Saturday, April 30, 2016

April 2016 Monthly HCV Rewind - 25 Years From Discovery To Cure: The Hepatitis C Story

Welcome to Monthly HCV Rewind, a look back at this months hepatitis C headlines with a bit of today's news.

Sift through a month of research articles, personal stories, hot topics, plus coverage of The International Liver Congress 2016; Advances in Chronic Hepatitis C: Management and Treatment.

In addition review key data presented at this months meeting; Conference Updates Indexed By Pharmaceutical Company.

In Case You Missed It
Don't miss out on viewing this video folks....
Published On April 25 2016 / TEDx February 2016
25 Years From Discovery To Cure: The Hepatitis C Story |
 Nezam Afdhal | TEDxOxford



The discovery of the hepatitis C virus in 1989 and 25 years of has led to new treatments that can now cure almost all patients with hepatitis C and have the ability to reach almost 200 million people globally. Dr. Afdhal discusses how discovery of the virus lead to understanding the global epidemiology and modes of spread of hepatitis C and the recognition that it was the commonest cause of cirrhosis, liver cancer and need for liver transplantation. The development of model systems to look at viral replication led to treatments initially with injectable interferon with low cure rates and poor patient tolerability to new all oral direct acting anti-viral agents which can cure patients with a simple, safe and effective 8 – 12 week treatment. Finally Dr. Afdhal discusses how these treatments have changed the discussion in the US on the cost of new medications and the ongoing plans to bring these expensive treatments to developing countries with high hepatitis C burden.

Nezam H. Afdhal, MD, is a Senior Physician at the Liver Center at Beth Israel Deaconess Medical Center in Boston, Massachusetts. He is also Professor of Medicine at Harvard Medical School. Dr. Afdhal received his MD degree in 1981 from the Royal College of Surgeons in Ireland and did fellowship training at University College Dublin and at Boston University School of Medicine. He is the Chief Medical Officer of Spring Bank Pharmaceuticals.


Dr. Afdhal’s clinical expertise focuses on the management of the complications of liver disease, including cirrhosis and portal hypertension. His research has been on liver fibrosis, hepatitis B and C where he has led national and international teams on the treatment and cure of HCV and HBV. He is currently working on issues of global access and education for HCV in the developing world.

Of Interest
The Origin Of Hepatitis:HCV and HBV

Today's News
April 30
Vaccines for People Living with Hepatitis C —Alan Franciscus, Editor-in-Chief

HepCBC’s MONTHLY NEWSLETTER
April Issue Just Published

Hepatitis C: Generic medicines hold the key, says expert
Generic medicines are expected to revolutionise Hepatitis C treatment in India and all across the world as they did in the case of HIV/AIDS.

Dr Rajoo Singh Chhina, Professor and Head of Gastroenterology, who is also Dean Academics at the local Dayanand Medical College and Hospital (DMCH), expressed these views while delivering a talk organised by S Jagdev Singh Jassowal Charitable Trust here today.

May Is Hepatitis Awareness Month
Each May, many partners across the federal government, including the Department of Health and Human Services (HHS) and its agencies, join with numerous non-federal and community allies to raise awareness of viral hepatitis during Hepatitis Awareness Month

Sofosbuvir/Velpatasvir CTAC Webinar
April 29, 2016 Hep C TIP
This Monday, May 2nd, from 11 AM to 12 PM (PDT/in BC) / 2 PM to 3 PM (EDT/in Ontario), the Canadian Treatment Action Council (CTAC) will be hosting a webinar about the exciting new hep C treatment sofosbuvir/velpatasvir.

Healing livers, saving lives: Hepatitis C screening in an era of cure
Article Outline
WHY SCREEN?
•WHO SHOULD BE SCREENED?
•HOW TO SCREEN
•Perform baseline testing
•Determine genotype
•Assess the degree of fibrosis
•SCREEN FOR HEPATOCELLULAR CARCINOMA
•AFTER THE DIAGNOSIS
•TREATMENT
•Antiviral therapy •Novel therapies
•Cost of treatment
•CONCLUSION

Suboptimal response in HCV genotype 4 in Egypt driven by noncompliance
Suboptimal treatment response in chronic HCV genotype 4 in Egypt was driven primarily by...

Safety, Efficacy, and Tolerability of Sofosbuvir and Ribavirin in Management of Recurrent Hepatitis C Virus Genotype 4 After Living Donor Liver Transplant in Egypt: What Have We Learned so far?
The aim of this study was to evaluate the efficacy, safety, and tolerability of sofosbuvir and ribavirin in LDLT recipients with recurrent HCV genotype 4

April 29
Elbasvir and grazoprevir
Zepatier shows high efficacy in hard-to-treat HCV populations
Watch Video
BARCELONA — In this exclusive video interview at the International Liver Congress, Jan Sperl, MD, of the Institute for Clinical and Experimental Medicine, Prague, Czech Republic, discusses results of the C-EDGE Head-to-Head clinical trial where Zepatier showed higher efficacy and sustained virologic response rates compared with Sovaldi, pegylated interferon alpha 2b plus ribavirin in patients with hepatitis C virus infection.

Watch - Independent Review of the 51st Annual EASL
Advances in Chronic Hepatitis C: Management and Treatment
Review will feature four HCV experts reviewing and discussing key presentations on chronic hepatitis C presented at EASL 2016.

Hepatitis C Controversies
There are some new controversies surrounding organ transplantation. In recent weeks I heard two highly respected liver specialists discuss dilemmas they are facing with their patients. Let’s dissect these issues.

The same debates, 25 years later
The experts in the European Liver Patients Association (ELPA) Hep-CORE advisory group provide a window on the broad range of hepatitis activities and..

Rare disease gene has a key role in chronic hepatitis C infection

HCV infection in Baby Boomers with Medicare is associated with mortality
Presence of hepatitis C infection in Baby Boomers with Medicare is independently associated with mortality and resource utilization, finds May's issue of the Alimentary Pharmacology & Therapeutics.

People treated for hepatitis C have unexpectedly high rate of liver cancer recurrence
aidsmap - ‎4 hours ago‎
Hepatitis C patients with cirrhosis who were treated with direct-acting antivirals had about twice the expected likelihood of developing hepatocellular carcinoma (HCC), with the excess risk seen in people with a previous history of HCC, according to ...

Association Between Hepatitis C Virus and Head and Neck Cancers
View Full Text (HTML)
Journal of the National Cancer InstituteApr 14, 2016 - Abstract. Background: Hepatitis C virus (HCV) infection is associated with ..... of care for this infection and to prevent progression of underlying liver disease.

April 27
Chronic Hepatitis C Virus Infection: A Review of Current Direct-Acting Antiviral Treatment Strategies/HCV Genotypes 1-6
Treatment guidelines are constantly evolving due to emerging regimens and real world treatment data. There also still remain subpopulations for whom current treatments are lacking or unclearly defined. Thus, the race for development of HCV treatment regimens still continues. This review of the current literature will discuss the current recommended treatment strategies and briefly overview next generation agents.

Inovio Partners with National Cancer Institute and Mayo Clinic to Initiate Hepatitis C Immunotherapy Clinical Trial
The study will enroll patients who are in the early stages of chronic HCV infection to determine the therapy’s ability to decrease and potentially eliminate HCV viral load, measure HCV specific immune responses and durability of these immune responses, and evaluate safety and tolerability

April 26
New York Insurers to Change Coverage of Hepatitis C Drugs
Seven health-insurance companies in New York will change their criteria for covering costly drugs that cure chronic hepatitis C under the terms of agreements with the office of State Attorney General Eric Schneiderman.

Novel Agents on Horizon for Advanced HCC
A number of novel therapies are currently being explored as second-line treatments for patients with advanced hepatocellular carcinoma (HCC), including a host of targeted therapies and various immune checkpoint inhibitors, according to Ghassan Abou-Alfa, MD, at the 1st Annual School of Gastrointestinal Oncology.

