Tuesday, May 31, 2016

Foretelling toxicity: FDA researchers work to predict risk of liver injury from drugs

Foretelling toxicity: FDA researchers work to predict risk of liver injury from drugs

Cassandra Willyard1, Journal name: Nature Medicine Volume: 22, Pages:450–451
Year published:(2016) DOI:doi:10.1038/nm0516-450
Published online 05 May 2016

In December 2014, the US Food and Drug Administration (FDA) approved a new drug cocktail, from the Chicago-based pharmaceutical company AbbVie, to treat hepatitis C infection. Less than a year later, the agency warned that the cocktail, Viekira Pak, and another, newer AbbVie hepatitis C therapy could cause serious liver injury in individuals with advanced liver disease. The agency noted that it had received reports of at least 26 cases of liver injuries that might have been caused by the drugs. Of these, ten patients experienced liver failure so severe that they either needed a transplant or died.....

Link To Article
Source - Nature
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Patient associations: a key catalyst for hepatitis advocacy and impact

Patient associations: a key catalyst for hepatitis advocacy and impact

The experts in the European Liver Patients Association (ELPA) Hep-CORE advisory group provide a window on the broad range of hepatitis activities and perspectives in Europe today. Hep-CORE PI Jeffrey Lazarus has been interviewing some of them about how they came to work with viral hepatitis, how the field has been changing, and what new research is called for.

Jeffrey V. Lazarus

The seventh interview in the series is with Charles Gore, Chief Executive and co-founder of The Hepatitis C Trust in the United Kingdom, and founder of the World Hepatitis Alliance (WHA)


FDA warns against fake Hepatitis C medicines

FDA warns against fake Hepatitis C medicines

The Philippines' Food and Drug Administration (FDA) has warned against a fake Hepatitis C medicines circulating in Southeast Asia.

The FDA said the fake medicine brands include: Sofosbuvir + Ledipasvir (Ledso) 400 mg/ 90 mg capsule Daclatasvir (Dakavir) 60 mg capsule It said that based on an advisory from the World Health Organization (WHO) the fake medicines have been circulating around South Est Asia and "may reach the Philippine market."

Continue reading....

Monday, May 30, 2016

Hepatitis C Myth Busters - Who Should Get Tested?

Saturday, May 28, 2016
WBAL NewsRadio 1090
May is Hepatitis C Awareness Month

Doctors are trying to encourage baby boomers, people born between 1945 and 1965 to get a one time blood test to determine if they have the disease.

Doctors say baby boomers are most at risk.

Dr. Anurag Maheshwari, a liver specialist with Mercy Medical System believes contaminate needles in medial procedures conducted years before is a possible cause of the disease. Maheshwari said about a third of his patients don't know how they got the disease.

Read more....

Of Interest
April 2016
Dear Baby Boomers: Hep C Isn’t Your Fault, According to New Study
A new report indicates the hepatitis C (HCV) epidemic peaked between 1940 and 1965 with reused medical syringes to blame, not injection drug use or high risk sexual practices among baby boomers, as has often been claimed.

Researchers and advocates alike hope this new information will help dispel some of the stigma attached to having hep C — particularly for older adults — and encourage more people to get tested and connected with potentially life-saving treatment. The research is further proof that anyone born between 1945 and 1964 should be tested for HCV, even if they feel like they've never been at risk. Published in The Lancet Infectious Diseases journal, the research shows that the hepatitis C epidemic can be traced to hospital transmissions caused by the practice of reusing needles in medical settings.
Continue reading....

Study Summary
Hepatitis C virus transmission peaked in 1950
The study shifted the epicenter of spread back by more than 15 years, to about 1950, when medical procedures were expanding after World War II at the same time that clinicians continued to reuse metal and glass syringes, said Dr. Jeffrey Joy of the British Columbia Centre for Excellence in HIV/AIDS, Vancouver, and his associates

Exponential HCV transmission had mostly ended by 1965, negating “the idea that the epidemic among baby boomers and other demographic groups in North America is primarily due to injection drug use, unsafe tattooing, high-risk sex, and travel to high endemic areas during youth,” the researchers added.
Continue reading...

New research says hep C epidemic not caused by 1960s sex and drug lifestyle
Peak of hep C infection epidemic actually occurred in 1950, not 1965 as previously thought
A new study, worked on by B.C. researchers, says baby boomers living a sex and drug lifestyle in the 1960s aren't to blame for hepatitis C infections in their demographic.
In fact, the research suggests all baby boomers should be tested for the hep C virus because widespread hospital practices predating the 1950's likely led to many accidental transmissions.
Continue reading...

In The News
Governments on Track to Eliminate Viral Hepatitis by 2030
LONDON, May 30, 2016
The Strategy sets a goal of eliminating hepatitis B and C by 2030 and includes a set of prevention and treatment targets which, if reached, will reduce annual deaths by 65% and increase treatment to 80%, saving 7.1 million lives globally by 2030.
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Australia a potential world leader to eliminate hepatitis C
“Australia is in a unique and privileged position to lead the world on hepatitis C elimination – we can stop the deaths and we can stop transmission.”
Burnet Institute recently signed a Memorandum of Understanding with The Kirby Institute to work together to eliminate hepatitis C in Australia within a decade.
Continue reading..

Top hepatitis stories for Hepatitis Awareness Month
May 30, 2016
As Hepatitis Awareness Month comes to an end, Healio.com/Hepatology and HCV Next have compiled a list of the latest, most relevant research on hepatitis B and C virus infections published on Healio.com in May.
Continue reading...

"I'm Worth..." Campaign to aid hepatitis C sufferers

Campaign to aid hepatitis C sufferers
Reporter: Lucy Kenderdine
Date online: 30 May 2016

A NEW campaign aiming to empower patients with hepatitis C to access treatment has been launched after research found that 97 per cent of those diagnosed with the condition are untreated.

