HCV New Drugs

This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.

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Wednesday, November 30, 2011

Boceprevir Often Successful as Rescue Treatment in Hepatitis C

Medscape Medical News from:

The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting

This coverage is not sanctioned by, nor a part of, the American Association for the Study of Liver Diseases.


Boceprevir Often Successful as Rescue Treatment in HCV

Neil Canavan

November 30, 2011 (San Francisco, California) — Patients with hepatitis C virus (HCV) infection who previously failed combination treatment with pegylated interferon alfa-2a (peginterferon) and ribavirin achieved up to a 50% sustained viral response (SVR) with the recently approved protease inhibitor boceprevir. This finding, from the preliminary results of the ongoing PROVIDE study, was reported here at The Liver Meeting 2011: American Association for the Study of Liver Diseases 62nd Annual Meeting.

"This study was designed to give boceprevir treatment to patients who were null responders in the control arms of our previous pivotal trials," said Michelle Treitel, PhD, from Merck Research Laboratories in Kenilworth, New Jersey.

Patients were rolled over from the SPRINT-1, SPRINT-2, RESPOND-2, and PEG 2a/BOC studies into PROVIDE. "These are patients who had either met the futility rule or who had relapsed after the end of treatment with peginterferon and ribavirin. After failure, they were immediately started on 44 weeks of boceprevir/peginterferon/ribavirin triple therapy." The aim of the study was to assess SVR after boceprevir, peginterferon, and ribavirin treatment in nonresponders.

Overall, 168 patients from the 4 studies were enrolled in PROVIDE. Patients were eligible if they received 12 or more weeks of peginterferon plus ribavirin treatment and failed to achieve a SVR (HCV RNA levels below the lower limit of detection of +9.3 IU/mL at treatment week 12 in treatment-experienced patients or at treatment week 24 in treatment-naïve patients), had a virologic breakthrough, or relapsed after the end of treatment (undetectable HCV RNA at the end of treatment but no SVR).

The subanalysis presented by Dr. Treitel involved 48 patients from the SPRINT-2 and RESPOND trials.

Patients were treated with boceprevir 800 mg orally twice daily, peginterferon 1.5 µg/kg subcutaneously once daily, and ribavirin 600 to 1400 mg/day (based on weight) orally in 2 divided doses. All patients received 4 weeks of peginterferon plus ribavirin induction therapy prior to receiving boceprevir. Patients received the boceprevir, peginterferon, ribavirin combination for up to 44 weeks, and were followed for an additional 24 weeks to determine SVR.

The PROVIDE cohort was 64.6% male, 68.8% white, had mean age of 51.0 years, and had a mean body mass index of 26.8 kg/m². Among the patients, 87.5% had a baseline viral load greater than 800,000 IU/mL, 64.6% were infected with HCV genotype 1a, and 4.2% had detectable cirrhosis.

The primary end point of PROVIDE was undetectable HCV RNA 24 weeks after therapy.

In this nonresponder subpopulation, 38% of patients treated with the triple combination achieved a SVR. The achievement of SVR differed by race (27% of black subjects and 42% of nonblack subjects), age (50% of those younger than 50 years and 29% of those older than 50 years), alanine transaminase levels (50% of those with normal levels and 34% of those with elevated levels), and genotype (41% of those infected with genotype 1a and 33% of those with genotype 1b).

"The difference by genotype is the reverse of what you would expect," said Dr. Treitel. "That most likely has to do with the small sample size."

The magnitude of decline in HCV RNA after 4 weeks of peginterferon plus ribavirin induction therapy was positively related to the rate of SVR. Dr. Treitel reported a 50% SVR for patients who experienced a reduction of at least 1 log in HCV RNA, compared with 34% SVR for patients who experienced a reduction of less than 1 log.

"This null group has not been specifically studied for boceprevir before, and these patients are really poor interferon responders," said Dr. Treitel. "In these traditionally very hard-to-treat subjects, we're still showing that you can get a 38% SVR."

Taking It to the Street

"I was very interested to see the rate of response to triple therapy in patients who have previously failed treatment or who were nonresponders," said Abu Hamour, MBBS, MSc, FRCP, from the University Hospital of Northern British Columbia in Prince George, Canada.

The lack of patients with cirrhosis in the study was a sticking point for Dr. Hamour. Although this does not reflect the population of patients he sees in his practice, the conclusions give him something valuable to take home.

"I have this information that I can give to my patients — a prognosis," he said. After treatment with this triple therapy, I can tell patients "who failed treatment with peginterferon/ribavirin or who were nonresponders...[that] if you have a more than a 1 log drop, you have a 50% chance of response; if you have less than a 1 log drop, then your response is much lower, around 35%. Patients can then make choices based on that information."

Dr. Treitel is an employee of Merck Research Laboratory. Dr. Hamour has disclosed no relevant financial relationships.

The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting. Abstract 931. Presented November 7, 2011.

Source-Medscape

Posted by HCV New Drugs at Wednesday, November 30, 2011 No comments:
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In The Spotlight-HCV Advocate and Ms. Lucinda K. Porter, RN.



Hey folks, it snowed in Michigan! Yep, I woke up to about an inch of snow, it feels like Christmas around here.

Ask yourself this, what was the best Christmas gift you ever received? Wait, let me go first.

In the year 2000 on December 22nd, the Friday before Christmas while anxiously sitting across from my physician, looking very lovely with my new post-treatment face, he announced the results of my six month post PCR. You know, the PCR which will tell me if I'm cured, or not.


My Christmas Present

With a gleam in his eye * almost like Santa, he began "You're going to have one great Christmas, congratulations, you're undetectable.

SHUT UP !

It took a few moments to sink in, could this be real?

That day I drove home with the Rolling Stones - I was "Dancing in the Street".

With this good news, my children felt assured they wouldn't lose another parent to HCV. I would be around to watch them grow, as a family we celebrated, what a Christmas we had that year.

In The Beginning There Was Little Hope

For the seasoned HCV patient, I'm talking about the tens of thousands of people who were first diagnosed around 1998 or so, when this all began for me, a time when it was rare to hear these life saving words: undetectable, cured, SVR. Heck, most us had no idea what this disease was about, we were pretty much on our own, with insufficient resources to satisfy our needs, in other words the information was almost null.

However, we did have our support forum, message board or email list where we bonded with the many brave people who will forever remain in our hearts. We lost far too many people back then to HCV, it's simply indescribable.

HCV Advocate

One by one we found it, the web site that would become instrumental in our journey. We finally had the answers we searched for, in an easy to understand format we longed for, HCV Advocate became our saving grace.

Today, I pay homage to a web site that began offering us guidance almost 15 years ago. In 1998 the information provided by "HCV Advocate" gave us freedom from the mental anguish and fear that goes along with this disease-the not knowing. Our devotion, and appreciation for the people's hepatitis C web site, runs deep.

During this dark time, HCV Advocate was our guiding light, it gave us accurate information and hope. We all read with enthusiasm each fact sheet, newsletter, and one extremely beneficial column deemed "HealthWise", authored by, Ms. Lucinda K. Porter, RN.

Ms. Porter contracted HCV in 1988 and went through treatment not once, but twice, her column first appeared in the 1998 second issue of HCV Advocate.

To understand the importance of this site and Ms. Lucinda K. Porter, let me give you a quick back story on HCV.

A point I feel compelled to make is that from 1992 to around 2001 many of us we were diagnosed or treated by our general practitioners, the advice we received was to go home and not worry about it. In those days we were told that HCV was a benign disease, with an emphasis on how brutal HCV therapy was, and in some cases worse than the disease itself.

HCV Advocate has been there from the beginning. We needed information, and HCV Advocate gave us what we needed. For many of us this site and founder Alan Franciscus, Editor-in-Chief validated our concern, in turn, we started to worry about it.

The easy to understand articles written by Ms. Lucinda K. Porter were read across the globe. We started to get the big picture, the insightful column gave us knowledge about this disease. We grew as patients, the community started to expect more from their physicians and demanded expert care. HCV Advocate saved many of us from denial, after all, most of our well meaning health care professionals were in denial. It was time to fight back, HCV Advocate and the HealthWise articles written by Ms. Porter showed us the way.

Below, I included a short time line with a few facts to shed light on the importance that HCV Advocate had to us, after all hepatitis C was still in it's early infancy.

In 1974, it was first recognized that not all cases of viral hepatitis were hepatitis A or hepatitis B. It proved difficult to identify the infectious agent responsible for these cases of non-A, non-B hepatitis. However, it become clear that many cases of post-transfusion non-A, non-B hepatitis are the result of infection with a new virus, hepatitis C.
Ten years later, in 1984 -
Scientists of the New York Blood Center have reported the discovery of a new virus they believe may be the major cause of hepatitis transmitted through blood transfusion.The report was the second in two weeks to claim discovery of the probable cause of most cases of post-transfusion hepatitis, a liver disease that affects 90,000 Americans each year. Whether or not the two reports represent the same virus is unknown. If either or both of the research teams that issued reports have found a major cause of this form of the disease, called non-A non-B hepatitis.

Dr. Prince said he did not believe the virus his group had found was a retrovirus. He proposes that it be called the ''hepatitis C virus.''


