Author Interviews, Hepatitis - Liver Disease, JAMA, Kaiser Permanente, Pharmacology / 10.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49631" align="alignleft" width="200"]Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety  Dr. McGlynn[/caption] Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue.  We found no evidence of increased risks of significant side effects associated with taking these drugs.  In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events:  death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia. 
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease, Kidney Disease, Transplantation / 18.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43183" align="alignleft" width="140"]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 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.
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease, Johns Hopkins, Opiods / 24.04.2018

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.
AACR, Author Interviews, Cancer Research, Hepatitis - Liver Disease / 29.03.2018

MedicalResearch.com Interview with: [caption id="attachment_39686" align="alignleft" width="165"]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.[/caption] 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. 
Author Interviews, Coffee, Gastrointestinal Disease, Hepatitis - Liver Disease / 03.10.2017

MedicalResearch.com Interview with: [caption id="attachment_37320" align="alignleft" width="200"]Coffee Wikipedia image Coffee
Wikipedia image[/caption] 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.
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease / 10.08.2017

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.
Author Interviews, Hepatitis - Liver Disease, Kidney Disease, Lancet, Merck / 01.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35005" align="alignleft" width="112"]Annette Bruchfeld MD, PhD Senior Consultant Associate Professor Karolinska Institute Dept of Renal Medicine, M99 Karolinska University Hospital Huddinge Stockholm, Sweden Dr. Bruchfeld[/caption] 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.
Author Interviews, Hepatitis - Liver Disease, NEJM / 31.05.2017

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.
Author Interviews, Gastrointestinal Disease, Hepatitis - Liver Disease / 10.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34426" align="alignleft" width="150"]Dr. Winston Dunn, MD Assistant Professor The University of Kansas Medical Center Dr. Dunn[/caption] 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.
Author Interviews, Hepatitis - Liver Disease, JAMA / 14.04.2017

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
Author Interviews, Hepatitis - Liver Disease / 14.03.2017

MedicalResearch.com Interview with: [caption id="attachment_23631" align="alignleft" width="132"]Stacey Fedewa, MPH Strategic Director, Screening and Risk Factor Surveillance Surveillance and Health Services Research program American Cancer Society Dr. Fedewa[/caption] 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.
Addiction, Author Interviews, Hepatitis - Liver Disease, Lancet / 27.12.2016

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.
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, 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, Emergency Care, Hepatitis - Liver Disease, NYU / 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.
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, 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, 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, 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, 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, HIV, Lancet / 05.02.2015

MedicalResearch.com Interview with: Prof Jean-Michel Molina Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Paris France MedicalResearch.com Interview with: Prof Jean-Michel Molina Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Paris France Medical Research: What is the background for this study? What are the main findings? Prof. Molina: Treatment of co-infected patients is complicated by drug drug interactions with HIV drugs, and the news DAAs are not very potent on HCV G2 and 3 infections.
Author Interviews, Hepatitis - Liver Disease, JAMA, University of Pittsburgh / 03.02.2015

Adeel A. Butt, MD, MS, FACP, FIDSA Adjunct Associate Professor of Medicine and Clinical and Translational Science University of Pittsburgh School of MedicineMedicalResearch.com Interview with: Adeel A. Butt, MD, MS, FACP, FIDSA Adjunct Associate Professor of Medicine and Clinical and Translational Science University of Pittsburgh School of Medicine   MedicalResearch: What is the background for this study? What are the main findings? Dr. Butt: Studying clinical consequences of hepatitis C virus (HCV) infection is often limited by the lack of knowledge of actual time of infection. We used the Electronically Retrieved Cohort of HCV-Infected Veterans (ERCHIVES), a well-established national cohort of HCV infected veterans and corresponding HCV-uninfected controls, to identify patients with a known time frame for HCV infection. Our primary aim was to determine the rate of liver fibrosis progression among HCV-infected persons over time, with and to determine factors associated with development of cirrhosis and hepatic decompensation among these persons. Among 1840 persons who were HCV+ and 1840 HCV− controls, we found that fibrosis progression started early after HCV infection tapered off after 5 years. After 10 years of follow-up, 18.4% of HCV+ and 6.1% of HCV- persons developed liver cirrhosis. Nine years after diagnosis of cirrhosis, only 1.8% of HCV+ and 0.3% of HCV- persons had developed hepatic decompensation.
Author Interviews, Hepatitis - Liver Disease, JAMA, University of Pittsburgh / 11.12.2014

Adeel A. Butt, MD, MS, FACP, FIDSA Vice Chair for Faculty Affairs Department of Medicine Hamad Medical Corporation, Doha, Qatar Adjunct Associate Professor of Medicine and Clinical and Translational Science University of Pittsburgh School of MedicineMedicalResearch.com Interview with: Adeel A. Butt, MD, MS, FACP, FIDSA Vice Chair for Faculty Affairs Department of Medicine Hamad Medical Corporation, Doha, Qatar Adjunct Associate Professor of Medicine and Clinical and Translational Science University of Pittsburgh School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Butt: Precise rate of progression of liver disease in Hepatitis C (HCV) infection is unknown because the precise time of infection with HCV is seldom known. Knowledge of liver disease progression is critical to determine the optimal time for treatment. We found that progression of liver disease starts early after acquiring HCV infection. This is more rapid than was previously thought. About 18% of HCV infected persons develop cirrhosis within 10 years of acquiring HCV infection, which is 3-fold higher than demographically similar HCV uninfected persons.