The "I'm Worth..." campaign aims to show that no matter how a person caught hepatitis C it is more important to ensure they get the care and treatment they deserve.

It has been supported by a variety of leading UK advocacy groups including Liver4Life, Adfam, Blenheim CDP, Addaction and the British Liver Trust.
Continue reading....

Swindon man shares story for Hepatitis C campaign
18 May 2016 at 2:20pm                          
A man from Swindon has shared his story of how he overcame hepatitis C, as he helps to support a national campaign.

Kelvin Marshall had no idea he had the virus until he became seriously ill and was admitted to hospital.

Kelvin ended up needing a liver transplant. He believes he'd been living with the virus for more than 30 years.

For more information on the campaign and to access materials designed to support people living with hepatitis C please visit www.imworth.co.uk

Saturday, May 28, 2016

Washington state told to lift restrictions on hepatitis C medicines

Washington state told to lift restrictions on hepatitis C medicines

The Washington state Medicaid program has been ordered to lift restrictions on coverage of pricey hepatitis C treatments, according to a preliminary injunction issued Friday by a federal judge in Seattle. 
 The ruling came in response to a lawsuit filed by state residents who claim the drugs are “medically necessary,” and that the decision by the Washington State Health Care Authority to provide coverage to only the sickest patients had caused them harm.
Continue reading...

Friday, May 27, 2016

Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union

EU regulators also recommended granting marketing approval for Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes on Friday.

Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union

May 27, 2016 07:46 AM Eastern Daylight Time

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients. The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. Merck anticipates that the European Commission decision will be made in mid-2016. The company continues to work to achieve manufacturing readiness to supply the EU market, with product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.

“Our application was based on the findings from a broad clinical development program evaluating the efficacy and safety of ZEPATIER across diverse populations of patients with chronic hepatitis C, including patients with compensated cirrhosis and those with stage 4 or 5 chronic kidney disease.”

The U.S. Food and Drug Administration and Health Canada approved ZEPATIER 50mg/100mg tablets in January 2016. In the United States, ZEPATIER is indicated for the treatment of adult patients with chronic HCV genotype 1 or 4 infection, with or without ribavirin (RBV).

“We are pleased with the CHMP’s positive opinion recommending the marketing authorization of ZEPATIER in the European Union, which marks an important step forward in the European regulatory process,” said Dr. Roy Baynes, senior vice president and head of clinical development, Merck Research Laboratories. “Our application was based on the findings from a broad clinical development program evaluating the efficacy and safety of ZEPATIER across diverse populations of patients with chronic hepatitis C, including patients with compensated cirrhosis and those with stage 4 or 5 chronic kidney disease.”

Selected Safety Information about ZEPATIER (elbasvir and grazoprevir)

ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). ZEPATIER is also not for use with organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors (e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s Wort), and efavirenz. If ZEPATIER is administered with RBV, healthcare professionals should refer to the prescribing information for RBV as the contraindications, warnings and precautions, adverse reactions and dosing for RBV also apply to this combination regimen.

Elevations of alanine transaminase (ALT) to greater than 5 times the upper limit of normal (ULN) occurred in 1% of subjects, generally at or after treatment week 8. These late ALT elevations were typically asymptomatic and most resolved with ongoing or completion of therapy. Healthcare professionals should perform hepatic lab testing on patients prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, additional hepatic lab testing should be performed at treatment week 12.

Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces. Healthcare providers should consider discontinuing ZEPATIER if ALT levels remain persistently greater than 10 times ULN. ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalized ratio.

The concomitant use of ZEPATIER with certain drugs may lead to adverse reactions or reduced therapeutic effect due to drug interactions. Certain strong CYP3A inhibitors may increase the plasma concentration of ZEPATIER, leading to possibly clinically significant adverse reactions. Moderate CYP3A inducers may decrease the plasma concentration of ZEPATIER, leading to reduced therapeutic effect and possible development of resistance. Coadministration of ZEPATIER with these drugs is not recommended. Physicians should consult the Prescribing Information for potential drug interactions.

In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache and nausea. In subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity (greater than or equal to 5%) were anemia and headache.

About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets

ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotype 1 or 4 infection in adults. ZEPATIER is a single tablet taken once daily. The recommended dosing is 12 or 16 weeks with or without RBV, depending on HCV genotype, prior treatment history and, for patients with genotype 1a infection, presence of certain baseline NS5A resistance-associated polymorphisms. See Prescribing Information for ZEPATIER for specific dosage regimens and durations. Refer to RBV prescribing information for RBV dosing and dosage modifications when ZEPATIER is given with RBV. To determine dosage regimen and duration of ZEPATIER for genotype 1a patients, testing for the presence of virus with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, or 93 is recommended prior to initiating treatment.

EU regulators recommend approving Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes

Today The European Medicines Agency (EMA) also recommended granting marketing approval for Mercks ZEPATIER™ (elbasvir and grazoprevir) to treat chronic hepatitis C virus (HCV).

European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

--Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection--

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 27, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Epclusa®, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection. The data included in the application support the use of Epclusa (SOF/VEL) in adults with all genotypes (GT1-6) of HCV infection.

The CHMP positive opinion was adopted following an accelerated review procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.

The MAA for Epclusa is supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of Epclusa. The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of Epclusa with or without ribavirin (RBV) or 24 weeks of Epclusa. The primary endpoint for each study was sustained virologic response 12 weeks after completing therapy (SVR12).

Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94 percent) compared to those who received Epclusa for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively). The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®. The fixed-dose combination of sofosbuvir and ledipasvir received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni®.

Gilead has also submitted a regulatory application for SOF/VEL in the United States. Gilead filed the NDA for SOF/VEL on October 28, 2015, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

Epclusa is an investigational product and its safety and efficacy has not yet been established.