NAFLD may increase risk for cardiovascular disease, mortality
Steatosis was an independent risk factor for atherosclerosis in a retrospective study, suggesting that patients with nonalcoholic fatty liver disease may have an increased risk for early cardiovascular disease and mortality.

April 25
AbbVie Receives NDA for Viekira Pak/HCV genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis
U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A). The application was previously granted priority review by the FDA, a designation given to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness

Diabetes Ups Risk of Hospitalization, Death From Liver Disease
In a cohort study of 40- to 89-year-old people who were followed for a decade, individuals with type 2 diabetes were more likely than nondiabetic individuals to be hospitalized for or die from chronic liver disease. These were defined as alcoholic liver disease, autoimmune liver disease, hemochromatosis, hepatocellular carcinoma, nonalcoholic fatty liver disease (NAFLD; including cirrhosis and hepatic fibrosis), and viral liver disease.

Understanding A Social Security Disability Denial
By Mariah Z. Leach
After the long, confusing process of applying for Social Security disability benefits, it is understandably very frustrating to receive a denial. While the Social Security Administration (SSA) has no official policy to...

April 24
Pediatric research: Researchers now think fibrosis can be reversed
Fibrosis, one of the most devastating consequences of hundreds of human diseases, has long been thought by biomedical science to be fixed and irreversible.

April 23
Best of viral hepatitis at ILC2016
In this video, Pr. Jean-Michel Pawlotsky and Pr. Thomas Berg review and discuss the “Best of viral hepatitis at ILC2016”. An extensive summary of the latest advances in the fields of hepatitis B and hepatitis C is covered

Successful antiviral treatment for hepatitis C associated with reduction in risk of cirrhosis, HCC and overall mortality, regardless of age.
Researchers found that successful antiviral treatment for hepatitis C is associated with a significant reduction in risk of cirrhosis, HCC and overall mortality, regardless of age. Therefore, delaying treatment should not be advised. Patients with hepatitis C aged 65 to 85 years who received less antiviral treatment than younger patients were more likely to develop cirrhosis and liver cancer than patients with hepatitis C aged 20 to 49 years.

My Complex Relationship with Hep C
Over the last five years I’ve had a difficult journey with Hep C. Since 2010, when I was diagnosed, first with HIV and then a week later with Hep C, there have been amazing advances in the Hep C treatments offered by the NHS

April 22
Safety and Tolerability of Direct-acting Anti-viral Agents in the New Era of Hepatitis C Therapy
This review characterises the burden of the most clinically significant AEs associated with approved DAAs in combination therapy, either with or without interferon and ribavirin. Herein, the safety of DAA therapy will be reviewed for single DAAs and DAAs in combination therapy, as seen fit.
Continue Reading

April 21
CCO - Our Expert Picks in HCV Now Available From Barcelona‏ EASL 2016*

April 19
HCV Next - Pangenotypic Regimen: A Step Forward in HCV Treatment

HCV Advocate
Check out what we have in store for you in the April Mid-Month Newsletter
The Five
Snapshots
Vaccines for People Living with Hepatitis C
The HCV Advocate Monthly Pipeline Update
Healthy Eating

Stress Busters for Hepatitis C
I have no filter these days. So what I’m feeling kind of blurts out. You can guess the result: most of my time is spent home alone. That works, but sometimes you’ve got to bop around town, be around folks. Thank goodness I have a good heart (that helps when you’re waaay honest)  but on those days when I’m feeling overwhelmed, it can be awkward, even stressful. I still haven’t decided what this blog is about. I’m thinking it will be about handling stress. I’ll guess it will be called stress busters for Hepatitis C.

Monitoring sugar metabolism in liver may be a key to cancer diagnosis
Study shows that normal, cancerous liver cells metabolize dietary fructose differently

April 18
Hep C Tests Predict Best Meds
The Hepatitis C virus can mutate and become drug resistant. But new tests could enable physicians to...

April 16
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 –

ABT-493 and ABT-530 - Reported By Healio *Video
ABT-493, ABT-530 produce high SVR4 rates in HCV genotype 3
BARCELONA — In this exclusive video interview at International Liver Congress, Paul Y. Kwo, MD, professor of medicine and director of liver transplantation at Indiana University, and HCV Next Editorial Board member, discusses results from the two SURVEYOR studies investigating the safety and efficacy of pangenotypic agents ABT-493 and ABT-530 in patients with hepatitis C virus genotype 3 infection with and without cirrhosis.“We are clearly in need of different strategies for these individuals so the genotype 3 population can get the same benefits as the other [genotype patients],” Kwo told HCV Next.

AbbVie's Press Release
AbbVie ABT-493 and ABT-530 For Genotypes 1-6: New Phase 2 Data Presented At The International Liver Congress
- 97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 in genotypes 1-3 hepatitis C virus patients without cirrhosis in SURVEYOR-1 and 2 studies(1,2)
- 100 percent SVR12 achieved with 12 weeks of treatment in difficult-to-treat genotype 3 patients with compensated cirrhosis (Child-Pugh A) new to therapy (3)
- 100 percent SVR12 achieved with 12 weeks of treatment in genotypes 4-6 patients without cirrhosis; eight-week duration investigated in this ongoing study (4)

LC2016/ ‘Personalisation’ of direct-acting antiviral treatment could help eradicate Hepatitis C virus from the body
The German study drew patients with failure to DAAs from a large European HCV DAA-resistance database made up of more than 3,500 patients. Patients were included if they had received interferon-free DAA regimens. Treatment combinations were specific to HCV genotype.

Re-treatment was started in 29% (n=57/195) of patients with genotype 1; the majority of these patients had failed treatment with the combination of simeprevir and sofosbuvir, and were re-treated with the combinations of ledipasvir and sofosbuvir or paritaprevir, ombitasvir, and dasabuvir. SVR12 was achieved in 90% of the re-treated patients with genotype 1. In the genotype 3 group, 23% (n=16/69) of patients were re-treated with sofosbuvir, daclatasvir ± ribavirin. All of the re-treated patients with available follow-up data achieved SVR12.

Low-cost generic direct-acting antiviral treatment for hep C is equivalent to branded formulations
New data demonstrates that generic direct-acting antivirals are as effective and safe as branded treatments to cure hepatitis C.

Study shows generics pose safe, economic option for patients with HCV
April 16, 2016
BARCELONA — Generic direct-acting antivirals for hepatitis C virus infection presented a similar biochemical makeup and sustained virological… “In this interim analysis, legally imported generic DAAs led to high SVR rates,” James Freeman, MD, executive director, GP2U Telehealth, Australia, said during a press conference. “A generic cure for hepatitis C is available now for $1,000 and works as expected. … Not in the future, but right now.”
Freeman explained that this endeavor began with one patient asking for assistance in obtaining a generic DAA as, at the time, only Olysio (simeprevir, Janssen) was available in Australia. He chose to assist the patient and test the generics to ensure safety. That patient went on to achieve SVR with the generic medication.
“The news leaked and one became a dozen,” Freeman said

April 15
European Medicines Agency’s PRAC extends the scope of its safety review on direct-acting antivirals for hepatitis
The PRAC also extended the scope of its ongoing safety review of medicines known as direct-acting antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi, Viekirax) used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).

April 15
Shorter treatment course potentially on the horizon for Hepatitis C patients
Investigational treatment, RG-101 combined with direct-acting antivirals shows potential to be effective in Hepatitis C with a ‘shorter than standard’ four week course

Healio Video - AbbVie - Viekirax (ombitasvir/parataprevir/ritonavir, and Exviera (dasabuvir)
Real-world experience with 3-D regimen lives up to phase 3 studies
BARCELONA — In this video perspective from the International Liver Congress 2016, Heiner Wedemeyer, MD, research group leader, department of gastroenterology, hepatology and endocrinology at Hannover Medical School in Germany, discusses his real-world experience with the German Hepatitis C-Registry. Specifically, Wedemeyer looked at the impact of Viekirax (ombitasvir/parataprevir/ritonavir, AbbVie) and Exviera (dasabuvir, AbbVie), together known as Viekira Pak in the United States, in his own practice, showing that the everyday impact is similar to that seen in phase 3 trials.

