Showing posts with label 2015-DDW. Show all posts
Showing posts with label 2015-DDW. Show all posts

Sunday, June 28, 2015

Weekend Reading - Natural history of hepatitis C: An Updated Look at the Rate of Progression to Cirrhosis and the Incidence of Decompensation

Weekend Reading: Natural history of hepatitis C

On most weekends this blog offers up a bit of easy "Weekend Reading" on the topic of HCV.

After receiving a hepatitis C diagnosis, the first task at hand is understanding how the virus damages the liver. A good place to start is with the Natural History Of Hepatitis C. 

To date the natural history of hepatitis C remains controversial. Among HCV-infected individuals progression to advanced liver disease generally requires decades but is influenced by several host factors, the following offers an update on the natural history of hepatitis C using information found online at MedscapeNATAP, and the interactive website Hepatitis C Online.

The Natural History of Chronic Hepatitis C. An Updated Look at the Rate of Progression to Cirrhosis and the Incidence of Decompensation in a Large U.S. Health Maintenance Organization

We begin with a commentary  titled, "Hepatitis C: 25 Years Old, and Fading," written by William F. Balistreri, MD., recently published over at Medscape. The good doctor writes about a study presented last month at "Digestive Disease Week," which suggested the rate of developing cirrhosis and decompensation in people with HCV is higher than previously thought. An excerpt follows with a link to corresponding slides provided this week by Jules Levin @ NATAP.  In addition stroll over to "Hepatitis C Online" or download "Natural History of Hepatitis C Infection" for a quick review of related studies including; spontaneous clearance versus chronic infection and factors that may impact the rate of fibrosis,


Cirrhosis and the Incidence of Decompensation

The projected public health burden of HCV is based on old natural history studies. One presentation[6] suggested a need to reexamine the natural history of HCV because the current patient cohort is older and confounded by a higher prevalence of obesity, and other comorbid conditions that may affect the outcome of the disease. Therefore, investigators conducted a retrospective cohort study at Kaiser Permanente Southern California.

From 2002-2013, 60,338 adults had an HCV diagnosis code or a positive HCV RNA lab test. Of these, 33,124 HCV cases met inclusion criteria and were matched with 164,221 controls. Mean age of the HCV cases and non-HCV controls was 54 years. Among case-patients, 41% were white and 27% were Hispanic; among controls, the respective proportions were 46% and 28%.

Prevalent cirrhosis was found in 19% of the HCV-infected cohort and 1.4% of the non-HCV controls. The incident decompensation rate among previously compensated HCV patients with cirrhosis was 47%, which was almost twice the incident decompensation rate among non-HCV cirrhotic controls. Of note, 23% of HCV cases were diagnosed with cirrhosis after a median follow-up of 2 years, which indicates that the rates of development of HCV-related cirrhosis and decompensation are higher than previously reported. The authors attributed this to aging of the HCV cohort and associated comorbidities, such as obesity. Multivariable analyses to explore the relationship between baseline comorbid conditions and the incidence of cirrhosis and decompensation are ongoing.

  1. Nyberg LM, Li X, Chiang K, et al. The natural history of chronic hepatitis C. An updated look at the rate of progression to cirrhosis and the incidence of decompensation in a large U.S. health maintenance organization. Program and abstracts of Digestive Disease Week; May 16-19, 2015; Washington, DC. Abstract 809.

View All Slides@ NATAP

The Natural History of Chronic Hepatitis C. An Updated Look at the Rate of Progression to Cirrhosis and the Incidence of Decompensation in a Large U.S. Health Maintenance Organization

Begin here....

About Hepatitis C Online
Hepatitis C Online is a free educational web site from the University of Washington.

The site is a comprehensive resource that addresses the diagnosis, monitoring, and management of hepatitis C virus infection. 

Hepatitis C Online

Website Site:

Spontaneous Clearance versus Chronic Infection 
Variable Outcomes of Chronic Infection 
Factors Impacting Rate of Progression of Fibrosis 
Summary Points 

Tuesday, May 19, 2015

DDW Daily News - Pricing remains main barrier to HCV eradication

May Updates
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

Pricing remains main barrier to HCV eradication
Posted By: DDW Daily News on: May 19, 2015

In: AASLD, By Society, DDW Daily News

Hepatitis C (HCV) can be eradicated, but the question is whether the global community, or even a single nation, has the financial and political will to do it.

Brian Edlin, MD

“This is a very exciting time in hepatitis C,” said Brian Edlin, MD, associate professor of medicine at Weill Cornell Medical College. “We now have safe, easy treatments that are quite effective. These potent tools can be used to cure disease and interrupt transmission. We are in a position to talk about eradication of hepatitis C; price is the major barrier.”

Eradication is technically feasible, Dr. Edlin said during a Monday morning AASLD Clinical Symposium, but not likely until current pricing policies change.

