Friday, June 30, 2017

Pangenotypic regimens and the next generation hepatitis C virus therapy

The latest issue of Clinical Liver Disease
Clinical Liver Disease (CLD) is a digital educational resource published on behalf of the American Association for the Study of Liver Diseases (AASLD). CLD publishes easy to read reviews on relevant topics for clinicians diagnosing and managing patients with liver disease. Each article is accompanied by a podcast audio version, and a video interview with the author to help emphasize the key teaching points for a clinical audience.

Issue Publication: June 2017
Volume 9, Issue 6 Pages 131 - 149, June 2017

Reviews
Hepatitis C
Guest Edited by Andrew Muir, MD
Pangenotypic regimens and the next generation hepatitis C virus therapy (pages 131–133)
Nancy S. Reau
Version of Record online: 29 JUN 2017 | DOI: 10.1002/cld.635
Three new antiviral therapies for viral hepatitis C are anticipated in the next several months: GP, glecaprevir (protease inhibitor [PI])/pibrentasvir (NS5A inhibitor); SOF/VEL/VOX, sofosbuvir (NS5B inhibitor)/velpatasvir (NS5A)/voxilaprevir (NS3); and MK3, grazoprevir (NS3) + MK-3682 (NS5B) + NS5A inhibitor (elbasvir or Ruzasvir).

Each is a pangenotypic all-oral fixed dose combination (FDC) with high potency and efficacy against common NS3 and NS5A polymorphisms. Multiple safety and efficacy abstracts were presented at the 67th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in November 2016. In this article, I will address why we need new therapies as well as what is still unaddressed in the arsenal against hepatitis C.
Watch a video presentation of this article
Watch the interview with the author
Full Text (HTML)
PDF (140.1KB) 

Noninvasive Diagnosis of Liver Fibrosis in Children and Adults
Guest Edited by Naim Alkhouri, MD and Jean Molleston, MD
Putting it all together: Noninvasive diagnosis of fibrosis in nonalcoholic fatty liver disease in adults and children (pages 134–137)
Naim Alkhouri
Multiple noninvasive tests have been developed and validated in the adult NAFLD population to predict the stage of fibrosis.[6] These tests are being widely used by gastroenterologists and hepatologists to risk-stratify patients with NAFLD without the need for liver biopsy. These tests can be divided into one of three categories: simple fibrosis scores that can be calculated from readily available clinical variables, complex fibrosis scores that rely on measuring serum biomarkers of fibrosis and extracellular matrix turnover, and imaging studies that are based on measuring liver stiffness as an indirect way to determine fibrosis stage.
Version of Record online: 29 JUN 2017 | DOI: 10.1002/cld.636
Watch a video presentation of this article
Watch the interview with the author
Full Text (HTML)
PDF (178.2KB)  

Antifibrotic therapies in liver disease: Ready for primetime? (pages 138–140)
David A. Rudnick
Version of Record online: 29 JUN 2017 | DOI: 10.1002/cld.641
Watch a video presentation of this article
Watch the interview with the author

LT in the High MELD Era: Perioperative Management of the Critically Ill Patient
Guest Edited by Julie Heimbach, MD and Michael Schilsky, MD
Transplantation for acute alcoholic hepatitis (pages 141–143)
Patrizia Burra and Giacomo Germani
Version of Record online: 29 JUN 2017 | DOI: 10.1002/cld.629
Watch a video presentation of this article
Watch the interview with the author

The Practice of Hepatology in a Non-Traditional Setting
Guest Edited by Mitchell Shiffman, MD
Contrasting the academic and nonacademic hepatology practice settings (pages 144–146)
Alexander T. Lalos and Coleman I. Smith
Version of Record online: 29 JUN 2017 | DOI: 10.1002/cld.638
Watch a video presentation of this article
Watch the interview with the author

Developing clinical research in a clinical hepatology practice (pages 147–149)
Oren K. Fix, Terri Spinelli and Kris V. Kowdley
Version of Record online: 29 JUN 2017 | DOI: 10.1002/cld.639
Watch a video presentation of this article
Watch the interview with the author

Begin here.....

Harvoni - Effectiveness and safety of ledipasvir/sofosbuvir ± ribavirin in the treatment of HCV infection: The real-world HARVEST study

Advances in Medical Sciences
Volume 62, Issue 2, September 2017, Pages 387–392

Original research article
Effectiveness and safety of ledipasvir/sofosbuvir ± ribavirin in the treatment of HCV infection: The real-world HARVEST study
Robert Flisiaka, , , Mariusz Łucejkoa, Włodzimierz Mazurb, Ewa Janczewskac, Hanna Berakd, Krzysztof Tomasiewicze, Iwona Mozer-Lisewskaf, Dorota Kozielewiczg, Andrzej Gietkah, Katarzyna Sikorskai, Marta Wawrzynowicz-Syczewskaj, Krzysztof Nowakk, Dorota Zarębska-Michalukl, Joanna Musialikm, Krzysztof Simonn, Aleksander Garlickio, Robert Pleśniakp, Barbara Baka-Ćwierzq, Iwona Olszokr, Krystyna Augustyniaks, Wojciech Stolarzt, Jolanta Białkowskau, Anna Badurekv, Anna Piekarskaw

Download Full Text Article

Abstract
Background
To evaluate the effectiveness and safety of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) regimen in a real-world setting.

Methods
Patients received a fixed-dose combination tablet containing LDV and SOF with or without RBV, for 8, 12 or 24 weeks. Patients were assessed at baseline, end of treatment, and 12 weeks after the end of treatment. The primary effectiveness endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12).

Results
Of the 86 patients, aged 20–80 years, 82.6% were HCV genotype 1b-infected and 50.0% were cirrhotic. More than half (52.3%) had previously followed pegylated interferon-containing (PEG-IFN) treatment regimens, and 38.5% were null-responders. SVR12 was achieved by 94.2% of patients. All non-responders were cirrhotic: two demonstrated virologic breakthrough and the remaining three relapsed. All patients treated with an 8-week regimen achieved SVR12 despite having high viral load at baseline (HCV RNA of >1 million IU/mL in 8/10 patients, including one with a viral load of >6 million IU/mL). Adverse events were generally mild and transient. Most frequently, fatigue (22.1%), headache (15.1%), and arthralgia (7.0%) were observed. Laboratory abnormalities included anemia and hyperbilirubinemia.

Conclusions
Treatment with LDV/SOF ± RBV is an effective and safe option for patients with HCV, including those with advanced liver disease or a history of non-response to PEG-IFN-based therapy.
Continue reading...

Full Text Article
Article link provided by Henry E. Chang via Twitter.
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C.

