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UPDATED: Gilead's sofosbuvir cures some of the toughest hepatitis C cases - FierceBiotech

Medical Daily
UPDATED: Gilead's sofosbuvir cures some of the toughest hepatitis C cases
FierceBiotech
Twenty-five members of the group received doses of ribavirin based on weight, with the other 25 getting a low dose and all taking sofosbuvir.
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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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CDC 2013 Viral Hepatitis Surveillance Report

CDC 2013 Viral Hepatitis Surveillance Report | Hepatitis C New Drugs Review | Scoop.it
The Centers for Disease Control and Prevention’s Division of Viral Hepatitis has released the 2013 Viral Hepatitis Surveillance Report, which provides data on hepatitis A virus (HAV), hepatitis B virus (HBV), and hepatitis C virus (HCV) in the.

 

Below are a few highlights from the 2013 viral hepatitis surveillance data:


Reported cases of acute (new) HCV infection increased by 152% from 2010 to 2013, with the largest increases in reports for cases among young adults aged 20-29 years. In 2013, about 132,000 cases of past or present hepatitis C (meaning persons who were once infected and cleared the infection and those who are still living with HCV infection) were reported to CDC. Most of these reported cases were among persons 40 years of age and younger.


Deaths from hepatitis C increased from 2009 through 2013; during this period, adults aged 55-64 years had the highest mortality rate.


Reports of acute (new) HBV infection increased for the first time since 1990; with a 5.4% increase from 2012.


Six jurisdictions funded to collect enhanced hepatitis data reported a total of 2,756 cases of chronic hepatitis B; about half of these cases were among Asians/Pacific Islanders (APIs) and almost two-thirds were among people born outside the United States. The number of hepatitis A cases reported to CDC in 2013 increased 14% over 2012; many of the reported infections occurred as part of an outbreak involving people who ate contaminated imported, frozen pomegranate seeds

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Surveillance for Viral Hepatitis – United States, 2013

Entire report in a printable format  [PDF - 1,511 KB - 65 pages]

Contents  Summary

 

±Background

  Hepatitis A

  Hepatitis B

  Hepatitis C

  Discussion


http://www.cdc.gov/hepatitis/Statistics/2013Surveillance/index.htm

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Galmed: Potential Blockbuster In NASH, A Market Not Unlike Hep-C 3 Years Ago ... - Seeking Alpha

Galmed: Potential Blockbuster In NASH, A Market Not Unlike Hep-C 3 Years Ago ... - Seeking Alpha | Hepatitis C New Drugs Review | Scoop.it
(Note: this article has been reviewed by Dr Maya Halpern, CMO, Galmed Pharma, for conceptual and factual errors. I have received no compensation from Galmed.
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How Hep C survives immune system attacks - R & D Magazine

How Hep C survives immune system attacks - R & D Magazine | Hepatitis C New Drugs Review | Scoop.it
Warring armies use a variety of tactics as they struggle to gain the upper hand. Among their tricks is to attack with a decoy force that occupies the defenders while an unseen force launches a separate attack that the defenders fail to notice.
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AbbVie Presents New Data for its Investigational Hepatitis C Treatment in Japanese Patients With and Without Cirrhosis - May 26, 2015

AbbVie Presents New Data for its Investigational Hepatitis C Treatment in Japanese Patients With and Without Cirrhosis - May 26, 2015 | Hepatitis C New Drugs Review | Scoop.it

NORTH CHICAGO, Ill., May 26, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) presented new results from the Phase 3 GIFT-I study of its investigational, all-oral, interferon (IFN)- and ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.1 GIFT-I evaluated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected Japanese patients, with and without cirrhosis, who were either treatment-naïve or IFN (with or without RBV) treatment-experienced.1 The primary endpoint was achieved, demonstrating 95 percent (n=106/112) SVR12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese patients who were eligible for therapy with IFN and had a high viral load.1 In study results related to the secondary endpoint, GT1b HCV patients with compensated cirrhosis achieved 91 percent (n=38/42) SVR12.1

In an additional intent-to-treat (ITT) analysis, SVR12 was achieved in 98 percent (n=104/106) of the GT1b HCV infected patients without cirrhosis (Arm B) who were randomized to initially receive double-blind placebo for 12 weeks, followed by open-label treatment with ombitasvir/paritaprevir/ritonavir.1 The ITT population included every patient that was randomized to placebo and received at least one dose of active, open-label study drug.

