Friday, September 29, 2017

TGIF HCV Review - Merck Discontinues MK-3682B and MK-3682C Development Programs

Happy Friday! Here are a few updates on viral hepatitis you may have missed this week.

Quick Links
Weekly news recap at HepCBC.

In The News
Merck Discontinues MK-3682B and MK-3682C Development Programs
Sep 29, 2017
Company to Focus on Maximizing the Potential of ZEPATIER ® (Elbasvir and Grazoprevir)
Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced its strategic decision to discontinue the development of the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/ uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection. This decision was made based on a review of available Phase 2 efficacy data and in consideration of the evolving marketplace and the growing number of treatment options available for patients with chronic HCV infection, including ZEPATIER® (elbasvir and grazoprevir).

8 top stories on injection drug users, HIV/HCV coinfection
Sep 29, 2017
At the recent International Symposium on Hepatitis Care in Substance Users, researchers presented new data on injection drug users and their unique risk factors for hepatitis C infection and transmission, including younger age, and the critical need for HCV education among addiction clinic workers.

Flu Updates
Sept 29, 2017



Read all past and current Seasonal Flu Vaccine articles posted on this blog.

Sep 28,2017
by Liz Highleyman
The FDA recently approved two new combination regimens for hepatitis C, raising the question of whether further drug development is warranted in this area.
Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir) and AbbVie's Mavyret (glecaprevir/pibrentasvir) work against all hepatitis C virus (HCV) genotypes, with cure rates exceeding 95%. And Mavyret, which many patients will be able to take for just 8 weeks, brings a lower cost option to the market.* Free registration required

 CDC
Weekly / September 29, 2017 / 66(38);1031
QuickStats: Death Rates* for Chronic Liver Disease and Cirrhosis, by Sex and Age Group — National Vital Statistics System, United States, 2000 and 2015
From 2000 to 2015, death rates for chronic liver disease and cirrhosis in the United States increased 31% (from 20.1 per 100,000 to 26.4) among persons aged 45–64 years. Rates in that age group increased 21% for men (from 29.8 to 36.2) and 57% for women (from 10.8 to 17.0). Among persons aged 25–44 years, the death rate for men decreased 10% (from 6.1 to 5.5), and the rate for women increased 18% (from 2.8 to 3.3). Overall, among persons aged ≥65 years, rates increased 3% (from 29.4 to 30.2). Death rates for both men and women increased with age.

CDC - Mandating HCV Screening Increased Newly Diagnosed and Access to Care
Sept 28, 2017
Implementation of the New York law mandating health care providers to offer HCV testing to persons born during 1945–1965 was associated with an increase in HCV testing, and an increase in the percentage of persons with newly diagnosed HCV infections who were linked to care. Marked increases in the number of HCV tests performed and rates of testing were observed immediately after enactment of the law and remained steady over a 12-month period. Smaller increases were noted in the number of persons who accessed care after receiving a positive HCV screening test result....

Related: Does Mandating HCV Screening Among Baby Boomers Improve Outcomes?

Does Sustained Virologic Response Improve Glycemic Control in HCV?
Sept 29, 2017
Eradicating hepatitis C virus (HCV) infection with direct-acting antiviral (DAA) agents in patients with diabetes reduced the amount of diabetic medication needed and significantly reduced the need for insulin, according to a study in Diabetes Care.

Hepatitis C Formulary Choices for 2018: Will CVS Risk Looking Bad?
Sep 28, 2017
AbbVie’s aggressive list pricing for its new Hepatitis C Virus (HCV) drug Mavyret is disruptive to the current PBM business model.  It essentially asks PBMs to align with client interests by adding a cost-effective drug to their national formularies despite little to no possibility for retained rebates.
On September 15, 2017 Express Scripts (ESRX) chose to align with client interests by opening up the HCV therapeutic class to include Mavyret as well as other HCV drugs previously excluded.   If CVS chooses not to add Mavyret, it will be a sign that CVS is so desperate for rebate income that it is willing incur a very public case of misaligned interests.