About Gilead

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that the European Commission or other regulatory agencies, including the FDA, may not approve SOF/VEL for the treatment of chronic hepatitis C and that any marketing approvals, if granted, may have significant limitations on its use. As a result, Gilead may not be able to successfully commercialize SOF/VEL for chronic hepatitis C. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Full European Summary of Product Characteristics for Sovaldi and Harvoni are available from the EMA website at www.ema.europa.eu

- See more at: http://www.gilead.com/news/press-releases/2016/5/european-chmp-adopts-positive-opinion-for-gileads-epclusa-sofosbuvirvelpatasvir-for-the-treatment-of-all-genotypes-of-chronic-hepatitis-c#sthash.sSbput3F.dpuf

Thursday, May 26, 2016

Watch Lisa Backus: Examining Efficacy of Hepatitis Medications

Examining Efficacy of Hepatitis Medications

Watch Video

As medications for hepatitis C become more widely used, studies are being done to see how effective these treatments are when used in combination. Speaking at the annual Digestive Disease Week (DDW) 2016 meeting in San Diego, California, Lisa Backus, MD, PhD , from the US Department of Veterans Affairs discussed the results of a recent study looking at some of the more popular medications available on the market. Backus said the study was important because they wanted to see whether the treatments were as effective in real-world practice as they were during clinical trials in the approval process.

Also on MD Magazine >>>

More news from Digestive Disease Week 2016 -: http://www.hcplive.com/conference-coverage/ddw-2016/lisa-backus-examining-efficacy-of-hepatitis-medications#sthash.osApZ4fG.dpuf

Wednesday, May 25, 2016

Investigative Combo ABT-493 plus ABT-530 - Succeeds Against Multiple HCV Genotypes

Novel Drug Combo Succeeds Against Multiple HCV Genotypes
by Ed Susman
Contributing Writer, MedPage Today

No cases of virologic failure observed with ABT-493 plus ABT-530

SAN DIEGO -- An investigative combination of two drugs helped patients infected with hepatitis C virus (HCV) across genotypes 1, 2, 3.4, 5 and 6 achieve sustained virologic responses, researchers reported here.

No cases of virologic failure were observed in the 8-week courses of ABT-493 plus ABT-530 in non-cirrhotic patients infected with genotypes 1, 2 and 3, and no virologic failures were observed among patients with genotypes 4, 5 and 6 who were treated in a 12-week course, according to Tarek Hassanein, MD, of the Southern California GI and Liver Centers/UC San Diego Health System, David Wyles, MD, of the University of California San Diego, and colleagues.

In multiple presentations at the annual Digestive Disease Week (DDW), they described preliminary studies using the pangenotypic agents against the 6 different genotypes of HCV.

The only patients across the studies who failed to achieve a sustained virologic response at 12 weeks (SVR12) -- the standard defined as a function cure of the disease -- were three individuals who failed to complete their regimens. All of them, however, had no quantitative level of circulating virus at the time they left the study, the researchers reported.

During a DDW press conference, Kimberly Brown, MD, of Henry Ford Hospital in Detroit, noted that ABT-493 plus ABT-450 were "able to achieve very similar outcomes with the 8-week regimen as compared with 12 weeks of therapy. And in a third study, they were able to treat more difficult genotypes 4, 5 and 6 with their 12-week therapy with excellent outcomes."

The studies "highlight the advances in safety and tolerability as well as the cure rates for these therapies," she said.

ABT-493 is a pangenotypic NS3/4A protease inhibitor which was paired with ABT-530, a pangenotypic NS5a inhibitor. The regimens did not contain either ribavirin or interferon, which up to 5 years ago were considered mainstays of HCV treatment, but have taken a bit of a backseat to more effective, better tolerated treatments.

For genotypes 1 and 2, the researchers enrolled non-cirrhotic treatment-naïve patients or pegylated interferon/ribavirin treatment-experienced non-responders who received once-daily ABT-493 at a dose of 300 mg plus ABT-530 at a dose of 120 mg for 8 weeks.

For genotype 3, the researchers enrolled treatment-naïve patients without cirrhosis and treated them with a once-daily ABT-493 dose of 300 mg plus ABT-530 at a dose of 120 mg for 8 weeks.

For genotypes 4, 5 and 6, the researchers enrolled treatment-naïve or pegylated interferon/ribavirin treatment-experienced patients who were treated with once-daily ABT-493 at a dose of 300 mg plus ABT-530 at a dose of 120 mg for 12 weeks.

Hassanein reported that in 34 patients diagnosed with genotype 1, 33 patients achieved an SVR12 after 8 weeks of treated with the investigative agents. In the modified intention-to-treat protocol, 33 of 33 patients achieved SVR12.

Also, in 54 patients diagnosed with genotype 2, 53 patients achieved an SVR12 after 8 weeks of treatment with the once-daily regimen, and in the modified intention-to-treat protocol, all achieved SVR12.

Wyles reported that in 29 patients diagnosed with genotype 3, 28 patients achieved an SVR12 after 8 weeks of treatment, and in the modified intention-to-treat protocol, all patients achieved SVR12.

In 11 patients diagnosed with genotype 4, all patients achieved an SVR12 after a 12-week treatment regimen, Hassanein stated.

One patient diagnosed with genotype 5 achieved an SVR12 after the 12-week regimen, and in 22 patients diagnosed with genotype 6, all achieved an SVR12 after the 12-week regimen, he said.

"Based on these findings, and those in patients with hepatitis C virus genotype 1, 2 and 3 infection, phase III studies are evaluating ABT-493 and ABT-530 in patient with and without cirrhosis across all 6 major hepatitis C virus genotypes, including 8-week duration treatments," Hassanein said.

Wyles and Hassanein reported few adverse events in the patients, with none discontinuing the trials due to adverse drug reactions. One patient left the study because he found blood draws intolerable. One patient was removed from the study due to advanced adenocarcinoma, not related to the drugs, Hassanein said. One person was lost to follow-up after 6 weeks of treatment.

