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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Thursday, September 28, 2017

The impact of an additional extra-hepatic primary malignancy on the outcomes of patients with hepatocellular carcinoma

The impact of an additional extra-hepatic primary malignancy on the outcomes of patients with hepatocellular carcinoma
Ming-Lun Yeh, Ching-I Huang, Chung-Feng Huang, Ming-Yen Hsieh, Zu-Yau Lin, Jee-Fu Huang, Chia-Yen Dai, Ming-Lung Yu, Shinn-Cherng Chen , Wan-Long Chuang Published: September 28,

2017 https://doi.org/10.1371/journal.pone.0184878

Full Text

Abstract
Background
The impact of additional extra-hepatic primary cancer (EHPC) on the outcomes of patients with hepatocellular carcinoma (HCC) remains uncertain.

Methods
We retrospectively analyzed the cancer registration database from a tertiary hospital in Southern Taiwan. Patients who were diagnosed with HCC from 2008 to 2012 were enrolled. Overall survival (OS), HCC-specific survival and recurrence after curative therapy were analyzed and compared between the patients with and the patients without EHPC.

Results
EHPC was found in 121/1506 (8.0%) patients. HCC patients with EHPC were older, more likely to be classified as Child-Pugh A, less likely to have viral hepatitis B or C, more likely to be single, had early stage HCC and received curative therapy for HCC. The OS did not significantly differ between the patients with and without EHPC(p = 0.061). However, significantly higher HCC-specific survival was observed in patients with EHPC (p<0.001), and a higher rate of non-HCC mortality was demonstrated in patients with EHPC (54.4% vs 9.3%). The subgroup analysis revealed better OS in patients with EHPC who were older than 65, had viral hepatitis B or C, had non-stage 1 HCC, had non-early stage BCLC and received non-curative therapy. Conversely, patients with HCC stage 1 who received curative therapy exhibited worse OS if they also had EHPC. The analysis of recurrence after curative therapy showed no difference between the two groups.

Conclusions
Our results implied that  extra-hepatic primary cancer (EHPC) did not affect overall survival (OS), but HCC-related survival was better in patients with EHPC. Based on these findings, the management of additional primary cancer is warranted.
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CDC - Mandating HCV Screening Increased Newly Diagnosed and Access to Care

Centers for Disease Control and Prevention
Morbidity and Mortality Weekly Report (MMWR)

Evaluation of the Impact of Mandating Health Care Providers to Offer Hepatitis C Virus Screening to All Persons Born During 1945–1965 — New York, 2014
Colleen A. Flanigan, MS1; Shu-Yin J. Leung, MA2; Kirsten A. Rowe, MS2; Wendy K. Levey, MA3; Andrea King, MPH4; Jamie N. Sommer, MS5; Johanne E. Morne, MS6; Howard A. Zucker, MD, JD7

Weekly / September 29, 2017 / 66(38);1023–1026

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.

Summary

What is already known about this topic?
Persons born during 1945–1965 account for approximately 75% of all hepatitis C virus (HCV) infections in the United States and 73% of HCV-associated mortality. Most infected persons do not know their status. In January 2014, New York became the first state to enact an HCV testing law, which is expected to increase the number of persons who are aware of their HCV status.

What is added by this report?
One year after implementation of the 2014 New York HCV Testing Law, marked increases were observed in the number of HCV screening tests and rates of testing. Increases were observed almost immediately after enactment of the law and remained steady at levels substantially higher than those in the years preceding enactment of the law. Smaller increases were noted in the number of persons who accessed HCV care following a positive HCV screening test.

What are the implications for public health practice?
State-level HCV testing laws could increase the number of persons who know their HCV status and of HCV-infected persons who are linked to care. With the availability of new therapies that can stop disease progression and provide a cure in most persons, testing and linkage to care for infected persons is likely to reduce HCV-related morbidity and liver cancer-associated mortality.

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Get your flu shots, US urges amid concerns about bad season

People 65 years and older, living with chronic liver disease, cirrhosis and liver transplant recipients are particularly at risk from the flu and are more susceptible to flu-related complications.

