association was not significant, at an odds ratio of 1.22.

Cohen and team conclude that physicians who care for patients with psoriasis should “consider screening patients with psoriasis for hepatitis C.”

MedWire ( is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010
Free abstract
Off The Cuff
ScienceDaily (Feb. 27, 2011) — Hashimoto's thyroiditis (HT), an inflammatory disorder of the thyroid, is the most common cause of hypothyroidism, but a study has suggested that even when thyroid function is normal, HT may increase symptoms and decrease quality of life, as described in an article in Thyroid, a peer-reviewed journal published by Mary Ann Liebert, Inc..
Understanding rheumatoid arthritis
Scientists at the University of Gothenburg in Sweden have taken a step closer to understanding rheumatoid arthritis after discovering a new mechanism behind the disease.
Researchers in Sweden have identified an enzyme that protects against inflammation and joint destruction. They made the discovery by blocking production of the enzyme GGTase-I in transgenic mice. They believe that this unexpected result could lead to the identification of new mechanisms that control the development of inflammatory disorders, as well as new therapies.
Blog Updates

Saturday, February 26, 2011

Preparing For Hepatitis C Treatment; Shaping Up, Before You Treat

Preparing For Hepatitis C Treatment
Shaping Up, Before You Treat

Today the IL28B test was Launced by AccuType® to physicians and for clinical trials research . In March, we all read the press release from Scripps which will be offering genetic testing to their hepatitis C patients. The nonprofit health system currently orders IL28B genotyping for HCV patients who are potential candidates for therapy.

Noted in the press release;

"If the patients have a favorable IL28B genotype and advanced fibrosis on liver biopsy, doctors can initiate therapy with the current standard of care. If patients have a less favorable genotype or they have mild fibrosis, doctors can recommend waiting for FDA approval of direct acting antiviral drugs to improve their chances of response. Currently, LabCorps Diagnostics is performing the IL28B testing for Scripps patients, a procedure covered by most insurance plans. The results are transmitted to the treating physician in about one week and the treatment choice is tailored based on the patient's likelihood to have a favorable response."

The test answers the most integral question left unanswered in regard to HCV treatment. Who will respond? Who will not? This advancement is extremely important, with published evidence showing the chances of achieving SVR are 2 to 3 times greater with the right genes. The test isn't perfect and is around 85% predictive, however, it sure is helpful to know what side of that 85% you might be on.
Early testing before and during therapy will predict the factors needed to guide you through a more successful and safer treatment regime. Another noted advancement mentioned by Scripps is a second test that will accurately predict anemia in hepatitis C patients during standard therapy. For just a moment, stop, compare the advancement in scientific research to five years ago, you may find that treating this disease has become much more attractive. Even if we become horribly unattractive while treating it. The side effects will be difficult and challenging but this time the outcome is encouraging.
However, there is another piece of the puzzle that is very seldom discussed, the medical and physical liability of the individual starting therapy. Ask yourself this; Am I in good medical shape to begin treatment, could I improve anything about my physical self to prepare?
Question; What did you have for breakfast ?
Answer; Facebook, Twitter a cigarette and a cup of coffee.
Me too, kidding, I never go on twitter before noon.
Seriously, its time to get in shape before starting treatment. Give yourself the best chance possible at achieving a cure.
Engaging in a healthy lifestyle can help avoid obesity, insulin resistance, and diabetes, which is linked to rapid disease progression, higher rates of HCC, and reduced antiviral responsiveness.
Starting With Alcohol
Abstaining from drinking alcohol, which is associated with a 30 times increased risk of cirrhosis and interference with antiviral effectiveness and adherence has always been recommended.
Studies have shown that people with HCV who abuse alcohol are more likely to die than those who have hepatitis C and do not drink. People with both alcoholic liver disease and hepatitis C have a higher chance of developing HCC than those with hepatitis C infection alone.
Alcohol contributes to the chronicity of Hepatitis C and the poor efficacy of interferon-based therapy
As published in a June 2010 edition of the journal Drug and Alcohol Dependence, researchers from Philadelphia found that undergoing interferon-based treatment to eliminate Hepatitis C is definitely not a reason to be lax with alcohol abstinence. Currently, the standard treatment for Hepatitis C is combination therapy with pegylated interferon and ribavirin.