 

About GIFT-I Study 
GIFT-I comprises 363 patients in two sub-studies. In sub-study 1, 321 genotype 1b (GT1b) patients without cirrhosis, both treatment-naïve and interferon (IFN) [with or without ribavirin (RBV)] treatment-experienced, were randomized to receive either ombitasvir/paritaprevir/ritonavir (Arm A) [OBV/PTV/r] or placebo (Arm B) [2:1 randomization ratio, stratified by treatment history, past response, viral load and IFN eligibility]. Patients initially randomized to placebo (Arm B) then received OBV/PTV/r for an additional 12 weeks of open-label treatment. Sustained virologic response was assessed 12 weeks post-treatment (SVR12) as a primary efficacy endpoint in a sub-group of previously untreated, non-cirrhotic GT1b patients who were eligible for therapy with IFN and had a high viral load, defined as an HCV RNA level ≥ 100,000 IU/mL and received at least one dose of the double-blind, active study drug.1

In sub-study 2, 42 GT1b treatment-naïve and IFN (with our without RBV) treatment-experienced patients with compensated cirrhosis received open-label treatment for 12 weeks (Arm C) with SVR12 and assessed as a secondary efficacy endpoint.1

Krishan Maggon 's insight:
NEW DATA FROM GIFT-I STUDY PRESENTED AT THE ANNUAL MEETING OF THE JAPAN SOCIETY OF HEPATOLOGY- PRIMARY ENDPOINT OF 95 PERCENT AND SECONDARY ENDPOINT OF 91 PERCENT SVR12 ACHIEVED IN GENOTYPE 1B HEPATITIS C VIRUS INFECTED JAPANESE PATIENTS WITHOUT AND WITH COMPENSATED CIRRHOSIS, RESPECTIVELY(1)- 98 PERCENT SVR12 ACHIEVED IN ADDITIONAL ANALYSIS OF PATIENTS WITHOUT CIRRHOSIS RECEIVING DOUBLE-BLIND PLACEBO FOR 12 WEEKS, FOLLOWED BY OPEN-LABEL THERAPY WITH ABBVIE'S INVESTIGATIONAL TREATMENT(1)- ABBVIE'S RIBAVIRIN-FREE TREATMENT FOR GENOTYPE 1 HEPATITIS C JAPANESE PATIENTS CONSISTS OF A 12-WEEK, TWO DIRECT-ACTING ANTIVIRAL, FIXED-DOSED COMBINATION OF PARITAPREVIR/RITONAVIR WITH OMBITASVIR, DOSED ONCE DAILY
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Gilead, Merck And Achillion/J&J Square Off In An HCV 'Nuc'lear Showdown - Seeking Alpha

Gilead, Merck And Achillion/J&J Square Off In An HCV 'Nuc'lear Showdown - Seeking Alpha | Hepatitis C New Drugs Review | Scoop.it
Some years ago, it became clear that HCV therapy would follow a similar paradigm as HIV, with the standard of care consisting of a multi-drug combination.

 

SummaryComparison of 7-day monotherapy of Sovaldi vs. MK-3682 and ACH 3422 indicate a rate of viral clearance of Sovaldi > MK-3682 > ACH 3422.Gilead will be reporting Phase 3 data on GS-5816 with Sovaldi in 3Q15 and could have this pan-genotypic combo on the market by the end of 2016.Merck initiated a Phase 2 study with their triple combo in GT3 patients and could field a best-in-class pan-genotypic regimen in 2018, some two years behind Gilead's next generation.Achillion’s nuke ACH 3422 suffers from poor bioavailability, has a tenuous IP position, and a slow pace of development.JNJ’s nucleotide AL-335 acquired from Alios is in Phase 1 and, with access now to ACH 3102, JNJ could have a pan-genotypic therapy approved in the 2019 to 2020 time frame.
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CDC DVH - Division of Viral Hepatitis - May is Hepatitis Awareness Month

CDC DVH - Division of Viral Hepatitis - May is Hepatitis Awareness Month | Hepatitis C New Drugs Review | Scoop.it
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Burden-of-Hepatitis-C.pdf

Hepatitis C is an infectious disease, caused by the hepatitis C virus, which primarily affects the liver. The disease is often asymptomatic and only progresses slowly. An estimated 160 million persons may be infected worldwide and the corresponding estimate for the European Union is 5.5 million.

 

Today’s prevalent cases were mainly infected through blood transfusion and unsafe medical procedures before 1989 when the disease was yet to be discovered. Due to the slow progressive nature of the disease, those infected before 1989 now find themselves in more advanced stages of the chronic disease and run a higher risk of developing liver cirrhosis or related complications.

