Wednesday, July 26, 2017

Review - HCC Risk and Direct-Acting Antivirals

Medscape Coverage from
Digestive Disease Week (DDW) 2017 

COMMENTARY
With Hepatitis C Virus on the Run, Meet the New Challenge: Hepatocellular Carcinoma
William F. Balistreri
July 26, 2017
Significant advances in the clinical practice of hepatology were addressed during this year's Digestive Disease Week. This review focuses on the concerns related to the apparent increase in the incidence of hepatocellular carcinoma (HCC).

HCC Risk and Direct-Acting Antivirals
The advent of direct-acting antivirals (DAAs) has clearly brought good news, as it may now be possible to achieve a sustained virologic response (SVR)—a "virologic cure"—in the majority of patients with chronic hepatitis C virus (HCV). However, emerging data suggest that the risk for HCC may persist or even be increased by DAA administration. This concern was addressed by two studies
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On This Blog
Liver Cancer After Treatment For Hepatitis C
Sift through a collection of current articles investigating the possible risk of developing liver cancer (hepatocellular carcinoma, or HCC) during and after direct-acting antiviral therapy in patients with hepatitis C.

Hepatitis C - Mylan Receives WHO Prequalification for Generic Sovaldi®

Mylan Receives WHO Prequalification for Generic Sovaldi®

First Generic Prequalification for Sofosbuvir Tablets

HERTFORDSHIRE, England and PITTSBURGH, July 26, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of approval from the World Health Organization Prequalification of Medicines Program (WHO PQ) of its application for Sofosbuvir Tablets, 400 mg, a generic version of Gilead Sciences' Sovaldi®. Sofosbuvir, a directly acting antiretroviral, will be available in developing countries to treat hepatitis C.

Mylan's Sofosbuvir Tablets, 400 mg, which are produced under license from Gilead Sciences, are the first generic version to be approved under the WHO PQ Program. With WHO PQ approval, international donors and purchasers, such as UNITAID and U.N. agencies, will able to fund and procure the product, and other buyers can be assured of the product's quality, safety and efficacy.

"This marks another important step in Mylan's leadership to help fight infectious diseases around the world," commented Mylan President Rajiv Malik. "It also furthers our mission of increasing access to high quality, affordable medicines to patients, healthcare practitioners, governments and other stakeholders to help treat hepatitis C."

Worldwide, there are more than 70 million people living with chronic hepatitis C, which results in nearly 400,000 related deaths every year. (1) The WHO estimates that antiviral medication can cure more than 95% of chronic hepatitis C cases. (2)

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.

(1, 2) http://www.who.int/mediacentre/factsheets/fs164/en/

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Modelling cost-effectiveness/health gains of a "universal" vs. "prioritized" HCV treatment policy in a real-life cohort

Modelling cost-effectiveness and health gains of a "universal" vs. "prioritized" HCV treatment policy in a real-life cohort.
Kondili LA, et al. Hepatology. 2017.

View Article
Accepted manuscript online:
Follow On Twitter
PDF Provided By @HenryEChang  

Abstract
We evaluated the cost-effectiveness of two alternative DAA treatment policies in a real-life cohort of HCV-infected patients: Policy 1 - "universal": treat all patients, regardless of the fibrosis stage; Policy 2 - treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and healthcare system perspective, was applied to the PITER cohort (representative of Italian HCV-infected patients in care). Specifically, 8,125 patients naïve to DAA treatment, without clinical, sociodemographic or insurance restrictions was used to evaluate the policies' cost-effectiveness. The patients' age, fibrosis stage, assumed DAA treatment cost of €15,000/patient and the Italian liver disease costs were used to evaluate Quality-Adjusted Life-Years (QALY) This article is protected by copyright. All rights reserved.

ECDC estimate: Around 9 million Europeans are affected by chronic hepatitis B or C

And large numbers of them are not even aware of their infection as they have not yet been tested

European Centre for Disease Prevention and Control (ECDC)

An estimated 4.7 million Europeans are living with chronic hepatitis B and almost 4 million (3.9) with chronic hepatitis C infection. However, large numbers of them are not even aware of their infection as they have not yet been tested and diagnosed. On the occasion of World Hepatitis Day on 28 July, ECDC Director Andrea Ammon highlights the need for Europe to scale-up coverage of testing, prevention interventions and linkage to suitable treatment services in order to achieve the target of eliminating viral hepatitis as a public health issue by 2030.

According to ECDC estimates, the prevalence of hepatitis B (HBV) across the European Union and European Economic Area (EU/EEA) is around 0.9% and about 1.1% for hepatitis C (HCV) - and these figures are likely to be an underestimation of the true burden as hepatitis infection often shows no symptoms.

European Commissioner for Health and Food Safety Vytenis Andriukaitis underlined the importance of increasing testing that leads to higher detection rates: ''Greater efforts are needed to reduce both the suffering and the costs that hepatitis inflicts across Europe. The Commission is fully committed to helping Member States achieve the Sustainable Development goal of ending HIV/AIDS and tuberculosis and reducing viral hepatitis by 2030. Together, we will scale up our prevention and testing programmes and reach out to the most vulnerable to reduce health inequalities. In order to tackle the underlying causes of the hepatitis epidemic we need to combine health instruments with social instruments and work together across health, social, and education policies.''

In 2015, the countries of the EU/EEA reported almost 60 000 newly diagnosed cases of these two infections - with 24 573 cases of hepatitis B and 34 651 of hepatitis C. For hepatitis C, this constitutes an increase of 4% compared to 2014 and follows the overall trend in Europe which saw a 26% rise of diagnosed and reported cases between 2006 and 2015. While the overall rise in diagnosed hepatitis cases indicates a general increase in testing practices across Europe, this does not apply to all of the European countries. A recent ECDC survey showed great variations across the countries and the proportion of undiagnosed infections ranges between 45-85% for HBV and between 20-89% for HCV, highlighting gaps in national testing programmes.

"There are highly effective drugs available to treat people infected with hepatitis B and C but the main bottleneck we see in Europe is the actual case detection: too many infections with viral hepatitis remain undiagnosed", says ECDC Director Andrea Ammon. "An ECDC study showed that less than half of the responding EU/EEA countries have dedicated hepatitis B or C testing guidance in place and even fewer countries could provide estimates on their undiagnosed infected population", Ammon continued. "There is also a clear need for countries to improve the quality and completeness of surveillance data, especially on the route of transmission. ECDC is currently working on an evidence-based testing guidance to support EU countries in their attempt to achieve the elimination target by 2030".

