Medical Research.com Interview with:
Surakit Pungpapong, M.D.
Transplant Hepatologist
Associate Professor of Medicine
Mayo Clinic, Jacksonville, Fla.
Medical Research: What is the background for this study? What are the main findings?Dr. Pungpapong: This study reports our multicenter experience from Mayo Clinic’s three sites using sofosbuvir and simeprevir with/without ribavirin for 12 weeks to treat hepatitis C genotype 1 recurrence after liver transplantation. We found that this all-oral interferon-free antiviral regimen was very well tolerated with minimal to mild side effects. It required minimal dose adjustment of immunosuppression and no episode of acute rejection occurred. Overall, sustained virologic response rate was very high, more than 90 percent.
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MedicalResearch.com Interview with:
Anita Kohli, MS, MD
Clinician Investigator, Clinical Monitoring Research Program (CMRP)
Leidos Biomedical Research, Inc. formerly SAIC-Frederick, Inc.
National Institutes of Health Bethesda, MD 20892
Medical Research: What is the background for this study? What are the main findings?Dr. Kohli: We previously treated 60 patients with sofosbuvir and ribavirin for 24 weeks. Patients who relapsed after treatment were offered re-treatment with another regimen of directly acting antivirals alone. 13 patients who relapsed were treated with sofosbuvir and ledipasvir for 12 weeks. All patients achieved SVR12. This is the first report of re-treating patients who failed a regimen including sofosbuvir with another regimen incorporating this same antiviral.
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MedicalResearch.com Interview with: Dr Daniel Bradshaw
Chelsea and Westminster Hospital, London
Medical Research: What are the main findings of the study?Dr. Bradshaw: Over 40% of men with hepatitis C (HCV) infection have HCV RNA in their semen, although the level of RNA was much lower than blood (usually 4 log less than blood).
Neither HIV nor acute hepatitis C led to increased shedding of HCV RNA in semen. Interestingly, however, in acute HCV, HIV-positive men with higher blood levels of HCV RNA were more likely to shed RNA in their semen.
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MedicalResearch.com Interview with:Sana Dastgheyb
National Institute of Allergy and Infectious Diseases, The National Institutes of Health, Bethesda, MDDepartment of Orthopedic Surgery,
Thomas Jefferson University, Philadelphia, PA andDr. Noreen Hickok
Department of Orthopedic Surgery
Thomas Jefferson University, Philadelphia, PA
Medical Research:What are the main findings of the study?Response: Physicians have long been resigned to the fact that staphylococcal joint infections are among the most challenging to treat. Our study points towards a definitive mechanism whereby bacteria become insensitive to antibiotics in the human joint environment. We added MRSA to synovial fluid and observed dense, biofilm-like aggregates, as well as a relative insensitivity to antibiotics as compared to ideal medium. Our findings suggest that serum/extracellular matrix proteins within synovial fluid contribute greatly to staphylococcal antibiotic insensitivity in synovial fluid. Furthermore, pre-treatment of synovial fluid with the enzyme plasmin, which degrades extracellular matrix proteins, significantly inhibits aggregate formation, and restores normal antibiotic sensitivity to MRSA.
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MedicalResearch.com Interview with: Naga Pothineni, MD
Division of Cardiology
University of Arkansas for Medical Science
MedicalResearch: What are the main findings of the study?Dr. Pothineni:Hepatitis C is a blood borne infection that is very common worldwide. Most pateints who contract hepatitis C develop a chronic form on infection that progresses to liver damage and eventually hepatocellular cancer. Coronary heart disease is a worldwide problem as well. There has been interest in chronic infections being a mechanism of progression of atherosclerosis and coronary heart disease. We wanted to study the association of coronary heart disease events in patients with hepatitis C. We conducted a retrospective study of around 24,000 patients of which around 10,000 were hepatitis C positive. Our study showed that patients who have hepatitis C have a higher incidence of coronary heart disease events (myocardial infarction) when compared to patients who are negative for hepatitis C. In our analysis, we found that hepatitis C positivity is an independent risk factor for coronary events after adjusting for traditional cardiovascular risk factors like age, hypertension, smoking and diabetes.