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Eur. Liver Patients Association

 

http://www.elpa-info.org/elpa-news---reader/items/elpa-launch-event-action-plan-and-burden-of-hepatitis-c.html

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Natural Killer Cells Promote Long-Term Hepatobiliary Inflammation in a Low-Dose Rotavirus Model of Experimental Biliary Atresia

Natural Killer Cells Promote Long-Term Hepatobiliary Inflammation in a Low-Dose Rotavirus Model of Experimental Biliary Atresia | Hepatitis C New Drugs Review | Scoop.it

by James E. Squires, Pranavkumar Shivakumar, Reena Mourya, Kazuhiko Bessho, Stephanie Walters, Jorge A. Bezerra

Abstract

Biliary atresia is a rapidly progressive obstructive cholangiopathy of infants. Mechanistic studies in the mouse model of Rhesus rotavirus (RRV)-induced biliary atresia have linked the importance of effector lymphocytes to the pathogenesis of extrahepatic bile duct (EHBD) injury and obstruction in experimental biliary atresia; however, studies of the progressive liver injury have been limited by early death of newborn mice. Here, we aimed to determine 1) if a lower inoculum of RRV induces obstruction of EHBDs while allowing for ongoing liver inflammation, and 2) if NK cells regulate intrahepatic injury. The administration of 0.25x106 fluorescence forming units of RRV induced an obstructive extrahepatic cholangiopathy, but allowed for restoration of the duct epithelium, increased survival, and the development of a progressive intrahepatic inflammatory injury with molecular and cellular signatures equivalent to the traditional infectious model. Investigating the mechanisms of liver injury, we found that NK cell depletion at the onset of jaundice decreased liver inflammation, suppressed the expression of fibrosis and inflammation/immunity genes, lowered plasma ALT and bilirubin and improved survival.

Conclusions

Lower inoculation of RRV-induced progressive liver injury and fibrosis via NK cells. These findings point to the potential use of NK cell-depleting strategies to block progression of liver disease in biliary atresia.

Krishan Maggon 's insight:

Citation: Squires JE, Shivakumar P, Mourya R, Bessho K, Walters S, Bezerra JA (2015) Natural Killer Cells Promote Long-Term Hepatobiliary Inflammation in a Low-Dose Rotavirus Model of Experimental Biliary Atresia. PLoS ONE 10(5): e0127191. doi:10.1371/journal.pone.0127191

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Interaction between the NS4B amphipathic helix, AH2, and charged lipid headgroups alters membrane morphology and AH2 oligomeric state — Implications for the Hepatitis C virus life cycle

Interaction between the NS4B amphipathic helix, AH2, and charged lipid headgroups alters membrane morphology and AH2 oligomeric state — Implications for the Hepatitis C virus life cycle | Hepatitis C New Drugs Review | Scoop.it
Highlights

 

Changes in membrane morphology studied by 2H and 31P Solid-state NMR.

Bilayer charge influences the oligomeric state of the amphipathic helix AH2 from NS4B.

Interaction of AH2 with charged lipid membranes reduces strain within bilayer.

AH2 from NS4B is involved in membrane remodelling and membranous web formation.

Lipid bilayer/NS4B interactions may regulate Hepatitis C virus lifecycle.

 

Abstract

The non-structural protein 4B (NS4B) from Hepatitis C virus (HCV) plays a pivotal role in the remodelling of the host cell's membranes, required for the formation of the viral replication complex where genome synthesis occurs. NS4B is an integral membrane protein that possesses a number of domains vital for viral replication. Structural and biophysical studies have revealed that one of these, the second amphipathic N-terminal helix (AH2), plays a key role in these remodelling events. However, there is still limited understanding of the mechanism through which AH2 promotes these changes. Here we report on solid-state NMR and molecular dynamics studies that demonstrate that AH2 promotes the clustering of negatively charged lipids within the bilayer, a process that reduces the strain within the bilayer facilitating the remodelling of the lipid bilayer. Furthermore, the presence of negatively charged lipids within the bilayer appears to promote the disassociation of AH2 oligomers, highlighting a potential role for lipid recruitment in regulating NS protein interactions.

Krishan Maggon 's insight:

 

 

 

 

Biochimica et Biophysica Acta (BBA) - Biomembranes

Volume 1848, Issue 8, August 2015, Pages 1671–1677

 Interaction between the NS4B amphipathic helix, AH2, and charged lipid headgroups alters membrane morphology and AH2 oligomeric state — Implications for the Hepatitis C virus life cycleEsther L. Ashworth Briggsa, Rafael G.B. Gomesa, b, Malaz Elhusseinc, William Colliera, I. Stuart Findlowa, Syma Khalidc, Chris J. McCormickb, , , Philip T.F. Williamsona, ,  Open Access funded by Wellcome TrustUnder a Creative Commons license Show moredoi:10.1016/j.bbamem.2015.04.015
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Comprehensive genome-wide evaluation of lapatinib-induced liver injury yields a single genetic signal centered on known risk allele HLA-DRB1*07:01 - Nature.com

Comprehensive genome-wide evaluation of lapatinib-induced liver injury yields a single genetic signal centered on known risk allele HLA-DRB1*07:01 - Nature.com | Hepatitis C New Drugs Review | Scoop.it

The Pharmacogenomics Journal

 

Abstract

 