More testing allows treatment of those infected and reduces transmission

Across Europe, there has been a downward trend in the rate of acute HBV notifications especially among young people - most likely reflecting the positive impact of national vaccination programmes on incidence. Trends in the notifications of acute HCV provide a less reliable proxy for incidence as the disease is largely asymptomatic and cases of acute infection are difficult to diagnose.

In order to achieve elimination of hepatitis by 2030, prevention and control practices need to be scaled up to interrupt existing transmission chains. Those who might be unknowingly infected with viral hepatitis need to be identified through more testing both for their own benefit but also to be able to reduce further transmission in the community.

Source - https://ecdc.europa.eu/en/news-events/ecdc-around-9-million-europeans-are-affected-chronic-hepatitis-b-or-c

ECDC World Hepatitis Day 2017 page

Resources:
ECDC report: Hepatitis B and C testing activities, needs, and priorities in the EU/EEA
Hepatitis B - Annual Epidemiological Report for 2015
Hepatitis C - Annual Epidemiological Report for 2015
Systematic review on hepatitis B and C prevalence in the EU/EEA
ECDC Guidance: Antenatal screening for HIV, hepatitis B, syphilis and rubella susceptibility in the EU/EEA

Diplomat Now Dispensing VOSEVI™ to Treat Chronic Hepatitis C Virus

The nation's largest independent specialty pharmacy is now dispensing VOSEVI™ (sofosbuvir, velpatasvir, and voxilaprevir)

FLINT, Mich., July 26, 2017 /PRNewswire/ -- Diplomat Pharmacy, Inc. is now dispensing newly approved VOSEVI™ (sofosbuvir/velpatasvir/voxilaprevir) to treat hepatitis C virus infection

VOSEVI is used to treat all genotypes of chronic hepatitis C virus infection. It is indicated for adults without cirrhosis (liver disease) or with compensated cirrhosis who have previously been treated with a regimen containing an NS5A inhibitor such as EPCLUSA® (sofosbuvir/velpatasvir); HARVONI® (ledipasvir/sofosbuvir); VIEKIRA PAK™ or VIEKIRA XR™ (dasabuvir/ombitasvir/paritaprevir/ritonavir); TECHNIVIE™ (ombitasvir/paritaprevir/ritonavir); ZEPATIER® (elbasvir/grazoprevir); or DAKLINZA™ (daclatasvir).

VOSEVI is also indicated for chronic hepatitis C infection with genotype 1a or 3 and previous treatment with a regimen containing SOVALDI® (sofosbuvir) without an NS5A inhibitor.

To learn more about Diplomat's hepatitis program, visit diplomat.is/areas-of-excellence/hepatitis.

VOSEVI is a fixed-dose, combination tablet administered once-daily with food for 12 weeks. It contains sofosbuvir and velpatasvir­, as well as the newly approved voxilaprevir.

"Diplomat is proud to expand its therapy offerings to patients who have been diagnosed with chronic hepatitis C," said Paul Urick, president of Diplomat. "Providing an opportunity to treat patients who have failed current treatment options, this combination tablet is a valuable addition to our product offering."

More than 2.7 million Americans have hepatitis C, according to the Centers for Disease Control and Prevention. Hepatitis C infection becomes chronic in approximately 75–85 percent of cases. Unlike many serious diseases, hepatitis C can be cured with treatment.

Hepatitis C causes liver inflammation. Some people with chronic hepatitis C infection develop cirrhosis, in which liver tissue is replaced by scar tissue, eventually preventing the liver from functioning properly.

VOSEVI is manufactured by Gilead Sciences, Inc. For full prescribing information, click here.

Hepatitis C Virus in Children: The Global Picture Archives of Disease in Childhood, July 26, 2017

Hepatitis C Virus in Children: The Global Picture

Tuesday, July 25, 2017

July Hepatitis Updates: Research and News From Around The Web

Hepatitis Updates: Research and News From Around The Web
Welcome to a mix of research, blog updates and news about hepatitis C you may have missed over the last week. Click here for previous updates. 

New Online
IDSA, AASLD critical of Cochrane review of HCV drugs
July 26, 2017
The IDSA and AASLD wrote a joint response, which was published in Clinical Infectious Diseases, to the Cochrane review that concluded that direct-acting antiviral (DAA) drugs have not been shown to reduce risks for HCV-related morbidity or all-cause mortality. The review also claimed that prior trials have underestimated DAA adverse effects.
Continue reading....

On This Blog
In July Newsletters - Rebuttal over Cochrane Review of DAAs
View each rebuttal and all ongoing media coverage. In June the HCV community was blindsided when an article with a somewhat "clickbait" headline was released by The Guardian. The Guardian reported on a systematic review published by the Cochrane Collaboration that suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits.

Modelling cost-effectiveness and health gains of a "universal" vs. "prioritized" HCV treatment policy in a real-life cohort.
Kondili LA, et al. Hepatology. 2017.
View Article
Accepted manuscript online:
PDF Download
Follow On Twitter
PDF Provided By @HenryEChang
Abstract
We evaluated the cost-effectiveness of two alternative DAA treatment policies in a real-life cohort of HCV-infected patients: Policy 1 - "universal": treat all patients, regardless of the fibrosis stage; Policy 2 - treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and healthcare system perspective, was applied to the PITER cohort (representative of Italian HCV-infected patients in care). Specifically, 8,125 patients naïve to DAA treatment, without clinical, sociodemographic or insurance restrictions was used to evaluate the policies' cost-effectiveness. The patients' age, fibrosis stage, assumed DAA treatment cost of €15,000/patient and the Italian liver disease costs were used to evaluate Quality-Adjusted Life-Years (QALY) This article is protected by copyright. All rights reserved.

New Zealand steamrolls Australia on the pharmaceutical paddock too
MENAFN Press - 25/07/2017
The Pharmaceutical Benefits Scheme (PBS), once a reasonably efficient beast which cost taxpayers 6.5 billion a year, is likely to surpass 11 billion this year. Most of it goes to Big Pharma, but just how much is hard to tell.
Continue reading...

Male hepatitis B patients suffer worse liver ailments, regardless of lifestyle
Why men with hepatitis B remain more than twice as likely to develop severe liver disease than women remains a mystery, even after a study led by a recent Drexel University graduate took lifestyle choices and environments into account.
Continue reading...

Hepatitis C Treatment Is Safe, Effective in Some CHC Patients
July 25, 2017
Treatment of hepatitis C virus (HCV) infection is safe and effective in patients with chronic HCV with or without human immunodeficiency virus (HIV) across sub-Saharan Africa, according to a recent study.
Continue reading...

