Saturday, June 2, 2012

Weekend Reading- Hep C Top Social Networks and Blogs

Hello Folks,
Most weekends this blog offers up a few substantial links to relevant HCV information, click here for previous "Weekend Reading" articles.

This weekend readers will be provided with links to hepatitis C support and information found on two popular social networks; Facebook and Twitter

These social sites offer current updates, and personal experiences along with support from people who understand the anxiety, fear and medical obstacles experienced after being diagnosed with this chronic and sometimes serious disease.

Despite all of these benefits, social networking has a potential risk if you're not careful.

 Facebook is not meant to replace your professional care, members offer support not medical advice.

Remember information you receive about HCV treatment, liver health or medications doesn't come from medical professionals. If you join a group that does have a healthcare professional, they do not know your particular medical background. The information may not be accurate, always consult with your physician before making any changes, or before taking any "natural" product such as herbs or

The Disease

Liver disease in people with hepatitis C affects everyone differently, while it may progress slowly in most people, it can also progress quickly in others. A few host factors including duration of infection, co-infection with HBV or HIV, age, race, gender, genotype, alcohol use, smoking, other underlying disease (diabetes), all have an impact on liver disease progression.

Connecting With Other People Who Have HCV

 Facebook is one way to connect with other people coping with HCV. You may run into a member which shares close to the same medical scenario as your own, rather they are healthy and living with hepatitis C, waiting to undergo therapy, or living with serious health conditions related to the virus.

HCV Treatment and Facebook

If you're considering HCV therapy, surrounding yourself with support will get you through those many ups and downs.  Sometimes just sharing information about HCV or treatment can go a long way.

Treatment is not for everyone, only you and your physician know if treatment is right for you. For people that do begin therapy, the side effects are not easy, but most people find out that it's something they can handle. The bottom line is that each person is different.

Hang On Its Gonna Be A Bumpy Ride

When it comes to therapy, general discussions about those lovely side effects are best left up to the people who hated them. Forming these close bonds online certainly provide what our families or physicians can not.


Its simple, they haven't ridden "Mr. Toad's Wild Ride." 

They have no idea what it feels like to feed a rash and starve a brain.

Whats The Price Of Admission ?

We have two price points, both are non-refundable.

Months on interferon and ribavirin.

2- More Expensive
Adding; either incivek or victrelis.  
I'm just kidding folks, but one thing I can attest to is the power of humor. For me treatment was a whole lot easier to get through when the people around me had a great sense of humor.  I found those people online, we laughed our way through therapy and lived to tell about it.  Laugh, its good for the soul

Before you check out these Facebook pages take a look see at; The Hepatitis Comics: Levity for the Liver

We begin with Facebook and HCV therapy

This Facebook page is one of my favorites, with 123 members waiting to answer your questions. The devoted woman (find out her name after you join Facebook) diligently watches over her wall, adding news and HCV research while in the throes of HCV treatment. Click here to join in on the support.

If you're fighting your way through treatment, Trish understands the challenge. She is eight weeks into 48 weeks of triple therapy. Please join her Facebook page by clicking here, or join Trish at one of  best and most established HCV support forums online.

Oh My Aches and Pains!
This talented author has an incredible blog you won't want to miss. Connect with Selena on Facebook, and Twitter.

Recently she updated her blog with this article;15 Ways Hepatitis C Treatment is Kicking My Butt. Read more about Selena here @ Oh My Aches and Pains.

Support For People After HCV Treatment

 After landing on this Facebook page you'll have the opportunity to connect with Jared Bryan Smith the author of Hippopotamus Sea. His book on sobriety, battle against hepatitis C, and subsequent spiritual awakening is written first hand for anyone to read, for free if need be, on, or download it on Smashwords for less then a dollar.

In April on the authors blog he writes about his post-treatment experience with brain fog, headaches, and the reason he made a conscious choice to use Celexa over opiates, you can read the entry here.