Lapatinib is associated with a low incidence of serious liver injury. Previous investigations have identified and confirmed the Class II allele HLA-DRB1*07:01 to be strongly associated with lapatinib-induced liver injury; however, the moderate positive predictive value limits its clinical utility. To assess whether additional genetic variants located within the major histocompatibility complex locus or elsewhere in the genome may influence lapatinib-induced liver injury risk, and potentially lead to a genetic association with improved predictive qualities, we have taken two approaches: a genome-wide association study and a whole-genome sequencing study. This evaluation did not reveal additional associations other than the previously identified association for HLA-DRB1*07:01. The present study represents the most comprehensive genetic evaluation of drug-induced liver injury (DILI) or hypersensitivity, and suggests that investigation of possible human leukocyte antigen associations with DILI and other hypersensitivities represents an important first step in understanding the mechanism of these events.

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The Pharmacogenomics Journal advance online publication 19 May 2015; doi: 10.1038/tpj.2015.40

Comprehensive genome-wide evaluation of lapatinib-induced liver injury yields a single genetic signal centered on known risk allele HLA-DRB1*07:01
OPEN

L R Parham1, L P Briley1, L Li1, J Shen1, P J Newcombe2, K S King1, A J Slater1, A Dilthey3, Z Iqbal3, G McVean3, C J Cox2, M R Nelson1 and C F Spraggs2

1GlaxoSmithKline Research & Development, Research Triangle Park, NC, USA2GlaxoSmithKline Research & Development, Stevenage, UK3Department of Statistics, University of Oxford, Oxford, UK

Correspondence: Dr CF Spraggs, GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, UK. E-mail: colin.f.spraggs@gsk.com

Received 19 November 2014; Revised 13 February 2015; Accepted 26 March 2015
Advance online publication 19 May 2015

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The Pharmacogenomics Journal advance online publication 19 May 2015; doi: 10.1038/tpj.2015.40

Comprehensive genome-wide evaluation of lapatinib-induced liver injury yields a single genetic signal centered on known risk allele HLA-DRB1*07:01
OPEN

L R Parham1, L P Briley1, L Li1, J Shen1, P J Newcombe2, K S King1, A J Slater1, A Dilthey3, Z Iqbal3, G McVean3, C J Cox2, M R Nelson1 and C F Spraggs2

1GlaxoSmithKline Research & Development, Research Triangle Park, NC, USA2GlaxoSmithKline Research & Development, Stevenage, UK3Department of Statistics, University of Oxford, Oxford, UK

Correspondence: Dr CF Spraggs, GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, UK. E-mail: colin.f.spraggs@gsk.com

Received 19 November 2014; Revised 13 February 2015; Accepted 26 March 2015
Advance online publication 19 May 2015

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How We’re Curing The Incurable

How We’re Curing The Incurable | Hepatitis C New Drugs Review | Scoop.it
For the past 25 years, hepatitis C has remained largely incurable and often fatal for the world’s 170 million patients with the disease.
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DCV/ASV/BCV for HCV Infection With Cirrhosis

DCV/ASV/BCV for HCV Infection With Cirrhosis | Hepatitis C New Drugs Review | Scoop.it
This open-label uncontrolled study of patients with chronic HCV genotype 1 infection and cirrhosis reports high rates of SVR12 in those who received a 12-week oral fixed-dose regimen of daclatasvir, asunaprevir, and beclabuvir, with or without ribavirin.

 

Abstract   JAMA

 

Importance  Effective and well-tolerated, interferon-free regimens are needed for treatment of patients with chronic hepatitis C virus (HCV) infection and cirrhosis.

Objective  All-oral therapy with daclatasvir (nonstructural protein 5A [NS5A] inhibitor), asunaprevir (NS3 protease inhibitor), and beclabuvir (nonnucleoside NS5B inhibitor), with or without ribavirin, was evaluated in patients with HCV genotype 1 infection and compensated cirrhosis.

Design, Setting, and Participants  The UNITY-2 study was conducted between December 2013 and October 2014 at 49 outpatient sites in the United States, Canada, France, and Australia. Patients were treated for 12 weeks, with 24 weeks of follow-up after completion of treatment. Adult patients with cirrhosis were enrolled in 2 cohorts: HCV treatment-naive or HCV treatment-experienced. Statistical analyses were based on historical controls; there were no internal controls.

Interventions  All patients received twice-daily treatment with the fixed-dose combination of daclatasvir (30 mg), asunaprevir (200 mg), and beclabuvir (75 mg). In addition, patients within each cohort were stratified according to HCV genotype 1 subtype (1a or 1b) and randomly assigned (1:1) to receive double-blinded weight-based ribavirin (1000-1200 mg/d) or matching placebo.

Main Outcomes and Measures  Sustained virologic response at posttreatment week 12 (SVR12).