Association between complicated liver cirrhosis and the risk of hepatocellular carcinoma in Taiwan
plos.org
Published: July 24, 2017
https://doi.org/10.1371/journal.pone.0181858
Hepatocellular carcinoma (HCC) represents 70%-85% of primary liver malignancies [1,2]. With abdominal sonography, we can screen for HCC and perform surveillance to detect and treat tumors in the early stages. It is well known that most cases of HCC are associated with cirrhosis regardless of the etiology [38]. The 5-year cumulative risk of developing HCC for patients with cirrhosis ranges between 5% and 30% [3, 4]. The mortality of patients with cirrhosis with cirrhosis-related complications is high and many of them die before they develop HCC [911]. However, it has not been reported whether the complications of cirrhosis are associated with the development of HCC. It is interesting and noteworthy to better understand the association between the two by using competing risk analysis model appropriately. It is well known that male patients have a higher risk of HCC than female patients do, and the risk of cirrhosis is also higher in male patients [1215]. Since cirrhosis is the most important risk factor of HCC, it will be interesting to know the difference in the incidence of HCC between the sexes in patients with cirrhosis, especially in those with complications.

This population-based cohort study aimed to explore the association between complicated cirrhosis and HCC, and identify the risk factors of HCC in patients with complicated cirrhosis.
View full text article....

Mediterranean diet linked to lower risk for gallbladder removal surgery

July 25, 2017
New data has revealed a link between high adherence to a Mediterranean diet, rich in fruits, vegetables, legumes and olive oil, and a lower risk for…
Continue reading....

Of Interest Thursday, June 29, 2017
Liver cirrhosis: a risk factor for gallstone disease in chronic hepatitis C patients in China

Changing trends in complications of chronic hepatitis C
Mei Lu, Jia Li, Loralee B. Rupp, Yueren Zhou, Scott D. Holmberg, Anne C. Moorman, Philip R. Spradling, Eyasu H. Teshale, Joseph A. Boscarino, Yihe G. Daida, Mark A. Schmidt, Sheri Trudeau and Stuart C. Gordon
Although cirrhosis and mortality among HCV-infected patients in the US have increased over the past decade, all-cause mortality has decreased in recent years
Version of Record online: 21 JUL 2017 | DOI: 10.1111/liv.13501
Continue reading....

The ethics, cost, & evidence surrounding current pharmacological treatment of HCV infection.
Patients and their caregivers are wedged between big ‘‘pharma’’ and government with regard to drug pricing and access. When will the taxpayer contributions that helped fund research for lifesaving therapies be quantified and acknowledged and used as a basis for decision making regarding drug access? How much profit is enough? How much of rationing is an excuse to distribute therapy based on merit of life?
Download PDF

The above link is provided by Henry E. Chang via Twitter.
If you are interested in reading full text articles about the treatment and management of hepatitis C I highly suggest you follow Henry E. Chang.

The New York Times
The Tasmanian Hep C Buyers’ Club
Sophie Cousins
An innovative Australian takes a cue from early AIDS fighters to distribute generic new drugs that treat another potential killer, hepatitis C.
Continue Reading .......

Vosevi - Frequently Asked Questions & Gilead's My Support Path® VOSEVI Program
These frequently asked questions will help you understand what Vosevi is, how it works, and help you decide if it is the right medication for you.
Continue reading....

The Financial Case for Action on Liver Disease
The Lancet Commission into Liver Disease in the UK
In this paper the Foundation for Liver Research seeks to make the financial case for concerted preventative action through public health measures to tackle the 3 main causes of liver disease: alcohol misuse, obesity and viral hepatitis. The paper summarises the escalating financial costs to the health and care system as well as the wider societal costs related to the 3 lifestyle-related factors.

Download Report

Most Individuals With Advanced Cirrhosis Have Sleep Disturbances, Which Are Associated With Poor Quality of Life
Marwan Ghabril , Mollie Jackson, Raghavender Gotur, Regina Weber, Eric Orman, Raj Vuppalanchi, Naga ChalasaniIn summary, we describe a high prevalence of disturbed sleep in patients with cirrhosis at a large transplant center. Disturbed sleep was predicted by muscle cramps, which is an important although poorly understood complication of end-stage liver disease. Disturbed sleep in this population appears to be multifactorial in etiology and may be associated with neurocognitive dysfunction. Disturbed sleep is strongly associated with decreased quality of life, and its severity may be meaningfully categorized on the basis of PSQI. Further studies to elucidate the pathogenesis and therapies for disturbed sleep in patients with cirrhosis are needed in the face of this significant and unmet need.
Full Text Article
Download PDF
View Article Online

Blog Updates Around The Web

World Hepatitis Alliance
http://www.worldhepatitisalliance.org/
We are an ambitious patient-led and patient-driven not-for-profit organisation who work with governments, national members and other key partners to raise awareness of viral hepatitis and influence global change – transforming the lives of the 325 million people living with viral hepatitis and the future we share.

World Hepatitis Day: an annual day with the power to change millions of lives
Raquel Peck
CEO at World Hepatitis Alliance
28 July 2017 marks the 10th World Hepatitis Day: a day that remains the single most important date in the year to give people living with viral hepatitis a voice, raise awareness and advocate for the elimination of the disease.
Continue reading....
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Médecins Sans Frontières/ Doctors Without Borders (MSF)
Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organisation. We offer assistance to people based on need, irrespective of race, religion, gender or political affiliation. Our actions are guided by medical ethics and the principles of neutrality and impartiality.

Fighting Hepatitis in Cambodia: Hep C 101
Medical Doctor  - Theresa Chan in Cambodia
20 July 2017
A lot of our patients have known they were infected with chronic hepatitis C for a long time, sometimes for decades. For all of these years, they have assumed there would be no chance of cure, and have wondered how many years of their lives would be cut short by the disease. This is why it’s a happy job to work at MSF’s hepatitis C clinic. We give out a lot of good news and we deliver hope.
Continue reading....
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Weekly Bull
HepCBC is a non-profit organization run by and for people infected and affected by hepatitis C. Our mission is to provide education, prevention and support to those living with HCV.

Latest Issue: Weekly Bull
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HEP - Blog Updates
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and Hep Magazine are the go-to source for educational and social support for people living with hepatitis.

World Hepatitis Day and Vosevi
July 24, 2017
By Lucinda K. Porter, RN
I want to write about two topics this week—the newest approved hepatitis C drug (Vosevi) and World Hepatitis Day.

Hepatitis C and Supplements
Lucinda K. Porter, RN
Hepatitis C and supplements might not be a good mix, as supplements can injure the liver.