The Facebook support group was set up by a gentlemen after he completed HCV therapy. For many people who complete treatment side effects may linger, this is a great place to connect with people who understand that these post side-effects "Aren't All In Your Head." Click here to join the support group.

HCV Vets On Facebook Educational Website & Support Forums
This group is provided by past and presents members of the United States Military with Hepatitis C (HCV) to assist fellow Retirees / Veterans / Active Military and Dependents with awareness to the Hep C virus exposure methods during military service. This informative Facebook page also offers information on the VA healthcare system and important political issues for veterans who are living with HCV. An additional great resource for information is the related HCV website. As a side note the individuals behind this Facebook page are experienced advocates who have devoted years to helping veterans with hepatitis C. Click here to join the group and begin making a connection with other veterans.

Support and HCV Awareness

Daryl Luster is responsible for the "Hepatitis C Kills"awareness poster which he has prepared for World Hepatitis Day. To learn more about HCV and view additional posters visit his incredible website.

I visit Daryl's Facebook page on a daily basis, (he has no idea I stalk him). One day I found this point on quote Daryl made casually in a reply to another Facebook member.

"Knowledge and understanding gives empowerment, and that is so very important for walking the path of HCV."

On Facebook Daryl truly connects with people who are dealing with Hep C. The good news is that Daryl is virus free, still he continues to offer support and awareness.

Click here to visit his Facebook page and join this compassionate, kind, HCV advocate.

For all those people living in the UK, this Facebook page is currently active laying the groundwork for a HCV awareness campaign unlike any other; Mr. Peter will be spreading HCV awareness from atop three peaks spread across the British Isles.

Read about Peters hepatitis C awareness campaign through the Hepatitis C Trust Website.

Learn more at his Facebook page or contact Peter on Twitter. Peter is awesome, and delightful to chat with, post on his wall!

Autoimmune Hepatitis And Hepatitis C Support

This Facebook page was created by a lovely lady who suffers with both hepatitis C and autoimmune hepatitis. The group offers support to all, although it was set up to support the Muslim community battling HCV. If you live in Pakistan, this Facebook page is a great starting point for support. Click here to join the group, and please visit the accompanying website; The Hepatic Muslim.  

A message from the web mistress;

"My Dear Sisters and Brothers, The Purpose of my starting this site, InshaALLAH is to raise awareness and educate others about Hepatitis, and to offer a means of emotional support for other Muslims who have this disease."


For me, Twitter is a beneficial tool for keeping up with HCV and liver disease news. I check updates a few times a day, and follow links to abstracts, full text data, clinical trials, and articles on the new drugs in development.

News and Journals HCV
No. 1–rated independent monthly newspaper providing news and information for 17,000+ gastroenterologists, colorectal surgeons, hepatologists, PAs and NPs.

AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease.

CCO Hepatitis‏@CCO_Hepatitis
Clinical Care Options creates innovative, interactive Hepatitis CME programs. Follow us to be the first to know when content is published.

Reuters Health‏@Reuters_Health

HCV Information

A peer reviewed, independent on-line audio/video/blog channel broadcasting to the global gastroenterology & hepatology community

Alan Franciscus‏@HCVAdvocate
Info about hepatitis C including news, updates to HCV Advocate Web site, HCV trainings, conferences and traveling around the country and speaking about HCV.

Lucinda K. Porter RN‏@LucindaPorterRN
Author of Free from Hepatitis C.Working to make the world healthier & free of hepatitis C, while offering occasional levity for the liver

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

Hep Magazine‏@hepatitismag
Hep is the go-to online source for educational and social support for people living with hepatitis C (HCV), hepatitis B (HBV) and hepatitis A (HAV).

Hepatitis Foundation‏@The_Liver_Lady
The Hepatitis Foundation International is dedicated to promoting liver wellness and preventing disease

Transplant HCV

Ian Quill‏@ianquill
Ian Quill : My World - I blog for me and people like me, beating HepC

Clinical Trials

Clinical Trials
Offering clinical trials news alerts on thousands of medical / heath conditions.

