Tuesday, February 19, 2019

Understanding Liver Disease with Dr. Joe Galati

In this timeless patient-friendly video, Dr. Joe Galati will explain medical jargon used to describe common and possible severe symptoms of liver disease, relaunched this month by Liver Specialists of Texas, located in Houston.

Topics
Varices
Encephalopathy - Video
Ascites
Peritonitis infection of ascitic fluid
Fever
Abdominal Pain
Shortness of breath
Chest Pain
Headache
Jaundice
Liver transplant evaluation



Links
View additional videos on Dr. Galati's YouTube Channel, connect on Facebook, follow on twitter, or visit both his blog and website.

Monday, February 18, 2019

The Year in Viral Hepatitis: Part 1

Gastroenterology & Endoscopy News
The Year in Viral Hepatitis: Part 1
Feb 18, 2019
Although 2018 saw no major drug approvals or dramatic breakthroughs for viral hepatitis, researchers continued to make progress against these infections. We asked Drs. Ira Jacobson and Saikiran Kilaru for an overview of the most important findings reported last year.

*** Free registration may be required to view article

Friday, February 15, 2019

Hepatitis C and HIV/AIDS Medications Costliest Group of Outpatient Prescription Drugs for Medicaid

Kaiser Family Foundation
Analysis Finds that Medications for Hepatitis C and HIV/AIDS Are the Costliest Group of Outpatient Prescription Drugs for Medicaid, While Diabetes Drugs Have Posted the Sharpest Rise in Costs 
Chris Lee
Published: Feb 15, 2019
Antiviral medications, including those that treat hepatitis C and HIV/AIDS, cost the Medicaid program more money (before rebates) than any other group of outpatient prescription drugs for each year from 2014 to 2017, according to a new KFF analysis.

The analysis of utilization and spending trends finds that antivirals accounted for more than 13 percent of the $63.6 billion in Medicaid outpatient drug spending pre-rebates in 2017 — a level disproportionate to their utilization and a reflection of the high cost of these drugs. Drugs for diabetes were the second most costly group that year, accounting for 10 percent of Medicaid outpatient drug spending before rebates. Spending for diabetes drugs rose faster than for any other group, nearly doubling from 2014 to 2017 — largely due to the rising price of insulin.




On This Blog 
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions implemented by private insurers/Medicaid/Medicare and the effectiveness, safety and availability of generic versions of hepatitis C medications. 

Thursday, February 14, 2019

Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C

Page updated with additional links on Feb 14, 2019

The Lancet
Published: February 11, 2019
DOI: https://doi.org/10.1016/S0140-6736(18)32111-1
Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study
Although direct-acting antivirals have been used extensively to treat patients with chronic hepatitis C virus (HCV) infection, their clinical effectiveness has not been well reported. We compared the incidence of death, hepatocellular carcinoma, and decompensated cirrhosis between patients treated with direct-acting antivirals and those untreated, in the French ANRS CO22 Hepather cohort.
Continue to "full-text article"
PDF shared on twitter by @HenryEChang

Direct-acting antiviral treatment for hepatitis C - Linked Comment
Writing in a linked Comment, Dr Raymond T Chung, Director of the Liver Center at Massachusetts General Hospital, USA, says: 
"The study by Carrat and colleagues offers substantive evidence that cure of HCV delivered by all-oral direct-acting antiviral regimens is associated with clinical benefits. These findings firmly counter those of a Cochrane review of direct-acting antiviral treatment trials that could neither confirm nor reject if direct-acting antivirals had an effect on long-term HCV-related morbidity and mortality. They also provide the best evidence to date to support guidance documents that recommend direct-acting antiviral treatment for all patients with chronic HCV infection. Finally, they provide credence to the achievability of the goals set out by WHO, not only to eliminate HCV but also to substantially reduce its complications." 
Read full comment here....

Media Coverage
Patient-friendly article
Feb 14, 2019
Scientists have firmly established an association between direct-acting antiviral treatment and a lower risk of liver cancer and death.

Feb 11, 2019
Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C 
Professor Fabrice Carrat of the Sorbonne Université, France, said: "Taking a large cohort like this provides the opportunity to evaluate the effect of direct-acting antiviral therapy on the long-term outcomes of patients with hepatitis C. We saw a reduction of risk for complications related to the disease, and to mortality, and believe this treatment should be considered for all patients with chronic hepatitis C infection."

The first prospective, longitudinal study investigating treatment of chronic hepatitis C with direct-acting antivirals finds that the treatment is associated with reduced risk of mortality and liver cancer, according to a study published in The Lancet.

The research is the first to demonstrate the clinical effectiveness of direct-acting antivirals on the disease and suggests that they should be considered for all patients with chronic hepatitis C infection.

For ethical reasons a trial with a control arm is not possible and researchers approached this by setting up an observational study of around 10,000 patients. At follow up, about three-quarters had been treated with direct-action antivirals and a quarter were untreated. The incidence of death and hepatocellular carcinoma - the most common form of liver cancer - were significantly decreased in patients who were treated. Their risk of decompensated cirrhosis was not reduced by the treatment.

Around the world, an estimated 71 million people are chronically infected with the hepatitis C virus (HCV). The infection causes complications such as cirrhosis, liver disease, hepatocellular carcinoma, and many people die as a result. Over the last 15 years, these complications have tripled and models predict they will peak between 2030 and 2035. The World Health Organization (WHO) has set targets for the elimination of hepatitis C, and a reduction of related complications. Recently, a modelling study published in The Lancet found that major progress towards these targets by 2030 is possible, but will require vast improvements in screening, prevention, and treatment [1].

Previous work has shown there is a reduction of risk for complications and mortality in patients who are treated with interferon or direct-acting antivirals, but few studies have compared treated and untreated patients. The aim of direct-acting antiviral drugs is to achieve a sustained virological response, meaning that the virus is undetectable in the blood of the patients. A recent Cochrane Review [2] found no evidence for or against the treatment having a long-term effect on death and disease, so this large study is timely, and may help doctors and patients with treatment plans.

In this study, 10,166 patients were recruited from 32 centres in France. At a median of 33 months, 9,895 patients had available follow up information and were included in the analysis, with 7,344 treated with direct-acting antivirals and 2,551 untreated. During follow-up, 218 patients died (129 treated, 89 untreated), 258 reported hepatocellular carcinoma (187 treated, 71 untreated), and 106 had decompensated cirrhosis (74 treated, 32 untreated).

Overall, the study finds that direct-acting antiviral treatment is associated with reduced risk for global mortality and hepatocellular cancer, but not decompensation of cirrhosis. The researchers initially found an increase in risk associated with treatment with direct-acting antiviral treatment, but once they had adjusted for variables such as age, sex, body-mass index, severity of liver disease, geographical origin, infection route and other factors, they found a reduced risk.

Patients who were treated were 52% less likely to die prematurely than people who were not treated (the estimated adjusted risk of death at one year in untreated patients in the cohort is 84 deaths per 10,000 patients, and in those who were treated was 40 per 10,000), and 33% less likely to present with hepatocellular carcinoma (the estimated adjusted risk of developing hepatocellular carcinoma within a year in untreated patients in the cohort was 129 cases per 10,000 patients, and 86 per 10,000 in people who were treated). [3]

In a subgroup of 3,045 patients with cirrhosis at baseline, the same association was found for mortality and hepatocellular cancer, provided the patients achieved an undetectable level of HCV in their blood. The researchers believe this is because the treatment induces a sustained virological response, allowing the liver to regenerate which decreases risk.