Of Interest 
Study Finds 275,000 Calls to Poison Control Centers for Dietary Supplement Exposures from 2000 through 2012

To view a list of all bloggers please click here.
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HEPATITISC.NET
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals

Truth and Consequences
By Daryl Luster - July 25, 2017
Having spoken about truth in an earlier piece, I dug into how it is a subjective thing with differing versions of truth that we believe, what I personally believe may vary dramatically...

Life’s Got A Rhythm, May As Well Dance To It 
By Rick Nash - July 24, 2017
In May of 2016 I was slotted to start Epclusa pending a blood test. While I had pushed my doctor to do an off-label Harvoni then Zepatier, Epclusa was about to be...

Messy Mouth with Hepatitis C
By Karen Hoyt -
July 20, 2017
This may sound disgusting, but when I was on treatment, there were times when my mouth was a mess. Not only were my teeth causing decay that required dental work, my mouth...

View all blog updates, here.
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The National Viral Hepatitis Roundtable NVHR
The National Viral Hepatitis Roundtable is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance.

What Are Hepatitis C Patients Experiencing in 2017?
This webinar is now archived.
Click here for the slides. Click here for the recording. (Click the link and then enter name and email address to view the webinar)
Please join us for a webinar on July 20, 2017 about what hepatitis C patients are experiencing in 2017. The webinar will feature three individuals who work with hepatitis C patients every day. They will share their perspective and knowledge of what patients are really grappling with currently. Presentations will be followed by question and answer and discussion.
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HIV and ID Observations
NEJM Journal Watch - An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.

Mystifying Cochrane Library Review on HCV Therapy Elicits Strong Response from IDSA
Paul E. Sax, MD
July 19th, 2017
Last month, The Cochrane Review published a controversial paper on HCV therapy that left many ID doctors and hepatologists rather perplexed.
After reviewing 138 randomized clinical trials using directly acting, non-interferon based therapies, they came to the following conclusions:
  • The use of sustained virologic response (“SVR”) — or “cure”, if you want to use plain English — as a valid endpoint for clinical outcomes is questionable.
  • There is insufficient evidence that treatment with DAA-based regimens improves clinical outcome.
  • The studies reviewed were at high risk of bias, so tended to overestimate benefits and minimize harm.
  • More randomized clinical trials are needed.
Anyone — clinician, researcher, or patient — who has experienced the miraculous advances in HCV therapy that started in 2014 could easily be scratching their heads at these conclusions.
The FDA might be surprised as well, since they have allowed permanent clearance of HCV RNA as an appropriate surrogate marker of the effectiveness of HCV therapy.
Fortunately, we now have a focused, persuasive response by the IDSA, just published in Clinical Infectious Diseases; Download PDF here....
Continue reading.......

Of Interest

REFILE-Treating HCV may improve glycemic control in diabetics
Last Updated: 2017-07-20
(Corrects affiliation in paragraph 2 to University of Washington, Seattle)

By Marilynn Larkin
NEW YORK (Reuters Health) - Treating hepatitis C virus (HCV) infection with direct-acting antiviral (DAA) agents is associated with improved glycemic control in patients with type 2 diabetes, researchers suggest.

HCV infection increases the risk of diabetes in individuals with metabolic syndrome, and may worsen glycemic control in those with diabetes, according to Dr. George Ioannou of the University of Washington, Seattle, and colleagues. To see whether clearing the virus with DAAs has an impact, the team reviewed data from 2,435 patients with diabetes (97% men, mean age 62, about 40% white/40% black) who underwent DAA-based antiviral treatment (no interferon or ribavirin) for HCV in the U.S. Veterans Affairs health care system in 2014 and 2015.

The team compared changes in average hemoglobin A1c (HbA1c) levels and use of antidiabetic medications the year before and after antiviral treatment between patients who achieved a sustained virologic response (SVR) - defined as a viral load below the lower limit of quantification 12 weeks or more after the end of treatment - and those who did not.

Almost all (99%) participants had genotype 1 HCV, and were treated with LDV/SOF (ledipasvir/sofosbuvir; 56.2%) or SMV (simeprevir) plus SOF (38.3%).

As reported online June 28 in Diabetes Care, 2,180 patients achieved an SVR and 255 did not.

Compared with those whose HCV treatment failed, patients who achieved an SVR were less likely at baseline to have cirrhosis (35.3% versus 54.5%) and decompensated cirrhosis (9.3% versus 20%).

They were also less likely to be taking antidiabetic medications (74.8% versus 78.0%) or insulin (41.3% versus 49.8%).

Among those with elevated baseline HbA1c, DAA treatment was associated with a greater HbA1c reduction in patients who achieved SVR (0.98%) than in those who did not (0.65%; adjusted mean difference 0.34, P = 0.02).

Use of antidiabetic medications decreased more in patients who achieved SVR than in those who did not, especially insulin use, which dropped significantly to 38% in patients achieving SVR compared with a slight increase to 51% in those who sustained treatment failure.

Comparing the pre- and post-treatment periods, weight increased slightly more in patients with an SVR than in those whose treatment failed. Hemoglobin concentrations decreased significantly more in patients whose treatment failed than in those who achieved an SVR.

Serum creatinine levels increased slightly and similarly in patients who did and did not achieve an SVR.

After adjusting for changes in weight, hemoglobin concentrations, and creatinine, the associations between SVR and an HbA1c drop or antidiabetic medication use remained essentially unchanged.

Summing up, Dr. Ioannou told Reuters Health by email, "After treatment of HCV with DAAs in diabetic patients, there appeared to be an improvement in glycemic control as demonstrated by decreased HbA1c levels and decreased number of insulin prescriptions. I believe our study does suggest an endocrine benefit to viral eradication and thus could be an additional compelling reason to treat chronic hepatitis C in diabetic patients."

Dr. Valentina Rodriguez, an endocrinologist at NYU Langone Medical Center in New York City, told Reuters Health, "It is exciting to have new data which not only confirms the previously studied association between type 2 diabetes and HCV, but also demonstrates beneficial effects of newer DAAs on improvement in A1C and reduction in insulin requirements."

The researchers did "a good job" of controlling for confounders such as weight loss, which might have accounted for the glycemic control benefits seen with interferon, she noted by email.

"Importantly," she added, "the study also accounted for other variables that could have falsely lowered/raised hemoglobin A1C testing in patients with treated/untreated HCV, including anemia and chronic kidney disease. This makes the interpretation of improved glycemic control more reliable."