This website specializes in Complementary and Alternative Medicine CAM for the Hepatitis C Virus HCV.

Misha Cohen‏@DocMisha
Doctor of Chinese Medicine - Hepatitis B, Hepatitis C, Cancer Support, Metabolic Syndrome X, Chinese Herbs, Acupuncturist, Integrative Medicine

HCV Support

Dedicated to Providing Knowledge, Support and Encouragement to those affected by Hepatitis C.


The Hepatitis Education Project aims to support people living with viral hepatitis and increase awareness about the disease through education and advocacy.


Fight Like A Girl C‏@FightLikeAGirlC
Join the Fight Like A Girl Club, tell your story, give and receive support, share hope, and claim your Power!


The latest news and views about the pharmaceutical industry, with Ed Silverman of

Pharma News
Tweeting pharma industry latest news and trends from various pharma platforms accross the Web

Adam Feuerstein The Street
Sr. Columnist at TheStreet


The Hepatitis C Mentor & Support Group, Inc.
The Hepatitis C Mentor and Support Group (HCMSG) was founded by two Hepatitis C patients. The founders joined forces in 2010 to ensure that Hepatitis C patients in New York State have access to information and support services that will help them manage and overcome Hepatitis C with strength, dignity and fellowship.

A MINORITY voice in the battle of Hepatitis C - "the silent liver killer"

News and research

Written by Dr Paul Targett-Adams
After completing his PhD on the molecular biology of herpes simplex type 1 DNA packaging at the MRC Virology Unit at Glasgow in 2001, he embarked upon his post-doctoral research career focusing upon the intricate molecular details of hepatitis C virus (HCV) RNA replication. Later, in 2008, he joined the Antivirals Research Unit at Pfizer UK to continue his work on HCV with the added bonus of directly translating his research knowledge to investigating HCV mechanisms amenable to drug discovery programs. It was at Pfizer that his interest in HCV NS5A inhibitors, an exciting and intriguing new class of anti-HCV molecules was first piqued. In 2012 he joined Medivir AB in Stockholm as a Principal Scientist committed to discovering and developing novel antiviral medicines to combat a range of virus infections of global medical significance; including, of course, HCV

Other HCV Websites
This page of links will take you to the premier Hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences, chat rooms, forums and more.

If you know of a great Facebook page or Twitter account you would like to add email me or reply to this message.

Have fun, laugh, learn, and share.

Tina :)

DDW-Liver Disease: Good News and Bad News

From Medscape Gastroenterology

Liver Disease: Good News and Bad NewsDigestive Disease Week 2012

William F. Balistreri, MD

Click here to view the new Medscape video with Dr. Bill Balistreri discussing data from last months DDW; including treatment for HCV, and fatty liver disease.

Emerging Data in Liver Disease
Hello, I am Dr. Bill Balistreri, Professor of Pediatrics and Medicine at the University of Cincinnati College of Medicine and Cincinnati Children's Hospital. I am here at Digestive Disease Week (DDW) in San Diego to discuss emerging data on liver disease for Medscape.

Studies presented at DDW 2012 have highlighted 2 major issues that have received attention over the past year. The first issue is new strategies for the treatment of hepatitis C virus (HCV) infection, including the possibility of an interferon-free regimen. The second issue is concern about the rising incidence and impact of obesity-related liver diseases: nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH)

The Good News: Treatment for HCV Infection
First, the good news: Combination therapy with pegylated interferon and ribavirin has long stood as the standard of care for patients with chronic HCV infection. Although effective in achieving high response rates, this regimen is associated with troublesome side effects. Thus, the development and approval of 2 effective protease inhibitors, telaprevir and boceprevir, was hailed as a new era of therapy for patients with hepatitis C genotype 1 infection.

Several studies were presented to document that these direct-acting antiviral agents allow more effective and shorter durations of treatment. For example, in patients infected with HCV genotype 1, for whom previous standard therapy failed to eliminate the virus, treatment with either of these protease inhibitors was shown to be significantly more effective, with sustained viral response rates 2- to 3-fold higher compared with traditional therapy.

