The Global Liver Institute Launches NASH Council To Fight Insidious Liver Disease

MedicalResearch.com Interview with:

Donna R. Cryer, JD CEO, Global Liver Institute

Donna Cryer JD

Donna R. Cryer, JD

CEO, Global Liver Institute

MedicalResearch.com: What is the background for this Council?

Response: The Global Liver Institute operates my constantly assessing the liver health landscape for what we call advocacy gaps to determine where we allocate our time and resources. We identified NASH 2 years ago as an imminent global public health crisis due to the tens of millions of diagnosed and estimated undiagnosed patients rising with rates of obesity and diabetes with no concomitant recognition and activity by public, patients, or physicians. We decided to launch the NASH Council with collaborative patient and physician leadership and involving Hepatology but deliberately reaching out to primary care, endocrine, cardiology, and obesity organizations.
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Drinking Coffee Reduced Mortality in Treated HIV-Hepatitis C Co-Infected Patients

MedicalResearch.com Interview with:

Coffee Wikipedia image

Coffee
Wikipedia image

Patrizia Carrieri PhD
INSERM U912 – ORS PACA
IHU – Faculté de Médecine
Marseille, France

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study is based on the longitudinal data of the French  ANRS HEPAVIH cohort of patients with HIV and Hepatitis C co-infection. This cohort was set up thanks to a collaboration between INSERM (National Institute of health and medical research) UMR912 in Marseille, the ISPED (public health and epidemiology institute) in Bordeaux and several hospital/university sites. Our INSERM team in Marseille is specialized in the study of the impact of behaviors on HIV and HCV outcomes, including mortality.

We could think that HCV cure was enough to reduce mortality in HIV-HCV patients as the mortality risk was 80% lower in those who were cured of (i.e. who “cleared”) Hepatitis C thanks to treatment.

However, our study showed that, even after HCV cure, sociobehavioral factors still matter: drinking at least 3 cups of coffee a day was associated with a 50% reduction in mortality risk as well as not smoking which was also associated with a reduced mortality risk. This association between elevated coffee intake and reduced mortality risk is probably due to the properties of polyphenols contained in coffee which can protect the liver and also reduce inflammation.

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Liver Key To Development of Diabetic Vascular Complications

MedicalResearch.com Interview with:

Dr. Mauricio Berriel Diaz Deputy Director & Head of Division Metabolic Dysfunction and Cancer Institute for Diabetes and Cancer IDC Helmholtz Center Munich and Joint Heidelberg-IDC Translational Diabetes Program Heidelberg University Hospital, Molecular Metabolic Control Medical Faculty, Technical University Munich Neuherberg, Germany

Dr. Berriel Diaz

Dr. Mauricio Berriel Diaz
Deputy Director & Head of Division Metabolic Dysfunction and Cancer
Institute for Diabetes and Cancer IDC
Helmholtz Center Munich and
Joint Heidelberg-IDC Translational Diabetes Program
Heidelberg University Hospital, Molecular Metabolic Control
Medical Faculty, Technical University Munich
Neuherberg, Germany 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our institute takes part in a german collaborative research consortium (https://www.klinikum.uni-heidelberg.de/index.php?id=132204&L=1), in which the key objective is to understand why in diabetes mellitus late complications occur even when blood sugar is well controlled.

Our study focused the role of the liver and of inflammatory signaling, as the latter is known to be increased in metabolic diseases such as obesity and diabetes mellitus. We found that TNF-α-induced reactive oxygen species (ROS) formation in the liver abolished the function of the transcription factor GAbp. Impaired hepatic GAbp function resulted in transcriptional inactivation of the cellular energy sensor AMPK, which in turn induced hepatic cholesterol secretion, hypercholesterolemia and eventually atherosclerotic lesion formation.

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Hepatitis C Can Be Safely Treated By Primary Care Providers

MedicalResearch.com Interview with:

Sarah Kattakuzhy, MD Clinical and Administrative Director, DC PFAP Hepatitis Clinical Research Program Assistant Professor, Institute of Human Virology Division of Infectious Diseases University of Maryland 

Sarah Kattakuzhy, MD
Clinical and Administrative Director, DC PFAP Hepatitis Clinical Research Program
Assistant Professor, Institute of Human Virology
Division of Infectious Diseases
University of Maryland  

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The recent introduction of highly effective, well-tolerated direct-acting antiviral (DAA) therapy for hepatitis C virus infection has raised the possibility of rapid treatment expansion and widespread cure. However, the current specialist workforce is insufficient to meet the treatment demands of the 2.7 million Americans living with HCV infection. Several studies of partial task shifting—shared treatment between specialists and primary care providers—have demonstrated success in improving access to HCV care. Yet, information on the success of nonspecialists practicing independent of specialist supervision is limited.

The primary objective of ASCEND was to evaluate the efficacy of Hepatitis C treatment managed independently by 3 community-based provider types—nurse practitioners (NPs), PCPs, and specialists—after a succinct, guideline-driven educational intervention, set within a real-world, urban population.

In this investigation, 516 out of 600 patients achieved SVR, a response rate of 86% (95% CI, 83.0% to 88.7%), with no major safety signals. Rates of SVR were consistent across the 3 provider types—NPs: 89.3% (CI, 83.3% to 93.8%); PCPs: 86.9% (CI, 80.6% to 91.7%); and specialists: 83.8% (CI, 79.0% to 87.8%). Patient loss to follow-up was the major cause of non-SVR.

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Liver Cancer Incidence and Deaths Rising, With Wide Ethnic Disparities

MedicalResearch.com Interview with:

Farhad Islami, MD PhD  Strategic Director, Cancer Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303

Dr. Islami

Farhad Islami, MD PhD
Strategic Director, Cancer Surveillance Research
American Cancer Society, Inc.
Atlanta, GA 30303

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Liver cancer is one of the leading causes of cancer death in the United States, accounting for nearly 29,000 deaths per year, with variations in occurrence by race/ethnicity and state.

We examined trends in liver cancer incidence, survival, and mortality in the United States and provided liver cancer mortality rates by race/ethnicity at the national and state level. State-level statistics are particularly important as they can inform state cancer control and prevention planning. We also provided detailed information on prevalence and trends in major risk factors for liver cancer and interventions to prevent or reduce their burden, to make our article a comprehensive yet concise source of information on liver cancer statistics, risk factors, and interventions in the United States.

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Cirrhosis May Raise Risk of Hemorrhagic Stroke

MedicalResearch.com Interview with:
Neal S. Parikh, M.D.
Administrative Chief Resident
Department of Neurology
Weill Cornell Medicine & NewYork-Presbyterian Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In contrast to the gastrointestinal and systemic hemorrhagic and thrombotic complications of cirrhosis, little was known about the risk of cerebrovascular complications.

In this analysis of Medicare beneficiaries’ claims data, we found cirrhosis to be associated with stroke, with associations appearing to be stronger for hemorrhagic stroke than for ischemic stroke. We controlled for demographic variables and stroke risk factors and relevant comorbidities, and our results were essentially unchanged in multiple sensitivity analyses.

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High Hepatitis C Cure Rate Using Elbasvir plus Grazoprevir In Chronic Kidney Disease

MedicalResearch.com Interview with:

Annette Bruchfeld MD, PhD Senior Consultant Associate Professor Karolinska Institute Dept of Renal Medicine, M99 Karolinska University Hospital Huddinge Stockholm, Sweden

Dr. Bruchfeld

Annette Bruchfeld MD, PhD Senior Consultant
Associate Professor
Karolinska Institute
Dept of Renal Medicine, M99
Karolinska University Hospital Huddinge
Stockholm, Sweden

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In patients with stage 4–5 chronic kidney disease(CKD), hepatitis C virus (HCV) infection can accelerate the decline in kidney function, impair health-related quality of life (HRQOL), and decrease survival chances of both patients and grafts in transplantation recipients.

In this study additional data from patients with stage 4–5 chronic kidney disease undergoing treatment for HCV infection in the C-SURFER study, including HRQOL and resistance analyses was presented not previously reported for this patient population with gwnotype 1 infection.