Original Article The clinical roles of rheumatoid factor in the treatment of chronic hepatitis C infection

Int J Clin Exp Med 2017;10(6):9456-9462 www.ijcem.com /ISSN:1940-5901/IJCEM0049611

Original Article The clinical roles of rheumatoid factor in the treatment of chronic hepatitis C infection
Wei-Ming Chen1,2,3*, Kao-Chi Chang1*, Ko-Ming Lin2,3,4, Kuo-Liang Wei1,3, Pey-Jium Chang2, Te-Sheng Chang1,2,3, Chein-Heng Shen1, Shui-Yi Tung1,3

Received January 24, 2017; Accepted April 28, 2017; Epub June 15, 2017; Published June 30, 2017

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Abstract: Objective:
The hepatitis C virus infection is associated with arthritis. However, the clinical roles of the rheumatoid factor in patients who received anti-viral treatment are not as clear.

Methods: To identify the association between the rheumatoid factor and the treatment response in hepatitis C virus infected patients, we enrolled patients who received anti-viral treatment with peg-interferon plus weight-based ribavirin according to response guided therapy. Patients who had a mix type hepatitis C infection, any autoimmune diseases, hepatitis B co-infection or intolerance to the side effects of therapy were excluded. Patients were divided into a rheumatoid factor (RF) positive (>20 IU/ml) group and a rheumatoid negative group. The patient’s characteristics, treatment response, dynamic changing of the rheumatoid factor and factors influenced the sustained virus response (SVR) of therapy, which were analyzed.

Results: A total of 271 patients completed the anti-viral treatment and analysis. The positive rate of the rheumatoid factor is 47.23% (128/271). In the RF positive group, the SVR rate was 82.8%, 71.0%, 96.6% for overall, genotype 1 infected, and non-genotype 1 infected patients, respectively. In the RF negative group, the SVR rate was 77.6%, 66.7%, 91.9% for overall, genotype 1 infected, and non-genotype 1 infected patients, respectively. There is a trend toward a higher SVR rate in RF positive patients, but no statistical difference was noted. In RF positive patients who achieved SVR, the RF values reduced significantly (56.4±78.0 vs. 39.4±39.6, P<0.001) after treatment but not in the non-SVR group (43.8±25.9 vs. 31.7±13.5, P=0.074). In the RF negative group, 37.8% and 34.4% of the patients’ RF became positive after treatment in the SVR group and in the non-SVR group. A lower virus load (<800,000 copies/ml), non-genotype 1 infection, alanine aminotransferase (ALT) rapid normalization, rapid viral response (RVR) and complete early viral response (cEVR) are significant predictive factors associated with SVR. The present or dynamic change of the rheumatoid factor cannot predict the effect of the treatment response.

Conclusions: The rheumatoid factor was positive in 47% of the chronic hepatitis C virus infected patients. In the RF positive group, the treatment response was better but not statistically significant. After treatment, the RF value was significantly reduced in cured patients.
Continue reading....

Recommended Reading
An Overview of Extrahepatic Manifestations of Hepatitis
A patient friendly fact sheet explaining conditions associated with HCV including symptoms.
The hepatitis C virus mainly affects the liver, but there are many other conditions that are associated with hepatitis C.  Extrahepatic manifestation means diseases or conditions that affect organs other than the liver.  Extrahepatic manifestations of hepatitis C can be found in the skin, eyes, joints, immune system, nervous system and kidneys.  Some of these conditions – cryoglobulinemia, for example – are somewhat more common and well documented, while others are infrequent or their association with hepatitis C has not yet been proven.

Recently published in Journal of Advanced Research is a nice collection of review articles on the extrahepatic manifestations of HCV.
Volume 8, Issue 2, March 2017, Pages 85–87

In The News
Lower Risk of Hep C Extrahepatic Manifestations With Sustained Virological Response
Patients who achieved a sustained virological response (SVR) to interferon-based antiviral therapy for hepatitis C virus (HCV) had a reduced risk of extrahepatic manifestations, according to a retrospective cohort study.

Hepatitis C is a pediatric disease now

Related
Hepatitis C and women of childbearing age
July 03, 2017
A pregnant woman with evidence of HCV antibodies but no detectable active virus in her body is very unlikely to transmit HCV to her baby. On the other hand, pregnant women with very high viral loads are believed to be at increased risk for vertical transmission of HCV.

Commentary
Hepatitis C is a pediatric disease now
Publish date: June 27, 2017
By: Kristina K. Bryant, MD
It is estimated that there are 23,000 to 46,000 U.S. children living with HCV. The wait for pediatricians is over. HCV is a pediatric disease now, and we need to educate ourselves about diagnosis and management. A first step might be to begin asking expectant mothers and the mothers of newborns if they know their HCV status.
Continue reading....
Follow @IDPractitioner  

Recommended Reading
Hepatitis C increasing among pregnant women
Published:



FDA approves two hepatitis C drugs for pediatric patients
Published: April 7, 2017
The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.
Read the announcement @ FDA Newsroom

FDA Approval Of Hepatitis C Drugs For Kids Is Likely To Speed Treatment






I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C. 

Thursday, June 29, 2017

Bloomberg -The Crazy Math Behind Drug Prices

The Crazy Math Behind Drug Prices
Intermediaries that negotiate to lower prices may cause them to increase, too.
By Paul Barrett and Robert Langreth 
David Hernandez, a 44-year-old restaurant worker and Type 1 diabetic, didn’t have insurance from 2011 through 2014 and often couldn’t afford insulin—a workhorse drug whose list price has risen more than 270 percent over the past decade. As a result of his skimping on dosages, Hernandez in 2011 suffered permanent blindness in his left eye...
In 2014, Gilead Sciences Inc. introduced Harvoni, which cures hepatitis C at a cost of $94,500 for a 12-week treatment. When Gilead offered only a 10 percent rebate, Express Scripts excluded Harvoni and substituted a cheaper drug from rival AbbVie Inc. Gilead got the message. It has said that rebates marketwide on Harvoni exceeded 50 percent in 2016—discounts unavailable to uninsured patients. Gilead declined to comment...
Continue reading......

Some cirrhosis deaths have moved out of the hospital

Some cirrhosis deaths have moved out of the hospital
Last Updated: 2017-06-26
By Scott Baltic

NEW YORK (Reuters Health) - Although in-hospital mortality for patients with cirrhosis has been on a downward trend, at least part of that decrease appears to have been paid for by an increased risk of death in the 30 days immediately following hospital discharge, according to a U.S. study.

"Our results suggest the improvement in overall outcomes of patients hospitalized with cirrhosis is considerably less than might be suggested by reduction in in-hospital mortality alone," the researchers concluded.