 

Results  One hundred twelve patients in the treatment-naive group and 90 patients in the treatment-experienced group were treated and included in the analysis. Enrolled patients were 88% white with a median age of 58 years (treatment-naive group) or 60 years (treatment-experienced group); 74% had genotype 1a infection. SVR12 rates were 98% (97.5% CI, 88.9%-100%) for patients in the treatment-naive group and 93% (97.5% CI, 85.0%-100.0%) for those in the treatment-experienced group when ribavirin was included in the regimen. With the fixed-dose combination alone, response rates were 93% (97.5% CI, 85.4%-100.0%) for patients in the treatment-naive group and 87% (97.5% CI, 75.3%-98.0%) for those in the treatment-experienced group. Three serious adverse events were considered to be treatment related and there were 4 adverse event–related discontinuations. Treatment-emergent grade 3 or 4 alanine aminotransferase elevations were observed in 4 patients, of which 1 had concomitant total bilirubin elevation.

Conclusions and Relevance  In this open-label uncontrolled study, patients with chronic HCV genotype 1 infection and cirrhosis who received a 12-week oral fixed-dose regimen of daclatasvir, asunaprevir, and beclabuvir, with or without ribavirin, achieved high rates of SVR12.

Krishan Maggon 's insight:
Original Investigation | May 5, 2015Daclatasvir in Combination With Asunaprevir and Beclabuvir for Hepatitis C Virus Genotype 1 Infection With Compensated CirrhosisAndrew J. Muir, MD1; Fred Poordad, MD2; Jacob Lalezari, MD3; Gregory Everson, MD4; Gregory J. Dore, MBBS, MPH, PhD5,6; Robert Herring, MD7; Aasim Sheikh, MD8; Paul Kwo, MD9; Christophe Hézode, MD, PhD10; Paul J. Pockros, MD11; Albert Tran, MD, PhD12,13; Joseph Yozviak, DO14; Nancy Reau, MD15; Alnoor Ramji, MD16; Katherine Stuart, MBBS, PhD17; Alexander J. Thompson, MBBS, PhD18,19; John Vierling, MD20; Bradley Freilich, MD21; James Cooper, MD22; Wayne Ghesquiere, MD23; Rong Yang, PhD24; Fiona McPhee, PhD25; Eric A. Hughes, MD, PhD24; E. Scott Swenson, MD, PhD25; Philip D. Yin, MD, PhD25[+] Author AffiliationsJAMA. 2015;313(17):1736-1744. doi:10.1001/jama.2015.3868.
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DDX60 Is Involved in RIG-I-Dependent and Independent Antiviral Responses, and Its Function Is Attenuated by Virus-Induced EGFR Activation: Cell Reports

DDX60 Is Involved in RIG-I-Dependent and Independent Antiviral Responses, and Its Function Is Attenuated by Virus-Induced EGFR Activation: Cell Reports | Hepatitis C New Drugs Review | Scoop.it
Highlights

 

•Human DDX60 functions as a ligand-specific sentinel for RIG-I activation•DDX60 plays a role in RIG-I-mediated innate immune response in vivo•DDX60 is involved in a viral RNA degradation pathway•Virus-mediated EGF receptor activation attenuates DDX60 antiviral activities

 

Summary

RIG-I-mediated type I interferon (IFN) production and nuclease-mediated viral RNA degradation are essential for antiviral innate immune responses. DDX60 is an IFN-inducible cytoplasmic helicase. Here, we report that DDX60 is a sentinel for both RIG-I activation and viral RNA degradation. We show that DDX60 is an upstream factor of RIG-I that activates RIG-I signaling in a ligand-specific manner. DDX60 knockout attenuates RIG-I signaling and significantly reduces virus-induced type I IFN production in vivo. In addition, we show that DDX60 is involved in RIG-I-independent viral RNA degradation. DDX60 and RIG-I adaptor MAVS double-knockout mice reveal a role for DDX60-dependent RNA degradation in antiviral responses. Several viruses induced DDX60 phosphorylation via epidermal growth factor receptor (EGFR), leading to attenuation of the DDX60 antiviral activities. Our results define DDX60 as a sentinel for cytoplasmic antiviral response, which is counteracted by virus-mediated EGF receptor activation.

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Cell Report  

Volume 11, Issue 8, p1193–1207, 26 May 2015Article DDX60 Is Involved in RIG-I-Dependent and Independent Antiviral Responses, and Its Function Is Attenuated by Virus-Induced EGFR ActivationHiroyuki Oshiumi56, Moeko Miyashita5, Masaaki Okamoto, Yuka Morioka, Masaru Okabe, Misako Matsumoto, Tsukasa Seya5Co-first author6Present address: Laboratory for Biologics Development, Research Center for Zoonosis Control, Hokkaido University, Sapporo 060-8638, JapanOpen AccessDOI: http://dx.doi.org/10.1016/j.celrep.2015.04.047 | Article Info
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CDC DVH - Hepatitis C FAQs for the Public

CDC DVH - Hepatitis C FAQs for the Public | Hepatitis C New Drugs Review | Scoop.it
Hepatitis C FAQs for the Public | CDC

 

What is hepatitis?