The final virological analysis of this study indicated a high cure rate with sustained virological response at 12 weeks after the end of treatment (SVR12) in more than 98% of all treated patients. Even in patients with resistance-associated substitutions (RASs) the SVR was high in 11 (84·6%) of 13 patients genotype 1a infection.

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Single Tablet Triple Therapy Effective For Refractory Hepatitis C

MedicalResearch.com Interview with:
Dr Marc Bourlière

Professeur Associé CHP (Associate Professor PHC)
Chef de service (Head of Department)
Hôpital Saint Joseph
Hépato-Gastroentérologie

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The majority of HCV patients can be cured with combinations of direct-acting antivirals (DAAs); however, there is still 5 to 10% of patients who relapse after treatment with DAAs for whom there are currently no approved therapeutic options available.

In these two international phase 3 studies, we have demonstrated that a single tablet triple regimen combining sofosbuvir, velpastasvir and voxilaprevir (a pangenotypic protease inhibitor) for 12 weeks cured 96% of the patients who had relapsed following prior treatment with DAA regimens including NS5A inhibitors and 98% of the patients who had relapsed following prior treatment with DAA regimens without an NS5A inhibitor. These two studies demonstrate that a pangenotypic retreatment option for this patient population could be soon available.

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Genetic Marker Can Determine Cirrhosis Patients Who Do Not Benefit From Hepatitis C Cure

MedicalResearch.com Interview with:

Dr. Winston Dunn, MD Assistant Professor The University of Kansas Medical Center

Dr. Dunn

Dr. Winston Dunn, MD
Assistant Professor
The University of Kansas Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is widely believed that everyone with HCV can be cured with the medications now a day. But sadly, about 5% of the patients already have very bad damage done to the liver. We call this decompensated cirrhosis. Our medication is still very effective in curing the virus, but in decompensated cirrhosis, curing the virus is not always enough.

Only about half to two-thirds of patients with decompensated cirrhosis clinically gets better, but the remaining struggles along or even gets worse after the cure. That is the problem. So, our research was to understand why that was.

We used genetic factor to predict which patient would get better and which patient would not. We found that a gene previous found to be predictive of fatty liver and fibrosis is also predictive of recovery in this setting.

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Xpert HCV Viral Load Test Can Detect Active Hepatitis C Infection From Fingerstick

MedicalResearch.com Interview with:

Jason Grebely PhD Associate Professor Senior Research Fellow (UNSW) Viral Hepatitis Clinical Research Program

Dr. Grebely

Jason Grebely PhD
Associate Professor
Senior Research Fellow (UNSW)
Viral Hepatitis Clinical Research Program

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Globally, testing and diagnosis of hepatitis C virus infection remain low. Although point of care tests for HCV infection exist, but many of these tests only measure HCV antibodies (previous exposure), not HCV RNA (active infection). Given that 25% of individuals spontaneously clear HCV infection, efforts to enhance diagnosis of chronic HCV infection and improve the HCV care cascade requires enhanced uptake of HCV RNA testing.

We conducted the first evaluation of the Xpert HCV Viral Load test (manufactured by Cepheid) – a point-of-care hepatitis C virus test that can detect active infection – from a finger-stick sample of blood. We established that there is good sensitivity and specificity of the Xpert HCV Viral Load point-of-care test using blood samples collected by finger-stick in participants attending drug health and homelessness services in Australia.

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Fecal Transplantation Reduced Hospitalizations and Improved Cognitive Function in Cirrhosis Trial

MedicalResearch.com Interview with:

Jasmohan S. Bajaj, M.D. Virginia Commonwealth University Associate Professor Department of Internal Medicine Division of Gastroenterology

Dr. Bajaj

Jasmohan S. Bajaj, M.D.
Virginia Commonwealth University
Associate Professor
Department of Internal Medicine
Division of Gastroenterology

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Hepatic encephalopathy is a devastating complication of cirrhosis, which often recurs despite standard of care therapy with lactulose and rifaximin. This has a basis in an altered gut milieu therefore we need to change that in a more meaningful way to help patients. This was an FDA-monitored Phase I safety study of Fecal microbiome transfer (FMT) using a rationally-derived donor compared to standard of care.

We found that FMT was safe and was associated with lower all-cause and hepatic encephalopathy-related hospitalizations over 5 months compared to standard of care.

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Spermidine in Foods Such As Aged Cheese Prevents Liver Damage and Extends Life — in Mice

MedicalResearch.com Interview with:

Leyuan Liu, Ph.D., Assistant Professor Center for Translational Cancer Research Institute of Biosciences and Technology Texas A&M University Houston, Texas 77030

Dr. Liu

Leyuan Liu, Ph.D., Assistant Professor
Center for Translational Cancer Research
Institute of Biosciences and Technology
Texas A&M University
Houston, Texas 77030

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our research team has been working on the question why people develop cancers and how we can prevent or cure them. In contrast to public views, we concluded from our studies that cancers, similar to our age-related diseases, originate from inefficiencies of our body to clean up cellular wastes accumulated during our lifespan. The most important pathway to clean up those wastes is called autophagy, or cellular self-eating behavior. We study how autophagy is regulated, how autophagy causes cancers, and whether we can control autophagy to prevent or cure cancers.

Previously we found autophagy is regulated by a protein called MAP1S and mice without MAP1S are more likely to develop liver cancer. We have been seeking ways to improve MAP1S-mediated autophagy to prevent liver cancer. Our current study show that spermidine, a natural component existing in many foods, can increase the stability of MAP1S proteins and activate MAP1S-mediated autophagy. Concurrent with the benefits of expand mouse lifespans ours also reported, spermidine can suppress the development of liver fibrosis and liver cancer specifically through MAP1S if we add spermidine into the daily drinking water of mice.

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Trunk and Branch Drivers Distinguish Early vs Late Mutations in Hepatocellular Carcinoma

MedicalResearch.com Interview with:
Sara Torrecilla Recio

PhD Student
Mount Sinai Liver Cancer Program – Division of Liver Diseases Icahn School of Medicine at Mount Sinai
New York, NY

MedicalResearch.com: What is the background for this study?

Response: Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, which represents the second-leading cause of cancer related death worldwide. The landscape of molecular alterations in HCC has been thoroughly explored using next-generation sequencing technologies in single biopsies of tumors. However, in the recent years it has been demonstrated that not all the regions of a tumor harbor the same molecular alterations. This intra-tumor heterogeneity may lead to a misinterpretation of the molecular landscape of the malignancy since not all the molecular alterations would be captured by single-biopsies.

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Hepatitis C Can Be Successfully Treated in Homeless Population

MedicalResearch.com Interview with:
Joshua Barocas, MD
Clinical and Research Fellow
Division of Infectious Diseases
Massachusetts General Hospital and Brigham and Women’s Hospital 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Boston Health Care for the Homeless Program began treating HCV-infected individuals with the new oral medications.

Based on clinical experience and previous experience with medication adherence in the setting of HIV, there were no clinical reasons that homeless persons should be excluded.

As a result, we began to track the experience of treated individuals including cure, side effects, and adherence.

We found that in the initial group of treated individuals, 62 of 64 persons achieved SVR. There were minimal side effects and adherence was excellent

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Most Baby Boomers Still Not Receiving Recommended Hepatitis C Testing

MedicalResearch.com Interview with:

Stacey Fedewa, MPH Strategic Director, Screening and Risk Factor Surveillance Surveillance and Health Services Research program American Cancer Society

Dr. Fedewa

Stacey Fedewa, Ph.D.
Strategic Director, Risk Factors & Screening Surveillance
American Cancer Society
Atlanta GA 30303-1002

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: About 3.5 million people in the US are chronically infected with Hepatitis C, the majority are unaware of their infection despite the availability of treatments that may reduce the risk of HCV-related diseases such as liver cancer. About 80% of those with the infection are baby-boomers (people born between 1945-1965). To help reduce growing burden of these HCV-associated diseases, the U.S. Preventive Services Task Force (USPSTF) recommended one-time HCV testing for baby-boomers in 2013.