Their study investigated whether alcohol impaired the immune function of human liver cells, which would promote Hepatitis C infection and replication.
The researchers found the following:
· Alcohol suppressed natural interferon action in the liver. (Our immune system contains natural interferons to protect us against disease.)

· Alcohol encouraged suppressors of cytokine signaling, which are negative regulators of interferon expression, thus impeding interferon action.

Based on their findings, the authors concluded that drinking alcohol contributes to the chronicity of Hepatitis C and the poor efficacy of interferon-based therapy.

Some people assume that as long as they are not an alcoholic, an occasional drink with Hepatitis C is OK. The evidence clearly indicates this assumption to be incorrect. Any bit of alcohol can worsen Hepatitis C infection and, for those who hope to clear the virus with interferon-based therapy, they shouldn't even bother with the treatment if they plan on drinking any alcohol...Continue reading....

The natural history of HCV infection is influenced by genetic and environmental factors of which chronic alcohol use is an independent risk factor for cirrhosis in HCV-infected individuals. Both the hepatitis C virus and alcohol damage the liver and result in immune alterations contributing to both decreased viral clearance and liver injury.
In 2009 at the Keck School of Medicine researchers found a complex molecular events that link alcoholism and HCV to increased risk of hepatocellular carcinoma (HCC)
Researchers conducted a series of experiments with mice and also examined liver biopsy samples from human patients infected with HCV, and found high levels of the protein NS5A and TLR4. In the subset of patients who were also alcoholics, the researchers saw signs of increased antibacterial response. The research also identified a specific molecule called Nanog, which acts as a stem cell marker in tumor development when activated by TLR4.

“There were several major findings that resulted from this study,” Machida said. “We established a mouse model which will enable us to better understand alcohol and hepatitis C virus infection and we found the signaling that causes tumor development in mice through the receptor TLR4.” ...Continue reading......
Smoking and Fibrosis
In this older study authors looked at liver biopsies from 310 patients with chronic HCV who were under going their first liver biopsy. They then went on to compare those biopsies with the patients who were current cigarette smokers (176 patients) or former cigarette smokers (56 patients). Last but not least, biopsies from patients who had never smoked (77 patients).

They found that current and former smokers had more inflammation and scarring of their livers than did nonsmokers. This finding could not be explained by other factors, such as concurrent alcohol use, that are known to aggravate the inflammation and scarring in hepatitis C. The authors concluded that smoking cigarettes could worsen their liver disease.

From HIV and Hepatitis
In 2008 a study suggested that cigarette smoking may enhance activity grade in patients with chronic hepatitis C, thereby increasing progression of fibrosis. This assumption mostly relies on epidemiological evidences in the absence of pathogenic studies.
Are we there yet ? Are you inspired to stop smoking ?

Smoking and Liver Cancer
NEW YORK (Reuters Health) - There appears to be a synergistic link between smoking and hepatitis C virus (HCV) infection, leading to a more than 136-fold increased risk of hepatocellular carcinoma (HCC) in men, according to a team at The University of Texas MD Anderson Cancer Center.

.Well, we have established that cigarette smoking increases fibrosis, how about the increased risk in men for developing liver cancer. Here we go, published in 2008 in the International Journal of Cancer, researchers investigated HCC and the risk factors such as smoking in men and women who have HCV.

The Results:
· Men with HCV who smoke have a more than 136-fold increased risk of HCC.
· Women with HCV who consume large amounts of alcohol have a more than 13-fold increased risk of HCC.

The facts; smoking increases the risk of liver cancer by over 100 times. Does this inspire you to stop smoking?

While on HCV therapy I was forced to stop smoking. Not because I wanted to, but because I developed a cough that I can only compare to an old, ugly, void of any sex appeal house woman.

This is the kicker, I found out nine years later I had developed COPD. My point: Even if you have never smoked you may still experience a chronic cough during therapy, If you do smoke, be prepared to wake up in the middle of the night gasping for air.

