Sunday, May 22, 2016

The AASLD Meeting at DDW 2016 - Program Overview

Digestive Disease Week® 2016 San Diego Convention Center San Diego, CA Digestive Disease Week (DDW)




Published on May 21, 2016
2016 DDW TV
AASLD Secretary - Kimberly A. Brown, MD, FAASLD – gives an overview of the most important things happening as part of AASLD’s program – and talks about what a huge difference a year makes in the treatment and – more importantly – the cure — of certain liver diseases.

Digestive Disease Week® 2016 San Diego Convention Center San Diego, CA Digestive Disease Week (DDW)

2016 DDW TV
Follow DDW TV for highlights from the 2016 meeting. We'll have studio interviews with leading experts in the field, session highlights, attendee perspectives and a look at what institutions around the world are doing to advance the field.


Next-generation HCV treatments should benefit challenging patient groups

Next-generation HCV treatments should benefit challenging patient groups
Posted By: DDW Daily News on: May 22, 2016In: AASLD, By Society, DDW Daily News, Sunday, May 22

Michael Fried, MD

Despite treatment success rates of 95 percent and better, hepatitis C (HCV) therapy can still improve. Finding a universal cure is the goal, according to Michael Fried, MD, professor of medicine and director of the UNC Liver Center at the University of North Carolina, Chapel Hill.

“We are really at the point of curing all patients of hepatitis C, of leaving no SVR [sustained viral response] behind,” Dr. Fried said. “Even though the regimens we have today are incredibly effective, there are certain populations that may benefit from longer duration of therapy, addition of ribavirin under certain circumstances or other tweaks so that we are approaching universal cure.”

Dr. Fried will moderate the AASLD Clinical Symposium, Prospects for New HCV Treatments, Monday afternoon. The session’s expert presenters will review the latest thinking on special populations that may need more intensive treatment, the prospects for curing patients with decompensated liver disease, dealing with patients who fail to respond to treatment and the prospects for new therapeutic agents in the near term.

“These are topics no one would have believed 10 years ago, even five years ago,” Dr. Fried said. “The world has changed in dramatic ways when we start talking about ways to improve on 95 percent treatment success. Patients with hepatitis C should be incredibly hopeful, as they already are.”

In the early days of HCV treatment, success rates fell between 7 and 20 percent. Today, overall response rates routinely top 95 percent. And while there are no longer problem populations, there are populations that are more challenging than most. For these patients, the goal is to optimize treatment from a growing armamentarium of direct-acting antiviral agents and combination regimens.

Patients with decompensated liver disease can be treated for HCV and even cured, Dr. Fried noted. However, these patients are excluded from certain treatment regimens because of potential toxicity. Additionally, the question remains whether curing these patients will bring significant long-term advantages, such as avoiding liver transplantation.

Patients who fail treatment are another challenging group. Fortunately only a relatively small number of patients do not respond to treatment even when they are 100 percent adherent.

“We think treatment failure for these patients may have to do with resistant variants of the virus that need to be managed,” Dr. Fried said. “When you truly fail therapy, you usually fail with a selection of resistant variants. Knowing what to do for these patients with some of the newer generations of medications will be very important for that minority who fail despite their best efforts.”

Several new agents and new combinations within existing treatment categories will likely be approved over the next 18 months, Dr. Fried added.

“I want to stress that the current regimens are incredibly effective,” he said. “But when people do fail therapy, we will have regimens that have non-overlapping resistance profiles with which to treat them. We are looking at the very real possibility of new dual- and triple-agent regimens that will treat more patients more effectively.”
Access to treatment is also improving, he said, noting that increased competition is bringing prices down and payors are beginning to recognize the advantage of curative treatment.

“We have an outstanding panel of speakers for this symposium who will present new and key information in a very concise way,” Dr. Fried said. “This symposium will immediately change clinical practice for those who currently manage or plan to manage patients with hepatitis C.”

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

http://ddwblog.org/2016/05/next-generation-hcv-treatments-should-benefit-challenging-patient-groups/

Chronic HCV boosts hospitalization risk, not just for liver

Chronic HCV boosts hospitalization risk, not just for liver

By: BIANCA NOGRADY, Family Practice News Digital Network May 21, 2016
FROM THE JOURNAL OF VIRAL HEPATITIS

Vitals

Key clinical point: Individuals with chronic hepatitis C infection have significantly greater risk of hospitalization for a range of health issues than other health system patients.