We examined nationwide data between 2013-2015 to see if HCV testing in baby-boomers has increased since the USPSTF recommendation.  We found that only about 14% of baby-boomers had ever been tested in 2015, which represented a very small increase from 2013 where testing prevalence was about 12%. In 2015, we estimated that there were about 76.2 million baby boomers and only 10.5 reported ever receiving HCV testing.

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Hepatitis C Screening of Baby-Boomers Still Underutilized

MedicalResearch.com Interview with:
Cheryl Isenhour, DVM, MPH

Epidemiologist |Prevention Branch
Division of Viral Hepatitis | NCHHSTP
Centers for Disease Control and Prevention

MedicalResearch.com: What is the background for this study?

Response: It is estimated that there are over 3 million people in the United States living with Hepatitis C virus (HCV) infection. Risk factors for infection include, but are not limited to, injection drug use, history of incarceration, HIV coinfection, and blood transfusion prior to July 1992. Several direct acting antiviral medications have recently been approved to treat, and in the majority of cases, cure HCV.

The first step in identifying infected persons so that they may be cured of this infection is a blood test for antibodies to HCV.
The greatest burden of HCV is among persons born from 1945 through 1965; the baby boomer birth cohort. Therefore, in 2012, the Centers for Disease Control and Prevention (CDC) published updated HCV antibody testing recommendations to include one-time testing of persons in the birth cohort. The United States Preventive Services Task Force (USPSTF) published similar recommendations the following year. Additionally, in recent years there has been an increase in HCV infections related to injection drug use among younger people.

We used commercial insurance claims data to describe trends in HCV antibody testing over a 10-year period (2005 – 2014), both to assess the impact of the CDC and USPSTF testing recommendations, and to better understanding how trends varied by gender, age group, and geography.

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ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries

MedicalResearch.com Interview with:

Paul Y. Kwo, MD, FACG Stanford University School of Medicine

Dr. Paul Y. Kwo

Paul Y. Kwo, MD, FACG
Stanford University School of Medicine

MedicalResearch.com: What is the background for this study?

Response: This guideline, which was jointly authored by Drs. Kwo, Cohen, and Lim provides a framework for physicians to approach the very common problem encountered of a patient whose liver chemistries are abnormal. This is particularly relevant as there remain large pools of individuals who have yet to be diagnosed with chronic hepatitis B and C, non-alcoholic fatty liver disease, advanced liver disease as well as less common conditions, all of whom will require evaluation.

In particular, the rise in the prevalence of non-alcoholic fatty liver disease worldwide will be addressed in part by identifying and evaluating these individuals prior to the development of advanced fibrosis. The guideline takes clinicians through a step-wise approach to the evaluation of elevated aminotransferase (ALT and AST), alkaline phosphatase, and bilirubin levels including appropriate historical questions, important physical examination findings, laboratory , radiological evaluation and finally liver biopsy if required.

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Metformin Associated With Lower Mortality in CKD, CHF and Chronic Liver Disease

MedicalResearch.com Interview with:

Matthew J. Crowley, MD, MHS Assistant Professor of Medicine Member in the Duke Clinical Research Institute Duke University Medical Center

Dr. Matthew Crowley

Matthew J. Crowley, MD, MHS
Assistant Professor of Medicine
Member in the Duke Clinical Research Institute
Duke University Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Although metformin is widely considered to be the first-line drug for type 2 diabetes, concerns about lactic acidosis have traditionally limited its use in some populations. However, FDA now indicates that metformin may be used safely for patients with mild-moderate chronic kidney disease and other historical contraindications like congestive heart failure. With the lactic acidosis question addressed for these groups, this review asked “what do we know about how metformin affects mortality and other outcomes for patients with historical contraindications and precautions?”

The main take-home message is that metformin appears associated with lower mortality in patients with mild-moderate chronic kidney disease, congestive heart failure, and chronic liver disease.

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New Microfluidic Technology Creates Microscale 3D Livers in a Droplet

MedicalResearch.com Interview with:

Prof. David A. Weitz Mallinckrodt Professor of Physics and Applied Physics School of Engineering and Applied Sciences Harvard University

Prof. David A. Weitz

Prof. David A. Weitz
Mallinckrodt Professor of Physics and Applied Physics
School of Engineering and Applied Sciences
Harvard University

MedicalResearch.com: What is the background for this technology study? What are the main findings?

Response: Currently, it is very time-consuming and expensive to develop new drugs. One reason is that many drugs fail in clinical trials after animal studies, simply because animals are very different from humans. One promising means of solving this problem is to replace animal experiments with artificial human tissues that can be used to directly screen a drug. However, it is a challenge to construct artificial human tissues, as almost all human tissues are composed of multiple types of cells and extracellular matrices in 3D structures.

In our studies, we have successfully developed a droplet-based microfluidic technique to fabricate large numbers of monodisperse, portable microtissues. We spatially assemble different types of cells in a 3D core-shell structure and construct an artificial human microtissue in each individual drop. The specific structures we create in the microdoplets are designed to mimic the behavior of the liver, and hence we call these structures a ‘liver in a drop.’  Continue reading

Incidence, Risk factors and Prevention of Hepatitis C Reinfection

MedicalResearch.com Interview with:
Naveed Zafar Janjua, MBBS, MSc, DrPH
Senior Scientist, Clinical Prevention Services
BC Centre for Disease Control
Clinical Associate Professor, School of Population and Public Health
University of British Columbia

MedicalResearch.com: What is the background for this study?

Response: Hepatitis C is a viral infection that affects the liver. About quarter of people infected with hepatitis C clear their infection spontaneously rest develop chronic infection. Left untreated, hepatitis C could results in scarring of liver (liver cirrhosis), liver cancer or death. New anti-viral drugs are highly effective in curing hepatitis C, about than 95 per cent of those treated can be cured. However, people who engage in high risk activities such as people who inject drugs (PWID) remain at risk of reinfection. As the cost of treatment is very high, re-infection is a concern among physicians and policy makers in Canada and around the world.

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Many High Risk Patients Not Screened for Hepatitis B

MedicalResearch.com Interview with:

Robert Wong MD, MS OakCare Medical Group Assistant Clinical Professor UCSF

Dr. Robert Wong

Robert Wong MD, MS
Assistant Clinical Professor of Medicine
Director of Research and Education
Division of Gastroenterology and Hepatology
Alameda Health System – Highland Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Hepatitis B Virus infection is a leading cause of chronic liver disease leading to hepatocellular carcinoma and cirrhosis worldwide. Early detection of chronic HBV through implementation of effective screening programs can improve early treatment to reduce disease progression and risk of hepatocellular carcinoma. Sub-optimal awareness of the importance of HBV screening among patients and providers and sub-optimal awareness of who constitutes as high risk may further contribute to low HBV screening rates. Our current study prospectively evaluated rates of HBV screening and awareness of HBV screening results among patients at high risk for chronic HBV among an ethnically diverse underserved safety-net hospital population.

Among nearly 900 patients that were evaluated, 62% were high risk and eligible for Hepatitis B screening. However, among this high risk population, less than 25% received HBV screening. Furthermore, among patients that have undergone previous HBV testing only 22% of patients were aware of those results.

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Recent Hepatitis E Infection Associated With Guillain-Barre Syndrome

MedicalResearch.com Interview with:

Philip Van Damme, MD, PhD Department of Neurology and Department of Neurosciences, Experimental Neurology KU Leuven University of Leuven VIB, Vesalius Research Center, Leuven, Belgium

Philip Van Damme, MD, PhD
Department of Neurology and Department of Neurosciences, Experimental Neurology
KU Leuven University of Leuven
VIB, Vesalius Research Center,
Leuven, Belgium

MedicalResearch.com: What is the background for this study?

