HCV Weekend Reading With An Update On Treatment Of Liver Cancer-Podcast

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Podcast-Feb 12
Source: Cancer Care Connect
Leading experts in oncology provide up-to-date information in one-hour workshops over the telephone or online.

Click Here To Listen

Topics Covered:
  • Overview of Liver Cancer
  • Current Standard of Care
  • New Treatment Approaches
  • The Role of Clinical Trials
  • How Research Contributes to Treatment Options
  • Controlling Symptoms and Pain
  • Nutritional Concerns and Tips
  • Communicating with Your Health Care Team
  • Questions for Our Panel of Experts

Just Published: HCV Newsletters

Read the hepc.bull -
Online monthly newsletter (.pdf)
In This Months Issue
Hep C Vaccines
Wouldn’t it be wonderful if, just
like polio or smallpox, no one had to worry
about catching Hep C ever again? Vaccines
do that. Unfortunately, there is no vaccine
against Hep C, but researchers keep trying…
and may be getting close.

Also In This Months Newsletter;
HCV News
ALS-2200 AND ALS-2158
NO INTERFERON
BMS ACQUIRES INHIBITEX

Recipe: 
Vegetable Curry

Hep C on the Internet

NYC Viral Hep Newletters

Additional February Newsletters;


Off The Cuff - For Your Sunday Reading Pleasure-Sort of
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From boobs to baldness: stem cells go cosmetic
use of stem cells for cosmetics and cosmetic procedures is exploding even while many important questions remain.

How legitimate are these stem cell cosmetic products and procedures?

Are they safe and effective?

What kinds of medical conditions are they being used to treat?

I also recently did a post on another area of medicine that is growing involving stem cells: sports medicine. There too much of what is happening is not backed up by published science.

Regardless of the science, for both sports medicine and cosmetics/plastic surgery, there are literally billions of dollars to be made per year and many companies want to tap into that money stream.

One type of reported stem cell-based procedure is for breast reconstruction after cancer, such as what celebrity Suzanne Somers (see photo at left, credit National Enquirer) reportedly recently had performed.

Beyond treatment of cancer patients,  the same kind of procedure is being performed for breast augmentation in women who have not had cancer. An interview with one of the pioneers of this medical procedure can be found here and is an interesting read.

What was the situation with Somers and what are the implications of her procedure?

The most recent headline of the National Enquirer screams “Suzanne Somers Stem Cell Boob Job“.

Somers, the actress who played the iconic ditzy blonde, Christmas “Chrissy” Snow, in the 70s sitcom “Three’s Company”,  was known back then almost 40 years ago for being a young, sexy actress.

Perhaps it is then no surprise that she is now known to a large extent for her series of books on staying sexy as one ages and her own line of health products that are pitched on her website.
She has millions of fans today just as she did 4 decades ago in her twenties.

A dozen years ago, cancer entered her life. Somers was diagnosed with breast cancer. Her treatment had side effects that understandably concerned her. As a cancer survivor (prostate) myself, her concerns seem very legitimate to me.

She is quoted on her website:
Like millions of other women who have been diagnosed with breast cancer, I had to face the numerous daunting decisions about my treatment and recovery. In 2000, I had a lumpectomy and full course of radiation that left me with a withered, nearly pancake breast on the right side (barely a B cup) and my full natural breast on the left side (a D cup)

One possible option that many women choose in that kind of situation is breast reconstruction that can involve an implant. In addition, moving fat from one part of the body to the breast to aid in reconstruction is also an option.

What Somers had done is more cutting-edge and less understood: using abdominal fat stem cells combined with her fat for an autologous transplant to the breast for reconstruction. Somers has a series of videos on another website showing her going through the surgical procedure and during her recovery. I believe it was very gutsy of her to have the procedure taped. Note that some of these videos are graphic and may not be appropriate for all viewers. See image below taken as a screen shot of the video of Somers’ adipose stem cells reportedly being added to her fat prior to transplant into the breast.