In The News
Flu Vaccine Cuts Rate of In-Hospital Deaths
October 5, 2017
Vaccination for influenza is associated with a reduction in adverse outcomes among adults who are hospitalized for influenza, according to a recent study......
Read the story here.....

 WASHINGTON (AP)
Get your flu shots, US urges amid concerns about bad season
By LAURAN NEERGAARD
It’s flu shot time, and health officials are bracing for a potentially miserable fall and winter.

The clues: The Southern Hemisphere, especially Australia, was hit hard over the past few months with a flu strain that’s notorious for causing severe illness, especially in seniors.

And in the U.S., small clusters of that so-called H3N2 flu already are popping up.

“We don’t know what’s going to happen but there’s a chance we could have a season similar to Australia,” Dr. Daniel Jernigan, influenza chief at the U.S. Centers for Disease Control and Prevention, told The Associated Press.
Read the story here.....

CDC - 2017-2018 Flu Season
CDC guidance for the 2017-2018 influenza season has been published.


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

Fall is Here. Have You Had Your Flu Shot?
September 21, 2017
By Lucinda K. Porter, RN   
Autumn is here, which means that flu season is around the corner. The flu is not a cold or “just a small bug.” Influenza is a potentially life-threatening illness, and if you have never had it, consider yourself lucky.
Continue reading....

Protect yourself with a free flu jab - living with hep C puts you at greater risk
Thu, 09/21/2017 - 17:09
People living with chronic liver disease are at particular risk of severe illness if they catch flu, because liver disease can affect their immune system, making it more difficult to fight off infection. People living with liver disease are 48 times more likely to die if they develop flu than healthy individuals.
Continue reading.....

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Environmental Contributions to Gastrointestinal and Liver Cancer in the Asia-Pacific Region

Journal of Gastroenterology and Hepatology
Accepted manuscript online: 28 SEP 2017

Environmental Contributions to Gastrointestinal and Liver Cancer in the Asia-Pacific Region
Kwang-Pil Ko1, Aesun Shin2, Sooyoung Cho2, Sue K. Park2, Keun-Young Yoo2,3

Full Text
Download PDF

Abstract 
In the Asia-Pacific region, gastric, colorectal and hepatocellular [liver] cancer show substantial regional variation in incidence consistent with the presence of important environmental factors. For gastric cancer, global incidence is concentrated in Asia with substantially higher rates in East Asia than in South-East Asia and Australia. The differences in incidence rates for gastric cancer in the Asia-Pacific region may be due, in part, to differences in the prevalence of H. pylori infection and the prevalence of H. pylori virulence factors. Smoking is also correlated with gastric cancer risk, and is responsible for the highest population attributable fraction among men in East Asia. Colorectal cancer has increased rapidly in incidence to become the third most common digestive cancer in Asia. According to cohort studies in Asia, smoking, alcohol use, obesity and physical inactivity increase the risk of colorectal cancer. Unlike West Asia, East Asia and Australia have high incidence rates for colorectal cancer that correlates with a high Human Development Index and a high prevalence of alcohol consumption and obesity. 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. The identification of the above and other environmental factors [currently under investigation] is central to the development and implementation of effective cancer control programs for the region. 

View article, here...
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Hepatitis C Formulary Choices for 2018: Will CVS Risk Looking Bad?

Hepatitis C Formulary Choices for 2018: Will CVS Risk Looking Bad?
Lawrence W. Abrams

Summary:
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.  
CVS Caremark has yet to announce its final choices for the HVC class despite promising that it would do so by mid-September 2017.

 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.


Click To Enlarge Image


In the United States, a pharmacy benefit manager (PBM) is a third-party administrator (TPA) of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, and state government employee plans.

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Behind The Headlines - Rates of newly diagnosed HIV increasing in over-50s

What is Behind the Headlines?
Each day the NHS Choices team selects health stories that are making headlines. These, along with the scientific articles behind the stories, are sent to Bazian, a leading provider of evidence-based healthcare information. Bazian's clinicians and scientists analyse the research and produce impartial evidence-based assessments, which are edited and published by NHS Choices.