1986 - In the New England Journal Of Medicine

Treatment of chronic non-A, non-B hepatitis with recombinant human alpha interferon. A preliminary report.Volume 315:1575-1578 December 18, 1986

Blood screening for hepatitis C began in 1990, and in 1991 the FDA approved (Schering’s Intron A) - Alpha Interferon for the treatment of Hepatitis C. In 1998- the FDA approved Rebetron (Schering’s Intron A plus ribavirin) * For this blogger it was the drug of choice. Finally in 2001 (Schering’s pegylated interferon alpha-2b)- Peg-Intron was FDA approved followed in 2002 by Pegasys -(pegylated interferon alpha-2a). We really thought we were making progress. Who knew in 2011 we would have two protease inhibitors- telaprevir/boceprevir to combat this hideous virus.


The Book

This brings us back to the lovely, Ms. Lucinda K. Porter, RN. You may have noticed a link to her new book on the side bar. Which is available for purchase on December 1st.

Now for the much anticipated book, written with only one agenda in mind, to serve the large population of individuals living with hepatitis C.

Free from Hepatitis C: Your Complete Guide to Healing Hepatitis C
Written by Ms. Lucinda K. Porter, RN

Book Description

For decades, a diagnosis of hepatitis C was the equivalent of serving a life sentence--with a dangerous liver disease. It left patients frightened, confused, and vulnerable, and they took little comfort in knowing that, at best, their condition could be managed but not cured. All of that changed with the discovery that the hepatitis C virus (HCV) could be defeated with new treatments. To shed light on these groundbreaking treatments, Lucinda Porter, a registered nurse, a passionate HCV advocate, and a Hep C patient herself, has written this all-important guide. This comprehensive volume is a must for anyone considering, undergoing, or just wanting to understand HCV treatment.



Thank you HCV Advocate for over a decade of your contribution to a community which at one time had very little. On a personal note *without you I may not have searched out my treatment option's in 1999.

To you Ms. Porter, may your book reach the newly diagnosed, and the numerous people suffering with the consequences of hepatitis C.

Your name evokes respect, gratitude and affection, I feel privileged to be among the many people who have benefited from your articles over the past fifteen years. Thank you.

In 2011 HCV Advocate along with their incredible staff continue to educate the HCV community with new information, news, clinical trials, newsletters, updated information on the new drugs to treat HCV and the well written HealthWise column. The site is updated on a daily basis.

Links

Alan Franciscus Editor-inChief

HCV Advocate
HCV/HBV Advocate Blog
HBV Advocate
Hepatitis & Tattoos
HCV Advocate Newsletters
Hepatitis C Treatments in Current Clinical Development

C.D. Mazoff, PhD- Webmaster and Managing Editor

Leslie Hoex
Design and Production Manager for Printed Materials

Rose Christensen
Office Manager

Lucinda K. Porter, RN
Nurse Educator, Contributor

Liz Highleyman
Contributor

Jacques Chambers,CLU
Benefits Counselor, Contributor

Clara I. Maltrás
Spanish Translator

Magali Thomas
French Translator

Irina Gavrilova, MSc
Russian Translator

Christine Kukka
HBV Project Manager
Posted by HCV New Drugs at Wednesday, November 30, 2011 No comments:
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AASLD-Liver Learning 2011:New Hepatitis C Treatments


The Liver Meeting® 2011 Educational Webcast of selected sessions

If you haven't yet explored the "LiverLearning" section available @ the AASLD web site you're missing out on the November meeting webcasts, video podcasts, abstracts and more. Free registration is required, it's quick and painless folks, start the process by clicking Here.
Once that is accomplished, check out some of the topics and programs available below .

View Complete list of selected sessions by clicking here

Access -50 Webcasts ,783 ePosters ,1229 Abstracts ,50 Video Podcasts
31 PPT Shared Files at LiverLearning


New Treatment Paradigms
by David R. Nelson
2011-11-07

Preparing the HCV Patient for Treatment
by Andrew Muir
2011-11-07

How direct-acting antivirals (DAA) Work and Their Limitations
by Raymond Chung
2011-11-07

Hepatitis Debrief
Dr. Gregory Everson
75 slide(s) – English
2011-11-08

Complications of Cirrhosis

HCV: Diagnosis and Natural History - 23 posters(s)
A 20-year cohort study on the natural history of untreated hcv infection in rural chinese plasmaphoresis donors
Jinyu Ren
2011-11-04

View Complete List of selected sessions
Free registration required
Register Here
Posted by HCV New Drugs at Wednesday, November 30, 2011 No comments:
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File Under AASLD Nov 2011, AASLD Nov 2011-Pocasts-Videos-Webcasts, hcv abstracts, HCV research

Tuesday, November 29, 2011

Telaprevir-Am I Anal Or Do I Itch?



Telaprevir-Anorectal Adverse Events

Define Anorectal- Pertaining to, or associated with the anus and rectum.

In clinical trials 29% of subjects treated with INCIVEK-telaprevir combination treatment* experienced anorectal adverse events, compared to 7% of those treated with pegIFN-RBV alone.

The majority of these events- eg, hemorrhoids, anorectal discomfort, anal pruritus and rectal burning - were mild to moderate in severity. Less than 1% led to treatment discontinuation. Events resolved during or after completion of INCIVEK dosing.

Yep, the topic on the blog today is one heck of a side effect, its horrible, annoying, painful, and unrelenting. Its Telaprevirs-Unmentionable-Itch, better known as the "anorectal side effect".

In 2011 during the April FDA Advisory Committee meeting Dr. Van Dyke asked the advisory committee a question on the anal topic.

Anal Itch; Burning sensation or an itching sensation

DR. VAN DYKE: My other question is, could you give us more clinical details on the anorectal symptoms in terms of what they were, what did they look like clinically, and how long did they last, and how much of a problem really were they for the subjects? Because they were quite common, like 29 percent.

DR. KAUFFMAN: Yes. We first became aware of this in Phase 2 with increased reports of hemorrhoids. And, frankly, I don't think it was really hemorrhoids, but hemorrhoids are present very commonly, so when you take a look, you often will find hemorrhoids, even if they're not really related to the phenomenon. We have really only anecdotal reports. But I have spoken to many investigators about this phenomenon. Upon examination, there is no inflammation. Either externally or on anoscopy, there's been no inflammation. And I'll just point out parenthetically that in all of our nonclinical studies, there is no inflammation or other findings related to the colon with telaprevir.

It's described as a burning sensation or an itching sensation. It occurs relatively rapidly after the beginning of administration of telaprevir. It actually often resolves either during the period of dosing or very rapidly thereafter. And as we pointed out, it's almost never associated with treatment discontinuation. It is an annoying side effect, but it really doesn't have any serious consequences in terms of compliance with the treatment regimen.

Back in 2009 at the The European Association of the Study of Liver Disease(EASL) columnist Adam Feuerstein reported on the phase III clinical studies for Telaprevir , he mentioned the anal itching scenario in his column. Here's the quote folks;

Telaprevir was the "butt" of some negative EASL chatter due to an anecdotal report that the drug was causing severe anal itching in patient(s). One EASL attendee described the side effect as "fire in the hole."

Ouch!

Perhaps you're that patient, and this side effect has taken on a life of its own. This blogger has received a few emails over the last year from men and women asking for more information on this itching, burning, anal phenomenon. Although, between the two sexes, male and female, the men are a little more graphic, more concerned and very direct. Why ? In part maybe because the male gender hasn't had the pleasure of experiencing the after effects of childbirth. I think most men are probably anorectal virgins, and my heart goes out to them. The majority of women on the other hand have felt post delivery anal pain, we're talking the- "mother of all hemorrhoids". The women write asking for an informational link, then mention the discomfort. Done.

Over the last year, I've corresponded with one such colorful male character. My friend was treating with the "anal itch" magic triple therapy.

Yesterday, I wrote this lovely gentlemen and asked him if I may paraphrase in a post his description of the irritating anal itch. I told him my readers needed a smile, he quickly replied with "Yes, please carry on, my pain is your pain".

First let me share one of his favorite quotes

The more serious the illness, the more important it is for you to fight back, mobilizing all your resources — spiritual, emotional, intellectual, physical.
Your heaviest artillery will be your will to live. Keep that big gun going.
Norman Cousins -Anatomy of an Illness

This charismatic man served in the Vietnam War, which explains his description of his anal irritation;

Hell, in Nam I had boot rot, give me boot rot over butt rot any day. Tell me woman, should I call my doctor and demand a shot of "butt rot fixer", or should I call Vertex asking to be reimbursed for a broken ass.

I quickly wrote back telling him I googled the said Pharmaceutical company and proceeded directly to the site, where I clicked on the "Contact Us" forwarding his email. We're still waiting to hear back.

Yes folks, there is a happy ending to his "telap-ass-rot" story, last week my sweet friend notified me with the results of his six month post PCR .. IT was....Undetectable.

I quickly replied with;

My heart is singing, my dog is excited, but I have one question.
Did your hemorrhoids make it outta the jungle alive ?

He replied;

Yeah, they couldn't take the heat.

No doubt treatment sucks, but when the end result is successful, its so worth the battle.

The following information is from Mayo and based on general clinical practice and current recommendations. It may help get you through the itch, I hope you find it beneficial.


Managing Anal Itching and Burning

Avoid irritants.
Avoid bubble baths and genital deodorants.

Switch tissue.
The skin around your anus may be sensitive to toilet paper that contains dyes or perfumes. Use unbleached, unscented toilet paper. You may want to use toilet paper that's moistened or made extra soft for comfort, or unscented flushable bathroom wipes

Cleanse gently.
Wash the area in the morning, at night and immediately after bowel movements. But don't scrub and avoid using soap. Instead, use a wet washcloth or a small squeeze bottle of water to cleanse the area.

