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

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
•Perform baseline testing
•Determine genotype
•Assess the degree of fibrosis
•Antiviral therapy •Novel therapies
•Cost of treatment

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
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

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 CEO Patrick Byrne discusses Hepatitis C 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

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