"Over the past 10 years, we have made huge strides in the area of hepatitis C, a disease which really impacts...3.5 million people in this country," Brown stated. "With this research, there is greater understanding of the genome and several proteins in the virus and that has led to several developments, which now means we have the opportunity to cure more than 95% of these patients."

"In particular, researchers have been looking at direct-acting agents, which target specific proteins within the virus, disrupting viral replication," she added. "With these advances, investigators are now looking to see if we can shorten therapies. We have gone from treatment periods that have lasted nearly a year for patients with fairly significant side effects to...the majority of treatment paradigms [lasting] 12 weeks with very minimal side effects."

The studies were supported and funded by AbbVie. The company participated in the interpretation of data, review, and approval of the content.

Hassanein disclosed relevant relationships with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb (BMS), Eisai, Gilead Sciences, Ikaria, Janssen, La Jolla Pharmaceuticals, Merck, Mochida, NGM BioPharmaceuticals, Obalon, Roche, Ocera, Sundise, Salix, Taigen, Takeda, Tobria, Vertex, Vital Therapies, and Baxter.

Wyles disclosed relevant relationships with AbbVie, BMS, Gilead, Merck, Tacere Therapeutics, and Janssen.
Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

Primary Source
Digestive Disease WeekSource Reference: Poordad F, et al "High SVR rates with the combination of ABT-493 + ABT-530 for 8 weeks in non-cirrhotic patients with HCV genotype 1 or 2 infection" DDW 2016; Abstract 752.

Secondary Source
Digestive Disease WeekSource Reference: Gane E, et al "SURVEYOR-1: 100% Svr12 and favorable safety of Abt-493 + Abt-530 administered for 12 weeks in non-cirrhotic patients with genotypes 4, 5, or 6 infection (Surveyor-I)" DDW 2016; Abstract 755.

Additional Source
Digestive Disease WeekSource Reference: Muir A, et al "High SVR Rates with ABT-493 + ABT-530 co-administered for 8 weeks in non-cirrhotic patients with HCV genotype 3 infection" DDW 2016; Abstract 753.

Tuesday, May 24, 2016

Big Pharma: Pushing the Edge of the Envelope

Big Pharma: Pushing the Edge of the Envelope

by Caroline Poplin MD, JD

Wall Street's drive for profits is hiking drug prices, says Caroline Poplin, MD, JD

The good news: in the last 20 years, pharmaceutical companies have developed novel, effective treatments, sometimes even cures, for some of the worst illnesses dogging humanity: HIV, hepatitis C, leukemia and other cancers, and autoimmune diseases like rheumatoid arthritis. Moreover, the new so-called specialty drugs are often safer and less toxic than older ones. 
The bad news: the prices of the new drugs are high and rising, any way you look at it. Kalydeco, a drug for cystic fibrosis patients with a particular genetic mutation, is perhaps the most extreme example -- over $300,000 a year, and this drug is taken for life.

Continue reading.....

Health Canada Approves DAKLINZA™ (daclatasvir) for Difficult-to-Treat Hepatitis C Patient Populations

Health Canada Approves DAKLINZA™ (daclatasvir) for Difficult-to-Treat Hepatitis C Patient Populations

SOURCE Bristol-Myers Squibb Canada

DAKLINZA™ is approved in Canada in combination with other agents for the treatment of chronic hepatitis C Patients with HIV co-infection, advanced cirrhosis and post-liver transplant HCV recurrence

MONTREAL, May 24, 2016 /CNW/ - Bristol-Myers Squibb Canada today announced Health Canada's approval of DAKLINZA™ (daclatasvir), in combination with sofosbuvir (with or without ribavirin) for 12 weeks in the treatment of chronic hepatitis C (CHC) in adult patients with hepatitis C virus (HCV) genotypes 1, 2 or 3 in three difficult-to-treat populations, including patients with HIV-1 co-infection, patients with compensated or decompensated cirrhosis and patients with HCV recurrence after liver transplantation.1

Both co-infected and post-transplant patient populations, historically, have been difficult to treat, in large part due to potential drug-to-drug interactions between the antiviral therapy regimens for HIV or anti-rejection drugs for post-transplant.2,3

"Chronic hepatitis C patients who have advanced disease, are co-infected with HIV or who have a recurrence of HCV after receiving a new liver pose complex treatment challenges to physicians," said Dr. Curtis Cooper, Director, The Ottawa Hospital and Regional Hepatitis Program. "These new indications for DAKLINZA™ give physicians more treatment options. We can now offer safe and highly curative HCV treatment to even the most complex and medically challenging of patients."

HCV and HIV co-infection is not rare. Approximately 20 per cent of Canadians with HIV have both infections.4 HCV progresses more rapidly to liver damage in people who are co-infected than in those who only have HCV.2 Currently, liver disease related to HCV is the leading cause of death among people with co-infection.2

"As part of our commitment to the HCV community, we have strived to make new treatment options available for patients with different genotypes, including those who are amongst the most difficult-to-treat," said Dr. Nawal Peacock, President and General Manager, Bristol-Myers Squibb Canada. "With this expanded label for DAKLINZA™, we are proud to provide an option that helps bridge what has been a challenging treatment gap for these patients."

The new indications are based on data from the ALLY-1 clinical trial (in post-transplant patients and patients with advanced cirrhosis) and the ALLY-2 clinical trial (in HIV-1 co-infected patients). In ALLY-1, DAKLINZA in combination with sofosbuvir and ribavirin achieved a cure rate of 94 per cent in patients with post-liver transplant and 92 to 94 per cent in patients with advanced cirrhosis.3 In ALLY-2, the DAKLINZA™ plus sofosbuvir combination achieved a 97 per cent cure rate in treatment naive co-infected patients and 98 per cent in treatment experienced co-infected patients.2

"As people in the advanced stages of the disease can attest, HCV can be a devastating illness," Dr. Morris Sherman, hepatologist and chair of the Canadian Liver Foundation, who has treated patients with hepatitis C for more than 20 years. "These patients are in great need of a cure so they can recover and enjoy their life again. The HCV community welcomes each new treatment option that can help to cure this illness, and bring us closer to seeing a day when HCV is gone for good."