An American Association for the Study of Liver Diseases (AASLD) plenary session presentation[1] reported that when telaprevir was used in combination with peginterferon and ribavirin, the dose of ribavirin was able to be substantially reduced. Ribavirin dose reduction to less than 600 mg/day had no substantial effect on sustained viral response (SVR) rates in patients given telaprevir combination treatment. In another study,[2] when boceprevir was used in combination with peginterferon and ribavirin, SVR was achieved in patients who had been nonresponsive to previous therapy.

Despite the optimism about the prospects for this treatment of HCV, a remaining concern is the fact that telaprevir and boceprevir must be used in combination with peginterferon and ribavirin. This is far from the ideal regimen. In fact, because of poor tolerability, many treatment candidates will decide not to pursue treatment or to defer treatment until a simpler regimen is available.

However, other studies suggest that an interferon-free regimen (and perhaps even a ribavirin-free regimen) is no longer a dream. A number of compounds encompassing several distinct drug classes are currently under development. These drugs bring us one step closer to the long sought-after ideal: the ability to delete interferon injections from treatment strategies.

In the interim, how can we tailor therapy and predict response rates? Investigators noted that patients infected with hepatitis C genotypes 2 and 3 achieve SVR rates between 70% and 80% in clinical trials. However, in real-life settings, lower SVR rates in the range of 55%-65% are reported. In work presented here,[3] predictive factors for nonresponsive patients with genotypes 2 and 3 included daily alcohol intake greater than 40 g, HIV co-infection, low thyroid-stimulating hormone (TSH) levels, the presence of cirrhosis, and the duration of infection. These risk factors should be assessed and may suggest the need for an intensified treatment course.

Further data[4] were presented on a major genetic predictive factor: a single nucleotide polymorphism in the upstream region of the interleukin-28B gene. Genotype CC is the strongest factor predictive of SVR in patients with HCV genotype 1 treated with peginterferon and ribavirin. This CC genotype was also shown to be associated with a significantly higher rate of spontaneous clearance in both white and African American patients with exposure to HCV. This information will be of value when counseling patients.

The Bad News: Fatty Liver Disease on the Rise
Now the bad news: NAFLD has become the leading cause of liver disease in North America, as a result of the rapidly increasing prevalence of obesity. However, accurate population-based data on the incidence of NASH are sparse, in part because the diagnosis requires histopathologic documentation.
In a study presented here,[5] the temporal trend in the prevalence of NASH in one US county over the past 30 years was reported. In this Mayo Clinic review of 555 autopsy records, there was a significant increase between 1981 and 2010 in mean body mass index, as well as in the prevalence of obesity, in this county. There was also a striking increase in the prevalence of steatosis and NASH. Among persons who were obese, the prevalence of steatosis increased from 23% in the 1980s to 49% in the 1990s, and to 60% in the most recent era. Even in nonobese patients, the prevalence of steatosis increased from 12% (1980s) to 27% (1990s) to 36% (today).

In a related study,[6] investigators examined trends in the prevalence of NAFLD in children over the past 2 decades. They used nationally representative data from the National Health and Nutrition Examination Survey (NHANES) data sets, spanning 1988-2008. More than 10,000 adolescents were included in this analysis. The percentage of adolescents who were obese increased from 11% to 21% over this 30-year period. Suspected NAFLD increased from 4% to 10%. Among obese adolescents, the prevalence of elevated aminotransferase levels increased 120%, from 17% to 37%.

The bottom line is that suspected NAFLD in children is increasing in prevalence and affects about 10% of all adolescents. Of note, the increase in NAFLD was not solely defined by the number of overweight children. The increased prevalence of NAFLD was much greater than the increase in the prevalence of obesity. These data strongly support recommendations to screen for NAFLD in obese adolescents. This raises the question as to the best screening and confirmation methods. Specifically, is there a noninvasive way to diagnose NASH?

