Dr. Branch[/caption]
Andrea D. Branch PhD
Professor of Medicine
Division of Liver Diseases
Associate Professor of Surgery
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: Liver cancer is a deadly condition with a high mortality rate. About 90% of people who develop liver cancer have cirrhosis (advanced liver scarring) due to a chronic underlying liver disease. Patients with cirrhosis are advised to undergo liver cancer surveillance. Early detection improves survival, but diagnosis requires more than a blood test, which makes surveillance complex and expensive. Black individuals are more likely to develop liver cancer than white individuals and are more likely to die from it. Black patients also have more advanced liver cancer at the time of diagnosis than Whites. We aimed to identify additional factors that distinguish liver cancer in African Americans, focusing on patients with hepatitis C virus infection, the most common chronic liver disease in people who die from liver cancer in the United States.
Dr. Caughey[/caption]
Aaron B. Caughey, M.D.,M.P.P., M.P.H.
Professor and Chair of the Department of Obstetrics and Gynecology
Associate Dean for Women’s Health Research and Policy
Oregon Health & Science University
Portland, OR
Founder and Chair
Centers for Disease Control and Prevention–funded Oregon Perinatal Collaborative
USPSTF Task Force Member
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Hepatitis B virus infection is a serious condition that affects about 860,000 people in the United States. Screening for hepatitis B can detect the infection early, so that you can receive treatment that will reduce the potential for serious complications, including cancer, liver failure, and even death. Hepatitis B often has no signs or symptoms, so clinicians should screen teens and adults who are at increased risk for hepatitis B to help protect their health.
Donna R. Cryer, JD[/caption]
Donna R. Cryer, JD
President & CEO of the Global Liver Institute
MedicalResearch.com: What is the background for this announcement? What is the mission of the GLI?
Response: Global Liver Institute 's (GLI) mission is to improve the impact of the liver community by promoting innovation, collaboration, and scaling optimal approaches to eradicating liver diseases. Our vision is for liver health to take its proper place on the global public health agenda consistent with its prevalence and impact. One of the ways we seek to fulfill that mission is through a #OctoberIs4Livers worldwide awareness campaign for the fight against liver cancer, reinforcing October as liver disease and liver cancer awareness month. Not only are we seeing a continuous rise of prevalence of liver cancers, but survival rates for liver cancers are also some of the lowest of any cancer.
Even more concerning is that the startling truth about the rise of liver cancer rates began before the COVID-19 pandemic. With the added burden of COVID-19, patients directly at risk from the virus may be diagnosed at a later stage due to delayed screening, and are getting sicker due to limitations on access to care during this pandemic. GLI is appealing to the US Congress to act now to secure the health and well-being of people living with liver disease and liver cancers during COVID-19. Funding is crucial to ensure federal agencies can restart and continue medical research, implement targeted prevention, and support awareness efforts for those impacted by liver disease as they are at increased risk for severe illness from COVID-19. [1]
Dr. Barry[/caption]
Dr. Michael Barry MD
Director of the Informed Medical Decisions Program
Health Decision Sciences Center at Massachusetts General Hospital
Physician at Massachusetts General Hospital
Professor of Medicine,Harvard Medical School
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Hepatitis C affects more people today than ever before, many of whom are younger. If left untreated, it can cause serious, lifelong health problems due to liver damage. The good news is that hepatitis C infection is both preventable and treatable, with recent evidence showing that new treatments for adults are highly effective. Knowing this, we’ve broadened our guidelines to recommend screening for hepatitis C in all adults between the ages of 18 and 79.
Dr. Turner[/caption]
Barbara J Turner MD, MSED, MA, MACP
Senior Advisor, Gehr Family Center for Health Systems Science
Professor of Clinical Medicine
Keck School of Medicine, USC
MedicalResearch.com: What is the background for this study?
Response: Chronic hepatitis C (HCV) infection affects millions of persons in the United States but especially minorities and persons from low income communities. Current national guidelines recommend testing all baby boomers (born 1945 – 65) for HCV with the aim of ultimately curing those with chronic HCV infection with a short course of highly effective medication. However implementation of these guidelines faces many hurdles in “safety net” practices serving vulnerable populations.
Dr. Eckman[/caption]
Mark H. Eckman, MD
Posey Professor of Clinical Medicine
Director, Division of General Internal Medicine
Director, Center for Clinical Effectiveness
University of Cincinnati Medical Center
Cincinnati, OH
MedicalResearch.com: What is the background for this study?
Response: People who are infected with hepatitis C virus and have kidney failure need a kidney transplant.
Recent studies have found that it is possible to transplant kidneys from donors who are infected with hepatitis C virus into patients who need a transplant and are already infected with the virus. In addition, drugs are available to cure most patients of hepatitis C virus, including those who have kidney failure. Infected patients who need a kidney transplant have 2 options. One option is to receive an infected kidney and then use drugs after the transplant to cure themselves and the transplanted kidney of the virus. Another option is to use the drugs first to get rid of the virus and then to receive a kidney from a donor who does not have hepatitis C virus infection.
