Hepatitis C New Drugs Review
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Hepatitis C New Drugs Review
FDA approved Incivek(telaprevir, Vertex) on Monday 23 May by its PDUFA deadline.A paradigm shift in the treatment of Hepatitis C virus infection. http://knol.google.com/k/krishan-maggon/boceprevir-merck-telaprevir-vertex/3fy5eowy8suq3/151#
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Created public version #121 of the knol: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval"

Created public version #121 of the knol: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval" | Hepatitis C New Drugs Review | Scoop.it
Krishan Maggon published version 121 of a knol titled: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval"...
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Nature Reviews Gastroenterology & Hepatology - Table of Contents alert Volume 13 Issue 10

Nature Reviews Gastroenterology & Hepatology - Table of Contents alert Volume 13 Issue 10 | Hepatitis C New Drugs Review | Scoop.it
If you are unable to see the message below, click here to view . Advertisement Covering the evolution of science since 1869
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Quantitative proteomics reveals FLNC as a potential progression marker for the development of hepatocellular carcinoma | Qi | Oncotarget

Quantitative proteomics reveals FLNC as a potential progression marker for the development of hepatocellular carcinoma | Qi | Oncotarget | Hepatitis C New Drugs Review | Scoop.it
Quantitative proteomics reveals FLNC as a potential progression marker for the development of hepatocellular carcinoma
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Medivir: Updated Interim Phase IIa Data Demonstrate That the Combination of Simeprevir, Odalasvir and AL-335 Has a High Level of Efficacy in HCV Patients

Medivir: Updated Interim Phase IIa Data Demonstrate That the Combination of Simeprevir, Odalasvir and AL-335 Has a High Level of Efficacy in HCV Patients | Hepatitis C New Drugs Review | Scoop.it
Medivir AB (STO:MVIRB) today announced that updated interim data from a phase IIa study being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies (Janssen), were presented on September 23rd at the European Association for the Study of the Liver (EASL) Special Conference in Paris, France.
Krishan Maggon 's insight:
Based on the interim data from this study, the triple combination of simeprevir 75mg QD, odalasvir 25mg QD and AL-335 400mg QD has been selected for further development. The development program for the triple combination will include a multi-center, randomized, open-label study that will enroll treatment-naive and treatment-experienced non-cirrhotic patients chronically infected with hepatitis C virus genotypes 1, 2, 4, 5, and 6. In addition, the ongoing phase IIa study is assessing the triple combination in patients with or without compensated cirrhosis, and with HCV genotype 3 infection.
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EASL Recommendations on Treatment of Hepatitis C 2016

EASL Recommendations on Treatment of Hepatitis C 2016 | Hepatitis C New Drugs Review | Scoop.it
RT @JHepatology: EASL Recommendations on Treatment of Hepatitis C 2016
https://t.co/zjeDd06OCp
#HCV #HepC #HepatitisC https://t.co/ZI1aAPvB…

Hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide [1]. The long-term impact of HCV infection is highly variable, ranging from minimal histological changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma (HCC). The number of chronically infected persons worldwide is estimated to be about 180 million [2], but most are unaware of their infection. Clinical care for patients with HCV-related liver disease has advanced considerably during the last two decades, thanks to an enhanced understanding of the pathophysiology of the disease, and because of developments in diagnostic procedures and improvements in therapy and prevention.
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Clinical and Translational Gastroenterology - Hepatitis C Treatment and Barriers to Eradication

Clinical and Translational Gastroenterology - Hepatitis C Treatment and Barriers to Eradication | Hepatitis C New Drugs Review | Scoop.it
Brought to you by the American College of Gastroenterology.
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Targeting Cardio-Metabolic Diseases: A focus on Liver Fibrosis and NASH Targets at CHI’s 14th Discovery Targets