The latest generation of HCV treatments effectively cure the disease in 90 to 95 percent of patients, said Nancy Reau, MD, FAASLD, associate professor of medicine, University of Chicago, IL. The utilization of liver transplantation for HCV-related disease is projected to fall dramatically during the next decade. The greater the proportion of HCV patients treated, the smaller the need for liver transplantation.

“It will take five to ten years to see the full impact of highly effective HCV treatment, but the benefits are enormous,” she said. “Effective treatments will improve neurocognitive function, lower rates of glycemic resistance and diabetes, reduce associated cardiovascular disease, improve the quality of life, reduce transmission, lower rates of work absence and reduce rates of health-care utilization.”

The new generation of HCV drugs, sofosbuvir, ledipasvir, paritaprevir/r, ombitasvir, dasabuvir and combination regimens, cost between $85,000 and $200,000, depending on the regimen and duration of treatment. Repeated studies have shown that all of these regimens are cost-effective, Dr. Reau said, ranging from less than $20,000 per quality adjusted life year (QALY) gained to just over $55,000 per QALY gained.

The problem is financial. At current prices, HCV treatment is expected to cost $136 billion over the next five years in the U.S. alone.

“HCV treatment is cost-effective, but the costs are not sustainable,” she said. “We are seeing that being cost-effective does not mean affordable or accessible.”

The high price of HCV treatment sows confusion and doubt, Dr. Edlin said. Payors ration access to limit their costs, sparking conflict between providers, patients and payors. Access is not being determined by medical necessity but by factors such as advanced disease, lack of substance abuse, lack of malignancy, provider experience and onerous prior authorization procedures.

Cost is not the issue, he said. Sofosbuvir costs about $1 per tablet to manufacture. That same tablet is priced about $1,000.

“Pricing decisions are not in the best interests of patients or providers,” Dr. Edlin said. “Pricing decisions are in the best interests of pharmaceutical manufacturers. We physicians are almost the sole voice for our patients’ interests. If we allow pricing policies to be set based on manufacturers financial goals, many patients with hepatitis C will progress and die, transmission will continue and any hope of eradication is lost. These new regimens offer the possibility of eradicating hepatitis C, but we need a public consensus to make it happen. All people with hepatitis C deserve treatment.”

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Monday, May 18, 2015

Hepatitis C Recommendations for 2015 - DDW

Hepatitis C Recommendations for 2015 - DDW 
This session was definitely one of the most popular AASLD Programs at DDW 2015. Dozens of people attended to hear the latest developments in the rapid advancements in the treatment of hepatitis C. DDW TV interviews the session moderator, Raymond Chung, about the key take home messages as well as session attendees. Watch to learn what you missed at the session…

Sunday, May 17, 2015

DDW 2015 - Several tools available for non-invasive assessment of fibrosis

Several tools available for non-invasive assessment of fibrosis

Posted By: DDW Daily News
May 17, 2015
In: AASLD, By Society, DDW Daily News

From biomarkers to imaging technology, clinicians now have an array of alternatives to biopsies when assessing and diagnosing liver disease.

Nezam H. Afdhal, MD, FAASLD, director of hepatology at Beth Israel Deaconess Medical Center and professor of medicine at Harvard Medical School in Boston, will provide an in-depth look at these tools during Monday’s AASLD State-of-the-Art Lecture Non-Invasive Assessment of Fibrosis. 

Dr. Afdhal said the three objectives for his talk are explaining how to use non-invasive diagnostic tests to stage liver disease; determining candidacy for treatment, particularly for hepatitis B and C; and determining prognosis and outcome in patients with chronic liver disease.

“We will look at all the diagnostic tests — serum markers, ultrasound elastography and magnetic resonance elastography,” he said. “Most people don’t have all of these, but most people have access to some of them. The idea is to say, ‘If this is what you have, this is how best to apply it in clinical practice so that you can get the types of evaluations that you need.’”

Dr. Afdhal will discuss the importance of accurately diagnosing cirrhosis, and then how to apply the AASLD guidelines around that diagnosis to screen for portal hypertension gastropathy and hepatocellular carcinoma.

He will also discuss using the new diagnostic tools for patients with hepatitis C who have advanced fibrosis, including Metavir stage three or four, or stage two with symptoms. Staging is essential when prescribing one of the new antiviral drugs, Dr. Afdhal said, since payors are insisting on that information.

Serum tests range from simple markers such as the nonalcoholic fatty liver disease fibrosis score and the AST to Platelet Ratio Index, to more specialized tests like the HepaScore and FibroSure. The latter tests use specific fibrosis-associated biomarkers to calculate a risk index for the amount of disease.

Vibration-controlled elastography using Fibroscan is another tool. The test sends a sheer wave into the liver and provides a real-time liver stiffness measurement that correlates to the degree of fibrosis.