I wanted to take this opportune moment to suggest that if you're a chronic smoker you may want to ask for a spirometry; (COPD) test before you begin treatment. If you are over forty and have smoked for more then 15 years, you may want to find out if you have COPD. Sadly, a horrendous thing to be diagnosed with, but a good thing to know before starting therapy.

Metabolic steatosis, HCV-induced steatosis and smoking, Oh My

This brings us to smoking and fatty liver disease. HCV has been proven to be caused directly from the virus. Genotype 3 patients are known to have a higher rate of fatty liver then other genotypes. .
There are two different forms of steatosis (Fatty Liver) that may be found in people with HCV:
Metabolic steatosis can result from obesity, raised blood fat levels (hyperlipidemia), insulin resistance and type II diabetes and is similar to the type of fatty infiltration caused by excessive alcohol consumption and that is also found in Non-Alcoholic Fatty Liver (NASH).

Metabolic steatosis is not triggered by the hepatitis C virus; however the combination of this form of steatosis and the presence of HCV can lead to a more rapid progression of scarring or fibrosis.
HCV-induced steatosis is fatty infiltration that is directly caused by the presence of the virus. It is possible for people with HCV to have both forms of steatosis simultaneously.
The Study

July 2010; accepted 16 July 2010. published online 18 November 2010

Conclusions/Bottom Line
Smoking history was associated with advanced liver fibrosis in this large multicenter cohort of NAFLD patients. The results indicate that smoking may enhance the progression of NAFLD partly through its effect on insulin resistance. Our results are consistent with recent animal studies suggesting that cigarette smoke may aggravate fatty liver. To our knowledge, this is the first study to show that cigarette smoking is associated with increased fibrosis severity in human NALFD, suggesting it may accelerate disease progression. These results may support a formal recommendation of smoking cessation in patients with NAFLD.
Fatty Liver and You, What Can You Do ?.

From Mayo;

Lose weight; If you're overweight or obese, reduce the number of calories you eat each day and increase your physical activity in order to lose weight.
Aim to lose 1 or 2 pounds a week. If you've tried to lose weight in the past and have been unsuccessful, ask your doctor for help.

Choose a healthy diet; Eat a healthy diet that's rich in fruits and vegetables. Reduce the amount of saturated fat in your diet and instead select healthy unsaturated fats, such as those found in fish, olive oil and nuts. Include whole grains in your diet, such as whole-wheat breads and brown rice.

Exercise and be more active; Aim for at least 30 minutes of exercise most days of the week. Incorporate more activity in your day. For instance, take the stairs instead of the elevator. Walk instead of taking short trips in your car. If you're trying to lose weight, you might find that more exercise is helpful. But if you don't already exercise regularly, get your doctor's OK first and start slowly.

Control your diabetes; Follow your doctor's instructions to stay in control of your diabetes. Take your medications as directed and closely monitor your blood sugar.
Lower your cholesterol; A healthy plant-based diet, exercise and medications can help keep your cholesterol and your triglycerides at healthy levels.
Protect your liver; Avoid things that will put extra stress on your liver. For instance, don't drink alcohol. Follow the instructions on all medications and over-the-counter drugs.
.Insulin Resistance And HCV

Insulin resistance is associated with a poorer treatment response in standard HCV therapy. Experts advise managing this complication by prescribing medications to address insulin resistance. One medication is the oral drug Metformin, a study in 2008 looked at adding Metformin to standard therapy.

The results from the study showed people who received metformin in combination with pegylated interferon/ribavirin had a better outcome than those without metformin, with women having a more dramatic reduction in their viral load than men.

Although using metformin along with pegylated interferon/ribavirin may not be the solultion for everyone, research has confirmed maintaining your blood sugar will hinder the progression of liver disease and increase the likelihood of achieving SVR.

ScienceDaily (Mar. 10, 2010)
In studying the insulin resistance of 29 people with Hepatitis C, Australian researchers have confirmed that they have high insulin resistance, a precursor to diabetes. However, almost all insulin resistance occurs in muscle, with little or none in the liver, a very surprising finding given that Hepatitis C is a liver disease.

