AASLD - The Liver Meeting® 2015 abstract supplement available online

The 66th Liver Meeting of the American Association for the Study of Liver Diseases will take place in San Francisco, California between 13th and 17th November 2015.

AASLD expects more than 9500 hepatologists and hepatology health professionals from all over the world to exchange the latest liver disease research, discuss treatment outcomes and networking with colleagues.

The Liver Meeting® 2015 abstract supplement, in full text, is available as a PDF, and online in a special issue of Hepatology.

Late-breaking Abstracts

 Late-breaking abstracts will be available on October 20th at 10 am ET

Meeting Event Link

Patients have mixed feelings about hepatitis drugs

Patients have mixed feelings about hepatitis drugs

By Vickie Aldous
Mail Tribune

Posted Oct. 4, 2015 at 12:01 AM

Patients who have coped for years with hepatitis C have had mixed reactions to new drugs that can cure the disease, from elation about the treatment to shock about the price.

The woman said the Sovaldi cost $85,000. Medicare and her supplemental insurance policy together covered $75,000 of the cost. Her doctor helped her get $10,500 from the Patient Access Network, a nonprofit organization dedicated to helping people with chronic or life-threatening diseases for whom costs limit access to critical treatments.

Continue reading... 

Gulf War Soldier infected with hepatitis C after being given tainted blood transfusion

Tainted blood transfusion felled Gulf War hero with Hepatitis C

A FORMER soldier has told how he was infected with Hepatitis C after being given tainted blood in a blood transfusion in the first Gulf War.

By JAYMI MCCANN
PUBLISHED: 00:01, Sun, Oct 4, 2015

The Warrant Officer in the Royal Scots Dragoon Guards, who has asked to remain anonymous, was medically discharged after almost 26 years of service.

He was given the blood transfusion during Desert Storm in December 1990 but became ill when serving in Kosovo in 2000.

It was still not until he collapsed in 2003 in Germany that it was discovered he had the devastating illness.

On top of the disease he has cirrhosis of the liver and may need to have a liver transplant.

Now, after more than 10 years he has described his experiences to back the Sunday Express Tainted Blood Campaign.

Continue reading....

HCV Weekend Reading - Diet, nutrition, physical activity, and liver cancer

Diet, nutrition, physical activity and liver cancer

Greetings to all on this cool autumn day, in Michigan we are looking at low 50s, with little sunshine. 

If you find yourself hanging inside today, maybe even sipping a cup of coffee, consider it a good thing, coffee consumption has been proposed to reduce risk for hepatocellular carcinoma and chronic liver disease. 

In honor of Liver Cancer Awareness Month, we focus today on lifestyle choices and liver cancer, using research that has established an association between the two, as well as disease progression in HCV.

Liver cancer types

There are several types of liver cancer based on the type of cells that becomes cancerous.

Hepatocellular carcinoma (HCC), also called hepatoma, HCC is the most common type of liver cancer accounting for approximately 75 percent of all liver cancers. HCC starts in the main type of liver cells, called hepatocellular cells. Most cases of HCC are the result of infection with hepatitis B or C, or cirrhosis of the liver caused by alcoholism.

Fibrolamellar HCC is a rare type of HCC that is typically more responsive to treatment than other types of liver cancer.

Cholangiocarcinoma (bile duct cancer) occurs in the small, tube-like bile ducts within the liver that carry bile to the gallbladder. Cholangiocarcinomas account for 10-20 percent of all liver cancers. Intrahepatic bile duct cancer begins in ducts within the liver. Extrahepatic bile duct cancer develops in ducts outside of the liver.

Angiosarcoma, also called hemangiocarcinoma, accounts for about 1 percent of all liver cancers. Angiosarcomas begin in the blood vessels of the liver and grow quickly. They are typically diagnosed at an advanced stage.

Secondary liver cancer, also known as a liver metastasis, develops when primary cancer from another part of the body spreads to the liver. Most liver metastases originate from colon or colorectal cancer. More than half of people diagnosed with colorectal cancer develop secondary liver cancer.

Learn more, here. 

What We Know

Chronic HCV and HBV are the most common risk factors for HCC, in fact close to 50 to 60%  people with HCC in the U.S. have hepatitis C, the risk factor is higher for persons with both HCV and cirrhosis.

Of all persons with severe fibrosis or cirrhosis, 81% were born from 1945-1965

Hepatitis C Is A Serious Disease

One in 30 baby boomers – the generation born from 1945 through 1965 – has been infected with hepatitis C, in addition, data presented at Conference on Retroviruses and Opportunistic Infections (CROI 2015) reported persons with HCV born between 1945 and 1965, again baby boomers - have more advanced liver disease.

An Excerpt; Progression to severe fibrosis or cirrhosis is common among baby boomers with hepatitis C in the US

The burden of hepatitis C virus (HCV) infection is high in the US, with a substantial number of individuals born between 1945 and 1965 having advanced liver fibrosis or cirrhosis and therefore being at high priority for treatment

"About one-half of HCV-infected persons born from 1945-1965 had severe fibrosis or cirrhosis as measured by FIB-4 scoring," the researchers concluded. "Of all persons with severe fibrosis or cirrhosis, 81% were born from 1945-1965."

Article written by Liz Highleyman, available online at aidsmap.

Yesterday, I read a disturbing study from the University of Michigan Health System over at Healio which found that; patients with hepatitis C virus infection treated in 2011 and 2012 had more advanced liver disease vs. patients seen in 1998 and 1999. 