"Some caveats we should keep in mind are the follow-up time for this study; though it is encouraging that insulin requirements and A1C decreased in the first 15 months post-therapy, longer term data with regards to micro/macrovascular complications (are) unavailable," Dr. Rodriguez continued.

"Also, not all HCV genotypes were studied; patients with HCV genotypes 2 and 3 were not included, possibly because they have been shown to be notably less cost-effective to treat with DAA therapy than the genotype 1 patients," she observed.

"The practical implementation of newer, more expensive drugs such as DAAs can be challenging," she acknowledged. "However, when considering that the price of insulin has increased by over 200% over the last four years, we must readdress the cost effectiveness of these drugs for patients with both type-2 diabetes and HCV."

Dr. Rodriguez concluded, "Future studies with longer follow up times will be helpful in establishing whether treatment of HCV with DAAs will also lead to decreased cardiovascular events and other diabetes-related deaths, which would impact healthcare spending even more significantly."

SOURCE: http://bit.ly/2tHimJ4

Diabetes Care 2017.

Thanks for stopping by!
Tina

The Tasmanian Hep C Buyers’ Club

The New York Times
The Tasmanian Hep C Buyers’ Club

Jefferys, a tall man with a thick silver mustache and beard, knew Gilead Sciences had developed a better option: a highly tolerable 12-week oral treatment with high cure rates, called sofosbuvir and sold under the brand name Sovaldi.

While the drug had been approved in the United States and Europe, it wasn’t yet approved in Australia. And in the United States, the retail price was $1,000 per daily pill — $84,000 in total.
But Jefferys also read that in late 2014, Gilead issued India a voluntary license to allow the manufacture of generic versions of sofosbuvir...

Continue Reading .......

Related On This Blog 
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"  

Watch Action Hepatitis Canada - Why We Need a National Strategy for Hepatitis C




Published on Jul 24, 2017
Action Hepatitis Canada

Eisai Submits Applications In U.S. (FDA) And Europe (EMA) For Lenvatinib In Hepatocellular Carcinoma

Eisai Submits Simultaneous Applications In The United States And Europe For Lenvatinib In Hepatocellular Carcinoma


Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced that it has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its in-house discovered and developed anticancer agent lenvatinib mesylate (lenvatinib) for the treatment of hepatocellular carcinoma (HCC). This follows the application in Japan. Lenvatinib for the treatment of HCC is designated as an orphan drug by the FDA.

This application is based on the results of the REFLECT study (Study 304), a multicenter, open-label, randomized, global Phase III trial comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for HCC, as a first-line treatment for 954 patients with unresectable HCC.*1

In the REFLECT study, lenvatinib met the primary endpoint and demonstrated an overall survival (OS) treatment effect by the statistical confirmation of non-inferiority compared to sorafenib. Developing first-line treatments for HCC is challenging, and over the past 10 years, four previous first-line Phase III studies investigating other agents compared to sorafenib have failed to achieve this endpoint in OS.*2

Additionally, lenvatinib showed highly statistically significant and clinically meaningful improvements in the secondary endpoints of Progression Free Survival (PFS), Time To Progression (TTP), and Objective Response Rate (ORR). In this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib.

Liver cancer is the second leading cause of cancer related death and is estimated to be responsible for 750,000 deaths per year globally (27,000 per year in the US, 62,000 per year in Europe), with 780,000 cases newly diagnosed each year (30,000 per year in the US, 63,000 per year in Europe).*3 HCC accounts for 85% to 90% of liver cancer cases. Treatment options for unresectable HCC are limited and the prognosis is very poor, making this an area of high unmet medical need.

Lenvatinib is approved as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, and in Europe, under the brand name Lenvima(R). Additionally, lenvatinib in combination with everolimus is approved for the treatment of renal cell carcinoma (RCC) in over 35 countries, including the United States and in Europe. In Europe, lenvatinib was launched under the brand name Kisplyx(R) for RCC.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is committed to exploring the potential clinical benefits of lenvatinib as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to patients with cancer, their families, and healthcare providers.

1. About lenvatinib mesylate (generic name, “lenvatinib”, product name: Lenvima® / Kisplyx®)

Discovered and developed in-house, lenvatinib is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other proangiogenic and oncogenic pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRα; KIT; and RET) involved in tumor proliferation.

Currently, Eisai has obtained approval for lenvatinib as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, and in Europe, under the brand name Lenvima®. Additionally, Eisai has obtained approval for the agent in combination with everolimus as a treatment for renal cell carcinoma (second-line) in over 35 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx® for RCC.

A Phase III study of lenvatinib in separate combinations with everolimus and pembrolizumab in renal cell carcinoma (first-line) was initiated and is underway. A Phase Ib/II study to investigate the agent in combination with pembrolizumab in select solid tumors (non-small cell lung cancer, renal cell carcinoma, endometrial cancer, urothelial cancer, head and neck cancer, and melanoma) and a Phase Ib study in HCC are also underway. Following the submission of applications in Japan (June 2017), the United States and Europe (July 2017), Eisai also plans to submit an application for lenvatinib for the treatment of HCC in China within the latter half of fiscal 2017.

2. About the RELECT study (Study 304) 1

The REFLECT study (A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable HCC) is a multicenter, open-label, randomized, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib. In the study, 954 patients were randomized in a 1:1 ratio to receive lenvatinib 12 mg (≥60 kg) or 8 mg (<60 kg) once a day, depending on baseline body weight (n= 478) or sorafenib 400 mg twice a day (n= 476). Treatment was continued until disease progression or unacceptable toxicity.

The primary endpoint of the study was Overall Survival (OS), with the goal of demonstrating non-inferiority. Other factors including Progression Free Survival (PFS), Time To Progression (TTP), Objective Response Rate (ORR) and Quality of Life (QOL) were assessed as secondary endpoints.

According to the results of the study, lenvatinib (13.6 months) met the statistical criteria for non-inferiority in the primary endpoint of median OS compared to sorafenib (12.3 months). (Hazard Ratio [HR] 0.92, 95% Confidence Interval [CI] = 0.79-1.06)

Additionally, lenvatinib showed statistically significant improvements in the three secondary efficacy endpoints, doubling sorafenib's median values and ratios: median PFS (lenvatinib 7.4 months versus sorafenib 3.7 months, HR 0.66, 95% CI = 0.57-0.77, P<0.00001), median TTP (lenvatinib 8.9 months versus sorafenib 3.7 months, HR 0.63, 95% CI = 0.53-0.73, P<0.00001) and ORR (lenvatinib 24% versus sorafenib 9%, P<0.00001).