Professor Fabrice Carrat of the Sorbonne Université, France, said: "Taking a large cohort like this provides the opportunity to evaluate the effect of direct-acting antiviral therapy on the long-term outcomes of patients with hepatitis C. We saw a reduction of risk for complications related to the disease, and to mortality, and believe this treatment should be considered for all patients with chronic hepatitis C infection." [4]

In the study, only a few patients underwent liver biopsy to confirm cirrhosis, with platelet levels or prothrombin time - a blood test - used to classify whether a patient had cirrhosis or not. A validation study using other non-invasive markers of fibrosis suggested that their methods correctly classified cirrhosis in the patients.

Patients who received more than one course of direct-acting antivirals were considered to have had continuous exposure, even where there may have been a lag time or if the first course may not have been associated with sustained virological response. This should have underestimated the response to the drugs rather than overestimated them so does not affect the result.

The study excluded patients with a history of decompensated cirrhosis and liver transplantation and these are the patients who would be at highest risk for complications. The potential benefits of treatment in this group could be underestimated because of their exclusion, as trial data shows improvements in liver function in patients with decompensated cirrhosis who achieved a sustained virological response.
https://www.eurekalert.org/pub_releases/2019-02/tl-pss020819.php

Recommended Reading
lastair Heffernan, MResProf Graham S Cooke, DPhilShevanthi Nayagam, PhDProf Mark Thursz, MDProf Timothy B Hallett, PhD
Jan 28, 2019
The revolution in hepatitis C virus (HCV) treatment through the development of direct-acting antivirals (DAAs) has generated international interest in the global elimination of the disease as a public health threat. In 2017, this led WHO to establish elimination targets for 2030. We evaluated the impact of public health interventions on the global HCV epidemic and investigated whether WHO's elimination targets could be met.

Netflix Model -Countries Use Novel Strategies to Tackle Price of HCV Drugs

Countries Use Novel Strategies to Tackle Price of HCV Drugs
Roxanne Nelson, RN, BSN
February 14, 2019
A recent study suggests that the WHO's goal of eliminating HCV infections worldwide by 2030 is potentially feasible but faces some daunting challenges, including the cost of DAAs.
To help overcome some of the barriers to treatment access, Australia and Brazil are each exploring innovative methods to circumvent the cost. Two perspective articles published February 14 in the New England Journal of Medicine outline how they hope to accomplish this goal.
The healthcare system in Australia is complex but is generally funded by the government. Drugs that are on the national formulary are usually paid for by the government. To help make DAAs more affordable to patients and the healthcare system, the Australian government has rolled out a strategy, nicknamed the "Netflix" plan because it is similar to the movie subscription service, in which payment is for bulk access.
Read more: https://www.medscape.com/viewarticle/909083 

New England Journal of Medicine
Perspective
Universal Medicine Access through Lump-Sum Remuneration — Australia’s Approach to Hepatitis C
Suerie Moon, M.P.A., Ph.D., and Elise Erickson, M.A.
High prices can restrict access to medicines in rich and poor countries alike. Australia’s approach to providing direct-acting antivirals (DAAs) for patients with hepatitis C virus (HCV) suggests that, under certain conditions, innovative approaches to payment can remove price as a barrier to access. In Australia, medicines on the national formulary are largely paid for by the government. In 2015, the authorities negotiated an agreement to spend approximately 1 billion Australian dollars (U.S.$766 million) over 5 years in exchange for an unlimited volume of DAAs for HCV from suppliers. This approach has been called the “subscription” or “Netflix” model, and the state of Louisiana announced in January 2019 that it was pursuing a similar approach for HCV. The Australian agreement is confidential, though the basic information above has been publicly reported..
Read more: https://www.nejm.org/doi/full/10.1056/NEJMp1813728?query=TOC 

New England Journal of Medicine
Brazil’s strategy for addressing hepatitis C, which combines evidence-based treatment protocols and innovative initiatives for local production of generic direct-acting antiviral drugs, needs to be considered in light of ongoing conflicts over pharmaceutical patents.
Payment may be required to view article. 

Wednesday, February 13, 2019

Cirrhosis: What Clinicians Need to Know

Cirrhosis: What Clinicians Need to Know
Listen to Christine Kerr, MD, AAHIVS, of Hudson River HealthCare, discuss specific challenges in managing cirrhosis in an easy to access webinar using a case-based patient scenario, provided by HepCure.

Although; Cirrhosis: What Clinicians Need to Know, is intended for physicians and health care professionals, anyone, especially patients will benefit from watching the presentation.


Learning Objectives
1. Describe cirrhosis.
2. Discuss screening guidelines and diagnostic algorithms for cirrhosis.
3. Review cirrhosis treatment best practices.
Begin here....

View All Presentations At HepCure
Webinar Archive 

Christine Kerr, MD, AAHIVS, is the medical director for the HIV and Hepatitis Programs for Hudson River HealthCare. She trained in internal medicine at Brown University and Infectious Disease at Harvard. She is the community co-chair for the New York State Hepatitis C Elimination Task force, the co-chair of the NYS AIDS institute Quality Advisory committee and is co-chair for the NYS AIDS Institute/Johns Hopkins Guidelines Committee for Treatment of Hepatitis C in the Primary Care Setting. Her areas of interest include treatment of HIV and Hepatitis C in the community setting, care of the underserved, and program development and evaluation.

Tuesday, February 12, 2019

Eating lots of meat tied to higher risk of liver disease

Reuters• February 12, 2019
By Lisa Rapaport
(Reuters Health) - People who eat a lot of animal protein may be more likely to have excessive fat in their livers and a higher risk of liver disease than individuals whose main source of protein is vegetables, a Dutch study suggests.

Researchers focused on what's known as non-alcoholic fatty liver disease (NAFLD), which is usually associated with obesity and certain eating habits. While dietary changes are recommended to treat this type of liver disease, research to date hasn't clearly demonstrated whether these changes can work for prevention.

Read more: 
https://news.yahoo.com/eating-lots-meat-tied-higher-risk-liver-disease-231806194.html

Study:
Association of dietary macronutrient composition and non-alcoholic fatty liver disease in an ageing population: the Rotterdam Study 

Monday, February 11, 2019

FDA announcing a new plan to strengthen regulation of dietary supplements

Your multivitamins and brain-boosting pills may be suspect, and regulators are cracking down on the $40 billion industry
Erin Brodwin 
On Monday, Scott Gottlieb, the head of the Food and Drug Administration (FDA), announced a series of steps his agency would take in coming months to crack down on manufacturers that tout the ability of their formulas to do everything from increase energy to cure cancer. Of particular concern, he said in a statement, are pills that claim to treat Alzheimer's, a serious brain disease that hinders memory and has no cure. 
Read more, here....

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

The use of dietary supplements, such as vitamins, minerals or herbs, has become a routine part of the American lifestyle. Three out of every four American consumers take a dietary supplement on a regular basis. For older Americans, the rate rises to four in five. And one in three children take supplements, either given to them by their parents or, commonly in teens, taking them on their own.

