Author Interviews, Hepatitis - Liver Disease, NEJM / 17.08.2016

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.
Annals Internal Medicine, Author Interviews, Diabetes, Hepatitis - Liver Disease, Pharmacology / 22.06.2016

MedicalResearch.com Interview with: [caption id="attachment_25367" align="alignleft" width="168"]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[/caption] 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.
Annals Internal Medicine, Author Interviews, Cost of Health Care, Hepatitis - Liver Disease / 20.06.2016

MedicalResearch.com Interview with: [caption id="attachment_25322" align="alignleft" width="160"]J. Morgan Freiman, MD Infectious disease research fellow Boston Medical Center Dr. Morgan Freiman[/caption] 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.
Author Interviews, Coffee, Hepatitis - Liver Disease / 24.05.2016

MedicalResearch.com Interview with: [caption id="attachment_24648" align="alignleft" width="200"]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[/caption] 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 MedicalResearch.com: What is the background for this study? What are the main findings? 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.
Author Interviews, Hepatitis - Liver Disease, Race/Ethnic Diversity / 24.05.2016

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 MedicalResearch.com: What is the background for this study? What are the main findings? 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.
Author Interviews, Diabetes, Genetic Research, Hepatitis - Liver Disease, Weight Research / 24.05.2016

MedicalResearch.com Interview with: [caption id="attachment_24667" align="alignleft" width="131"]Prof-Dr. Annette Schürmann Department of Experimental Diabetology German Institute of Human Nutrition Potsdam-Rehbruecke Nuthetal, Germany Dr. Annette Schürmann[/caption] 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 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 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.
Author Interviews, Cost of Health Care, Gastrointestinal Disease, Hepatitis - Liver Disease / 16.05.2016

MedicalResearch.com Interview with: [caption id="attachment_24409" align="alignleft" width="200"]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[/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.
Author Interviews, Cancer Research, Hepatitis - Liver Disease, HPV, JNCI, MD Anderson / 15.04.2016

MedicalResearch.com Interview with: [caption id="attachment_23475" align="alignleft" width="114"]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[/caption] 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 Medical Research: What is the background for this study? What are the main findings? 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.
Author Interviews, Hepatitis - Liver Disease, HIV, JAMA, Vaccine Studies / 13.04.2016

MedicalResearch.com Interview with: [caption id="attachment_23342" align="alignleft" width="160"]Odile Launay MD, PhD Paris Descartes University Assistance Publique Hôpitaux de Paris, Cochin Hospital 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
Author Interviews, Emergency Care, Hepatitis - Liver Disease, NYU/NYMC / 26.01.2016

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.
Author Interviews, Hepatitis - Liver Disease, Nature / 01.12.2015

[caption id="attachment_19732" align="alignleft" width="125"]Prof. Yaakov Nahmias Director of the Alexander Grass Center for Bioengineering Hebrew University of Jerusalem Dr. Nahmias[/caption] 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.
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease / 24.11.2015

[caption id="attachment_19589" align="alignleft" width="200"]Dr. Tianhua He MD Beijing China, 100005 Dr. Tianhua He[/caption] 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.
Author Interviews, Hepatitis - Liver Disease / 19.11.2015

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.
Author Interviews, Beth Israel Deaconess, Hepatitis - Liver Disease, NEJM / 18.11.2015

[caption id="attachment_19403" align="alignleft" width="144"]Dr. Michael P. Curry, MD Medical Director for Liver Transplantation Harvard Medical Faculty Physicians Beth Israel Deaconess Medical Center Dr. Curry[/caption] 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.
Author Interviews, Hepatitis - Liver Disease, Surgical Research, Transplantation, Weight Research / 17.11.2015

[caption id="attachment_19426" align="alignleft" width="97"]Barry Schlansky, M.D., M.P.H Assistant Professor of Medicine Oregon Health & Science University Dr. Schlansky[/caption] 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.
Author Interviews, Biomarkers, Gastrointestinal Disease, Hepatitis - Liver Disease / 22.08.2015

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.
Author Interviews, Hepatitis - Liver Disease, OBGYNE / 12.08.2015

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.
Author Interviews, Hepatitis - Liver Disease, NIH / 03.06.2015

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.
Author Interviews, Hepatitis - Liver Disease, Transplantation / 04.05.2015

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.
Author Interviews, Cancer Research, Hepatitis - Liver Disease, UCSD / 27.04.2015

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).
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease / 26.04.2015

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.
Author Interviews, CDC, Hepatitis - Liver Disease, Outcomes & Safety / 22.04.2015

MedicalResearch.com Interview with: Chong-Gee 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.
Author Interviews, Cost of Health Care, Hepatitis - Liver Disease / 10.04.2015

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.
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease, MD Anderson / 17.03.2015

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.
Author Interviews, Hepatitis - Liver Disease, Menopause, Nutrition, Weight Research / 01.03.2015

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.
Author Interviews, Hepatitis - Liver Disease, HIV, JAMA, NIH / 28.02.2015

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:  Due to shared routes of transmission, almost half of all HIV-infected patients also have HCV infection. Traditionally, interferon based therapies have resulted in lower cure rates of HCV in HIV-infected subjects. Treatment for HCV is rapidly changing from an injection (interferon) based therapy to oral well tolerated pill based therapy for a shorter duration.Our intention was to test whether a treatment regimen without the use of interferon and ribavirin can be effective in HIV/HCV infected patients. Our study demonstrated that HIV/HCV connected patients without cirrhosis can be effectively treated with ledipasvir and sofosbuvir in 12 weeks. Overall 98% of patients were cured.
Author Interviews, Hepatitis - Liver Disease / 23.02.2015

Andrew L. Mason MBBS MRCPI Professor of Medicine, Senior Scholar, Alberta Heritage Foundation for Medical Research Director, The Applied Genomic Core, Division of Gastroenterology and Hepatology University of Alberta, EdmontonMedicalResearch.com Interview with: Andrew L. Mason MBBS MRCPI Professor of Medicine, Senior Scholar, Alberta Heritage Foundation for Medical Research Director, The Applied Genomic Core, Division of Gastroenterology and Hepatology University of Alberta, Edmonton Medical Research: What is the background for this study? What are the main findings? Response: The study of viruses resembling mouse mammmary tumour virus (MMTV) dates back to the 1970s when virus like particles were discovered in breast milk of breast cancer patients. The virus was detected at low levels and ultimately researchers met a stalemate by the 1980s because no one could prove the existence of this agent. Interest waned in the study of betaretroviruses in humans when HIV was discovered in the 1980s. We first found a similar agent in patients with primary biliary cirrhosis, an autoimmune liver disease in 2003. History repeated itself in as much as others could not find the virus and challenged us to show that a significant amount of patients had evidence of proviral integrations into the human genome, the gold standard for providing proof of retroviral infection. This we achieved by isolating biliary epithelium from patients undergoing liver transplantation and then investigating the presence of betaretrovirus proviral integrations in DNA extracted from liver, lymph nodes and biliary epithelial cells using a ligation mediated PCR technique coupled with next generation sequencing. The majority of patients with primary biliary cirrhosis had viral integration and RNA detected in their biliary epithelium, the site of disease and lymph nodes; however, the virus was difficult to detect in whole liver, reflecting the problem with prior studies.