In short researchers looked at 1,348 adults with HCV seen at the University of Michigan Health System in 1998/1999 deemed (Era 1) and 2011/2012 in a group called (Era 2), patients in the Era 2 were older, and most patients were treatment experienced. In the Era 2 group more patients were diagnosed with advanced liver disease, such as compensated or decompensated cirrhosis or hepatocellular carcinoma. 

The article reported on the dire need of affordable regimens and improvement in early diagnosis for patients currently being treated or (Era 2) group. 

“Reduction in HCV disease burden will require development of treatment regimens targeted towards patients in the current Era …, improvement in early diagnosis and referral of infected patients to appropriate centers for treatment, and reduction in costs of newly approved DAAs; otherwise, implementation of screening programs and availability of highly efficacious treatment regimens will have little impact on disease burden.” – by Melinda Stevens

Link to the article; Recent HCV patients show more complications than decades prior.

Cancer risk two times higher for HCV patients after excluding liver cancer

This year a study presented at The International Liver Congress suggested; patients with HCV were 2.5 times more likely than non-HCV patients to be diagnosed with cancer, including liver cancer. When liver cancer was excluded, cancer risk was still almost two times higher for patients with HCV

The aim of the study was to describe the rates of all cancers in the cohort of HCV patients compared to the non-HCV population. Known cancer types associated with hepatitis C include non-Hodgkin's lymphoma, renal and prostate cancers, as well as liver cancer.

For their study, Dr. Nyberg and colleagues assessed all cancer diagnoses that had occurred at KPSC among HCV and non-HCV patients aged 18 and older between 2008 and 2012.

The researchers found that, compared with patients without HCV, patients with HCV are not only at increased risk of liver cancer but of other cancers, including non-Hodgkin lymphoma and prostate and renal cancers.

The team identified 2,213 cancer diagnoses among patients with HCV during the 5-year study period. When liver cancer was excluded, 1,654 cancer diagnoses remained. Among patients without HCV, 84,419 cancer diagnoses were identified, with 83,795 cancer diagnoses remaining after the exclusion of liver cancer.

Based on their findings, the researchers calculated that patients with HCV were 2.5 times more likely than non-HCV patients to be diagnosed with cancer, including liver cancer. When liver cancer was excluded, cancer risk was still almost two times higher for patients with HCV, according to the study.

Source

Hepatocellular Carcinoma and Lifestyles

This brings us to a review article investigating an association between lifestyles and HCC; Hepatocellular Carcinoma and Lifestyles, published last month in the Journal of Hepatology, the full text is provided by NATAP, download or read the article, here.

" The preventive and therapeutic impact of lifestyle on cancer is remarkable and its exploitation should be further promoted. HCC is a cancer tightly linked to lifestyle.......Epidemiological studies have indicated that physical activity lowers the risk of various carcinomas (esophagus, colon, breast, bladder, lung, kidney, prostate, pancreas, endometrium and ovary)"

Hepatocellular Carcinoma and Lifestyles 

The Key Points

• The growing epidemic of metabolic conditions such as obesity and DM and their close link to NAFLD in turn contribute to the increased risk of HCC development independent of cirrhosis. 

• Both human and animal studies have demonstrated an inverse association between physical activity and liver cancer. 

• Smoking increases the risk of developing HCC. 

• Coffee intake is associated with a decreased risk of developing HCC. 

• The molecular mechanisms underlying the effects of lifestyles and HCC involve changes in metabolism, in particular, the activation of AMPK, changes in the immune system and in inflammation.

Jump Over To NATAP To Read More....

LIVER CANCER REPORT 2015 

Finally, an overview of the 2015 Liver Cancer Report from World Cancer Research Fund, read the full report, here.

Diet, nutrition, physical activity and liver cancer

World Cancer Research Fund International/American Institute for Cancer Research. Continuous Update Project Report: Diet, Nutrition, Physical Activity and Liver Cancer.  

Available at: wcrf.org/sites/default/files/Liver-Cancer-2015-Report.pdf

Background and context

The latest statistics reveal that cancer is now not only a leading cause of death worldwide, but that liver cancer is one of the deadliest forms. Indeed, liver cancer is the second most common cause of death from cancer worldwide, accounting for 746,000 deaths globally in 2012 [1]. 

One of the reasons for the poor survival rates is that liver cancer symptoms do not manifest in the early stages of the disease, which means that the cancer is generally advanced by the time it is diagnosed. In Europe the average survival rate for people five years after diagnosis is approximately 12 per cent [2]. 

In addition, the number of new cases is also on the increase. World Health Organization statistics show that 626,162 new cases of liver cancer were diagnosed in 2002, but by 2012 the figure had risen to 782,451. This figure is projected to increase by 70 per cent to 1,341,344 cases by 2035 [1]. 

Statistics on liver cancer show that the disease is more common in men than women, and that 83 per cent of liver cancer cases occur in less developed countries, with the highest incidence rates in Asia and Africa. On average, the risk of developing liver cancer increases with age and is highest in people over the age of 75, although it can develop at a younger age in people in Asia and Africa - typically around the age of 40. In addition to the findings in this report, other established causes of liver cancer include: 

1. Disease: u Cirrhosis of the liver. 

2. Medication: 

Long term use of oral contraceptives containing high doses of oestrogen and progesterone. 

3. Infection: 

 Chronic viral hepatitis.