The study, based on 10 years of data from the Veterans Administration healthcare system, is the first to examine temporal trends in the overall outcomes for U.S. cirrhosis patients requiring hospitalization, its authors say.

Continue reading...

Liver cirrhosis: a risk factor for gallstone disease in chronic hepatitis C patients in China

Research Article: Observational Study
Full Text Article Available Online
Medicine: June 2017 - Volume 96 - Issue 26 - p e7427
doi: 10.1097/MD.0000000000007427

Liver cirrhosis: a risk factor for gallstone disease in chronic hepatitis C patients in China
Li, Xu PhD; Wang, Zhongfeng PhD; Wang, Le MD; Pan, Meng MD; Gao, Pujun PhD*

Abstract: We investigated the possible link between liver cirrhosis and gallstone risk in chronic hepatitis C (CHC) patients in China.

To analyze the association between liver cirrhosis and gallstone development, we compared outcomes of 133 Chinese CHC patients with gallstones and an age-, sex-, and hepatitis C virus RNA level-matched control group of 431 CHC patients without gallstones.

We found that liver cirrhosis was more prevalent in gallstone patients (40.6%) than in the control group (24.4%). Logistic regression analyses adjusting for demographic features and other gallstone risk factors revealed that liver cirrhosis increased the risk of gallstone development 2-fold (adjusted odds ratio [AOR]: 2.122; 95% confidence interval [CI]: 1.408–3.198). Moreover, multivariate analyses comparing the risk of gallstone development in liver cirrhosis patients with decompensated or compensated liver cirrhosis yielded an estimated AOR (95% CI) of 2.869 (1.277–6.450) in patients with decompensated liver cirrhosis. Gallstone risk also increased significantly with older age (>60 years) (AOR: 2.019; 95% CI: 1.017–4.009).

Liver cirrhosis significantly correlates with increased risk of gallstone development in CHC patients in China. Decompensated liver cirrhosis and older age further heighten this risk in patients diagnosed with hepatitis C-related cirrhosis.
View Full Text Article

Recommended Reading

Gallstones and gallbladder disease
More than 25 million Americans have gallstones, and a million are diagnosed each year. However, only 1 to 3% of the population complains of symptoms during the course of a year, and fewer than half of these people have symptoms that return.

Women are much more likely than men to develop gallstones. Gallstones occur in nearly 25% of women in the U.S. by age 60, and as many as 50% by age 75. In most cases, they have no symptoms. In general, women are probably at increased risk because estrogen stimulates the liver to remove more cholesterol from blood and divert it into the bile.
Continue reading...

Review Article
Full Text Review Article Available Online
Volume 2017 (2017), Article ID 9749802, 8 pages
https://doi.org/10.1155/2017/9749802

Gallstones in Patients with Chronic Liver Diseases
Xu LiXiaolin GuoHuifan JiGe Yu, and Pujun Gao
With prevalence of 10–20% in adults in developed countries, gallstone disease (GSD) is one of the most prevalent and costly gastrointestinal tract disorders in the world. In addition to gallstone disease, chronic liver disease (CLD) is also an important global public health problem. The reported frequency of gallstone in chronic liver disease tends to be higher. The prevalence of gallstone disease might be related to age, gender, etiology, and severity of liver disease in patients with chronic liver disease. In this review, the aim was to identify the epidemiology, mechanisms, and treatment strategies of gallstone disease in chronic liver disease patients.
Read the article published January 2017 online in BioMed Research International.

Wednesday, June 28, 2017

The Liver - Super Foods & Supplements

Liver Super Foods



Published on May 30, 2017
Source - American Liver Foundation Great Lakes Division



In The News
Go Easy on the Avocado Toast: ‘Good Fat’ Can Still Be Bad for You, Research Shows
By on

Patient Friendly Video On Managing Medications With Liver Disease & Cirrhosis

Cirrhosis - Managing Medications with Liver Disease



Published on Jun 27, 2017
Source - American Liver Foundation Great Lakes Division

A quick overview on the safety and use of medications commonly used to treat various complications of cirrhosis.

Topic Highlights
Lactulose
Rifaximin
Water Pills - Diuretics
Antibiotics
Over The Counter Drugs (OTC) - Drugs with hidden acetaminophen (Tylenol)
Herbal Products
Prescription drugs that can cause confusion
Hepatitis C Medications
Transplant Medications

Tuesday, June 27, 2017

MedPage Today - Hep C Experts Condemn Cochrane Review Dissing Direct Antivirals

Today the European Association for the Study of the Liver EASL published a response to the Cochrane Systematic Review that suggested there was no evidence new treatments for hepatitis C improve outcomes in patients infected with the virus. Other rebuttals can be viewed over at Gastroenterology & Endoscopy News, and in the Lancet, as well as a statement by the American Association for the Study of Liver Diseases AASLD and Infectious Diseases Society of America IDSA. In Australia a joint Position Statement was released by Australian Health Organisations   urging medical professionals and patients not to be influenced by the report. In addition Hepatitis C Trust responded with concern over media coverage, citing an article published by The GuardianIn the week following the Cochrane review, an excerpt:
In an extraordinary show of unity, hepatitis C researchers, clinicians, and advocates have denounced the Cochrane analysis and its implications, pointing to clear-cut evidence that current DAAs not only cure hepatitis C, but also reduce the risk of liver transplant, cancer, and other complications later in life..
Continue reading.....

EASL
June 27, 2017
Response to the Cochrane Systematic Review on DAA-Based Treatment of Chronic Hepatitis C
The European Association for the Study of the Liver, one of the world leading associations of liver specialists, feels compelled to express its serious concerns after the recent publication of a Cochrane Group systematic review entitled “Direct acting antivirals for chronic hepatitis C” by Jakobsen et al. After reviewing 138 clinical trials, including 25,232 participants, the authors conclude that: “Overall, direct acting antivirals (DAAs) on the market or under development do not seem to have any effects on risk of serious adverse events. […] we could neither confirm nor reject that DAAs had any clinical effects. DAAs seemed to reduce the risk of no sustained virological response. The clinical relevance of the effects of DAAs on no sustained virological response is questionable, as it is a non-validated surrogate outcome. All trials and outcome results were at high risk of bias, so our results presumably overestimate benefit and underestimate harm. The quality of the evidence was very low.”
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On Twitter - Tweeted by Henry E. Chang
Reactions from Hepatitis C Community on a Recent Cochrane Review of DAAs
Cochrane Review Group's fallacious conclusions are missing real issue of access to effective and highly curative therapy for chronic HCV infection. Irresponsible reporting by news media of the results risks even more harm than the original review.