Furthermore, EORTC QLQ-C30 and QLQ-HCC18 questionnaires were used to evaluate overall QOL. In both groups, scores decreased after the administration of the agents. However, within 3 categories in EORTC QLQ-C30 (role functioning, pain, diarrhea) and two categories in QLQ-HCC18 (nutrition, body image), it was found that Lenvatinib helped to delay deterioration of QOL compared to sorafenib (nominal P-value < 0.05)

In this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib.

3. About Hepatocellular Carcinoma (HCC)

Liver cancer is the second-leading cause of cancer death, estimated to be responsible for 750,000 deaths per year globally. Additionally, 780,000 cases are newly diagnosed each year. 3 There is a large regional difference, with about 80% of new cases occurring in Asian regions, including China and Japan. HCC accounts for 85% to 90% of liver cancer. HCC is associated with chronic liver disease, in particular cirrhosis. Major causes of cirrhosis include hepatitis B virus and hepatitis C virus. However, according to a recent investigation, non-B/non-C HCC is on the rise. Surgery is the first option for treatment, but patients with unresectable HCC who are not amenable for potentially curative therapeutic interventions, which include liver transplant, surgical resection, tumor ablation (typically radiofrequency ablation or cryotherapy), or who are not suitable for transarterial chemoembolization (TACE), are difficult to treat with a poor prognosis. Additionally, there is currently only one approved systemic therapy for frontline treatment of these patients, underscoring a great unmet medical need.

*1 Cheng A et al. "Phase 3 trial of lenvatinib vs sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma", the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), (June 2017), Abstract No: 4001
*2 Llovet JM and Hernandez-Gea V. Hepatocellular carcinoma: Reasons for Phase III failure and novel perspectives on trial design. Clin Cancer Res. 2014;20(8):2072-2079.
*3 GLOBOCAN2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. http://globocan.iarc.fr/

NSW Podcast - Australia Hepatitis B and Hepatitis C

Sydney Sexual Health Centre

Welcome to the third episode of the new Sydney Sexual Health Centre podcast! This episode ties into Hepatitis Awareness Week, which is held at the end of July and incorporates World Hepatitis Day on July 28th. Two campaigns will run throughout July in the lead up to Hepatitis Awareness Week and World Hepatitis Day.

We talk to Stuart Loveday from Hepatitis NSW about hepatitis B and hepatitis C, as well as the state-wide hepatitis B and hepatitis C awareness campaigns.



More on the hepatitis B campaign: www.hepB.org.au
More on the hepatitis C campaign: www.hepC.org.au
More on Hepatitis NSW: www.hep.org.au
More on Sydney Sexual Health Centre: www.sshc.org.au

Most Individuals With Advanced Cirrhosis Have Sleep Disturbances, Which Are Associated With Poor Quality of Life

Clinical Gastroenterology and Hepatology
August 2017 Volume 15, Issue 8, Pages 1271–1278.e6

Most Individuals With Advanced Cirrhosis Have Sleep Disturbances, Which Are Associated With Poor Quality of Life
Marwan Ghabril , Mollie Jackson, Raghavender Gotur, Regina Weber, Eric Orman, Raj Vuppalanchi, Naga Chalasani
In summary, we describe a high prevalence of disturbed sleep in patients with cirrhosis at a large transplant center. Disturbed sleep was predicted by muscle cramps, which is an important although poorly understood complication of end-stage liver disease. Disturbed sleep in this population appears to be multifactorial in etiology and may be associated with neurocognitive dysfunction. Disturbed sleep is strongly associated with decreased quality of life, and its severity may be meaningfully categorized on the basis of PSQI. Further studies to elucidate the pathogenesis and therapies for disturbed sleep in patients with cirrhosis are needed in the face of this significant and unmet need.
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Abstract
Background & Aims
Sleep disturbances are common in patients with cirrhosis, but their determinants and effects on health-related quality of life are not well-understood. We investigated the prevalence of disturbed sleep in these patients, factors associated with sleep disruption, and effects on quality of life.

Methods
We performed a prospective, cross-sectional study of 193 stable ambulatory patients with cirrhosis (154 with decompensated cirrhosis). Participants completed the Pittsburgh Sleep Quality Index (to assess sleep quality), the Chronic Liver Disease Questionnaire (CLDQ), and muscle cramp questionnaires and underwent neurocognitive testing. Actigraphy was performed in a subset of patients with normal and disturbed sleep. We collected serum samples from subjects with normal and disturbed sleep and performed non-targeted metabolomic analyses.

Results
Of the study subjects, 157 (81%) had disturbed sleep, with Pittsburgh Sleep Quality Index scores >5. Disturbed sleep was associated with muscle cramps, daytime somnolence, and decreased quality of life on the basis of CLDQ scores. Factors independently associated with disturbed sleep in logistic regression analysis included hypoalbuminemia, opiate therapy, and muscle cramps. Disturbed sleep was independently associated with CLDQ score (correlation parameter, –36.6; 95% confidence interval, –24 to –49; P < .001) on linear regression. Disturbed sleep was associated with neurocognitive impairment and with significantly delayed bedtime and decreased total sleep time, measured by actigraphy. Disturbed sleep was associated with metabolome signatures of alterations to the intestinal microbiome and lipid, arginine, and urea cycle metabolism.

Conclusions
Most patients with advanced cirrhosis (81%) have disturbed sleep. This has negative effects on quality of life and is associated with disruptions of several metabolic pathways, including metabolism by the intestinal microbiota.

Princeton researchers report new system to study chronic hepatitis B

Princeton researchers report new system to study chronic hepatitis B
Princeton University

Scientists from Princeton University's Department of Molecular Biology have successfully tested a cell-culture system that will allow researchers to perform laboratory-based studies of long-term hepatitis B virus (HBV) infections. The technique, which is described in a paper published July 25 in the journal Nature Communications, will aid the study of viral persistence and accelerate the development of antiviral drugs to cure chronic hepatitis B, a condition that affects over 250 million people worldwide and can cause severe liver disease, including liver cancer.

HBV specifically infects the liver by binding to a protein called sodium-taurocholate co-transporting polypeptide (NTCP) that is only present on the surface of liver cells. Once inside the cell, HBV hijacks its host's cellular machinery to convert the virus's DNA into a stable "mini-chromosome." This allows the virus to establish persistent, long-term infections that can ultimately cause liver fibrosis, cirrhosis and hepatocellular carcinoma. The World Health Organization estimates that 600,000 people die every year as a result of HBV infection.