4. Smoking: 

Smoking increases the risk of liver cancer generally, but there is a further increase in risk among smokers who also have the hepatitis B or hepatitis C virus infection and also among smokers who consume large amounts of alcohol.

In this latest report from our Continuous Update Project - the world’s largest source of scientific research on cancer prevention and survivorship through diet, weight and physical activity - we analyse worldwide research on how certain lifestyle factors affect the risk of developing liver cancer. 

This includes new studies as well as studies published in our 2007 Second Expert Report, 'Food, Nutrition, Physical Activity and the Prevention of Cancer: a Global Perspective' [3]. 

How the research was conducted 

The global scientific research on diet, weight, physical activity and the risk of liver cancer was systematically gathered and analysed, and then the results were independently assessed by a panel of leading international scientists in order to draw conclusions about which of these factors increase or decrease the risk of developing the disease. 

The research included in this report largely focuses on the main type of liver cancer, hepatocellular carcinoma, which accounts for 90 per cent of all liver cancers [4]. 

More research has been conducted in this area since our 2007 Second Expert Report [3]. In total, this new report analyses 34 studies from around the world; this comprises over eight million (8,153,000) men and women and 24,600 cases of liver cancer. 

To ensure consistency, the methodology for the Continuous Update Project (CUP) remains largely unchanged from that used for our 2007 Second Expert Report [3]. 

Findings 

Strong evidence

There is strong evidence that being overweight or obese is a cause of liver cancer. Being overweight or obese was assessed by body mass index (BMI).

There is strong evidence that consuming approximately three or more alcoholic drinks a day is a cause of liver cancer. 

There is strong evidence that consuming foods contaminated by aflatoxins (toxins produced by certain fungi) is a cause of liver cancer. (Aflatoxins are produced by inappropriate storage of food and are generally an issue related to foods from warmer regions of the world. Foods that may be affected by aflatoxins include cereals, spices, peanuts, pistachios, Brazil nuts, chillies, black pepper, dried fruit and figs).

There is strong evidence that drinking coffee is linked to a decreased risk of liver cancer. 

Limited evidence

There is limited evidence that higher consumption of fish decreases the risk of liver cancer. 

There is limited evidence that physical activity decreases the risk of liver cancer.

Findings that have changed since our 2007 Second Expert Report 

The findings on being overweight or obese, coffee, fish and physical activity in this report are new; those for alcoholic drinks were strengthened and for aflatoxins remain unchanged from our 2007 Second Expert Report [3]. 

Recommendations 

To reduce the risk of developing liver cancer: 

1. Maintain a healthy weight. 

2. If consumed at all, limit alcohol to a maximum of 2 drinks a day for men and 1 drink a day for women. 

This advice forms part of our existing Cancer Prevention Recommendations (available at wcrf.org). Our Cancer Prevention Recommendations are for preventing cancer in general and include eating a healthy diet, being physically active and maintaining a healthy weight.

1. Foods that may be contaminated with aflatoxins include cereals (grains), as well as pulses (legumes), seeds, nuts and some vegetables and fruits.

2. Based on evidence for alcohol intakes above around 45 grams per day (about 3 drinks a day). No conclusion was possible for intakes below 45 grams per day. There is insufficient evidence to conclude that there is any difference in effect between men and women. Alcohol consumption is graded by the International Agency for Research on Cancer (IARC) as carcinogenic to humans (Group 1) [2].

3. Body fatness is marked by body mass index (BMI).

4. Physical activity of all types.

1. Summary of panel judgements 

Overall the Panel notes the strength of the evidence that aflatoxins, body fatness and alcoholic drinks are causes of liver cancer, and that coffee protects against liver cancer. The Continuous Update Project (CUP) Panel judges as follows:

Aflatoxins: Higher exposure to aflatoxins and consumption of aflatoxin-contaminated foods are convincing causes of liver cancer.

Alcoholic drinks: Consumption of alcoholic drinks is a convincing cause of liver cancer. This is based on evidence for alcohol intakes above about 45 grams per day (around 3 drinks a day).

Body fatness: Greater body fatness (marked by BMI) is a convincing cause of liver cancer.

Coffee: Higher consumption of coffee probably protects against liver cancer.

Fish: The evidence suggesting that a higher consumption of fish decreases the risk of liver cancer is limited.

Physical activity: The evidence suggesting that higher levels of physical activity decrease the risk of liver cancer is limited

1 - Summary of panel judgements
2. Trends, incidence and survival
3. Pathogenesis
4. Other established causes
5. Interpretation of the evidence
6. Methodology
7. Evidence and judgements
8. Comparison with the Second Expert Report
9. Conclusions
Acknowledgements
Glossary
References
Our Recommendations for Cancer Prevention

Download PDF To View Full Report

Worth A Click

Oily fish, coffee and walnuts: Dietary treatment for nonalcoholic fatty liver disease
World J Gastroenterol 2015 October 7; 21(37): 10621-10635
Rates of non-alcoholic fatty liver disease (NAFLD) are increasing worldwide in tandem with the metabolic syndrome, with the progressive form of disease, non-alcoholic steatohepatitis (NASH) likely to become the most common cause of end stage liver disease in the not too distant future. Lifestyle modification and weight loss remain the main focus of management in NAFLD and NASH, however, there has been growing interest in the benefit of specific foods and dietary components on disease progression, with some foods showing protective properties. This article provides an overview of the foods that show the most promise and their potential benefits in NAFLD/NASH, specifically; oily fish/ fish oil, coffee, nuts, tea, red wine, avocado and olive oil.
Full Text Available @ World J Gastroenterol

Learn More About Liver Cancer

American Liver Foundation Celebrates Liver Cancer Awareness Month
ALF is in full campaign mode offering information about liver cancer, as well as encouraging people at risk to discuss the facts with their doctor. Visit here to learn more about this deadly disease.