Keep Reading Here... 
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More On Suzanne Somers @ Celebrity Diagnosis-
Suzanne Somers used Belly Fat Stem Cells to grow Her New Breasts


In the News 

Yesterday, the FDA issued its long-awaited guidance for a pathway to develop biosimilars. A wide array of groups - drugmakers, investors and payers, among others - have been clamoring for details about the approval process that would be required to bring lower-cost versions of expensive biologics to patients (here is the guidance). The advent of these biosimilars is forecast to eventually become a multi-billion-dollar market. Biosimilars, which would largely be injectable products, are already available in Europe. But reaching agreement on a so-called pathway for making biosimilars has been an arduous process because these medications are much more difficult to make than pills and capsules because of a complex manufacturing process that may not yield exact copies. We spoke with Jonathan Pan, a manager at the Scientia Advisors consulting firm, about the implications…
Continue reading at Pharmalot

On The Blog : FDA Outlines Path Forward For Biosimilars

Interferon and Ribavirin Control HCV Genotype 6

From Reuters Health Information

By David Douglas

NEW YORK (Reuters Health) Feb 08 - Pegylated interferon and ribavirin are effective against chronic infection with hepatitis C virus (HCV) genotype 6, a recent study shows.

"This large randomized study provides new information on treatment of genotype 6 patients, particularly on shortening duration of therapy in select patients (and) thus limiting costs of an expensive treatment," said Dr. K. Rajender Reddy of the University of Pennsylvania, Philadelphia in an email to Reuters Health.

Genotype 6 (which now includes genotypes 7, 8 and 9) is endemic in Southeast Asia, where it accounts for up to 47% of HCV infections. Once problematic mainly in that part of the world, "in the changing era of increasing migration of populations, it has been recently reported in the United States, as well as in China, Taiwan, and Hong Kong," Dr. Reddy and colleagues wrote in a paper online January 17 in the Journal of Hepatology.

The interferon/ribavirin combination is the standard treatment for HCV, but genotype is considered to be a strong predictor of sustained virological response (SVR) and little is known about response and optimal treatment duration with genotype 6, the investigators say.

The new trial included 105 treatment-naive HCV genotype 6 patients in Vietnam who were randomized to 24 or 48 weeks of treatment with pegylated interferon alfa-2a 180 mcg per week and ribavirin 15 mg/kg per day.

The study was not funded, and the patients had to pay for their care. Six dropped out for economic reasons and another seven were lost to follow-up.

Even so, on intention-to-treat analysis the SVR was 60% in the 24-week group and 71% in the 48-week group. The difference was not significant. Corresponding biochemical responses were 63% and 77%.

Rates of virological relapse were 7% with the shorter course of treatment and 5% with the longer course.

Overall, SVR was most likely in those with a rapid virological response. In the 24-week group, 75% of such patients achieved SVR. In the 48-week group, the proportion was 86%.

Rates of hematologic and general adverse events were similar between the two groups, except the rate of anemia was lower with shorter treatment (31% vs 57%).

According to the paper, "24 weeks of therapy in younger patients, with low viral load and rapid virological response appeared equally effective as 48 weeks of therapy and this is likely to have a major economic impact on HCV therapy, in such subpopulations."

In fact, Dr. Reddy noted that the efficacy of shorter-duration therapy is scientifically worth pursuing in larger trials, but given the lack of support for the current study, "challenges are in funding."

"While new drugs are being developed for non-genotype 6 hepatitis C infections," he concluded, "pegylated interferon and ribavirin will remain the standard of care for the foreseeable future for genotype 6 infections."

J Hepatol 2012.

  HIV

My ribbon is red: Planned Parenthood fights HIV/AIDS
Angered by a horde of reactionary, women-hating, chastity obsessed right-wingers who huddled and spewed venom this week at the Conservative Political Action Conference , spouting pseudo-pious obscenities bewailing "contraception" as if it is a communist plot against America.


Desert AIDS Project fundraiser event breaks attendance record
Joan Rivers attends the 18th Annual Steve Chase Humanitarian Awards at the Palm Springs Convention Center on Saturday, February 11, 2012.

 
Healthy You

Featured Article-Berkeley March 2012 Newsletter

The Alcohol/Cancer Connection
New research complicates women’s decision about whether to drink or not
Does alcohol increase the risk of breast cancer? Yes, even light to moderate drinking, according to a new analysis from the well-known Nurses’ Health Study, which followed 106,000 women for more than 25 years. It found that women who routinely consumed 3 to 6 drinks per week were 15 percent more likely to develop breast cancer than nondrinkers, regardless of the type of alcoholic beverage they drank. For women averaging 6 to 19 drinks per week, the increased risk was 20 percent. Among those consuming more than 19 drinks per week, the risk jumped by 50 percent.