Targeting Cardio-Metabolic Diseases: A focus on Liver Fibrosis and NASH Targets at CHI’s 14th Discovery Targets | Hepatitis C New Drugs Review | Scoop.it
LIVE 9/21 8AM to 2:40PM Targeting Cardio-Metabolic Diseases: A focus on Liver Fibrosis and NASH Targets at CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston http://www.discoveryontarget.com/ http://www.discoveryontarget.com/crispr-therapies/...
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Akarna Therapeutics FXR Agonists NASH

Akarna Therapeutics FXR Agonists NASH | Hepatitis C New Drugs Review | Scoop.it
NASH and FXR Accumulation of lipids (steatosis) within the liver cells (hepatocytes) leads to fatty liver disease, which is followed by chronic liver inflammation and liver fibrosis resulting in progression of fatty liver disease to NASH. FXR plays a key role in regulating each of these stages of NASH.
Krishan Maggon 's insight:
FXR agonists reduce lipid accumulation
FXR agonists reduce inflammation
FXR agonists block the progression of fibrosis

Akarna is  developing small molecule, non-bile acid FXR agonist drugs and has been acquired by Allergan
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Hepatitis C infection: A multi-faceted systemic disease with clinical, patient reported and economic consequences

Hepatitis C infection: A multi-faceted systemic disease with clinical, patient reported and economic consequences | Hepatitis C New Drugs Review | Scoop.it
Summary Hepatitis C virus infection (HCV) affects approximately 170–200 million individuals globally. HCV is one of the primary causes of hepatocellular carcinoma (HCC) and cirrhosis and has been identified as the leading indication for liver transplantation in most Western countries. Because HCV is a systemic disease with hepatic, extrahepatic, economic and patient reported consequences, it is important for healthcare practitioners to understand the comprehensive and multi-faceted picture of this disease. In this context, it is important to fully appreciate the impact of HCV on the individual patient and the society. With the recent advent of the new generation of direct antiviral agents, the long standing goal of eradicating HCV in most infected patients has been accomplished. Therefore, now more than ever, it is critical to assess the total benefits of sustained virological response in a comprehensive manner. This should not be limited to the clinical benefits of HCV cure, but also to account for the improvement of patient reported health and economic outcomes of HCV cure. It is only through this comprehensive approach to HCV and its treatment that we will understand the full impact of this disease and the tremendous gains that have been achieved with the new antiviral regimens.
Krishan Maggon 's insight:
DOI: http://dx.doi.org/10.1016/j.jhep.2016.07.005

October 2016Volume 65, Issue 1, Supplement, Pages S109–S119
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The history of hepatitis C virus (HCV): Basic research reveals unique features in phylogeny, evolution and the viral life cycle with new perspectives for epidemic control

The history of hepatitis C virus (HCV): Basic research reveals unique features in phylogeny, evolution and the viral life cycle with new perspectives for epidemic control | Hepatitis C New Drugs Review | Scoop.it
Summary The discovery of hepatitis C virus (HCV) in 1989 permitted basic research to unravel critical components of a complex life cycle for this important human pathogen. HCV is a highly divergent group of viruses classified in 7 major genotypes and a great number of subtypes, and circulating in infected individuals as a continuously evolving quasispecies destined to escape host immune responses and applied antivirals. Despite the inability to culture patient viruses directly in the laboratory, efforts to define the infectious genome of HCV resulted in development of experimental recombinant in vivo and in vitro systems, including replicons and infectious cultures in human hepatoma cell lines. And HCV has become a model virus defining new paradigms in virology, immunology and biology. For example, HCV research discovered that a virus could be completely dependent on microRNA for its replication since microRNA-122 is critical for the HCV life cycle. A number of other host molecules critical for HCV entry and replication have been identified. Thus, basic HCV research revealed important molecules for development of host targeting agents (HTA). The identification and characterization of HCV encoded proteins and their functional units contributed to the development of highly effective direct acting antivirals (DAA) against the NS3 protease, NS5A and the NS5B polymerase. In combination, these inhibitors have since 2014 permitted interferon-free therapy with cure rates above 90% among patients with chronic HCV infection; however, viral resistance represents a challenge. Worldwide control of HCV will most likely require the development of a prophylactic vaccine, and numerous candidates have been pursued. Research characterizing features critical for antibody-based virus neutralization and T cell based virus elimination from infected cells is essential for this effort. If the world community promotes an ambitious approach by applying current DAA broadly, continues to develop alternative viral- and host- targeted antivirals to combat resistant variants, and invests in the development of a vaccine, it would be possible to eradicate HCV. This would prevent about 500 thousand deaths annually. However, given the nature of HCV, the millions of new infections annually, a high chronicity rate, and with over 150 million individuals with chronic infection (which are frequently unidentified), this effort remains a major challenge for basic researchers, clinicians and communities.
Krishan Maggon 's insight:
J. Hepatology October 2016Volume 65, Issue 1, Supplement, Pages S2–S21