“Hepatitis” means inflammation of the liver. Toxins, certain drugs, some diseases, heavy alcohol use, and bacterial and viral infections can all cause hepatitis. Hepatitis is also the name of a family of viral infections that affect the liver; the most common types are Hepatitis A, Hepatitis B, and Hepatitis C.

What is the difference between Hepatitis A, Hepatitis B, and Hepatitis C?

Hepatitis A, Hepatitis B, and Hepatitis C are diseases caused by three different viruses. Although each can cause similar symptoms, they have different modes of transmission and can affect the liver differently. Hepatitis A appears only as an acute or newly occurring infection and does not become chronic. People with Hepatitis A usually improve without treatment. Hepatitis B and Hepatitis C can also begin as acute infections, but in some people, the virus remains in the body, resulting in chronic disease and long-term liver problems. There are vaccines to prevent Hepatitis A and B; however, there is not one for Hepatitis C. If a person has had one type of viral hepatitis in the past, it is still possible to get the other types.

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Authoritative official reliable  CDC info

 

 

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Crucial step in helping to prevent Hepatitis C virus replicating identified - Tsepa

Crucial step in helping to prevent Hepatitis C virus replicating identified - Tsepa | Hepatitis C New Drugs Review | Scoop.it
New research from the University of Southampton has identified how changes in the cell membrane play a pivotal role in how the Hepatitis C virus replicates.
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GlobeImmune Hepatitis B virus HBV Vaccine GS-4774 Fails in phase II

GlobeImmune Hepatitis B virus HBV Vaccine GS-4774 Fails in phase II | Hepatitis C New Drugs Review | Scoop.it

LOUISVILLE, CO–(Marketwired – May 27, 2015) – GlobeImmune, Inc. (NASDAQ: GBIM) today announced top line results from the GS-4774 Phase 2 study in patients with chronic hepatitis B on long term viral suppression with an oral antiviral treatment. In this study, patients treated with the highest dose of GS-4774 plus ongoing oral antiviral therapy (OAV) did not show a reduction in hepatitis B surface antigen (HBsAg) at week 24, the primary endpoint of the study, but at 48 weeks had a mean -0.17 log10 reduction of HBsAg compared with a -0.04 log10 reduction in the OAV alone group (p=not significant). Three patients receiving the highest dose of GS-4774 had HBsAg reductions between -0.94 and -3.89 log10 at 48 weeks. There was no difference in HBsAg reductions between the two lowest dose groups versus the control arm at 48 weeks. Further characterization of the T cell response to GS-4774 and association with HBsAg changes are ongoing.

 

GS-4774 was found to be generally safe and well tolerated, with injection site reactions identified as the primary adverse event. Data from this trial are expected to be submitted for future presentation and publication.

Krishan Maggon 's insight:

GS-4774 is a therapeutic vaccine engineered to activate an HBV-specific T cell immune response to reduce the number of cells containing HBV. GS-4774 has been exclusively licensed to Gilead Sciences, Inc.


GS-4774 is being developed as a therapeutic vaccine designed to generate T cell immune responses against cells containing HBV antigens in combination with antiviral therapy with the goal of increasing the cure rate in patients with chronic HBV infection. The GS-4774 Tarmogen expresses a fusion protein utilizing sequences of the hepatitis B virus contained in the four major HBV genotypes worldwide, in order to ensure applicability for this product across multiple markets.

Clinical ProgramPhase 1

In August 2013, we completed a Phase 1 clinical trial of GS-4774 in 60 healthy volunteers. Twenty subjects were enrolled to one of three dose groups. The Phase 1 results indicated that GS-4774 elicited HBV specific T cell immune responses in all three dose groups. Overall, eighty-eight percent of subjects across all three dose groups responded to receiving GS-4774 by at least one measure of T cell immune response.