Alcohol, in moderation, has gotten a healthy reputation because it helps prevent heart attacks (and possibly diabetes, dementia, osteoporosis and other disorders), so you may be surprised to hear that it can boost cancer risk. In the past 15 years, accumulating evidence has strongly linked alcohol to a number of cancers, notably of the esophagus, mouth and throat, but also of the liver, colon and breast. It may contribute to breast cancer by raising blood levels of estrogen.
The studies on alcohol and breast cancer have mostly blamed heavy drinking; many have not found significantly higher risk among light drinkers. The new study, in the Journal of the American Medical Association, got lots of attention not only because it was large and comprehensive, but because it found that light or moderate drinkers also face increased risk. In addition, it concluded that lifetime alcohol consumption (starting in early adulthood), rather than current levels, was the best measure of risk.

Why it’s hard to prove the link
All studies of alcohol and cancer are observational; it would be very difficult to do clinical trials in which subjects are randomly assigned long-term alcohol consumption or abstinence. In the new study, researchers observed how many cases of cancer occurred in the women over the decades, and matched these up with how much alcohol they consumed (based on self-reports, which can be unreliable). They took into account factors such as age, weight, smoking, family history and hormone use. This type of research cannot prove cause and effect or precisely indicate where the risk thresholds lie, but it can be strongly suggestive.

Putting the risk into perspective
Any additional cancer risk is bad, of course, but a 15 percent increased risk (found for 3 to 6 drinks a week in this study) is not as threatening as it may sound. At age 50, for instance, the average woman has a 2.4 percent chance (1 in 42) of developing breast cancer in the next 10 years. An increase of 15 percent would raise the risk to about 2.8 percent (1 in 37).
Stated another way, among 1,000 women age 50, light drinking may cause an extra 3 or 4 cases of breast cancer during the next decade—which would presumably be more than offset by a reduction in heart attacks. Keep in mind, these are only averages. For women with a family history of breast cancer, for example, the estimated risks will be higher. For others, the risks may be lower.

Our advice
If you’re a woman and drink, should you quit to reduce your risk of breast cancer? Or should you continue to drink to help protect your heart, particularly if you’re at high risk for heart disease?

Here are some pointers:
• If you drink, keep your intake light to moderate. For a woman, that means no more than a drink a day (for men, it’s two drinks). A standard drink is 4 to 5 ounces of wine, 12 ounces of beer or 1.5 ounces of 80-proof liquor, which all contain about 14 grams of pure alcohol (ethanol). That’s all you need for heart health. And that limits the increase in cancer risk.

• If you know you are at high risk for breast cancer, or if you have had breast cancer, it may make sense to quit drinking or drink only occasionally. Discuss your risk factors for both breast cancer and heart disease with your doctor.
• If you are a light or moderate drinker at average risk for breast cancer, you may reduce the risk somewhat by giving up drinking—but nobody knows for sure.

Words to the wise: Alcohol has many known harms as well as many known or potential benefits. An increased risk of breast cancer is only one factor to consider. Age is another. Women are far more likely to die from cardiovascular disease than breast cancer, especially later in life. So for older women, the benefits of light or moderate drinking are more likely to outweigh the risks.
For more about alcohol, see “Should You Drink? How Much?”

 Folate to the rescue?
Woman who drink should be sure to consume enough folate, one of the B vitamins. Studies suggest that an adequate folate intake reduces the increased risk of breast cancer associated with alcohol. Alcohol impairs folate absorption in the body and increases its excretion, and folate deficiency is linked to an increased risk of certain cancers, including breast cancer. Thus, female drinkers with low folate intake, in particular, may be at increased risk for breast cancer.
The recommended dietary allowance (RDA) for folate is 400 micrograms a day. Leafy greens and citrus fruit are good sources; many grain products are fortified with folic acid (the form of folate used for fortification and in supplements). A basic multivitamin provides the RDA. Higher-dose supplements are not necessary or recommended. Exception: Women who may become pregnant should take 400 to 800 micrograms of folic acid a day to help prevent birth defects.


 In Memory

 Whitney Houston, Pop Superstar, Dies at 48
Whitney Houston, the multimillion-selling singer who emerged in the 1980s as one of her generation’s greatest R & B voices, only to deteriorate through years of cocaine use and an abusive marriage, died on Saturday in Beverly Hills, Calif. She was 48. 


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FDA Outlines Path Forward For Biosimilars

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What Are Biosimilars?

Biosimilars are copycat versions of expensive biotechnology drugs. Although technically these "biosimilars" are not called generic.

Example of biologics made with recombinant DNA technology :
Erythropoietin = Epogen / stimulation of red blood cell production


In Todays News

FDA Outlines Path Forward For Biosimilars
Feb/11/2012 5:31 AM ET

(RTTNews) - Finally, the long overdue FDA guidance for approval of biosimilar products has been unveiled.