That’s why today we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as a part of a comprehensive care plan. It’s clear to me that dietary supplements play an important role in our lives as we strive to stay healthy. It’s also clear that the U.S. Food and Drug Administration plays an important role in helping consumers make use of safe, high-quality dietary supplements while also protecting Americans from the potential dangers of products that don’t meet the agency’s standards for marketing.

In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.

DSHEA imposes a number of requirements around the manufacture and labeling of dietary supplements. We know that most players in this industry act responsibly. But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.

Making healthy choices about diets can have a significant and positive impact on Americans’ health. To be able to make those choices with respect to dietary supplements, consumers need to have access to safe, well-manufactured, and appropriately labeled products. One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.

Today, we’re announcing new steps we intend to advance to achieve these twin goals. These steps include communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.

The opportunity to strengthen the framework that governs dietary supplements couldn’t come at a more pivotal time. On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers.

Legitimate industry benefits from a framework that inspires the confidence of consumers and providers. Patients benefit from products that meet high standards for quality.

I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks. To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products. Toward these goals, the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by DSHEA.

As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer. Products intended to treat Alzheimer’s disease must gain FDA approval before they are sold in order to help ensure they are safe and effective for their intended medical use. Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer’s. Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions. In recent years, we’ve also taken action against companies and dietary supplements making similar claims regarding treatment of serious conditions such as cancer and opioid addiction. These enforcement actions are just one part of our overall efforts to update our policy framework governing dietary supplements.

At the FDA, we have an obligation to ensure that we’re using the resources that we have as efficiently and effectively as we can, and as we engage in discussions about whether our existing resource levels are adequate, I take that obligation very seriously. That’s why I recently directed the establishment of a Dietary Supplement Working Group at the FDA, led out of my office and comprised of representatives from multiple centers and offices across the agency. I’ve tasked this group with taking a close look at our organizational structures, processes, procedures and practices in order to identify opportunities to modernize our oversight of dietary supplements.

Additionally, when the FDA created the Office of Dietary Supplement Programs (ODSP) three years ago, the agency recognized that keeping up with the evolving marketplace meant giving dietary supplement regulation more attention and making it a higher priority. One of the things that this office has done is to articulate the FDA’s strategic priorities on dietary supplements to ensure that we’re focusing our attention and using our resources in ways that make sense.

Our first priority for dietary supplements is ensuring safety. Above all else, the FDA’s duty is to protect consumers from harmful products. Our second priority is maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards. Our third priority is informed decision-making. We want to foster an environment where consumers and health care professionals are able to make informed decisions before recommending, purchasing or using dietary supplements.

In the coming months, we’ll be providing additional details on the steps we are taking to continue moving our dietary supplement program forward to implement these priorities. Our new approach benefits consumers by balancing new policies to promote innovation and efficiency in the marketplace for dietary supplements with increased steps to protect the public from potential safety issues.

Today, I’m also announcing the first of several important steps to help advance our important policy goals. Among the steps that we’re considering or actively formulating, first are new ways to communicate more quickly when we have concerns that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements. We’re developing a new rapid-response tool to alert the public so consumers can avoid buying or using products with that ingredient, and to notify responsible industry participants to avoid making or selling them.

Second, we also need to ensure that our regulatory framework is flexible enough to adequately evaluate product safety while promoting innovation. The key to this effort will be important steps to foster the submission of new dietary ingredient (NDI) notifications. An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources. We’re continuing to develop guidance for preparing NDI notifications to ensure FDA can thoroughly review the safety of these ingredients. In conjunction with this effort, we’re planning to update our compliance policy regarding NDIs.

We know these are important and timely issues and we’re also planning a public meeting this spring on the topic of responsible innovation in the dietary supplement industry. I expect the feedback received during this meeting will be essential as we move to modernize our approach toward NDIs. We’ll look to address other challenges that may act as barriers to dietary supplement innovation and safety including issues such as what the right incentives might be for establishing dietary supplement exclusivity, and the scope of permitted dietary ingredients. We invite all our stakeholders to share their views on how the FDA should strengthen the dietary supplement program for the future. So, please stay tuned for more information regarding registration and logistics.

Third, as with other commodities that the agency regulates, it’s critical that the FDA continue to work closely with our partners in industry to achieve our primary goal of protecting public health and safety. As the dietary supplement industry develops new products and ingredients, advances new delivery systems and innovates in other ways, the FDA must do more to leverage its existing resources and authorities to evaluate these products. This requires collaborative research and a shared understanding. I’m pleased to announce that we’ve recently created the Botanical Safety Consortium, a public-private partnership that will gather leading scientific minds from industry, academia and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders.

Fourth, we’ll continue to take actions to protect public health – like those we took today for illegal Alzheimer’s disease products – and develop new enforcement strategies, as a key element of our approach to protecting consumers as the risks evolve. We’re already making our internal processes more efficient for taking enforcement action when products claiming to be supplements contain unlawful ingredients, including drug ingredients. For example, last April we took strong action to protect consumers from the dangers of dietary supplement products marketed in bulk and containing pure and highly concentrated caffeine. We warned consumers in November to not purchase Rhino male enhancement products because they were unapproved new drugs that contained sildenafil and/or tadalafil, which are among active ingredients in the FDA-approved prescription drugs Viagra and Cialis. During the same month, we issued warnings to companies for unlawfully marketing as dietary supplement products that contained a compound called tianeptine; these products were unapproved new drugs that bore unproven claims that the products could be used to treat opioid addiction. We’ve also been active with compliance and enforcement efforts against firms that have shown persistent inability to comply with the current good manufacturing practice requirements for dietary supplements, and taking action to protect the public against unsafe imports and recalled products.

Finally, we’ll engage a public dialogue around whether additional steps to modernize DSHEA are necessary. We’ve heard from stakeholders who want to open such a dialogue. While the FDA is committed to leveraging its existing resources and authorities to the fullest extent possible, we believe there may be value in a broader public conversation about whether certain changes to the law might be helpful. We believe there may be opportunities to modernize DSHEA for the future, while preserving the law’s essential balance. For example, some stakeholders have suggested that the statute should be amended to establish avenues for dietary supplement exclusivity and add a product listing requirement. A mandatory listing requirement could provide significant benefits by improving transparency in the marketplace and promoting risk-based regulation. It could also help facilitate efficient enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry.

We’re interested in hearing other ideas our stakeholders may have, and not just those limited to changes to the law, so we can go about the task of regulating this space in a way that reflects where the industry is today, and continue to safeguard consumers’ ability to access safe, compliant dietary supplements for the next 25 years. For example, is it possible to design a product listing regime that helps us protect consumers and level the playing field for responsible industry participants by making it easier for us to take swift action against illegitimate and dangerous products, such as products that are tainted with drug ingredients? And is it possible to do this without disrupting the balance struck by DSHEA, and without imposing any significant new burdens on responsible firms? The answer to these questions may very well be yes. And if that’s the case, these are absolutely things that we should be talking about.

