Chronic fatigue syndrome is in your gut, not your head
Physicians have been mystified by chronic fatigue syndrome, a condition where normal exertion leads to debilitating fatigue that isn't alleviated by rest. There are no known triggers, and diagnosis requires lengthy tests administered by an expert.
Now, for the first time, Cornell University researchers report they have identified biological markers of the disease in gut bacteria and inflammatory microbial agents in the blood.
In a study published June 23 in the journal Microbiome, the team describes how they correctly diagnosed myalgic encephalomyeletis/chronic fatigue syndrome (ME/CFS) in 83 percent of patients through stool samples and blood work, offering a noninvasive diagnosis and a step toward understanding the cause of the disease.
"Our work demonstrates that the gut bacterial microbiome in chronic fatigue syndrome patients isn't normal, perhaps leading to gastrointestinal and inflammatory symptoms in victims of the disease," said Maureen Hanson, the Liberty Hyde Bailey Professor in the Department of Molecular Biology and Genetics at Cornell and the paper's senior author. "Furthermore, our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin."
"In the future, we could see this technique as a complement to other noninvasive diagnoses, but if we have a better idea of what is going on with these gut microbes and patients, maybe clinicians could consider changing diets, using prebiotics such as dietary fibers or probiotics to help treat the disease," said Ludovic Giloteaux, a postdoctoral researcher and first author of the study.
In the study, Ithaca campus researchers collaborated with Dr. Susan Levine, an ME/CFS specialist in New York City, who recruited 48 people diagnosed with ME/CFS and 39 healthy controls to provide stool and blood samples.
The researchers sequenced regions of microbial DNA from the stool samples to identify different types of bacteria. Overall, the diversity of types of bacteria was greatly reduced and there were fewer bacterial species known to be anti-inflammatory in ME/CFS patients compared with healthy people, an observation also seen in people with Crohn's disease and ulcerative colitis.
At the same time, the researchers discovered specific markers of inflammation in the blood, likely due to a leaky gut from intestinal problems that allow bacteria to enter the blood, Giloteaux said.
Bacteria in the blood will trigger an immune response, which could worsen symptoms.
The researchers have no evidence to distinguish whether the altered gut microbiome is a cause or a whether it is a consequence of disease, Giloteaux added.
In the future, the research team will look for evidence of viruses and fungi in the gut, to see whether one of these or an association of these along with bacteria may be causing or contributing to the illness.
###
The study was funded by the National Institutes of Health.
http://mediarelations.cornell.edu/2016/06/27/3770/
Monday, 27 June 2016
Saturday, 25 June 2016
Now that we have the hepatitis C virus on the run, can a universal cure be attained?
COMMENTARY
Hepatitis C: Let's Get 'Real'
Digestive Disease Week (DDW) 2016
William F. Balistreri, MD
June 24, 2016
Hepatitis C virus (HCV) infection remains a significant problem worldwide, with risk for progression to cirrhosis, liver failure, and hepatocellular carcinoma. The good news is that with the development and validation of a spate of new direct-acting antiviral (DAA) drugs and novel treatment strategies, a significant proportion of patients can be cured of HCV infection.
Current highly successful strategic treatment approaches have achieved high sustained virologic response (SVR) rates in clinical trials. However, the question remains: Can this degree of success be replicated in a real-world application of these strategies? And will this level of success apply to all patients? Research presented at this year's Digestive Disease Week (DDW) discussed real-world outcomes and the prospects for ensuring the best outcome for all patients with chronic hepatitis C, including certain patient populations—those with cirrhosis or decompensated liver disease and those who failed to respond to treatment—who may require enhanced strategies such as a longer duration of therapy, the addition of ribavirin, or the use of new ribavirin-free combinations. There are also new possibilities, therapeutic agents that will soon be available to add to the expanding armamentarium of DAAs and combination regimens. For example, the next-generation investigational pangenotypic once-daily combination tablet containing 400 mg of sofosbuvir (SOF) and 100 mg of velpatasvir (VEL) was granted priority review designation from the US Food and Drug Administration (FDA) and is scheduled for approval this quarter. A key area of concern is the possibility of treatment failure due to the existence and emergence of resistant variants of the virus. Investigators discussed the potential impact and use of regimens that offer non-overlapping resistance profiles.
Curative treatment has clear advantages compared with the management of end-stage disease, yet treatment costs and access to treatment for HCV infection are ongoing issues, even though increased competition among pharmaceutical manufacturers may ultimately reduce the price of DAA regimens.
Some of the relevant presentations from DDW 2016 in which investigators shed light on these important issues are highlighted herein.
Current highly successful strategic treatment approaches have achieved high sustained virologic response (SVR) rates in clinical trials. However, the question remains: Can this degree of success be replicated in a real-world application of these strategies? And will this level of success apply to all patients? Research presented at this year's Digestive Disease Week (DDW) discussed real-world outcomes and the prospects for ensuring the best outcome for all patients with chronic hepatitis C, including certain patient populations—those with cirrhosis or decompensated liver disease and those who failed to respond to treatment—who may require enhanced strategies such as a longer duration of therapy, the addition of ribavirin, or the use of new ribavirin-free combinations. There are also new possibilities, therapeutic agents that will soon be available to add to the expanding armamentarium of DAAs and combination regimens. For example, the next-generation investigational pangenotypic once-daily combination tablet containing 400 mg of sofosbuvir (SOF) and 100 mg of velpatasvir (VEL) was granted priority review designation from the US Food and Drug Administration (FDA) and is scheduled for approval this quarter. A key area of concern is the possibility of treatment failure due to the existence and emergence of resistant variants of the virus. Investigators discussed the potential impact and use of regimens that offer non-overlapping resistance profiles.