A special thank you to Henry E. Chang for sending us to each rebuttal and all ongoing media coverage.

Blog Updates: Taking Harvoni & Fighting Hepatitis in Cambodia

Blog Updates From Around The Web
Welcome, sit back and enjoy the following articles written by dedicated men and women that help change the way we think about viral hepatitis.

Hepatitis C Links
To learn more about managing and treating hepatitis C review this comprehensive list of HCV informational and support websites.

The Hill
The Hill is the premier source for policy and political coverage, reporting on every aspect of the business of Washington and the campaign trail. The views expressed by contributors are their own and are not the views of The Hill.

Capping Medicaid threatens our ability to care for poorest, sickest patients
By Sherry Glied and Richard Frank, opinion contributors
Another strategy for avoiding high-cost patients could be even more dangerous. States have considerable leeway in choosing to cover specific treatments or medications. For example, when Sovaldi, a new, very effective treatment for Hepatitis C entered the market in 2014, state Medicaid programs spent an unexpected additional $1.3 billion on these drugs; many cash-strapped states sought to restrict access to the drug. The federal government, using the power of its purse strings, clarified that states were required to provide access to “medically necessary treatments.”
Continue reading...

_______________________________________
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.

Hepatitis C: Good News for a Change
By Lucinda K. Porter, RN
Hepatitis C and bad news never go on vacation. It's time for some good news.
Continue reading...

Some Tips For Taking Harvoni
By Greg Jefferys
Some suggestions on how to improve bioavailability of hepatitis C medicines.
Continue reading....

To view a list of all bloggers please click here.
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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: Reminders
Medical Doctor  - Theresa Chan in Cambodia
Being cured of a disease like Hepatitis C isn't just a case of finding the right treatment. Patients must also stick to a long drug regimen, taking...

Fighting Hepatitis in Cambodia: A fish on a bicycle
With her medical interpreter off to a new role, Theresa has been finding new ways to contribute to the MSF hepatitis C project in Phnom Penh,...

View all blogs, photos and stories, 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

If it isn’t one thing…
By Daryl Luster - June 26, 2017
As I am fond of saying, if it isn’t one thing, it is six. The original version goes like “or another” instead of six but I have to tell you it is...

Pamela Anderson Still Healthy Post–Hepatitis C Treatment
By Jenelle Marie Pierce - June 25, 2017
Pamela Anderson is a Canadian woman who was first discovered at a sporting event. She went on to become a cast member of the 1990s sitcom Home Improvement before becoming internationally known...

Lessons Learned
By Daryl Luster - June 23, 2017
Recently I saw something about lessons learned, and I thought I might tackle it from my screwball perspective. I thought what the heck, I might as well. I am a fan of...

View all blog updates, here.
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Hep BOOMers
Hep BOOMers is dedicated to the millions of Baby Boomers who contracted hepatitis C and to the boom in medical research that could cure them.

Hepatitis drug coverage in English-speaking countries
Posted on June 25, 2017 by Elizabeth
Today I have a few updates about drug coverage in some English-speaking countries

Read all updates, here
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MD Whistleblower
Michael Kirsch, M.D.
I am a full time practicing physician and writer. I write about the joys and challenges of medical practice including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When I'm not writing, I'm performing colonoscopies.

Why I Don't Prescribe Pain Medicines

It may seem strange that a gastroenterologist like me does not prescribe pain medicines. Let me rephrase that. I don’t prescribe opioids or narcotics. I write prescriptions for so few controlled substances that I do not even know my own DEA number. You might think that a gastroenterologist who cares for thousands of patients with abdominal pains would have a heavy foot on the opioid accelerator. But, I don’t. Here’s why.

View additional blog updates, here.
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Hepatitis B Foundation
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure for hepatitis B and helping to improve the lives of those affected worldwide through research, education and patient advocacy. Our monthly electronic newsletter, provides research updates, healthy liver tips, information on public health initiatives, and other HBF news.
Click here to subscribe

You Have Hepatitis B, Will Liver-Detox Diets or Supplements Help? Experts Weigh In
By Christine Kukka
Manufacturers and health “gurus” around the world market liver detox diets and supplements that promise to remove toxins, reduce inflammation, strengthen the immune system and help you lose weight. But do they help people with chronic hepatitis B?

Continue reading....

View all updates, here.
________________________________________

In The News

Hepatitis C Rates in Young Adults Increasing in California
By California Department of Public Health - June 27, 2017, 10:15:42 AM

SACRAMENTO June 27, 2017 – New data released today by the California Department of Public Health (CDPH) show an increase in newly reported hepatitis C cases among young adults in the state. Between 2007 and 2015, newly reported hepatitis C infections increased 55 percent among men 20-29 years of age and 37 percent among women in the same age group.
Continue reading....


Hot Topics
Hep C Experts Condemn Cochrane Review Dissing Direct Antivirals
In an extraordinary show of unity, hepatitis C researchers, clinicians, and advocates have denounced the Cochrane analysis and its implications, pointing to clear-cut evidence that current DAAs not only cure hepatitis C, but also reduce the risk of liver transplant, cancer, and other complications later in life.

Recommended Links
HCV Education
Review learning activities, editorials, with new data about interferon-free regimens approved for HCV, as well as investigational drugs still in the pipeline. Links are provided to support, patient friendly information, clinical trials, peer-reviewed journals, videos, conferences with commentary updated on a continuous basis.

Fibrosis

Until next time.....
Tina

AASLD Expresses Concern for Cochrane Review of DAAs

In Case You Missed It
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.
Begin here....

AASLD and IDSA would like to express our serious concerns regarding the recent Cochrane Group
Review concluding that there is a lack of valid evidence supporting the benefit of direct acting antiviral (DAA) therapy for chronic infection with hepatitis C virus (HCV), and its supposition: "the possibility of potentially harming people with chronic hepatitis ought to be considered before treating people with hepatitis C with DAAs." Our review of this Cochrane publication suggests significant flaws in this analysis, yielding a misleading and a harmful conclusion.

The objective as stated is to assess the benefits and the harms of DAAs in people with chronic HCV. The selection criteria used only randomized clinical trials comparing DAA versus no intervention or placebo in patients with chronic HCV. Randomized trials in chronic HCV have only focused on the FDA recommended virologic endpoint of sustained virologic response (SVR), which is limited to a short follow-up period meant only to confirm permanent eradication of the virus from the blood stream. The Review's conclusion stating a lack of evidence that SVR impacts long term clinical outcomes (morbidity) and mortality ignores both fundamental mechanisms and mounting published literature supporting the clear clinical benefit of SVR obtained with DAAs.