AbbVie's Press Release
AbbVie's Investigational Regimen ABT-493 and ABT-530 Shows High SVR In HCV Genotype 1 Patients Who Failed Previous Therapy
- 95 percent of patients achieved SVR12 with 12 weeks of ABT-493 and ABT-530 with and without RBV in GT1 chronic HCV infected patients without cirrhosis who failed previous therapy with DAAs in a modified intent-to-treat analysis
- 91 percent achieved SVR12 with RBV in the primary intent-to-treat analysis; 86 percent achieved SVR12 without RBV

April 14
Don’t deny hepatitis C patients a cure
How do you justify withholding a wonder drug from patients infected with a liver-killing virus until the disease starts to ravage their bodies? Why, in other words, do they have to become seriously ill before receiving help? Although biomedical advances have given rise to a new class of drugs that can cure hepatitis C, which is often fatal, a basic socioeconomic problem remains to be solved: Because of the high cost of the medicine, many public and private health insurers restrict access to treatment until the onset of liver damage. It’s a short-sighted approach that causes suffering and is at odds with a basic tenet of modern medicine — early intervention.

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

Head-to-head study: once daily oral combination of elbasvir and grazoprevir versus sofosbuvir and pegylated interferon alpha 2b + ribavirin
The combination of elbasvir and grazoprevir resulted in an SVR12 of 99.2% (128/129) compared to 90.5% (114/126) in the sofosbuvir/pegylated interferon/ribavirin group.
View All Conference News, Here....

Does sustained virologic response represent a cure for hepatitis C virus infection?
BARCELONA — In this video perspective from the International Liver Congress 2016, Ronald Koretz, MD, Emeritus professor of medicine at University of California Los Angeles School of Medicine, discusses results of a systematic review that asks: Does sustained virologic response represent a cure for hepatitis C virus infection?

High rate of cancer recurrence in Hepatitis C patients despite successful virus eradication by direct-acting antiviral therapy
Scientists call for close monitoring of Hepatitis C virus patients prescribed direct-acting antivirals, particularly for those with a history of liver cancer

April 13
WHO issuing updated guidelines for treatment of hepatitis C infection
The field of HCV therapeutics continues to evolve rapidly and, since the World Health Organization (WHO) issued its first Guidelines for the screening, care and treatment of persons with hepatitis C infection in 2014, several new medicines have been approved by at least one stringent regulatory authority. These medicines, called direct-acting antivirals (DAAs), are transforming the treatment of HCV, enabling regimens that can be administered orally, are of shorter duration (as short as eight weeks), result in cure rates higher than 90%, and are associated with fewer serious adverse events than the previous interferon- containing regimens. WHO is updating its hepatitis C treatment guidelines to provide recommendations for the use of these new medicines.
View Guidelines: 2016 Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection

April 12
EASL: Liver Meeting 'Diversity' Increases
As focus on HCV eases, more attention shifts to to other areas of hepatology.....

This nonprofit is playing a valuable role in framing the drug price discussion
For the past two years, the Institute for Clinical and Economic Review has issued high-profile reports assessing the worth of pricey new drugs for treating hepatitis C and high cholesterol, among other conditions

Gilead Acquires Nimbus' Biotech Drugs for NASH Treatment
With the purchase of the drug line, the biotechnology giant is expanding its development portfolio of treatments for NASH.

Liver disease risk increased by type 2 diabetes, study finds

Hepatitis C virus transmission peaked in 1950
Transmission of HCV genotype 1a peaked in North America in 1950, when the oldest baby boomers were 5 years old.
Study - The Lancet / The spread of hepatitis C virus genotype 1a in North America: a retrospective phylogenetic study

Hepatitis C virus as a systemic disease: reaching beyond the liver - cancers/kidney/diabetes/CVD/Brain
Chronic hepatitis C is also associated with cognitive impairment, especially in memory and concentration. Thus, extrahepatic CHC manifestations involve multiple organ systems outside the liver linked to a variety of comorbidities which may lead to significantly increased mortality from non-liver-related events.

Genetic tests identify 6 types of liver cancer among Japanese patients
TOKYO -- Researchers have identified through genetic testing six categories of liver cancer occurring among Japanese, a discovery having broad implications toward developing diagnoses and treatments for the disease.

70% of Baby Boomers Did not Know They Had Increased Risk for HCV; 48% Did Not Know HCV is Curable
from Jules: clearly that is why its estimated 75% in the USA who have Hcv remain undiagnosed, only perhaps 300,000 have been treated. I estimate as many as 8-9 million have HCV in the USA although the CDC estimates 2.5 million & others estimate 5 million, because none of these estimates include immigrant populations who come from countries where Hcv is very prevalent like India, Pakistan, sections of Africa, Thailand, Southeast asia, China, japan.

Simeprevir and Sofosbuvir to Treat Chronic HCV Genotype 1
The American Journal of Gastroenterology, April 12, 2016

Abstract
Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population

April 11
How Best To Address The Increase In Liver Cancer Deaths
“Liver cancer incidence is increasing, and this is due to a high prevalence of hepatitis C and the inability of many people to have access to the new drugs that are used to treat it, so even though we have these new treatments for hepatitis C, it is not expected that the prevalence of the disease will drop until 2025,” says Reddy.

Viral Hepatitis Can Be Eliminated If It Is a Top Priority
“But the barriers to elimination of hepatitis B and C are consequences of a more basic problem – that viral hepatitis is simply not a public priority in the U.S.,” Strom said.

Hepatitis B and C could be eliminated as public health problems in US
It is possible to end the transmission of hepatitis B and C and prevent further sickness and deaths from the diseases, but time, considerable resources, and attention to various barriers will be required, says a new report from the National Academies of Sciences, Engineering, and Medicine. However, controlling the diseases by reducing the number of new and overall cases in the U.S. is more feasible in the short term. This is the first report of a two-phase study; the second report, to be released in early 2017, will outline a strategy for meeting the goals discussed in this report.

Antiviral therapy effective in patients with HCV, non-Hodgkin's lymphoma
Antiviral therapy was effective in patients with hepatitis C virus infection-associated B-cell non-Hodgkin’s lymphoma and produced sustained virologic response rates over 70%, according to results of a meta-analysis

Video-Overstock.com CEO Patrick Byrne discusses Hepatitis C
Overstock.com CEO Patrick Byrne discusses his decision to take a medical leave of absence due to Hepatitis C.

April 9
Despite Advances in Hepatitis C Treatment, More Research Needed (Video)

Understanding the Magnitude of the Viral Hepatitis Epidemics in the United States
Let’s start with the lowest estimate from the CDC website (3.4 million people). Twenty-one states and DC all have total populations that are smaller than the estimated number of people living with HCV or HBV in the United States.

Promising new blood test is first of its kind to detect liver scarring
Newcastle scientists and medics have developed a new type of genetic blood test that diagnoses scarring in the liver - even before someone may feel ill.

April 7
Veterans Groups Fight Stigma Associated With Hepatitis C
More veterans say the military gave them hepatitis C during the Vietnam War. They say the virus was spread via a vaccination jet injector gun, and the same gun was used on hundreds of soldiers.

Study: HCV Treatment Regimen Not Impacted by Acid-Reducing Agents
According to data from recent Phase 3 trials, the use of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) plus dasabuvir (DSV) (Viekira Pak; AbbVie) with ribavirin (RBV) in patients with hepatitis C virus (HCV) genotype 1 infection led to high SVR12 rates regardless of acid-reducing agents (ARAs) and proton-pump inhibitors (PPIs) use or PPI dose.

Elderly veterans with chronic HCV at increased risk for cirrhosis, HCC
Elderly veterans with hepatitis C virus infection had a higher risk for developing cirrhosis or hepatocellular carcinoma compared with younger patients, according to results from a retrospective cohort study.