Curative treatment has clear advantages compared with the management of end-stage disease, yet treatment costs and access to treatment for HCV infection are ongoing issues, even though increased competition among pharmaceutical manufacturers may ultimately reduce the price of DAA regimens.
Some of the relevant presentations from DDW 2016 in which investigators shed light on these important issues are highlighted herein.
Index
Hepatitis C: Let's Get 'Real'
Efficacy and Impact of Treatment
New Strategies
Special Populations
Can We Improve Outcomes?
Cost and Access
In The Journals
Access to Treatment Regimens in Chronic HCV Patients
Journal of Viral Hepatitis, June 24, 2016
Access to Treatment Regimens in Chronic HCV Patients
Journal of Viral Hepatitis, June 24, 2016
The Direct-acting Antiviral Era in HCV Cirrhosis
Alimentary Pharmacology & Therapeutics, June 24, 2016
HCV Transmission Associated With a CAM Injection Therapy
Morbidity & Mortality Weekly Report, June 23, 2016
Direct Acting Antiviral Therapy After Liver Transplantation
Current Opinion in Gastroenterology, June 22, 2016
Monday, 20 June 2016
Enanta Initiates Proof-of-Concept Study with Pan-genotypic Cyclophilin Inhibitor EDP-494/Geno 1 or Geno 3 Chronic Hepatitis C Virus
Enanta Pharmaceuticals Initiates Proof-of-Concept Study with Pan-genotypic Cyclophilin Inhibitor EDP-494 in Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C Virus
New non-DAA mechanism retains potency against important DAA resistance-associated variants (RAVs), regardless of class
EDP-494 represents a new host-targeted approach that may play an important role in future treatment regimens for chronic hepatitis C virus (HCV) patients that have failed therapy due to resistance arising from direct-acting antiviral (DAA) therapies currently on the market WATERTOWN, Mass. --(BUSINESS WIRE)--Jun. 20, 2016-- Enanta Pharmaceuticals, Inc. , (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has initiated a proof of concept study (POC) and has begun dosing with EDP-494, a potent, pan-genotypic cyclophilin inhibitor to treat patients with genotype 1 (GT1) or genotype 3 (GT3) chronic hepatitis C virus.
The double-blind, randomized POC portion of this ongoing phase 1 study will assess the safety, pharmacokinetics and anti-viral activity of two planned different doses of EDP-494 in treatment-naïve HCV patients dosed orally, once daily for 14 days. Safety and pharmacokinetics of single and multiple ascending doses of once daily, orally administered EDP-494 have been established in healthy volunteers and these data support the testing of EDP-494 in a proof-of-concept study in HCV patients.
EDP-494, a Cyclophilin Inhibitor for HCV Infection
Due to resistance arising with direct-acting antiviral HCV therapies currently on the market, Enanta has developed an alternative treatment approach to HCV that targets the human host protein cyclophilin, which is essential for replication of HCV. Since cyclophilin inhibitors act as host-targeted antivirals, the viral mutation resistance that arises from direct-acting antiviral (DAA) treatments would not be expected for this mechanism, and thus cyclophilin inhibitors may have the highest barrier to resistance of any class of HCV treatments.
“As the number of patients treated with the current HCV DAA regimens on the market rapidly increases, the treatment failure population will become an important unmet medical need in patients with hepatitis C and may require new mechanisms of therapy such as cyclophilin inhibition,” commented ProfessorEdward J. Gane , MD, Professor of Medicine at the University of Auckland, New Zealand and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital and chief investigator of the EDP-494 study. “This host-targeted approach may prove valuable not only in the toughest to treat patients with DAA resistance, but also in the general HCV patient population, given its pangenotypic mechanism of action and high barrier to resistance.”
Data presented at the International Liver Congress™ 1 inBarcelona in April, 2016 demonstrated that EDP-494 in replicon assays is a potent inhibitor of HCV replication and has shown no loss of potency against all major NS5A RAVs, NS5B RAVs (both Nucleotide and non-Nucleotide) as well as NS3 protease inhibitor RAVs.
Following the completion of the phase 1 study, Enanta plans to develop EDP-494 in combination with one or more DAAs for the treatment of any emerging HCV resistance to currently marketed therapies or any other therapies in development that use DAAs. Enanta anticipates that a DAA-cyclophilin inhibitor combination could provide one of the highest barrier to resistance combination treatments for HCV.
About EDP-494
EDP-494 is a cyclophilin inhibitor that targets the human host protein, cyclophilin, which is essential for replication of chronic hepatitis C virus (HCV). Host-targeted antivirals (HTAs) such as cyclophilin inhibitors are not affected by changes in the virus and, therefore, use of this class of inhibitor may provide a unique solution for a subset of hard-to-treat HCV patients. Enanta has demonstrated in replicon assays that EDP-494 is a potent inhibitor of HCV. A phase 1 clinical study in HCV patients is currently underway.