Rates of newly diagnosed HIV increasing in over-50s
Wednesday September 27 2017

"HIV rises among over-50s as they neglect safe sex" is the headline from The Times.

The news is based on a European study that found more over-50s are being diagnosed with HIV compared with 12 years ago.

The study collected data on more than 360,000 people who had been newly diagnosed with HIV between 2004 and 2015 in Europe.

The researchers looked at infection rates over time according to age, route of transmission and country.

They found a number of differences between the patterns of infection and diagnosis in those aged 15 to 49 and in those aged 50 and over.

In the over-50s age group, though people remained more likely to become infected with HIV through heterosexual sex, the rate of infection in men who have sex with men and through drug injection had increased between 2004 and 2015.

But in younger adults, infection rates hadn't changed over time and men having sex with men remains the most likely route of transmission.

Older people were also more likely to be diagnosed when the disease was advanced compared with younger people.

This study highlights the need for people of all ages to be aware of the risks of HIV infection from unprotected sex.

HIV tests are free on the NHS and can be done in various places, including walk-in sexual health clinics. There are also home testing kits available.

Find out more about HIV tests and find HIV testing services near you.

Where did the story come from?
The study was carried out by researchers from the European Centre for Disease Prevention and Control in Sweden in collaboration with members of the European Union/European Economic Area HIV Surveillance Network.
It was funded by the European Centre for Disease Prevention and Control.
The study was published in the peer-reviewed journal The Lancet. The abstract is available free online.

Some of the media stories suggested the rise in HIV cases among older people was because this age group neglected messages about safer sex.

Mail Online went as far as saying: "Reckless sexual behaviour by divorcees is behind an increase in HIV cases among the over-50s, a major study suggests".

But the study didn't report on marital or relationship status, and didn't investigate sexual behaviour.
Several stories also focused on the number of older people who have been infected through heterosexual contact.

While heterosexual sex is the most likely transmission route for the over-50s age group, these rates have remained stable over the last 12 years.

It's the rate of infection from sex between men and from drug injection that has increased over time for this age group.

What kind of research was this?
This was an observational study using data sent by EU and EEC member states to the European Surveillance System for HIV.
This type of study is useful for identifying trends in diagnosis rates, but relies on accurate data reporting and collection.
Actual rates of HIV may be higher, as this only takes into account people who have had a positive test.

What did the research involve?
The researchers collated data from 31 countries on new cases of HIV diagnosed between January 2004 and December 2015.
The data was anonymised, but included:
  • date of diagnosis
  • age
  • sexual history
  • mode of transmission
  • country of birth
  • country of diagnosis
  • stage of disease according to CD4 count, with late diagnosis defined as less than 350 cells/µL and advanced disease as less than 200 cells/µL
They analysed the data according to two age groups: younger people aged 15 to 49 and older people aged 50 or over.

What were the basic results?
Overall, between 2004 and 2015:
  • There were 312,501 new cases of HIV in people aged 15 to 49, a rate of 11.4 per 100,000 people. This rate of infection didn't change over time.
  • There were 54,102 new cases of HIV in adults over 50, a rate of 2.6 per 100,000 people. The rate of infection increased by 2.1% per year over the 12-year period.
In the UK:
  • There was an increase of 3.6% in new diagnosis rates for older people between 2004 and 2015, from 3.1 to 4.32 new cases per 100,000 people. This is higher than the European average.
  • There was a 4% reduction in new diagnosis rates for younger adults during this time.
Diagnosis by age group:
  • Older people were more likely to have a delayed diagnosis, with significantly lower CD4 counts than younger adults.
Men compared with women:
  • Over the 12-year period, the average diagnosis rate for older men increased from 3.5 to 4.8 per 100,000, while older women had an increase from 1.0 to 1.2 per 100,000.
  • Over the same period, the average rate of diagnosis increased by 1.4% in younger men and reduced by 4.8% for younger women.
Mode of transmission in 2015:
  • The most common route of infection for older adults was heterosexual contact (42.4% of cases), followed by sex between men (30.3%), "other" or unknown causes (24.6%), and injecting drugs (2.6%).
  • For younger adults, sex between men was the most common route of infection (45.1% of cases), followed by heterosexual contact (30.8%), other or unknown (19.5%), and injecting drugs (4.6%).
Changes in mode of transmission from 2004 to 2015:
  • The rate of HIV infection from heterosexual sex remained stable in older people, and decreased in younger people.
  • Infection resulting from injecting drugs increased in older people and decreased in younger people.
  • The rates of HIV infection in men who have sex with men increased in both age groups, but more so in older people at 5.8% compared with 2.3%.
How did the researchers interpret the results?The researchers concluded that the "increasing new HIV diagnoses among older adults point towards the compelling need to heighten awareness among healthcare providers and deliver more targeted prevention interventions for this age group and the total adult population".