Several studies[7,8] presented here indicate that this is possible, to a degree, using serum biomarkers of hepatocyte apoptosis and oxidative stress. Circulating markers of hepatic cell death -- cytokeratin 18 fragments and soluble Fas (Fas ligand) -- were shown to be useful for the diagnosis of NAFLD and NASH. A prediction model was also developed.

A combination of these markers had superior diagnostic performance for detecting NASH compared with measurement of the individual markers.

In addition, newer magnetic resonance techniques, such as measurement of the proton-density fat fraction, correlate with histology-determined steatosis grade in adults with NAFLD. However, a study[9] reported here documented that the amount of hepatic steatosis on imaging does not necessarily correlate with the severity of liver disease, and steatosis is not linearly related to disease progression. Future studies will need to explore the natural history of NAFLD, the interplay between hepatic steatosis and fibrosis, and whether novel imaging or MRI techniques can be used as a noninvasive means to study disease progression by fat mapping and changes in fat distribution over time.

Why are we concerned? Obese patients with fatty liver are at increased risk for early morbidity and mortality.

This begins during adolescence. A study presented at DDW 2012[10] evaluated the association among obesity, fatty liver, and cardiovascular risk in pediatric patients. They documented that obesity may in fact confer a cardiovascular disease risk burden that is comparable to that of patients with familial dyslipidemias. Thus, earlier recognition and medical intervention is warranted.

Another study[11] reported that moderately severe obstructive sleep apnea and hypoxia are common in obese patients with biopsy-proven NAFLD. Obstructive sleep apnea and hypoxia were also associated with more advanced fibrosis in pediatric patients. A large multicenter cohort further documented that NAFLD is a predisposing condition for hepatocellular carcinoma. Of concern, NAFLD-associated hepatocellular carcinoma often occurs in the absence of cirrhosis. This may suggest the need to revise current guidelines, which suggest surveillance programs for cancer in patients with cirrhosis.

Finally, one study[12] reported the long-term follow-up of a liver-related death rate in patients with nonalcoholic fatty liver disease and alcoholic-related fatty liver disease. A similar proportion of patients with NAFLD and with alcoholic fatty liver disease developed cirrhosis. However, patients with NAFLD had a worse overall survival than patients with alcoholic-related fatty liver disease. These sobering studies underscore the urgent need to enhance our efforts to reduce the trend in obesity rates and the prevalence of fatty liver disease.

Thank you for listening. This is Bill Balistreri, for Medscape.

Friday, June 1, 2012

Hepatitis B-Court ruled against Tennessee veteran who claims he contracted HBV at Murfreesboro VA hospital

Court rules against Tenn. vet in colonoscopy case

Posted at: 06/01/2012 6:05 PM

(AP) NASHVILLE, Tenn. - Years after thousands of veterans learned they may have been exposed to infections at government-run hospitals, many are still mired in legal battles seeking compensation from the Department of Veterans Affairs.
In the latest legal setback, a federal appeals court has ruled against a Tennessee veteran who claims he contracted hepatitis B after employees at the Murfreesboro VA hospital negligently failed to properly clean colonoscopy equipment. The ruling could have an impact on similar lawsuits against the VA. 
The court found that Carl Huddleston’s claim, filed more than three years after the procedure, came too late, even though he acted within months after he learned his health could have been endangered. The three-judge panel of the 6th Circuit Court of Appeals ruled last week. 
Huddleston was one of more than 10,000 veterans notified in 2009 that they needed to be tested for hepatitis B and C and HIV infection because of endoscopic cleaning mistakes at VA facilities in Murfreesboro, Tenn., Augusta, Ga. and Miami. The VA said Friday that 90 patients were found to be positive with one or more of the three viruses.....

Continue Reading.........