Researchers have so far failed to develop drugs that can cure chronic HBV infections, partly because they have not been able to study the long-term infection of liver cells grown in the laboratory. Liver cells--also known as hepatocytes--lose their function within days of being isolated from donor livers, preventing researchers from studying anything other than the acute stage of HBV infection. Hepatocytes can be maintained for longer when they are co-cultured with other, supportive cells.

"In previous studies using hepatocytes and cells known as fibroblasts grown on micro-patterned surfaces, HBV infections worked with only a few donors, and infection lasted for no longer than 14-19 days and required the suppression of antiviral cell signaling pathways, which poses problems for studying host-cell responses to HBV and for antiviral drug testing," said Alexander Ploss, an assistant professor of molecular biology at Princeton University.

Dr. Ploss and colleagues at Princeton and the Hurel Corporation, led by graduate student Benjamin Winer, tested a different system, in which primary human hepatocytes are co-cultured with non-parenchymal stromal cells, which are cells that support the function of the parenchymal hepatocytes in the liver. When plated in collagen-coated labware, the co-cultures self-assemble into liver-like structures. These self-assembling liver-like cultures could be persistently infected with HBV for over 30 days, without the aid of antiviral signaling inhibitors. Moreover, the system worked with hepatocytes grown from a variety of donors and with viruses isolated from chronically-infected patients, which are harder to work with than lab-grown strains of HBV.

"The establishment of a co-culturing system of human primary hepatocytes and non-parenchymal stromal cells for extended HBV infection is a valuable addition to the armamentarium of cell culture model systems for the study of HBV biology and therapeutic development, which has been hampered by a relative lack of efficient infectious cell culture systems," said T. Jake Liang, a senior investigator at the National Institute of Diabetes and Digestive and Kidney Diseases, who was not involved in the research.

Ploss and colleagues were able to scale down their co-culture infections to volumes as small as a few hundred microliters. This will be important for future high-throughput screens for anti-HBV drug candidates. As a proof-of-principle for these screens, the researchers found that they could block HBV infections in their co-culture system using drugs that either prevent the virus' entry into hepatocytes or inhibit a viral enzyme that is essential for the virus' replication. "The platform presented here may aid the identification and testing of novel therapeutic regimens," Ploss said.

This study is supported in part by grants from the National Institutes of Health (R21AI117213 to Alexander Ploss and R37GM086868 to Tom W. Muir), a Burroughs Wellcome Fund Award for Investigators in Pathogenesis (to Alexander Ploss) and funds from Princeton University (to Alexander Ploss). Benjamin Y. Winer is a recipient of F31 NIH/NRSA Ruth L. Kirschstein Predoctoral awarded from the National Institute of Allergy and Infectious Diseases. Felix Wojcik is supported by a German Research Foundation (DFG) postdoctoral fellowship.

The study, "Long-term hepatitis B infection in a scalable hepatic co-culture system," by Benjamin Y. Winer, Tiffany S. Huang, Eitan Pludwinski, Brigitte Heller, Felix Wojcik, Gabriel E. Lipkowitz, Amit Parekh, Cheul Cho, Anil Shrirao, Tom W. Muir, Eric Novik, Alexander Ploss, was published in Nature Communications on July 25, 2017.

Monday, July 24, 2017

Stopping cholesterol-lowering drugs could be deadly

Stopping cholesterol-lowering drugs could be deadly
Andrew M. Seaman
(Reuters Health) - Stopping a cholesterol-lowering drug because of a muscle ache or stomach pain can be dangerous in the long run, suggests a new study.

Researchers found that people who stopped taking statins after reporting a side effect were 13 percent more likely to die or have a heart attack or stroke over the next four years than people who kept taking the drugs.

Statins include the drugs atorvastatin, known commercially as Lipitor; rosuvastatin, also known as Crestor, and simvastatin, or Zocor.

They work by inhibiting the liver's ability to produce cholesterol while also helping the organ remove existing fats in the blood, according to the U.S. Centers for Disease Control and Prevention.
Continue reading @ Reuters Health

Recommended Reading
Michael Carter / 18 April 2017
Treatment with statins reduces the risk of decompensated liver disease for people with cirrhosis caused by hepatitis B virus (HBV) and hepatitis C virus (HCV), investigators from Taiwan report in the online edition
Continue reading.....

Study Finds 275,000 Calls to Poison Control Centers for Dietary Supplement Exposures from 2000 through 2012

Study Finds 275,000 Calls to Poison Control Centers for Dietary Supplement Exposures from 2000 through 2012

Researchers calling for FDA regulation of yohimbe and energy products

Columbus, OH - 7/24/2017
U.S. Poison Control Centers receive a call every 24 minutes, on average, regarding dietary supplement exposures, according to a new study from the Center for Injury Research and Policy and the Central Ohio Poison Center, both at Nationwide Children’s Hospital.

The study, published online today in the Journal of Medical Toxicology, found the rate of calls regarding dietary supplement exposures increased (46.1%) during 2000 to 2002, decreased (8.8%) during 2002 to 2005 and increased again (49.3%) from 2005 to 2012. The decrease from 2002 to 2005 most likely resulted from the U.S. Food and Drug Administration’s (FDA) ban of the botanical stimulant ma huang previously found in some dietary supplements.

Seventy percent of dietary supplement exposure calls occurred among children younger than six years old and the majority of these were unintentional. Most exposures (97.3%) occurred at home, and in more than 97 percent of the cases, the child swallowed the substance. Serious medical outcomes accounted for 4.5 percent of exposures and the most serious outcomes (95%) occurred among children six years and older.

“Many consumers believe dietary supplements are held to the same safety and efficacy standards as over-the-counter medications,” said Gary Smith, MD, DrPH, senior author of the study and director of the Center of Injury Research and Policy at Nationwide Children’s. “However, dietary supplements are not considered drugs, thus they are not required to undergo clinical trials or obtain approval from the FDA prior to sale, unless the product is labeled as intended for therapeutic use.”

Miscellaneous substances found in commonly used dietary supplements accounted for the majority of exposure calls (43.9%). Other substances involved in exposures included botanicals (31.9%), hormonal products (15.1%), and other supplements (5.1%). Amino acids, cultural medicines and energy products each account for less than (2%) of exposures.

The dietary supplements with the highest proportion of serious medical outcomes were energy products, botanical and cultural medicines. Within the botanical category, yohimbe accounted for the largest proportion of serious medical outcomes (28.2%).

Nearly 30 percent of yohimbe exposure calls resulted in moderate or major effects. Yohimbe can cause heart beat rhythm changes, kidney failure, seizures, heart attack, and death.