Another interesting finding in our study was that patients with hepatitis C have lower levels of cholesterol compared to patients without hepatitis C. Low cholesterol levels in these patients do not seem to be protective against future coronary heart disease events.
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MedicalResearch.com Interview withJagpreet Chhatwal, Ph.D.
Assistant Professor
Department of Health Services Research
Houston, TX 77098
Medical Research: What are the main findings of the study?Dr. Chhatwal:The recent updates in hepatitis C virus (HCV) screening policy and ongoing therapeutic advances can make hepatitis C a rare disease in the US by 2036. However, more aggressive screening strategies are needed to further reduce the burden of disease. For example, 1-time universal screening further identify 487,000 chronic hepatitis C virus cases in the next 10 years, and can make hepatitis C a rare disease in the next 12 years.
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MedicalResearch.com Interview with: Ai Kubo, MPH PhD
Kaiser Permanente Division of Research
2000 Broadway
Oakland, CA 94612
MedicalResearch: What are the main findings of the study?Dr. Kubo:The main findings of the study are three folds:
1) The CDC guideline works for the majority of infants in preventing vertical transmission, if the immunizations are done according to the recommended schedule.
2) It takes an organized effort to case-manage each mother-infant pairs in order to achieve almost complete immunization rates and very low transmission rates.
3) Highest risk group was mothers with extremely high viral load and e-antigen positivity. This group of women may benefit from additional therapy to prevent the vertical transmission. However, for others, the risk of transmission is extremely low as long as the infants are immunized according to the guideline.
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MedicalResearch.com Interview with:Zobair Younossi, MD, MPH
Chairman, Department of Medicine, Inova Fairfax Hospital
Vice President for Research, Inova Health System
Falls Church, Virginia, USA
MedicalResearch: What are the main findings of the study?Dr. Younossi:We conducted the analysis of the patient reported outcomes (PROs) data that were systematically collected during clinical trials of sofosbuvir-containing regimens. The highlights of our findings are as follows:
Patients with Hepatitis C (HCV) have a significant impairment of their health related quality of life including those related to activity and fatigue. Their work productivity is also impaired.
Cirrhosis can add additional negative impact on some of these patient reported outcomes.
During treatment, patients with cirrhosis who were treated with an interferon-free sofosbuvir and ribavirin containing regimen did experience mild decline in their patient related outcome scores. However, this decline was similar for HCV patients with or without cirrhosis.
On the other hand, patients with cirrhosis who were treated with an interferon-containing regimen showed a significant decline in their patient reported outcomes scores compared to those with Hepatitis C and without cirrhosis.
Nevertheless, at the end of week 12 follow up, there was no longer a significant deficit in PROs noted regardless of the treatment arm for patients with cirrhosis.
Furthermore, for the patients (HCV and cirrhosis) who achieved a sustained virologic response at 12 weeks, there were significant improvements (compared to baseline) in some PRO scores.
During treatment, changes in patient reported outcomes scores were similar between cirrhotics and non-cirrhotics for both treatment regimens (all p>0.05).
MedicalResearch.com Interview with:Amit Singal MD MS
Assistant Professor of Medicine
Medical Director, Liver Tumor Program
Dedman Scholar of Clinical Care
Division of Digestive and Liver Diseases
University of Texas Southwestern
Dallas TX 75201 - 8887
MedicalResearch: What are the main findings of the study?Dr. Singal: We conducted a meta-analysis of current studies to characterize the association between hepatocellular carcinoma surveillance and early detection, curative treatment rates, and overall survival in patients with cirrhosis. We identified 47 studies with 15,158 patients, of whom 6,284 (41.4%) had hepatocellular carcinoma detected by surveillance. Hepatocellular carcinoma surveillance was associated with improved early stage detection (OR 2.08, 95% CI 1.80–2.37) and curative treatment rates (OR 2.24, 95% CI 1.99–2.52). These associations were robust to several sensitivity analyses, including study design, study location, and study period. Hepatocellular carcinoma surveillance was associated with significantly prolonged survival (OR 1.90, 95% CI 1.67–2.17), which remained significant in the subset of studies adjusting for lead-time bias. Three-year survival rates were 50.8% among patients who underwent surveillance, compared to only 28.2% among hepatocellular carcinoma patients with tumors detected outside of a surveillance program.