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Johnson & Johnson Just Stepped Up Its Hepatitis C Game - Motley Fool

Johnson & Johnson Just Stepped Up Its Hepatitis C Game - Motley Fool | Hepatitis C New Drugs Review | Scoop.it
Johnson & Johnson has inked a licensing deal with Achillion Pharmaceuticals that could threaten Gilead Sciences market share in hepatitis C. Should Gilead investors worry?
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Optimism for patients with genotype 4 HCV infection: Clinical trials with direct-acting antivirals finally available - Journal of Hepatology

Optimism for patients with genotype 4 HCV infection: Clinical trials with direct-acting antivirals finally available - Journal of Hepatology | Hepatitis C New Drugs Review | Scoop.it
Peter J. Ruane, Dani Ain, Richard Stryker, Raymond Meshrekey, Mina Soliman, Peter R. Wolfe, Joseph Riad, Sameh Mikhail, Kathryn Kersey, Deyuan Jiang, Benedetta Massetto, Brian Doehle, Brian J. Kirby, Steven J. Knox, John G. McHutchison, William T. SymondsSofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestryJournal of Hepatology, Volume 62, Issue 5, May 2015, Pages 1040-1046 Purchase PDF (703 K)Christophe Moreno, Christophe Hezode, Patrick Marcellin, Stefan Bourgeois, Sven Francque, Didier Samuel, Fabien Zoulim, Jean-Didier Grange, Umesh Shukla, Oliver Lenz, Sivi Ouwerkerk-Mahadevan, Bart Fevery, Monika Peeters, Maria Beumont, Wolfgang JessnerEfficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4Journal of Hepatology, Volume 62, Issue 5, May 2015, Pages 1047-1055 Purchase PDF (862 K)  Supplementary contentTarek Hassanein, Karen D. Sims, Michael Bennett, Norman Gitlin, Eric Lawitz, Tuan Nguyen, Lynn Webster, Zobair Younossi, Howard Schwartz, Paul J. Thuluvath, Helen Zhou, Bhaskar Rege, Fiona McPhee, Nannan Zhou, Megan Wind-Rotolo, Ellen Chung, Amber Griffies, Dennis M. Grasela, David F. GardinerA randomized trial of daclatasvir in combination with asunaprevir and beclabuvir in patients with chronic hepatitis C virus genotype 4 infectionJournal of Hepatology, Volume 62, Issue 5, May 2015, Pages 1204-1206 Purchase PDF (333 K)  Supplementary contentReferred to byPeter J. Ruane, Dani Ain, Richard Stryker, Raymond Meshrekey, Mina Soliman, Peter R. Wolfe, Joseph Riad, Sameh Mikhail, Kathryn Kersey, Deyuan Jiang, Benedetta Massetto, Brian Doehle, Brian J. Kirby, Steven J. Knox, John G. McHutchison, William T. SymondsSofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestryJournal of Hepatology, Volume 62, Issue 5, May 2015, Pages 1040-1046 Purchase PDF (703 K)Christophe Moreno, Christophe Hezode, Patrick Marcellin, Stefan Bourgeois, Sven Francque, Didier Samuel, Fabien Zoulim, Jean-Didier Grange, Umesh Shukla, Oliver Lenz, Sivi Ouwerkerk-Mahadevan, Bart Fevery, Monika Peeters, Maria Beumont, Wolfgang JessnerEfficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4Journal of Hepatology, Volume 62, Issue 5, May 2015, Pages 1047-1055 Purchase PDF (862 K)  Supplementary contentTarek Hassanein, Karen D. Sims, Michael Bennett, Norman Gitlin, Eric Lawitz, Tuan Nguyen, Lynn Webster, Zobair Younossi, Howard Schwartz, Paul J. Thuluvath, Helen Zhou, Bhaskar Rege, Fiona McPhee, Nannan Zhou, Megan Wind-Rotolo, Ellen Chung, Amber Griffies, Dennis M. Grasela, David F. GardinerA randomized trial of daclatasvir in combination with asunaprevir and beclabuvir in patients with chronic hepatitis C virus genotype 4 infectionJournal of Hepatology, Volume 62, Issue 5, May 2015, Pages 1204-1206 Purchase PDF (333 K)  Supplementary content
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doi:10.1016/j.jhep.2015.03.003

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German IQWIG Dasabuvir in hepatitis C: Benefit in treatment naive HCV patients without cirrhosis

German IQWIG Dasabuvir in hepatitis C: Benefit in treatment naive HCV patients without cirrhosis | Hepatitis C New Drugs Review | Scoop.it

The drug dasabuvir (trade name Exviera) has been available since January 2015 for the treatment of adults with chronic hepatitis C infection. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this drug offers an added benefit over the appropriate comparator therapy.

 

According to the findings, there are indications of an added benefit in patients who have not yet developed cirrhosis of the liver and who are infected with the hepatitis C virus (HCV) genotype 1a. In case of genotype 1b, this only applies to treatment-naive, but not to treatment-experienced patients. The extent of added benefit is non-quantifiable, however. No added benefit can be derived from the dossier for seven other Patient groups.

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 The German Institute for Quality and Efficiency in Health Care (IQWiG)

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Janssen/J&J bet $1.1 billion on Achillion Hepatitis C R&D pipeline

Janssen/J&J bet $1.1 billion on Achillion  Hepatitis C R&D pipeline | Hepatitis C New Drugs Review | Scoop.it

NEW HAVEN, Conn., May 19, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir.


Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets.