About Enanta
Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs for viral infections and liver diseases. Enanta’s research and development efforts are currently focused on four disease targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors and NS5A inhibitors that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). Enanta’s protease inhibitors, developed through its collaboration withAbbVie , include paritaprevir, which is contained in AbbVie’s marketed DAA regimens for HCV, and ABT-493, Enanta’s second protease inhibitor, which AbbVie is developing in phase 3 studies in combination with ABT-530, AbbVie’s NS5A inhibitor. Enanta has also discovered a cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for HCV, which is now in phase 1 clinical development, and EDP-305, an FXR agonist, which Enanta plans to advance into clinical development for NASH later in 2016. Please visit www.enanta.com
The double-blind, randomized POC portion of this ongoing phase 1 study will assess the safety, pharmacokinetics and anti-viral activity of two planned different doses of EDP-494 in treatment-naïve HCV patients dosed orally, once daily for 14 days. Safety and pharmacokinetics of single and multiple ascending doses of once daily, orally administered EDP-494 have been established in healthy volunteers and these data support the testing of EDP-494 in a proof-of-concept study in HCV patients.
EDP-494, a Cyclophilin Inhibitor for HCV Infection
Due to resistance arising with direct-acting antiviral HCV therapies currently on the market, Enanta has developed an alternative treatment approach to HCV that targets the human host protein cyclophilin, which is essential for replication of HCV. Since cyclophilin inhibitors act as host-targeted antivirals, the viral mutation resistance that arises from direct-acting antiviral (DAA) treatments would not be expected for this mechanism, and thus cyclophilin inhibitors may have the highest barrier to resistance of any class of HCV treatments.
“As the number of patients treated with the current HCV DAA regimens on the market rapidly increases, the treatment failure population will become an important unmet medical need in patients with hepatitis C and may require new mechanisms of therapy such as cyclophilin inhibition,” commented Professor
Data presented at the International Liver Congress™ 1 in
Following the completion of the phase 1 study, Enanta plans to develop EDP-494 in combination with one or more DAAs for the treatment of any emerging HCV resistance to currently marketed therapies or any other therapies in development that use DAAs. Enanta anticipates that a DAA-cyclophilin inhibitor combination could provide one of the highest barrier to resistance combination treatments for HCV.
About EDP-494
EDP-494 is a cyclophilin inhibitor that targets the human host protein, cyclophilin, which is essential for replication of chronic hepatitis C virus (HCV). Host-targeted antivirals (HTAs) such as cyclophilin inhibitors are not affected by changes in the virus and, therefore, use of this class of inhibitor may provide a unique solution for a subset of hard-to-treat HCV patients. Enanta has demonstrated in replicon assays that EDP-494 is a potent inhibitor of HCV. A phase 1 clinical study in HCV patients is currently underway.
About Enanta
Enanta has discovered novel protease inhibitors and NS5A inhibitors that are members of the direct-acting-antiviral (DAA) inhibitor classes designed for use against the hepatitis C virus (HCV). Enanta’s protease inhibitors, developed through its collaboration with
Friday, 17 June 2016
Kiwis chase overseas drugs to help battle Hepatitis C
Kiwis chase overseas drugs to help battle Hepatitis C
CATE BROUGHTON
Last updated 05:00, June 18 2016
CATE BROUGHTON
Last updated 05:00, June 18 2016
50,000 people have Hep C in New Zealand, but a recent Pharmac announcement about funding for two new drug treatments will not help all of them, CATE BROUGHTON writes.
Naomi Wickens lived with Hepatitis C (HVC) for 45 years, but was cured with a generic drug imported from India this year at a cost of $2500.
Wickens, 67, is one among many Kiwis forced to use generic drugs sourced from overseas to treat their condition.
This month, Pharmac announced it would fund two new hepatitis C treatments, Harvoni and Viekira Pakbut, but doctors say it will only help 50 per cent of those with the illness.
Pharmac's money will help patients with genotype 1 and a small number who are on death's door with severe liver failure, giving them hope for a healthy future.
But for 50 per cent of patients with other genotypes there is no celebrating.
"While it is good news for those with genotype 1 Hepatitis C, there is no funded Direct Acting Anti-Virals (DAAV) for people with the other strains so that's difficult for those patients," says hepatitis specialist Catherine Stedman.
Naomi Wickens lived with Hepatitis C (HVC) for 45 years, but was cured with a generic drug imported from India this year at a cost of $2500.
Wickens, 67, is one among many Kiwis forced to use generic drugs sourced from overseas to treat their condition.
This month, Pharmac announced it would fund two new hepatitis C treatments, Harvoni and Viekira Pakbut, but doctors say it will only help 50 per cent of those with the illness.
Pharmac's money will help patients with genotype 1 and a small number who are on death's door with severe liver failure, giving them hope for a healthy future.
But for 50 per cent of patients with other genotypes there is no celebrating.
"While it is good news for those with genotype 1 Hepatitis C, there is no funded Direct Acting Anti-Virals (DAAV) for people with the other strains so that's difficult for those patients," says hepatitis specialist Catherine Stedman.
Faced with this news many sufferers will do like Wickens and consider importing generic drugs produced in India, China or Bangladesh which they are legally entitled to do with a prescription from a New Zealand doctor.