First, experience from earlier HCV therapies (based on interferon), for which long term follow-up data are now available, clearly demonstrate numerous health benefits including a decrease in liver inflammation as reflected by improved aminotransferase levels and a reduction in the rate of progression of liver fibrosis as reflected in paired liver biopsy studies (Poynard, 2002). Of 3010 treatment-naive HCV-infected patients with pretreatment and posttreatment biopsies from four randomized trials of 10 different interferon-based regimens, 39 percent to 73 percent of patients who achieved an SVR had improvement in liver fibrosis and necrosis in liver biopsies separated by a mean of 20 months (Poynard, 2002). Cirrhosis resolved in half of the cases. Portal hypertension, splenomegaly and other clinical manifestations of advanced liver disease also improved. Among HCV-infected persons with advanced fibrosis, SVR is associated with a more than 70 percent reduction in the risk of hepatocellular carcinoma (HCC) and a 90 percent reduction in the risk of liver-related mortality and liver transplantation (Morgan, 2013); (van der Meer, 2012); (Veldt, 2007). It is precisely for these reasons that the FDA recommended SVR as the primary endpoint for all contemporary HCV trials. SVR is a validated surrogate for long-term benefits. Based on these data, there is every reason to expect that analogous clinical benefits will be observed with cure of HCV infection obtained via DAAs after a sufficient follow-up period.

Second, even early data from the DAA experience support clear improvements in clinical outcomes that can be measured in the short term. Cure of HCV infection immediately reduces symptoms and organ dysfunction from severe extrahepatic manifestations including cryoglobulinemic vasculitis, a complication affecting up to 10 percent of HCV-infected patients (Saadoun, 2017); (Sise, 2016). Historically, HCV-infected persons with non-Hodgkin lymphoma (NHL) and other B-cell lymphoproliferative disorders achieved complete or partial remission in up to 75 percent of cases following successful IFN-based therapy for HCV infection (Gisbert, 2005); (Takahashi, 2012); (Svoboda, 2005); (Mazzaro, 2002); (Hermine, 2002). Recent data show that DAA regimens produce similar remission rates in NHL and even higher rates of SVR (Arcaini, 2016). Perhaps the most striking evidence of direct clinical improvement comes from data demonstrating the success of DAAs in patients with decompensated liver disease for whom SVR was associated with improved MELD scores and albumin levels in the majority of patients with Child B and C cirrhosis (Charlton, 2015). Indeed, success in this group in many cases obviates the need for liver transplantation, meaning that more donor organs could become available to other patients on the waitlist (Belli, 2016). Thus, even without long term follow-up to prove a survival benefit, there are already clear indications of the clinical benefit of SVR offered by use of DAAs to reduce disease complications.

AASLD and IDSA are troubled by the implications of this review for the ongoing international efforts to halt the HCV epidemic, and to give patients back their futures. In the face of the National Academies of Science, Engineering, and Medicine statement that elimination of HCV is possible by 2030 with optimal implementation of high efficacy therapy, we believe that the Cochrane Review does a grave disservice to these efforts and to patients living with chronic HCV infection, a disease responsible for tens of thousands of deaths around the world each year. We stand behind our Associations' recommendations that all patients with HCV should be treated to prevent complications of this curable disease (www.hcvguidelines.org (link is external)) and we will continue to fight for the global elimination of this viral infection. In light of the evidence that we have cited, we urge the Cochrane Review authors to retract or to revise their conclusions.

Sincerely,
Anna Lok, President, AASLD
William Powderly, President, IDSA

References
  1. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. www.hcvguidelines.org (link is external).
  2. Arcaini L, Besson C, Frigeni M, et al. Interferon-free antiviral treatment in B-cell lymphoproliferative disorders associated with hepatitis C virus infection. Blood. 2016 Nov 24;128(21):2527-2532. Epub 2016 Sep 7
  3. Belli, L.S., Berenguer, M., Cortesi, P.A., Strazzabosco, M., Rockenschaub, S.R., Martini, S. et al, Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: A European study. J Hepatol. 2016; 65:524–531.
  4. Charlton M, Everson GT, Flamm SL, et al. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.
  5. Gisbert JP, Garcia-Buey L, Pajares JM, Moreno-Otero R. Systematic review: regression of lymphoproliferative disorders after treatment for hepatitis C infection. Aliment Pharmacol Ther. 2005;21(6):653-662
  6. Hermine O, Lefrere F, Bronowicki JP, et al. Regression of splenic lymphoma with villous lymphocytes after treatment of hepatitis C virus infection. N Engl J Med. 2002;347(2):89-94.
  7. Mazzaro C, Little D, Pozzato G. Regression of splenic lymphoma after treatment of hepatitis C virus infection. N Engl J Med. 2002;347(26):2168-2170.
  8. Morgan RL, Baack B, Smith BD, Yartel A, Pitasi M, Falck-Ytter Y. Eradication of hepatitis C virus infection and the development of hepatocellular carcinoma: a meta-analysis of observational studies. Ann Intern Med. 2013;158(5 Pt 1):329-337.
  9. Poynard T, McHutchison J, Manns M, et al. Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C. Gastroenterology. 2002;122(5):1303-1313.
  10. Saadoun D, Pol S, Ferfar Y, et al. Efficacy and Safety of Sofosbuvir Plus Daclatasvir for Treatment of HCV-Associated Cryoglobulinemia Vasculitis. Gastroenterology. 2017 Mar 10. pii: S0016-5085(17)30269-X. doi: 10.1053/j.gastro.2017.03.006. [Epub ahead of print]
  11. Sise ME, Bloom AK, Wisocky J, et al. Treatment of hepatitis C virus-associated mixed cryoglobulinemia with direct-acting antiviral agents. Hepatology. 2016 Feb;63(2):408-17. Epub 2015 Dec 11.
  12. Svoboda J, Andreadis C, Downs LH, Miller Jr WT, Tsai DE, Schuster SJ. Regression of advanced non-splenic marginal zone lymphoma after treatment of hepatitis C virus infection. Leuk Lymphoma. 2005;46(9):1365-1368.
  13. Takahashi K, Nishida N, Kawabata H, Haga H, Chiba T. Regression of Hodgkin lymphoma in response to antiviral therapy for hepatitis C virus infection. Intern Med. 2012;51(19):2745-2747.
  14. van der Meer AJ, Veldt BJ, Feld JJ, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012;308(24):2584-2593.
  15. Veldt BJ, Heathcote EJ, Wedemeyer H, et al. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Ann Intern Med. 2007;147(10):677-684.
AASLD
https://www.aasld.org/about-aasld/press-room/aasld-expresses-concern-cochrane-review-daas

Related
Friday, June 9, 2017
Response to Cochrane Collaboration review in to Hepatitis C medicines

Listen: Access to essential medicines in the US and around the world

High drug prices force 1 in 6 Americans to ration their use of needed medicines

Measuring access to essential medicines in the US and around the world
By Luke Vargas   
Published June 26, 2017

Luke Vargas: Earlier this year, an expert panel of the World Health Organization updated something called the Essential Medicines List, a collection of the most effective medicines used to treat the most prevalent health conditions. To save lives, extend life expectancies and raise billions out of poverty, essential medicines need to be made available. How well is the world doing in that quest? What about here in the U.S., and where does the principal of health access figure in the health reform push in Washington?  We’re coming to you today from U.N. headquarters in New York as we look at the life-and-death topic of health access, and in particular at access to the world’s most essential medicines.