 

A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration.

 

Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation - JJDC, Inc. will invest $225 million in Achillion and, in return, receive approximately 18.4 million newly issued, unregistered shares of Achillion at a price of $12.25 per share.


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Achillion Enters Into Worldwide Collaboration for Hepatitis C With Janssen

 

- Transactions include up to $1.1 billion in potential development, regulatory and sales milestone payments and a separate equity investment -

- Achillion eligible for tieredroyalties between mid-teens and low-twenties on future worldwide sales -

- Janssen responsible for all development costs within the collaboration and all subsequent costs related to commercialization of the assets -

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Crucial Hepatitis C Replication Discovery Could Lead to Vital Treatments - MD Magazine

Crucial Hepatitis C Replication Discovery Could Lead to Vital Treatments - MD Magazine | Hepatitis C New Drugs Review | Scoop.it
Preventing the replication of the hepatitis C virus (HCV) may be a future reality thanks to an important exploration.
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Scientists identify crucial step in helping to prevent Hepatitis C virus ... - Phys.Org

Scientists identify crucial step in helping to prevent Hepatitis C virus ... - Phys.Org | Hepatitis C New Drugs Review | Scoop.it
New research from the University of Southampton has identified how changes in the cell membrane play a pivotal role in how the Hepatitis C virus replicates.
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Interaction between the NS4B amphipathic helix, AH2, and charged lipid headgroups alters membrane morphology and AH2 oligomeric state—Implications for the Hepatitis C virus life cycle," Biochimica et Biophysica Acta (BBA) - Biomembranes, Volume 1848, Issue 8, August 2015, Pages 1671-1677, ISSN 0005-2736, dx.doi.org/10.1016/j.bbamem.2015.04.015


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Long-term treatment outcomes of patients infected with Hepatitis C virus: a systematic review and meta-analysis of the survival benefit of achieving a Sustained Virological Response

Long-term treatment outcomes of patients infected with Hepatitis C virus: a systematic review and meta-analysis of the survival benefit of achieving a Sustained Virological Response | Hepatitis C New Drugs Review | Scoop.it
Abstract

Background. Achievement of a sustained virologic response (SVR) after treatment for Hepatitis C infection is associated with improved outcomes. This meta-analysis aimed to determine the impact of SVR on long-term mortality risk compared with non-responders in a range of populations.

Methods. An electronic search identified all studies assessing all-cause mortality in SVR and non-SVR patients. Eligible articles were stratified into general, cirrhotic, and HIV co-infected populations. The adjusted hazard ratio (95%CI) for mortality in patients achieving SVR versus non-SVR, and pooled estimates for the five-year mortality in each group were calculated.

Results. 31 studies (n=33,360) were identified as suitable for inclusion. Median follow-up time was 5.4 years (IQR 4.9-7.5) across all studies. The adjusted hazard ratio of mortality for patients achieving SVR versus non-SVR was 0.50 (95%CI 0.37-0.67) in the general population, 0.26 (95%CI 0.18-0.74) in the cirrhotic group, and 0.21 (0.10-0.45) in the co-infected group. The pooled five-year mortality rates were significantly lower for patients achieving SVR compared with non-SVR in all three populations.

Conclusions. The results suggest that there is a significant survival benefit of achieving an SVR compared with unsuccessful treatment in a range of HCV-infected populations.

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Clin Infect Dis. (2015)doi: 10.1093/cid/civ396First published online: May 17, 2015 Long-term treatment outcomes of patients infected with Hepatitis C virus: a systematic review and meta-analysis of the survival benefit of achieving a Sustained Virological ResponseBryony Simmons1, Jawaad Saleem1, Katherine Heath1, Graham S. Cooke1, and Andrew Hill2

+Author Affiliations

1Division of Medicine, Imperial College London, London, UK2Pharmacology and Therapeutics, Liverpool University, Liverpool, UKContact information for corresponding author: Ms Bryony Simmons MPH, St Mary's Campus, Imperial College London, Norfolk Place, London, W2 1PG. Email:bryony.simmons13@imperial.ac.uk
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Investing in hepatitis C drugs could save the economy billions, researchers suggest

Investing in hepatitis C drugs could save the economy billions, researchers suggest | Hepatitis C New Drugs Review | Scoop.it
New hepatitis C drugs may be more expensive but have have higher cure rates and fewer side effects, and could save the US and five European countries $3.2 billion a year.

Via #BBBundyBlog #NOMORELIES Tom Woods #Activist Award #Scoopiteer >20,000 Sources >250K Connections http://goo.gl/ruHO3Q
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New Hope for Patients with Hepatitis C

New Hope for Patients with Hepatitis C | Hepatitis C New Drugs Review | Scoop.it
New and forthcoming medicines can halt the progression of hepatitis C and, in many cases, provide a cure.
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