Hepatitis C Treatment and Cirrhosis
Treating cirrhotic hep C patients is tricky business. Cirrhosis is a serious medical condition, and although it can remain stable for a long time, it can also go south quickly. Patients with hep C-related cirrhosis clearly need to be treated, and treated soon. This article will discuss some of the risks and benefits of hepatitis C treatment in cirrhotic patients.

Galmed Pharmaceuticals to Hold a Symposium on Non-Invasive Diagnostics during the International Liver Congress in Spain
TEL AVIV, Israel, April 7, 2016 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of a once-daily, oral therapy for the treatment of liver diseases, announced today that it will hold the 2nd "NASH 2020" forum entitled "NASH: Beyond Liver Biopsy – Current and Next Generation Diagnostic Methods" during the International Liver Congress (ILC), the annual meeting of the European Association for the Study of the Liver (EASL), on April 16th in Barcelona, Spain.

Grim projections for hepatitis C disease burden in the U.S.
The results of the model provided an estimate of 320,000 for the cumulative number of HCV-associated deaths in individuals treated with oral DAAs from 2015 to 2050. In addition, the projected cumulative incidence of hepatocellular carcinoma was 157,000, and the projected cumulative incidence of decompensated cirrhosis was 203,000 in individuals treated with oral DAAs from 2015 to 2050. Furthermore, the projected number of liver transplants for those on DAAs between 2015 and 2050 was 32,000.

Generic Hepatitis C Drugs
By Jenelle Marie Davis
Why are some drugs “name brand” and others considered “generic?” Pharmaceutical companies exist in order to create new or better drugs for current medical problems. They spend billions of dollars finding new...

No Alcohol with Hepatitis C
By Karen Hoyt
Drinking with hepatitis C is like throwing fuel on a flame. This may not be a popular opinion. Some of you might even think that it’s too restrictive. I can tell you...

April 6
Hepatitis C in Limelight Again at Liver Congress
"Hepatitis C still dominates the field, but the focus is shifting to difficult-to-treat patient groups, other genotypes, and a lot of real-life data," said EASL Vice-Secretary Tom Hemming Karlsen, MD, PhD.
Other hepatitis C trials will address regimens for difficult-to-treat patients, such as those infected with genotype 3, transplant patients, and patients who failed previous treatment with a direct-acting antiviral. There will also be discussions on post-treatment monitoring for patients with hepatitis B or hepatitis C, who could still be at risk for hepatocellular carcinoma.

JAMA Forum: We Can’t All Have It All: The Economic Limits of Pharmaceutical Innovation
In fact, we may have already have reached the point of confronting the fact that we cannot all have it all. New, expensive drugs for hepatitis C—Viekera Pak, Sovaldi, and Harvoni—severely stress budget-constrained programs like Medicaid and the Veterans Health Administration. Even at the steep discounts those programs receive, these

April HCV Newsletters: Greed and the Necessity for Regulation/Treatment Action Group
Welcome to this months collection of newsletters, todays news, and updates from around the web.

Educate Congress on the Burden of Liver Disease
By Erika Miller, Cavarocchi – Ruscio – Dennis Associates, Consultants to AASLD Reports from Washington may be making you question what is in store for your research, your patients, and your practice. The NIH finally just saw funding increase, but promoting the Institute’s growth is a priority during the continuing debates on the fiscal health of this country.

FDA Warns of Heart-Failure Risk With Two Diabetes Drugs
The US Food and Drug Administration (FDA) has issued a new alert about the potential for increased risk for heart failure in patients taking the type 2 diabetes drugs saxagliptin (Onglyza, AstraZeneca) and alogliptin (Nesina, Takeda).

Novel 3-D imaging offers new tool for identifying advanced fibrosis in liver
Researchers have conducted a prospective study of 100 patients (56 percent women) with biopsy-proven NAFLD to assess the efficacy of two-dimensional magnetic resonance elastography (MRE) and a novel 3-D version. They found that both MRE technologies were highly accurate for diagnosing advanced fibrosis, with 3-D perhaps providing additional capabilities in some patients.

April 3
Getting Up to Speed on HCV Therapies - Experts discuss HCV before, during and after treatment.

New research says hep C epidemic not caused by 1960s sex and drug lifestyle
 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.

New treatments for hepatitis C virus (HCV): scope for preventing liver disease and HCV transmission in England
R. J. Harris, N. K. Martin, E. Rand, S. Mandal, D. Mutimer, P. Vickerman, M. E. Ramsay, D. De Angelis, M. Hickman and H.E. Harris
Article first published online: 29 MAR 2016 | DOI: 10.1111/jvh.12529

Previous Month: News and Research
HCV News Digest


Friday, April 29, 2016

Watch Advances in Chronic Hepatitis C: Management and Treatment/Independent Review of the 51st Annual EASL

 
Happy Friday everyone, if you have the time check out this recently released Internet symposium over at ViralEd. The program will feature real-world data on current HCV therapies presented at The International Liver Congress this month.
 
The Advances in Chronic Hepatitis C: Management and Treatment
Independent Review of the 51st Annual EASL
 
Internet Symposium: EASL 2016 Review 
The review and discussion will focus on HCV therapeutic options and developments, including: current treatment and management strategies, algorithms and recommendations; therapies in development; epidemiology; and diagnosis and clinical management of specific patient populations, including HCV/HIV co-infected and cirrhotic patients.
 
 
 
 
 

HCV infection in Baby Boomers with Medicare is associated with mortality

News image
HCV infection in Baby Boomers with Medicare is associated with mortality

Presence of hepatitis C infection in Baby Boomers with Medicare is independently associated with mortality and resource utilization, finds May's issue of the Alimentary Pharmacology & Therapeutics.

Hepatitis C virus is common among Baby Boomers.
As this cohort ages, they will increasingly become Medicare eligible.
 
Dr Younossi and colleagues from Virginia, USA evaluated resource utilization and mortality of BB-Medicare recipients with HCV.
The team used in-patient and out-patient Medicare databases.
HCV was identified using ICD-9 codes.
Outcomes included resource utilization, and short-term mortality.
The investigators reported that of 1,153,862 Baby Boomers Medicare recipients, 3% had HCV.
Overall mortality increased from 3.15% to 3.31%
Alimentary Pharmacology & Therapeutics
During this period, in-patient Medicare-Baby Boomers, and their claims increased.
The investigators found that the patients' overall mortality increased from 9% to 10%.
The investigative team found that HCV, older age, male gender, ESRD, Charlson score and length of stay predicted mortality.
The team found that length of stay decreased from 13 to 12 days, whereas total payments increased from $22,157 to $23,185.
During the study, the number of out-patient Medicare Baby Boomers patients, and claims also increased.
Furthermore, overall mortality increased from 3.15% to 3.31%.
The investigators observed that HCV, older age, ESRD, disabled status and Charlson score predicted mortality.
The team found that the annual total out-patient payments increased from $3781 to $4001.
HCV, 45–49 age, ESRD, disabled status, Charlson score, and study year independently predicted increases in payments.
Dr Younossi's team concludes, "In Baby Boomer Medicare recipients, diagnosis of HCV is independently associated with higher mortality and resource utilization."

Aliment Pharmacol Ther 2016: 43(10): 1060–1068
29 April 2016

http://www.gastrohep.com/news/news.asp?id=111801


Rare disease gene has a key role in chronic hepatitis C infection

Rare disease gene has a key role in chronic hepatitis C infection
PLOS

Caption
ABHD5 (green) co-localizes with ADRP (red) to the lipid droplet surface ('donut' shape) in human liver-derived cells.

Credit
Gabrielle Vieyres (Twincore, Hannover) (sample preparation & imaging).


Hepatitis C virus (HCV) hijacks the host's fat metabolism for its own survival, growth, and transport in the human body. A study published on April 28th in PLOS Pathogens identifies a host gene involved in the formation of HCV virus particles and helps explain why humans with a rare mutation in the gene have problems with their fat metabolism.