I’m confident that the efforts we’re announcing today, and the ones that we’ll continue to advance in the months and years to come, will help us achieve these goals on behalf of consumers. The steps outlined today highlight both where we are currently and where we look forward to moving toward. We are eager to continue our work with both our industry partners and dietary supplement consumers and will announce more upcoming ideas that we hope to roll out in the near future.

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.

Gilead Data On Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

Media
A fatty liver drug from Gilead Sciences posts negative results in late-stage clinical trial
By Adam Feuerstein @adamfeuerstein
February 11, 2019
Gilead Sciences said Monday that its experimental drug, called selonsertib, failed to improve liver scarring compared to a placebo in a Phase 3 clinical trial. The study enrolled nearly 900 patients with compensated cirrhosis, an advanced form of NASH at higher risk for liver-related death.
Read it here...

Press release
Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that STELLAR-4, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH), did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.

In the study of 877 enrolled patients who received study drug, 14.4 percent of patients treated with selonsertib 18 mg (p=0.56 vs. placebo) and 12.5 percent of patients treated with selonsertib 6 mg (p=1.00) achieved a ≥ 1-stage improvement in fibrosis according to the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment, compared with 12.8 percent of patients who received placebo. Selonsertib was generally well-tolerated and safety results were consistent with prior studies.

“While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments. Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases. Data from this large study of patients with compensated cirrhosis due to NASH, including the extensive set of biomarkers collected, will further advance our understanding of the disease and inform our broader NASH development programs,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead. “We are grateful to the patients and investigators who participated in the STELLAR-4 study, and we now await the upcoming results from the Phase 3 STELLAR-3 trial of selonsertib in patients with bridging fibrosis (F3) due to NASH and the Phase 2 ATLAS combination trial of selonsertib, cilofexor (GS-9674) and firsocostat (GS-0976) in patients with advanced fibrosis due to NASH later this year.”

Further in-depth analysis of the findings is ongoing and the data will be submitted to an upcoming scientific conference. Gilead will work with the Data Monitoring Committee and investigators to conclude the STELLAR-4 study in a manner consistent with the best interests of each patient.

Selonsertib, cilofexor and firsocostat, alone or in combination, are investigational compounds and are not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established for these agents.

About Selonsertib and the STELLAR-4 Study
Selonsertib is an investigational small molecule inhibitor of ASK1, a protein that promotes inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress. Oxidative stress can be increased in many pathological conditions including liver diseases such as NASH.

The STELLAR-4 study is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib in patients with compensated cirrhosis (F4) due to NASH. Eligible adults ages 18 to 70 years were randomized and received selonsertib 18 mg (n=354), selonsertib 6 mg (n=351) or placebo (n=172) for up to 240 weeks. Either selonsertib or placebo is being administered orally once daily. The primary endpoints of the study are a composite of the proportion of patients who achieve a ≥ 1-stage improvement in fibrosis according to the NASH CRN classification without worsening of NASH at week 48 and event-free survival at week 240 as assessed by time to the first clinical event. Further information about the clinical study can be found at www.clinicaltrials.gov.

About Gilead’s Clinical Programs in NASH
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis, including bridging fibrosis (F3) or compensated cirrhosis (F4), are at a significantly higher risk of liver-related mortality and all-cause mortality.
Gilead is advancing multiple novel investigational compounds for the treatment of advanced fibrosis due to NASH, evaluating single-agent and combination therapy approaches against the core pathways associated with NASH – hepatocyte lipotoxicity, inflammation and fibrosis. Investigational compounds in development include the ASK1 inhibitor selonsertib, the selective, non-steroidal FXR agonist cilofexor (GS-9674) and the ACC inhibitor firsocostat (GS-0976). The STELLAR-3 Phase 3 trial evaluating selonsertib among NASH patients with bridging fibrosis (F3) is ongoing. Cilofexor and firsocostat are currently in Phase 2 studies in NASH, including the ATLAS Phase 2 trial evaluating combinations of selonsertib, cilofexor and firsocostat in advanced fibrosis (F3 and F4) due to NASH.

About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

Insights From Antiviral Therapy Into Immune Responses to Hepatitis B and C Virus Infection

Gastroenterology
January 2019 Volume 156, Issue 2, Pages 369–383 

Insights From Antiviral Therapy Into Immune Responses to Hepatitis B and C Virus Infection Barbara Rehermann, Robert Thimme 

Abstract
There are 257 million persons worldwide with chronic hepatitis B virus (HBV) infection, a leading causes of liver cancer. Almost all adults with acute HBV infection have a rapid immune response to the virus, resulting in life-long immunity, but there is no cure for individuals with chronic HBV infection, which they acquire during early life. The mechanisms that drive the progression of HBV through distinct clinical phases to end-stage liver disease are poorly understood. Likewise, it is not clear whether and how immune responses can be modulated to allow control and/or clearance of intrahepatic HBV DNA. We review the innate and adaptive immune responses to acute and chronic HBV infections and responses to antiviral therapy. Comparisons with hepatitis C virus infection provide insights into the reversibility of innate inflammatory responses and the potential for successful therapy to recover virus-specific memory immune responses.

Shared On Twitter: Henry E. Chang

Testosterone in Men With Chronic Hepatitis C Infection and After Hepatitis C Viral Clearance

Corrected Proof
Clinical Infectious Diseases, ciy965, https://doi.org/10.1093/cid/ciy965
Published: 02 February 2019
Testosterone in Men With Chronic Hepatitis C Infection and After Hepatitis C Viral Clearance
We evaluated testosterone levels and the prevalence of low testosterone in a cohort of 327 men with chronic HCV infection (human immunodeficiency virus [HIV] coinfection = 150) and in a subset of 85 men with testosterone levels obtained pre-HCV treatment and after sustained virologic response (SVR). Median follow-up was 36 months.
Full text available online:

Commentary: Healio
Low testosterone persists after HCV clearance
February 11, 2019 
Low levels of free testosterone are common among men with chronic hepatitis C infection following SVR and persist after HCV clearance, according to findings from a prospective, longitudinal cohort study.

“Previous research has shown that low total testosterone (TT), low free testosterone (FT), and elevated sex hormone-binding globulin (SHBG) are extrahepatic manifestations of chronic HCV when compared with healthy controls,” Chloe S. Chaudhury, MD, post-baccalaureate research fellow at the National Institute of Allergy and Infectious Diseases, and colleagues wrote. “There is now a need for studies to examine the effect of HCV and HCV viral clearance on long-term testosterone levels and hypogonadal status.” 

Read more:

Saturday, February 9, 2019

What are the Long-term Effects of DAA Therapy on HCV-associated Cryoglobulinemia Vasculitis?

What are the Long-term Effects of DAA Therapy on HCV-associated Cryoglobulinemia Vasculitis?
Dr. Kristine Novak
More than 95% of patients with hepatitis C virus–associated cryoglobulinemia vasculitis (HCV-CryoVas) have a full or partial response of symptoms to treatment with direct-acting antiviral (DAA) agents, researchers report in a long-term follow-up study in the February issue of Clinical Gastroenterology and Hepatology. Fewer than 5% of patients stopped therapy prematurely and fewer than 3% died. A severe form of CryoVas and peripheral neuropathy were associated with a lack of response of CryoVas to DAA therapy.
CryoVas is an immune complex–mediated systemic vasculitis that affects mainly small- and medium-sized vessels—it is observed in approximately 15% of patients with HCV infection and has an estimated 5-year mortality rate of 25%. Outcomes of patients with HCV-CryoVas associate with level of liver fibrosis and vasculitis of the kidney, central nervous system, heart, and digestive tract. Remission of vasculitis is associated with reponse to DAA therapy; a complete clinical response was reported in 90.2% of patients with HCV-CryoVas. 