DAKLINZA™, a potent, pan-genotypic NS5A replication complex was approved by Health Canada in August 2015 for use in combination with other agents for the treatment of adult patients with HCV genotypes 1, 2, or 3 and compensated liver disease, including cirrhosis.1 In Canada, genotypes 1, 2 and 3 account for 65 per cent, 14 per cent and 20 per cent of HCV infections respectively.5

About Bristol-Myers Squibb Canada Co.
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb global operations, visit www.bms.com. Bristol-Myers Squibb Canada has been delivering innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, neuroscience, immunoscience and virology for over 80 years. Bristol-Myers Squibb Canada employs over 300 people across the country. For more information, please visit www.bmscanada.ca.

Additional Information:

About ALLY-1 Clinical Trial1
In the trial, the DAKLINZA™ plus sofosbuvir and ribavirin regimen demonstrated overall SVR12 in 94 per cent of post-liver transplant patients and 83 per cent of patients in the advanced cirrhosis cohort, including 92 to 94 per cent of patients with compensated cirrhosis (Child-Pugh A or B). In the cirrhosis cohort, four subjects with hepatocellular carcinoma underwent liver transplantation after 1 to 71 days of treatment; three of the four subjects received 12 weeks of post-liver transplant treatment extension and one subject, treated for 23 days before transplantation, did not receive treatment extension. All four subjects achieved SVR12.

In the ALLY 1 trial, the most common adverse reactions (frequency of 10% or greater) among the 113 subjects were headache, anemia, fatigue and nausea. Most adverse reactions were mild to moderate in severity. Fifteen (13%) subjects experienced an SAE; all SAEs were considered unrelated to treatment. Of the 15 (13%) subjects who discontinued study drug for adverse events, 13 (12%) subjects discontinued ribavirin only and 2 (2%) subjects discontinued all study drugs.

About ALLY-2 Clinical Trial1
In ALLY-2, the DAKLINZA™ plus sofosbuvir regimen demonstrated overall SVR12 in 97 per cent in treatment-naive patients and 98 per cent in treatment-experienced patients, including 100 per cent in genotype 3 (n=10). SVR12 rates were high regardless of combination antiretroviral therapy (cART) regimens, including boosted-protease inhibitor-, NNRTI-, and integrase inhibitor-based therapies. In the trial, 2 per cent of subjects experienced SAEs and no discontinuations due to AEs. The most common adverse reaction (=10% or greater) was fatigue (14%).

1 Bristol-Myers Squibb Canada DAKLINZA™ Product Monograph. Revised: May 13, 2016.
2 Wyles DL, et al. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015;373:714-25.
3 Poordad, F., Schiff, E.R., Vierling, J.M., et al, Daclatasvir, sofosbuvir, and ribavirin combination for HCV patients with advanced cirrhosis or posttransplant recurrence: phase 3 ALLY-1 study. J Hepatol. 2015;62:261.
4 Centre for Communicable Diseases and Infection Control Infectious Disease Prevention and Control Branch Public Health Agency of Canada. Hepatitis C in Canada: 2005-2010 Surveillance Report. 2012. Page 25.
5 RP Myers, RP, Shah KW, Cooper, C, et al. An update on the management of chronic hepatitis C: 2015 consensus guidelines from the Canadian Association for the Study of the Liver. Can J Gastroenterol Hepatol 2015.

Monday, May 23, 2016

The Future of Hep C Treatment

The Future of Hep C Treatment
Posted By: DDW Communications
on: May 23, 2016
In: AASLD, By Society, Explore Sessions, Watch Videos

DDW TV covered this exciting and informative State-of-the-Art Lecture which presented the very latest information on hepatitis C. We talked to the session’s speaker, Norah Terrault, MD, MPH, about a range of new therapies coming out that will help difficult to treat populations. Dr. Terrault also talks about the future – and what the discussions around hepatitis C are likely to be in 2017.

DDW 2016 abstracts are available via the Online Planner
1 - Click on Abstracts
2 - Under Abstract Category​ click on hepatitis C

Of Interest
May 24
Digestive Disease Week 2016
ASTRAL studies: New combination yields encouraging patient-reported outcomes
SAN DIEGO —   Treatment with velpatasvir/sofosbuvir was associated with improvements in a number of patient self-reported quality of life measures, according to findings presented at Digestive Disease Week 2016.

May 13
THE FIVE The International Liver Congress
Alan Franciscus, Editor-in-Chief

Gilead Sciences (GILD) Presents at 2016 UBS Global Healthcare Brokers Conference - Transcript
May 23
We have a few other programs in clinical development, the first one is a combination of sofosbuvir and velpatasvir, this is a once-daily Pan-Genotypic single-tablet regimen, the NDA was filed late last year and we've a PDUFA date coming up next month, June 28th. And in the United in the -- this was by the way joined the priority of review and in the Europe we have the similar timelines....
*Free registration required

Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857
Gilead's Press Release
Gilead's Sofosbuvir/Velpatasvir and SOF/VEL Plus GS-9857 at The International Liver CongressTM
– Studies Highlight Progress with Approved Therapies and Investigational Pangenotypic Regimens, Including Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 –

April 14
Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 
The International Liver Congress 2016 Press Release
Sofosbuvir/velpatasvir and experimental compound GS-9857 shows promise in Hepatitis C infected patients whose previous treatment has failed
High sustained virologic response achieved with sofosbuvir/velpatasvir and GS-9857, even in patients unsuccessfuly treated with direct-acting antivirals