Lipid droplets are are involved in the regulation of fat storage and metabolism and found in the body´s fat cells and in liver cells (also called hepatocytes). Some pathogens, including HCV, which targets the liver, exploit the host's lipid droplets for their own propagation. In fact, HCV travels through in the blood as a lipo-viro particle, a lipid-rich blob that closely resembles human very low density lipoproteins (VLDL) such as cholesterol. And this camouflage makes it hard for the immune system to detect and fight the virus.

In a rational quest to find host factors involved in HCV infection, Gabrielle Vieyres and Thomas Pietschmann from Twincore in Hannover, Germany, with colleagues focused on a list of genes with proposed roles in the formation and maintenance of lipid droplets or VLDL. The researchers set up a system to systematically test whether any of these genes were essential for initial or chronic HCV infection, and found a number of candidates that appeared to affect different stages of the HCV life-cycle.

They selected one of them, called ABHD5, for a more detailed analysis. ABHD5 stood out because mutations in the gene cause a rare human genetic disease called Chanarin-Dorfman syndrome (CDS) that causes defects in lipid storage, and also because the earlier tests suggested that the gene had an interesting role in lipid droplet metabolism.

More detailed experiments showed that ABHD5 had no effects on the entry of HCV into human cells or on the multiplication of the viral genome, but that ABHD5 expression levels specifically regulated the efficiency of virus assembly and release from the human host cells. Having identified ABHD5 as novel HCV assembly co-factor, the researchers tested two variants of the protein involved in CDS and found that both of the mutations abolished the protein's role in HCV assembly.

When the researchers examined the localization of ABDH5 in the cells, they found it preferentially at the surface of lipid droplets and the cellular secretion machinery, which are also the sites of HCV assembly. In HCV-infected cells, normal ABDH5 protein (but not the CDS mutants) consistently co-localized with virus components as well as other known host assembly factors.

Examining the functional consequences of the observed associations, the researchers saw fewer lipid droplets in cells expressing higher-than-normal levels of ABDH5. However, high levels of CDS mutant did not affect the cell lipid droplets. Moreover, cells with lower-than-normal ABDH5 levels showed accumulation of large numbers of lipid droplets.

By systematically mutating different parts of the ABHD5 protein, the researchers were able to identify a part of the protein that they called the 'tribasic lipid droplet consumption motif'. Mutations in this motif retained the protein's co-localization with lipid droplets but no longer promoted "consumption" of the droplet. The researchers speculate that mutation of the motif specifically abrogates ABHD5's interaction with its partner lipase (a lipid-degrading enzyme) and hope that "therefore this mutant will be a precious tool for the identification of ABHD5 effector lipase(s) in hepatocytes".

"Our findings", the researchers summarize, "indicate that ABHD5 supports HCV assembly and release by triggering the mobilisation of the lipid droplet stores for the assembly and release of infectious lipo-viro-particles. They shed light on host determinants of HCV and VLDL morphogenesis, on the role of ABHD5 in hepatocytes and the etiology [the biological origin] of the liver dysfunctions observed in the Chanarin-Dorfman patients".
 
In your coverage please use this URL to provide access to the freely available article in PLOS Pathogens: http://dx.plos.org/10.1371/journal.ppat.1005568
Please contact plospathogens@plos.org if you would like more information.
Funding: This work was funded by the Deutsche Forschungsgemeinschaft (DFG) Sonderforschungsbereiche (SFB) 900, project A6 (http://www.dfg.de/foerderung/programme/koordinierte_programme/sfb/) (TP), by the Deutsches Zentrum für Infektionsforschung (DZI-F, http://www.dzif.de/, TP, FWRV) and by a grant from the Initiative and Networking Fund of the Helmholtz Association SO-024 (http://www.helmholtz.de/en/home/, TP). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: The authors have declared that no competing interests exist.
Citation: Vieyres G, Welsch K, Gerold G, Gentzsch J, Kahl S, Vondran FWR, et al. (2016) ABHD5/CGI-58, the Chanarin-Dorfman Syndrome Protein, Mobilises Lipid Stores for Hepatitis C Virus Production. PLoS Pathog 12(4): e1005568. doi:10.1371/journal.ppat.1005568


Wednesday, April 27, 2016

Inovio Partners with National Cancer Institute and Mayo Clinic to Initiate Hepatitis C Immunotherapy Clinical Trial

Inovio Partners with National Cancer Institute and Mayo Clinic to Initiate Hepatitis C Immunotherapy Clinical Trial

DNA-based immunotherapy will be tested for safety and immune responses in quest to eliminate HCV infection

PLYMOUTH MEETING, Pa., April 27, 2016 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (INO) announced today its immunotherapy for hepatitis C (INO-8000) will be evaluated in a phase I trial in chronically infected patients who are not receiving other hepatitis C virus (HCV) treatments. The study will enroll patients who are in the early stages of chronic HCV infection to determine the therapy’s ability to decrease and potentially eliminate HCV viral load, measure HCV specific immune responses and durability of these immune responses, and evaluate safety and tolerability. In this dose-escalation study INO-8000 will be combined with increasing doses of DNA-based IL-12 (INO-9012), an immune activator, which in previous studies has been shown to increase the therapeutic immune response to DNA immunotherapies.
The study is funded by the National Cancer Institute’s Division of Cancer Prevention and will be conducted at the Mayo Clinic and other U.S. sites.
 
Among those initially infected with HCV, 75 to 85 percent will go on to develop chronic illness. More than 170 million people around the world are chronically infected with HCV. According to the U.S. Centers for Disease Control (CDC) an estimated 3.5 million people in the US are chronically infected with HCV, with about 20,000 new cases of chronic HCV reported in the US in the last year. About 15,000 people in the US die each year of HCV-related causes.
 
Inovio's SynCon® DNA immunotherapy, INO-8000, is encoded for the antigens NS3/4A, NS4B, and NS5A of HCV genotypes 1a and 1b, the most difficult-to-treat genotypes. The product is designed to induce robust T cells to eliminate cells displaying these antigens and has been shown in published preclinical studies to generate powerful HCV-specific T cell responses throughout the body and in the liver.
 
Dr. Jeffrey Jacobson, the study’s Principal Investigator, said “Development of a vaccine therapy against hepatitis C would be important as a less expensive, simpler treatment alternative to several months of medication that should encourage better patient compliance, particularly in difficult-to-treat patient populations. It also holds the promise of inducing immunity protective against re-infection in patients who continue to be exposed, a not uncommon problem.” Dr. Jacobson is Professor of Medicine, Neuroscience and Neurovirology at the Lewis Katz School of Medicine, Temple University.
 
Dr. J. Joseph Kim, President and CEO, said, “Despite recent treatment advances, HCV infection remains a burden on our healthcare and payor system and continues to spread. Today’s expensive drugs are highly effective in treating HCV but are not available to the majority of infected individuals. We are pleased to join the NCI and Mayo Clinic in this quest to develop an alternative medical solution to fight this disease, which remains one of the fastest-developing markets in healthcare."
 
Inovio previously announced that it signed a collaborative agreement with GeneOne Life Sciences to develop INO-8000, along with a DNA IL-28 immune activator, in drug-resistant HCV patients in a phase I study in Korea. That study is on-going.
 
 

Tuesday, April 26, 2016

New York Insurers to Change Coverage of Hepatitis C Drugs

New York Insurers to Change Coverage of Hepatitis C Drugs
By Corinne Ramey                
April 25, 2016 10:00 p.m. ET

Seven health-insurance companies in New York will change their criteria for covering costly drugs that cure chronic hepatitis C under the terms of agreements with the office of State Attorney General Eric Schneiderman.

The agreements, expected to be announced Tuesday, require the insurers to cover hepatitis C medications for nearly all patients who have commercial insurance plans in the state.

Last year, Mr. Schneiderman’s office began an investigation into coverage of drugs for chronic hepatitis C, issuing subpoenas for documents and claims data to all commercial health insurers in the state. The investigation showed a wide discrepancy in how companies cover these drugs and found some insurers largely covered only patients with advanced stages of the disease, the attorney general’s office said.