Protect your liver:
Eat healthy, stay active. 

Ask your doctor before taking any prescription, over-the-counter medications, supplements or vitamins. For instance, some drugs, such as certain pain medications, can potentially damage the liver

Avoid alcohol since it can increase the speed of liver damage
Talk to your doctor about getting vaccinated against Hepatitis A and B

Get Tested For HCV

In the past, or even today, some people find out by accident that they have the virus, maybe they had a blood test before a blood donation or were diagnosed during a routine checkup.  Sadly, some people are not aware they have HCV.

If you have any of the following risk factors get tested

Born during 1945-1965

Most people with Hepatitis C don’t know they are infected so getting tested is the only way to know.
Baby boomers are five times more likely to have Hepatitis C than other adults.

The longer people live with Hepatitis C undiagnosed and untreated, the more likely they are to develop serious, life-threatening liver disease.

Liver disease, liver cancer, and deaths from Hepatitis C are on the rise.

Getting tested can help people learn if they are infected and get them into lifesaving care and treatment.

You should have routine hepatitis C viral testing if any of the following apply: 

You have ever used IV drugs
You had a blood transfusion or organ transplant before 1992
You have been on long-term hemodialysis
You have persistently abnormal liver test results
You are or were a health care worker who may have been exposed to hepatitis C through blood exposure, for example a needle stick
You are a child born to a mother who had hepatitis C

Where Can I find a specialist to treat HCV?

Find a Specialist In Your Area
Testing, Diagnosis and Treatment

Get out folks, go for a walk and enjoy this lovely time of the year. 

Tina

Searching for Sovaldi: Buying Generic Sofosbuvir in India: A Travel Journal

Searching for Sovaldi: Buying Generic Sofosbuvir in India: A Travel Journal

Did you all read the story today published online in The Sydney Morning Herald about the hepatitis C buyers club. The article is about FixHepC, a Non-Profit website launched by Australian GP Dr James Freeman. The site offers Australian HCV patients information about purchasing hepatitis C medications from overseas through GP2U Telehealth, Freeman is from GP2U and founded Skype2doctor, a virtual medical center based at Battery Point in Hobart, Tasmania. Here is the story; FixHepC, the buyers club for hepatitis C drug, inundated with inquiries.

According to the article; "Visits to the FixHepC website shot up from 5000 to more than 217,000 after a report on the initiative was published by Fairfax Media last weekend." 

The first time I read about the Australian site was on a favorite blog of mine written by Greg Jefferys, over at hepmag.com. In addition to reading his blog - I never miss an entry, I downloaded his remarkable journal; Searching for Sovaldi: Buying Generic Sofosbuvir in India: A Travel Journal, available at Amazon. If you haven't read his inspirational story yet, you will after reading this overview.

Description

This is the amazing story of one man’s journey to cure himself of Hepatitis C, a debilitating and often fatal disease. It is a journey that begins with his own quest for a cure and ends with him assisting hundreds of others to access the same cure. Originally written as a guide to buying generic antiviral drugs in India it is an entertaining, frightening and uplifting journey that takes the reader into the murky world of the international pharmaceutical industry where profits are more important than people’s lives. The author’s journey ultimately brought hope to thousands of people suffering from the global epidemic of Hepatitis C and helped in the global effort to put pressure on governments and pharmaceutical companies to make new generation medicines available to their citizens at affordable prices. 

Diagnosed with Hep C after suddenly experiencing extreme, unexplained fatigue the author was faced with the prospect that he either had liver cancer or extreme cirrhosis of the liver. He was offered a treatment that included a cocktail of drugs based on Interferon. However after researching the Interferon therapy he found that it offered a cure rate of not much better than 50% and side effects that were so bad that up to half the people who started the treatment quit, preferring to risk liver cancer than endure the horrendous side effects of Interferon.

 
The author instead decided to manage his disease through life style and dietary changes while waiting for the arrival of a new generation of anti-viral drugs that were rumoured to be on the horizon.
However when the new drugs did eventually become available, Gilead’s Sofosbuvir, offering a 99% cure rate and almost no side effects, the price asked for them was an extraordinary US$1,000 per tablet. The average treatment would require between 84 and 168 tablets, or between US$84,000 and US$168,000 per treatment. 

All around the world the more than 150 million people suffering from Hepatitis C saw their cure and at the same time saw that for most of them the cure was unaffordable. 

Then, courageously, India refused to grant a patent on the new drugs and Indian manufacturers began to produce generic varieties for sale at one hundredth of the price that the drug was being sold in Western countries. 

The author was the first person from the West to publicly go to India to source and buy generic Sofosbuvir for his own treatment. He kept a diary of his experiences and published it on the internet so that others could follow his path into India and know how to access this cheaper version of the life saving drug. 

This story is an extension of the author’s diaries and journals, originally intended as a guide to purchasing generic Sofosbuvir in India, this expanded content takes the reader into the heart of India where ancient values and customs create a fierce independence from American and European social, economic and corporate pressures. Witty and exciting the story also contains tragic stories gleaned from the hundreds of emails the author has received from people who have Hepatitis C themselves or who are supporting family members with the disease.
It is an inspiring read. 