They were also careful to say that "no data for the reasons behind such an increase [in new HIV diagnoses in older people] have been published".

Conclusion
This was a well-conducted study and the results are likely to be reliable, though there are some limitations, including missing data.

For example, the researchers had no information on the migration status or CD4 count (an indicator for stage of the disease) for a quarter of cases.

This study found that although the overall rate of infection is higher in younger people, this has remained stable over the last 12 years while the rate of infection in older people has increased.
Some of the media stories focused on the finding that older people are most likely to have become infected through heterosexual sex.

While true, this is nothing new: the rate of infection from heterosexual sex has in fact been stable for over-50s over the study period, whereas the rates of infection in men having sex with men and drug use have both increased for this age group.

What makes further analysis of this trend difficult to interpret is the high proportion of people for whom "other" or "unknown" infection was recorded.

The finding that older people were more likely to have a delayed diagnosis highlights the importance of HIV testing for people of all ages who are at risk of infection.

What's of most concern is that the rates of infection remain high in all age groups despite public health campaigns about practising safe sex.

HIV tests are free on the NHS and can be done in various places, including walk-in sexual health clinics. There are also home testing kits available.

Find out more about HIV tests and find HIV testing services near you.
Analysis by Bazian
Edited by NHS Choices
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Hospital Impact—Pharmacy benefit managers are a lot like car dealers

Hospital Impact—Pharmacy benefit managers are a lot like car dealers
by Sheila Arquette |
Sep 28, 2017 8:26am 
The system for car purchases—where Americans buy cars from dealerships instead of directly from the companies making them—makes it hard to know how much it actually costs to make a car, so it’s hard to know you’re getting the best price. 
The same system applies to buying lifesaving prescriptions. Drug manufacturers set a list price, but consumers rarely pay that, and how much drugs should really cost is uncertain.
Continue reading.... 

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Factors associated with hepatitis C prevalence differ by the stage of liver fibrosis

Factors associated with hepatitis C prevalence differ by the stage of liver fibrosis: A cross-sectional study in the general population in Poland, 2012-2016
Magdalena Rosińska , Natalia Parda, Agnieszka Kołakowska, Paulina Godzik, Karolina Zakrzewska, Kazimierz Madaliński, Andrzej Zieliński, Anna Boguradzka, Rafał Gierczyński, Małgorzata Stępień Published: September 20, 2017

https://doi.org/10.1371/journal.pone.0185055

Full Text

Abstract
Background & aims
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.

Methods
A cross-sectional study was conducted in 2012–2016 adopting a stratified random sampling of primary health care units followed by systematic sampling of patients within each unit. Study participants filled a questionnaire and donated blood for laboratory HCV testing. Additionally, the results of liver function tests and platelet count were collected to calculate APRI and FIB-4 scores. Cases were classified according to the level of fibrosis: ‘significant fibrosis’ (APRI≥0.7 or FIB4≥1.45) and ‘no significant fibrosis’ (APRI<0.7 and FIB4<1.45).

Results
Of 21 875 study participants, 102 were HCV-RNA positive. Prevalence of HCV infections and significant fibrosis was estimated at 0.47% (95% CI 0.38% - 0.57%) and 0.12% (0.08% - 0.17%), respectively. Cases with significant fibrosis accounted for 51.6% (33.4%-69.9%) in men and 34.4% (17.3%-51.4%) in women. There was no correlation between the HCV prevalence and age. Blood transfusion prior to 1992 strongly predicted significant fibrosis as did the history of injecting drug use (IDU) and ever having an HCV-infected sexual partner in men and caesarean sections in women. Factors associated with HCV infection without significant fibrosis were tattooing in men and younger age in women. We acknowledge limited possibility to study the associations between IDU and ever having HCV-infected sexual partner, given small sample sizes for these exposures.