Dry thoroughly.
After cleansing, pat the area dry with toilet paper or a towel. Avoid any greasy products such as Vaseline, the idea is to keep the area dry, not moist.

Wear cotton underwear and loose clothing.
This helps keep the area dry. Avoid wearing pantyhose and other tight-fitting garments because these can trap moisture

Don't scratch.
Scratching further irritates your skin and leads to persistent inflammation. If you can't tolerate the itching, apply a cold compress to the area or take a lukewarm bath or sitz baths to find some immediate relief.


Treatments that may help manage symptoms



The only “natural” cleaning agent that is 100% safe and effective on the anus is water.

A protective ointment that contains zinc oxide (Desitin, Balmex) applied to the affected area may help relieve symptoms.

To relieve mild or moderate itching, try over-the counter cream or ointment that contain hydrocortisone (Cortaid, Preparation H Anti-Itch Cream). This should be used over a short period of time as prolonged usage may thin the perianal skin. Apply sparingly and as directed.

If nothing seems to relieve your symptoms alert your physician as they can prescribe an ointment, antihistamine or both.

*Antihistamines before bedtime may help relieve nocturnal itching.


Hemorrhoids
Swollen veins in the rectum or anus

Mild pain, swelling and inflammation from hemorrhoids often can be managed with self-care measures.

Hydration and fiber:
Softening and bulking up stool for easier passage is helpful. Strategies include drinking six to eight glasses of water or other nonalcoholic beverages daily, eating high-fiber foods, and taking fiber supplements such as Metamucil and Citrucel.

If diet alone isn't working talk to your provider about over the counter laxatives.

For Pain

Swelling relief: Ice packs or cold compresses on the anus can relieve swelling.

Again, plain warm tub or sitz baths several times a day, for about 10 minutes.

Ask your physician which nonprescription pain relievers such as acetaminophen (Tylenol, others), you should use.

In the end having a side effect validated is medically important and reassuring. Side effects are serious and must be reported. They're also stressful and can lead to apprehension, anxiety or fear. The last thing you need is to feel bleak about the future. Please remember its only temporary, keep your eye on the end result. Stay in close contact with your doctor, never hesitate to call him/her if you experience any discomfort.
You're not overreacting, you're advocating.

Please forgive me Vertex, I owe you my gratitude. Thank you. Please start those clinical trials for the post transplant patient soon.

Please see the full Prescribing Information.


In a reply to this article is a tip from HCV Advocates own-Ms. Lucinda K. Porter, RN.

Great article. I just wrote a similar one and if you don't mind my adding one more tip, here's part of what I wrote: Physicians are concerned that patients with anal itching may not be absorbing the full dose of telaprevir. The theory is that drug is “leaking out” rather than being fully metabolized, and telaprevir goes into the gut, which passes through to the other end. Therefore, not only do patients have an itching problem, they are not getting all of their medication. You can find the rest of the article by Clicking Here

Please check out this new post on the blog

In The Spotlight-HCV Advocate and Ms. Lucinda K. Porter, RN.


Posted by HCV New Drugs at Tuesday, November 29, 2011 3 comments:
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Monday, November 28, 2011

Drug-resistant Hepatitis C

Drug-resistant Hepatitis C

Nov. 28, 2011




Research into range of mutations provides clues to improve treatment


A team of international researchers, led by Matthias Götte from McGill’s Department of Microbiology and Immunology, believes it has found a key factor in understanding why certain drug-resistant strains of the hepatitis C virus are seen so frequently, while others are rarely detected.


It has been estimated that 170 million people around the world are infected with the hepatitis C virus (HCV). Close to 300,000 of them live in Canada. Chronic infection with the virus is associated with severe liver disease, including cirrhosis and cancer. Unlike hepatitis A and B, there is currently no vaccine to prevent people from catching the disease. Although new medications show great promise in curing HCV infection, the virus is able to develop resistance to each class of antiviral drugs. And as a result, treatment may fail.


It was already known that humans are not infected by a single species of virus, but rather by billions of different, mutant viruses that sometimes differ from one another only by a single nucleotide, i.e. the basic building blocks of viral RNA. The researchers have now demonstrated that the viral polymerase, the enzyme responsible for copying sequences from RNA, is inaccurate in the way it replicates these sequences and as a result generates mutations when connecting one nucleotide after the other. “The surprising finding we had is that some mutations are much more easily made than others,” says Götte.


They next submitted HCV RNA samples taken from infected patients to sequence analyses and were able to distinguish between rare and common types of mutations. Together, the data suggest that the bar for the development of drug resistance is much higher if rare mutations are involved. This study has therefore important implications for the development of potent drug combinations that are less likely to result in the emergence of resistance.


The research was funded by: Cancer Research Society, Canadian Institutes of Health Research


Career awards and stipends were provided by: Fonds de Recherche en santé du Québec, Canadian Institutes of Health Research, and the National Canadian Research Training Program in Hepatitis C.


The paper describing the research was published by the Proceedings of the National Academy of Sciences (PNAS).


To read an abstract of the paper: http://www.pnas.org/


More news from McGill University: http://www.mcgill.ca/newsroom/


PHOTO: High magnification micrograph of a liver with cirrhosis, a complication of hepatitis C. (Wikimedia Commons)


Source

Posted by HCV New Drugs at Monday, November 28, 2011 No comments:
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Hepatitis C News Ticker-Tissue regeneration and block scarring by manipulating the actions of serotonin?

CARL VILHELM HOLSOE (1863-1935)


New On The Blog


Drug-resistant Hepatitis C
Committee to Continue and Complete Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer as Planned
What Is Magnetic Resonance Elastography (MRE) ?
Hepatitis C - Dry Mouth and Treatment
Quack medicines, insect immigrants, and what eats what among secrets revealed by DNA barcodes


In The News

Publishing in Nature Medicine and showcased in Nature Research Highlights, the paper describes how working in mouse models the team were able to tip this balance to favour healthy tissue regeneration and block scarring by manipulating the actions of serotonin - the “happy” drug.

Manipulating serotonin can promote healthy repair in chronic liver disease
Publishing in the leading medical journal Nature Medicine, a team led by Newcastle University academics have identified serotonin receptors which can be targeted with drugs to enhance the natural healing properties of the liver.

In liver disease, extent of tissue damage depends on the balance between the generation of scar tissue and the regeneration of new liver cells. In a significant minority of people who get injury to their organs instead of repairing them, they form scars. This can progress to chronic liver disease and cirrhosis where the scarring is so extensive the liver is unable to clean blood or produce vital hormones and clotting factors. Liver scars also provide an ideal environment for the development of cancers.

Publishing in Nature Medicine and showcased in Nature Research Highlights, the paper describes how working in mouse models the team were able to tip this balance to favour healthy tissue regeneration and block scarring by manipulating the actions of serotonin - the “happy” drug. Normally when a liver is injured – by a virus such as Hepatitis C or B, by alcohol, environmental factors or by a metabolic or autoimmune condition – specialised blood cells known as platelets make general repairs and secrete serotonin. However, the team found that when scar-forming cells - Hepatic stellate cells (HSC) – are present they are instructed by the serotonin to make more scar tissue and switch off the healthy regeneration.

Identifying the receptor called 5-HT2B through which serotonin instructs the scar forming cells to switch off regeneration, they found that this resulted in less scarring and more regeneration. Of the work funded by the Medical Research Council and the Wellcome Trust, lead author, Professor Derek Mann said; “These are promising results in mouse models of liver disease and suggest that chemicals targeting 5-HT2B , which are currently in clinical trials for mood disorders and pulmonary hypertension might also have an application in the treatment of chronic liver disease.” The group believe the mechanism may also be found in other organs and offers an exciting opportunity for study in the future.

More information: Stimulating healthy tissues regeneration by targeting the 5-HT2B receptor in chronic liver disease, Derek A Mann et al. Nature Medicine.10.1038/10.1038/nm.2490

Provided by Newcastle University


HCV Worldwide


About 10 million people infected with Hepatitis- C in Pakistan

KARACHI: Viral hepatitis is affecting about 400 million people, out of which one third cases are due to Hepatitis-C Virus (HCV) alone.

In Pakistan about 10 million people, which is about 6 per cent of the total population, is affected with hepatitis- C.

This was stated at a lecture jointly organised by Dr. Panjwani Centre for Molecular Medicine and Drug Research (PCMD).

It was pointed out that Hepatitis is an inflammation of the liver generally due to the viral infection or due to some metabolic abnormalities.

In his lecture Prof. Dr. Aqeel Ahmed of the Department of Microbiology, University of Karachi, expressed the apprehension that mortality rates due to hepatitis- C are expected to go up in future.

The Karachi University statement on Sunday said that the topic of his talk was ‘HCV: Disease and Prevention’.

It was jointly organised by PCMD and Virtual Education Project Pakistan (VEPP) as a part of series of popular lectures for public awareness on common diseases of Pakistan.

Health professionals, students, research scholars, NGO representatives and general public attended the lecture.

Prof Ahmed said that hepatitis is inflammation of the liver generally due to viral infection caused by hepatitis viruses; these unrelated viruses have different epidemiologic profiles and are transmitted through different routes which are either water-borne, or spread through the blood, blood products or unethical medical or social practices.

He said that Hepatitis viruses produce inflammation in the liver, resulting in clinical illness characterised by fever, and often non-specific symptoms like pain in abdomen, loss of appetite, nausea, vomiting and jaundice, he said, adding more than 70 per cent of HCV infected patients become chronic, which may lead to death of patient.