Available On Amazon 

Blog 

Greg Jefferys

My Hep C Travel Diary, Hepatitis C Advocate

Now that Hepatitis C Treatment is Over

A Door Slams on Hepatitis C Treatment
Hepatitis C Treatment: Don't Put Off Until Tomorrow That Which You Can Do Today
Hep C: The Whole Story
Hep C Free by Christmas?
Hepatitis C: Get Healed Now
Some Interesting News On UK Doctors
Hep C Treatment: A Sudden and Unexpected Development
Hepatitis C Treatment with Generics: Bad News, Good News
Generic Harvoni From India and Possible Delays

Webcast - Hepatitis C: where are we now? The landscape

The Viral Hepatitis Congress 2015

Last month researchers and physicians gathered at "The Viral Hepatitis Congress 2015" held in Kap Europa, Frankfurt, Germany to discuss new data on the changing treatment landscapes in both hepatitis B and hepatitis C. Other important topics included HIV co-infection, advances in managing HCC, to name a few.

Anyone living with HCV or considering treatment may be interested in viewing a webcast of the scientific program over at "ViralHepatitisTV." Abstracts from this meeting are published online in the "Journal of Viral Hepatitis."

The webcast is still in the process of being uploaded, links are provided below. 

The Viral Congress Sept 10-12

Welcome and introduction
Ira Jacobson, New York, US and Stefan Zeuzem, Frankfurt, Germany - Click here to view

Hepatitis C: where are we now? The landscape
US vs. EU: differences in the labels and guidelines for anti-HCV regimens
Nezam Afdhal, Boston, US – Click here to view

Hepatitis C:where are we now? The landscape - Q&A and panel discussion – Click here to view

Keynote lecture
HCV registries: what have we learned beyond the phase III trials?
David Nelson, Gainsville, US – Click here to view

Which DAA regimen should include ribavirin?
Graham Foster, London, UK – Click here to view

Drug–drug interactions: what remains relevant in HCV treatment?
David Back, Liverpool, UK – Click here to view

New data from latest clinical trials
Real-life results of triple therapy with the combination of sofosbuvir-pegylated interferon-ribavirin for Egyptian patients with hepatitis C
Gamal Esmat, Cairo, Egypt – Click here to view

Efficacy and safety of paritaprevir/r/ombitasvir/dasabuvir ± ribavirin in genotype 1 HCV infected patients treated in real life settings (AMBER study)Robert Flisiak, Bialystok, Poland – Click here to view

Daclatasvir plus sofosbuvir with or without ribavirin for the treatment of HCV in patients with severe liver disease: interim results of a compassionate use program
Tania Welzel, Frankfurt, Germany – Click here to view

Ledipasvir/sofosbuvir with ribavirin is safe and efficacious in decompensated and post liver transplantation patients with HCV infection: preliminary results of the prospective SOLAR 2 trial Didier Samuel, Villejuif, France – Click here to view

HCV-infected patients with renal and/or hepatic impairment and post-transplant
Treatment of patients with pre-terminal and terminal renal insufficiency
Paul Martin, Miami, US – Click here to view

Treatment of patients with decompensated liver cirrhosis: who benefits, who deteriorates, where is the point of no return?
Marc Bourlière, Marseille, France – Click here to view

Anti-viral management post-liver transplantation
Paul Kwo, Indianapolis, US – Click here to view

Scientific Posters
You can view the posters now as downloadable PDFs or as interactive, page-turning books, these files (which open in a new window) require the latest version of Flash Player to be viewed.

Book 1
Interactive Book or PDF
ORAL PRESENTATIONS
HEPATITIS C VIRUS – DIAGNOSIS (P1–P3)
HEPATITIS C VIRUS – NATURAL HISTORY AND EPIDEMIOLOGY (P5–P7)
HEPATITIS C VIRUS – TREATMENT AND LATE-STAGE CLINICAL TRIALS (P8-P10)

Book 2
Interactive Book or PDF
HEPATITIS C VIRUS – PRACTICAL MANAGEMENT STRATEGIES (P11)
HEPATITIS C VIRUS – TREATMENT MONITORING AND PREDICTORS OF THERAPEUTIC RESPONSE (P13–P16)
HEPATITIS C VIRUS – DIRECT-ACTING ANTIVIRAL COMBINATIONS (P17-P20)
HEPATITIS C VIRUS – MOLECULAR BIOLOGY AND CHARACTERISATION (P21–P22)

Book 3
Interactive Book or PDF
HEPATITIS C VIRUS – OTHER (P24–P25)
HEPATITIS B VIRUS – DIAGNOSIS AND MONITORING (P28-P29)
HEPATITIS B VIRUS – PRACTICAL MANAGEMENT STRATEGIES (P32)
HEPATITIS B VIRUS – MOLECULAR BIOLOGY AND CHARACTERISATION (P33–P43)
HEPATITIS B VIRUS – OTHER (P44)
HEPATOCELLULAR CARCINOMA (HCC) (P45)
TRANSPLANTATION AND VIRAL HEPATITIS (P47–P48)

Source - http://viral-hep.org/congress/

ABBVIE Announces New data on studies of VIEKIRA PAK™ and Investigational Agents, ABT-493 AND ABT-530 at The Liver Meeting® 2015