Though a legislation giving authority to the FDA to approve biosimilar products was enacted in March of 2010 itself, biosimilars manufacturers hav been waiting for a formal regulatory guidance on the approval pathway.

The long wait came to an end on February 9, 2012, with the FDA releasing 3 draft guidance documents on biosimilar product development.

Before a take a look at the draft guidance, here's what biological products and biosimilars mean, in simple terms.

Biological products, which are manufactured through biotechnology, are complex in structure and are derived from natural sources, or, in some cases, produced synthetically. Vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and proteins are examples of biological products. Being inherently very difficult to copy and replicate, biologics have not been subject to intense generic competition even after they lose patent protection.

A biosimilar, also known as follow-on biologic, or biopharmaceutical, is a biological product that is highly similar to a U.S.-licensed reference biological product. Biosimilars can only be proven to be "highly similar" and not "identical" to the reference product. And the reason - biologics being large and complex molecules, it is impossible for a manufacturer of biosimilars to exactly replicate the innovator's process. Therefore even subtle differences in the structure of follow-on biologics may lead to variations in safety or efficacy compared to the innovator biologics.

The FDA approval pathway for biosimilars is known as 351(k) and it was created under the Patient Protection and Affordable Care Act that was signed into law by President Obama on March 23, 2010. Through this new approval pathway, biological products are approved based on demonstrating they are biosimilar to, or interchangeable with, a biological product that is already approved by the FDA, which is called a reference product.

The three draft guidance documents issued by the FDA touch upon the scientific considerations in demonstrating biosimilarity to a reference product; quality considerations in demonstrating biosimilarity to a reference protein product, and answers to common questions from people interested in developing biosimilar products.

The FDA's guidance on scientific considerations in determining biosimilarity has three approaches namely,
* A stepwise approach of comparing the proposed product and the reference product with respect to structure, function, animal toxicity, human pharmacokinetics, pharmacodynamics , clinical immunogenicity, clinical safety and efficacy.
* The totality-of-the-evidence approach wherein the FDA will consider the totality of the data and information submitted in the application, including structural and functional characterization, nonclinical evaluation, human pharmacokinetics and pharmacodynamics data, clinical immunogenicity data, and clinical safety and effectiveness data.
* General considerations like no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

The FDA's guidance on quality considerations in determining biosimilarity provides an overview of analytical factors to consider in demonstrating biosimilarity between a proposed protein product and the reference product.

The factors for consideration in assessing whether the products are highly similar are - genetic stability, manufacturing process, assessment of physicochemical properties of the proposed biosimilar product and the reference product, assessment of functional activity and receptor binding and immunochemical properties, to name a few.

The guidance, which provides answers to common questions from people interested in developing biosimilar products, seeks to promote transparency and gives a better picture regarding the appropriate statutory authority under which certain products will be regulated.

The FDA is accepting public comments on the three draft guidance documents.
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said, "These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."
Europe is currently the most advanced in terms of having established an approval pathway for biosimilars. The biosimilar pathway was established by the European Medicines Agency, or EMA, in 2006.

According to reports, nearly 14 biosimilars, including generic versions of human growth hormone, anemia treatment erythropoietin and G-CSF (Granulocyte colony-stimulating factor) that stimulates the production of white blood cells , have been approved by the European regulators under the biosimilar pathway.
The EMA follows the "similar biological medicinal products" approach, which means that in order to be considered a biosimilar, it needs to demonstrate similarity to a reference innovator biologic , in addition to comparable safety and efficacy. The EMA guidelines do not address the issue of interchangeability and it is for a physician to decide whether to treat a patient with the biosimilar or with the reference medicine. Since a biosimilar and its biological reference medicine are not identical they do not qualify to be automatically interchangeable as per approval standard in Europe.

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HCV Friday Round Up:When Will We Have Interferon-Free Treatment for Hepatitis C?

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Jean Galbert Salvage (circa 1812)
Vintage Anatomy Facial Muscles




In The News

From Medscape Gastroenterology > Ask the Experts

When Will We Have Interferon-Free Treatment for Hepatitis C?
William F. Balistreri, MD
Posted: 02/09/2012

Question:
Is it true that we are close to treatment of patients with chronic hepatitis C virus (HCV) infection with an interferon-free regimen?