Prof. Ahmed said that this has immense financial implications, so early detection and treatment of Hepatitis- C is recommended.

Genotypes 3a and 3b, amongst 11 genotypes of hepatitis, are found to be the most common genotypes in some regions of the world.
He stated that patients with these genotypes also had good chances of response rate to the therapy.

There are some host-factors attributed to increased risk of HCV infection, including older age, male gender, co-infection with HIV, HBV.

Other factors such as alcohol consumption, iron overload and hepatotoxic medicines also have damaging effects.

Patients with chronic hepatitis ‘C’ can develop many extra hepatic symptoms like rheumatoid arteritis, keratoconjunctivitis sicca, glomerulonephritis and lymphoma which are probably due to altered immune response.

Psychological disorders like depression are seen in about 20 to 30 per cent patients.

Talking about prevention of the fatal disease, he said that there are some important preventive measures that include increasing awareness of disease; blood screening before transfusion; avoiding re-use of syringes and sharing common household items such as razors and tooth brushes; training of healthcare workers; treating Hepatitis- C patients with appropriate drugs including interferon and ribavirin.


Hepatitis C outbreak hits Anhui

A Hepatitis C epidemic has broken out in Woyang county in Bozhou, Anhui Province, and may have been caused by unsafe injections, said local health authorities.

According to a press release issued by the Anhui Provincial Health Bureau on Monday, 56 potential carriers of the virus were examined and 13 were tested positive.

Many of the Hepatitis C carriers are children, according to China National Radio, which reported parents in Woyang often take their kids to the nearby Miaoqian clinic in Maqiao, Henan Province, to see doctors.

After hearing rumors that some children in Maqiao, who go to the same clinic, contracted Hepatitis C, the parents in Woyang took their kids to local hospitals to get blood tests and found out their children are also infected.

According to the press release, the Anhui Provincial Health Bureau received a report from the Bozhou Health Bureau on Friday indicating a Hepatitis C epidemic had broken out. The initial investigation suggested the epidemic may have been caused by unsafe injections because all the carriers had intravenous injections at the private clinic in Henan Province.

"The number of the Hepatitis C virus carriers remains at 13 for the time being. We received the report from the Bozhou Health Bureau on Friday," said an employee at the public relations office in Anhui Province, who refused to give her name or reveal more details of the case. "We will have a meeting to discuss the public awareness strategy."

Hepatitis C is an infectious disease primarily affecting the liver. It usually spreads through contact with infected blood and there is no vaccine for it.

Most of those infected have no symptoms until the virus causes liver damage, which can take 10 or more years to occur.

Though some people can fight off the virus, most Hepatitis C infections become chronic. Without treatment, chronic Hepatitis C can scar the liver and lead to liver cancer or liver failure.

The outbreak comes one year after a cholera epidemic in Anhui, which infected 33 people.

In August 2010, health authorities in Mengcheng, Anhui Province, withheld the statistics of the cholera epidemic for 12 days.

The county said the numbers were delayed because it was not at liberty to release them.

Wang Jianjun, a vice director of the Anhui Center for Disease Prevention and Control, said people will become indifferent to epidemics if they publicize each infection case immediately.

And the decision on whether or not to notify the public was also based on a discussion with the Ministry of Heath, according to the Southern Metropolis Daily.


In Case You Missed It

Hep C Protease Inhibitors May Not Be Cost-Effective For Some First-Time Treatment Takers

Hepatitis C virus (HCV) protease inhibitors are not cost-effective for first-time treatment takers with HCV genotype 1 and the IL-28B CC genotype, according to analysis conducted by Ziad Gellad, MD, MPH, of Duke University Medical Center in Durham, North Carolina, and his colleagues. They reported their findings on Monday, November 7, at the 62nd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco. According to the study authors, people with the IL-28B CC genotype are more likely to be cured with pegylated interferon and ribavirin alone than people with the IL-28B CT or TT genotypes, for whom the addition of either Incivek (telaprevir) or Victrelis (boceprevir) may be more cost effective.

A 24- to 48-week course of pegylated interferon and ribavirin ranges from $18,000 to $30,000. As Gellad noted, “adding Incivek (telaprevir) or Victrelis (boceprevir)”—both recently approved HCV protease inhibitors—“more than doubles the cost of therapy, to a range of $48,000 to $85,000.” Read More Here


MT MRI Contrast No Help in Cirrhosis Diagnosis

By Diagnostic Imaging Staff | November 27, 2011

Magnetization transfer (MT) contrast-prepared magnetic resonance imaging is “unlikely to be of clinical utility” in diagnosing cirrhosis, according to a study published online Nov. 23 in the journal Radiology.

The study did confirm the ability of MT contrast prepared MRI to help distinguish substances of varying protein concentration, according to New York University researchers led by radiologist Andrew B. Rosenkrantz, MD.

Researchers studied 20 patients with cirrhosis and portal hypertension and 20 healthy volunteers with no known liver disease. Rosenkrantz and colleagues had previously optimized the MT sequence using agar phantoms with protein concentrations ranging from 0 percent to 4 percent. The subjects underwent liver MR imaging that included eight separate breath-hold MT contrast sequences, each performed by using a different MT pulse frequency offset (range, 200–2500 Hz). Regions of interest were then placed to calculate the MT ratio for the liver, fat, and muscle in the volunteer group and for the liver in the cirrhosis group.

The MT ratio was nearly identical between healthy (26.0 percent to 80.0 percent) and cirrhotic livers (26.7 percent to 81.2 percent) for all frequency offsets.

But as has been showed with previous studies, MT ratio can indeed differentiate tissue types. MT ratio increased with decreasing MT pulse frequency offset for each of the four phantoms and the assessed in vivo tissues, consistent with previous reports. At all frequency offsets, MT ratio increased with increasing phantom protein concentration. In volunteers, at frequency offsets greater than 400 Hz, the MT ratio was significantly greater for muscle (34.4 percent to 54.9 percent) and much lower for subcutaneous fat (10.3 percent to 12.6 percent), compared with that for the liver (22.8 percent to 46.9 percent).


From Journal of Viral Hepatitis

HIV and HCV Health Beliefs in an Inner-city Community

K. Krauskopf; T. G. McGinn; A. D. Federman; E. A. Halm; H. Leventhal; L. K. McGinn; D. Gardenier; A. Oster; I. M. Kronish

Posted: 11/27/2011; J Viral Hepat. 2011;18(11):785-791.

© 2011 Blackwell Publishing

HIV and HCV Health Beliefs in an Inner-city Community
This study underscores the importance of public health interventions to educate the public about the dangers of hepatitis C, especially in vulnerable inner-city communities.
Journal of Viral Hepatitis
, November 2011

Discussion Only
Click Here For Full Text

In this study of inner-city adults from a community at high risk for HIV and HCV, participants were more likely to have inaccurate health beliefs about risks factors for causes, sequelae and control of HCV than of HIV. Overall, our results demonstrate that study participants have accurate health beliefs for HCV only 58% of the time. Furthermore, as hypothesized, our study population demonstrated significantly less accurate health beliefs about HCV than about HIV, despite the fact that participants were recruited from a community with higher prevalence of HCV than of HIV. This discrepancy in health beliefs for the two infections was present for several key domains within the Common Sense Model.

Results of our study also highlight specific health belief inaccuracies that might be important targets for public health interventions. When compared to HIV, fewer participants accurately believed that HCV could be prevented, fewer believed that HCV could be transmitted by sharing needles, and less than half accurately believed that it is a potentially life-long infection. The fact that beliefs were more accurate for HIV than for HCV in our study suggests that lessons might be learned from successful HIV interventions to improve similar health beliefs about the risk for and long-term consequences of HCV.

In contrast with HIV that cannot yet be cured, HCV treatments are curative (defined as sustained viral response 6 months after completing treatment). While treatment with pegylated interferon and ribavirin is involved and often arduous, a sustained viral response can be obtained in 40–80% of treated cases of chronic HCV, depending on viral genotype and certain patient characteristics. Furthermore, the advent of new therapies suggests that cure rates may rise in the near future. Yet, only 25% of our study participants believed there to be a potential cure for HCV infection. In general, low uptake of HCV treatment poses a persistent challenge – despite the possibility of SVR, 20–30% of patients with HCV initiate and complete therapy.[26,27] The decision to initiate treatment for HCV is complex and health beliefs may pose an important component. The commonly held belief among patients in our study that HCV is not curable may stem in part from limited knowledge about treatment options. It is also possible that treatment side effects or treatment failures have been disproportionately represented in our survey community, thus contributing to the belief that HCV is not curable.

A number of additional associations deserve comment. First, only one quarter of our survey participants accurately believed that both HIV and HCV can cause cancer. These are concerning results as HCV continues to represent the leading cause of liver transplantation in the United States, contributing significantly to growing rates of cirrhosis and hepatocellular carcinoma.[28] Similarly, since the advent of HAART, rates of cancer – in particular non-AIDS malignancies – continue to rise in the HIV-infected population.[29,30] It may be difficult for individuals to modify perceptions of HIV and HCV as infectious diseases that are capable of resulting in long-term, even chronic, health consequences. Interventions to improve health beliefs about HIV and HCV might highlight the growing overlap of infectious disease elements with long-term, chronic disease characteristics within these illnesses. Helping patients understand that engaging in healthier behaviours related to HIV and HCV may prevent not just the infection, but also the development of chronic disease and cancer, may prove to be a compelling public health strategy. Sylvestre et al.,[31] for example, have demonstrated that peer-based educational interventions have successfully engaged members of an urban community of drug users in care, with subsequent increases in HCV testing and treatment uptake. Broader application of these techniques might serve to improve health beliefs and HCV health outcomes in additional at-risk communities.