Conclusions
As no clear birth cohort affected by HCV could be identified, risk factor-based screening in the general population should be considered, taking into account the association between the increased risk of liver fibrosis and the history of transfusion prior to 1992 and caesarean sections.

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Wednesday, September 27, 2017

FDA conducts global operation to protect consumers from rogue online pharmacies


FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online
September 25, 2017
Illegally marketed opioids are among the products targeted, along with the websites that sell them, during international Operation Pangea X

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.

These actions were part of a major global operation that the FDA participated in to target illegal drugs being marketed online, and shipped and distributed through the postal system, directly to American consumers. Among other actions, the FDA also issued warning letters to the operators of a majority of the illegal websites that were targeted in the operation and worked with internet registrars to confiscate certain websites. Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances. Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk by individuals who put financial gains above patient safety,” said FDA Commissioner Scott Gottlieb, M.D. “The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country. Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids. As part of a broader effort to target this illegal activity, in addition to the operation that we are announcing today, the FDA is also working on a comprehensive Enforcement Operations Work Plan that’s focused on combating the sale of foreign unapproved drugs to U.S. consumers and aimed at increasing the scope of our operations related to these risks.”

This effort was part of Operation Pangea X, as part of the 10th annual International Internet Week of Action (IIWA), a global cooperative effort led by Interpol, to combat the unlawful sale and distribution of illegal and potentially counterfeit or substandard medical products on the internet. The IIWA ran from Sept. 12 to Sept. 19, 2017. The goal of Operation Pangea X was to identify the makers and distributors of illegal prescription drug products and to remove these products from the supply chain. Commissioner Gottlieb joined efforts to kick off the operation with a visit he made to the International Mail Facility (IMF) in New York on Aug. 25, 2017.

During Operation Pangea X, the FDA sent 13 warning letters to the operators of 401 websites. The FDA also seized nearly 100 website domain names, such as buyhydrocodoneonline.com, canadian-pharmacy24x7.com and buyklonopin.com. FDA inspectors, in collaboration with other federal agencies, screened packages suspected of containing illegal drug products at IMFs in Chicago, Miami and New York during the IIWA. These screenings resulted in nearly 500 parcels being detained for appropriate FDA compliance follow up. Parcels found in violation of the Federal Food, Drug, and Cosmetic Act will be refused entry into the country.

“The FDA is proud to partner with our international counterparts on this important operation,” Commissioner Gottlieb said. “However, our work to fight illegal online pharmacies is not over. In addition to the multifaceted work plan we will soon unveil, we’ve recently tripled the staff we have in the IMFs to improve our ability to inspect packages that are suspected of containing illegal drugs, and we have doubled the number of cybercrime and port of entry special agents for the Office of Criminal Investigations. These efforts are part of a much broader work plan that the FDA is developing aimed at beefing up our efforts to interdict illegal drugs.”

In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses. The FDA encourages consumers to report suspected criminal activity to the FDA’s Office of Criminal Investigation.

The FDA also provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy.

The IIWA is a collaborative effort between the FDA, the U.S. Attorney’s Office for the District of Colorado, the U.S. Department of Homeland Security, National Intellectual Property Rights Coordination Center, Interpol, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the European Heads of Medicines Agencies Working Group of Enforcement Officers, the U.S. Drug Enforcement Administration, the pharmaceutical industry and national health and law enforcement agencies from 115 participating countries.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Barriers to hepatitis C treatment in the era of direct-acting anti-viral agents

Barriers to hepatitis C treatment in the era of direct-acting anti-viral agents
Article Summary @ GastroHep
Reasons for lack of treatment included waiting for newer therapy, co-morbidities and alcohol/drug abuse. Dr Kanwal's team comments, "Half of patients with established HCV care were followed-up in the direct-acting anti-virals era and only 29% received DAAs."