Response: The hepatitis E virus (HEV) has been discovered more that 60 years ago. Its clinical manifestations are usually self-limiting and mild. More recently, several immune-mediated neurological complications of this virus have been described, such as the Guillain-Barre syndrome (GBS) and neuralgic amyotrophy. In this study, we investigated the frequency of a preceding HEV infection in patients presenting with a GBS syndrome or one of its less common disease variants. At the same time, we tested for other known pathogens known to be associated with GBS.

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Fatty Liver At Least Partially Mediated By Epigenetic Influences

MedicalResearch.com Interview with:

Annette Schürmann PhD Department of Experimental Diabetology German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE) Nuthetal Germany German Center for Diabetes Research (DZD München-Neuherberg Germany

Dr. Annette Schürmann

Annette Schürmann PhD
Department of Experimental Diabetology
German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE)
Nuthetal
Germany German Center for Diabetes Research (DZD
München-Neuherberg Germany

MedicalResearch.com: What is the background for this study?

Response: The aim of our study was to clarify why genetically identical mice respond very different to a high fat diet. Some of the mice react with an elevated body weight, others not. We analyzed the expression pattern
of liver at two time points, at the age of 6 weeks, (the earlierst time
point to distiguish between those that respond to the diet (responder
mice) and those that did not (non-responders)), and at the age of 20
weeks. One transcript that was significantly reduced in the liver of
responder mice at both time points was Igfbp2. The reason for the
reduced expression was an elevated DNA-methylation at a position that is
conserved in the mouse and human sequence. The elevated DNA-methylation
of this specifc site in human was recently described to associate with
elevated fat storage (hepatosteatosis) and NASH. However, as 6 weeks old
mice did not show differences in liver fat content between responder and
non-responder mice we conclude that the alteration of Igfbp2 expression
and DNA metyhlation occurs before the development of fatty liver.

Our data furthermore showed that the epigenetic inhibition of Igfbp2
expression was associated with elevated blood glucose and insulin
resistance but not with fatty liver.

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POISE Data Support New Medication Ocaliva For Primary Biliary Cholangitis

MedicalResearch.com Interview with:

Prof. Dr. F. Nevens, MD, PhD Professor of Medicine Hepatology and liver transplantation University Hospitals KU Leuven, Belgium

Prof. Dr. F. Nevens, MD, PhD
Professor of Medicine
Hepatology and liver transplantation
University Hospitals KU Leuven, Belgium

MedicalResearch.com: What is the background for this study?

Response: Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. PBC is primarily a disease of women, affecting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population.

The POISE trial evaluated the safety and efficacy of once-daily treatment with Ocaliva® (obeticholic acid) in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA), the current standard of care. Ocaliva is the first PBC therapy that targets the farnesoid X receptor (FXR), a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.

The trial’s primary endpoint was an alkaline phosphatase (ALP) level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% from baseline, and a total bilirubin level at or below the upper limit of the normal range after 12 months of obeticholic acid therapy. These liver biomarkers have been shown to predict progression to liver failure and resulting liver transplant or premature death in patients with PBC.

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Pioglitazone Is Safe and Effective Option For Patients with Type 2 Diabetes and NASH

MedicalResearch.com Interview with:

Kenneth Cusi, M.D., F.A.C.P., F.A.C.E. Professor of Medicine VAMC staff Chief, Division of Endocrinology, Diabetes and Metabolism The University of Florida Gainesville, FL 32610-0226

Dr. Kenneth Cusi

Kenneth Cusi, M.D., F.A.C.P., F.A.C.E.
Professor of Medicine
VAMC staff
Chief, Division of Endocrinology, Diabetes and Metabolism
The University of Florida
Gainesville, FL 32610-0226

MedicalResearch.com: What is the background for this study?

Dr. Cusi: Many patients with prediabetes or Type 2 Diabetes Mellitus (T2DM) are not diagnosed with Nonalcoholic steatohepatitis (NASH), a disease that is the second cause of liver transplantation in the United States. It is also associated with worse cardiovascular disease and harder to control T2DM. We had done in this population a proof-of-concept study published in Nov 2006 in the NEJM. But we lacked a larger, long-term study for definitive proof. This is the largest SINGLE center study, and the longest ever (3 years).

NASH is an overlooked problem for perhaps as many as one-third of patients with Type 2 Diabetes Mellitus. There is now a safe and effective treatment option for patients with T2DM and NASH – pioglitazone will become for NASH what metformin is to the treatment of T2DM: a safe, effective, the “backbone therapy” to which other treatments will be added.

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Single-Step Testing Can Improve Access To Hepatitis C Testing

MedicalResearch.com Interview with:

J. Morgan Freiman, MD Infectious disease research fellow Boston Medical Center

Dr. Morgan Freiman

J. Morgan Freiman, MD
Infectious disease research fellow
Boston Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Freiman:  There are 130-150 million persons infected with chronic HCV with 75% of all cases occurring in low- and middle- income countries (LMICs). Diagnosis is a 2-step process that starts with screening for exposure with an assay that detects antibodies to HCV (anti-HCV), followed by nucleic acid testing (NAT) for persons with reactive anti-HCV to measure HCV ribonucleic acid (RNA) and confirm active viremia.

In LMICs diagnostic capacity is low, and fewer than 1% of patients are aware of their infection. Additionally, a significant proportion of patients who test positive for anti-HCV are lost to follow-up before nucleic acid testing. The 2-step diagnostic process is thus a major bottleneck to the HCV cascade of care. Testing for hepatitis C virus core antigen (HCVcAg) is a potential replacement for NAT.

Our systematic review evaluated the accuracy of diagnosis of active HCV infection among adults and children for 5 commercially available HCVcAg tests compared with NAT. We found that HCVcAg assays with signal amplification have high sensitivity, high specificity, and have the potential to replace NAT in settings with high HCV prevalence.

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Baby-Boomers May Be Underscreened for Hepatitis C

MedicalResearch.com Interview with:
Dr. Rashmee Patil
Mount Sinai St. Luke’s Roosevelt

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Patil: Baby boomers, people born between 1945 and 1965 have higher likelihood of being infected with HCV, mainly due to blood transfusions prior to discovery of HCV or due to IV drug use. National guidelines recommend screening of this population. Our research looked at hepatitis C virus (HCV) screening for patients born between 1945 and 1965, who were admitted by resident physicians to the internal medicine inpatient service at an urban community hospital between January 2014 to March 2015. We showed that there are resident physician barriers to HCV screening, that may be related to human error, oversight or electronic medical record deficiencies.

We conducted this research as a quality improvement project. We wanted to find out the rate of Hepatitis C screening—and, in addition, we wanted to focus on how many “baby boomers” were not tested and ascertain the reasons why. Our data showed that 75% of patients admitted to an inpatient internal medicine service who were eligible for birth-cohort HCV screening remained unscreened. Of those patients who were screened for HCV, we found a higher seroprevalence (5%) compared to the US general population (1.6 to 1.8%).

MedicalResearch.com: What should readers take away from your report?

Dr. Patil: Lack of HCV screening represents a missed opportunity to link HCV-infected patients with potential cure. Continuing education of and vigilance by healthcare providers to conduct HCV screening in various settings (such as the emergency department, during inpatient admissions, etc.) and ensuring streamlined systematic implementation of hepatitis testing with linkage-to-care processes are paramount.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Dr. Patil: Additional research should be done after an in-service/focused training of the resident physicians and enhancement of the EMR admission/HCV screening process by the IT department. We anticipate conducting this next step of the quality improvement project, which includes conducting resident surveys pre- and post-intervention (i.e. in-service regarding HCV screening).

MedicalResearch.com: Is there anything else you would like to add?