Response from William F. Balistreri, MD

Professor of Medicine, University of Cincinnati College of Medicine; Staff Physician, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 

A New Era of Therapy
Combination therapy with pegylated interferon (PEG-IFN) and ribavirin long stood as the standard of care for chronic hepatitis C virus (HCV) infection. Although effective in achieving high rates of sustained virologic response (SVR), this combination regimen was associated with troublesome side effects.[1] Therefore, the development of 2 effective protease inhibitors -- telaprevir and boceprevir -- was hailed as a new era of therapy for patients with HCV genotype 1 infection.[2] These direct-acting antiviral agents act at specific steps in the viral lifecycle and allow more effective treatment with a shorter duration.

Telaprevir and boceprevir, linear inhibitors of the HCV nonstructural protein 3/4A (NS3/4A) serine protease, were approved by the US Food and Drug Administration for HCV treatment in May 2011. However, the recent American Association for the Study of Liver Diseases (AASLD) recommendations indicate that these direct-acting antiviral agents must be used in combination with PEG-IFN and ribavirin.[1] This is far from the ideal regimen; because of poor tolerability, many treatment candidates will decide not to pursue treatment or to defer treatment until an IFN-free regimen is available. 

An Ideal Strategy for HCV
It is true that an IFN-free regimen is "no longer a dream."[3] It is now viewed as part of a larger goal: the development and validation of an ideal strategy to treat HCV infection. The long sought-after therapeutic objective is to define a strategy that would be highly effective against allHCV genotypes, simple (oral drugs only, low pill burden, and short duration), and safe and tolerable, with low rates of resistance emergence. The recommended strategy would also assess each potential treatment candidate for interleukin 28B genotype, which is a robust pretreatment predictor of SVR to therapy in patients with genotype 1 chronic HCV infection.[1]

How close are we? Various compounds, encompassing at least 5 distinct drug classes, are currently under development for the treatment of chronic HCV infection, and the results of trials of several investigational agents were recently published.[3-5] Many other drug trials were presented at The Liver Meeting 2011: The AASLD 62nd Annual Meeting. These drugs bring us one step closer to the long sought-after ideal: the ability to delete noisome IFN injections from treatment strategies. 

Promising Preliminary Results
Let me illustrate by focusing on phase 2 studies presented by 2 groups who reported exciting preliminary results of an investigational agent (PSI-7977) even in the absence of IFN coadministration.[6,7] PSI-7977, a uridine nucleotide analog polymerase inhibitor, is administered orally once daily and has strong antiviral activity against HCV genotype 1 when used in combination with PEG-IFN and ribavirin. A double-blind placebo-controlled dose-ranging study of PSI-7977 in patients with HCV genotype 1 documented a rapid virologic response (RVR) in 98% of patients, with an end-of-treatment response at 24 weeks in 91%.[6] The RVR in the placebo group was 19%, and the end-of-treatment response was 50%. Of specific note, all patients with the difficult-to-treat interleukin 28B single-nucleotide polymorphism T/T mutation had an RVR -- all became HCV-negative by week 3, and 100% went on to achieve an SVR.

In another phase 2 study, this investigational compound allowed all patients to achieve an RVR. More than 80% of the treatment group had nondetectable HCV RNA at 2 weeks, and all patients had undetectable levels at 3 weeks.[7] All patients achieved normalization of serum alanine aminotransferase levels. No serious adverse events were attributable to PSI-7977, and as expected, safety and tolerability were greatest in the IFN-free treatment group.

Thus, PSI-7977 exhibits high-potency antiviral activity against a broad range of HCV genotypes, has a high barrier to resistance, and has a reassuring safety profile. This drug also allowed a shorter duration of therapy for viral clearance. These studies support the continued exploration of this drug and related compounds -- alone, with other direct-acting antiviral agents, or with shorter duration of IFN therapy in patients with all HCV genotypes. Further studies will hopefully confirm the initial excitement and optimism and, of note, will document the spectrum of potential adverse effects. 

Getting to IFN-Free Regimens
Within the next 5 years, IFN-free regimens may be a reality and available in the clinic. As Sharma and Lok[3] stated, "[I]t is possible that some of these regimens will also be ribavirin free. This will be good news for patients who wish to be treated but have to defer treatment because of contraindications to use of PEG-IFN or ribavirin, or out of concerns about their ability to tolerate these medications." The ideal strategy is on the horizon.