Mavyret - Safety and efficacy in patients receiving opioid substitution therapy/HCV genotypes 1-6

Int J Drug Policy. 2019 Feb 5;66:73-79. doi: 10.1016/j.drugpo.2019.01.011. [Epub ahead of print]

Safety and efficacy of glecaprevir/pibrentasvir in patients with chronic hepatitis C genotypes 1-6 receiving opioid substitution therapy.
Grebely J1, Dore GJ2, Alami NN3, Conway B4, Dillon JF5, Gschwantler M6, Felizarta F7, Hézode C8, Tomasiewicz K9, Fredrick LM3, Dumas EO3, Mensa FJ3.

Open Access

Abstract
BACKGROUND:
International guidelines recommend treatment of hepatitis C virus (HCV) infection in people who inject drugs (PWID), including those on opioid substitution therapy (OST). The pangenotypic combination of glecaprevir and pibrentasvir has shown high sustained virologic response at post-treatment Week 12 (SVR12) in clinical trials. Herein, we evaluate the safety and efficacy of glecaprevir/pibrentasvir in patients receiving OST.

METHODS:
Pooled data from patients with HCV genotypes 1-6 who were treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks in eight Phase 2 and 3 trials were categorized by use of OST. Treatment completion, treatment adherence, SVR12, adverse events (AEs), and laboratory abnormalities were evaluated for patients receiving and not receiving OST.

RESULTS:
Among 2256 patients, 157 (7%) were receiving OST. Compared with patients not receiving OST, OST patients were younger (mean age, 46.8 vs 52.8 years), male (69% vs 54%), white (93% vs 80%), HCV treatment-naïve (86% vs 72%), had HCV genotype 3 (60% vs 26%), and had a history of depression or bipolar disorder (43% vs 19%). Most patients completed (OST: 98% [n/N = 154/157]; non-OST: 99% [n/N = 2070/2099]) and were adherent (received ≥90% of study drug doses) to glecaprevir/pibrentasvir treatment (OST: 98% [n/N = 121/123]; non-OST: 99% [n/N = 1884/1905] among patients with available data). In the intention-to-treat population, SVR12 rates in OST and non-OST patients were 96.2% (n/N = 151/157; 95% CI 93.2-99.2) and 97.9% (n/N = 2055/2099; 95% CI 97.3-98.5), respectively. For OST patients, reasons for nonresponse included virologic relapse (<1%; n = 1), premature study drug discontinuation (<1%; n = 1), and loss to follow-up (3%; n = 4). AEs occurring in ≥10% of OST patients were headache, fatigue, and nausea. Drug-related serious AEs, AEs leading to study drug discontinuation, and Grade 3 or higher laboratory abnormalities were infrequent in both groups (<1%). No HCV reinfections occurred through post-treatment Week 12.

CONCLUSION:
Glecaprevir/pibrentasvir is highly efficacious and well tolerated in HCV-infected patients receiving OST.


Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.
KEYWORDS: Glecaprevir/pibrentasvir; Hepatitis C virus; Opioid substitution therapy; People who inject drugs

Friday, February 8, 2019

1 in 3 complementary medicine users do not disclose use to medical providers

Study reveals complementary medicine use remains hidden to conventional medicine providers
by University of Technology, Sydney
Research reveals that 1 in 3 complementary medicine (CM) users do not disclose their CM use to their medical providers, posing significant direct and indirect risks of adverse effects and harm due to unsafe concurrent use of CM and conventional medicine use.

The first international systematic review conducted by researchers at the Australian Research Centre in Complementary and Integrative Medicine provides an update on the prevalence and characteristics of disclosure of CM use to medical providers since previous research conducted in 2003.

"This figure has hardly changed since the last review of the topic 13 years ago. This is despite the fact that the authors of every paper included in our review called for improved communication between doctors and patients to facilitate better disclosure," says lead author and PhD candidate Hope Foley.

The study found that disclosure of CM use to medical providers is influenced by the providers' communication style. Perceived provider knowledge of CM use was reported to be a barrier to discussions about CM use in clinical consultations.

When the actual response of the provider to disclosure of CM use was explored by researchers, negative or discouraging responses were reported by less than 20% of disclosers or were not reported at all. Positive or encouraging responses to disclosure of CM use by a medical doctor were reported by a substantial proportion of respondents and neutral responses from medical providers were also common.

More than 67% of participants agreed that disclosure was important.

"Patient autonomy and preference are important features of person-centered care to be considered by medical providers alongside safety and treatment outcomes in their patient management," the authors write.

On a global public health level, the World Health Organisation recognises the importance of integrated care which encompasses CM. Yet public health policies and procedures often create barriers to effective integration, limiting appropriate management of concurrent use and access to the recognised benefits of integrated care".

"As CM becomes more As CM becomes more separate from mainstream health services, disclosure is only going to become more and more important for public safety."

The researchers conclude that in the context of contemporary person-centred health care models, discussions and subsequent disclosure of CM use may be facilitated by direct inquiry about CM use by providers.

"This is a topic which should be treated with gravity," the researchers say. "Disclosure of CM use is central to wider patient management and care in contemporary clinical settings, particularly for primary care providers acting as gatekeeper in their patients' care."

https://www.uts.edu.au/research-and-teaching/our-research/complementary-and-integrative-medicine/news/study-reveals

The full article is available in Scientific Reports.
H. Foley et al, Disclosure of complementary medicine use to medical providers: a systematic review and meta-analysis, Scientific Reports (2019). DOI: 10.1038/s41598-018-38279-8 

Thursday, February 7, 2019

Impact of Hepatitis C Virus and Insurance Coverage on Mortality

The American Journal of Managed Care February 2019
Impact of Hepatitis C Virus and Insurance Coverage on Mortality
Haley Bush, MSPH; James Paik, PhD; Pegah Golabi, MD; Leyla de Avila, BA; Carey Escheik, BS; and Zobair M. Younossi, MD, MPH

View Full-text Article Online

Takeaway Points
Hepatitis C virus (HCV) prevalence is significantly higher among patients with Medicaid compared with patients with private insurance and Medicare. 

Medicaid patients who are infected with HCV have a higher risk of all-cause mortality than HCV-positive patients with private insurance coverage. 

Policy makers should consider providing additional resources to Medicaid to cover all HCV-infected individuals.

The Medicaid population has significantly higher hepatitis C virus (HCV) prevalence and mortality rates than patients with private insurance. These data must be considered when policy makers assess providing additional support to Medicaid programs for HCV elimination.

ABSTRACT
Objectives: To assess the association of payer status and mortality in hepatitis C virus (HCV)–infected patients.

Study Design: For this retrospective observational study, we used the National Health and Nutrition Examination Survey from 2000 to 2010. Adults with complete data on medical questionnaires, HCV RNA, insurance types, and mortality follow-ups were included.