Insulin, a hormone made by the pancreas, helps the body use glucose for energy. The two most important organs that respond to insulin are the liver and muscle. A healthy liver responds to insulin by not producing glucose, while healthy muscle responds by using glucose. An insulin resistant liver produces unwanted glucose, while insulin resistant muscle cannot absorb it from the bloodstream, leading to high levels of sugar in the blood.
Fatty Liver
"Contrary to all expectations, not only did we find no significant insulin resistance in the liver of the patients in the study, half of them suffered from a strain of Hepatitis C that causes about three times the normal level of fat to accumulate in the liver," said Professor Chisholm.
"The fifteen people with very high levels of fat in the liver had the same degree of insulin resistance as the fourteen that didn't have fatty livers."
The extra insulin resistance caused by Hepatitis C apparently brings on diabetes at 35 or 40, instead of 65 or 70."
"In our study, we gave intravenous glucose, a specific stimulus to insulin secretion, and showed that insulin secretion was not impaired in Hepatitis C patients compared to our control group."
"This finding tells us that people with Hepatitis C who develop diabetes probably have susceptible insulin-producing cells, and would probably get it anyway -- but much later in life. The extra insulin resistance caused by Hepatitis C apparently brings on diabetes at 35 or 40, instead of 65 or 70."
"At this stage, it is helpful for people with Hepatitis C to understand insulin resistance and what it can mean for them. If they have relatives with Type 2 diabetes, they will be genetically prone to developing it themselves and so would be advised to manage their diets very carefully and take plenty of exercise -- to slow onset.".... Continue reading........
Fatty Liver , What Now ?
As the study suggested if you have type II diabetes in the family then you are advised to manage your diet. Hate it, but what choice do ya have ?

Researchers have preached that changes in diet and exercise reduced the development of type II diabetes by 58%. So there you have it, the free ticket needed to help prepare yourself for treatment, and a healthy lifestyle.

Lose weight.; Losing as little as 5 to 10 percent of your body weight can reduce insulin levels and blood pressure, and decrease your risk of diabetes.
Exercise; Doctors recommend getting 30 to 60 minutes of moderate-intensity exercise, such as brisk walking, every day.
Stop smoking; Smoking cigarettes increases insulin resistance and worsens the health consequences of metabolic syndrome.
Eat fiber-rich foods. Make sure you include whole grains, beans, fruits and vegetables in your grocery cart. These items are packed with dietary fiber, which can lower your insulin levels.
Stop the sugar, fats, and anything wrapped up to go.
Click here to Check It Out Folks.

If you're getting ready to treat with telaprevir or boceprevir then take the time to prepare your mind, body and soul for treatment. Start today, walk instead of smoking, eat lean instead of mean, read instead of watching TV, and work the body, instead of the computer. . .

The goal is to help increase your cure rate, the benefits are enormous. Enter you, free of HCV with a post-treatment healthy lifestyle. ,

Wishing you all a successful, healthy and safe HCV journey.
... .

Friday, February 25, 2011

HCV Advocates Very Own Lucinda K. Porter, RN

HCV Advocates Very Own

Lucinda K. Porter, RN and author, talks about her new book, Free of Hepatitis C.

.I ha.


Just a sampling of Ms. Porters work in HCV Advocates February Newsletter

HealthWise: Vitamin D and the Liver

HCV Snapshots

I personally have benefited tremendously from Ms. Porters dedication to the HCV community. I have read her Healthwise articles for many years, and with great anticipation look forward to each new contribution. Here are a few other accomplishments from the lovely and talented author.


Lucinda K. Porter, RN Website

Lucinda is a nurse, writer, poet, community educator, mother, wife and traveler. Her undergraduate degree is in Women's Studies from Syracuse University. After becoming a certified childbirth assistant or doula, Lucinda went to nursing school. Serendipity and the kindness of others led her to the hepatitis C world.