The beauty of the Fibroscan, Dr. Afdhal said, is that you can perform it the office “and you know the answer in five minutes so you can actually have a real-time discussion with the patient.”

Magnetic resonance elastography is another useful diagnostic tool because it provides a three-dimensional view of the liver and also measures things like the amount of fat and iron in the liver. The downside is that it’s time-consuming for the patient, involves referring them offsite and is significantly more expensive than a Fibroscan.

Please refer to the schedule-at-a-glance in Monday’s issue for the time and location of this and other DDW® events.

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DDW 2015 - Despite advances, issues remain in fight to eradicate hepatitis C

Also View; Hepatitis C fix could yield huge economic benefit
While a new generation of safer, more effective oral medications to treat hepatitis C patients may cost tens of thousands of dollars for a 12-week regiment, investing in these new therapies could generate savings estimated at more than $3.2 billion annually in the U.S. and five European countries, according to a new study (abstract 228) released today at Digestive Disease Week® (DDW) 2015. These savings would have a significant economic impact on society.

Despite advances, issues remain in fight to eradicate hepatitis C
Posted By: DDW Daily News on: May 17, 2015

With headlines proclaiming that new antiviral drugs have forever changed the game for patients infected with hepatitis C (HCV), it’s easy to forget that issues still remain in identifying and treating the disease.

Nancy S. Reau, MD, FAASLD, associate professor of medicine in the department of hepatology at the University of Chicago Medical Center, will discuss some of these issues on Monday during the AASLD State-of-the-Art Lecture Issues in Hepatitis C: Identification, Access to Care and Cost.

As noted in a 2014 journal article that Dr. Reau co-authored, a 12-week course of therapy with one of the new antiviral drugs can be in excess of $84,000. Compared to the cost of a liver transplant, which is estimated at $600,000 on average on the United Network for Organ Sharing’s (UNOS) Transplant Living website, that might seem like a bargain. But, despite increasing competition among pharmaceutical companies, cost is still an obstacle, Dr. Reau said.

The cost issue is further complicated by the fact that many HCV patients come from socio-economic groups where many still lack insurance and substance abuse is prevalent, Dr. Reau said. Access to care is also an issue.

“The medicine could be dirt cheap, but if you don’t have enough people to actually give care then you are still going to have access issues,” Dr. Reau said.

The current dearth of providers presents challenges not only for immediate treatment, but also for follow-up to ensure patients are cured, don’t get re-infected, and for people with advanced disease, that they don’t have long-term consequences as opposed to going on to live normal lives.

Yet some observers are concerned about expanding the provider pool now that HCV is considered a curable disease. Dr. Reau said she’s in the camp that argues more specialists are needed because of the increasing prevalence of other liver diseases.

Screening is another challenging topic. While most hepatologists don’t consider screening to be controversial, Dr. Reau said “we still have people who believe that expanding screening for HCV is potentially harmful and not cost effective.”

Risk-based screening is universally endorsed, but the consensus ends there.

In 2012, the Centers for Disease Control and Prevention recommended one-time screening of all adults born between 1945 and 1965, as this group has the highest concentration of HCV infection in the U.S. Dr. Reau said traditional risk factors such as IV drug use and blood transfusions prior to 1991 contribute to a higher prevalence among baby boomers, but it’s mainly due to iatrogenic transmission through activities causing surreptitious blood exposure. This could be mundane things like getting a haircut or going to the dentist, as baby boomers were born before universal precautions for HCV were implemented.

Another school of thought is to screen other at-risk groups, such as people who emigrate from high-prevalence countries or the pregnant population. But the larger the net, the more controversial the practice becomes and the higher the risk of overscreening, Dr. Reau said.

Please refer to the schedule-at-a-glance in Monday’s issue for the time and location of this and other DDW® events.

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Saturday, May 16, 2015

DDW 2015 - Experts to describe prospects for hepatic fibrosis therapy

Experts to describe prospects for hepatic fibrosis therapy
Posted By: DDW Daily News on: May 16, 2015
In: AASLD, By Society, DDW Daily News, Saturday, May 16

Researchers are gaining insights into the mechanisms underlying hepatic fibrosis, creating the potential for new, antifibrotic treatments in the coming years.

“It’s an exciting time because decades of solid, basic biologic studies are now translating into a clearer understanding of the disease and how to attack it therapeutically,” said Scott L. Friedman, MD, FAASLD, dean for therapeutic discovery at the Icahn School of Medicine at Mount Sinai in New York, NY.

Dr. Friedman and Nezam H. Afdhal, MD, FAASLD, director of hepatology at Beth Israel Deaconess Medical Center and professor of medicine at Harvard Medical School, Boston, will moderate Sunday’s AASLD Clinical Symposium Prospects for Therapy of Hepatic Fibrosis.