Energy products, including drinks, advertised to increase energy and mental performance, can cause bad clinical effects as well. Many energy product exposures were unintentional and occurred among young children, causing heart and breathing problems, seizures, and other clinical problems. Findings support the need for improved energy product regulation, child-resistant packaging, and caregiver information, according to the study authors.
Nationwide Children's Hospital

Abstract

The Financial Case for Action on Liver Disease - Escalating costs of alcohol misuse, obesity and viral hepatitis JULY 2017

The Foundation for Liver Research

Monday 17th July 2017
The Lancet Commission into Liver Disease in the UK has today published 'The Financial Case for Action on Liver Disease'

In this paper the Foundation for Liver Research seeks to make the financial case for concerted preventative action through public health measures to tackle the 3 main causes of liver disease: alcohol misuse, obesity and viral hepatitis. The paper summarises the escalating financial costs to the health and care system as well as the wider societal costs related to the 3 lifestyle-related factors.






Hepatitis C: The public-health worry lurking behind the opioid epidemic

Hepatitis C: The public-health worry lurking behind the opioid epidemic
Julianne Stanford

The National Institute on Drug Abuse estimates that every drug user infected with a blood-borne disease like hepatitis C is likely to infect at least 20 others through shared needles or contact with infected blood. Coles said she believes at least a third of the people who use her organization's services are infected with hepatitis C.

Nonetheless, state health officials are focused on immediate problems caused by the opioid crisis, rather than things that could be problematic down the road.

“We’re certainly looking at the big picture, but ... our focus is just on the opioid epidemic as it is, which is focusing on saving lives,” said Sheila Sjolander, ADHS assistant director of public health prevention services. "We’re really focused on preventing further deaths by expanding access to Naloxone, helping prescribers do best practices with opioid prescriptions and working with our partners to expand access to treatment.”

First patient treated in trial of a novel liver dialysis device, DIALIVE

First patient treated in trial of a novel liver dialysis device, DIALIVE
European Association for the Study of the Liver

The first patient in an international trial of a new liver dialysis system has been recruited at the Royal Free Hospital in London. The device, called DIALIVE, was invented by scientists and doctors at University College London and Royal Free London NHS Foundation Trust. The principles behind DIALIVE are based on recent advances in the understanding of the mechanisms underlying liver failure, a condition that affects about 200,000-300,000 people every year across Europe. ii This patient group treated in the trial has a greater than 25% likelihood of death within a 28-day period if they do not undergo a liver transplant.

Twenty-four patients will be included in this first trial, which is aimed at establishing DIALIVE's safety and performance. It is being conducted at seven centers across Europe: London, Birmingham, Nottingham, and Edinburgh in the UK, Rostock in Germany, Paris, France, and Madrid, Spain. A second trial that plans to enroll more than 100 patients across Europe is already being designed. That study is scheduled to begin in 2018 and will include patients at another 18 widely distributed European referral hospitals for liver diseases that are part of the European Foundation for the Study of Chronic Liver Failure (EF-Clif) consortium of hospitals.

"Many patients with liver failure are relatively well until the time they present to the hospital": said Professor Rajiv Jalan, the Coordinator of the ALIVER project and an inventor of DIALIVE at UCL. "Within a matter of 28-days, about 25% of these patients will die with multi organ failure. Given the huge regeneration potential of the liver, many can recover," he said. "DIALIVE removes toxins that accumulate in liver failure to prevent inflammation. It has the potential to allow the liver to regenerate."

Prof Jalan added: "The Horizon 2020 EU grant and the collaboration with the leaders in the field will allow us to further develop DIALIVE for benefit of liver failure patients".

Dr Banwari Agarwal, who is a Consultant Intensivist at Royal Free Hospital is the Chief Investigator for the trial.

Today's standard of care for this patient group is multi-organ support in the intensive care unit. Many patients require a liver transplant, though the shortage of donor organs means this is often not possible. There are currently over 5000 liver transplants per year in Europe, more than 1,500 patients are on the Eurotransplant waiting list for a new liver, and many more in other countries of the EU who are not members of the Eurotransplant network .

The 24-patient ALIVER study is funded by a €6.4 million EU Horizon 2020 grant 733057, awarded to a consortium of 11 institutions from seven countries in Europe, including Yaqrit Ltd, a spinout company from University College London that is developing the DIALIVE device and IBM Ireland Ltd, which will be applying data analytics to identify new biomarkers that can help to optimise treatment protocols.

The DIALIVE device was invented at UCL and is based on the principle that bacterial products (toxins) from the gut enter the blood in patients with liver disease, and trigger a damaging immunological and inflammatory response. DIALIVE is designed to remove these toxins from the blood and replace damaged blood albumin with fresh albumin to increase the body's natural defenses against bacterial toxins allowing the liver to regenerate.ii If the results show a successful outcome, Yaqrit Ltd. will seek regulatory approval for DIALIVE in 2019/20.

Sunday, July 23, 2017

Vosevi - Frequently Asked Questions & Gilead's My Support Path® VOSEVI Program

PROJECT INFORM  
Vosevi: Frequently Asked Questions
These frequently asked questions will help you understand what Vosevi is, how it works, and help you decide if it is the right medication for you.

FDA
Prescribing Information

Gilead's Patient Support Program - Support Path®
To support these patients and their families, Gilead's U.S. Support Path® program provides information regarding access and reimbursement coverage options to patients in the United States who need assistance with coverage for their Gilead HCV medications, including Vosevi. Support Path conducts benefits investigations and provides patients with information regarding their insurance options.

Further, the Vosevi Co-pay Coupon Program offers co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs.

Gilead's Support Path® Program
Start Page - Support Path

My Support Path® VOSEVI Program
VOSEVI 

Eligible patients may pay no more than $5 per co-pay for VOSEVI
Restrictions apply. To check your eligibility, please call 1-855-7-MYPATH (1-855-769-7284) and speak with a VOSEVI Support Path® specialist, Monday through Friday from 9AM to 8PM Eastern Time.
  • Not valid for patients enrolled in government healthcare prescription drug programs, such as Medicare Part D and Medicaid. Patients in the coverage gap known as the "donut hole" also are not eligible
  • The HARVONI, EPCLUSA, SOVALDI, and VOSEVI co-pay coupon programs will cover the out-of-pocket costs for HARVONI, EPCLUSA, SOVALDI, and VOSEVI prescriptions up to a maximum of 25% of the catalog price of a 12-week regimen of HARVONI, EPCLUSA, SOVALDI, or VOSEVI

IMPORTANT FACTS
This is only a brief summary of important information about VOSEVI and does not replace talking to your healthcare provider about your condition and your treatment

News & Updates