Major finding: The risk of hospitalization was 3.7 times greater in individuals with chronic hepatitis C infection, compared with general health system patients.

Data source: An observational cohort study in 10,131 patients with chronic hepatitis C infection (the Chronic Hepatitis Cohort Study) and 20,262 other health system patients.

Disclosures: The Chronic Hepatitis Cohort Study was funded by the CDC Foundation, which receives grants from a range of pharmaceutical companies. No other conflicts of interest were declared.

People with chronic hepatitis C infection were nearly four times more likely than other health system patients to be hospitalized, and not only with liver-related problems.

An observational cohort study of 10,131 patients with chronic hepatitis C infection (the Chronic Hepatitis Cohort Study) and 20,262 health system patients showed the overall hospitalization rate was 3.7 times higher in patients with chronic hepatitis C.

The study, published online May 15 in the Journal of Viral Hepatitis, found patients with chronic hepatitis C experienced an average of 3.5 hospitalizations over a mean of 5.5 years follow-up, compared with 1.9 hospitalizations in other patients over an average of 4.8 years. Investigators excluded HCV patients with HIV or hepatitis B coinfection, or who had received a liver transplant.

Hospitalization rates in both groups were significantly higher among patients who were older than 65 years, black, or who had a household income less than $15,000 per year (J Viral Hepat. 2016 May 15. doi: 10.1111/jvh.12548).

Patients with chronic hepatitis C had a nearly 25-fold greater risk of being hospitalized with liver-related conditions, compared with other health system patients.

“Liver-related conditions are the third leading cause of nonsurgical hospitalizations of chronic HCV patients after cardiovascular diseases and infections,” wrote Dr. E. H. Teshale, from the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and coauthors.

However liver-related complications only accounted for 9.1% of all hospitalizations in this group, compared with 1.3% of hospitalizations in the control group.

The analysis also revealed a sixfold greater risk of hospitalization for infection, a sevenfold greater risk for dermatologic and hematologic problems, a 10-fold greater risk of hospitalization for substance abuse, and a nearly threefold greater risk of being hospitalized for cardiovascular disease, compared with other health system patients.

Hospitalizations were significantly lower among patients receiving treatment for hepatitis C and who had achieved a sustained virologic response, the authors noted.

“Initiation of treatment prior to progression to advanced liver disease can reduce the cost of hospitalization, which in many cases may include repeated hospitalizations and other costly interventions,” the investigators reported. “Some studies have found a significant health care cost alleviation following HCV therapy, which [was] primarily due to costs associated with hospitalizations for non-HCV–related comorbidities.”

The Chronic Hepatitis Cohort Study was funded by the CDC Foundation, which receives grants from a range of pharmaceutical companies. No other conflicts of interest were declared.

Source -   




How sick must hepatitis C patients be to get help?

How sick must hepatitis C patients be to get help?
by Don Sapatkin, Staff Writer

"They said, 'You're not sick enough,' " said Luongo, who is staying with his ailing mother in Northeast Philadelphia. "How do they tell somebody you've got a disease that's deadly, that's going to kill you, but you're not sick enough for the cure?" 
"A disenfranchised, vulnerable community was one where they could draw the line," said Robert Greenwald, a Harvard law professor and coauthor of a study last year that found most states were rationing hepatitis C treatment. "A person with Alzheimer's on Medicaid would have family who would not tolerate not getting the cure," he said, if one became available.

 Read more here....

Thursday, May 19, 2016

The real reason Big Pharma wants to help pay for your prescription

The real reason Big Pharma wants to help pay for your prescription
Benjamin Elgin and Robert Langreth - Bloomberg - Thursday, May 19, 2016

In August 2015, Turing Pharmaceuticals and its then-chief executive, Martin Shkreli, purchased a drug called Daraprim and immediately raised its price more than 5,000 percent. Within days, Turing contacted Patient Services Inc., or PSI, a charity that helps people meet the insurance copayments on costly drugs. Turing wanted PSI to create a fund for patients with toxoplasmosis, a parasitic infection that is most often treated with Daraprim.

Having just made Daraprim much more costly, Turing was now offering to make it more affordable. But this is not a feel-good story. It’s a story about why expensive drugs keep getting more expensive, and how U.S. taxpayers support a billion-dollar system in which charitable giving is, in effect, a very profitable form of investing for drug companies—one that may also be tax-deductible.