Dr. Patil: People should not conclude that the lack of hepatitis c screening was solely due to resident physician oversight. Rather, the focus must remain on improving resident physician knowledge and electronic medical record (EMR) infrastructure with built-in ordering hard-stops, screening reminders, and referral generation, to ensure that Hepatitis C screening and linkage-to-care are undertaken prior to and upon hospital discharge.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation: Abstract Presented at the May 2016 Digestive Disease Conference
Hepatitis C screening barriers in 2015: Unusual suspects.
Author Block: Rashmee Patil1, Mel A. Ona2, Peter Saikali4, Charilaos Papafragkakis3, Sury Anand2
1 Internal Medicine, Mount Sinai St. Luke’s Roosevelt, New York, New York, United States; 2 Gastroenterology, The Brooklyn Hospital Center, Brooklyn, New York, United States; 3 Gastroenterology, Hepatology, and Nutrition, M.D. Anderson Cancer Center, Houston, Texas, United States; 4 Internal Medicine, Norwalk Hospital, Clinical Affiliate of Yale University, Norwalk, Connecticut, United Statesm

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Caffeine May Slow Progression of Liver Fibrosis in Chronic Hepatitis C

MedicalResearch.com Interview with:

Sikarin Upala MD, MS, LLB Internal Medicine, Bassett Medical Center and Columbia University College of Physicians and Surgeons, Cooperstown, New York Preventive and Social Medicine Mahidol University, Bangkok, Thailand

Dr. Sikarin Upala

Sikarin Upala MD, MS, LLB
Internal Medicine, Bassett Medical Center and Columbia University College of Physicians and Surgeons, Cooperstown, New York
Preventive and Social Medicine
Mahidol University, Bangkok, Thailand

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Dr. Upala: Chronic hepatitis C virus infection is the most common cause of chronic liver disease and cirrhosis as well as the most common cause of liver transplantation in the United States. As caffeine has been found to be related to decreased liver enzymes, chronic liver disease,cirrhosis, and risk of hepatocellular carcinoma in several liver disease pathologies. There is inconclusive findings on the effect of caffeine on hepatitis C infected patients. Thus, we conducted a systematic review and meta-analysis to summarize the effect of caffeine consumption in patients with chronic hepatitis C.

We found that caffeine consumers have a 61% reduced risk of developing advanced hepatic fibrosis, which is one of the consequence of chronic hepatitis C. Our meta-analysis result is in the same way with other studies who found that coffee consumption could prevent the development of hepatic fibrosis in patients with liver disease. However, we cannot conclude about the effect of caffeine on HCV viral load as there is not enough information.

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Blacks Have Reduced Survival After Diagnosis of Liver Cancer

MedicalResearch.com Interview with:
Dr. Patricia Jones MD
Medicine, Division of Hepatology
Sylvester Comprehensive Cancer Center
University of Miami Miller School of Medicine
Miami, Florida, United States

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Dr. Jones: This study reviewed 999 patients diagnosed with hepatocellular carcinoma in a diverse American population over the past ten years. The main findings were that Blacks had reduced survival, only 301 days, when comparison to Whites (534.5 days) and Hispanics (437 days) after being diagnosed with liver cancer. This was adjusted for insurance status, chemotherapy and gender and the findings still persisted. We found that Blacks present at later stages, when the tumor is too large for some of the treatments that we would like to offer, such as liver transplant.

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Epigenetic Factors Linked to Glucose Tolerance and Fatty Liver Development

MedicalResearch.com Interview with:

Prof-Dr. Annette Schürmann Department of Experimental Diabetology German Institute of Human Nutrition Potsdam-Rehbruecke Nuthetal, Germany

Dr. Annette Schürmann

Prof-Dr. Annette Schürmann
Department of Experimental Diabetology
German Institute of Human Nutrition Potsdam-Rehbruecke
Nuthetal, Germany

MedicalResearch.com: What is the background for this study?

Dr. Schürmann: The aim of our study was to clarify why genetically identical mice respond very different to a high fat diet. Some of the mice react with an elevated body weight, others not. We analyzed the expression pattern
of liver at two time points, at the age of 6 weeks, (the earliest time
point to distinguish between those that respond to the diet (responder
mice) and those that did not (non-responders)), and at the age of 20
weeks. One transcript that was significantly reduced in the liver of
responder mice at both time points was Igfbp2. The reason for the
reduced expression was an elevated DNA-methylation at a position that is
conserved in the mouse and human sequence. The elevated DNA-methylation
of this specific site in human was recently described to associate with
elevated fat storage (hepatosteatosis) and NASH. However, as 6 weeks old
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non-responder mice we conclude that the alteration of Igfbp2 expression
and DNA methylation occurs before the development of fatty liver.
Our data furthermore showed that the epigenetic inhibition of Igfbp2
expression was associated with elevated blood glucose and insulin
resistance but not with fatty liver.

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Insurers Can Pay High Cost of Hepatitis C Drugs, But Not Benefit If Patient Switches Plans

MedicalResearch.com Interview with:

Darius Lakdawalla PhD Quintiles Chair in Pharmaceutical Development and Regulatory Innovation School of Pharmacy Professor in the Sol Price School of Public Policy University of Southern California

Dr. Darius Lakdawalla

Darius Lakdawalla PhD
Quintiles Chair in Pharmaceutical Development and Regulatory Innovation
School of Pharmacy
Professor in the Sol Price School of Public Policy
University of Southern California 

MedicalResearch.com: What is the background for this study?
Dr. Lakdawalla: New treatments for hepatitis-C are highly effective but also involve high upfront costs.  Because they effectively cure the disease, all the costs of treatments are paid over a short period of time – about three months – but the benefits accrue for the rest of a patient’s life.  This creates problems for the private health insurance system, where patients switch insurers.  The insurer that pays the bill for the treatment might not be around to enjoy the benefits of averting liver damage, liver transplants, and other costly complications associated with hepatitis-C.
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Hepatitis C Raises Risk of HPV Head and Neck Cancers

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Harrys A. Torres, MD, FACP, FIDSA Associate Professor Director of Hepatitis C Clinic Department of Infectious Diseases, Infection Control and Employee Health The University of Texas MD Anderson Cancer Center Houston TX 77030

Dr. Harrys Torres

Harrys A. Torres, MD, FACP, FIDSA
Associate Professor
Director of Hepatitis C Clinic
Department of Infectious Diseases, Infection Control and Employee Health
The University of Texas MD Anderson Cancer Center
Houston TX 77030

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Dr. Torres: Hepatitis C virus (HCV) is an oncogenic virus and is associated with an increased risk of liver cancer and certain types of non-Hodgkin lymphomas. In 2009, at MD Anderson Cancer Center, we set up the first clinic in the United States, and probably in the world, specifically devoted to managing HCV infection in cancer patients. In the clinic, we expected to see a number of patients with liver cancers and non-Hodgkin’s lymphoma, as these have documented associations with HCV. Unexpectedly, we saw a high number of HCV-infected patients with head and neck cancers, and wondered whether there was an undiscovered association between having the infection and head and neck cancers. To explore this, we conducted a case-control study using 409 head and neck cancer subjects (164 oropharyngeal, 245 non-oropharyngeal [oral cavity, nasopharynx, larynx] cancers) and 694 control subjects with other smoking-associated cancers (378 lung, 168 esophagus, and 148 urinary bladder cancers), and compared the prevalence of HCV infection in the two groups. We observed a high prevalence of HCV infection in oropharyngeal (14%) and non-oropharyngeal (20%) cancer patients when compared to control subjects (6.5%). After adjusting for confounders such as smoking, alcohol intake, and socioeconomic status, HCV-infected individuals were 2.04 times more likely to have oropharyngeal cancers and 2.85 times more likely to have non-oropharyngeal cancers. Of note, HCV was associated only with patients with oropharyngeal cancers that tested positive for human papilloma virus, which is one of the main virus linked with increased risk of oropharyngeal cancers.

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4-Dose Hepatitis B Vaccine Schedule For HIV Patients Induces Longer Protection

MedicalResearch.com Interview with:

Odile Launay MD, PhD Paris Descartes University Assistance Publique Hôpitaux de Paris, Cochin Hospital

Dr. Odile Launay

Odile Launay MD, PhD
Paris Descartes University
Assistance Publique Hôpitaux de Paris, Cochin Hospital 

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Dr. Launay: In patients with HIV infection, responses to standard HBV vaccination regimens remain suboptimal compared with responses in HIV seonegative individuals. We previously reported that alternative regimens (a 4 injection IMdouble dose regimen and a 4 injection intradermal low dose regimen) improve antibody response compared with the standard HBV vaccination regimen (ANRS HB03 VIHVAC-B study). Further precision on the duration of response achieved with alternative HBV vaccination regimes was needed.