Five of the insurers denied from 30% to 70% of claims, the office said.

Continue reading....

Monday, April 25, 2016

AbbVie Receives NDA for Viekira Pak/HCV genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis


AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis
Apr 25, 2016

- Approval supported by TURQUOISE-III study showing 100 percent SVR12 (N=60/60) in chronic hepatitis C virus (HCV) infected genotype 1b patients with compensated cirrhosis (Child-Pugh A)
- Supplemental New Drug Application was previously granted priority review designation by the FDA

NORTH CHICAGO, Ill., April 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A). The application was previously granted priority review by the FDA, a designation given to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness.

VIEKIRA PAK is a prescription medicine used with or without RBV to treat adults with genotype 1 (GT1) chronic (lasting a long time) HCV infection, and can be used in people who have a certain type of cirrhosis (compensated). VIEKIRA PAK is not for people with advanced cirrhosis (decompensated). Patients with cirrhosis should talk to a doctor before taking VIEKIRA PAK.

The Centers for Disease Control and Prevention estimates that in the United States, approximately 2.7 million people are chronically infected with HCV.1 Genotype 1 is the most common HCV in the U.S.2 Of the total U.S. population with GT1 HCV infection, approximately 77 percent are genotype 1a (GT1a) and 23 percent are GT1b.2

"We are constantly striving to advance clinical care for patients living with chronic hepatitis C," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This approval is especially significant because patients with chronic HCV with compensated cirrhosis are among the tough to treat, and in our study VIEKIRA PAK demonstrated 100 percent cure rates in GT1b patients without the use of ribavirin."

"This provides a very useful option for people infected with genotype 1b infection and compensated cirrhosis. The ability to cure these individuals with just 12 weeks of treatment and without the need for ribavirin is a great benefit," said TURQUOISE-III lead investigator Jordan J. Feld, MD, MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada. "The outstanding 100 percent cure rate from the study confirms that this is likely to be a very effective strategy."

The TURQUOISE-III study included in the sNDA evaluated the use of VIEKIRA PAK without RBV for 12 weeks in GT1b patients with compensated cirrhosis (Child-Pugh A). Results demonstrated 100 percent (N=60/60) sustained virologic response at 12 weeks post-treatment (SVR12). Patients who achieve SVR12 are considered cured of HCV, as the virus is no longer detectable in the blood. No patients discontinued treatment due to adverse events. The most commonly-reported adverse events (?10 percent) were fatigue (22 percent), diarrhea (20 percent), headache (18 percent), arthralgia (10 percent), dizziness (10 percent), insomnia (10 percent) and pruritus (10 percent).3

On February 26, AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for VIEKIRAX® (ombitasvir/ paritaprevir/ ritonavir tablets) + EXVIERA® (dasabuvir tablets) and this RBV-free option is now approved for use for the treatment of chronic HCV infected GT1b patients with compensated cirrhosis (Child-Pugh A) in Europe.

About the TURQUOISE-III Study
TURQUOISE-III is a multi-center, open-label, single-arm Phase 3b study to evaluate the safety and efficacy of 12 weeks of treatment with VIEKIRA PAK without ribavirin (RBV) in adult patients (N=60) with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated liver cirrhosis (Child-Pugh A) who were treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). The primary endpoint is the rate of sustained virologic response 12 weeks after treatment (SVR12).1

Read more...



Diabetes Ups Risk of Hospitalization, Death From Liver Disease

Diabetes Ups Risk of Hospitalization, Death From Liver Disease
Marlene Busko
April 25, 2016

In a cohort study of 40- to 89-year-old people who were followed for a decade, individuals with type 2 diabetes were more likely than nondiabetic individuals to be hospitalized for or die from chronic liver disease. These were defined as alcoholic liver disease, autoimmune liver disease, hemochromatosis, hepatocellular carcinoma, nonalcoholic fatty liver disease (NAFLD; including cirrhosis and hepatic fibrosis), and viral liver disease.

For example, diabetic men were three times more likely than other men their age to be hospitalized for or die from NAFLD — the most common type of liver disease in diabetic patients — whereas this was five times more likely to occur in diabetic versus nondiabetic women of the same age.

Thus, the increasing prevalence of type 2 diabetes is likely to result in an increasing burden of all chronic liver diseases, conclude Sarah H Wild, MB, BChir, PhD, University of Edinburgh, Scotland, and colleagues in their study, published online in the Journal of Hepatology.

Continue reading...

Sunday, April 24, 2016

Pediatric research: Researchers now think fibrosis can be reversed

Pediatric research: Researchers now think fibrosis can be reversed
Fibrosis, one of the most devastating consequences of hundreds of human diseases, has long been thought by biomedical science to be fixed and irreversible.

But new research hints this harmful biological process might not be permanent after all.

One of the most dramatic examples of reversibility is seen after treatment of hepatitis C, a chronic viral infection, with newly approved antiviral drugs.

In the laboratory, research has created a much better understanding of the biological intricacies of fibrosis.

Continue reading...

Saturday, April 23, 2016

Successful antiviral treatment for hepatitis C associated with reduction in risk of cirrhosis, HCC and overall mortality, regardless of age.

Successful treatment for hepatitis C reduces risk of liver cancer later in veterans

Researchers found that successful antiviral treatment for hepatitis C is associated with a significant reduction in risk of cirrhosis, HCC and overall mortality, regardless of age. Therefore, delaying treatment should not be advised. Patients with hepatitis C aged 65 to 85 years who received less antiviral treatment than younger patients were more likely to develop cirrhosis and liver cancer than patients with hepatitis C aged 20 to 49 years.

A new study by researchers at Baylor College of Medicine found that treatment and cure of chronic hepatitis C reduce the risk of hepatocellular carcinoma (HCC), especially if given early, before cirrhosis develops, and while patients are still young. The report appears in the journal Hepatology.

Chronic hepatitis C is a common and progressive liver infection caused by the hepatitis C virus, a strong risk factor for HCC, the most common type of primary liver cancer.

“With the advent of new highly effective medications for treating hepatitis C, we expect to see a lot of people cured of the disease,” said Dr. Hashem El-Serag, chief of gastroenterology and hepatology at Baylor and at the Michael E. DeBakey Veterans Affairs Medical Center and lead author of the study. “However, we did not have good information about what happens to these people in terms of their future risks of developing HCC after cure.”

This large and definitive study involved 33,005 individuals infected with the hepatitis C virus who received treatment in Veterans Health Administration hospitals throughout the United States, and of whom 10,817 patients achieved cure. Researchers tracked their risk of developing HCC liver cancer over several years of follow-up and examined the association between several demographic and clinical features at the time of the cure with the future risk of liver cancer.

Researchers found that successful antiviral treatment for hepatitis C is associated with a significant reduction in risk of cirrhosis, HCC and overall mortality, regardless of age. Therefore, delaying treatment should not be advised. Patients with hepatitis C aged 65 to 85 years who received less antiviral treatment than younger patients were more likely to develop cirrhosis and liver cancer than patients with hepatitis C aged 20 to 49 years.

“Patients with cirrhosis or diabetes or those who are older than 55 who get cured of hepatitis C need continued surveillance according to current guidelines,” said El-Serag.

The time of cure is essential for determining prognosis. High emphasis should be given to increasing screening and diagnosis of hepatitis C before those infected develop cirrhosis, through assessment of degree of liver fibrosis, said El-Serag.

Others who took part in this study include Dr. Fasiha Kanwal, Peter Richardson, and Jennifer Kramer, all from Baylor College of Medicine.