U.S. Prepares Groundwork for Biosimilar Approval

U.S. Prepares Groundwork for Biosimilar Approval
With the recent release of FDA draft guidelines, launch of the first oncology biosimilars is looming
by Rosemary Frei, MSc
As biosimilar drugs make their way to American soil, clinicians, regulators, pharmaceutical executives and patients alike are asking: How long will it take for the first biosimilars to reach the U.S. market? How much lower will their prices be than the original molecules they mimic? How quickly will they be accepted by clinicians and patients?
Biosimilar medications—also known as follow-on biologics—are virtually identical or highly similar versions of large and intricate biologic molecules like monoclonal antibodies. Brand-name biologics are already essential for the treatment of breast, colorectal, esophageal, gastric, head and neck, kidney and non-small cell lung cancers; and Hodgkin’s and non-Hodgkin’s lymphoma. They also are vital in the treatment of cancer- and chemotherapy-induced anemia and neutropenia. The hope is that biosimilars will significantly improve the affordability of, and access to, cancer medications.

The clock is already ticking toward the entry of biosimilars into the American market. This is because the 12-year patent-protection period will soon end for some brand-name products (Table 1, page 48). For the epoetin-alfa products Epogen (Amgen) and Procrit (Janssen Products), as well as Aranesp (darbepoetin alfa, Amgen) and Neupogen (filgrastim, Amgen), protection will run out in 2013. Some monoclonal antibody products, such as Rituxan (rituximab, Genentech/Biogen Idec), will likely lose their exclusivity protection as soon as the fourth quarter of 2015 and early 2016.

Continue Reading..............

Liver Cancer Rates Continue to Rise, Vigilance Warranted

By: MITCHEL L. ZOLER, Family Practice News Digital Network
June 1

SAN DIEGO – The U.S. incidence of hepatocellular carcinoma continues to soar, and will likely remain on that trajectory for at least a couple of decades, fed in large part by the obesity and type 2 diabetes epidemics, as well as by infections with hepatitis virus types C and B.

"I think rates will increase for another 10-20 years," predicted Dr. Alita Mishra, one of two researchers who reported results at the meeting from independent studies that documented increased rates of U.S. hepatocellular carcinoma (HCC) cases during the 2000s.

Greater vigilance is therefore needed to spot incident cases early, she said in an interview. While patients infected with hepatitis C virus who develop cirrhosis usually undergo routine, serial ultrasound screening for liver lesions, regular surveillance occurs less often in patients with cirrhosis who are infected with hepatitis B virus, or those with cirrhosis due to non-alcoholic fatty liver disease (NAFLD) secondary to obesity or type two diabetes. "Patients with cirrhosis should undergo regular HCC screening regardless of the underlying cause," Dr. Mishra said at the annual Digestive Disease Week.

One analysis, based on data collected by the Surveillance Epidemiology and End Results (SEER) registry of the National Cancer Institute, showed that U.S. HCC rates rose three-fold from 1975-2007, including a 33% rise during 1998-2007, Jessica A. Davila, Ph.D. reported at the meeting.

The second analysis, using data collected by the Nationwide Inpatient Sample (NIS), showed that the number of patients hospitalized with HCC per 100,000 hospital discharges jumped from 148 in 2005 to 213, said Dr. Mishra, a hospitalist at Inova Farifax (Va.) Hospital.

"HCC is rising because of hepatitis C viral infection, especially in people born during 1945-1965," Dr. Mishra said in an interview. Many of these people don’t know they are infected, and it usually takes decades for them to develop HCC.

The second big factor is the rising prevalence of obesity and type 2 diabetes. "Hepatitis C infections are now falling, so perhaps the rise in new HCC cases will eventually peak, but not if other factors like obesity and type 2 diabetes continue to push it up," she said.

"What is driving a lot of the increase is hepatitis C virus, and the high prevalence of hepatitis B virus in foreign-born Asians," said Dr. Davila, a clinical epidemiologist at the Houston VA Medical Center and Baylor College of Medicine in Houston.

"A lot also has to do with obesity and type 2 diabetes and their association with non-alcoholic fatty liver disease, especially in middle-aged, Hispanic women. I think we’ll see the greatest increase in HCC in women during the next 2 decades," Dr. Davila said. She also predicted increasing numbers of hepatitis C virus-driven HCC cases in the short term "as the [infected] cohort ages, increasing numbers will develop advanced fibrosis and eventually HCC," she said.