We report in this paper the results from the follow-up of the study.

The results of this study show that the 4 dose IM regimen induces higher seroconversion rate but also higher long term seroprotection in HIV infected patients

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All Baby Boomers Should Be Screened At Least Once For Hepatitis C

Dr Waridibo Allison MD PhD Department of Medicine, Division of Infectious Diseases and Immunology New York Langone University School of Medicine New York, NY 10016MedicalResearch.com Interview with:
Dr Waridibo Allison MD PhD
Department of Medicine, Division of Infectious Diseases and Immunology
New York Langone University School of Medicine
New York, NY 10016

Medical Research: What is the background for this study? What are the main findings?

Dr. Allison: It was found that among 383 baby boomers presenting to a large urban emergency department in New York City the prevalence of HCV antibody reactivity was 7.3%. Only four patients were successfully linked to care and only one patient was started on HCV treatment. The study highlights the possibility that there may be problems in linking patients to care from the ED compared to other clinical settings such as primary care and inpatient settings. It was concluded that only with strategies to improve linkage to care could a screening program for baby boomers be recommended in the ED where the study was carried out.

The study additionally had a qualitative component and, via structured interviews, evaluated knowledge about HCV infection amongst baby boomers presenting to the ED. Overall knowledge was good but some misconceptions about transmission persisted and many patients mistakenly believed that there is a vaccine for hepatitis C.

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Scientists Grow Liver Cells In Lab, Paving Way For Artificial Liver

Prof. Yaakov Nahmias Director of the Alexander Grass Center for Bioengineering Hebrew University of Jerusalem

Dr. Nahmias

MedicalResearch.com Interview with:
Prof. Yaakov Nahmias PhD
Director of the Alexander Grass Center for Bioengineering
Hebrew University of Jerusalem

Medical Research: What is the background for this study?

Prof. Nahmias: The liver has a limitless capacity of the human liver to regenerate from even a massive loss of mass.

However, the intrinsic capacity of liver cells to proliferate is lost when cells are removed from the body.

Medical Research: What are the main findings?

Prof. Nahmias: We found that a weak expression of Human Papilloma Virus (HPV) proteins released hepatocytes from cell-cycle arrest and permitted the cells to multiply in response to Oncostatin M (OSM) an immune cytokine recently found to be involved in liver regeneration.

While previous efforts caused hepatocytes to multiply without control, converting hepatocytes  into tumor cells with little metabolic ability, we selected colonies that only multiply in response to OSM.

Activation with OSM triggered cell growth with a doubling time of 40 hours. Removal of OSM caused  growth to stop, allowing the cells to regain a high level of metabolic activity within 4 days.

We produced hepatocytes from ethnically diverse individuals. Importantly, the growing hepatocytes  showed a similar toxicology response to normal human hepatocytes across 23 different drugs.

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Screening and Treating Hepatitis C In Prisons Cost Effective For Wider Community

Dr. Tianhua He MD Beijing China, 100005

Dr. Tianhua He

MedicalResearch.com Interview with:
Dr. Tianhua He MD
Beijing China, 100005

Medical Research: What is the background for this study? What are the main findings?

Response: The prevalence of Hepatitis C (HCV) infection is high (17%) in US prisons. And about 30% of all HCV-infected persons in US spend part of the year in correctional facilities.

However, most state prisons offer no routine screening for Hepatitis C. Undiagnosed and untreated inmates, after releasing, will contribute to the spread of the disease in society. HCV infection is now the leading cause of liver cancer, and the most common indication for liver transplant. With the recently launched highlyy effective antiviral drugs, previous studies have shown that treating infected prisoners was cost-effective. However, no studies yet have evaluated the effect of interventions including screening and treatment among prisoners on prevention of Hepatitis C transmission and reduction of disease burden, neither the cost effectiveness of such interventions.

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New Test Suggests Hepatitis E May Be Widely Underestimated

Brittany Kmush, ScM Doctoral Candidate Global Disease Epidemiology and Control Department of International Health Johns Hopkins Bloomberg School of Public Health Baltimore, MDMedicalResearch.com Interview with:
Brittany Kmush, ScM
Doctoral Candidate
Global Disease Epidemiology and Control
Department of International Health
Johns Hopkins Bloomberg School of Public Health
Baltimore, MD 

Medical Research: What is the background for this study? What are the main findings?

Response: Hepatitis E virus (HEV) is a global pathogen responsible for approximately 20 million infections every year in developing countries. In the general population, HEV causes acute, self-limiting hepatitis with only a 1-2% case fatality rate. However, in pregnant women, Hepatitis E virus infection can be very severe, resulting in fulminant hepatic failure and death, with a case fatality rate around 30%. Despite this important burden, Hepatitis E virus remains an under-recognized and under-reported pathogen. The early years of HEV research were plagued by poor quality commercial assays, highly variable in sensitivity and specificity. As a result, there is still no diagnostic assay approved for commercial use in the United States. However, over the past two decades, several new, highly sensitive and specific assays have been developed.

In this study, we re-tested banked sera from a population-based sero-survey of over 1000 participants from rural Bangladesh in order to investigate the comparability of a high-performing first generation test to recently developed, commercially available assay. In the early 2000s, the Walter Reed Army Institute of Research (WRAIR, Bethesda, MD) developed an in-house enzyme immune-assay (EIA) to diagnose Hepatitis E virus infections by detecting anti-HEV total immunoglobulin (Ig) in serum. More recently, Wantai Diagnostics (Beijing, China) developed a commercially available EIA for detecting anti-HEV IgG.

The WRAIR assay estimated the overall population seroprevalence as 26.6% while the Wantai assay produced significantly higher estimated seroprevalence, 46.7%. There was a 77% agreement between the two tests.  Overall, the Wantai assay found a much higher seroprevalence of anti-HEV antibodies compared to the WRAIR assay, using the same serum. Additionally, the majority of the differences between the two tests are from people initially classified by WRAIR as anti-HEV negative that Wantai classified as anti-HEV positive.

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New HCV Treatment Improves Hepatitis C Cirrhosis

Dr. Michael P. Curry, MD Medical Director for Liver Transplantation Harvard Medical Faculty Physicians Beth Israel Deaconess Medical Center

Dr. Curry

MedicalResearch.com Interview with:
Dr. Michael P. Curry, MD
Medical Director for Liver Transplantation
Harvard Medical Faculty Physicians
Beth Israel Deaconess Medical Center

Medical Research: What is the background for this study? What are the main findings

Dr. Curry: As the population that is infected with the hepatitis C virus (HCV) ages, the number of patients with decompensated cirrhosis is expected to increase. For many years, the only treatment option for these patients was liver transplantation. Recently, however, clinical trials of newly approved direct-acting antiviral agents (DAAs) have shown that it is possible to treat HCV infection safely and effectively in patients with decompensated cirrhosis. We conducted this Phase 3, open-label trial to assess the efficacy and safety of a fixed dose combination of sofosbuvir/velpatasvir with or without ribavirin for 12 weeks or sofosbuvir/velpatasvir for 24 weeks in patients infected with hepatitis C virus genotypes 1 through 6 and with decompensated cirrhosis. We found that treatment with sofosbuvir/velpatasvir resulted in high rates of sustained virologic response (SVR) and early improvements in hepatic function in this patient population. SVR rates were 83 percent  in patients who received sofosbuvir/velpatasvir for 12 weeks, 94 percent among those who received sofosbuvir/velpatasvir plus ribavirin, and 86 percent among those who received sofosbuvir/velpatasvir for 24 weeks.