ABBVIE DEMONSTRATES COMMITMENT TO HEPATITIS C PATIENTS WITH NEW DATA ON VIEKIRA PAK™ (OMBITASVIR, PARITAPREVIR, RITONAVIR TABLETS; DASABUVIR TABLETS) AND ONGOING CLINICAL DEVELOPMENT PROGRAM AT THE LIVER MEETING® 2015

- NEW DATA TO BE PRESENTED ON VIEKIRA PAK IN GENOTYPE 1 HEPATITIS C PATIENTS WITH CHRONIC KIDNEY DISEASE AND ON ABBVIE'S INVESTIGATIONAL HCV PIPELINE MEDICINES, ABT-493 AND ABT-530

Oct 1, 2015
NORTH CHICAGO, Ill., Oct. 1, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research-based biopharmaceutical company, today announced that 34 abstracts from its chronic hepatitis C clinical development program have been accepted for presentation at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco from November 13-17, further demonstrating AbbVie's strong leadership and ongoing commitment to patients with chronic hepatitis C virus (HCV) infection.

Presentations will highlight new data from Phase 3b studies of AbbVie's FDA-approved VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), taken with or without ribavirin (RBV), for adults with genotype 1 (GT1) chronic HCV infection, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis. Additionally, new clinical studies will be presented on AbbVie's HCV pipeline medicines, ABT-493 and ABT-530, focused on investigating pan-genotypic, ribavirin-free, once-daily treatment options that may allow for shorter treatment durations of as little as eight weeks.

"We are pleased to present new data from studies of the VIEKIRA PAK regimen in HCV patients, including those with chronic kidney disease and GT1b compensated cirrhosis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These data, as well as our findings from our investigational compounds, further demonstrate AbbVie's firm commitment to supporting the care of patients with chronic HCV infection."

Select AbbVie clinical presentations include:

• RUBY-I: Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir +/- Ribavirin in Non-Cirrhotic HCV Genotype 1-infected Patients With Severe Renal Impairment or End-Stage Renal Disease; Pockros, P, et al.; Poster #1039; Sunday, November 15, 2015,8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)RUBY-I is an ongoing open-label study evaluating 3D+/-RBV in patients with stage four or five chronic kidney disease and GT1 infection.
• TURQUOISE-III: 12-Week Ribavirin-Free Regimen of Ombitasvir/Paritaprevir/r and Dasabuvir for Patients with HCV Genotype 1b and Cirrhosis; Poordad, F, et al.; Poster #1051; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)Hepatitis C virus infected patients have historically been more difficult to treat when they have cirrhosis. This poster reports on the safety and efficacy of the 3D regimen without RBV in patients with HCV GT1b infection and compensated cirrhosis. VIEKIRA PAK is not recommended for patients with decompensated liver disease.
• Efficacy, Change in MELD Score, and Safety by Baseline MELD Score in Patients With Compensated Cirrhosis Receiving Ombitasvir/Paritaprevir/r and Dasabuvir Plus Ribavirin in Phase 3 TURQUOISE-II Trial; Jacobson, I, et al.; Poster #1106;Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)Model for end-stage liver disease (MELD) scores assess liver disease severity. In this analysis, the efficacy and safety of 3D+RBV and changes in MELD score by baseline MELD score is evaluated.
• Preliminary Safety and Efficacy Results in TOPAZ-II: A Phase 3b Study Evaluating Long-Term Clinical Outcomes in HCV Genotype 1-infected Patients Receiving Ombitasvir/Paritaprevir/r and Dasabuvir +/-Ribavirin; Reau, N, et al.; Poster #1065; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)TOPAZ-I (ex-U.S.) and TOPAZ-II (U.S.) are evaluating the impact of SVR12 on the progression of liver disease through five years post-treatment in a broad population of HCV GT1-infected patients receiving 3D+/-RBV. This interim analysis reports on-treatment safety and efficacy of 3D+/-RBV among patients in the TOPAZ-II study.
• Long-Term Efficacy of Ombitasvir/Paritaprevir/r and Dasabuvir With or Without Ribavirin in HCV GT1-Infected Patients With or Without Cirrhosis; Zeuzem, S, et al.; Poster #1086; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)In this analysis, the efficacy through post-treatment week 48 of the 3D regimen in HCV GT1-infected patients with or without cirrhosis is examined.
• SVR4 Results in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated Interferon/Ribavirin Null Responders with the Combination of the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 (SURVEYOR-1); Poordad, F, et al.; Oral presentation #41; Sunday, November 15, 2015, 4:00 p.m. – 4:15 p.m. PT; Parallel Session 5, Hep C Clinical TrialsIn this Phase 2 study, treatment with ABT-493 and ABT-530 for 12 weeks is evaluated in HCV GT1-infected subjects without cirrhosis. Efficacy and safety results are reported.
• SVR4 Rates with the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 2 Infection (SURVEYOR-2); Wyles, D, et al.; Oral presentation #250; Tuesday, November 17, 2015; 12:00 p.m. – 12:15 p.m. PT; General Session, Parallel 37: Hepatitis C: Pre-approval Clinical Studies IIThis presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without RBV in non-cirrhotic GT2-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.
• SVR4 Rates with the NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection (SURVEYOR-2); Kwo, P, et al.; Oral presentation #248; Tuesday, November 17, 2015, 11:30 a.m.– 11:45 a.m. PT; General Session, Parallel 37: Hepatitis C: Pre-approval Clinical Studies IIThis presentation evaluates the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in non-cirrhotic GT3-infected treatment-naïve and pegylated interferon/RBV treatment-experienced subjects.