FDA improves access to reports of adverse drug reactions
Sep 28, 2017
The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

Japan - AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) of Chronic Hepatitis C in All Major Genotypes (GT1-6)
Sept. 27, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved MAVIRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes
Sep 26,2017
Most patients with hepatitis C genotype 2, 4, 5 or 6 who received Mavyret for 8 weeks achieved sustained virologic response with a high safety profile, according to results from three phase 3 studies. The rate of virologic failure was less than 1%.

Communication of the Alcohol Guidelines ‘needs to be improved’
Posted on 25th September 2017
A study published today concludes that more needs to be done to communicate the drinking guidelines to the public. The study, published in the Journal …

Fibrosis
September 28, 2017
There is a considerable burden of hepatitis C in Europe related to the lack of prompt diagnosis. We aimed to estimate the prevalence and related risk factors of HCV infections by the stages of liver fibrosis, using non-invasive methods, to understand testing needs in Poland.

Accepted manuscript online:
Article provided by @HenryEChang via Twitter

Cirrhosis
Muscle Volume Loss Linked to Mortality in Patients with Liver Cirrhosis
September 26, 2017
In a recent study, researchers examined whether muscle volume loss or portal hypertension were predictive of mortality among patients with liver cirrhosis.

Cirrhosis deaths: more action is needed now
Gut Health - Deaths from liver disease are soaring and people in deprived areas are at far higher risk. Now doctors are calling for more action to cut the death toll.

In case you missed it
Study of prevalence and pattern of peripheral neuropathy in patients with liver cirrhosis
Mahim Mittal, Pavan Kumar Singh, Sonu Kurian
Peripheral neuropathy is present in more than half of cirrhosis patients and is unrelated to etiology and nutritional status but related to the severity of cirrhosis.
LINK: Download Full Text - PDF

Liver Transplant
Liver transplant, cancer stage increase HCC care costs, survival time
September 28, 2017
A recently published analysis of veterans with hepatocellular carcinoma showed that receipt of liver transplantation, Barcelona Clinic Liver Cancer stage and…

Searching For A Fairer Way To Distribute Donor Livers
September 26, 2017
Patel and Su are among more than 16,000 Americans waiting for a liver transplant because of conditions such as hepatitis, cancer or cirrhosis. But only about 7,000 livers are donated each year. So they know their odds aren't great.

Rising Rates of Hepatocellular Carcinoma Leading to Liver Transplantation in Baby Boomer Generation with Chronic Hepatitis C
25 September 2017
We aim to study the impact of the baby boomer (BB) generation, a birth-specific cohort (born 1945–1965) on hepatocellular carcinoma (HCC)-related liver transplantation (LT) in patients with chronic hepatitis C virus (HCV), alcoholic liver disease (ALD), and non-alcoholic steatohepatitis (NASH).

Liver Cancer
Quantitative imaging predicts microvascular invasion in hepatocellular carcinoma
Last Updated: 2017-09-28
By Will Boggs MD
NEW YORK (Reuters Health) - Quantitative image analysis of preoperative CT scans can be used to predict microvascular invasion in patients with hepatocellular carcinoma (HCC), researchers report...

Reduce Liver Cancer Risk and Join a Liver Cancer Awareness Twitter Chat Oct. 12
October is Liver Cancer Awareness Month and it’s time to “chat” about reducing liver cancer, particularly in people living with hepatitis B and C. On Thursday, Oct. 12, representatives from Hepatitis B Foundation, CDC’s Division of Viral Hepatitis, and NASTAD (the National Alliance of State and Territorial Aids Directors) will co-host a twitter chat at 2 p.m. EST using the hashtag #liverchat.

Estrogen receptor expression in chronic hepatitis C and hepatocellular carcinoma pathogenesis
World J Gastroenterol. Oct 7, 2017
AIM - To investigate gender-specific liver estrogen receptor (ER) expression in normal subjects and patients with hepatitis C virus (HCV)-related cirrhosis and hepatocellular carcinoma (HCC). Various epidemiological studies around the globe have recognized the role of gender bias in the progression of HCV infection to chronic liver disease and cirrhosis due to poor therapeutic responses or further development of HCV-related HCC in these patients...