Supported in part by National Institutes of Health (NIH) grant from the National Cancer Institute R01 116845, the Houston VA HSR&D Center of Innovations (CIN13-413), the Texas Digestive Disease Center NIH DK58338. Drs. El-Serag and White's effort is supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases (K24-04-107 and K01 DK081736, respectively).

https://www.bcm.edu/news/cancer/hepatitis-c-treatment-liver-cancer-risk

Best of viral hepatitis at ILC2016



Published on Apr 22, 2016
Video Link
In this video, Pr. Jean-Michel Pawlotsky and Pr. Thomas Berg review and discuss the “Best of viral hepatitis at ILC2016”. An extensive summary of the latest advances in the fields of hepatitis B and hepatitis C is covered

For webcasts, posters and slides from the ILC2016 see LiverTree http://livertree.easl.eu/

Friday, April 22, 2016

China Eases Path for Foreign Drugmakers’ Hepatitis C Treatments

China Eases Path for Foreign Drugmakers’ Hepatitis C Treatments
Source - WSJ

China’s Food and Drug Administration expedites domestic drug applications to encourage innovation. But its lengthy drug-approval process for foreign companies means none of the direct-acting antiviral agents that have been shown to cure more than 90% of hepatitis C patients within a few months have been approved in China, which has among the highest rates of the disease in the world with an estimated 10 million people infected.

Chinese patients tired of old-generation therapies such as interferon injections have increasingly traveled overseas to access the new therapies.

Continue reading....

Thursday, April 21, 2016

CCO - Our Expert Picks in HCV Now Available From Barcelona‏ EASL 2016*

CCO Independent Conference Coverage: Clinical Impact of New Data From EASL 2016*

Capsule Summaries

David R. Nelson, MD
Nancy Reau, MD, FAASLD, AGAF

Examine key data emerging from the most important HCV studies presented in Barcelona, as selected by the experts. Capsule Summaries available to date include:

C-EDGE Head to Head: Grazoprevir/Elbasvir Superior to Sofosbuvir + PegIFN/RBV in the Treatment of HCV Genotype 1 and 4 Infection
Interferon-free therapy demonstrates superior efficacy and safety to interferon-containing regimen in comparative study.
Read More

GS-1168/1169: 12 Weeks of Sofosbuvir/Velpatasvir + GS-9857 Highly Effective Across Genotypes in Treatment-Experienced HCV-Infected Patients
Novel all-oral, multiclass regimen effective regardless of HCV genotype, cirrhosis status, and extent of treatment experience.
Read More

ASTRAL-5: 12 Weeks of Sofosbuvir/Velpatasvir Safe, Highly Effective in Patients With HCV/HIV Coinfection on Stable ART
Treatment was well tolerated without renal perturbations or HIV virologic rebound.
Read More

HEPA-C: Decompensated Cirrhosis Associated With Decreased Response and Increased Risk of Severe Outcomes After DAA Therapy in Real-World Setting
MELD score of ≥ 18 predicted increased risk of severe adverse events or death.
Read More

Real-World Data Suggest Feasibility of Individualized Retreatment After IFN-Free DAA Combination Failure in Genotypes 1 and 3 HCV
Selecting the retreatment regimen based on resistance analysis revealed DAA combination regimens likely to be effective after failure of an initial interferon-free DAA combination regimen.
Read More

HCV-TARGET: Baseline RAVs Are Frequently Detected in Patients With Genotype 1 HCV But Have Limited Effect on Efficacy of LDV/SOF or SMV + SOF ± RBV
Little evidence that specific variants influence response to sofosbuvir-containing regimens, although Y93C/H/N RAV may reduce effectiveness of ledipasvir/sofosbuvir.
Read More

SURVEYOR-II: 100% SVR12 Rate With Once-Daily ABT-493 + ABT-530 ± Ribavirin in Treatment-Naive Patients With Genotype 3 HCV Infection and Compensated Cirrhosis
Presence of baseline NS3 and/or NS5A variants did not impact efficacy.
Read More

HepNet IV: 6-Week Regimen of Ledipasvir/Sofosbuvir Highly Effective in Acute Genotype 1 HCV Monoinfection
A short course of ledipasvir/sofosbuvir achieved an SVR12 rate of 100% against genotype 1 HCV with rapid normalization of ALT and bilirubin in most patients.
Read More

Monday, April 18, 2016

Tainted Scope Infections Far Exceed Earlier Estimates

Tainted Scope Infections Far Exceed Earlier Estimates
By Chad Terhune April 15, 2016

The number of potentially deadly infections from contaminated medical scopes is far higher than what federal officials previously estimated, a new congressional investigation shows.

As many as 350 patients at 41 medical facilities in the U.S. and worldwide were infected or exposed to tainted gastrointestinal scopes from Jan. 1, 2010, to Oct. 31, 2015, according to the Food and Drug Administration.

A separate Senate investigation released in January found 250 scope-related infections at 25 hospitals and clinics in the U.S. and Europe. That probe looked at a narrower period, from 2012 to 2015.

The FDA supplied the new information in response to a yearlong inquiry by U.S. Rep. Ted Lieu (D-Torrance) and staff of the House Oversight and Government Reform committee.

The FDA says it is not permitted by law to name the medical facilities involved in the 41 incidents it disclosed. But the device manufacturers weren’t identified either. The full report is expected to be released Friday.

Continue reading...

Saturday, April 16, 2016

ABT-493 and ABT-530 gets 1 step closer to offering HCV genotype 3 patients an effective therapeutic option

Related: View Todays Meeting Coverage @ Healio

ABT-493, ABT-530 produce high SVR4 rates in HCV genotype 3
BARCELONA — In this exclusive video interview at International Liver Congress, Paul Y. Kwo, MD, professor of medicine and director of liver transplantation at Indiana University, and HCV Next Editorial Board member, discusses results from the two SURVEYOR studies investigating the safety and efficacy of pangenotypic agents ABT-493 and ABT-530 in patients with hepatitis C virus genotype 3 infection with and without cirrhosis.

AbbVie Press Release
AbbVie ABT-493 and ABT-530 For Genotypes 1-6: New Phase 2 Data Presented At The International Liver Congress
- 97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 in genotypes 1-3 hepatitis C virus patients without cirrhosis in SURVEYOR-1 and 2 studies(1,2)
- 100 percent SVR12 achieved with 12 weeks of treatment in difficult-to-treat genotype 3 patients with compensated cirrhosis (Child-Pugh A) new to therapy (3)
- 100 percent SVR12 achieved with 12 weeks of treatment in genotypes 4-6 patients without cirrhosis; eight-week duration investigated in this ongoing study (4)

Today At The International Liver Congress™

Phase 2 data show treatment efficacy in 'difficult-to-cure' hepatitis C patients

Investigational oral combination hepatitis C (HCV) treatment gets 1 step closer to offering HCV genotype 3 patients an effective therapeutic option

European Association for the Study of the Liver

April 16, 2016, Barcelona, Spain: A Hepatitis C (HCV) drug currently under investigation, ABT-493 and ABT-530, which is an all-oral once-daily antiviral treatment, helped HCV genotype 3 patients with heavily scarred livers and no previous treatment history to achieve a 100% sustained virologic response after receiving the treatment for 12 weeks (SVR12).

Additional data from this study, also presented at The International Liver CongressTM today in Barcelona, Spain, show that 97% of patients with the same HCV genotype, but without scarred livers, achieved SVR12 after eight weeks on the same treatment without ribavirin (RBV).

As treatments for HCV have evolved, genotype 3 patients have become the most difficult subgroup of patients to cure.1 Although there have been recent advances in direct-acting antiviral therapies for HCV genotype 1, genotype 3 remains a challenge and is a highly prevalent strain of the infection globally, with a particularly high concentration of cases in Asia.1

The current standard of care for HCV genotype 3 is the nucleotide polymerase inhibitor sofosbuvir with weight-based RBV for 24 weeks. This recommendation comes from the Valence study where high SVR rates were seen in those who had no previous HCV treatment history, without or with scarring of the liver, known as cirrhosis (93% and 92%, respectively). However, treatment-experienced genotype 3 cirrhotic patients experienced a lower SVR rate of 60%.2

"We are pleased to see the efficacy of this two direct-acting antiviral investigational, pan-genotypic regimen has been validated for treatment-naïve Hepatitis C genotype 3 patients - with 100% of cirrhotic patients treated for 12 weeks and 97% of non-cirrhotic patients treated for eight weeks achieving sustained virologic response at 12 weeks post treatment," said Dr Paul Kwo from Indiana University School of Medicine, Indianapolis, US and one of the lead study authors. "Clinical trials are ongoing to evaluate the safety and efficacy of the investigational treatment, and we are now focusing on a larger cohort of HCV genotype 3 patients, including treatment-experienced patients."