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Obese and Normal Weight Patients Do Equally Well After Liver Transplantation

Barry Schlansky, M.D., M.P.H Assistant Professor of Medicine Oregon Health & Science University

Dr. Schlansky

MedicalResearch.com Interview with:
Barry Schlansky, M.D., M.P.H
Assistant Professor of Medicine
Oregon Health & Science University

Medical Research: What are the main findings and significance of this study?

Dr. Schlansky: This study examines how obese patients fare before and after liver transplantation. Similar to other researchers, we found that obese patients do just as well as normal weight patients after liver transplantation. We were surprised, however, to find that very obese patients died more often while on the wait list before liver transplant.

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Extent of Liver Damage May Be Underestimated In Hepatitis C Patients

Stuart Gordon, M.D. Director of Hepatology at Henry Ford HospitalMedicalResearch.com Interview with:
Stuart Gordon, M.D.

Director of Hepatology at Henry Ford Hospital
Detroit, Michigan

Medical Research: What is the background for this study? What are the main findings?

Dr. Gordon: The U.S. Centers for Disease Control and Prevention’s Division of Viral Hepatitis estimates 2.7 to 3.9 million people in the United States currently suffer from chronic hepatitis C. But, unfortunately, many of these patients may be unaware of the severity of their liver damage. We looked at evidence of cirrhosis among hepatitis C patients by examining four different parameters: ICD9 codes; liver biopsy reports; evidence of liver failure; and the FIB-4 test, an easily calculated biomarker. By using all four indicators of cirrhosis, we found a far higher prevalence of cirrhosis than would be indicated by any one method.

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Liver Inflammation During Pregnancy Linked To Later Life Cancer, Cardiac and Autoimmune Disease

Prof. Hanns-Ulrich Marschall Professor of clinical hepatology Wallenberg Laboratory Sahlgrenska Academy Göteborg, Sweden

MedicalResearch.com Interview with:

Prof. Hanns-Ulrich Marschall
Professor of clinical hepatology
Wallenberg Laboratory
Sahlgrenska Academy
Göteborg, Sweden

Medical Research: What is the background for this study?

Dr. Marschall: Intrahepatic cholestasis of pregnancy, or ICP, is the most common liver disease during pregnancy, affecting 1.5% of all pregnancies in Sweden. ICP is characterized by otherwise unexplained pruritus with elevated bile acids and/or transaminases in the late second and third trimester of pregnancy. It is well established that ICP is associated with risks for the unborn child, in particular preterm delivery, but also stillbirth.

In contrast, for the mother, ICP has for a long time only been considered as an annoying but not serious condition that spontaneously resolves after delivery.

However, ICP obviously is not such a benign condition for the mother: We have recently shown that women with ICP have a 3- to 5-times increased risk of hepatobiliary diseases, such as hepatitis C, cirrhosis and gallstones. Here we extended our study to investigate the association between ICP and later cancer, diabetes mellitus and other autoimmune-mediated diseases, and cardiovascular diseases.  

Medical Research: What are the main findings?

Dr. Marschall: Our study showed that women with ICP were at about 25% increased risk to be later diagnosed with immune-mediated diseases, in particular diabetes mellitus and Crohn’s disease but not ulcerative colitis. There was also a small increased risk of later cardiovascular disease, in particular if the woman with ICP also suffered from preeclampsia.

Most important were the data on the risk of later malignancy: We found a 2.5-times higher risk for cancer in the biliary tree and even a 3.5-times increased risk of liver cancer. Even after adjusting for a diagnosis of hepatitis C, which is very strongly associated with liver cancer, more than 30-times, women with ICP were still at 2.5-times increased risk of later liver malignancy.

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HCV Viral Load Testing Not Useful As Measure of New Hepatitis C Drug Effectiveness

Shyamasundaran Kottilil MBBS, PhD University of MarylandMedicalResearch.com Interview with:
Shyamasundaran Kottilil MBBS, PhD
Division of Infectious Diseases, Institute of Human Virology
University of Maryland, Baltimore
Laboratory of Immunoregulation
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Bethesda, Maryland

Medical Research: What is the background for this study? What are the main findings?

Dr. Kottilil: During treatment with interferon-based therapies, hepatitis C viral load levels were clinically useful as on-therapy markers of treatment outcome. However, the standard-of-care for HCV treatment has recently evolved from interferon-based regimens to short-duration, all-oral, direct-acting antiviral (DAA) therapies. Therefore, it is important that we re-evaluate the utility of HCV viral loads during DAA regimens in guiding clinical decision-making.

We found that Hepatitis C viral loads on treatment and at end of treatment were not predictive of treatment success versus relapse with DAA therapy. Contrary to our experience with interferon-containing regimens, low levels of quantifiable HCV RNA at end of treatment did not preclude treatment success.

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Combination Medication Effective For Hepatitis C Recurrence After Liver Transplantation

MedicalResearch.com Interview with:
Dr. Audrey Coilly MD
Fellow at the Centre Hepato-Biliaire
Paul Brousse Hospital
Villejuif, France

Medical Research: What is the background for this study? What are the main findings?

Dr.
Coilly: Hepatitis C (HCV) recurrence used to be a major issue during two decades for patients transplanted with an active HCV infection at the time of transplantation impacting both patient and graft survival. The combination of sofosbuvir and daclatasvir has not been studied after liver transplantation. The main findings are a high efficacy profile with an overall SVR12 rate of 95%. The safety profile is also good​. The most frequent adverse event is anemia, particularly when ribavirin is still used.

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Cancer Risk Elevated In Patients With Hepatitis C

Lisa M. Nyberg, MD, MPH Transplant Hepatologist Director, Hepatology Research Kaiser Permanente, Garfield Specialty Center San Diego, CA  92111MedicalResearch.com Interview with:
Lisa M. Nyberg, MD, MPH
Transplant Hepatologist
Director, Hepatology Research
Kaiser Permanente, Garfield Specialty Center
San Diego, CA  92111

Medical Research: What is the background for this study? What are the main findings?

Dr. Nyberg: The overall cancer rates were higher in patients with Hepatitis C (HCV) vs those without HCV. Of note, though, the HCV cohort had higher rates of alcohol abuse, tobacco use, cirrhosis and diabetes mellitus (DM). However, even after stratification for the variables alcohol abuse, tobacco use, body mass index (BMI) and DM; the increased cancer rates remained significant for total cancer sites, liver cancer and NHL.

Note that this study does not establish a cause and effect relationship between Hepatitis C and cancer. A strength of this study is that it is an evaluation of a large patient population (n=35,712 with HCV and 5,297,191 without HCV). Limitations of the study are those inherent in epidemiological studies using large databases. For example, confounders may not be accurately recorded in automated databases (smoking and alcohol abuse may be under-recorded).

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Single Pill Combination Therapy For Some Hepatitis C Subtypes

Stefan Zeuzem, MDProfessor of Medicine Chief Department of Medicine Goethe University Hospital FrankfurtMedicalResearch.com Interview with:
Stefan Zeuzem, MD
Professor of Medicine
Chief Department of Medicine
Goethe University Hospital
Frankfurt

Medical Research: What is the background for this study? What are the main findings?

Dr. Zeuzem: Interferon- and ribavirin-free regimens are needed to treat HCV infection. The objective of the study was to evaluate the safety and efficacy of grazoprevir (NS3/4A-protease-inhibitor) and elbasvir (NS5A-inhibitor) in previously untreated patients with chronic hepatitis C (without and with liver cirrhosis). Among 421 participants, 194 (46%) were women, 157 (37%) were non-white, 382 (91%) had genotype-1 infection, and 92 (22%) had cirrhosis. Of 316 patients receiving immediate treatment, 299/316 achieved SVR12 (undetectable HCV 12 weeks after treatment), including 144/157  with genotype-1a, 129/131  with genotype-1b, 18/18  with genotype-4, 8/10 with genotype-6, 68/70 with cirrhosis, and 231/246 without cirrhosis. Virologic failure occurred in 13 patients including 1 breakthrough and 12 relapses, and was associated with baseline NS5A-polymorphisms and emergent NS3- and/or NS5A-variants. Serious adverse events occurred in 9 (2.8%) and 3 (2.9%) patients in the active and placebo arms, respectively; none were considered drug-related.
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Opioid Tampering By Health Care Providers Can Lead To Hepatitis C Transmission

MedicalResearch.com Interview with:
ChongGee Teo, MD, PhD
Chief, Laboratory Branch
Division of Viral Hepatitis
CDC

Medical Research: What is the background for this study?