Methods: We used Cox proportional hazards models to evaluate independent associations of insurance type with mortality in HCV-infected individuals. These models were rerun in the subset of HCV-positive subjects to determine the association of insurance type with mortality. The data used in this study predated the implementation of the Affordable Care Act.

Results: Among 19,452 eligible participants, 311 (1.4%) were HCV positive. HCV-positive patients were older, were more likely to be non-Hispanic black and male, and had higher prevalence of hypertension (all P <.001). HCV-positive patients were also less likely to have private insurance and more likely to be covered by Medicaid or be uninsured relative to HCV-negative patients (P <.001). Among HCV-positive patients, after adjustment for confounders, those with Medicaid coverage had an increased risk of mortality compared with those with private insurance (hazard ratio [HR], 6.31; 95% CI, 1.22-29.94) and uninsured individuals (HR, 8.83; 95% CI, 1.56-49.99).

Conclusions: Patients who have HCV are more likely to be uninsured or covered by Medicaid. HCV-positive patients with Medicaid have an increased mortality risk compared with those with private insurance. Given the high burden of HCV infection and adverse prognosis among individuals covered by Medicaid, policy makers must prioritize funding and supporting Medicaid programs.

Source Full-text article:
Am J Manag Care. 2019;25(2): In Press

Hepatitis C cure does not improve glucose control in type 2 diabetes

Article Source: infohep
The aim of infohep.org is to develop a high-quality online resource to increase awareness of viral hepatitis, its treatment, and the needs of people living with viral hepatitis in Europe. NAM (aidsmap.com) is working with the World Hepatitis Alliance and the European Liver Patients Association (ELPA) on infohep.org.

Hepatitis C cure does not improve glucose control in type 2 diabetes
Michael Carter
Published: 07 February 2019
A successful response to HCV therapy does not result in long-term improvements in glucose metabolism for patients with type-2 diabetes, according to US research published in Liver International. 
A sustained virological response (SVR) was associated with a short-term improvement in a key marker of glucose control, but these improvements were not sustained in the longer-term and within three years glucose control was comparable between SVR patients and individuals who did not receive any HCV therapy or who had an unsuccessful treatment response. 
The investigators found the same results when they restricted their analysis to patients who had a SVR after receiving treatment with direct-acting agents (DAAs). “A number of studies have reported significant decreases in HbA1c [glycosolated haemoglobin] immediately after SVR. In contrast, a recent report found that reductions in HbA1c immediately following successful treatment were not sustained after a mean duration of 2.5 years,” write the authors. “A strength of our longitudinal analysis is that our results allow us to reconcile these apparently conflicting reports.”
Read more: http://www.infohep.org/page/3426435/
Abstract: Sustained virological response does not improve long‐term glycaemic control in patients with type 2 diabetes and chronic hepatitis C

Wednesday, February 6, 2019

China Investigates Reports of H.I.V.-Tainted Blood Plasma Treatment

Chinese Blood Plasma Feared Contaminated With HIV Tests Negative ...
TIME
A statement from the National Medical Products Administration said tests for HIV, hepatitis B and hepatitis C all turned out negative. The samples were from a …

China Investigates Reports of H.I.V.-Tainted Blood Plasma Treatment
BEIJING — Officials in Shanghai are investigating reports that a Chinese pharmaceutical company may have sold more than 12,000 units of a blood plasma product contaminated with H.I.V., potentially the latest in a series of scandals that have threatened to undermine public trust in China’s medical institutions and health care system.
In a statement on its website, the Shanghai Food and Drug Administration said Wednesday night that authorities had ordered the company, Shanghai Xinxing Medicine Company, to begin an emergency recall of the potentially tainted batch of intravenous immunoglobulin, a treatment made from pooled blood plasma that is often used to treat immune disorders, and halt its production.
Read more: https://www.nytimes.com/2019/02/06/world/asia/china-blood-plasma-treatment.html

Treat All - Barriers and facilitators of hepatitis C treatment uptake among people who inject drugs enrolled in opioid treatment programs in Baltimore

Barriers and facilitators of hepatitis C treatment uptake among people who inject drugs enrolled in opioid treatment programs in Baltimore
Oluwaseun Falade-Nwulia, Risha Irvin, Alana Merkow , Mark Sulkowski, Alexander Niculescu, Yngvild Olsen, Kenneth Stoller , David L. Thomas, Carl Latkin, Shruti H. Mehta

Links
Download full-text article
Shared On Twitter: Henry E. Chang 

Highlights
•Most PWID with HCV have not been treated despite existence of effective treatments.
•Only 20% of PWID in Baltimore opioid treatment programs (OTPs) received HCV treatment.
•Recent drug use was identified as a barrier to HCV treatment.
•Peer support and HCV treatment at OTPs were identified as facilitators to HCV treatment.

Abstract

Background
Hepatitis C virus (HCV) infection is a major public health issue among people who inject drugs (PWID) with prevalence of 50–80% in the United States. Effective, simple, oral direct acting agents (DAA) of short duration with minimal side effects have been associated with cure rates > 95%. However, HCV treatment uptake among PWID remains low. We characterized the HCV care continuum, HCV treatment knowledge, as well as barriers and facilitators to HCV treatment uptake among PWID enrolled in two opioid treatment programs (OTPs) in Baltimore, Maryland, USA.

Methods
Between July and November 2016, 124 HCV infected PWID were recruited from two opioid treatment programs in Baltimore through convenience sampling. Participants completed a 50-item questionnaire to assess HCV treatment knowledge, attitudes, and practices. Progress through the HCV care continuum was assessed based on a series of questions assessing evaluation for HCV treatment, recommendation for HCV treatment by a provider, and HCV treatment initiation. HCV status was assessed based on participant self-report.

Results
The median age was 52 years (IQR 44–58), 56% were male, the majority were African American (69%), and 19% reported HIV coinfection. Participants had been tested for HCV at their primary care provider's PCP's office (34%), drug treatment center (20%), emergency room (11%), or prison (9%), and most (60%) had been diagnosed with HCV over 5 years prior. The majority reported that HCV was a major health concern for them (91%), were aware there were new treatments for HCV (89%), and that the new treatments cure most people (69%). More than half (60%) had seen a health professional who could treat HCV, 40% had HCV therapy recommended by their HCV specialist, and 20% had started or completed treatment. In univariable analysis, PWID were significantly more likely to have been treated if they were HIV co-infected (OR 3.4 (95% CI 1.3–9.2)) or had a partner or friend concerned about their HCV (OR 3.4 (95% CI 1.2–9.7)), and were significantly less likely to have been treated if they had used any illicit drugs in the preceding 6 months (OR 0.4 (95% CI 0.2–0.99). In multivariable analysis, having a friend or partner concerned about their HCV remained significantly associated with HCV treatment (OR 5.0 (95% CI 1.4–17.7)). When questioned about what would facilitate HCV treatment, the majority (85%) reported that a friend telling them that HCV treatment had helped them and having HCV treatment provided at their opioid treatment program would make them more likely to engage in HCV treatment.

Conclusion

Despite a high prevalence of HCV among opioid treatment program patients and the availability of effective treatments, uptake remains low. We identified several key barriers and facilitators that can affect HCV treatment uptake.