In the international Phase 2 clinical trial, two study arms enrolled 24 cirrhotic patients each, none who had previously been treated for HCV infection. In the two patient groups taking the investigational combination treatment ABT-493 and ABT-530 with and without once-daily RBV, all achieved SVR12 after 12 weeks on treatment. No patient discontinued the study or experienced virologic failure.

In another trial treatment arm that focused on non-cirrhotic patients, 29 genotype 3-infected patients were enrolled. SVR12 was achieved by 97% (28/29) of patients with no patient experiencing virologic failure. The most common side effects were the same across both studies, including headache, and fatigue.

"These data mark another step forward in continued research efforts to address the unmet medical need among HCV patients," said Professor Frank Tacke, EASL Governing Board member. "We will be watching with close interest to see whether similar efficacy levels can be achieved for treatment-experienced genotype 3 HCV patients - a group known for being hard to cure."

###

About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ takes place from April 13 - 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.

About EASL

Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Contact

For more information, please contact the ILC Press Office at:

Email: ILCpressoffice@ruderfinn.co.uk
Telephone: +44 (0)7841 009 252

Onsite location reference

Late-breaker session, Hall 6.0
Saturday 16 April, 16:00 - 18:00
Presenter: Paul Kwo, United States
Abstract: LB01, 100% SVR4 with ABT-493 and ABT-530 with or without Ribavirin in Treatment-Naïve HCV Genotype 3-Infected Patients with Cirrhosis

Viral hepatitis C (2), Hall 6.0
Saturday 16 April, 11:30 - 13:30
Presenter: Andrew Muir, United States
Abstract: PS098, High SVR Rates with ABT-493 + ABT-530 Co-Administered for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 3 Infection

Author disclosures of interest

Paul Kwo - Advisory board: Abbott, Abbvie, BMS, Gilead, Merck, Janssen. Grant support: Abbvie, BMS, Gilead, Janssen, Merck

Andrew Muir - Research grants: AbbVie, Achilion, BMS, Gilead, GSK, Hologic, Intercept, Janssen, Merck, NGM Biopharm, Roche. Educational activities: Salix. Consulting services: AbbVie, Achilion, BMS, Gilead, Inovio Pharmaceuticals, Intercept, Janssen, Lumena, Merck, Portola Pharmaceuticals, Regulus Therapeutics, Salix, Shire Pharmaceuticals, Theravance.

References

1 US National Library of MedicineNational Institutes of Health. Review article: HCV genotype 3 - the new treatment challenge. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24612116. Last accessed: March 2016.
2 The Hepatitis C Trust. Genotype 3: One of the Remaining Challenges for Hepatitis C. Available from: http://www.hepctrust.org.uk/news/may-2015/genotype-3-one-remaining-challenges-hepatitis-c. Last accessed: March 2016.

Generic direct-acting antivirals for hepatitis C virus infection Presented at International Liver Congress

Low-cost generic direct-acting antiviral treatment for hep C is equivalent to branded formulations

New data indicate that generics are a feasible alternative to support access to direct-acting antiviral treatment for hepatitis C sufferers

European Association for the Study of the Liver

April 16, 2016, Barcelona, Spain: Data presented today demonstrates that generic direct-acting antivirals (DAAs) are as effective and safe as branded treatments to cure Hepatitis C.

The summary results presented today at The International Liver Congress™ 2016 in Barcelona, Spain, showed high sustained virologic response (SVR) after treatment with generic sofosbuvir, ledipasvir, daclatasvir and ribavirin, confirming clinical efficacy equivalent to outcomes seen in Phase 3 clinical trials of branded combination treatments.

The high costs of branded DAAs prevent access to treatment in many countries.1 Generic DAAs are being mass-produced and are available for less than 1% of the retail price of their branded counterparts. Medication costing $94,000 per person in the US can currently be obtained for less than $1,000 as a generic, and a 12 week course of treatment could be produced for as little as $200 in the future.1

"Our interim data suggests a potential solution for Hepatitis C patients in areas where treatment access has been restricted as a result of the high prices demanded for branded treatment," said Dr James Freeman, of GP2U Telehealth, Hobart, Australia and lead author of the study. "At the price level of generic direct-acting antivirals, treating the entire global Hepatitis C epidemic could be financially feasible. Furthermore, if a patient is cured of Hepatitis C, there is evidence for improved survival, and lower risks of liver cancer and liver cirrhosis and cured patients could return to work, delivering further economic benefits to society."

In this study, people with HCV legally imported low-cost generic treatment to cure their infection. The study included people treated in Australia, USA, UK, Canada, Europe, SE Asia and Africa.

Generic DAAs were first evaluated for quality in Australia, using high precision liquid chromatography, nuclear magnetic resonance and mass spectroscopy. Patients were assessed pre-treatment, during treatment, and then at weeks 4 (SVR4) and 12 (SVR12) following the end of treatment. The objective of the analysis was to assess the efficacy and safety of generic DAAs legally imported for each patient's personal use.

The interim results show that for genotype 1 the overall SVR rate was 95%. Treatment with generic sofosbuvir and ledipsavir led to SVR4 rates of 93% and treatment with generic sofosbuvir and daclatasvir led to SVR4 rates of 97%.

"Across all genotypes, the SVR rate was 94% after treatment with generic DAAs. This indicates that generic DAAs can deliver the same success rates as branded equivalents, but at a price which is 1/100th of the current cost," explained Dr James Freeman.

"There is a clear role for generic treatments such as these for people with Hepatitis C across the world. The implications of increased availability of these drugs could be enormous, presenting more people with the possibility of a 'cure' for what is often a debilitating condition," said Professor Laurent Castera, EASL Secretary General.

Low-cost generic hepatitis C drugs match branded products in viral response
 Keith Alcorn
Generic versions of direct-acting antivirals purchased from China and India by people unable to obtain treatment in their own countries were just as effective and safe as the branded products, a study
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Study shows generics pose safe, economic option for patients with HCV
April 16, 2016
BARCELONA — Generic direct-acting antivirals for hepatitis C virus infection presented a similar biochemical makeup and sustained virological… “In this interim analysis, legally imported generic DAAs led to high SVR rates,” James Freeman, MD, executive director, GP2U Telehealth, Australia, said during a press conference. “A generic cure for hepatitis C is available now for $1,000 and works as expected. … Not in the future, but right now.”

Freeman explained that this endeavor began with one patient asking for assistance in obtaining a generic DAA as, at the time, only Olysio (simeprevir, Janssen) was available in Australia. He chose to assist the patient and test the generics to ensure safety. That patient went on to achieve SVR with the generic medication.

“The news leaked and one became a dozen,” Freeman said
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View Todays Meeting Coverage @ Healio

ABT-493, ABT-530 produce high SVR4 rates in HCV genotype 3
BARCELONA — In this exclusive video interview at International Liver Congress, Paul Y. Kwo, MD, professor of medicine and director of liver transplantation at Indiana University, and HCV Next Editorial Board member, discusses results from the two SURVEYOR studies investigating the safety and efficacy of pangenotypic agents ABT-493 and ABT-530 in patients with hepatitis C virus genotype 3 infection with and without cirrhosis.

“We are clearly in need of different strategies for these individuals so the genotype 3 population can get the same benefits as the other [genotype patients],” Kwo told HCV Next.

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BARCELONA — Physicians need to counsel patients with hepatitis C virus and MELD score higher than 18 prior to treatment with direct-acting…

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