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MedicalResearch.com Interview with:Stefan Zeuzem, M.D.
Professor of Medicine, Chief Department of Medicine
JW Goethe University Hospital
Frankfurt Germany
MedicalResearch.com: What are the main findings of the study?Dr. Zeuzem: Main finding is that also patients infected with HCV 3 can be cured with an IFN-free regimen. However, duration of therapy must be prolonged to 24 weeks.
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MedicalResearch.com Interview with: Jordan Feld MD MPH
Toronto Western Hospital Liver Center
University Health Network
Sandra Rotman Centre for Global Health
MedicalResearch.com: What are the main findings of the study?
Dr. Feld: The SAPPHIRE 1 study was an international, large (631 patients) Phase 3 study of 3 direct acting antivirals combined with ribavirin for 12 weeks for the treatment of patients with genotype 1 hepatitis C virus (HCV) infection without cirrhosis. The antivirals used were ABT-450, which is a protease inhibitor that is boosted with ritonovir to allow for once daily dosing along with ombitasvir (formally ABT 267), a potent NS5A inhibitor and dasabuvir (formerly known as ABT 333), a non-nucleoside polymerase inhibitor. The ABT-450, ritonovir and ombitasvir were all co-formulated into a single tablet and dasabuvir was taken twice daily, as was ribavirin. The results of the study showed that the treatment is highly effective with 96% of patients achieving a sustained virological response (SVR) at 12 weeks after completing treatment. SVR is a cure of HCV infection. Importantly, patients with genotypes 1a and 1b had similar results with a rate of SVR12 of 95% in genotype 1a and 98% in genotype 1b. These results were clearly superior to a historical control treatment with telaprevir combined with peginterferon and ribavirin. Baseline factors were not predictive of outcome, including factors associated with non-response to interferon such as the IL28B genotype, baseline HCV viral load and older age.
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MedicalResearch.com Interview with: Christophe Moreno, MD, PhD
Directeur clinique, clinique d’Hépatologie
Service de Gastroentérologie
Hépatopancréatologie et Oncologie Digestive
MedicalResearch.com: What are the main findings of the study?Dr. Moreno: The RESTORE study is an open label, phase 3 study, evaluating Simeprevir in combination with PegIFN and ribavirin in genotype 4 Chronic Hepatitis C patients, either naïve or treatment experienced. Results of this study demonstrated high efficacy of this combination, with an overall SVR rate of 65.4%. Efficacy is particularly high in treatment naïve and prior relapsers patients, with SVR rate of 82.9% and 86.4%, respectively.
Moreover, treatment naïve patients and prior relapsers were eligible to a shorter treatment duration of 24 weeks if they met response-guided therapy (RGT) criteria (defined by an HCV RNA below 25 at week 4 and undetectable at week 12). 89.5% met RGT criteria. Of those, 94.1% achieved a SVR. (more…)
MedicalResearch.com Interview with: Kris V. Kowdley, MD
Director of Research & Director of the Liver Center of Excellence
Digestive Disease Institute
Virginia Mason Medical Center
Seattle, WA 98111
MedicalResearch.com: What are the main findings of the study?Dr. Kowdley: A fixed-dose combination of ledipasvir and sofosbuvir in chronic Hepatitis C (HCV) genotype 1 patients without cirrhosis for 8 weeks without ribavirin was equally effective as the same combination with ribavirin added and also a 12 week combination of ledipasvir-sofosbuvir (without ribavirin).
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MedicalResearch.com Interview with: Woon-Puay Koh (Associate Professor)
Office of Clinical Sciences
Duke-NUS Graduate Medical School Singapore
8 College Road Level 4 | Singapore 169857
MedicalResearch.com: What are the main findings of the study?Answer:The main finding is that coffee intake was associated with a lower risk of death from cirrhosis, specifically for non-viral hepatitis related cirrhosis. Subjects who drank two or more cups per day had a 66% reduction in mortality risk, compared to non-daily coffee drinkers. However, coffee intake was not associated with viral hepatitis B related cirrhosis mortality.