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Most patients prefer oral dual therapy in chronic hepatitis C

Most patients prefer oral dual therapy in chronic hepatitis C | Hepatitis C New Drugs Review | Scoop.it
(HealthDay)—For patients with chronic hepatitis C (CHC), most prefer oral therapy with sofosbuvir (SOF) and ribavirin (RBV) versus triple therapy involving pegylated interferon (PegIFN), according to a study published onlin...
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QSAR and Molecular Modeling Studies on a Series of Indole-based Pyridone Analogues as HCV NS5B Polymerase Inhibitors : Ingenta Connect

QSAR and Molecular Modeling Studies on a Series of Indole-based Pyridone Analogues as HCV NS5B Polymerase Inhibitors : Ingenta Connect | Hepatitis C New Drugs Review | Scoop.it

Abstract: Quantitative structure-activity relationship (QSAR) and molecular modeling studies have been performed on a series of indole-based pyridone analogues as hepatitis C virus (HCV) NS5B polymerase inhibitors. A multiple linear regression (MLR) analysis has shown that the presence of hydrogen- bond donors in the molecule plays a negative role, but the substituents present on the indole ring sterically favor the activity of indole-based pyridine analogues. Using the MLR analysis model, some new analogues of indole-based pyridone with better potency have been predicted. Docking study has been performed on all the predicted compounds to study their binding modes with the receptor.


Keywords: Hepatitis C virus inhibitors; Indole-based pyridone analogues; Molecular docking; NS5B polymerase inhibitors; Quantitative structureactivity relationships Document Type: Research Article Publication [...]
Krishan Maggon 's insight:
Authors: Singh, Neelu; Shaik, Basheerulla; Agrawal, Neeraj; K, Anita; K. Agrawal, Vijay; P. Gupta, Satya 

Source: Letters in Drug Design & Discovery, Volume 13, Number 8, October 2016, pp. 757-770(14) 

Publisher: Bentham Science Publishers
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Affinity maturation of a broadly neutralizing human monoclonal antibody that prevents acute HCV... - Linkis.com

Affinity maturation of a broadly neutralizing human monoclonal antibody that prevents acute HCV... - Linkis.com | Hepatitis C New Drugs Review | Scoop.it
Affinity maturation of a broadly neutralizing human monoclonal antibody that... https://t.co/jYKrN0M7ee by @darmtag via @c0nvey
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AbbVie VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets)  Eight-Week Treatment SVR 98% in Genotype 1b Chronic Hepatitis C 

AbbVie VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets)  Eight-Week Treatment SVR 98% in Genotype 1b Chronic Hepatitis C  | Hepatitis C New Drugs Review | Scoop.it
NORTH CHICAGO, Ill., Sept. 23, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data showing high response rates with just eight weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) treatment. In the Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12).1 These data were presented today at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, in Paris, France and included in the newly published 'EASL Recommendations on Treatment of Hepatitis C.' VIEKIRAX + EXVIERA is currently approved in the European Union for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.
Krishan Maggon 's insight:
98 percent of previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVR12 in Phase 3b GARNET study1 - First study evaluating 8 weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets)1