Dr. Davila’s study used data from SEER, which the National Cancer Institute began in 1973 to collect data on cancer cases from about 14% of the U.S. population in selected states and metropolitan areas. During 1975-2007, SEER tallied a total of 21,472 HCC cases, about 80% of which occurred in people aged 50-79 years, and about three-quarters of cases in men.

Continue Reading Page Two @ Family Practice News, Page One....

Bristol CEO says Gilead holding out on hep C tie-up

Bristol CEO says Gilead holding out on hep C tie-up

June 1, 2012 | By Ryan McBride

FierceBiotechBristol-Myers Squibb ($BMY) isn't giving up on pushing Gilead Sciences ($GILD) to move ahead with further study of the two companies' oral drugs as a combo treatment for the hepatitis C virus, with Bristol boss Lamberto Andreotti reiterating that joining forces could be best for patients and each of the drugmakers, Reuters reported.

In April a mid-stage study showed that a combo of Gilead's nucleotide inhibitor GS-7977 and Bristol's daclatasvir wiped out signs of hep C in 97% of patients with genotype 1 cases of hep C after 12 weeks of treatment--impressive results that generated enthusiasm among analysts and clinicians. However, Gilead, which acquired 7977 in its $10.8 billion Pharmasset buyout, hasn't budged amid calls from Bristol and clinicians to agree to a Phase III program involving the companies' experimental drugs.

As Reuters reports, Gilead has focused on developing oral drug combos against the liver-damaging disease from its own pipeline. But Bristol, which made a smaller Hep C gamble of its own with the $2.5 billion buyout of Inhibitex in January, is obviously keen on teaming up in the race to develop all-oral treatment for hep C, which is typically treated with injections of interferon, which causes miserable side effects. With the Pharmasset purchase, Gilead put itself at the front of the pack of oral Hep C drug developers that also includes Vertex Pharmaceuticals ($VRTX), Abbott Labs ($ABT) and the small developer Achillion Pharmaceuticals ($ACHN).

"[Bristol and Gilead] have a different point of view about whether to enter Phase III (trials) with that combination," Andreotti said, as quoted by Reuters. "We believe, for both patients and companies, it is better to move forward" with the late-stage studies.

With some 170 million hepatitis C patients around the world, and many patients forgoing treatment with existing drugs, the patient-friendly oral drugs are eventually expected to generate $20 billion in annual revenue. Gilead has clearly bet hugely to grab its share of that market.
- check out Reuters' report


Related Articles:
Analysts pounce on positive Phase II data on hep C combo
Lack of Gilead and BMS teamwork on hep C draws ire
Gilead wows analysts as 7977 combos quell hep C in most patients
Gilead Sciences bags Pharmasset's hep C pipeline in $11B buyout

TGIF-Weekly Rewind - Hepatitis C News and Research

HCV Rewind is a weekly publication with a look back at this weeks headlines, including today's news with updates as the day progresses. Click here to view previous or future"HCV Weekly Rewind" articles.

We begin with Bristol-Myers shout out to Gilead Sciences - hinting once again for a collaboration. The drugs; Gilead's HCV drug  GS-7977 and Bristol's drug daclatasvir. Interim results were at 100% SVR in genotype 1 treatment-naive patients, view the data here .

Reuters  excerpt;
Bristol-Myers Chief Executive Lamberto Andreotti, speaking on Thursday at the Sanford Bernstein Strategic Decisions Conference in New York, said patients and both drugmakers stand to benefit if combined Phase III trials of the two medicines are pursued.

"We have a different point of view about whether to enter Phase III (trials) with that combination," Andreotti said. "We believe for both patients and companies, it is better to move forward" in the short term.