Dr. Teo: Hepatitis C outbreaks in the course of providing healthcare continue to occur. Some happen when hepatitis C virus (HCV) is transmitted to patients following breakdowns in safe injection and infection control practices, and mishaps during surgery. Another route of provider – to patient HCV transmission is diversion, self-injection and substitution of opioids intended for anesthetic use (collectively referred to as “tampering”). A patient acquires infection when an HCV-infected provider, who is an injecting drug user, self-injects from a syringe prefilled with opioid anesthetic, fills the syringe with a volume substitute (e.g., saline or water), and then administers the adulterated preparation to the patient.

The study consisted of two parts:
1) to quantify the extent that anesthetic opioid tampering contributes to hepatitis C outbreaks by analyzing healthcare-associated outbreaks occurring between 1990 and 2012 in developed countries.

2) to estimate the probabilities of provider-to-patient transmission reflecting the “real-world” setting in which a patient presents for health care, unaware of risks posed by procedures conducted by a provider who may or may not be an injecting drug user or HCV infected.

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Antihistamine May Be Useful In Fight Against Hepatitis C

MedicalResearch.com Interview with: Dr. Jake Liang MD Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MDMedicalResearch.com Interview with:
Dr. Jake Liang MD
Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD

Medical Research: What is the background for this study? What are the main findings?

Dr. Liang: Currently existing drugs against HCV, like Sovaldi, are expensive, have some side effects and are associated with drug resistance. They are not reaching the populations that are most in need of treatment. We discovered that certain over-the-counter medications used to treat allergies can block HCV infection in the laboratory and animal model. We still need to test their benefit in treating people with HCV. The drug blocks the step of HCV getting into the cells and is different from the current HCV drugs, which block the step of viral replication.

Medical Research: What should clinicians and patients take away from your report?

Dr. Liang: We don’t know whether this drug works in people with hepatitis C. It still needs to be tested in human trial.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Liang: Since CCZ has been used widely and have a good safety profile in people, it is reasonable to consider a trial in people. However we would have to use the currently accepted dosing for any clinical trial, because chlorcyclizine at high dose may have significant side effect, such as drowsiness. It is possible that chlorcyclizine in current dosing may not be active against HCV in people. To further optimize this drug for testing in people, we may have to modify the drug to make it more active, minimize its antihistamine effect, and improve its pharmacological properties. This effort will require additional pharmacological research and development.

Citation

Repurposing of the antihistamine chlorcyclizine and related compounds for treatment of hepatitis C virus infection
Shanshan He1, et al

Sci Transl Med 8 April 2015:
Vol. 7, Issue 282, p. 282ra49
Sci. Transl. Med. DOI: 10.1126/scitranslmed.3010286

MedicalResearch.com Interview with: Dr. Jake Liang MD (2015). Antihistamine May Be Useful In Fight Against Hepatitis C 

Costs To Treat Inmates With Hepatitis C Potentially Staggering

Brian Montague, DO MS MPH Assistant Professor of Medicine and of Health Services, Policy and Practice Division of Infectious Diseases Brown University / The Miriam HospitalMedicalResearch.com Interview with:
Brian Montague, DO MS MPH
Assistant Professor of Medicine and of Health Services, Policy and Practice
Division of Infectious Diseases
Brown University / The Miriam Hospital

Medical Research: What is the background for this study?

Dr. Montague: Hepatitis C is in an important public health problem affecting 4-5 million persons in the US alone.  Given the risk of infection associated with drug use, the prevalence of hepatitis C in corrections has been significantly higher than in the general population.

Prior to 2013, the available treatment options were both expensive and of significant toxicity and limited efficacy.  Uptake to these therapies were low.  Starting in 2013, new therapeutics options offering shorter course treatments and efficacies greater than 90% became available.  These therapies offer new possibilities to increase uptake to treatment, however the cost of the therapies has made rapid scale up of treatment impossible.  Given the risk of serious harms to patients with advanced liver disease if not treated, insurance has begun to approve these new therapies for patients with more advanced disease.

Departments of corrections are obliged to provide the same standard of care to persons in corrections as they would receive in the community.  Unlike Medicaid and community insurance providers, correctional systems worker under a fixed budget. Large increases in expenditures for treatment of hepatitis C without establishing mechanisms to offset these costs risks compromising other essential programs and functions in the correctional health system.

Medical Research: What are the main findings?

Dr. Montague: In a cross-sectional analysis we estimated the burden of hepatitis C within the department of corrections.  At the time of the study, an estimated 836 persons have chronic hepatitis C.  Among these an estimated 119 have advanced liver disease, stage 3 or 4 fibrosis, and would meet criteria for treatment under most insurance programs.  Even a conservative approach of restricting treatment in corrections to those with stage 3 or 4 fibrosis would incur costs of over $15 million, which is greater than 6 times the current correctional health budget for pharmaceuticals and 76% of the overall correctional health budget.

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New Oral Hepatitis C Virus Treatment Works But Will Cost Billions

Jagpreet Chhatwal Ph.D. Assistant Professor, Department of Health Services Research Division of Cancer Prevention and Population Sciences The University of Texas MD Anderson Center Houston, TXMedicalResearch.com Interview with:
Jagpreet Chhatwal Ph.D
.
Assistant Professor, Department of Health Services Research
Division of Cancer Prevention and Population Sciences
The University of Texas MD Anderson Center
Houston, TX

Medical Research: What is the background for this study? What are the main findings?

Dr. Chhatwal: More than two million people in the U.S. are infected with Hepatitis C (HCV), a virus found in the liver. In 2012, the Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force both recommended a one-time hepatitis C screening for baby boomers – people born between the years 1946 and 1964. Last year, the Food and Drug Administration approved the medications sofosbuvir and ledipasvir for Hepatitis C treatment. The newly approved oral regimen comes at a staggering price to payers – as much as $1,125 per day. As a result, several payers have questioned if the price is justified.

The study results show that using new therapies is cost-effective in the majority of patients. However, the budget required to treat all eligible patients would be $136 billion over the next five years. Compared with the old drugs, new therapies would cost an additional $65 billion, whereas the cost offsets would be only $16 billion.

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Phytochemical May Prevent Liver Damage In Post Menopause Women

Colette Nicole Miller FDN Department of Foods and Nutrition Edgar L. Rhodes Center for Animal and Dairy Science University of Georgia, Athens, GeorgiaMedicalResearch.com Interview with:
Colette Nicole Miller FDN
Department of Foods and Nutrition
Edgar L. Rhodes Center for Animal and Dairy Science
University of Georgia, Athens, Georgia

Medical Research: What is the background for this study?

Response: Our laboratory has been interested for quite some time in the relationship that natural, plant-derived compounds have on various tissues in the body. Both bone and adipocytes are derived from the same progenitor cell, mesenchymal stem cells. Thus, if a drug or compound affects one type of cell, it may affect both. When women transition through menopause, and see a reduction in their female sex hormones like estrogen, they can see adverse changes in both how much fat they store and their bone density. Thus our lab is interested in compounds that can be used to prevent the bone loss and visceral adipogenesis that menopausal women often experience. Previous work both in vivo and in vitro has shown that phytochemicals have synergistic effects and thus can ultimately work together to reduce the dosages needed to promote overall health. Through this work we have identified a combination of genistein, resveratrol, quercetin and Vitamin D that improve bone density in addition to promoting apoptosis of adipocytes. However, the health of the liver had never been addressed with our phytochemical blend. We know that supplements are sometimes toxic to the liver for many different reasons. Thus, it was very important for us to address the toxicity and potential risk of non-alcoholic fatty liver disease with our phytochemical blend in a menopausal rat model.

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