GT1b is the most common subtype globally,2 accounting for 47 percent of the nine million people infected with chronic HCV in Europe alone3,4 

- GARNET study results on 8-week treatment duration included in newly published 'EASL Recommendations on Treatment of Hepatitis C'
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Drug Users on Direct-Acting Virals Need Help to Complete Hep C Regimens

Drug Users on Direct-Acting Virals Need Help to Complete Hep C Regimens | Hepatitis C New Drugs Review | Scoop.it
Even when people inject drugs have access to direct-acting antivirals for hepatitis C infection there can be barriers to getting them to complete their drug regimens.
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How Gilead Dominates the HCV Space - Market Realist

How Gilead Dominates the HCV Space - Market Realist | Hepatitis C New Drugs Review | Scoop.it
In January 2012, Gilead Sciences (GILD) acquired Pharmasset and got access to sofosbuvir. In December 2013, the FDA approved sofosbuvir under the brand name Sovaldi.
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Mayo Clinic researchers update understanding of damaging liver disease

Mayo Clinic researchers update understanding of damaging liver disease | Hepatitis C New Drugs Review | Scoop.it
ROCHESTER, Minn. — An article published today in the New England Journal of Medicine updates the medical community on a potentially d…
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Sofosbuvir plus simeprevir for the treatment of genotype 1 chronic hepatitis C: a review of evidence

Sofosbuvir plus simeprevir for the treatment of genotype 1 chronic hepatitis C: a review of evidence | Hepatitis C New Drugs Review | Scoop.it
(2016). Sofosbuvir plus simeprevir for the treatment of genotype 1 chronic hepatitis C: a review of evidence. Expert Review of Gastroenterology & Hepatology. Ahead of Print.
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Glypican-3 Targeting Immunotoxins for the Treatment of Liver Cancer

Glypican-3 Targeting Immunotoxins for the Treatment of Liver Cancer | Hepatitis C New Drugs Review | Scoop.it
Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, yet no effective therapeutics exist.

Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, yet no effective therapeutics exist. This review provides an overview of the recent development of recombinant immunotoxins for the treatment of glypican-3 (GPC3) expressing HCC. GPC3 is a cell surface heparan sulfate proteoglycan that is overexpressed in HCC, but is absent from normal adult human tissues. Treatment of HCC with anti-GPC3 immunotoxins represents a new therapeutic option. Using phage display and hybridoma technologies, three high affinity antibodies (HN3, HS20 and YP7) have been generated against GPC3. Two of these antibodies (HN3 and HS20) have demonstrated the ability to inhibit Wnt/Yap signaling, leading to a reduction in liver cancer cell proliferation. By combining the HN3 antibody capable of inhibiting Wnt/Yap signaling with the protein synthesis inhibitory domain of the Pseudomonas exotoxin, a recombinant immunotoxin that exhibits a dual inhibitory mechanism was generated. This immunotoxin was found to be highly effective in the treatment of human HCCs in mouse xenograft models. Engineering of the toxin fragment to reduce the level of immunogenicity is currently being explored. The development of immunotoxins provides opportunities for novel liver cancer therapies. 

Keywords: recombinant immunotoxin; glypican-3 (GPC3); hepatocellular carcinoma; liver cancer; monoclonal antibodies; pseudomonas exotoxin
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Allergan: Examining The Premiums Paid

Allergan: Examining The Premiums Paid | Hepatitis C New Drugs Review | Scoop.it
Allergan acquires Tobira Therapeutics for +$1B to gain entry into the NASH market.Tobira's leading drug candidate can serve as a cornerstone for Allergan's new
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Big Pharma, Biotech Attack NASH Liver Illness From All Sides

Big Pharma, Biotech Attack NASH Liver Illness From All Sides | Hepatitis C New Drugs Review | Scoop.it
It’s been called a “silent epidemic” that’s slowly wasting away the livers of millions of Americans while doctors have a paltry understanding of the disease and no approved treatments.

