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
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PDF Provided By @HenryEChang
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.
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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.
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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.
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Association between complicated liver cirrhosis and the risk of hepatocellular carcinoma in Taiwan
Published: July 24, 2017
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…
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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
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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?
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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.
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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.
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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
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Blog Updates Around The Web

World Hepatitis Alliance
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.
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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.
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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

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.

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.

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.

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.

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