The Hepatitis Comics:
Levity for the Liver

It takes a bit of gall to poke fun at hepatitis. As a nurse, I've seen the wreckage of liver disease and I revere the strength it takes to live with adversity. I have hep C, and I know it isn't exactly a picnic. However, I believe that when it comes to wellness, laughter is better than an apple a day. Just in case I am wrong about this, I eat a lot of apples. Although I endorse going to the doctor, I take a joke book along to survive the waiting room time. I probably should take an apple too so I don't die of starvation during the long wait.
I think that laughter is a worthy pursuit and I invite others to share their stories or witticisms that might amuse those with liver disease. Welcome to The Hepatitis Comics.

Lucinda K. Porter: A Writer's Blog

Although a picture may be worth a thousand words, I prefer to draw with language. Given a choice between a palette or a dictionary, I'd choose the lexicon. A Chinese proverb that better describes my sentiments is, " A book is like a garden carried in the pocket." Blogging is a bit like casting seeds. One never knows what will germinate...

Lucinda K. Porter, RN, B.A. has been with the Hepatitis C Support Project (HCSP) since 1998. She is a member of the HCSP advisory board and writes for various HCSP publications. She received an award for recognition of contributions and service 1998-2003 from the Hepatitis C Support Project. Lucinda was a clinical research nurse at Stanford University Medical Center’s Hepatology division. In 1998, she co-founded the Redwood City Hepatitis C Support Group.Lucinda has been a guest speaker, educator and consultant, particularly on the subject of hepatitis C. She is actively engaged in community awareness activities focusing on issues surrounding viral hepatitis.

Hepatitis C-Small RNAs and the Clinic

Small RNAs and the Clinic
February 2011
By Matthew Dublin

Each month, more and more evidence emerges to link microRNAs to a range of diseases. Despite all their progress in making miRNA-gene expression connections, researchers on the front lines of RNA research say they have only recently begun to understand how these tiny molecules — typically one one-thousandth the size of an mRNA molecule — actually function.
"The basic biology of microRNAs is still poorly developed, and although we have really seen an explosion in the study of microRNAs in the last two or three years, it takes longer than that to really have a good grasp of what the general functions of them are — and even longer to figure out the specific functions. So I think it's very early in the field," says MIT's Phillip Sharp, who was the co-recipient of the 1993 Nobel Prize in physiology or medicine. "Clearly, you can deliver single-strand nucleic acids or inhibitors of single-strand nucleic acids [to] cells in a clinical setting. I think there are open avenues and it will just take awhile to work it all out."
Moving miRNAs into the clinic has gained momentum since 2005, when researchers at Rockefeller University used modified single-stranded RNA analogs, or antagomirs, to target specific miRNAs. During the last few years, a small but growing number of miRNAs have been incorporated into pharmaceutical companies' drug-development pipelines. Some miRNA researchers say they envision diagnostic roles for these molecules more than therapeutic ones. Late last year, Rosetta Genomics, which has brought three miRNA tests to the market, announced an improved version of its miRview Mets diagnostic tool, which the company says can identify 42 tumor types of unknown origin.
There are currently a handful of miRNAs in the sights of several pharmaceutical companies. One miRNA target that is ripe for clinical development is miR-21, which is thought to be up-regulated in cardiac and lung fibroblasts as well as in several different types of cancers. Regulus Therapeutics and Sanofi-Aventis have partnered up to establish methods for inhibiting miR-21 with antagomirs. With support from several studies demonstrating that miR-34 played a key role in the p53 tumor-suppressor network, Mirna Therapeutics began a program last year to develop a -miR-34 mimic that could be used to treat various cancers. Miragen Therapeutics has licensed the 2008 work of the University of Texas Southwestern Medical Center's Eric Olson — in which he linked miR-208 to heart disease — with the hopes of developing an miRNA-targeting drug for heart failure.
But the miRNA that has attracted the most attention for the clinic is miR-122. Rosetta Genomics, Santaris, Regulus Therapeutics, and Mirrx Therapeutics are all interested in this particular miRNA, which has been shown to play a role in replication of the hepatitis C virus. The only miR-122-targeting drug that has been tested in humans to date is Santaris Pharma's phase II hepatitis C therapy, miravirsen. It might not be the only one for long, though, as Regulus Therapeutics and GlaxoSmithKline teamed up last year to develop their own hepatitis C drug candidate that targets miR-122.
In the liver
As miR-122 has been shown to be expressed highly in the liver, diseases that affect this organ are attractive — and potentially the most tractable — prospects for miRNA-based therapeutics.
To date, researchers have added more than 5,000 microRNAs to a stockpile of data that promises to shed light on the range of roles these endogenous molecules play in various diseases, and propogates their potential as tools for the clinic