  1. Ghany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology. 2011;54:1433-1444. Abstract
  2. Jensen DM. A new era of hepatitis C therapy begins. N Engl J Med. 2011;364:1272-1274. Abstract
  3. Sharma P, Lok AS. Interferon-free treatment regimens for hepatitis C: are we there yet? Gastroenterology. 2011;141:1963-1967.
  4. Gane EJ, Roberts SK, Stedman CA, et al. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet. 2010;376:1467-1475. Abstract
  5. Zuezem S, Asselah T, Angus P, et al. Efficacy of the protease inhibitor BI 201335, polymerase inhibitor BI 207127, and ribavirin in patients with chronic HCV infection. Gastroenterology. 2011;141:2047-2055. Abstract
  6. Lawitz E, Lalezar JP, Hassanein T, et al. Once-daily PSI-7977 plus PEG/RBV in treatment-naive patients with HCV GT1: robust end of treatment response rates are sustained post-treatment. Program and abstracts of The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting; November 9-13, 2011; Boston, Massachusetts. Abstract 225.
  7. Gane EJ, Stedman CA, Hyland RH, et al. Once daily PSI-7977 plus RBV: pegylated interferon-alfa not required for complete rapid viral response in treatment-naive patients with HCV GT2 or GT3. Program and abstracts of The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting; November 9-13, 2011; Boston, Massachusetts. Abstract 34. 

Chronic Liver Disease Foundation Issues Statement in Support of Birth-Cohort Screening for Hepatitis C
Recommendations Include Expanded Testing with Rapid Point-of-Care HCV TestCLARK, N.J., Feb. 9, 2012 (GLOBE NEWSWIRE) -- The Chronic Liver Disease Foundation (CLDF), a leading educational organization dedicated to increasing awareness of the effect of chronic liver disease (CLD) in the United States, issued today a position paper in support of expanding screening for hepatitis C (HCV) in the United States.

The position paper, "Endorsement of Birth-Cohort Approach to Expand Screening for Hepatitis C," outlines the CLDF's recommendations for a more effective strategy to identify patients with HCV infection and link such patients to expert care and treatment.
HCV is the most common blood-borne chronic viral infection in the U.S., with more than four million Americans currently infected with the HCV virus. Of these, up to 75 percent are unaware of their infection. Individuals born between the years of 1945 and 1965 have an HCV prevalence level four times higher than those born outside the birth cohort.

While the CDC currently recommends HCV screening only for individuals found to be at risk for the HCV infection, it is currently evaluating the potential benefits of using a birth-cohort based approach to HCV screening to help increase identification of HCV-positive patients.
The CLDF issued the following recommendations in support of the expansion of HCV screening efforts:
  • Routine screening for HCV among persons born between 1945 and 1965
  • Use of the OraQuick HCV rapid point-of-care test to expand testing opportunities and facilitate immediate care
  • Educational programs aimed at primary care providers to increase awareness of HCV risk factors
  • Testing for HCV in primary care setting with established linkages to HCV
  • Creative ways to increase access to HCV testing and care for injection-drug users and other underserved populations.
"Today, more than 4 million Americans are infected with hepatitis C and the vast majority does not know it," said Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. "Hepatitis C is a leading cause of chronic liver disease, cirrhosis and liver cancer. However, new therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV – particularly among those born between 1945 and 1965 – a critical step in fighting this epidemic."

About the Chronic Liver Disease Foundation
Established in 2001, the Chronic Liver Disease Foundation is a nonprofit 501(c)(3) educational organization dedicated to providing hepatology related continuing medical education, news and information to healthcare professionals across the US. The CLDF is led by a Board of Trustees comprised of nationally renowned liver disease specialists. Furthermore, the CLDF believes that educational programs should be developed by the specialists who are actively involved in the research, treatment and management of a disease. As such, the CLDF has developed a network of 75 Centers of Educational Expertise and multiple Advisory Boards who are actively involved in program creation related to specific disease topics which include: hemochromatosis, hepatic encephalopathy, hepatitis B, hepatitis C, hepatocellular carcinoma, HIV co-infection, liver transplantation and NASH/NAFLD. The CLDF's educational opportunities are offered in a variety of formats including an interactive web site, live meetings, teleconferences, print pieces, webcasts and other electronic mediums.  For more information, please visit www.chronicliverdisease.org.

Newsletter-February  

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.GI & Hepatology News is published monthly

Big Pharma

BOSTON (MarketWatch) — 
Can Vertex Pharmaceuticals Inc. shares stage a comeback?
That’s a nagging question for investors, who have watched Vertex’s once-bright star fade as the shares of rival hepatitis C-drug developers supernovae. But Vertex shares could get a good stoking by mid-year, when the results of three key drug studies are due out.
Vertex’s stock had a banner 2011, its shares propelled to new heights by enthusiasm for its drug Incivek, a treatment for the hepatitis C virus, or HCV, a potentially deadly disease that attacks the liver. The drug belongs to a class of medications known as protease inhibitors that also includes Merck & Co.’ss new HCV drug Victrelis. 