Second, the association between female gender and accurate health beliefs about HIV deserves some exploration. Perhaps this association reflects the fact that women, more often then men, participate in the health care system and in accessing community-based health information – either in caring for themselves or as caregivers for others.[32–34] As a result, women may come into contact more often with accurate health information, may be more motivated themselves to seek screening and treatment in general, and may be more likely to encounter others seeking screening and treatment for HIV. These factors may subsequently contribute to more accurate HIV health beliefs.

To our knowledge, at present there are no studies formally comparing health beliefs about HIV and HCV in an at-risk community in the United States, using the Self-Regulation model. Several limitations of our study are worth noting. The overall sample size and response rate were modest. Yet the sociodemographics of participants in our study were representative of the clinic population in general, and the high rate of Medicaid insurance was reflective of the study community at large. In addition, our study was conducted in a single, hospital-based, academic internal medicine practice, and findings should therefore be interpreted carefully in the context of other settings. Interviews for this study were conducted in-person, which may have resulted in some response bias because of the highly personal and sensitive nature of some of the survey questions. Less-public approaches to asking them, such as audio computer assisted self-interviews, might have been more effective at eliciting some participants' health beliefs. In addition, 'history of sex without a condom with a person at risk for HCV' was included as an independent variable in our regression model. Use of this variable as a predictor is ambiguous, as evidence in the time period since this study was conducted demonstrates that HCV is not a sexually transmitted infection in the traditional sense, given that its mode of transmission is blood borne. Finally, our study suggests that further research might explore health beliefs compared to health knowledge in a similar population.

Prominent public health messages about HIV appear to have largely been received and remembered by this at-risk population. This does not appear to have been the case with HCV in this same population, despite shared risk factors. This deficit, therefore, is likely not due to underlying low health literacy of this population. Instead, it may reflect that our study population has not been effectively exposed to detailed HCV public health messages or that these messages simply do not exist. As Klein et al. describe, despite the creation of the National Hepatitis C Prevention Strategy in 2001, federal funding for HCV in the United States through the Centers for Disease Control and Prevention Division of Viral Hepatitis has been limited to supporting HCV coordinators on a State level. Thus, federal funding has not been sufficient for the development of sustainable HCV public health prevention programmes or services implementation.[35] Furthermore, if HCV public health messages have been created on a local level, they may not have effectively connected with our study population. As the burden of HCV infection continues to mount in the United States and promising new therapies become available to combat it, screening and treatment must increase beyond their current, disappointingly low rates. The Institute of Medicine recently acknowledged this need when it issued its Report on Hepatitis Prevention and Control, which recommends the development of national public health strategies to improve awareness of HCV in at-risk communities and in the general population.[3] Disseminating accurate information about HCV may be a key element to modifying patient behaviour and may subsequently result in better health outcomes for patients. Educational efforts should extend beyond providing correct health information to improve knowledge and should also address specific socio-cultural experiences that influence the development of health beliefs to perhaps foster healthier behaviours.


Hepatitis B



Liver cancer occurs in immigrants with Hep B younger than screening guidelines
11/24/2011 GastroHep.com News
A study in November's issue of the American Journal of Gastroenterology reports on risk factors for hepatocellular carcinoma in Asian immigrants with Hep B in the USA.


Antigens and not genotypes predict viral load in Hep B
11/24/2011 GastroHep.com News
Hepatitis B e antigen and not genotypes predicts viral load in patients with hepatitis B in Denmark, reports the latest issue of the Scandanavian Journal of Gastroenterology.



Liver Transplants


Novel score improves guidelines for allocation in liver transplants
The latest Annals of Surgery reports on a novel score targeting justice and utility in the Model for End-Stage Liver Disease era.

Dr Philipp Dutkowski and colleagues designed a new score on risk assessment for orthotopic liver transplantation based on both donor and recipient parameters.

The balance of waiting list mortality and posttransplant outcome remains a difficult task in the era of the model for end-stage liver disease (MELD).

Using the United Network for Organ Sharing database, a risk analysis was performed in adult recipients of orthotopic liver transplantation in the United States of America between 2002 and 2010.

Living donor-, partial-, or combined-, and donation after cardiac death liver transplants were excluded.

Predictors included recipient MELD score and recipient age
Annals of Surgery
The research team then calculated a risk score on the basis of logistic regression factors, and validated using our own orthotopic liver transplantation database.

Finally, the team compared the new score with other prediction systems including donor risk index, survival outcome following liver transplantation, donor-age combined with MELD, and MELD score alone.

The team identified 6 strongest predictors of posttransplant survival.

The predictors were recipient MELD score, cold ischemia time, recipient age, donor age, previous orthotopic liver transplantation, and life support dependence prior to transplant.

The researchers found that the new balance of risk score stratified recipients best in terms of patient survival in the United Network for Organ Sharing data, as in the European population.

Dr Dutkowski's team concluded, "The BAR system provides a new, simple and reliable tool to detect unfavorable combinations of donor and recipient factors, and is readily available before decision making of accepting or not an organ for a specific recipient."

"This score may offer great potential for better justice and utility, as it revealed to be superior to recent developed other prediction scores."
Ann Surg 2011: 254(5): 745–754
28 November 2011


Nonalcoholic steatohepatitis (NASH)

From Medscape Medical News

More Nonalcoholic Steatohepatitis Requiring Transplant

Neil Canavan

November 28, 2011 (San Francisco, California) — Nonalcoholic steatohepatitis (NASH) as an indication for liver transplantation rose 5-fold from 2002 to 2009. Although metabolic changes related to NASH risk have increased in the general population as a whole, the criteria for establishing risk for NASH-related liver failure remain unclear, according to data presented here at The Liver Meeting 2011: American Association for the Study of Liver Diseases 62nd Annual Meeting.

"NASH is increasingly an indication for liver transplant," said Danielle Brandman, MD, from the University of California at San Francisco. "Factors for this include the addition of NASH as a diagnosis in the UNOS [United Network for Organ Sharing] database, and increased awareness of NASH as a cause of end-stage liver disease." Up to half of all cases of cryptogenic cirrhosis are likely a result of unrecognized NASH, although Dr. Brandman noted that there are no uniform diagnostic criteria to define cryptogenic cirrhosis caused by NASH.

To identify the NASH-related risk factors driving this increase, the researchers conducted a comparison of pre- and post-MELD score measures.

The findings suggest that steep increases in the incidence of obesity and insulin resistance are the culprits, as opposed to the recorded rates of hypertension and dyslipidemia, which have remained essentially stable since 2002.

In addition to these changes occurring over time in the general population, "we must think about how patients with NASH undergoing liver transplant may be changing over time," said Dr. Brandman. This study is an investigation of changes in the characteristics of liver transplant recipients secondary to NASH over time, as well as patient survival after transplantation for NASH.

The data for this retrospective investigation were drawn from the UNOS database. The inclusion criteria included being 18 years or older and undergoing liver transplantation from 2002 to 2009. Exclusion criteria included retransplantation, HIV positivity, fulminant hepatic failure, and rare liver diseases.

Cases of NASH and "probably NASH" were combined for the analysis. NASH was determined using primary diagnostic code at liver transplantation, and probably NASH was defined as preliver transplant diabetes mellitus, preliver transplant hypertension, and/or a body mass index (BMI) of 40 kg/m² or higher.

After reviewing 30,182 charts, Dr. Brandman's team identified 1355 cases of NASH and 1537 cases of probably NASH. In the probably NASH group, 70% had diabetes, 32% were hypertensive, and 9% had a BMI of 40 kg/m² or higher. Many patients had more than 1 condition, and half of the remaining liver transplant recipients were positive for hepatitis C virus infection.

There were more females in the NASH/probably NASH group than in the no NASH group (43% vs 29%), more patients with a BMI of 40 kg/m² or higher (31.7% vs 27.5%), more white patients (31.7 vs 27.5), more preliver transplant diabetes (67% vs 19%), and more hypertension (43% vs 16%). Patients in the NASH/probably NASH group had a low prevalence of hepatocellular carcinoma but a high requirement for renal replacement therapy just before transplantation.

Five-year survival rates after liver transplantation in the 2 groups were the same (81.1%).

Matching temporal trends of these measures to risk and outcome has been problematic. "Since 2002, NASH is an increasing indication for liver transplant; it was responsible for just over 4% of transplants in 2002 and more than 12% in 2009," said Dr. Brandman. "At the same time, those identified as having NASH/probably NASH exhibited less preliver transplant diabetes and pretransplant hypertension over time, despite increases in these conditions in the general population."

Dr. Brandman surmises that the selection criteria for liver transplantation are likely being applied. "Additional studies are needed to determine what these criteria are, and which are the strongest predictors of outcome."

There's Something Happening Here

"NASH can definitely kill an individual," said Arun Sanyal, MD, chair of gastroenterology, hepatology, and nutrition at Virginia Commonwealth University in Richmond. Patients with NASH have a 15% to 20% risk of progressing to cirrhosis and end-stage liver disease, and there is increasing evidence that NASH may be connected to the development of hepatocellular carcinoma, even in the absence of cirrhosis. "That has huge public health implications because this cancer has one of the fastest rising incidences in the country."

Dr. Sanyal concurs with Dr. Brandman that the factors driving the increase in NASH are not clear.