“It looks great for pharmaceutical companies to say they are helping patients get the drugs,” says Adriane Fugh-Berman, a doctor who’s studied pharma marketing practices for three decades and is an associate professor of pharmacology and physiology at Georgetown University. The intent of these donations, she says, is to “deflect criticism of high drug prices. Meanwhile, they’re bankrupting the health-care system.”

Continue reading....

Hepatitis C is Killing Americans in Record Numbers While Patients Cannot Access Life Saving Medicine

Hepatitis C is Killing Americans in Record Numbers While Patients Cannot Access Life Saving Medicine
David Rein

According to the CDC and reported recently by Lena Sun in the Washington Post, Hepatitis C now kills more people annually than the next 60 reportable infectious diseases combined, and, yes, the list of the next 60 infectious diseases includes HIV. In fact, hepatitis C has been killing more Americans than HIV since 2007, a fact the CDC first reported in 2012. That hepatitis C deaths set a new record in 2014 is not surprising. Hepatitis C deaths have set new records in every year since at least 2003, but the continued rise is alarming given that the vast majority of these deaths are preventable with the wide range of treatments now available.

In 2010, my NORC colleague John Wittenborn and I, along with CDC coauthors (none of whom have reviewed this post - the post reflects my thoughts alone), shopped a paper forecasting the mortality we are seeing today to three major American medical journals...



Johns Hopkins to Celebrate 1,000 Hepatitis C Cures

Media Advisory: Johns Hopkins to Celebrate 1,000 Hepatitis C Cures
Doctors, staff members, patients to gather Thursday to mark historic milestone
Release Date: May 17, 2016

In a little more than a year, 1,000 people infected with the hepatitis C virus have been cured with help from the Johns Hopkins Infectious Disease Center for Viral Hepatitis. Doctors, nurses and other staff members from the clinic will celebrate this historic milestone with many of their cured patients on Thursday, May 19, at the William H. Welch Medical Library on the Johns Hopkins University School of Medicine campus.

Within the last 18 months, there have been historic breakthroughs in the treatment of hepatitis C. In years past, the treatment was arduous and yielded spotty results. Today’s treatments can typically clear the virus from the body’s system in three months. The Infectious Disease Center for Viral Hepatitis recruits patients who test positive for hepatitis C virus and guides them, step by step, through their treatment to a cure.

“We have an entire network devoted to curing people of hepatitis C,” says Mark Sulkowski, M.D., medical director of the center. “From testing all the way to medication, we support patients through the process.”

The clinic brings together doctors, nurses, pharmacists, social workers, peer counselors and others to help patients manage their treatment regimen. Many of the clinic's patients are Medicaid or Medicare recipients, and the clinic supports patients with the necessary paperwork to access medications and offset copays.

“While the cost of hepatitis C virus treatments can be a challenge, our team has assembled the resources to help patient access these curative therapies,” says Sulkowski.

The hepatitis C virus causes severe, and often fatal, liver diseases, like cirrhosis and cancer. People can live for decades without knowing they’re infected with the virus. The virus is spread through blood and other body fluids. New infections are most commonly associated with intravenous drug use.

An estimated 60,000 people in Baltimore City live with the hepatitis C virus, many of whom don’t know they’re infected.

Between noon and 1:30 p.m. on May 19, Sulkowski, other clinic staff members and patients will be available to talk to members of the media about the first 1,000 Baltimoreans cured and the hepatitis C challenges that the city still faces.

WHAT: Media availability to discuss milestone of 1,000 hepatitis C patients cured at Johns Hopkins

WHO: Doctors, nurses, staff members and former patients of the Johns Hopkins Infectious Disease Center for Viral Hepatitis

WHEN: Thursday, May 19, noon to 1:30 p.m.

WHERE: William H. Welch Medical Library, 1900 E. Monument St., Baltimore, MD 21205. Arranged parking is available for media at the Washington Street garage located at the corner of Monument and Washington Streets. Please tell the attendant you are on-site for this event.

RSVP: Please RSVP by Thursday, May 19, at 10 a.m. to Kim Polyniak, 443-510-5807, kpolyni1@jhmi.edu.

Wednesday, May 18, 2016

Could hepatitis C treatments help prevent virus transmission?

Could hepatitis C treatments help prevent virus transmission?
University of Bristol

An international team of researchers has shed light on the potential impact of new drugs for hepatitis C virus (HCV).