In recent months, however, investor faith in Incivek’s long-term marketability has been deeply shaken by positive news about rival HCV drugs in development, particularly those in a class of drugs known as nucleotides, or “nukes.” 

As a result, shares of Vertex swung from a 52-week peak of $58.87 in mid-May 2011, to a low of $26.50 by late November, when Gilead Sciences Inc. announced it was buying nuke-drug developer Pharmasset Inc. for $11 billion, a move that further underscored the perceived value of nuke drugs. 

Over the past couple of months, the stock has managed to climb back into the upper $30s, due largely to anticipation ahead of the expected approval of the company’s drug Kalydeco. A novel treatment for the genetic disease cystic fibrosis, or CF, Kalydeco won approval earlier this month.
What’s still haunting the stock, say analysts, is concern about how well Incivek sales will hold up when the first nuke drugs hit the market and how well Vertex will be able to build-out its HCV and CF franchises. 

With key clinical data for both drug programs looming on the horizon, many analysts have taken a wait-and-see approach to the stock. According to FactSet, the average analyst rating currently for Vertex is overweight, with a price target of just over $46 a share.
Two upcoming events, however, could give the shares a needed jolt. 

The first is the expected release of early clinical data for two HCV nuke drugs that Vertex is co-developing with Alios BioPharma. The data is expected in the second quarter.
“Vertex’s HCV franchise is quickly becoming obsolete; to stay in the race, Vertex has to develop all oral, pan-genotypic combinations as quickly as possible, and the Alios nukes are the key to such hope,” wrote William Blair analyst Katherine Xu in a recent note, about the significance of the data.
Xu recently lowered her price target for Vertex to $44 from $45, citing slower than expected sales of Incivek, but maintained her buy rating on the stock. 

The second set of data, which involves the company’s CF drugs, could be the real market mover, however.
“Positive results in CF could get the stock moving again,” said Needham & Co. analyst Alan Carr, who also has a hold rating on the stock. 

The CF data will be from a Phase II trial that is testing Kalydeco, which is only approved for use in about CF patients with a rare gene mutation called G551D, or about 4% of CF patients, with another experimental CF drug dubbed VX-809. 

Vertex is banking that the Kalydeco/VX-809 combo can successfully treat patients with the F508del gene mutation, which is carried by up to 90% of all CF patients. The data is expected mid-year.
Kalydeco, by the way, isn’t cheap. At nearly $300,000 a year, it ranks as one of the most expensive drugs on the market. It’s high price is due in part to its regulatory status as an “ultra-orphan” drug. The regulatory designation is designed to encourage the development of drugs for life-threatening and extremely rare conditions by offering certain financial incentives, such as market exclusivity.
Carr said that even with its current narrow prescribing indication, Kalydeco could reach peak sales of $1 billion a year. Even if Vertex were forced to lower the price of the product, which would like happen if it were approved for a much larger patient population, sales could still be in the billions.
“According to our probability-adjusted net present value model, for every 10% increase in the probability of success for the combo, Vertex’s stock will have $4-$5 per share in upside, representing a powerful lever,” wrote Xu, of the CF drugs. 

“We believe there is a good chance for the Phase II combo data to be successful, which may compensate for the decline of the HCV franchise and lead to the next leg of growth for Vertex,” Xu added. 

That said, the Kalydeco data may also prove to be a bust. Data from an earlier segment of the Phase II trial showed the combination to be only modestly effective. Vertex is hoping that data from a second segment of the trial, which is administering VX-809 in higher doses over a longer period of time, yields more impressive results.
“People are getting pretty excited, but I’m just not there yet,” said JMP Securities analyst Liisa Bayko in a recent interview. Bayko currently has a hold rating on the stock.

FDA sets draft rules for biotech drug copies
Thu Feb 9, 2012 4:46pm EST
By Deena Beasley
(Reuters) - The Food and Drug Administration's long-awaited guidelines for the sale of lower-cost versions of biotechnology drugs leave open the possibility that some products might not need to be tested in humans.