"The increasing incidence of obesity and insulin resistance are 2 factors certainly." Other suggested contributors are the consumption of high-fructose corn syrup and environmental exposure to pollution. "There are studies that have linked exposure to various hydrocarbons to the development of fat in the liver — one of the defining characteristics of NASH."

Genetics also play a role. "We know that African Americans have a high incidence of hypertension and diabetes, but seem to be protected from fatty liver disease. In contrast, Hispanics have a high rate of metabolic syndrome and fatty liver disease," Dr. Sanyal said.

What is the clinician to do for the obese or hypertensive patient regarding NASH? "This is an emerging trend, so we're not quite there yet with a general clinical recommendation." There is no set diagnostic criteria for the disease, and other than lifestyle interventions, there is no approved treatment, although vitamin supplements can help. "We published a study last year showing that vitamin E at 800 units/day reverses NASH in roughly 40% of patients [N Engl J Med. 2010;362:1675-1685]," Dr. Sanyal noted.

Dr. Brandman and Dr. Sanyal have disclosed no relevant financial relationships.

The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting. Abstract 12. Presented November 8, 2011.

Authors and Disclosures
Journalist
Neil Canavan

Neil Canavan is a freelancer for Medscape.


Tattoos


Florida tattoo industry to get cleaned up




By Alexia Campbell, Sun Sentinel

8:14 p.m. EST, November 27, 2011

Florida's largely unregulated tattoo industry soon will get cleaned up. Starting in January, tattoo artists and studios will need to meet levels of hygiene, training and supervision now required at places such as body-piercing studios and nail salons.
Read More Here


More Stories Skin Deep
Rob Norman
This is part two of Stories On The Skin: The Life and Times of Tattoos, Piercings, and Modifications.Tattoos had been used in ancient Greece and Rome to mark ownership of slaves and as punishment for criminals.

Excerpt;
Health Considerations
What about the piercing and tattoo scene and where is it headed? Both forms of adornment have their dangers. The American Dental Association opposes oral (tongue, lip, or cheek) piercing and calls it a public health hazard. The American Academy of Dermatology has taken a position against all forms of body piercing with one exception: the ear lobe.

People piercing their bodies should concern themselves with more than just sensitivity and allergic reactions. One of the biggest problems many of us see is keloid formation. Although the ear lobe is made of fatty tissue and has a good blood supply, it does not protect you from the wrath of keloids and other disfiguring growths that can sprout up in response to piercing.

A keloid is a large scar or raised portion of abnormal skin. I have removed horrendous keloids on those that have had ear piercings including one recently that had grown to the size of a small tomato on the right ear of an African-American man.

The tattooing procedure involves a variable amount of pain and a small amount of bleeding. The medical complications can be classified as either infectious or noninfectious. Noninfectious include scarring (common), skin allergies to the jewelry metals, urticarial (hive-like) reactions, and prolonged bleeding. Malignant melanoma, basal cell carcinoma, squamous cell carcinoma, psoriasis, sarcoidosis and lupus have been attributed to tattoos.

Infectious agents include Hepatitis B and C, tetanus, syphilis, leprosy, tuberculosis, warts, fungus, HIV, and pyogenic Staphylococcus and Streptococcus infections (cellulitis and gangrene necessitating amputation). One must even be cautious of the benign, pretty tattooed butterfly, for it may be a vector of mycobacteria.

Make sure that wherever you go for piercing is a reputable place. It’s important to ask what tools and devices they are using and whether they’re going to check for allergic reactions.

Both the U.S. and Canadian Red Cross will give you a year’s deferment if you’ve been pierced or tattooed except at a state-licensed shop. Why? Both procedures can transmit dangerous blood-borne diseases. Beyond the immediate pain and suffering of the procedure, other factors including the risk of chronic infection including abscesses or boils, prolonged bleeding, scarring, Hepatitis B and C, Tetanus, skin allergies to the jewelry that’s used, permanent holes, chipped or broken teeth, choking from mouth jewelry, and a speech impediment.

Tattoos require appropriate aftercare, including keeping them clean while they heal, usually 5-10 days. Once they’re healed, sunscreen is strongly recommended, both because the skin is more susceptible to the rays of the sun and to prevent fading.

Read More Here


AIDS

Compound dissolves HIV on contact

November 28, 2011

TEXAS A&M (US) — Researchers are closer to developing a topical compound that stops HIV by dissolving the virus on contact.

The ability of the synthetic compound known as “PD 404,182″ to break apart the AIDS-causing virus before it can infect cells was discovered by Zhilei Chen, assistant professor of chemical engineering at Texas A&M University, and her team of researchers. Their findings appear in the journal Antimicrobial Agents and Chemotherapy.

“This is a virucidal small-molecule compound, meaning that it has the ability to kill a virus; in this case that virus is HIV,” Chen says. “Basically, it acts by breaking the virus open. We found that when HIV comes in contact with this compound, it breaks open and loses its genetic material.

“In a sense, the virus ‘dissolves,’ and its RNA becomes exposed. Since RNA is pretty unstable, once it is exposed it’s gone very quickly and the virus is rendered non-infectious.”

Straight from the Source

Read the original study

DOI: 10.1128/​AAC.05722-11

In other words, the compound works by quickly ripping open the virus before it can inject its genetic material into a human cell. What’s more—and perhaps even more important—the compound, Chen explains, achieves this by acting on something within the virus other than its viral envelope protein, meaning that the virus can’t alter its proteins to bolster its resistance—something that’s made HIV notoriously difficult to treat.

“We believe this compound is not working on the viral protein of the viruses but on something else common in all the viruses on which we tested it—some cellular material common in these viruses,” Chen notes. “Because this compound is acting on a component that is not encoded by the virus, it will be difficult for the virus to evolve resistance against this compound.”

While not a cure for HIV, the compound demonstrates significant potential for use as a preventative, specifically in the form of a topical gel that could be applied in the vaginal canal, Chen explains.

“We conducted a number of tests to demonstrate that this compound remains active in vaginal fluid and is not rendered ineffective,” Chen says. “In the form of a vaginal gel, the compound would serve as a barrier, acting almost instantaneously to destroy the virus before it could infect a cell, thereby preventing HIV transmission from one person to another.”

Surprisingly, Chen and her team did not set out to discover an HIV preventative. Instead, they were conducting screenings of molecules for use in potential drug therapies targeting hepatitis C virus, which causes the dangerous and often fatal disease of the liver. Employing a screening system developed by Chen, the team screened thousands of molecular compounds, in search of those that could block aspects of the HCV life cycle.

During the course of the screenings, the team made an interesting discovery—not only was PD 404,182 an HCV inhibitor, it also worked on lentiviruses (the group’s negative control in its experimental procedures). Intrigued by that finding, Chen then tested PD 404,182 on HIV, which itself is a lentivirus and found the compound to be even more effective on HIV than on HCV.

“We believe PD 404,182 acts through a unique and important mechanism,” Chen notes. “Most of the known virucidal compounds interact with the virus membrane, but our compound does not appear to interact with the virus membrane. Instead, it bypasses interaction with the membrane and still compromises the structural integrity of the virus.”

The ability of the compound to avoid interaction with the virus membrane is important because human cells have similar membranes, Chen notes. If the compound were to disrupt the structure of the virus membrane, it could also disrupt and ultimately kill human cells. PD 404,182 doesn’t interact with these membranes and is therefore a more attractive option for clinical treatment.

As is the case with any potential pharmaceutical, several key steps are still needed before it winds up on drug store shelves. In addition to several rounds of animal studies to ensure the compound is safe for humans, further collaborations with chemists are needed to continue to improve the efficiency of the compound. Chen says.

Chen also plans to further explore the mechanism by which PD 404,182 breaks apart HIV. Collaborators include scientists at the Scripps Research Institute.

More news from Texas A&M University: http://tamutimes.tamu.edu



Global Fund halts new funding until 2014

Crossposted from Nature's news blog

The Global Fund to Fight AIDS, Tuberculosis and Malaria has cancelled its 11th funding round because of the current economic crisis.

“Substantial budget challenges in some donor countries, compounded by low interest rates have significantly affected the resources available for new grant funding,” the fund said in a statement on 23 November.

It will still provide some funding to existing projects to keep them going over the next couple of years, but will award no new grants before 2014. The fund, a public-private partnership supported by around 150 donor countries, also announced that it would create a new general manager position, taking management responsibility away from executive director

Michel Kazatchkine.

Continue reading on Nature's news blog.


Healthy You-Vitamin D


Vitamin D Benefits: Hope or Hype?
By Michael Smith, North American Correspondent, MedPage Today
Published: November 27, 2011

Vitamin D is good for what ails you. Or at least that's what patients and doctors might conclude if they read only the headlines.

In the past few months, deficiency in the substance has been linked to chronic obstructive pulmonary disease, tuberculosis, spinal inflammatory diseases, age-related macular degeneration ... and the list goes on.

On the other hand, taking high doses of vitamin D didn't help patients with multiple sclerosis, MedPage Today reported, and it was of no benefit in reducing left ventricular mass in patients with chronic kidney disease.

But overall, vitamin D gets pretty good press. The trouble is that hard evidence to back up the vitamin's benefits is lacking, according to Clifford Rosen, MD, of the Maine Medical Center Research Institute in Scarborough. "There's no data," Rosen told MedPage Today. "It's all weak association studies."

Benefit Beyond the Bones

At the American Heart Association meeting earlier this month, several studies suggested associations between low vitamin D and various aspects of heart disease.