2019 Hepatitis C - Testing, Treatment Options, Stages of fibrosis and Care

Caring for patients with chronic hepatitis C infection
Basic information about hepatitis C, published Jan 31, 2019 in: Nursing2019 - Ahead of Print, available in PDF format only.

Highlights
Who is at risk?
How HCV infection progresses
Extrahepatic complications of HCV infection
Testing for HCV
Stages of fibrosis
Treatment options
Removing treatment barriers
Promising future

Nursing. 2019 Jan 31. doi: 10.1097/01.NURSE.0000553271.39804.a4. [Epub ahead of print]
Caring for patients with chronic hepatitis C infection
Chaney, Amanda, DNP, APRN, FNP-BC, FAANP
Abstract:
Hepatitis C virus (HCV) infection is the most common chronic bloodborne infection in the US. This article discusses the pathophysiology of HCV infection, new treatment options, and nursing care and patient teaching for patients with chronic HCV infection.
Begin, here..….

For Patients On This Site
2019 February Hepatitis Newsletters: Finding Support 

HCV Special Conference - Worldwide HCV Epidemiology and Impact of Treatment

Website 
February 1-2, 2019 
The goal of the conference is to promote global elimination of hepatitis C infection. World leaders in the related disciplines will assemble to establish the current state of the science and public health challenges. The experts will then formulate the most effective future steps toward elimination.

Coverage 
Executive Director - Publisher, Editor, Reporter: Jules Levin

View slides and commentary from the HCV special conference over at (NATAP), here are a few presentations to get you started:

Baby Boomers; Is There a Need to Re-Focus our Efforts for Hepatitis C Screening Away from Baby Boomers? 23% HCV+ in Rural Drug Users Pennsylvania

Worldwide; HCV Epidemiology and Impact of Treatment 

What Is The Value Of HCV Treatment?
The Cost of HCV Elimination

Begin here: http://www.natap.org/2019/AASLDEASL/AASLDEASL.htm

Tuesday, February 5, 2019

Immunotherapy combinations show promise for liver cancer

Immunotherapy combinations show promise for liver cancer
Liz Highleyman

Over years or decades, chronic hepatitis B or C, heavy alcohol use, fatty liver disease or other causes of liver damage can lead to cirrhosis and HCC, the most common type of primary liver cancer. Often diagnosed at a late stage, liver cancer is hard to treat and is a leading cause of cancer deaths worldwide. HCC does not respond well to traditional chemotherapy and a majority of people do not respond to current targeted therapies or immunotherapies. Biliary tract cancer, involving the gallbladder or bile ducts, is even more difficult to treat.

Charalampos Floudas and colleagues from the US National Cancer Institute evaluated a combination of durvalumab and tremelimumab in 10 people with HCC and 12 with biliary tract cancers that could not be surgically removed or treated locally. 

Baby Boomers and the Flu

Page Last Updated: Feb 15, 2019
This post will be updated with news and current flu activity from the CDC as information is made available. Articles with a focus on liver disease, viral hepatitis, baby boomers and the flu are found further down this page.

News
Feb 13 - Earlier Tamiflu May Cut Death Risk in Some Severe Cases , observed 30% decrease in mortality with early oseltamivir among influenza A/H3N2 patients in ICU. Feb 18 - Research: 'Killer' cells raise hope of universal flu vaccine.

Latest CDC Update: Feb 15, 2018
2018-2019 Influenza Season Week 6 ending February 9, 2019

View Interactive Map


According to CDC's; Weekly U.S. Influenza Surveillance Report, this flu season has not been as severe as last year, although activity is now widespread, and at the highest levels since the start of the season. This week NBC news reported the flu season may be milder due to a better flu vaccine match; but less severe flu season doesn't underscore the very serious consequences flu can have, experts say. Watch the following video for additional information: CDC Touts Effectiveness Of This Year's Flu Vaccine.

A total of 6,868 influenza-associated hospitalizations were reported between October 1, 2018 and February 9, 2019, and a total of 34 influenza-associated pediatric deaths occurring during the 2018-2019 season have been reported.

Here is the latest updated from the CDC:
Influenza activity continues to increase in the United States. Influenza A(H1N1)pdm09, influenza A(H3N2), and influenza B viruses continue to co-circulate. Below is a summary of the key influenza indicators for the week ending February 9, 2019:
  • Viral Surveillance:The percentage of respiratory specimens testing positive for influenza viruses in clinical laboratories increased. Influenza A(H1N1)pdm09 viruses have predominated in most areas of the country, however influenza A(H3) viruses have predominated in the southeastern United States (HHS Region 4). In the most recent three weeks, influenza A(H1N1)pdm09 and influenza A(H3) viruses were reported in approximately equal numbers in HHS Regions 6 and 7.
    • Virus Characterization: The majority of influenza viruses characterized antigenically are similar to the cell-grown reference viruses representing the 2018–2019 Northern Hemisphere influenza vaccine viruses.
    • Antiviral Resistance: The vast majority of influenza viruses tested (>99%) show susceptibility to oseltamivir and peramivir. All influenza viruses tested showed susceptibility to zanamivir.
  • Influenza-like Illness Surveillance: The proportion of outpatient visits for influenza-like illness (ILI) increased to 4.8%, which is above the national baseline of 2.2%. All 10 regions reported ILI at or above their region-specific baseline level.
    • ILI State Activity Indictor Map: New York City and 26 states experienced high ILI activity; the District of Columbia, Puerto Rico and eight states experienced moderate ILI activity; 11 states experienced low ILI activity; and the U.S. Virgin Islands and five states experienced minimal ILI activity.
  • Geographic Spread of Influenza: The geographic spread of influenza in Puerto Rico and 48 states was reported as widespread; one state reported regional activity; the District of Columbia and one state reported local activity; the U.S. Virgin Islands reported sporadic activity; and Guam did not report.
  • Influenza-associated Hospitalizations A cumulative rate of 23.8 laboratory-confirmed influenza-associated hospitalizations per 100,000 population was reported. The highest hospitalization rate is among adults 65 years and older (64.1 hospitalizations per 100,000 population).
  • Pneumonia and Influenza Mortality: The proportion of deaths attributed to pneumonia and influenza (P&I) was below the system-specific epidemic threshold in the National Center for Health Statistics (NCHS) Mortality Surveillance System.
  • Influenza-associated Pediatric Deaths: Six influenza-associated pediatric deaths were reported to CDC during week 6.
Continue reading: Read : https://www.cdc.gov/flu/weekly/index.htm

Preliminary In-Season U.S. Influenza Burden Estimates
The 2018-2019 flu season is the first season CDC has reported in-season burden estimates of flu in the U.S. These in-season estimates will be updated over the course of the flu season.
CDC estimates that, from October 1, 2018 through January 26, 2019, there have been:
--10.1 million – 11.7 million flu illnesses
--4.7 million – 5.6 million flu medical visits
--118,000 – 141,000 flu hospitalizations
Read the report, here...….