Wake” is a weekly foreign policy broadcast produced by Talk Media News and hosted by Luke Vargas from our studio at U.N. Headquarters in New York.

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The following is a complete transcript of Episode 11, “Essential Medicines.”
Luke Vargas: Can you highlight some of the changes that have been made to the list recently? There are some pretty basic “essential medicine,” things like oxygen, or charcoal powder or aspirin, but are the medicines being added in 2017 much more complex?
Suzanne Hill: Indeed. A couple of recent changes just to highlight – so for example, two years ago in 2015, for the first time medicines used for treating Hepatitis C – direct-acting antivirals were added. So the very expensive product such as sofosbuvir was added. This time around the latest combination product for Hepatitis C were included, because they offer the option of treating all types of Hepatitis C with a single regiment, with a single pill per day. That was one example....
Source
http://www.talkmedianews.com/wake/2017/06/26/wake-essential-medicines-access/

Read transcript, here.

Related:
Wednesday, June 7, 2017
WHO Essential Medicines List - New advice on use of antibiotics; adds meds for hep C, HIV, tuberculosis, cancer

Watch - Patients Saved After Receiving Hepatitis C Organs

A Look At A New, Bold Experiment At UPenn For Organ Transplants | NBC Nightly News 

Published on Jun 26, 2017
NBC News
Doctors at the University of Pennsylvania treated 10 patients on the organ transplant waiting list with a Hepatitis C infected kidney. All 10 got the virus and were treated with one pill for 12 weeks. Today, all 10 are healthy with functioning kidney.


Monday, June 26, 2017

Swiss hepatitis C sufferers to get full access to expensive drug

Swiss hepatitis C sufferers to get full access to expensive drug
By Anand Chandrasekhar
The Federal Office of Public Health has announced that it will make the hepatitis C drug Zepatier available to all patients from July 1. The 12-week treatment costs CHF31,000 ($31,952) per patient and was previously only available to those with an advanced form of the disease.
Continue reading...

Fatality rates are high within 2 years of drug-induced liver injury

Fatality rates are high within 2 years of drug-induced liver injury
Most patients suffering liver toxicity due to medications or herbal or dietary supplements recover from the acute liver injury without long-term problems, but some do not survive the injury or they require liver transplantation. In a recent study, nearly 10% of patients with definite, highly likely, or probable drug-induced liver injury had a fatal outcome within 2 years of onset.

In the 107 deaths among 1089 patients in the study, drug-induced liver injury was the primary cause of death in 68 patients and was a contributing cause in another 15 (at total of 7.6%). The remaining 22 patients had fatal outcomes unrelated to drug-induced liver injury.

The findings are published in Hepatology.

Response Tailored Protocol Versus the Fixed 12 Weeks of Dual Sofosbuvir/Daclatasvir Treatment in Egyptian Patients With Chronic Hepatitis C Genotype-4 Infection

Response Tailored Protocol Versus the Fixed 12 Weeks of Dual Sofosbuvir/Daclatasvir Treatment in Egyptian Patients With Chronic Hepatitis C Genotype-4 Infection: A Randomized, Open-label, Non-inferiority Trial
Mostafa Yakoot Correspondence information about the author Mostafa Yakoot Email the author Mostafa Yakoot , Alaa M. Abdo, Siham Abdel-Rehim, Sherine Helmy

Highlights
It would be prudent to consider vRVR to therapy at week 2 before shortening HCV treatment duration with SOF/DCV to 8 weeks.

This will consider the variability of response as a factor at individualized level not just a point of estimate at a population level.

Response-tailored duration of 8 or 12 weeks based on achieving vRVR was non-inferior to the fixed 12 weeks course.

The decision of shortening the duration of therapy of non-cirrhotic chronic hepatitis C genotype-4 patients with dual sofosbuvir plus daclatasvir to 8 weeks instead of the recommended 12 weeks, if based on achieving viral negativity in serum at week 2 as an on-treatment qualifier, could provide a prudent basis to avoid unnecessary long treatment courses. This could not only reduce the drug exposure and the risk of adverse drug reactions, but also cut the cost of full treatment course with such expensive medications by one third.

View full text article, here.

HCV Treatment Options in 2017/2018: What’s Here and What’s Coming Soon

HCV Treatment Options in 2017/2018: What’s Here and What’s Coming Soon
Clinical Care Options
*Free registration required

Greetings, hope everyone had a great weekend and are looking forward to the week ahead. When new research articles or educational resources related to managing and treating viral hepatitis become available a link to the activity can be found on this blog here, in addition check out a comprehensive list of HCV informational and support websites, here

What's New
Recently published over at Clinical Care Options, Ira M. Jacobson, MD, and Norah Terrault, MD, MPH present an update on current and future HCV therapies.



Coming Soon At Clinical Care Options
Video Modules
Initial HCV Therapy
Challenging Cases
Begin here.....

Changing trends in complications of chronic hepatitis C

Original Article
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, Stuart C. Gordon
Accepted manuscript online: 21 June 2017
DOI: 10.1111/liv.13501  

Full Text
Download PDF

Abstract
Background and Aims
Chronic hepatitis C virus (HCV)-related complications have increased over the past decade.

Methods
We used join-point regression modeling to investigate trends in these complications from 2006–2015, and the impact of demographics on these trends. Using data from the Chronic Hepatitis Cohort Study (CHeCS), we identified points at which the trend significantly changed, and estimated the annual percent change (APC) in rates of cirrhosis, decompensated cirrhosis, and all-cause mortality, adjusted by race, sex, and age.