Nam aidsmap
Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857
Reported by Liz Highleyman
Sofosbuvir/velpatasvir + GS-9857 works well for treatment-experienced hepatitis C patients
A triple combination of Gilead Sciences' sofosbuvir, velpatasvir and GS-9857 demonstrated a high sustained response rate for treatment-experienced people with all hepatitis C virus (HCV) genotypes who previously were not cured with prior direct-acting antivirals (DAAs), according to two presentations yesterday at the 2016 International Liver Congress in Barcelona.Interferon-free DAA therapy has revolutionised treatment for chronic hepatitis C, but there is still room to optimise therapy for difficult-to-treat patients. Ideally such regimens will be pangenotypic, meaning they could be routinely prescribed without the need for HCV genotype testing.
Eric Lawitz of the Texas Liver Institute presented findings from studies of a three-drug regimen consisting of the HCV NS5B polymerase inhibitor sofosbuvir (Sovaldi), the pangenotypic second-generation NS5A inhibitor velpatasvir (formerly GS-5816), and the investigational pangenotypic HCV NS3/4A protease inhibitor GS-9857. Combining drugs that attack multiple steps of the HCV lifecycle improves efficacy and may enable shorter treatment.

Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 -

Racial disparities found in liver cancer survival rates

Public Release: 23-May-2016

Racial disparities found in liver cancer survival rates

Blacks have greater risk of mortality and are transplanted less often

Digestive Disease Week

San Diego, CA (May 23, 2016) -- Black patients diagnosed with hepatocellular carcinoma (HCC), the most common liver cancer, had a 33 percent increased risk of death compared to non-Hispanic whites. They also were far less likely to receive life-saving liver transplants, according to a new study being presented at Digestive Disease Week® (DDW) 2016, the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"When we looked at a diverse sample of patients being diagnosed with HCC, race was the strongest predictor of survival," said Patricia D. Jones, MD, MSCR, the study's lead author, assistant professor of medicine and member at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, FL. "Black patients were more likely to present with tumors that were larger -- indicating that they were at a later stage of HCC when diagnosed, potentially delaying their eligibility for a liver transplant, a curative option for HCC."

When researchers analyzed patient records by race, they found the median survival after diagnosis was 301 days for black patients, compared to 534.5 days for non-Hispanic white patients and 437 days for Hispanics. After adjusting for factors, such as alcohol use, tobacco use, insurance and age at diagnosis, non-Hispanic whites had a 25 percent reduced risk of death and Hispanics had a 21 percent reduced risk of death, compared to black patients. Researchers also found that black patients were more likely to have hepatitis B virus (HBV), which is an underlying cause of HCC.

Dr. Jones and her team conducted a retrospective analysis of 999 patients diagnosed with HCC at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospitals between 2005 and 2014. These centers serve a diverse patient population, where 14.7 percent of patients are black, 34.9 percent are Hispanic, and approximately 50 percent are born outside North America.

The team also found that, overall, liver transplants were associated with a 66 percent reduction in deaths, but only 11.9 percent of black patients received a transplant, compared to 33.3 percent of non-Hispanic whites.

"We are conducting additional research to determine which factors contribute to the lower survival rate in black patients, such as access to care, birthplace, socio-economic status or increased prevalence of viral hepatitis," added Dr. Jones. "Hepatitis B can be prevented by vaccination and management of this infection depends on access to care, which may be an underlying issue for this community."

According to the National Cancer Institute, HCC is the sixth most prevalent cancer and the third leading cause of cancer-related deaths worldwide. Its incidence in the U.S. is rising, specifically in relation to the spread of hepatitis C virus (HCV) infection. HBV and HCV infections appear to be the most significant causes of HCC globally.

Researchers plan to conduct additional community-based research to explore the perceptions of HBV and HCV in at-risk populations and determine where the opportunities for further education and screening exist in order to ensure earlier cancer detection.

Dr. Patricia D. Jones will present data from the study, "Racial Disparities in Survival after Hepatocellular Carcinoma Diagnosis in a Diverse American Population," abstract Mo1491, on Monday, May 23, at 9:30 a.m. PT, in Hall C of the San Diego Convention Center. For more information about featured studies, as well as a schedule of availability for featured researchers, please visit http://www.ddw.org/press. Dr. Jones did have any disclosures for DDW research. Faculty disclosures can be found online at http://www.ddw.org/DDW_Disclosure_Index.pdf.


Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 21-24, 2016, at the San Diego Convention Center, San Diego, CA. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at http://www.ddw.org.

Follow us on Twitter @DDWMeeting; hashtag #DDW16. Become a fan of DDW on Facebook

Specialty care improves liver disease survival

May 23, 2016

Study: Specialty care improves liver disease survival

Access to health care for veterans with liver disease is highlighted as study links specialists to better outcomes

Veterans with liver disease who had at least one appointment with a gastroenterologist or hepatologist lived longer than those who didn’t see a specialist, according to a recent study.

The paper, published in the American Journal of Gastroenterology, may not be generalized for all adults due to its limited study population. But identifying the best way to treat liver diseases across the public is increasingly on the health care radar. Obesity is driving non-alcoholic fatty liver disease and hepatitis C is also a growing medical problem, for example.

In the research, five-year survival for patients with liver disease improved with specialty care. Researchers are trying to pinpoint exactly what mattered most in the interaction.

“Precisely how subspecialist access may influence survival is unknown, but we have learned the impact is dose-dependent,” says senior author and hepatologist Grace L. Su, M.D., chief of gastroenterology at the VA Ann Arbor Healthcare System and professor of internal medicine at the University of Michigan Health System. “Survival rates were better among those who had two or more GI visits compared to those who had one or two visits.”

Higher rates of screening for hepatocellular carcinoma, greater familiarity with and rapid recognition of complications and greater likelihood of referral for a liver transplant when appropriate may all have a role in better results from specialists’ care, the paper finds.