HCV is an important cause of liver cancer and is transmitted through blood to blood contact. People who inject drugs (PWID) and men who have sex with men (MSM), who are also infected with HIV, are key risk groups for HCV infection in UK.

New HCV treatments are highly effective, with cure rates often better than 90 per cent, but treatment is expensive and patients with severe liver disease are being prioritised by NHS England.

The team, supported by funding from the NIHR and NIH, including researchers from the University of San Diego, University of Bristol, Public Health England as well as collaborators from London, Cambridge, Scotland, and Australia, has published a series of studies assessing the potential of HCV treatment in preventing HCV transmission, as well as future liver disease.

In a study looking specifically at HCV infection rates in HIV-positive gay men, the researchers found the proportion of HIV positive gay men with HCV increased slightly from 2004 to 2011, and that current treatment rates were unlikely to reduce HCV transmission over time. Professor Peter Vickerman, from the University of Bristol's School of Social and Community Medicine, said: "Our results, based on modelling, suggest a combination of scaling up HCV treatment and behaviour modification may be required to have a substantial impact on HCV transmission among gay men."

Using an economic model, the team also examined which patients should be prioritised for early HCV treatment. Professor Vickerman said: "The model suggests that in most settings in the UK, the most cost-effective group to treat early were people who inject drugs with moderate or mild disease, due to the prevention benefit of reducing onward infection. For example, if chronic HCV infection was 20 per cent among PWID, then for every one PWID treated for HCV, two new HCV infections are averted. In contrast, if the risk of re-infection is high then HCV treatment should be delayed."

Dr Natasha Martin, from the Division of Global Public Health at the University of California in San Diego said: "We also studied the cost-effectiveness of HCV case finding among prisoners. That study suggested that increasing testing could be cost-effective with shorter duration HCV treatments, especially if HCV treatment rates were increased. The prevention benefit in the community of HCV treatment increases the cost-effectiveness of case-finding in prisons.

"Earlier analyses had suggested that HCV testing in prison was unlikely to be cost-effective, because continuity of care between prison and community couldn't be guaranteed, as most prison sentences would exceed the average duration of treatment with traditional therapies."

The team's final study showed that HCV treatments need to be increased in order to reduce the number of cases of End Stage Liver Disease (ESLD) or HCV-related cancers or deaths. Strategies that target people with severe disease are unlikely to have any impact on reducing HCV transmission; while strategies that target people with mild disease, which is necessary to reduce HCV transmission, will have virtually no impact on ESLD within short to medium term.

Professor Matthew Hickman, from the School of Social and Community Medicine, said: "The studies collectively show the potential benefits of HCV treatment for prevention. They are not intended, however, to question the targeting of scarce resources - while drug treatments remain expensive -- for people with serious HCV related disease."

"Reversing trends in HCV-related mortality and morbidity should be the priority. "However, our studies raise important hypotheses on the use of HCV treatment as prevention in combination with other interventions, which should be tested in order to guide future clinical and public health policy and practice. There is good evidence that HCV treatments have very high cure rates, but we need better evidence through research that HCV treatment also can reduce the incidence of disease."

###

Papers

'How should HCV treatment be prioritized in the direct-acting antiviral era? An economic evaluation including population prevention benefit' by Natasha K Martin et al in Journal of Hepatology

'New treatments for hepatitis C virus (HCV): scope for preventing liver disease and HCV transmission in England' by R J Harris et al in The Journal of Viral Hepatitis

'Can Hepatitis C virus (HCV) direct-acting antiviral treatment as prevention reverse the HCV epidemic among men who have sex with men in the United Kingdom? Epidemiological and modelling insights' by Natasha K Martin & Alicia Thornton et al in Clinical Infectious Diseases

'Is increased hepatitis C virus case-finding combined with current or 8-week to 12-week direct-acting antiviral therapy cost-effective in UK prisons? A prevention benefit analysis' by Natasha K Martin et al in Hepatology

For further information or to arrange an interview with one of the authors, please contact Simon Davies at the University of Bristol press office -- 44-0-117-928-8086 or simon.l.davies@bristol.ac.uk

Notes

The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. The NIHR is the research arm of the NHS. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government's strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website.

Funder: This study received funding from NIHR Health Protection Research Unit in Evaluation of Interventions, the National Institute for Drug Abuse [grant number R01 DA037773-01A1] and the University of California San Diego Center for AIDS Research(CFAR), a National Institute of Health (NIH) funded program [grant number P30 AI036214].