Select Health Economics and Outcomes Research (HEOR) abstracts include:

• Lifetime Risks of Liver Morbidity and Mortality in Patients with Chronic Genotype 1 Hepatitis C Virus and HIV Coinfection Treated with 3D±R (Ombitasvir/ Paritaprevir/ Ritonavir, Dasabuvir ± Ribavirin) vs other Standards of Care in the U.S.; Saab, S, et al.; Poster #1087; Sunday, November 15, 2015, 8:00 a.m. – 5:30 p.m. PT, Hepatitis C: Therapeutics (Approved Agents)This study evaluates the lifetime risks of liver morbidity and mortality in patients with GT1 HCV and HIV coinfection treated with 3D±R for 12 or 24 weeks compared to other standards of care in the U.S.
• The Healthcare Cost Burden of HCV-infected Baby Boomers in the U.S.; Brookmeyer R, et al.; Poster #1068; Sunday, November 15, 2015,  8:00 a.m. – 5:30 p.m. PT; Hepatitis C: Therapeutics (Approved Agents)This study quantifies healthcare costs for 50-64 year-old "baby boomers" with HCV by diagnosis and insurance status.

The full AASLD 2015 scientific program can be found at www.aasld.org.

About VIEKIRA PAK

USE
VIEKIRA PAK™ (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection, including people who have a certain type of cirrhosis (compensated).

VIEKIRA is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a healthcare provider before taking VIEKIRA.

IMPORTANT SAFETY INFORMATION

When taking VIEKIRA in combination with ribavirin, people should also read the Medication Guide that comes with ribavirin, especially the important pregnancy information.

What is the most important information to know about VIEKIRA?
VIEKIRA can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).
Ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) must be stopped before starting treatment with VIEKIRA. If these medicines are used as a method of birth control, another method must be used during treatment with VIEKIRA, and for about 2 weeks after treatment with VIEKIRA ends. A healthcare provider can provide instruction on when to begin taking ethinyl estradiol-containing medicines.
A healthcare provider should do blood tests to check liver function during the first 4 weeks of treatment and then as needed.
A healthcare provider may tell people to stop taking VIEKIRA if signs or symptoms of liver problems develop. A healthcare provider must be notified right away if any of the following symptoms develop or if they worsen during treatment with VIEKIRA: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, or color changes in stools.

VIEKIRA must not be taken if people:
have severe liver problems
take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) • carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) • efavirenz (Sustiva®, Atripla®) • ergot containing medicines, including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines • gemfibrozil (Lopid®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • midazolam (when taken by mouth) • phenytoin (Dilantin®, Phenytek®) • phenobarbital (Luminal®) • pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil citrate (Revatio®), when taken for pulmonary artery hypertension (PAH) • simvastatin (Zocor®, Vytorin®, Simcor®) • St. John's wort (Hypericum perforatum) or a product that contains St. John's wort • triazolam (Halcion®)
have had a severe skin rash after taking ritonavir (Norvir®)

What should people tell a healthcare provider before taking VIEKIRA?
If they have: liver problems other than hep C infection, HIV infection, or any other medical conditions.

If they have had a liver transplant. If they take the medicines tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®, Sandimmune®), a healthcare provider should check blood levels and, if needed, may change the dose of these medicines or how often they are taken, both during and after treatment with VIEKIRA.

If they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if VIEKIRA will harm a person's unborn baby or pass into breast milk. A healthcare provider should be consulted about the best way to feed a baby if taking VIEKIRA. Pregnant females who have both hep C and HIV infection should talk with a healthcare provider about enrolling in the antiretroviral pregnancy registry.

About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with VIEKIRA.

A new medicine must not be started without telling a healthcare provider. A healthcare provider will provide instruction on whether it is safe to take VIEKIRA with other medicines.

When VIEKIRA is finished, a healthcare provider should be consulted on what to do if one of the usual medicines taken was stopped or if the dose changed during VIEKIRA treatment.

What are the common side effects of VIEKIRA?
For VIEKIRA used with ribavirin, side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.
For VIEKIRA used without ribavirin, side effects include nausea, itching, and sleep problems.

These are not all of the possible side effects of VIEKIRA. A healthcare provider should be notified if there is any side effect that is bothersome or that does not go away.

This is the most important information to know about VIEKIRA. For more information, talk with a healthcare provider.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including the Medication Guide.

If people cannot afford their medication, they should contact www.pparx.org for assistance.

Additional Information about VIEKIRA PAK™

VIEKIRA PAK™ (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) has been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naive to some of the most difficult to treat, such as patients with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV). VIEKIRA PAK is not recommended in patients with moderate hepatic impairment (Child-Pugh B), and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). VIEKIRA PAK consists of the fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal. VIEKIRA PAK is taken for 12 weeks, except in GT1a patients with cirrhosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients, and in all patients who have cirrhosis or who have received a liver transplant.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is being investigated by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

For VIEKIRA PAK Full Prescribing Information, including the Medication Guide, click here.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie

For further information: Media: Jackie Finley, +1 (847) 937-3998, jaquelin.finley@abbvie.com; or Jillian Griffin, +1 (847) 935-9331, jillian.griffin@abbvie.com, Investor Relations: Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

How coffee loves us back

Of Interest
Sept 17
Caffeine Decreases Risk of Hepatic Fibrosis in Male HCV Patients
In a cross-sectional study, researchers found that coffee and caffeine were associated with a decreased risk of developing advanced hepatic fibrosis among a majority of male veterans with hepatitis C virus infection, according to study data.