The session will review how recent insights into hepatic fibrosis pathogenesis are leading to novel therapeutic approaches. The presenters will also examine emerging technologies that will enhance clinicians’ ability to quantify fibrosis without performing a liver biopsy.

Hepatic fibrosis has received increased research attention at least in part because of advancements in the treatment of hepatitis C and B. Dr. Friedman said the growing problem of nonalcoholic steatohepatitis (NASH) has also increased interest in hepatic fibrosis.

“There is a real sense of urgency that we need to understand not only the pathogenesis of NASH, but also the fibrosis that develops because of NASH,” he said. “With that comes a greater emphasis on partnering with FDA and regulatory agencies to develop new ways to test new drugs and to get them to patients faster.”

There are no drugs currently on the market to treat hepatic fibrosis, Dr. Friedman said, but recent advances in clarifying hepatic stellate cell biology and the mechanisms of fibrosis progression and regression have raised the realistic expectation for new antifibrotic treatments.

“The old tried-and-true cellular target — the hepatic stellate cell, the key fibrogenic cell in the liver — remains quite relevant and at the center of therapeutic efforts,” Dr. Friedman said. “But in addition, we have layered on to that a large number of new pathways including cytokines, lipogenesis and insulin signaling that also may uncover new targets for therapy.”

The session will also include a review of non-invasive techniques now available for the diagnosis of fibrosis. “The trend is going away from liver biopsy and moving toward serological and radiological tests for fibrosis,” Dr. Afdhal said.

These tools include transient elastography and new ultrasound machines that use supersonic shear waves, he added. The accuracy of the tests, as well as the possibility of missing patients with more advanced disease, is one downside to the non-invasive approaches, Dr. Afdhal acknowledged.
During the session, he and Dr. Friedman will demonstrate how to use the tests and discuss their success rates in making the right diagnosis and avoiding misdiagnoses.

Please refer to the schedule-at-a-glance in Sunday’s issue for the time and location of this and other DDW® events.

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DDW2015- Experts to discuss rapidly evolving hepatitis C recommendations

Experts to discuss rapidly evolving hepatitis C recommendations
Posted By: DDW Daily News on: May 16, 2015

Even with the groundbreaking oral regimens to fight hepatitis C, certain populations still require special care. Those populations will be a primary focus of Sunday’s AASLD Clinical Symposium Hepatitis C Recommendations for 2015.

The symposium will also provide a comprehensive overview of regimens to fight hepatitis C
virus (HCV) treatment options that will be available for clinical use in 2015. The session will open with a review of current treatment protocols for patients across the disease spectrum, followed by three talks about the treatment of special populations.

The special patient groups to be discussed are: recipients of liver transplants, patients with HIV co-infection and patients with renal failure, said Raymond T. Chung, MD, FAASLD, director of hepatology and the Liver Center at Massachusetts General Hospital, Boston. Dr. Chung will co-moderate the symposium with Paul Martin, MD, FRCP, FRCPI, chief of the division of hepatology at the University of Miami Miller School of Medicine, FL.

“Broadly, what we will see [this year] is an extension of treatment to populations that had been underserved by regimens that were interferon based,” Dr. Chung said. “Many more patients will become eligible for treatment.”

The new antiviral HCV drugs have been game-changers for liver transplant patients and persons with HIV co-infection, Dr. Chung added. This is particularly remarkable for recipients of liver transplants for HCV liver disease, he said, because essentially all of these patients experience a recurrence of hepatitis C, and previous interferon-based regimens produced limited response rates and often-intolerable side effects.

Yet, Dr. Chung noted, the advent of new oral agents does not eliminate the need to take special steps with these populations. This is due in large part because of the other types of medications these patients take, such as anti-rejection drugs prescribed for transplant recipients or anti-retroviral agents for HIV-infected patients.

“Those populations, in some cases, will need to be navigated carefully with the regimens that we are talking about using for hepatitis C,” Dr. Chung said. “But are they manageable? Absolutely, with a little bit of forethought.”

Dr. Martin noted that patients with genotype-3 infection remain a hard-to-serve population. The same goes for patients with renal failure, Dr. Chung said, because the kidneys clear or filter some of the key antiviral medications.

The session will draw from the HCV guidance developed by AASLD and the Infectious Diseases Society of America. Drs. Martin and Chung helped develop the guidance, which are published online at The guidance will be updated as new information becomes available and new sections will be added to the website as needed. Visitors will be able to access an ongoing summary of “recent changes” for updates.

Creating a living document is a major boon to physicians and patients, Dr. Martin said. “I think it’s one of the best things I have ever been involved in,” he said. “And, very importantly, it is driving practice.”

Please refer to the schedule-at-a-glance in Sunday’s issue for the time and location of this and other DDW® events.