But Andreotti said Gilead instead seemed intent on looking "in-house" -- focusing instead on combinations of its own products. Gilead officials could not immediately be reached to comment.
Continue Reading @ Reuters

Incivek- Vertex Receives FDA Warning Letter
Speaking of big Pharma, Vertex was in the hot seat over a warning letter issued on May 25th by the FDA. Vertex published a patient story describing their personal experience treating with  Incivek. The FDA found the patients letter misleading and said it implied most or all cirrhotic prior null responders will successfully achieve SVR on Incivek, here's an excerpt from the warning letter.

Overstatement of Efficacy 
Promotional materials are misleading if they contain representations or suggestions that a drug is better or more effective than has been demonstrated by substantial evidence or substantial clinical experience. The branded story is an account of James’ life and medical history since being diagnosed with hepatitis C. Specifically, the story describes James’ diagnosis of stage 3 cirrhosis and subsequent null response after 6-months of treatment with pegylated-interferon and ribavirin combination therapy. After treatment with Incivek combination therapy, the story claims:

"And six months after treatment ended, I found out I’d cleared the virus. That made me feel so good. I was so happy to know I’d be around a little longer to see my son grow up." [page 5]
". . .I’m cleared, I can take my son to the batting cage. We go sailing on my boat and take nice vacations. I even retired from the railroad and started a successful cab business, which I really enjoy. I’m loving life." [page 5]

 While these claims may be an accurate reflection of James’ own experience with hepatitis C and treatment with Incivek, this branded story misleadingly implies that most or all cirrhotic prior null responders infected with hepatitis C will successfully achieve Sustained Virologic Response (SVR) on Incivek combination therapy. FDA is not aware of substantial evidence or substantial clinical experience to support this implication. One patient’s treatment response does not constitute substantial evidence. According to the Clinical Studies section of the PI, of the prior null responders with cirrhosis tested in clinical trials, 14% who received

Read the FDA warning letter here,and the patients Incivek story here.

New guidelines for Nonalcoholic Fatty Liver Disease (NAFLD)
In other news the AASLD along with the American College of Gastroenterology and American Gastroenterological Association, published new guidelines for Nonalcoholic Fatty Liver Disease (NAFLD).  The recommendations in the guideline include the following topics;
NAFLD in other chronic liver diseases
Natural History
Screening of Family Members
Non-invasive assessment of steatohepatitis and advanced fibrosis in NAFLD
Vitamin E
Ursodeoxycholic acid (UDCA), Omega-3 fatty acids, and Miscellaneous Agents
Alcohol use in patients with NAFLD and NASH
Statin use in patients with NAFLD and NASH
Aspects of NAFLD Specific to Children and Adolescents
Lifestyle modification
Lifestyle intervention
and more...............
Download this timely and free practice guideline.

EASL-Interferon-free drugs in development
On May 28th published over at, Dr. Paul Targett-Adams, Principal Scientist at Medivir AB,  offers us coverage from the March EASL conference, highlighting the data on HCV all-oral interferon-free drug regimens. If you stroll over to the site check out this March article; NS5A inhibitors: Picomolar power to combat hepatitis C virus?,  also published by the doctor.

Risk; Over-the-counter (OTC) pain medication containing the active ingredient acetaminophen
A few days ago a study put together by Dr. Michael Wolf, from Northwestern University in Chicago investigated the misuse of over-the-counter (OTC) pain medication containing the active ingredient acetaminophen. In the paper published online in the Journal of General Internal Medicine², the team of researchers asked  participants in the study if taking a second medicine containing acetaminophen would put them at a risk of overdosing, here is what they found.

To assess 'double-dipping', the patients were told to imagine they were taking a maximum dose of a primary OTC drug and asked whether it would be safe to also take a second medicine with the primary medicine - both of which contained acetaminophen. 
Wolf and team found that nearly a quarter of the participants were at risk of overdosing on pain medication using a single OTC acetaminophen product, by exceeding the dose of four grams in a 24-hour period; 5 percent made serious errors by dosing out more than six grams. In addition, nearly half were at risk of overdosing by 'double-dipping' with two acetaminophen containing products.
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