Shan Juan and Wang Qingyun
(China Daily, February 3, 2012)
"Analysis by Medicins sans Frontieres, an international health organization, suggests India now makes one-fifth of the world's generic drugs, with about 50 percent shipped abroad and sold (often illegally) at a fraction of the cost…To tackle the problem of illegally imported drugs, the State Council last year launched a special health campaign. 'It mainly aimed at Internet scams in which profiteers promoted and sold fake drugs or those sourced through illegal channels,' said Bian Zhenjia, deputy director of the State Food and Drug Administration, who added that medication designed for long-term use, such as treatments for impotence, diabetes, hypertension and cancer, are major targets for criminals…Jia Ping [a Beijing lawyer who specializes in public health cases] said he fears that the drugs market is not currently a priority for authorities in China…Although there is no legal barrier to such a system in China, 'no domestic pharmaceutical company has so far applied for compulsory licensing of a foreign patent drug,' he said, adding that Chinese manufacturers had a 'relatively poor understanding about World Trade Organization treaties and public health.'"

Healthy You

Fallout From Fatigue Syndrome Retraction Is Wide
 David Tuller 
(The New York Times, February 6, 2012) 
"When scientists reported in 2009 that a little-known mouse retrovirus was present in a large number of people with chronic fatigue syndrome, suggesting a possible cause of the condition, the news made international headlines. For patients desperate for answers, many of them severely disabled for years, the finding…seemed a godsend…In hopes of treating their condition, some patients even began taking antiretroviral drugs used to treat H.I.V., a retrovirus related to the murine leukemia viruses suddenly suspected of involvement in chronic fatigue syndrome. More recently, however, the hopes of these patients have suffered an extraordinary battering. In a scientific reversal as dramatic and strange as any in recent memory, the finding has been officially discredited; a string of subsequent studies failed to confirm it, and most scientists have attributed the initial results to laboratory contamination. In late December, the original paper, published in the journal Science, and one other study that appeared to support it were retracted within days of each other. As the published evidence for the hypothesis fell apart, a legal melodrama erupted, dismaying and demoralizing patients and many members of the scientific community."


Diet & Chronic Disease Prevention
David Brown
(The Washington Post, February 8, 2012)"The amount of trans fat in the American bloodstream fell by more than half after the Food and Drug Administration [FDA] required food manufacturers to label how much of the unhealthful ingredient is in their products, according to a new study. Blood levels of trans fat declined 58 percent from 2000 to 2008. FDA began requiring trans-fat labeling in 2003. During the same period several parts of the country -- New York most famously -- passed laws limiting trans fats in restaurant food and cooking. The makers of processed food also voluntarily replaced trans fats with less harmful oils. The decline, unusually big and abrupt, strongly suggests government regulation was effective in altering a risk factor for heart disease for a broad swath of the population. Researchers at the Centers for Disease Control and Prevention discovered the decline by analyzing blood drawn as part of the National Health and Nutrition Examination Survey, which interviews and examines a sample of Americans at least once a decade. The trend was seen in white adults; researchers are looking to see if it occurred in other ethnic and racial groups, too. Trans fats, which are used for deep-frying and as an ingredient in baked goods and spreads, increase the risk of heart disease.

Processed Foods

Here’s an interesting video from Stefani Bardin, a TEDxManhattan 2011 fellow, and Braden Kuo, MD, a gastroenterology instructor at Harvard. According to their description, the video uses “the M2A and SmartPill devices to look at how the human body responds to processed versus whole foods.” While I’m by no means an expert on this subject, the video makes for some interesting watching.
Via Devour


 FYI

(The Economist, London, February 4, 2012)
"More than 2,700 researchers from around the world have so far signed an online pledge…promising not to submit their work to Elsevier’s journals, or to referee or edit papers appearing in…[they agree with Cambridge University mathematician Timothy Gowers] First, that Elsevier charges too much for its products. Second, that its practice of 'bundling' journals forces libraries which wish to subscribe to a particular publication to buy it as part of a set that includes several others they may not want. And third, that it supports legislation…that would forbid the government requiring that free access be given to taxpayer-funded research. Elsevier insists it is being misrepresented…[the] petition, though, is symptomatic of a wider conflict between academics and their publishers -- a conflict that is being thrown into sharp relief by the rise of online publishing…This situation has been simmering for years…And there have indeed been attempts to create alternatives to commercial publishing…But despite the enthusiasm…there are reasons for the continued dominance of traditional publishers…Commercial publishers have begun to experiment with open-access ideas, such as charging authors for publication rather than readers for reading. But...things could become more urgent. After all, publishers need academics more than academics need publishers."

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