Driving long distances for care

Of the 28,861 Veterans Affairs patients with liver disease in the study, a reported 37 percent had a GI visit.

The low number of subspecialist visits, especially for an integrated health system such as the VA, may point to access issues.

The study titled “Access to Care and Survival in Liver Disease” revealed the patients, with a mean age of 56, drove an average of 69 miles for their GI visit.

Patients who lived farther from a specialty care center were less likely to be seen. Those who had a diagnosis of hepatitis C and cirrhosis were more likely to be seen, according to the study.

The landscape is changing for hepatitis treatment. As newer, more tolerable, all-oral regimens with shorter treatment durations and fewer side effects become available, expectations of those with hepatitis may grow.

“Before a concrete diagnosis, when liver tests are abnormal, perhaps patients aren’t considered sick enough to see us,” says Su, who describes cirrhosis, an irreversible scarring of the liver, as underdiagnosed. “There are different ways to support this specialty interaction, and it may not require an actual trip.”

Programs such as SCAN-ECHO, e-referrals and telehealth initiatives are emerging as important ways for patients with chronic diseases to obtain specialized care wherever they live.

Through virtual clinics, specialists and community providers share treatment strategies, results and the latest medical research to analyze their patient cases and develop solutions.

The connections generate communication and expertise among primary care physicians.

“The association between GI specialty care and improved survival may not be related to GI specialty care exclusively, but may result from a connection to health care in general,” says Su. “Improvement in mortality may reflect the combined effects of both primary and specialty care of the patients’ liver disease and other health issues.”

Primrose Healthcare Launches an Innovative Alcohol App to Help Hepatitis C Patients Overcome Alcohol Addiction

Primrose Healthcare Launches an Innovative Alcohol App to Help Hepatitis C Patients Overcome Alcohol Addiction

Robust tools and resources help patients control alcohol urges, stop drinking and enjoy improved health

May 23, 2016 08:00 AM Eastern Daylight Time

PHOENIX--(BUSINESS WIRE)--Primrose Healthcare has just launched an innovative alcohol application (app) designed to help hepatitis C patients, who often struggle with substance abuse, overcome alcohol addiction. Leveraging mobile technology and powered by Here and Now Systems, the alcohol app provides personalized education and resources through goal setting, alerts, coaching, and ongoing feedback to better engage and support hepatitis C patients on their journey toward alcohol addiction recovery.

“I’m very excited to partner with Primrose and make the alcohol app available to a broader audience of health plans, providers and consumers”Tweet this

“The app addresses a need for an approach to hepatitis C treatment that focuses on the overall health of the patient, including comorbidities or any substance abuse issues that may be present,” said Henri Cournand, CEO of Primrose Healthcare.

Alcohol abuse is literally a life and death matter for hepatitis C patients, who already have a compromised liver. In fact, “88 percent of liver-related events or in-hospital deaths occurred in patients with chronic alcohol abuse disorders or severe comorbidities,” according to the European Association for the Study of the Liver (EASL). In spite of the facts, many of the estimated 3.5 million infected with the hepatitis C virus in the U.S. continue to struggle with alcohol abuse and need support.

Leveraging mobile technology, the app helps hepatitis C patients control and manage alcohol urges so they can stop drinking and improve their health. It gives individuals easy access to useful tools, feedback and personalized coaching. This provides an extra layer of support, outside of counseling sessions and support groups, when hepatitis C patients need it the most—at the moment when alcohol urges occur. With this added support, patients can make positive steps toward improved health. For patients who stopped drinking, they saw a 29 percent reduction in risk for either a liver-related event or in-hospital death compared to those who continued to drink, according to an EASL study.

“The app was developed based on decades of research on effective interventions and our research into its effectiveness has been very promising,” said Patrick Dulin, Ph.D., Founder of Here and Now Systems and Associate Professor of Psychology at the University of Alaska, Anchorage. “People who used the prototype app for only six weeks cut down the days they spent engaged in heavy drinking by 60 percent and reduced their overall number of drinks consumed by over 50 percent.”

“I’m very excited to partner with Primrose and make the alcohol app available to a broader audience of health plans, providers and consumers,” Dulin said. “Managing substance abuse issues is truly an important part of a holistic hepatitis C management program.”

For physicians, this innovative app provides a valuable resource that begins to bridge the gap between behavioral health, typically used for substance abuse issues, and primary care for physical care. Gastroenterologists can prescribe the app as an additional resource that can be combined with referrals to more behavioral health oriented services such as a psychiatrist or support group. The physician can also be involved in monitoring the patient’s use of the app and provide encouragement at follow-up visits as needed.

“Everyone has a phone these days and it makes sense to leverage mobile technology in caring for patients,” Cournand said. “Health care providers should consider finding a way to leverage this highly effective, yet low cost technology, that works to better engage patients and improve health.”

The app is designed to enhance awareness of drinking and related problems, assist in goal setting and help manage triggers using “in-the-moment” tools. Patients initially build a profile that allows the app to provide customized interventions. For instance, patients input days and times when they typically drink. The app then sends them alerts and instruction on doing something different besides drinking during those times. The app also helps users manage cravings wherever and whenever they occur. If a patient has a craving to drink they can use the immediate, research-based help functions to manage the urge and avoid drinking. The app checks in with the patient daily and provides a weekly progress report that can be shared with a friend, family member or health care provider. The app also notifies the patient when a goal has been met (i.e, 15 days sober) and encourages rewards for meeting it.

About Here and Now Systems (Step Away)

Here and Now Systems, LLC is the creator of Step Away, which offers alcohol addiction support to individuals who are struggling to quit drinking. Leveraging technology and mobile applications, Step Away provides the structure and support to help individuals overcome alcohol addiction during high risk times and ultimately stop drinking. For more information, visit www.stepaway.biz.