Alimentary Pharmacology & Therapeutics
ORIGINAL ARTICLE

Full Text Article:  Available Online

 Barriers to hepatitis C treatment in the era of direct-acting anti-viral agents
Authors M. Lin, J. Kramer, D. White, Y. Cao, S. Tavakoli-Tabasi, S. Madu, D. Smith, S. M. Asch, H. B. El-Serag, F. Kanwal

First published: 26 September 2017
DOI: 10.1111/apt.14328

Summary
Background
Direct-acting anti-virals (DAA) are safe, effective treatment of hepatitis C virus (HCV). Suboptimal linkage to specialists and access to DAAs are the leading barriers to treatment; however, data are limited.

Aim
To determine predictors of follow-up, receipt of DAAs, and reasons for the lack thereof.

Methods
We used clinical data from retrospective cohort of HCV-infected patients with previously established HCV care in the US Department of Veterans Affairs to examine predictors of follow-up in HCV clinics and DAA treatment (during 12/1/2013-4/30/2015). We then conducted a structured review of medical charts of HCV patients to determine reasons for lack of follow-up and treatment.

Results
We identified 84 221 veterans who were previously seen in HCV clinics during the pre-DAA era. Of these, 47 165 (56.0%) followed-up in HCV specialty clinics, 13 532 (28.7%) of whom received DAAs. Older age, prior treatment, presence of cirrhosis or HCC, HIV/HBV co-infection and psychiatric illness were predictors of follow-up. Alcohol/drug abuse and medical co-morbidity were predictors of lack of treatment. Of the 905 prospectively recruited patients, 56.2% patients had a specialist visit and 28% received DAAs. Common reasons for lack of follow-up were relocation (n = 148, 37.4%) and missed/cancelled appointments (n = 63, 15.9%). Reasons for lack of treatment included waiting for newer therapy (n = 99, 38.8%), co-morbidities (n = 66, 25.9%) and alcohol/drug abuse (n = 63, 24.7%).

Conclusions
Half of patients with established HCV care were followed-up in the DAA era and only 29% received DAAs. Targeted efforts focusing on patient and system-levels may improve the reach of treatment with the new DAAs.

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People enrolled in harm-reduction program five times more likely to go into recovery

Recommended Reading 
"We're seeing infection hotspots," Talal said, noting that this is partly a result of the opioid epidemic, particularly where needle exchange programs, for example, are not available.

Regardless of active drug use or Opioid agonist therapy (OAT), patients who received DAA therapy at an urban primary care clinic achieved high HCV cure rates. We found no clinical evidence to justify restricting access to HCV treatment for patients actively using drugs and/or receiving OAT.

Opioid epidemic causing rise in hepatitis C infections and other serious illnesses
Many Americans now know that, over the past decade, opioid addiction and deaths from opioid overdose in the U.S. have skyrocketed.

HuffPost:
‘Our Compassion Is Being Challenged’: A West Virginia Doctor’s War Against Opioids
By Tom Kutsch
09/27/2017 08:41 am ET
Brumage, executive director and health officer of the Kanawha-Charleston Health Department, runs a harm-reduction program that includes overseeing a clean needle exchange for opioid users. It’s powered not with federal or state dollars, but with donations, grants and volunteers. In just over two years, it has grown as large as a similar program run by the city of Baltimore after 20 years ― serving some 3,700 patients. People enrolled in a harm-reduction program are five times more likely to go into recovery than if they’re not a part of it, he said...
Can you briefly describe the extent of the problem that you’re up against with the opioid crisis?
As you really peel back the onion, it’s not an epidemic. It’s an epidemic of epidemics, because you have everything from overdose deaths to the hepatitis C rate, which is now the No. 1 infectious killer in America. You have children who have been abandoned because their parents are using drugs. You have needles which are in public spaces, which is an environmental hazard. And just so many other aspects of this. This is a very, very complex public health emergency. And I’m not quite certain that most Americans or even most policymakers have grappled with the true complexities of where we are on a day-to-day basis.
Continue reading......
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A documentary following the lives of three people in America who have been cured of Hepatitis C