Public Health Agency of Canada:
The most up-to-date influenza information from Canada is available at http://www.phac-aspc.gc.ca/fluwatch
British Columbia Influenza Surveillance Bulletin Influenza
Influenza activity remains elevated in BC and is dominated by the H1N1 strain. 
Joint ECDC - WHO/Europe Weekly Flu Update: https://flunewseurope.org/Severity

News

Video:
This flu season should serve as a wake-up call – we need to redouble our efforts to prevent and treat the flu
Seasonal outbreaks of the flu cause thousands of deaths even in a good year, and the last flu season, 2017-2018, was a terrible one. It killed 80,000 Americans and sent 900,000 to the hospital, making it the worst influenza season in decades.


Baby Boomers and the Flu 
Did you know that you are more susceptible to flu-related complications if you're over 65, living with chronic liver disease, or viral hepatitis? Yep, I knew it too. 

Currently information on this blog is aimed at people living with or treating hepatitis C, for the most part that is the baby boomer generation; born between 1946 to1964. 

Speaking of baby boomers, if you haven't read the CDC's eye- opening report on last years flu season, it was reported 80,000 flu-related deaths occurred in the US, the highest in 40 years. The death rate among young baby boomers, aged 50 to 64 were shocking as well; 
"Death rates were highest in the over-65 age group, which is typical, but the second most affected group comprised those aged 50 to 64 years old; normally, the second highest death rates occur in children, from birth through age 4 years. The ferociousness of the flu season overall, combined with above-average impacts on younger baby boomers, made 2017-2018 one for the record books."
Read the article: Flu Season 2017-2018: A Look at What Happened and What's to Come, CDC report, here. Or read this more recent article, updated Oct 19, 2018: 80,000 Americans died of the flu last winter.That’s more than the number killed in traffic collisions, from gun violence, or from opioid overdoses.

Liver Disease & The Flu
As we age our immune system is less effective in fighting infections, and new infections can have a severe impact on the liver. This can be especially serious for liver transplant recipients and people who have cirrhosis. Flu-related complications could develop into bronchitis or pneumonia, which in rare cases can also be fatal.

Even though the flu vaccine won’t keep everyone from getting sick, it helps prevent serious flu complications. For instance people over 65 who were vaccinated had a lower rate of flu-related death, according to a 2017 study, found on the CDC's website.
"Flu vaccination reduced deaths, intensive care unit (ICU) admissions, ICU length of stay, and overall duration of hospitalization among hospitalized flu patients; with the greatest benefits being observed among people 65 years of age and older."
October - In The News
October 29, 2018
Getting Flu Vaccine One Year Doesn't Reduce Vaccine Effectiveness the Next Year
By Amy Orciari Herman
Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Getting the flu vaccine every year doesn't reduce its effectiveness — and might even boost its performance — suggests a study in JAMA Network Open.

Researchers examined the vaccination status of nearly 3400 children who presented with acute febrile respiratory illness during one of three successive flu seasons between 2013 and 2016. About one-fourth had flu confirmed on reverse-transcription polymerase chain reaction testing; the rest were considered negative for flu.

The researchers found that while vaccine effectiveness varied by vaccine type (e.g., live attenuated influenza vaccine [LAIV) or inactivated influenza vaccine) and flu virus strain, past-season vaccination did not reduce vaccine effectiveness. In fact, in some cases — for example, the effectiveness of LAIV against influenza A(H3N2) — previous vaccination appeared to improve the vaccine's effectiveness.

Of note, residual protection from past-season flu vaccine alone was observed only for influenza B.
A commentator writes, "The results thus suggest additional support for the current Advisory Committee on Immunization Practices' recommendation that children be vaccinated annually against influenza."
LINK(S):
JAMA Network Open article (Free)
JAMA Network Open commentary (Free)
Background: Physician's First Watch coverage of American Academy of Pediatrics recommendation of inactivated flu vaccine over LAIV (Free)

Oct 28, 2018
New Flu Drug Offers Convenience, Fast Activity, and a Novel Mechanism — at a Price
Last week, the FDA approved a new drug for treatment of influenza, baloxavir marboxil (Xofluza).
The drug is indicated for treatment of symptomatic influenza in patients 12 years of age or older. As with existing treatments, it should be started within 48 hours of symptom onset....

Oct 24, 2018
"I figured [the flu] was something that's dangerous to the elderly and the young, not somebody who is healthy and in their 30s," says Hinderliter, who is 39 and the director of government affairs at the St. Louis Realtors association
"Turns out, I was wrong," he says
Read the article, here.....

Should I or Shouldn't?
September 27, 2018
"People say they never had the flu until they got the shot. That argument doesn’t hold water. Either you got your shot too late, you got a strain of the flu that isn’t covered by the vaccine, or you had a one-day immune response which may make you feel like crap for the day, but isn’t anywhere like having the flu. If you are over 65, high dose flu shots are recommended, and some people feel a bit low and fluish the next day. This is not the flu – it is an immune system reaction"
Read the article: The Flu Shot Debate, written by HCV advocate Lucinda Porter.

CDC Information
People 65 years and older should get a flu shot and not a nasal spray vaccine.
They can get any flu vaccine approved for use in that age group with no preference for any one vaccine over another. There are regular flu shots that are approved for use in people 65 and older and there also are two vaccines designed specifically for people 65 and older:
High Dose Flu Vaccine:
The “high dose vaccine” contains 4 times the amount of antigen as a regular flu shot. It is associated with a stronger immune response following vaccination (higher antibody production). Results from a clinical trial of more than 30,000 participants showed that adults 65 years and older who received the high dose vaccine had 24% fewer influenza infections as compared to those who received the standard dose flu vaccine. The high dose vaccine has been approved for use in the United States since 2009.
Learn more about high dose flu vaccine here.

Adjuvanted Flu Vaccine:
The adjuvanted flu vaccine, Fluad, is made with MF59 adjuvant an additive that creates a stronger immune response to vaccination. In a Canadian observational study of 282 people aged 65 years and older conducted during the 2011-12 season, Fluad was 63% more effective than regular-dose unadjuvanted flu shots. There are no randomized studies comparing Fluad with Fluzone High-Dose. This vaccine was available for the first time in the United States during the 2016-2017 season. Learn more about adjuvanted flu vaccine here.

For Adults with LIVER DISEASE: Important information about a dangerous infection
If you have chronic liver disease, you are more likely to have serious complications if you get pneumococcal disease

Get pneumococcal vaccines 
People who are 65 years of age and older should also be up to date with pneumococcal vaccination to protect against pneumococcal disease, such as pneumonia, meningitis, and bloodstream infections. Talk to your doctor to find out which pneumococcal vaccines are recommended for you. Pneumococcal pneumonia is an example of a serious flu-related complication that can cause death. 

You can get the pneumococcal vaccine your provider recommends when you get the flu vaccine.

CDC - Got Questions?
Flu vaccines recommended this season.

Detailed flu and flu vaccine information specific to the current flu season

If you have HIV, you are at high risk of serious influenza-related complications and should get an injectable influenza vaccine (a flu shot).

Recommended Reading:
Flu and Colds: In Depth
What do we know about the effectiveness of complementary approaches for flu and colds?

Is It A Nasty Cold Or The Flu?
So, if you do have the flu, it's important to consult with your health care provider about treatment. And distinguishing between a cold and flu may be easier than you think, Ejnes says.

Stay healthy!
Tina