Results
Among 11,167 adults with chronic HCV infection, prevalence of cirrhosis increased from 20.8% to 27.6% from 2006 to 2015 with adjusted annual percentage change (aAPC) of 1.2 (p<0.01). Although incidence of all-cause mortality increased from 1.8% in 2006 to 2.9% in 2015, a join-point was identified at 2010, with aAPCs of 9.6 before (2006<2010; p<0.01) and -5.2 after (2010≤2015; p<0.01), indicating a decrease in mortality from 2010 and onward. Likewise, although overall prevalence of decompensated cirrhosis increased from 9.3% in 2006 to 10.4% in 2015, this increase was confined to patients 60 or older (aAPC=1.5; p=0.023). Asian American and Black/ African American patients demonstrated significantly higher rates of cirrhosis than White patients, while older patients and men demonstrated higher rates of cirrhosis and mortality.

Conclusions
Although cirrhosis and mortality among HCV-infected patients in the US have increased in the past decade, the mortality has decreased in recent years.
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Recommended Reading
Full Text

The effect of SVR on the risk of extrahepatic manifestations of HCV infection
Gut. 2017 Jun 20. pii: gutjnl-2017-313983. doi: 10.1136/gutjnl-2017-313983. [Epub ahead of print]
Compared with HCV-infected individuals who did not receive treatment, SVR attainment was associated with a reduced risk of mixed cryoglobulinaemia, glomerulonephritis, porphyria cutanea tarda, non-Hodgkin's lymphoma, diabetes mellitus and stroke, but not lichen planus or coronary heart disease. Risk reductions were also observed when patients with SVR were compared with treated patients without SVR for mixed cryoglobulinaemia, glomerulonephritis, porphyria cutanea tarda and diabetes.
Download here....

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Full Text Articles
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C.

Friday, June 23, 2017

Hepatitis C: AbbVies MAVIRET (glecaprevir/pibrentasvir) and Gilead’s Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) Receives CHMP Positive Opinion

AbbVies  MAVIRET (glecaprevir/pibrentasvir) and Gilead’s Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) Receives CHMP Positive Opinion

Two new medicines recommended for the treatment of chronic hepatitis C

Maviret and Vosevi evaluated under accelerated assessment

The European Medicines Agency has recommended granting marketing authorisations in the European Union (EU) for Maviret and Vosevi, two new medicines indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.

HCV infection is a major public health challenge. It affects between 0.4% and 3.5% of the population in different EU Member States and is the most common single cause of liver transplantation in the EU. Approximately 15 million people are chronically infected with HCV throughout Europe.

Both Maviret and Vosevi are active against all genotypes of the virus and, with some differences between the two medicines, may be specifically useful in some patients who failed or cannot use previously available therapies. As this is considered to be of major public health interest in terms of therapeutic innovation, both medicines were evaluated under the EU’s accelerated assessment mechanism, which aims to speed up patients’ access to new medicines where there is an unmet medical need.

Maviret and Vosevi belong to the direct acting antivirals against HCVs which have reshaped the way chronic HCV infection is treated. By blocking the action of proteins essential for HCV replication, this type of medicine achieves high cure rates of the infection and does not require the concomitant use of interferons, medicines which are associated with poor tolerability and potentially serious side effects.

Despite the rapid development of new therapies there is still a need for a range of alternative treatment options to serve the different medical needs of the millions of people suffering from the disease. The more treatment options that are available, the better chance a patient has to get the right treatment to cure the disease and to lead a longer and healthier life.

Maviret and Vosevi are the first medicines for which accelerated assessment has been carried out within 120 days, after a recent review of the timetable for this mechanism.

Maviret contains two next generation direct-acting and antiviral agents: glecaprevir, an inhibitor of HCV NS3/4A protease, and pibrentasvir, an inhibitor of HCV NS5A. Both components are pangenotypic.

The effects of Maviret were studied in a total of 2,376 patients who participated in eight pivotal and three supportive clinical trials. The hepatitis C virus could no longer be detected in over 90% of patients 12 weeks after the end of treatment. If the blood of patients is clear of hepatitis C virus for more than 12 weeks they are generally considered as being cured of the infection. Adverse events reported with Maviret were generally mild, including headache, fatigue, diarrhoea, nausea and abdominal pain.

The applicant for Maviret received scientific advice from the Agency during the development of the medicine.

Vosevi is composed of sofosbuvir (a nucleotide analogue non-structural protein NS5B polymerase inhibitor), velpatasvir (an HCV NS5A inhibitor), which were previously approved in other medicinal product, to which is added voxilaprevir (a novel pangenotypic HCV NS3/4A protease inhibitor).

The effects of Vosevi were studied in four main clinical trials involving over 1,700 patients. Two studies were in previously untreated patients and two in patients in whom previous treatment (in some cases with an NS5A inhibitor) had not cleared the virus. Treatment was given for 12 weeks in the previously treated patients and eight weeks in the untreated. The hepatitis C virus could no longer be detected in over 90% of patients 12 weeks after the end of treatment with Vosevi. Mild nausea, headache and diarrhoea were the most common side effects observed. Other potentially related adverse effects were decreased appetite, vomiting, muscle spasms and rash.

The opinions adopted by the CHMP at its June 2017 meeting are an intermediary step on Maviret's and Vosevi’s path to patient access. The CHMP opinions will now be sent to the European Commission for the adoption of decisions on EU-wide marketing authorisations through an accelerated procedure. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of these medicines in the context of the national health system of that country.

Notes
The applicant for Maviret is AbbVie Ltd.
The applicant for Vosevi is Gilead Sciences International Ltd.


Press Release
European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes
– Vosevi is Gilead’s Fourth Sofosbuvir-Based Treatment to Receive CHMP Positive Opinion for the Treatment of Chronic HCV Infection –
  
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 23, 2017-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vosevi®, an investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients. The data included in the application support the use of SOF/VEL/VOX in patients with and without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy, including 8 weeks of treatment for HCV direct-acting antiviral (DAA)-naïve patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen.
  
The CHMP positive opinion was adopted following an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.
  
The MAA for SOF/VEL/VOX is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4), evaluated 12 weeks of the single tablet regimen in patients with genotypes 1-6 HCV infection previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of SOF/VEL/VOX in DAA-naïve patients with genotypes 1-6 HCV infection. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with SOF/VEL/VOX (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with genotypes 1-6 HCV infection with and without cirrhosis treated with SOF/VEL/VOX (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and cirrhosis treated with SOF/VEL/VOX (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse events among patients who received SOF/VEL/VOX in the POLARIS studies were headache, fatigue, diarrhea and nausea.
  
Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®, for use in combination with other agents. The single tablet regimen of sofosbuvir (400 mg) and ledipasvir (90 mg) received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni®. The single tablet regimen of sofosbuvir (400 mg) and velpatasvir (100 mg) received marketing authorization in the European Union on July 8, 2016, under the trade name Epclusa®.
  