Scripps Health ;IL28B Genetic Testing to Hepatitis C Patients Now Available

Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C Patients
Individualized Therapies Now Available for Drug Treatment of Hepatitis C

"Later this year, a second test will be available that will accurately predict anemia in hepatitis C patients taking the pegylated interferon and ribavirin drug combination. Anemia is one of the most common side effects of the regimen. This will allow doctors to modify the therapy before starting the regimen to prevent patients from developing this problematic side effect."

SAN DIEGO, Feb. 25, 2011 (GLOBE NEWSWIRE) -- Scripps Health is one of the first health systems in the United States to offer genetic testing as part of its care for hepatitis C patients planning to undergo drug treatment.

The tests offer hope to the more than 4 million patients diagnosed annually in the U.S. with hepatitis C and could spare them from taking interferon, which is commonly prescribed. Interferon causes flu-like symptoms as a side effect and costs more than $50,000 annually. Instead, the genetic test determines whether patients have a common gene variant that predicts a favorable cure rate if they are treated with the drug combination therapy of pegylated interferon and ribavirin.

A manuscript describing this approach to treatment, authored by Paul J. Pockros, MD, clinical director of research at the Scripps Translational Science Institute, head of the Division of Gastroenterology and Hepatology and director of the Liver Disease Center at Scripps Clinic, will be published in the journal Drugs in March.

"This is a huge step forward in the movement toward individualized medicine," said Dr. Pockros, "As a physician, knowing what drug therapies will have benefit and which ones won't based on a patient's IL28B genotype is significant because we are able to be more targeted in our approach to treatment."

This is the first of numerous genetic tests that will accurately give doctors vastly improved data, leading to better prescription of drug treatments. Later this year, a second test will be available that will accurately predict anemia in hepatitis C patients taking the pegylated interferon and ribavirin drug combination. Anemia is one of the most common side effects of the regimen. This will allow doctors to modify the therapy before starting the regimen to prevent patients from developing this problematic side effect.

Genetic testing for hepatitis C patients carries significant implications for patient care, as there are more than 4 million infected people in the United States, most of them undiagnosed and untreated.

Scripps Clinic now routinely orders IL28B genotyping on all patients with Hepatitis C who are potential candidates for anti-viral therapy. If the patients have a favorable IL28B genotype and advanced fibrosis on liver biopsy, doctors can initiate therapy with the current standard of care. If patients have a less favorable genotype or they have mild fibrosis, doctors can recommend waiting for FDA approval of direct acting antiviral drugs to improve their chances of response.
Currently, LabCorps Diagnostics is performing the IL28B testing for Scripps patients, a procedure covered by most insurance plans. The results are transmitted to the treating physician in about one week and the treatment choice is tailored based on the patient's likelihood to have a favorable response.

The hepatitis C genetic testing is the latest example of Scripps' leadership in individualized medicine. Scripps doctors were the first to use genetic testing for cardiovascular patients planning to undergo elective stent procedures to determine if they have one or more of the common gene variants linked to an inability to metabolize the anti-clotting drug Plavix (clopidrogel). Plavix is the second-most commonly prescribed drug in the United States and is given to most patients after they receive coronary stents.

Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a $2.3 billion nonprofit community health system based in San Diego, Calif. Scripps treats a half-million patients annually through the dedication of 2,500 affiliated physicians and 13,000 employees among its five acute-care hospital campuses, home health care services, and an ambulatory care network of physician offices and 22 outpatient centers and clinics. Scripps has been recognized by Thomson Reuters as one of the Top 10 health systems in the nation for quality care. Scripps is also at the forefront of clinical research, genomic medicine, wireless health and graduate medical education. With three highly respected graduate medical education programs, Scripps is a longstanding member of the Association of American Medical Colleges. More information can be found at

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