A documentary following the lives of three people in America who have been cured of
Hepatitis C

https://www.youtube.com/watch?v=_0x_32KX1ZY

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Rising Rates of Hepatocellular Carcinoma Leading to Liver Transplantation in Baby Boomer Generation with Chronic Hepatitis C

Rising Rates of Hepatocellular Carcinoma Leading to Liver Transplantation in Baby Boomer Generation with Chronic Hepatitis C, Alcohol Liver Disease, and Nonalcoholic Steatohepatitis-Related Liver Disease
George Cholankeril 1, Eric R. Yoo 2, Ryan B. Perumpail 3, Andy Liu 4, Jeevin S. Sandhu 1, Satheesh Nair 5, Menghan Hu 6 and Aijaz Ahmed 1,*

Received: 28 August 2017 / Accepted: 25 September 2017 / Published: 26 September 2017

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Abstract
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). We performed a retrospective analysis using the United Network for Organ Sharing (UNOS)/Organ Procurement Transplant Network (OPTN) database from 2003 to 2014 to compare HCC-related liver transplant surgery trends between two cohorts—the BB and non-BB—with a secondary diagnosis of HCV, ALD, or NASH. From 2003–2014, there were a total of 8313 liver transplant recipients for the indication of HCC secondary to HCV, ALD, or NASH. Of the total, 6658 (80.1%) HCC-related liver transplant recipients were BB. The number of liver transplant surgeries for the indication of HCC increased significantly in NASH (+1327%), HCV (+382%), and ALD (+286%) during the study period. The proportion of BB who underwent LT for HCC was the highest in HCV (84.7%), followed by NASH (70.3%) and ALD (64.7%). The recommendations for birth-cohort specific HCV screening stemmed from a greater understanding of the high prevalence of chronic HCV and HCV-related HCC within BB. The rising number of HCC-related LT among BB with ALD and NASH suggests the need for increased awareness and improved preventative screening/surveillance measures within NASH and ALD cohorts as well.

Table 1. Baby Boomer HCC Liver Transplantation Annual Trends with HCV, ALD, and NASH; UNOS 2003–2014.
HCVNASHALD
BB †OverallPercentBBOverallPercentBBOverallPercent
200314921669.0%111957.9%223759.5%
200416722474.6%203852.6%163348.5%
200521829773.4%224746.8%285947.5%
200627135177.2%377152.1%367548.0%
200737346180.9%549060.0%388544.7%
200842750584.6%8012464.5%487960.8%
200946054085.2%9615163.6%567673.7%
201049258584.1%10113276.5%456668.2%
201156763289.7%9112871.1%8110775.7%
201261970787.6%12716875.6%7710672.6%
201364672289.5%15319180.1%699275.0%
201471979490.6%15719182.2%8511474.6%
Total5108603484.7%949135070.3%60192964.7%
APC ‡+2.6%+3.5%+2.1%
† BB = Baby Boomer; ‡ APC = Annual Percent Change.
Table 2. Demographic and Clinical Characteristics in HCC Liver Transplant Recipients among Baby Boomers versus Non-Baby Boomers; UNOS 2003–2014.
HCVNASHALD
BB
n = 5108		Non-BB
n = 926		pBB
n = 949		Non-BB
n = 401		pBB
n = 601		Non-BB
n = 328		p
Age, median5766<0.015967<0.015867<0.01
Gender
 Male80.3%66.1%<0.0173.0%65.1%<0.0190.5%89.6%0.67
Ethnicity
 White67.7%59.1%<0.0175.9%77.6%0.5069.6%78.7%<0.01
 Black13.3%11.1%0.075.4%3.7%0.203.8%1.2%0.02
 Hispanic13.6%17.6%<0.0114.7%14.5%0.9314.7%14.5%0.14
 Asian4.1%11.1%<0.012.6%2.2%0.673.0%1.2%0.89
 Other9.9%1.1%<0.011.4%2.0%0.498.9%4.4%<0.05
HE40.2%34.8%<0.0143.4%41.4%<0.5050.3%43.9%0.09
Diabetes23.6%28.4%<0.0147.7%47.7%<0.0135.1%33.5%0.63
Ascites50.9%46.8%<0.0555.2%55.2%0.8468.6%62.5%0.06