However, in recent weeks, doctors who have prescribed drugs for HCV patients have been sent a warning letter and prescription form to complete from Medsafe about "unapproved" medications...
However, in recent weeks, doctors who have prescribed drugs for HCV patients have been sent a warning letter and prescription form to complete from Medsafe about "unapproved" medications...
Listen - Overcoming Hepatitis C
Guest: Carleen McGuffy, Hepatitis C Survivor
From the Show: Melanie Cole's Health Radio
Summary: Treatment is now available for hepatitis C.
Duration: 10 Minutes
Prevalence of extrahepatic manifestations of Hepatitis C
Prevalence of extrahepatic manifestations of Hepatitis C
This month's issue of Gastroenterology reviews the prevalence, quality of life, and economic burden of extrahepatic manifestations of Hepatitis C.
Hepatitis C virus infection has hepatic and extrahepatic manifestations with various costs and impairments to health-related quality of life.
Dr Zobair Younossi and colleagues from Virginia, USA performed a meta-analysis to determine the prevalence of extrahepatic manifestations in patients with HCV infection, how these impair HRQL, and their costs.
Dr Zobair Younossi and colleagues from Virginia, USA performed a meta-analysis to determine the prevalence of extrahepatic manifestations in patients with HCV infection, how these impair HRQL, and their costs.
The researchers performed systematic reviews of the literature using MEDLINE, CINAHL, and the Cochrane Systematic Review Database, from 1996 through 2014.
The research team identified studies of the following extrahepatic manifestations of HCV infection: mixed cryoglobulinemia, chronic kidney or end-stage renal disease, type 2 diabetes, B-cell lymphoma, lichen planus, Sjögren’s syndrome, porphyria cutanea tarda, rheumatoid-like arthritis, or depression.
The researchers performed a separate meta-analysis for each condition to determine prevalence rates of extrahepatic manifestations of HCV infection and their effects on health-related quality of life.
The team determined the annual costs associated with extrahepatic manifestations of HCV infection.
In an analysis of data from 102 studies, the research team found the most common extrahepatic manifestations to be diabetes, and depression.
HRQL data showed that HCV infection had negative effects on overall physical and mental health.
The research team found that total direct medical costs of extrahepatic manifestations of HCV infection, in 2014 US dollars, were estimated to be $1506 million.
Dr Younossi's team concludes, "In a systematic review and meta-analysis we determined the prevalence, risks, and costs associated with extrahepatic manifestations of HCV infection."
"These estimates should be added to the liver-related burden of disease to obtain a more accurate assessment of the total burden of chronic HCV infection."
"Prospective, real-world studies are needed to increase our understanding of the total clinical and economic effects of HCV infection and treatment on patients and society."
Gastroenterol 2016: 150(7): 1599–1608
17 June 2016
The research team identified studies of the following extrahepatic manifestations of HCV infection: mixed cryoglobulinemia, chronic kidney or end-stage renal disease, type 2 diabetes, B-cell lymphoma, lichen planus, Sjögren’s syndrome, porphyria cutanea tarda, rheumatoid-like arthritis, or depression.
The researchers performed a separate meta-analysis for each condition to determine prevalence rates of extrahepatic manifestations of HCV infection and their effects on health-related quality of life.
The team determined the annual costs associated with extrahepatic manifestations of HCV infection.
In an analysis of data from 102 studies, the research team found the most common extrahepatic manifestations to be diabetes, and depression.
HRQL data showed that HCV infection had negative effects on overall physical and mental health.
The research team found that total direct medical costs of extrahepatic manifestations of HCV infection, in 2014 US dollars, were estimated to be $1506 million.
Dr Younossi's team concludes, "In a systematic review and meta-analysis we determined the prevalence, risks, and costs associated with extrahepatic manifestations of HCV infection."
"These estimates should be added to the liver-related burden of disease to obtain a more accurate assessment of the total burden of chronic HCV infection."
"Prospective, real-world studies are needed to increase our understanding of the total clinical and economic effects of HCV infection and treatment on patients and society."
Gastroenterol 2016: 150(7): 1599–1608
17 June 2016
Source Abstract http://www.gastrohep.com/news/news.asp?id=111904
Thursday, 16 June 2016
June - Recruiting and upcoming hepatitis C clinical trials
Hello folks, as we wait for the FDA's final decision on the approval of Gilead's Sofosbuvir/Velpatasvir expected on June 28, here is a short list of recruiting and upcoming hepatitis C clinical trials for the month of June.
Peppered throughout this post you will find correlating news and interim results from ongoing hepatitis C clinical trials placed before some recruiting information.
Peppered throughout this post you will find correlating news and interim results from ongoing hepatitis C clinical trials placed before some recruiting information.
However, this is not a complete list; to find out if a study is enrolling patients in your area, please click here, or here for hepatitis trials listed by state, as well as HCV Advocate Monthly Pipeline Update for additional information.
News
GS-9857, in combination with sofosbuvir and velpatasvir
June 14 2016
New Combination Therapy May Be Effective Against Chronic HCV Infection
NEW YORK (Reuters Health) - The new NS3/4A protease inhibitor GS-9857, in combination with sofosbuvir and velpatasvir (SOF/VEL), produces sustained viral response in most patients with hepatitis C virus (HCV) genotype 1 or 3 infections, according to a phase 2 trial from Gilead Sciences.