For the more than 500,000 patients receiving dialysis for end-stage renal disease (ESRD), less than 4% receive kidney transplants. Because of the limited organ availability, hemodialysis is the final treatment for most patients with ESRD. Of the 10% or so of U.S. patients receiving dialysis who are infected with the hepatitis C virus (HCV), some are willing to accept HCV-infected kidneys, in part, because the wait times for such kidneys are shorter than those for HCV-uninfected kidneys. Because the yearly mortality rate for patients receiving hemodialysis is so high, between 4% and 16%, reducing the time to kidney transplant can have a dramatic effect on both survival and quality of life.
Because it may not be possible to do this type of research with actual people, we created a model that allowed us to estimate possible outcomes without using actual people.
The model was a computer program that combined the best available information to approximate what might happen to participants in a real-world clinical trial.
Hepatitis Virions
Primary hepatocytes grown in 3D microfluidic “liver-on-a-chip” platform following infection with hepatitis B virus. Credit: Marcus Dorner/Imperial College London[/caption]
Marcus Dorner, PhD
Non-Clinical Senior Lecturer in Immunology
Wellcome Trust Investigator
Imperial College London
Department of Medicine, Section of Virology
School of Medicine
London United Kingdom
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Hepatitis B virus (HBV) infection globally affects over 250 million people and is currently not curable. This infection can lead to liver cirrhosis and liver cancer and is among the leading causes for liver transplantation. Unfortunately, HBV is among the most difficult viruses to study in the laboratory, since model systems are not very good at recapitulating what happens in infected humans.
We have just described the first model to effectively change this. Using an artificial “Liver-on-a-Chip”, we have developed a tool, which can potentially revolutionise how we study viral infections by merging the study of viruses with tissue engineering. This model is over 10,000-fold more susceptible to HBV infection and accurately mimics, what happens in an infected patient. This can now be utilised to develop novel and potentially curative therapies, which would benefit millions of people currently living with chronic HBV infection.
In the United States, hepatitis A, hepatitis B and hepatitis C are the most common types, but also included are hepatitis D and E.
Dr. Grebely[/caption]
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.
Dr. Paul Y. Kwo[/caption]
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.
Dr. Robert Wong[/caption]
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.
Dr. Darius Lakdawalla[/caption]
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.
Dr. Odile Launay[/caption]
Odile Launay MD, PhD
Paris Descartes University
Assistance Publique Hôpitaux de Paris, Cochin Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
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
MedicalResearch.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.
MedicalResearch.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.
MedicalResearch.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.
MedicalResearch.com Interview with:
Dr Daniel Bradshaw
Chelsea and Westminster Hospital, London
Medical Research: What are the main findings of the study?
Dr. Bradshaw: Over 40% of men with hepatitis C (HCV) infection have HCV RNA in their semen, although the level of RNA was much lower than blood (usually 4 log less than blood).
Neither HIV nor acute hepatitis C led to increased shedding of HCV RNA in semen. Interestingly, however, in acute HCV, HIV-positive men with higher blood levels of HCV RNA were more likely to shed RNA in their semen.
MedicalResearch.com Interview with
Dr. Stuart Gordon MD
Gastroenterologist
Henry Ford Hospital
Detroit, MI 48202.
MedicalResearch: What are the main findings of the study?
Dr. Gordon: In a large American cohort of Hepatitis B patients, those who took antiviral therapy had a significantly lower risk of developing liver cancer than those who did not take such therapy.
MedicalResearch.com Interview with:
Ai Kubo, MPH PhD
Kaiser Permanente Division of Research
2000 Broadway
Oakland, CA 94612
MedicalResearch: What are the main findings of the study?
Dr. Kubo: The main findings of the study are three folds:
1) The CDC guideline works for the majority of infants in preventing vertical transmission, if the immunizations are done according to the recommended schedule.
2) It takes an organized effort to case-manage each mother-infant pairs in order to achieve almost complete immunization rates and very low transmission rates.
3) Highest risk group was mothers with extremely high viral load and e-antigen positivity. This group of women may benefit from additional therapy to prevent the vertical transmission. However, for others, the risk of transmission is extremely low as long as the infants are immunized according to the guideline.
MedicalResearch.com Interview with:
Zobair Younossi, MD, MPH
Chairman, Department of Medicine, Inova Fairfax Hospital
Vice President for Research, Inova Health System
Falls Church, Virginia, USA
MedicalResearch: What are the main findings of the study?
Dr. Younossi: We conducted the analysis of the patient reported outcomes (PROs) data that were systematically collected during clinical trials of sofosbuvir-containing regimens. The highlights of our findings are as follows:
MedicalResearch.com Interview with:
Stefan Zeuzem, M.D.
Professor of Medicine, Chief Department of Medicine
JW Goethe University Hospital
Frankfurt Germany
MedicalResearch.com: What are the main findings of the study?
Dr. Zeuzem: Main finding is that also patients infected with HCV 3 can be cured with an IFN-free regimen. However, duration of therapy must be prolonged to 24 weeks.