But as one observer said at the time, there are no clinical trials yet that show improving vitamin D status does anything to reduce cardiovascular risk.

One study, the Vitamin D and Omega-3 (VITAL) trial, may shed some light on the issue. It is a randomized trial that is enrolling some 20,000 patients to see if daily vitamin D supplements prevent cancer and cardiovascular disease.

It will be one of the few randomized trials -- if not the only one -- to look at the issue directly, according to JoAnn Manson, MD, of Brigham and Women's Hospital in Boston, who is the principal investigator.

Although other randomized trials have produced evidence for a vitamin D benefit in several important clinical categories, Manson told MedPage Today it was mostly as an afterthought.

"Many of the randomized trials people have heard about were trials designed to look at the effect of vitamin D on fractures and falls," she said, with other effects as secondary outcomes.

It's in the nature of statistics, she pointed out, that if researchers look at enough outcomes, some will be significant just on the basis of chance.

The vast mass of the evidence for any kind of nonskeletal benefit is observational, and therefore suspect until confirmed by a properly designed, randomized trial, Manson said.

Among other things, a host of confounding factors -- obesity, poor nutrition, lack of exercise -- might play a role. No matter how carefully an observational study is done, she said, confounding is always possible. "Correlation does not prove causation," Manson reminded.

She noted that randomized trials have demolished observational evidence many times in the past, notably in the cases of such former fads as beta-carotene and selenium.

According to Rosen, there is reasonable evidence that improved vitamin D status leads to better bone health and some evidence that supplements reduce all-cause mortality in elderly women.

For almost everything else, he said, hard evidence is missing.

Biologically Active D

Measuring exposure to vitamin D is relatively easy -- it's a simple matter of serum levels of a compound called 25-hydroxyvitamin D, or 25(OH)D, Rosen said.

But the relationship between circulating 25(OH)D and the active form of the vitamin, 1,25-dihydroxycholecalciferol, is not clear. It's entirely possible, he said, to have low levels of 25(OH)D and yet have a perfectly adequate amount of the hormonally active form.

Indeed, Manson said, the Institute of Medicine (IOM) recently estimated that the average requirement of 25(OH)D is really only 16 nanograms per milliliter -- a level that would in most cases ensure adequate amounts of the active vitamin.

"It's extremely variable," she noted, "and there is much that isn't known about vitamin D and metabolism."

"So the tissues and cells may be seeing adequate amounts of biological active vitamin D and adequate stimulation of the vitamin D receptor even in those who have lower blood levels," she said.

So the question of how much vitamin D is enough is a vexing one. But doctors and their patients still want an answer.

The IOM last year released new guidelines for vitamin D, which say that healthy people should aim to have at least 20 nanograms of 25(OH)D per milliliter of serum.

That can be achieved, the IOM said, by taking 600 IU a day of a vitamin D supplement if people are between ages 1 and 70, and 800 a day if they are 70 or older.

Manson, who along with Rosen was part of the IOM panel, said that "relatively modest amount" of vitamin D will keep 97.5% of the general population in good bone health.

And, she noted, the IOM really was only concerned about bone health, because there's such a dearth of evidence for benefits in other areas.

But even if there's no evidence for a benefit, is there any harm in taking a bit extra? Well, possibly.

One of the functions of vitamin D is to regulate calcium and phosphorus; too much can lead to hypercalcemia. The IOM set the tolerable upper limit at between 2,500 and 4,000 IU per day, depending on age.

The institute also cautioned, Manson said, that there is some evidence of a U-shaped curve for vitamin D -- too little is bad and so is too much.

In particular, the IOM reported that, although the evidence is weak, more than 4,000 IU a day of the vitamin might increase the risk of cardiovascular disease, some cancers, and all-cause mortality.

"There's no evidence that more is better, so why use more?" Rosen asked.

On a day to day basis, most people can ensure they have enough vitamin D by eating certain foods – fatty fish like salmon, for example – and taking a multivitamin, Manson said.

But there's no need to screen the healthy population for vitamin D levels at least until there's more evidence that it matters, the IOM concluded.

On the other hand, the Endocrine Society has called for regular screening for groups at risk for vitamin D deficiency such as the obese, African Americans, and pregnant women.


Patients With Chronic Viral Hepatitis Should Be Tested for Vitamin D

Low Prevalence of Testing Despite High Prevalence of Insufficiency
By David Wild
Nov 9th 2011
Chicago—Retrospective findings presented at the 2011 Digestive Disease Week meeting revealed that 64% of patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection have low levels of vitamin D (abstract Su1302). In light of the results, researchers are urging clinicians to monitor vitamin D levels in all patients with chronic viral hepatitis.

“If we treat vitamin D deficiency, we can potentially decrease the high rate of osteopenia and osteoporosis in this population, including bone loss related to some of the antiviral therapies” said co-investigator Maya Gambarin-Gelwan, MD, assistant professor of clinical medicine, Weill Cornell Medical College, New York City.

Up to 53% of patients with viral hepatitis–related cirrhosis develop osteoporosis. Given the risk for bone loss associated with low levels of serum 25-hydroxyvitamin D (25[OH]D), investigators set out to determine the prevalence of vitamin D deficiency and insufficiency among patients with HBV and HCV treated at Weill Cornell Medical Center. They defined vitamin D deficiency as serum 25[OH]D less than 20 ng/mL and vitamin D insufficiency as levels between 20 and 30 ng/mL.

Among 2,312 patients with chronic viral hepatitis seen at the center between 2007 and 2009, only 17% (395 of 2,312) had been tested for vitamin D levels. Of those who underwent vitamin D testing, 31% (122 of 395) were vitamin D insufficient and 33% (132 of 395) were vitamin D deficient. The prevalence of vitamin D insufficiency was similar among the 29% (115 of 395) of patients with chronic viral hepatitis who had cirrhosis and those who did not (26% vs. 33%, respectively; P=0.10). However, the difference in vitamin D deficiency among patients with cirrhosis and those without cirrhosis was significant (44% vs. 29%; P=0.01).

Interestingly, vitamin D insufficiency was more prevalent among those infected with HBV than among those infected with HCV (73% vs. 60%, respectively; P=0.01). Although she suspects that ethnicity may play a role in this difference, Dr. Gambarin-Gelwan said that her data set did not include adequate information on ethnicity to draw a conclusion.

Zobair Younossi, MD, MPH, a liver specialist who was not involved in the study, said that prior studies have shown low vitamin D levels tend to be more common in patients with advanced stage fibrosis and cirrhosis. “However, this study shows insufficiency can also be seen in non-cirrhotic patients with hepatitis B and C, and particularly in those with chronic hepatitis B,” said Dr. Younossi, vice president for research, Inova Health System, and chairman, Department of Medicine, Inova Fairfax Hospital, Falls Church, Va.

Dr. Gambarin-Gelwan said that she hopes her research will spur clinicians to routinely monitor vitamin D levels in patients with chronic HBV and HCV infection. She said the small percentage of patients who were screened for vitamin D levels demonstrates that “gastroenterologists and hepatologists are paying too little attention to vitamin D levels.”
Source


Caucasians who avoid sun more likely D-deficient

Palo Alto, Calif. — Light-skinned people who avoid the sun are twice as likely to have vitamin D deficiency as those who do not — and, surprisingly, the use of sunscreen does not significantly affect blood levels of the vitamin, a new study suggests.

Stanford University School of Medicine researchers led by dermatologist Eleni Linos, M.D., Ph.D., analyzed data from the National Health and Nutrition Examination Survey of nearly 6,000 people collected by the Centers for Disease Control and Prevention from 2003 to 2006. The survey asked respondents about their sun-protection behavior — such as whether they wore long sleeves, hats and sunscreen — and whether they sought shade on sunny days. Data also included each respondent’s race and blood levels of 25-hydroxyvitamin D.

Investigators found that blood levels of vitamin D in Caucasians who avoided the sun with clothing or stayed in the shade were about 3.5 and 2.2 nanograms per milliliter lower than levels for those who did not report such behavior. In contrast, the association between sun avoidance and reductions in vitamin D levels in Hispanic or African-American survey-takers was not statistically significant.

Respondents with blood levels of 20 nanograms per milliliter or below were considered to be vitamin D-deficient. Researchers found that though about 40 percent of all survey participants were deficient, the prevalence increased to 53 and 56 percent among those who wore long sleeves and stayed in the shade.

Caucasians who wore long sleeves and stayed in the shade were twice as likely to be vitamin D-deficient as those who did not.

According to a university news release, researchers were surprised that reported use of sunscreen did not significantly affect vitamin D levels. Because sunscreens block the UV rays that trigger vitamin D production, investigators expected to find lower levels. The release quotes Dr. Linos as saying, “People are probably not applying (sunscreen) often or thickly enough. Often, people use sunscreen when they anticipate getting a lot of sun exposure, unlike others who spend time in the shade in order to avoid the sun.”

Dr. Linos says sun protection is “not as simple as telling everyone to wear sunscreen. We may instead need to begin tailoring our recommendations to the skin tones and lifestyles of individual patients. It’s clearly a very complex issue.”

Study results notwithstanding, Dr. Linos cautions against wholesale use of vitamin D dietary supplements until more is known. She notes that two large, randomized clinical trials are under way to test the health effects of relatively high doses of vitamin D.

The study was published online Nov. 4 in Cancer Causes and Control.


