Double-Edge Sword of Drug Epidemic

MedicalResearch.com Interview with:
Christine Marie Durand, M.D
.
Assistant Professor of Medicine
Johns Hopkins Medicine 

MedicalResearch.com: What is the background for this study

Response: Most Americans know that the United States faces an epidemic of deaths due to drug overdose.  And many are also aware that there is a critical shortage of organs available for transplant.  Perhaps less widely known is that today, more than 1 in every 8 deceased organ donors died from a drug overdose.  The objective of our study was to look at the outcomes of patients who received transplants with organs donated after an overdose.

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Most Baby Boomers Still Aren’t Screened For Hepatitis C

MedicalResearch.com Interview with:

In the United States, hepatitis A, hepatitis B and hepatitis C are the most common types, but also included are hepatitis D and E. CDC/ E.H. Cook, Jr.

Hepatitis Virions
CDC/ E.H. Cook, Jr.

Dr. Monica Kasting PhD first author
Dr. Anna Giuliano PhD
Susan. T. Vadaparampil, Ph.D., M.P.H.
Senior Member/Professor
Center for Infection Research in Cancer
H. Lee Moffitt Cancer Center, Tampa,
Florida.Department of Cancer Epidemiology,
H. Lee Moffitt Cancer Center,
Tampa, Florida 

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

Response: In the U.S., approximately 1 in 30 baby boomers are chronically infected with hepatitis C virus. Half of all cases of liver cancer are caused by hepatitis C and liver cancer is one of only three cancer types that are actually increasing in incidence in the US. Because of this, in 2012 the CDC issued a recommendation for universal screening for hepatitis C virus for everyone born between 1945 and 1965 (baby boomers). We wanted to look at the time period after that to see if the rates of screening in that population increased. From 2013-2015 screening among baby boomers only increased by 0.9% (from 11.8% to 12.7%) which indicates we still have a long way to go before we meet our goal of universal screening.  Continue reading

‘Liver-on-a-Chip’ Technology Can Accurately Mimic Hepatitis B Infection

MedicalResearch.com Interview with:

Primary hepatocytes grown in 3D microfluidic “liver-on-a-chip” platform following infection with hepatitis B virus. Credit: Marcus Dorner/Imperial College London

Primary hepatocytes grown in 3D microfluidic “liver-on-a-chip” platform following infection with hepatitis B virus. Credit: Marcus Dorner/Imperial College London

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.  Continue reading

Hepatitis: 8 Weeks of Once Daily, Combination Pill Found Effective in HCV 1 and 3

MedicalResearch.com Interview with:

In the United States, hepatitis A, hepatitis B and hepatitis C are the most common types, but also included are hepatitis D and E. CDC/ E.H. Cook, Jr.

In the United States, hepatitis A, hepatitis B and hepatitis C are the most common types, but also included are hepatitis D and E.
CDC/ E.H. Cook, Jr.

Stefan Zeuzem, M.D.
Professor of Medicine
Chief Internal Medicine
Goethe University Hospital
Frankfurt, Germany

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

Response: Chronic hepatitis C virus (HCV) infection is a major global public health problem with more than 71 million people infected worldwide, and can result in significant morbidity and mortality, including liver cirrhosis, hepatocellular carcinoma, and death.1

This publication describes the efficacy and safety results from two Phase 3 clinical trials, ENDURANCE-1 and ENDURANCE-3, in patients with chronic HCV genotypes (GT) 1 or 3 infection who were treated with an all-oral, once-daily combination regimen of direct-acting antiviral agents (DAA) glecaprevir (GLE) at 300 mg and pibrentasvir (PIB) at 120 mg.

The findings from ENDURANCE-1 trial show that the GLE/PIB combination regimen (G/P) given for 8 weeks to HCV GT1 chronically infected non-cirrhotic treatment-naïve or treatment-experienced (with sofosbuvir and/or interferon with ribavirin) patients was safe and well-tolerated, achieved high efficacy with a sustained virologic response at post-treatment week 12 (SVR12) rate >99% and was non-inferior to 12-week treatment with G/P.

The trial also included subjects who were co-infected with human immunodeficiency virus (HIV), and all of these subjects achieved SVR12 while maintaining HIV suppression throughout the study. ENDURANCE-3 trial results show that the G/P regimen given for 8 weeks to HCV GT3 chronically infected non-cirrhotic treatment-naïve patients was safe and well-tolerated, achieved high efficacy in this historically difficult to cure GT with an SVR12 rate >94%, and was non-inferior to 12-week treatment with G/P, which in turn was non-inferior to the treatment with 12-week DAA regimen of sofosbivir and daclatasvir.  Continue reading

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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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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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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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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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 

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

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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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