NEW YORK (Reuters Health) - The new NS3/4A protease inhibitor GS-9857, in combination with sofosbuvir and velpatasvir (SOF/VEL), produces sustained viral response in most patients with hepatitis C virus (HCV) genotype 1 or 3 infections, according to a phase 2 trial from Gilead Sciences.
Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02745535
Condition: Chronic Hepatitis C
Intervention: Drug: Sofosbuvir/Velpatasvir/GS-9857
Contacts
Contact: Eleanor Wilson, MD 410-706-1710 ewilson@ihv.umaryland.edu
Contact: Jennifer Hoffmann, MSN/MPH 410-706-0294 jhoffmann@som.umaryland.edu
Condition: Chronic Hepatitis C
Intervention: Drug: Sofosbuvir/Velpatasvir/GS-9857
Contacts
Contact: Eleanor Wilson, MD 410-706-1710 ewilson@ihv.umaryland.edu
Contact: Jennifer Hoffmann, MSN/MPH 410-706-0294 jhoffmann@som.umaryland.edu
Locations
United States, Maryland
Institute of Human Virology Recruiting
Baltimore, Maryland, United States, 21201
United States, Maryland
Institute of Human Virology Recruiting
Baltimore, Maryland, United States, 21201
News
Sofosbuvir/Velpatasvir
Jan 2016
Gilead's Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection received FDA priority review status in January 2016 -- Final FDA Decision Anticipated by June 28, 2016 --
Gilead's Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection received FDA priority review status in January 2016 -- Final FDA Decision Anticipated by June 28, 2016 --
May 2016
EU regulators recommend approving Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes
--Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection--
EU regulators recommend approving Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes
--Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection--
Research
Healio
VIDEO: Sofosbuvir/velpatasvir may offer improved patient reported outcomes
June 6
SAN DIEGO — In this exclusive video from DDW 2016, Zobair Younossi, MD, MPH, chairman of the department of medicine, Inova Fairfax Hospital, and vice president for research of Inova Health System, discusses new data showing the pan-genotypic regimen of a fixed-dose combination of Sovaldi (sofosbuvir, Gilead Sciences) and velpatasvir (Gilead Sciences) was associated with improved patient reported outcomes, or PROs.
Watch the video, here
Additional Information on this blogs website - Sovaldi /Velpatasvir
Not Recruiting Yet
This study is not yet open for participant recruitment
Please refer to this study by its ClinicalTrials.gov identifier: NCT02781558
Contacts - Locations
Contact: Gilead Study Team 342-2097alerts@gilead.com
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF/VEL; Drug: RBV
Contacts - Locations
Contact: Gilead Study Team 342-2097alerts@gilead.com
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF/VEL; Drug: RBV
Not Recruiting Yet
This study is not yet open for participant recruitment
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
Please refer to this study by its ClinicalTrials.gov identifier: NCT02781571
Contacts - Locations
Contact: Gilead Study Team 342-2104alerts@gilead.com
Condition: Hepatitis C Virus Infection Intervention: Drug: SOF/VEL Sponsor: Gilead Sciences
Contacts - Locations
Contact: Gilead Study Team 342-2104alerts@gilead.com
Condition: Hepatitis C Virus Infection Intervention: Drug: SOF/VEL Sponsor: Gilead Sciences
verified May 2016 (Source: ClinicalTrials.gov)
May 20, 2016
May 20, 2016
Recruiting
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
Please refer to this study by its ClinicalTrials.gov identifier: NCT02671500
Condition: Hepatitis C Virus Infection
Intervention: Drug: SOF/VEL
Locations
Malaysia
University of Malaya Recruiting
Kuala Lumpur, Malaysia, 59100
Hospital Tengku Ampuan Afzan Recruiting
Pahang, Malaysia, 25100
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
Please refer to this study by its ClinicalTrials.gov identifier: NCT02671500
Condition: Hepatitis C Virus Infection
Intervention: Drug: SOF/VEL
Locations
Malaysia
University of Malaya Recruiting
Kuala Lumpur, Malaysia, 59100
Hospital Tengku Ampuan Afzan Recruiting
Pahang, Malaysia, 25100
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02738333
Locations - Japan
Contacts
Contact: Gilead Study Team GS-US-337-1903@gilead.com
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: SOF; Drug: RBV
Contact: Gilead Study Team GS-US-337-1903@gilead.com
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: SOF; Drug: RBV
Research
Daclatasvir and Sofosbuvir
Hepatology May 2016
Patients with hepatitis C virus (HCV) genotype 3 infection, especially those with advanced liver disease, are a challenging population in urgent need of optimally effective therapies. The combination of daclatasvir (DCV; pangenotypic nonstructural protein 5A inhibitor) and sofosbuvir (SOF; nucleotide nonstructural protein 5B inhibitor) for 12 weeks previously showed high efficacy (96%) in noncirrhotic genotype 3 infection. The phase III ALLY-3+ study (N = 50) evaluated DCV-SOF with ribavirin (RBV) in treatment-naïve (n = 13) or treatment-experienced (n = 37) genotype 3-infected patients with advanced fibrosis (n = 14) or compensated cirrhosis (n = 36).