About Primrose Healthcare

Primrose Healthcare is dedicated to leading the healthcare industry in delivering the most advanced technology and evidence-based care protocols available for the optimized treatment of Hepatitis C. The company’s leadership team has decades of experience in their respective fields of healthcare technology, medicine and healthcare management. For more information, visit http://www.primrosehealthcare.com.

Treatment options evolve as HCC becomes more common

Treatment options evolve as HCC becomes more common
Posted By: DDW Daily News on: May 23, 2016
In: AASLD, By Society, DDW Daily News, Monday, May 23

A panel of experts will discuss the latest surveillance options, liver transplantation rules and immunotherapy guidelines for the treatment of hepatocellular carcinoma (HCC) during an AASLD Clinical Symposium Tuesday morning titled Hepatocellular Cancer.

Lewis R. Roberts, MB, ChB, PhD

Lewis R. Roberts, MB, ChB, PhD, professor of medicine and director of the hepatobiliary neoplasia clinic at Mayo Clinic, Rochester, MN, will co-moderate the session with Laura Kulik, MD, associate professor of hepatology at Northwestern University’s Feinberg School of Medicine, Chicago, IL.

“HCC is increasing in the U.S. and worldwide,” Dr. Roberts said. “It may not be inherently more pernicious than other cancers, but it is too often diagnosed at a late stage when effective treatment is difficult.”

As the prevalence of HCC increases, a growing body of evidence is helping to refine surveillance and increase earlier detection when treatment is more likely to be effective. At the same time, the profile of HCC is changing. Many clinicians matured in an era when viral hepatitis was the primary risk factor for HCC. Newer, more effective therapies can cure hepatitis C (HCV) in most patients, but simply curing a patient of HCV does not completely eliminate the need for HCC surveillance. And mounting evidence linking fatty liver disease to HCC adds to the importance of identifying patients at increased risk of progressing to cirrhosis and possibly HCC.

And even as the HCC burden shifts from patients with viral hepatitis to patients with advanced fatty liver disease, organ allocation rules for liver transplants are changing.

“The new rules are basically making HCC patients wait longer to get a liver,” Dr. Kulik said. “There is a kind of time-out period — six months — before the priority points that HCC patients get begin to work in their benefit. That six-month waiting period makes it particularly important for physicians to refer patients for transplant as early as possible.”

The new rules are intended to weed out patients with aggressive HCC who are less likely to benefit from a liver transplant. One consequence of the waiting period is a renewed push for liver-directed therapy.

“What we are seeing is a need to be more aggressive in treatment for these patients,” Dr. Roberts said. “For some patients, we treat in the hope of downstaging them so they become eligible for transplantation. For others with advanced cancer who have no likelihood of becoming eligible for transplantation, the focus is on developing more effective treatments.”

Novel checkpoint inhibitors that block tumor cells’ ability to evade the immune system have shown significant effects in treating lung cancers and melanomas. Some of those same agents show promise against liver cancer in early-stage clinical trials, Dr. Roberts noted.

“Researchers have identified some of the mechanisms by which cancer cells cloak themselves from attack by the immune system,” he explained. “New agents such as the PD1 inhibitor nivolumab unmask tumor cells so the immune system finds and destroys them. The early results were quite exciting because we could see significant response rates even in advanced HCC.”

The new checkpoint inhibitors can cause both gastrointestinal and hepatic side effects, therefore it is important for GIs to become familiar with the agents, Dr. Kulik noted.

“We know that clinicians are only going to be seeing more HCC in daily practice,” she said. “This symposium will provide the most up-to-date information so they can better handle these patients.”

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

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.


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


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."



'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


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].

Study Shows Nearly 90 Percent of Coloradans Diagnosed With Hepatitis C Go Untreated

Study Shows Nearly 90 Percent of Coloradans Diagnosed With Hepatitis C Go Untreated
New 'Curative' Treatments Exist But Many Coloradans Still Suffer From the Illness
09:30 ET from Center for Improving Value in Health Care (CIVHC)

DENVER, May 18, 2016 /PRNewswire-USNewswire/ -- A new report from the Center for Improving Value in Health Care (CIVHC) finds that most Coloradans with the Hepatitis C virus are not being treated for what can be a serious, long-term chronic liver infection. The analysis also found that in spite of availability of new revolutionary drugs, 89 percent of Coloradans in with Hepatitis C did not receive any treatment for their condition.

The study analyzed claims data from the Colorado All Payer Claims Database (CO APCD) for the commercially insured (excluding those on self-insured plans), Medicaid and Medicare Advantage members in 2013 and 2014.

Until recently, the most common treatment for Hepatitis C had significant side effects and was difficult for many patients to tolerate. At the end of 2013, oral medications with fewer serious side effects became available that not only treat but eliminate symptoms. Sovaldi was the first medication to hit the market, and later in 2014, Harvoni became available as the first drug that could eliminate symptoms without the need for a second drug. Both Solvadi and Harvoni have made headlines for being among the most expensive drugs sold in America.

In 2013, four percent of Coloradans received medication for Hepatitis C prior to the release of the new treatments. When the new drugs entered the marketplace, the number of Coloradans receiving drug treatment increased substantially, with seven percent on the new treatment and four percent remaining on the old regimen. With only 11 percent of the affected population on medication, nearly 90 percent of Coloradans with the condition are still not receiving any treatment as part of their health care insurance benefit.

The analysis does not reflect Coloradans who may have received medication but paid out-of-pocket or received treatment through a financial assistance program.

"In the coming months, CIVHC and partners across Colorado will continue to investigate Hepatitis C and treatment patterns, including regional trends and breakouts by insurance type. These explorations will help us understand why some patients are receiving new treatments and why some are not, plus determine the cost implications and impact on the health of Coloradans," said Ana English, CIVHC CEO and president.

Media Contact:
Cari Frank
303.903.6007 or cfrank@civhc.org