Non-alcoholic steatohepatitis, or NASH, is now in the sights of more than a dozen drugmakers. Allergan Plc became the latest Tuesday. It announced two deals in less than 12 hours to acquire companies developing NASH treatments, including Tobira Therapeutics Inc. for as much as $1.7 billion in what Chief Executive Officer Brent Saunders said Wednesday was a “very competitive situation.” 

Allergan is racing companies ranging from startup Intercept Pharmaceuticals Inc. to giants including Gilead Sciences Inc. and Pfizer Inc. to reach an untapped market that could be worth $5 billion to $10 billion a year, according to a May estimate by RBC Capital Markets Corp. analyst Michael Yee.
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Host – hepatitis C viral interactions: The role of genetics

Host – hepatitis C viral interactions: The role of genetics | Hepatitis C New Drugs Review | Scoop.it
Summary Hepatitis C virus (HCV) is a major cause of chronic viral hepatitis that can lead to cirrhosis and hepatocellular carcinoma. Only a minority of patients can clear the virus spontaneously. Elimination of HCV during acute infection correlates with a rapid induction of innate, especially interferon (IFN)-induced genes, and a delayed induction of adaptive immune responses. There is a strong association between genetic variants in the IFNλ (IL28B) locus with the rate of spontaneous clearance. Individuals with the ancestral IFNλ4 allele capable of producing a fully active IFNλ4 are paradoxically not able to clear HCV in the acute phase and develop chronic hepatitis C (CHC) with more than 90% probability. In the chronic phase of HCV infection, the wild-type IFNλ4 genotype is strongly associated with an induction of hundreds of classical type I/type III IFN stimulated genes in hepatocytes. However, the activation of the endogenous IFN system in the liver is ineffective in clearing HCV, and is even associated with impaired therapeutic responses to pegylated (Peg)IFNα containing treatments. While the role of genetic variation in the IFNλ locus to the outcome of CHC treatment has declined, it is clear that variation not only at this locus, but also at other loci, modulate clinically important liver phenotypes, including inflammation, fibrosis progression and the development of hepatocellular cancer. In this review, we summarize current knowledge about the role of genetics in the host response to viral hepatitis and the potential future evolution of knowledge in understanding host-viral interactions.
Krishan Maggon 's insight:
J. Hepatology October 2016Volume 65, Issue 1, Supplement, Pages S22–S32


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San Francisco on Track to Eliminate HCV

San Francisco on Track to Eliminate HCV | Hepatitis C New Drugs Review | Scoop.it
San Francisco, CA, with the backing of generous state Medicaid coverage, believes it can wipe out hepatitis C in vulnerable populations including people with HIV, intravenous drug users, homeless people, and prisoners in the city's jails.
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Affinity maturation of a broadly neutralizing human monoclonal antibody that prevents acute HCV infection - Keck - 2016 - Hepatology - Wiley Online Library

Affinity maturation of a broadly neutralizing human monoclonal antibody that prevents acute HCV infection - Keck - 2016 - Hepatology - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
Affinity maturation of a broadly neutralizing human monoclonal antibody that prevents acute HCV infection https://t.co/i50Sq8qNEv
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Hepatitis C: The Silent Epidemic

Hepatitis C: The Silent Epidemic | Hepatitis C New Drugs Review | Scoop.it
Maylin Rodriguez-Paez Hepatitis C is taking our country by surprise. Over three million people ar
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Phase 3 NASH Trials: Genfit's Drug Will Beat Intercept's OCA To Market

Phase 3 NASH Trials: Genfit's Drug Will Beat Intercept's OCA To Market | Hepatitis C New Drugs Review | Scoop.it
PHASE 3 NASH Trials: GENFIT’s DRUG WILL BEAT INTERCEPT’s OCA TO MARKET https://t.co/unlqBwwzLN
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