Patients were randomized 1:1 to receive open-label DCV-SOF (60 + 400 mg daily) with weight-based RBV for 12 or 16 weeks. The primary endpoint was sustained virological response at post-treatment week 12 (SVR12). SVR12 (intention-to-treat) was 90% overall (45 of 50): 88% (21 of 24) in the 12-week (91% observed) and 92% (24 of 26) in the 16-week group. All patients with advanced fibrosis achieved SVR12. SVR12 in patients with cirrhosis was 86% overall (31 of 36): 83% (15 of 18) in the 12-week (88% observed) and 89% (16 of 18) in the 16-week group; for treatment-experienced patients with cirrhosis, these values were 87% (26 of 30), 88% (14 of 16; 93% observed), and 86% (12 of 14), respectively. One patient (12-week group) did not enter post-treatment follow-up (death unrelated to treatment). There were 4 relapses (2 per group) and no virological breakthroughs. The most common adverse events (AEs) were insomnia, fatigue, and headache. There were no discontinuations for AEs and no treatment-related serious AEs.
Conclusion: The all-oral regimen of DCV-SOF-RBV was well tolerated and resulted in high and similar SVR12 after 12 or 16 weeks of treatment among genotype 3-infected patients with advanced liver disease, irrespective of past HCV treatment experience.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02673489
Condition: Hepatitis C
Interventions: Drug: DCV; Drug: SOF; Drug: RBV
Locations
United States, California
University Of Southern California
Los Angeles, California, United States, 90033
Contact: Saro Khemichian, Site 0011
U.Cal.-San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Norah Terrault, Site 0019
United States, Georgia
Gastrointestinal Specialists Of Georgia Pc
Marietta, Georgia, United States, 30060
Contact: Aasim Sheikh, Site 0018
United States, Illinois
Ruth M. Rothstein Core Center
Chicago, Illinois, United States, 60612
Contact: Gregory Huhn, Site 0010
United States, Maryland
Digestive Disease Associates, P.A.
Catonsville, Maryland, United States, 21228
Contact: Natarajan Ravendhran, Site 0014
United States, Pennsylvania
Eastern Pennsylvania Gastroenterology And Liver Specialists
Allentown, Pennsylvania, United States, 18104
Contact: Adam Peyton, Site 0012
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
Contact: Thomas Sepe, Site 0017
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Contact: Reem Ghalib, Site 0009
Methodist Transplant Physicians
Dallas, Texas, United States, 75203
Contact: Parvez Mantry, Site 0020
Texas Liver Institute
San Antonio, Texas, United States, 78215
Contact: Fred Poordad, Site 0013
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22031
Contact: James Cooper, Site 0008
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
Richmond, Virginia, United States, 23226
Contact: Mitchell Shiffman, Site 0016
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4Z6
Contact: Site 0003
Local Institution
Edmonton, Alberta, Canada, T6G 2G3
Contact: Site 0005
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2K5
Contact: Site 0004
Local Institution
Victoria, British Columbia, Canada, V8V 3P9
Contact: Site 0001
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2C4
Contact: Site 0007
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0002
Canada
Local Institution Recruiting
Regina Saskatchewan, Canada, S4O 0W5
Contact: Site 0006
Condition: Hepatitis C
Interventions: Drug: DCV; Drug: SOF; Drug: RBV
Locations
United States, California
University Of Southern California
Los Angeles, California, United States, 90033
Contact: Saro Khemichian, Site 0011
U.Cal.-San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Norah Terrault, Site 0019
United States, Georgia
Gastrointestinal Specialists Of Georgia Pc
Marietta, Georgia, United States, 30060
Contact: Aasim Sheikh, Site 0018
United States, Illinois
Ruth M. Rothstein Core Center
Chicago, Illinois, United States, 60612
Contact: Gregory Huhn, Site 0010
United States, Maryland
Digestive Disease Associates, P.A.
Catonsville, Maryland, United States, 21228
Contact: Natarajan Ravendhran, Site 0014
United States, Pennsylvania
Eastern Pennsylvania Gastroenterology And Liver Specialists
Allentown, Pennsylvania, United States, 18104
Contact: Adam Peyton, Site 0012
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
Contact: Thomas Sepe, Site 0017
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Contact: Reem Ghalib, Site 0009
Methodist Transplant Physicians
Dallas, Texas, United States, 75203
Contact: Parvez Mantry, Site 0020
Texas Liver Institute
San Antonio, Texas, United States, 78215
Contact: Fred Poordad, Site 0013
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22031
Contact: James Cooper, Site 0008
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
Richmond, Virginia, United States, 23226
Contact: Mitchell Shiffman, Site 0016
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4Z6
Contact: Site 0003
Local Institution
Edmonton, Alberta, Canada, T6G 2G3
Contact: Site 0005
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2K5
Contact: Site 0004
Local Institution
Victoria, British Columbia, Canada, V8V 3P9
Contact: Site 0001
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2C4
Contact: Site 0007
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0002
Canada
Local Institution Recruiting
Regina Saskatchewan, Canada, S4O 0W5
Contact: Site 0006
Research
Of Interest
Aim
Real-world experience with 3-D regimen lives up to phase 3 studies
BARCELONA — In this video perspective from the International Liver Congress 2016, Heiner Wedemeyer, MD, research group leader, department of gastroenterology, hepatology and endocrinology at Hannover Medical School in Germany, discusses his real-world experience with the German Hepatitis C-Registry. Specifically, Wedemeyer looked at the impact of Viekirax (ombitasvir/parataprevir/ritonavir, AbbVie) and Exviera (dasabuvir, AbbVie), together known as Viekira Pak in the United States, in his own practice, showing that the everyday impact is similar to that seen in phase 3 trials.