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Japan - AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) of Chronic Hepatitis C in All Major Genotypes (GT1-6)

AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in Japan

- MAVIRET is the first and only 8-week treatment for genotype 1 and 2 hepatitis C virus (HCV) infected patients without cirrhosis and who are new to DAA treatment* in Japan
- Approval is supported by a 99 percent virologic cure** rate in these patients, who comprise the majority of people living with HCV (1,2)
- AbbVie's pan-genotypic, ribavirin-free treatment was recently approved for use in the European Union and United States
- Japan has one of the highest rates of HCV infection in the industrialized world (2,3)

NORTH CHICAGO, Ill., 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 (GT1-6). MAVIRET is the first and only 8-week treatment option in Japan for GT1 and GT2 HCV infected patients without cirrhosis and who are new to direct-acting antiviral (DAA) treatment,* including those with chronic kidney disease (CKD). These patients represent the majority of people living with HCV in Japan.2

In Japan, MAVIRET is also a 12-week option for patients infected with GT3-6, patients with specific treatment challenges including patients with compensated cirrhosis, and those with limited treatment options such as those not cured with previous DAA treatment.1

"New pan-genotypic, ribavirin-free treatments like MAVIRET that have a short treatment duration have the potential to become a first-line HCV treatment option and will also be fundamental to addressing challenges that remain in the care of this serious and complex disease in Japan," said Hiromitsu Kumada, M.D., Director General, Department of Hepatology, Toranomon Hospital Kajigaya, Kanagawa, Japan. "High cure rates were shown in dedicated clinical trials with MAVIRET in Japanese patients, as well as a favorable tolerability profile, demonstrating the potential of MAVIRET to meet evolving unmet needs for both patients and physicians."

Japan has one of the highest rates of HCV infection in the industrialized world, with approximately 2 million people living with the disease, 97 percent of whom are infected with GT1 and GT2 chronic HCV.2,3 Japan also has the highest prevalence of liver cancer amongst the industrialized countries with chronic hepatitis C and its complications being the leading causes.4

"The human, social and economic burden of HCV to individuals in Japan can be significant as the disease progresses to the later stages," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie is committed to working with health authorities to get MAVIRET to physicians and patients as quickly as possible, so that the opportunity for virologic cure in as short as 8 weeks may be a reality for the majority of people living with HCV."

Authorization is supported by data from the Phase 3 CERTAIN studies in Japanese patients and supplemented with registrational studies from AbbVie's global clinical development program for MAVIRET. With just 8 weeks of treatment, a 99 percent (n=226/229) SVR12 rate was achieved across GT1 and GT2 chronic HCV infected Japanese patients without cirrhosis and who were new to DAA treatment.*1 This high SVR12 rate was achieved in patients with varied patient and viral characteristics and including those with CKD.1 In patients not cured with previous DAA treatment, a 94 percent (n=31/33) SVR12 rate was achieved with 12 weeks of treatment. The most commonly reported adverse reactions were pruritus, headache, malaise and blood bilirubin increase (none of which had an incidence greater than 5 percent).1

MAVIRET combines two new, potent§ direct-acting antivirals that target and inhibit proteins essential for the replication of the hepatitis C virus. The presence of more difficult-to-treat genotypes or baseline mutations that are commonly associated with resistance have been shown to have minimal impact on efficacy of MAVIRET.

Approval of MAVIRET follows priority review, designated by the Japanese MHLW to certain medicines based on the clinical usefulness of the treatment and severity of the disease. AbbVie's pan-genotypic treatment was also recently granted marketing authorization by the European Commission and approved by the U.S. Food and Drug Administration as an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.

*Patients without previous treatment that included a DAA (direct-acting antiviral) NS3/4A protease inhibitor, NS5A inhibitor and/or NS5B polymerase inhibitor.
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

Based on EC50 values of glecaprevir and pibrentasvir against full-length or chimeric replicons encoding NS3 or NS5A from laboratory strains and chimeric replicons from clinical isolates.

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