Gilead has also submitted a regulatory application for SOF/VEL/VOX in the United States. Gilead filed the New Drug Application for SOF/VEL/VOX on December 8, 2016, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act of August 8, 2017.
  
SOF/VEL/VOX is an investigational product and its safety and efficacy has not been established and is not approved anywhere globally.
http://www.gilead.com/news/press-releases/2017/6/european-chmp-adopts-positive-opinion-for-gileads-vosevi-sofosbuvirvelpatasvirvoxilaprevir-for-the-treatment-of-all-chronic-hepatitis-c-genotypes

Press Release
AbbVie Receives CHMP Positive Opinion for MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
- If approved, MAVIRET™ will provide a shorter, 8-week, pan-genotypic (GT1-6), once-daily option for the majority of people living with the hepatitis C virus (HCV)(1)*
- MAVIRET would also be an additional HCV treatment option for patients with specific treatment challenges, such as those with compensated cirrhosis, chronic kidney disease and genotype 3
- Final European Commission decision expected Q3 2017

NORTH CHICAGO, Ill., June 23, 2017 /PRNewswire/ -- AbbVie ABBV 0.32%, a global biopharmaceutical company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending marketing authorization of MAVIRET™ (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes (GT1-6), who comprise the majority of people living with HCV.1 The European Commission will now review the CHMP opinion and a final decision is expected in Q3 2017.

"MAVIRET represents a new generation of HCV therapy and has the potential to be a shorter, 8-week option for patients living with this serious, chronic illness," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Today's CHMP positive opinion takes us closer to delivering on AbbVie's mission to address continued unmet needs by bringing a new pan-genotypic option to people living with HCV in Europe."

The CHMP positive opinion is supported by 97.5 percent (n=807/828) SVR12 rates with 8 weeks of MAVIRET across GT1-6 chronic HCV infected patients without cirrhosis and who are new to treatment, with varied patient and viral characteristics.2 In an integrated analysis (n=2,265), less than 0.4 percent of patients discontinued treatment.3 The reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.3 The type and severity of adverse reactions in patients with cirrhosis were overall comparable to those seen in patients without cirrhosis.3

"While the HCV treatment landscape has transformed significantly over recent years, the disease continues to be a global public health problem and treatment challenges remain," said Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "In clinical studies, MAVIRET demonstrated high SVR rates across all genotypes of HCV patients (GT1-6). If approved, MAVIRET would remove many of the complexities of pre-treatment patient evaluation and has the potential to help facilitate the care and management of HCV."

MAVIRET is also intended to be an additional option for patients with specific treatment challenges. This includes chronic HCV patients with compensated cirrhosis (Child-Pugh A), and those who currently have limited treatment options, such as patients with severe chronic kidney disease, including those on dialysis, and patients infected with genotype 3.

The marketing authorization application (MAA) for MAVIRET is under an accelerated assessment by the EMA, which is granted to new medicines of major public health interest. The MAA evaluation is conducted under the centralized licensing procedure, and if approved, will result in a marketing authorization valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. AbbVie's investigational, pan-genotypic regimen has also been granted accelerated review designations by other regulatory authorities including the U.S. Food and Drug Administration and Japanese Ministry of Health, Labour and Welfare. MAVIRET is an investigational regimen and its safety and efficacy have not been established. 

About MAVIRET™ (glecaprevir/pibrentasvir)
AbbVie's MAVIRET™ (glecaprevir/pibrentasvir) clinical development program was designed to investigate a pan-genotypic, once-daily, ribavirin-free treatment with the potential to provide a faster path to virologic cure** for all major HCV genotypes (GT1-6) and with the goal of addressing specific treatment challenges, including compensated cirrhosis (Child-Pugh A), chronic kidney disease and genotype 3. MAVIRET is being evaluated as a potential 8-week, pan-genotypic treatment for the majority of people living with HCV,1 those without cirrhosis and who are new to treatment,* and regardless of viral and patient characteristics.

MAVIRET is a fixed-dose combination of two distinct antiviral agents: glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals ENTA 1.16% for HCV protease inhibitors and regimens that include protease inhibitors.

*Patients who are treatment-naive or had prior treatment experience with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. 
http://www.prnewswire.com/news-releases/abbvie-receives-chmp-positive-opinion-for-maviret-glecaprevirpibrentasvir-for-the-treatment-of-chronic-hepatitis-c-in-all-major-genotypes-gt1-6-630334863.html

Thursday, June 22, 2017

Listen Or Watch: Mark Sulkowski, MD discuss current treatment options for all HCV genotypes

Managing Chronic Hepatitis C in the Primary Care Setting: Best Practices From Screening to Treatment

Source: PeerView CME/CE Audio Podcast - Gastroenterology

Podcast
Listen to Mark Sulkowski, MD discuss HCV screening, diagnosis, noninvasive tests for assessing liver fibrosis and current treatment options for all HCV genotypes (1-6). Although this podcast and online CME is aimed at clinicians the use of clinical vignettes make it easy for patients to understand.

Either listen only to the podcast or click here to access the complete two part presentation. The second part of this learning activity will discuss: A Closer Look at Current Recommendations and Options for the Treatment of HCV. Topics include HCV guidelines, liver disease staging "FibroTest" and treating HCV according to genotype.

Pick Me
I highly suggest you choose the patient friendly online learning activity, the program is uncomplicated and easy to navigate. The user can skip through any part of the program by clicking on the "next" button located in the upper right hand corner of the presentation.



Managing Chronic Hepatitis C in the Primary Care Setting: Best Practices From Screening to Treatment
Activity Overview
Join us for one of the live, in-person meetings we will be carrying out at state chapters of the AAFP. A nationally recognized expert will review age-based and risk-based HCV screening recommendations, approaches to diagnosis, optimal treatment and counseling strategies for HCV-infected patients, and the parameters that warrant referral to specialist care.

Activity Description
Enormous progress has been made in recent years toward effectively treating and curing patients with chronic hepatitis C. However, at least half of the possible 7 million individuals infected with hepatitis C virus (HCV) in the US remain undiagnosed. The formidable task of increasing the number of patients diagnosed, and subsequently linked to appropriate care has fallen to primary care clinicians. In this activity, the guest speaker will address the challenges encountered by primary care clinicians faced with the increasing societal need to screen for HCV and make appropriate diagnoses. The importance of counseling patients regarding current HCV treatment options will be examined, and the guest speaker will also provide a discussion focused on identifying HCV-infected patients who can be managed in primary care versus those requiring linkage to specialist care.

Recommended Links
HCVguidelines.org

On This Blog
HCV Education

Helpful Links
Premier Hepatitis C Websites, Blogs and Support Forums