BARCELONA — In this video perspective from the International Liver Congress 2016, Heiner Wedemeyer, MD, research group leader, department of gastroenterology, hepatology and endocrinology at Hannover Medical School in Germany, discusses his real-world experience with the German Hepatitis C-Registry. Specifically, Wedemeyer looked at the impact of Viekirax (ombitasvir/parataprevir/ritonavir, AbbVie) and Exviera (dasabuvir, AbbVie), together known as Viekira Pak in the United States, in his own practice, showing that the everyday impact is similar to that seen in phase 3 trials.
Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02581189
Contacts
Contact: Nabil Ackad, MD 514-832-7439 nabil.ackad@abbvie.com
Contact: Catherine Pinsonnault, BS 514-832-7015 catherine.pinsonnault@abbvie.com
Locations
Canada
Condition: Chronic Hepatitis C
Intervention:
Contacts
Contact: Nabil Ackad, MD 514-832-7439 nabil.ackad@abbvie.com
Contact: Catherine Pinsonnault, BS 514-832-7015 catherine.pinsonnault@abbvie.com
Locations
Canada
Condition: Chronic Hepatitis C
Intervention:
Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02615145
Locations
Germany
Condition: Chronic Hepatitis C
Recruiting
Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02636608
Locations
Hungary
Condition: Chronic Hepatitis C
Recruiting
Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02798315
Locations
Kuwait
Condition: Chronic Hepatitis C
Recruiting
Condition: Chronic Hepatitis C
Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02618928
Locations
France
Condition: Chronic Hepatitis C
Condition: Chronic Hepatitis C
Not Recruiting Yet
This study is not yet open for participant recruitment
Please refer to this study by its ClinicalTrials.gov identifier: NCT02783976
Contacts - Locations
Contact: 334-1685 Gilead Study Team GS-US-334-1685@gilead.com
Condition: HCV Infection Intervention: Drug: SOF Sponsor: Gilead Sciences
Contacts - Locations
Contact: 334-1685 Gilead Study Team GS-US-334-1685@gilead.com
Condition: HCV Infection Intervention: Drug: SOF Sponsor: Gilead Sciences
verified May 2016 (Source: ClinicalTrials.gov)
May 24, 2016
May 24, 2016
Not Recruiting Yet
Drug: sofosbuvir/ledipasvir; Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: elbasvir/grazoprevir
This study is not yet open for participant recruitment
Please refer to this study by its ClinicalTrials.gov identifier: NCT02781571
Contacts
Contact: Gilead Study Team 342-2104alerts@gilead.com
Condition: Chronic Hepatitis C Interventions
Contacts
Contact: Gilead Study Team 342-2104alerts@gilead.com
Condition: Chronic Hepatitis C Interventions
Drug: sofosbuvir/ledipasvir; Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: elbasvir/grazoprevir
Sponsors: University of North Carolina, Chapel Hill; Patient-Centered Outcomes Research Institute; Merck Sharp & Dohme Corp.; AbbVie - verified May 2016 (Source: ClinicalTrials.gov)
Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Contact: Leila Bucary Leila.Bucary@gunet.georgetown.edu
Principal Investigator: Coleman Smith, MD
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Diane White, CCRP 734-763-6647 dfwhite@umich.edu
Principal Investigator: Anna SF Lok, MD
United States, Minnesota
Minnesota Gastro
Minneapolis, Minnesota, United States, 55455
Contact: Teri Carlson 612-625-0673 carls273@umn.edu
Principal Investigator: Coleman Smith, MD
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Mahado Ali, RN 612-626-1716 alixx639@umn.edu
Principal Investigator: Mohamed Hassan, MD
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
Contact: Karri L Moore 314-977-9400 kmoore35@slu.edu
Principal Investigator: Adrian DiBisceglie, MD
United States, Nebraska
University of Nebraska Medical Ctr
Omaha, Nebraska, United States, 68105
Contact: Mary Capadano 402-559-3652 mcapadano@unmc.edu
Principal Investigator: Mark Mailliard, MD
United States, New Mexico
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
Contact: Christopher Gallegos 505-216-1546 cgallegos@southwestcare.org
Principal Investigator: Trevor N Hawkins, MD
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Contact: Jennie Chavis 212-305-3839 jc4380@cumc.columbia.edu
Principal Investigator: Elizabeth Verna, MD
United States, North Carolina
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Tiffany Pritchett, B.A. tpritch@med.unc.edu
Principal Investigator: Michael W. Fried, M.D
Duke University Medical Center
Durham, North Carolina, United States, 27710
Contact: Loranda Ross 919-681-2941 loranda.ross@duke.edu
Principal Investigator: Anrdrew Muir, MD
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Contact: Susan Sibert, RN, CCRC 513-584-2363 susan.sibert@uc.edu
Principal Investigator: Kenneth Sherman, MD
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Amina Wirjosemito 215-615-5471 Amina.Wirjosemito@uphs.upenn.edu
Principal Investigator: Rajender Reddy, MD
United States, Texas
Research Specialist of Texas
Houston, Texas, United States, 77030
Contact: Paula Juarez 713-634-5110 pjuarez@texasliver.com
Principal Investigator: Joseph Galati, MD
United States, Virginia
Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)
Richmond, Virginia, United States, 23226
Contact: Susan Vollum, RN, CRC 804-977-8921 susan_vollum@bshsi.org
Principal Investigator: Mitchell L. Shiffman, MD
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Contact: Leila Bucary Leila.Bucary@gunet.georgetown.edu
Principal Investigator: Coleman Smith, MD
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Diane White, CCRP 734-763-6647 dfwhite@umich.edu
Principal Investigator: Anna SF Lok, MD
United States, Minnesota
Minnesota Gastro
Minneapolis, Minnesota, United States, 55455
Contact: Teri Carlson 612-625-0673 carls273@umn.edu
Principal Investigator: Coleman Smith, MD
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Mahado Ali, RN 612-626-1716 alixx639@umn.edu
Principal Investigator: Mohamed Hassan, MD
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
Contact: Karri L Moore 314-977-9400 kmoore35@slu.edu
Principal Investigator: Adrian DiBisceglie, MD
United States, Nebraska
University of Nebraska Medical Ctr
Omaha, Nebraska, United States, 68105
Contact: Mary Capadano 402-559-3652 mcapadano@unmc.edu
Principal Investigator: Mark Mailliard, MD
United States, New Mexico
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
Contact: Christopher Gallegos 505-216-1546 cgallegos@southwestcare.org
Principal Investigator: Trevor N Hawkins, MD
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Contact: Jennie Chavis 212-305-3839 jc4380@cumc.columbia.edu
Principal Investigator: Elizabeth Verna, MD
United States, North Carolina
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Tiffany Pritchett, B.A. tpritch@med.unc.edu
Principal Investigator: Michael W. Fried, M.D
Duke University Medical Center
Durham, North Carolina, United States, 27710
Contact: Loranda Ross 919-681-2941 loranda.ross@duke.edu
Principal Investigator: Anrdrew Muir, MD
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Contact: Susan Sibert, RN, CCRC 513-584-2363 susan.sibert@uc.edu
Principal Investigator: Kenneth Sherman, MD
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Amina Wirjosemito 215-615-5471 Amina.Wirjosemito@uphs.upenn.edu
Principal Investigator: Rajender Reddy, MD
United States, Texas
Research Specialist of Texas
Houston, Texas, United States, 77030
Contact: Paula Juarez 713-634-5110 pjuarez@texasliver.com
Principal Investigator: Joseph Galati, MD
United States, Virginia
Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)
Richmond, Virginia, United States, 23226
Contact: Susan Vollum, RN, CRC 804-977-8921 susan_vollum@bshsi.org
Principal Investigator: Mitchell L. Shiffman, MD
Additional Clinical Information
Downloadable slideset
Regimens for treating genotype 2, 3, 4, 5, or 6 HCV infection
New At Clinical Care Options
Non–Genotype 1 HCV Now and in the Near Future
Posted June 9
In this downloadable slideset, Jordan J. Feld, MD, MPH, and Andrew J. Muir, MD, review current and emerging regimens for treating patients with genotype 2, 3, 4, 5, or 6 HCV infection.
Download slides here, view all updates here...
Best of viral hepatitis at ILC2016
April 23
Video Link
In this video, Pr. Jean-Michel Pawlotsky and Pr. Thomas Berg review and discuss the “Best of viral hepatitis at ILC2016”. An extensive summary of the latest advances in the fields of hepatitis B and hepatitis C is covered
New At Clinical Care Options
Non–Genotype 1 HCV Now and in the Near Future
Posted June 9
In this downloadable slideset, Jordan J. Feld, MD, MPH, and Andrew J. Muir, MD, review current and emerging regimens for treating patients with genotype 2, 3, 4, 5, or 6 HCV infection.
Download slides here, view all updates here...
** Free registration required
Watch
Advances in Chronic Hepatitis C: Management and Treatment
Review will feature four HCV experts reviewing and discussing key presentations on chronic hepatitis C presented at EASL 2016. The review and discussion will focus on HCV therapeutic options and developments, including: current treatment and management strategies, algorithms and recommendations; therapies in development; epidemiology; and diagnosis and clinical management of specific patient populations, including HCV/HIV co-infected and cirrhotic patients.
LAUNCH ON-DEMAND PROGRAM
Advances in Chronic Hepatitis C: Management and Treatment
Review will feature four HCV experts reviewing and discussing key presentations on chronic hepatitis C presented at EASL 2016. The review and discussion will focus on HCV therapeutic options and developments, including: current treatment and management strategies, algorithms and recommendations; therapies in development; epidemiology; and diagnosis and clinical management of specific patient populations, including HCV/HIV co-infected and cirrhotic patients.
LAUNCH ON-DEMAND PROGRAM
Best of viral hepatitis at ILC2016
April 23
Video Link
In this video, Pr. Jean-Michel Pawlotsky and Pr. Thomas Berg review and discuss the “Best of viral hepatitis at ILC2016”. An extensive summary of the latest advances in the fields of hepatitis B and hepatitis C is covered
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