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MedicalResearch.com Interview with: Scott D. Holmberg, MD, MPH
Chief, Epidemiology and Surveillance Branch
Division of Viral Hepatitis.
MedicalResearch.com: What are the main findings of the study?Dr. Holmberg:Based on interview and testing of over 30, 000 National Health and Nutrition and Examination Survey (NHANES) participants from 2003 to 2010, 273 US residents or about 1%, are chronically (actively) infected with hepatitis C virus (HCV). This translates to about 2.7 million chronic HCV-infected persons in the non-institutionalized population.
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MedicalResearch.com Interview with: Dr. Jason Grebely PhD
The Kirby Institute
University of South Wales, Australia
MedicalResearch.com: What are the main findings of the study?Dr. Grebely:Although 20%-40% of persons with acute hepatitis C virus (HCV) infection demonstrate spontaneous clearance, the time course and factors associated with clearance remain poorly understood. This study investigated the time to spontaneous clearance and predictors among participants with acute HCV. Female sex, favorable IL28B genotype, and HCV genotype 1 were identified to be independent predictors of spontaneous clearance. This study provides important insights into factors affecting HCV viral control and offers guidance in clinical decision-making for the treatment of acute HCV infection.
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MedicalResearch.com Interview with:Harrys A. Torres, MD, FACP
Assistant Professor, Director of Hepatitis C Clinic
Department of Infectious Diseases, Infection Control and Employee Health
The University of Texas MD Anderson Cancer Center
MedicalResearch.com: What are the main findings of the study?Dr. Torres:The main findings of the study were that patients with hepatitis C virus (HCV) infection who were successfully treated with antivirals and attained sustained virologic response (SVR) did not have a relapse of HCV infection after receiving immunosuppressive chemotherapy for cancer. Patients in the study received different chemotherapeutic agents, including rituximab and systemic corticosteroids. Durability of SVR was maintained up to 14 years after chemotherapy in cancer patients.
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MedicalResearch.com Interview with:Prof Eric Lawitz MD
Vice President of Scientific and Research Development at The Texas Liver Institute
Clinical professor of Medicine
San Antonio University of Texas Health Science Center.
MedicalResearch.com: What are the main findings of the study?Dr. Lawitz: Currently available treatments for HCV involve weekly injections of pegylated interferon and daily doses of oral antivirals that must be taken for up to a year. These regimens are not only burdensome for patients, but are not always effective and can cause serious and debilitating side effects, including anemia. So there is a significant need for new tablet-based treatment regimens for HCV that eliminate interferon and ribavirin, are more effective, better tolerated and easier for patients to take.
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MedicalResearch.com Interview with:Marina Klein, MD, MSc, FRCP(C)
Associate Professor of Medicine
McGill University Health Centre
Division of Infectious Diseases and Chronic Viral Illness Service
3650 Saint Urbain
Montreal, Quebec H2X 2P4
Disease in HIV–Hepatitis C Coinfection: A Longitudinal Cohort Analysis MedicalResearch.com: What are the main findings of the study?Dr. Klein: We showed that people with HIV and hepatitis C infection who smoked marijuana did not tend to progress more rapidly to liver fibrosis, liver cirrhosis or end-stage liver disease, even with increasing numbers of joints smoked per week. Previous studies that reported that marijuana was harmful to the liver were likely biased because they did not ensure that marijuana smoking occurred before the development of liver problems.
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MedicalResearch.com: eInterview with: Soo Aleman
Department of Gastroenterology and Hepatology, and Infectious Diseases
Karolinska University Hospital, at Karolinska Institute
171 76 Stockholm, Sweden,
MedicalResearch.com: What are the main findings of the study?Answer: In this long-term, prospective study of 351 hepatitis C infected patients with liver cirrhosis, we found a reduced but persistent risk for hepatocellular cancer after successful treatment with eradication of the virus. This risk for hepatocellular cancer remained at a level of 1% per year for those with sustained virological response, and could persist as long as 8 years after eradication.
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