How coffee loves us back

By Alvin Powell, Harvard Staff Writer 

Health benefits a recurring theme in Harvard research

Coffee, said the Napoleon-era French diplomat Talleyrand, should be hot as hell, black as the devil, pure as an angel, sweet as love.

Bach wrote a cantata in its honor, writers rely on it, and, according to legend, a pope blessed it. Lady Astor once reportedly remarked that if she were Winston Churchill’s wife, she’d poison his coffee, to which Churchill acerbically replied: “If I were married to you, I’d drink it.”

Coffee is everywhere, through history and across the world. And increasingly, science is demonstrating that its popularity is a good thing.

Harvard scientists have for years put coffee under the microscope. Last year, researchers announced they had discovered six new human genes related to coffee and reconfirmed the existence of two others. The long-running Nurses’ Health Study has found that coffee protects against type 2 diabetes and cardiovascular disease. Researchers are continuing to follow up on 2001 findings that it protects against Parkinson’s disease.

The work at Harvard is just part of an emerging picture of coffee as a potentially powerful elixir against a range of ailments, from cancer to cavities.

Sanjiv Chopra, a professor of medicine at Harvard Medical School and Harvard-affiliated Beth Israel Deaconess Medical Center, has been so impressed he’s become something of a coffee evangelist. The author of several books, Chopra included a chapter on coffee in his 2010 book, “Live Better, Live Longer.”

Chopra first became aware of the potentially powerful protective effects of coffee when a study revealed that consumption lowers levels of liver enzymes and protects the liver against cancer and cirrhosis. He began asking students, residents, and fellows on the liver unit to quiz patients about their coffee habits, finding repeatedly that none of the patients with liver ailments drank coffee.

Chopra himself makes sure to have several cups a day, and encourages others to do the same. Though other researchers are less bold in their dietary recommendations, they’re convinced enough to continue investigations into the benefits.

Alberto Ascherio, a professor of epidemiology and nutrition at the Harvard T.H. Chan School of Public Health and a professor of medicine at HMS, has been studying the potential anti-Parkinson’s effects first suggested in the 2001 findings. That study showed that four or five cups of coffee daily cut disease risk nearly in half compared with little or no caffeine.

Professor of Nutrition and Epidemiology and Professor of Medicine Frank Hu, who leads the diabetes section of the long-running Nurses’ Health Study, has become interested in whether coffee drinking affects total mortality.

“I’m not a huge coffee drinker, two to three cups a day,” Hu said. “[But] I like it and, thinking about the extra benefits, that’s comforting.”

Last year, a Harvard team led by then-research associate Marilyn Cornelis — today an assistant professor at Northwestern University — traced coffee’s fingerprints to the human genome, discovering six new genes related to coffee consumption and reconfirming two others found earlier. The six genes included two related to metabolism, two related to coffee’s psychoactive effects, and two whose exact purpose in coffee consumption is unclear, but which are related to lipid and glucose metabolism.

Daniel Chasman, an associate professor of medicine at HMS and associate geneticist at Harvard-affiliated Brigham and Women’s Hospital, who worked with Cornelis on the study, said caffeine consumption habits are highly heritable and that the genes they found appear to explain about 7 percent of the heritability. That’s a significant amount, he said, considering how strong an influence culture also plays on coffee consumption.

Though the links between coffee and better health have become considerably clearer, what exactly confers the benefit remains murky. Caffeine alone does not explain the effects. For starters, some of the benefits are seen even with decaf, which has prompted researchers to turn their attention to the many other active compounds — including antioxidants such as chlorogenic acid — in your morning cup.

“Coffee is a complex beverage. It’s very difficult to pinpoint which component of coffee is responsible for the benefit,” Hu said. “There are numerous bioactive compounds.”

Other highlights from Harvard research include:
A 2005 study exploring concerns that too much coffee was bad for blood pressure found no link between higher blood pressure and coffee and found some suggestion that it improved blood pressure.
Regular coffee drinking was linked in a 2011 Harvard study to lower risk of a deadly form of prostate cancer.

Also in 2011, a study showed that drinking four or more cups a day lowered the rate of depression among women.

A 2012 study tied three cups a day to a 20 percent lower risk of basal cell carcinoma.

A 2013 Harvard study linked coffee consumption to a reduced risk of suicide.

Also in 2013, a Harvard analysis of 36 studies covering more than a million people found that even heavy coffee consumption did not increase the risk of cardiovascular disease and that three to five cups of coffee daily provided the most protection against cardiovascular disease.

Also in 2014, Harvard Chan School researchers found that increasing coffee consumption by more than a cup a day over a four-year period reduced type 2 diabetes risk by 11 percent.

The same study showed that those who decreased their coffee consumption by more than a cup a day increased their type 2 diabetes risk by 17 percent.

“That first cup of coffee in the morning is happiness.” Chopra said. “It’s a real joy.”

Source - Harvard Gazette 

Published on Sep 29, 2015

Coffee is everywhere, through history and across the world. And increasingly, science is demonstrating that its popularity is a good thing.

The work at Harvard is just part of an emerging picture of coffee as a potentially powerful elixir against a range of ailments, from cancer to cavities.