Healthy You

Pill-free diet swaps to lower your cholesterol

By Emily Main

A nutrient-poor diet filled with added sugars and unhealthy trans fats is known to cause high cholesterol, so it sure makes sense try and fix the problem with healthy food.

Although 25 percent of adults over the age of 45 take cholesterol-lowering drugs called statins -- which can sap your energy and cause problems for your sex life -- a new study reveals that changes to your diet might actually do a better job without the energy-sapping, sex-killing side effects.

A new study in the Journal of the American Medical Association followed 345 people with high cholesterol who were placed on one of two vegetarian low-cholesterol diets for six months. The first was a low-saturated-fat diet and participants were told simply to eat low-fat dairy and get more fruits and vegetables into their meals. The second group had help from nutritionists to incorporate specific cholesterol-lowering foods into their meals, including soy proteins, nuts, oats, peas, and beans. That group saw a drop in cholesterol three times higher than the group on the regular low-saturated-fat diet, and both diets proved to be at least as successful as early trials of statins.

If you've been battling high cholesterol, try some of these swaps for a tasty, low-cholesterol diet:

Breakfast: The low-fat group ate Raisin Bran cereal for breakfast, but the second group ate oat-bran cereal with strawberries and jam. For a seasonal twist, try this recipe for a Peachy Oat Breakfast and chase it down with a glass of soy milk, as those in the study did.

Mid-Morning Snack: For a cholesterol-lowering hunger fix, grab another peach (or some cantaloupe, grapes, nectarines, or apricots also in season now) and a handful of almonds when hunger strikes, and chase them down with another glass of soy milk. Or throw all your fruit, soy milk, and nuts, along with a little ice, into a blender to make something like the Women's Health Immunity Builder smoothie.

Lunch: For lunch, the low-cholesterol group downed sandwiches made with oat-bran bread, tofu slices, lettuce, tomato, and cucumber, accompanied by Spicy Black Bean Soup. The tofu slices provided the soy protein that proved so successful at lowering cholesterol, but if that doesn't tempt your palate, replace tofu with avocado, as in this Roasted Bell Pepper and Avocado Sandwich and have another glass of soy milk instead.

Mid-Afternoon Snack: The healthy dieters had more almonds and fresh fruit in the afternoon, but with an added dose of psyllium, a form of soluble fiber made from ground up psyllium seeds. Psyllium may not be very appetizing, so to get your fill of fiber, try these Banana, Yogurt, and Walnut Muffins; the bananas and oatmeal both contain high levels of soluble fiber.

Dinner: Dieters who shed the most cholesterol swapped pasta for pearled barley and an omelet for a tofu bake with ratatouille. To jazz up plain barley, make a Creamy Barley Risotto or add asparagus and cucumbers and top with a yogurt-dill dressing. Then add some tofu to this recipe for Easy Ratatouille. Just be sure your tofu is organic; nonorganic tofu has been found to contain high levels of cancer-causing hexane.


Really? The Claim: Coffee Can Prevent Some Medications From Working

By ANAHAD O'CONNOR

Coffee and espresso can have consequences in people taking certain medications, by either blocking their absorption or enhancing their effects.

In many cases, the interactions are caused by caffeine. But other compounds in coffee may also play a role. Studies show that more than a dozen medications — as varied as antidepressants, estrogen and thyroid and osteoporosis drugs — can be affected by coffee consumption.

A study in 2008, for example, found that people who drank coffee shortly before or after taking levothyroxine, a common thyroid medication, experienced a reduction of up to 55 percent in absorption of the drug. Read More Here


Big Pharma


November 28, 2011 - The Wall Street Transcript has just published Biotechnology and Pharmaceuticals Report offering a timely review of the sector. This Special Report contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. Please find an excerpt below.

PSI-7977 The Most Advanced Hepatitis C Drug According To Dr. Duane Nash; Pharmasset (VRUS) Predicted To Play A Dominant Role In HCV Therapy

TWST: What about on the liver side? Who are your favorites there?

Dr. Nash: The liver side is a different space, where all the companies tend to be affected by similar events because they are all on the same market. Here, these are companies that are developing drugs to treat the virus, hepatitis C. Fortunately, unlike hepatitis B and HIV, hepatitis C is curable. If you don't treat patients, it can lead to hepatocellular carcinoma as well as cirrhosis. But if you do treat them with the current regimens, you get about 75% cure rate, which is better than the 40% to 50% cure rate we saw last year before some new drugs came out. There are a whole host of new drugs coming out which are aspired to being able to cure hepatitis C without the use of interferon.

The most advanced one is a drug PSI-7977, which is being developed by a company I do not cover, Pharmasset (VRUS). Their market cap is about $6 billion. That drug keeps showing fairly astonishing data. There are four main classes of drugs that are directed to HCV, and this drug is in a class called nucleotides. Over the course of 2011, nucleotides have distinguished themselves as the single most promising class by far. At the moment, it is assumed that Pharmasset will play a very large role in therapy for HCV for the future.The market is very big. It's probably about 3 million people in the United States with a chronic HCV, cost of therapy is roughly $80,000. So for the full U.S. market, you are talking over $200 billion, although it's very unlikely we will get anywhere near full penetration.

Instead, the total revenues will probably be somewhere in the tens of billions of dollars. For every one American who has HCV, there are 40 foreigners who have HCV, although many of these foreign countries are very poor and don't have the ability to afford expensive drugs. But needless to say, this could be a very lucrative market. While Pharmasset is very well positioned, there are a host of other companies out there whose position and ability to capitalize on this market is far more tenuous. Read More Here


FDA, Adulterated Drugs And Industry Silence

The various scandals involving adulterated drugs and pet food in recent years prompted some members of Congress to ask the US General Accountability Office to review how the FDA oversees product safety to prevent and respond to economic adulteration. Not surprisingly, the GAO found that the increasing complexities of the global supply chain pose significant challenges - particularly, tracking ingredients back to their original sources.


Recalled

Several recalls were issued over the Thanksgiving holiday.

Perhaps, most notable on the list was Ocean Spray’s recall of its dried cranberries. The FDA’s notice stated that Ocean Spray announced it has taken the precautionary measure of voluntarily recalling certain production lots of its Original Flavor Craisins® Dried Cranberries product in 5-ounce, 10-ounce and 48-ounce packages as well as bulk sweetened dried cranberries in 10-pound packages due to the possible presence of very small hair-like metal fragments that are unlikely to cause consumer injury.

The recalled product lots (only dates followed by the letter M are affected) are:

—5-oz. Craisins UPC: 00293-000 Best By Dates/Letter: Oct 27 2012 M

—10-oz. Craisins UPC: 29456-000 and 29464-000 Best By Dates/Letter: Oct 27 2012 M, Oct 28 2012 M, Oct 29 2012 M

—48-oz. Craisins UPC: 00678-318 Best By Dates/Letter: Oct 27 2012 M, Oct 28 2012 M, Nov 3 2012 M, Nov 4 2012 M, Nov 5 2012 M, Nov 6 2012 M, Nov 7 2012 M, Nov 10 2012 M, Nov 11 2012 M.

—10-lb. bulk ingredient & foodservice UPC: 03477-000 Best By Dates/Letter: 30 Oct 2013 M, 31 Oct 2013 M, 1 Nov 2013 M, 5 Nov 2013 M.
There is no indication of the size of the recall or how the issue was discovered by the company. To date, it has not received any reports of consumer complaints relating to this recall. No injuries or adverse effects have been reported regarding these products to date. Ocean Spray issued the voluntary recall out of an abundance of caution to ensure the safety of our consumers.

The product labels are below:

Recalled OceanSpray Dried Cranberries package

Recalled OceanSpray Dried Cranberries label


FYI


Viral Hepatitis - 2011 HCV Symposium - Welcome
The promise of highly efficacious drugs soon to be made available drives the impetus to screen for and detect active and incident HCV infection. CDC is organizing a symposium entitled “Identification, Screening and Surveillance of HCV Infections in the Era of Improved Therapy for Hepatitis C,” which will be held on December 1st and 2nd at CDC’s Roybal Campus in Atlanta. A unique array of international experts will present their latest perspectives and findings, and there will be ample opportunity for an exchange of ideas including roundtable discussions. You are cordially invited to participate. No registration fee is required.

Dates: December 1st & 2nd, 2011

Program: Schedule of events and speakers

Location: Tom Harkin Global Communication Center, Roybal Campus, 1600 Clifton Road, Centers for Disease Control and Prevention, Atlanta, GA 30333

Accommodations: For those coming from outside the Atlanta area, here is a list of local hotels, including directions to the Symposium from the more remote ones.

Registration: The registration page was closed, as of November 14.

This event is hosted by the Division of Viral Hepatitis, CDC

Posted by HCV New Drugs at Monday, November 28, 2011 No comments:
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The above links offer data about interferon-free regimens approved to treat HCV, with learning activities,  editorials, and tips from patient bloggers who understand the ups and downs of liver disease, in addition to a list of outstanding hepatitis C websites, blogs and support forums.

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The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"
Latest Update Feb 12, 2019 
Lancet Study: 
Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C 
These findings firmly counter those of a Cochrane review of direct-acting antiviral treatment trials that could neither confirm nor reject if direct-acting antivirals had an effect on long-term HCV-related morbidity and mortality. They also provide the best evidence to date to support guidance documents that recommend direct-acting antiviral treatment for all patients with chronic HCV infection.

The Controversy 
Rebuttal over Cochrane Review of DAAs 
A systematic review published by the Cochrane Collaboration suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits. View each rebuttal and all ongoing media coverage.

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