Environmental Contributions to Gastrointestinal and Liver Cancer in the Asia-Pacific Region
September 28, 2017
Liver cancer is the second most common digestive cancer in Asia. The high incidence of liver cancer in East Asia and South-East Asia is concordant with the high prevalence of hepatitis B virus and hepatitis C virus infection. Other important risk factors include alcohol use, smoking, and diabetes.

New At Clinical Care Options
* Free registration required
Downloadable Slides: Latest Developments in the Treatment of HCC in Veterans
9/19/2017          
Download this slideset to review the latest data on best practices for the care of patients with HCC across the disease spectrum and to address specific issues unique to treating veterans.   

Quick Reference Guide: HCV Screening and Testing
9/26/2017          
Download this practical guide to help you appropriately screen your patients for hepatitis C virus infection
                                    
At a Glance: Prescribing Information for HCV Treatments
9/26/2017
Download this practical reference sheet on all the FDA-approved regimens for treating hepatitis C virus 
Start here.....

Updated
HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C
September 21, 2017
New Genotype 1 & 3 Treatment-Naïve & Treatment-Experienced
This version of the guidance has been updated to reflect several important developments, including the recent approvals of glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir. Updated recommendations reflecting these approvals are provided throughout the guidance.

Blog Updates From Around The Web
Liver Disease and Muscle Loss
September 27, 2017
By Kimberly Morgan Bossley
Liver Disease can cause severe muscle loss and weakness..

September 27, 2017
By Connie M. Welch
Hepatitis C patients have many obstacles to fight and deal with, one of the first and biggest is stigma, the danger of labels...

September 25, 2017
By Lucinda K. Porter, RN
Before the Affordable Health Care Act (Obamacare), I was uninsurable. Hepatitis C marked me as having a preexisting condition.  This meant that insurance companies could deny me insurance...

By Kare Hoyt - September 28, 2017
It’s nearly impossible to get medical care without feeling judgment about Hepatitis C. You get used to it, but when you don’t feel good and need help, you expect professionals to show...

Dread and Test Results 
By Debra Walters - September 27, 2017
My first dance with Hepatitis C treatment was in 2008-2009. The only option was Ribavirin and peginterferon, so I signed up for a study at Baylor College of Medicine. I was randomized...

Living with PTSD and Hepatitis C (Part 3) 
By Karen Hoyt - September 25, 2017
Check out Part 1 and Part 2 of Karen’s series on PTSD. Post-Traumatic Stress Disorder or PTSD can come from a lot of little traumas and hepatitis C is one of them....

Off The Cuff
The British Liver Trust highlights the common causes of hepatitis A
Published in July, download it, here

In obese adults and children, the microbiome plays key role in one of the most common and serious liver diseases
September 29, 2017
BUFFALO, N.Y. — New clues to non-alcoholic fatty liver disease (NAFLD), which affects nearly all obese adults and a rising percentage of obese children, have been reported in a paper published earlier this month in the journal Gut.

The cost of drugs confounds this gastroenterologist
Michael Kirsch, MD | Meds | September 25, 2017
Most of us do not know the basics of economics, although we should. It impacts every one of us every day that we are alive. Yet, for most of us, once we get beyond the law of supply and demand, our knowledge of the subject starts to vaporize. I can't explain fiscal or monetary policy. While I regard economics as a science, it seems that experts routinely interpret data differently, ...

Abdominal wall pain as its own diagnosis
Sep 2017
By Mollie Durkin
Internists can diagnose chronic abdominal wall pain with a simple physical exam and some savvy history taking, experts said, and reassure patients that their condition is not serious and may respond to treatment.... 

Posted September 28, 2017 
Monique Tello, MD, MPH, Contributing Editor Plenty of research supports the common-sense notion that a healthy lifestyle can prevent or treat many diseases. A diet high in fruits, veggies, whole grains, and plant protein and low in processed carbs, added sugars, saturated fats; regular physical activity; and emotional well-being are the potent treatments that can prevent the need for or even…

Enjoy the rest of your day!
Tina

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