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New HCV Treatment Guidelines from US medical societies, including `off label` recommendations.
(Preview)
US medical societies launch new hepatitis C treatment guidelines `The American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA) and International Antiviral Society-USA (IAS-USA) yesterday announced the first new hepatitis C treatment guid...
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Cinnamon Girl
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European Commission Grants Marketing Authorization for Gilead’s Sovaldi (Sofosbuvir) for the Treatment of Chronic Hepat
(Preview)
Gilead today announced that the European Commission has granted marketing authorization for Sovaldi® (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection in adults, in combination with other antivi...
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Karen
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FDA issues warning on drugs containing acetaminophen/paracetamol (Tylenol)
(Preview)
Acetaminophen/Paracetamol has long been known to be liver toxic. The FDA is recommending health care professionals change their prescribing habits. The link is to a Fox report on the subject. Best to be cautious whenever taking this medication, especially us. http://www.foxnews.com/health/...
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Tig
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Hep C virus dried on inanimate surfaces can remain infectious for up to six weeks, new study shows
(Preview)
`Dried spots of blood contaminated with hepatitis C virus (HCV) can remain infectious for up to six weeks at normal room temperatures, research published in the online edition of the Journal of Infectious Diseases shows. Commercially available antiseptics reduced the infectivity of the blood...
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Cinnamon Girl
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Health Canada approves Sovaldi (sofosbuvir)
(Preview)
TORONTO, 17th Dec - Health Canada has approved Sovaldi (sofosbuvir), a once-daily tablet for the treatment of chronic hepatitis C that could transform treatment of the disease for thousands of Canadians.Gilead Sciences Canada said on Monday the cost of Sovaldi to consumers won't be available un...
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Cinnamon Girl
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January 2014 HCV Advocate Newletter
(Preview)
January 2014 HCV Advocate Newletter...http://www.hcvadvocate.org/news/newsLetter/2014/advocate0114.html
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Cinnamon Girl
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AASLD 2013 Liver Meeting, final day Hep C treatments overview
(Preview)
The final day of AASLD Liver Meeting, recently held in Washington, DC, featured an overview of the status of new hepatitis C therapies, similarities between HCV and HIV, and a look towards the future of hepatitis C treatment. The development of next-generation HCV drugs has been remarkably rapid...
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Cinnamon Girl
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"Therapeutic Review" of all new HCV Drugs in BC
(Preview)
http://m.yahoo.com/w/ygo-mail/message/proxyattached.bp?m=2_0_0_1_119773_ABt3k0UAACgYUspDjQAAAEMCVrY&f=Inbox&p=2&op=htm...
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dustbear
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Idenix Announces Phase II All-Oral Combination Study of Samatasvir and Simeprevir
(Preview)
Idenix Pharmaceuticals Announces Initiation of Phase II All-Oral Combination Study of Samatasvir (IDX719) and Simeprevir (TMC435) for the Treatment of Hepatitis C Virus (HCV) InfectionIdenix Pharmaceuticals, Inc...today announced the initiation of the phase II HELIX-1 clinical trial eva...
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Cinnamon Girl
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Gilead Announces SVR12 Rates For Three Phase 3 Studies of Sofosbuvir/Ledipasvir With and Without Ribaviran
(Preview)
http://www.gilead.com/news/press-releases/2013/12/gilead-announces-svr12-rates-from-three-phase-3-studies-evaluating-a-oncedaily-fixeddose-combinati...
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lauralou57
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Phase III data show Boehringer Ingelheim`s faldaprevir is effective even with common drug-resistant viral variant
(Preview)
INGELHEIM, 16 December, 2013 - Data show that Boehringer Ingelheim`s second-generation protease inhibitor faldaprevir, when used in combination with pegylated interferon and ribavirin, was effective even with the presence of naturally-occurring mutant variants of the hepatitis C virus (H...
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Cinnamon Girl
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FDA throws up surprise labelling for Gilead Sciences' hepatitis C treatment Sovaldi
(Preview)
Hey All I was reading some of the news in about Sovaldi and this topic about Gilead getting approval for GT-1's being able to either receive treatment for 24 weeks with Ribavirin only or 12 weeks with peg & Riba. Like the article reads, I don't remember any hard data that suggested that 24 weeks with...
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Matt Chris
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December 2013 HCV Advocate Newsletter (AASLD Edition)
(Preview)
December 2013 HCV Advocate Newsletter (AASLD Edition)(Simeprevir).[url]http://www.hcvadvocate.org/news/newsLetter/2013/advocate1213.htm...
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Cinnamon Girl
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Boehringer Ingelheim's faldaprevir granted accelerated assessment from European Medicines Agency
(Preview)
Nov 26th, Ingelheim, Germany - The application for European marketing authorisation of faldaprevir a potent second generation oral protease inhibitor, has been fully validated and granted accelerated assessment by the European Medicines Agency. Boehringer Ingelheim is seeking marketing a...
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Cinnamon Girl
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Proposed cost of Olysio (simeprevir)
(Preview)
(Well, we knew it wasn`t going to be cheap!)`November 26 2013 - Janssen's hepatitis C drug Olysio (simeprevir) scored FDA approval Friday evening, kicking off a new wave of hepatitis C drugs. It offers modest benefit over standard of care, but a subgroup of patients has encountered resistance, an...
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Cinnamon Girl
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European Medicines Agency advises on compassionate use of daclatasvir/sofosbuvir combo
(Preview)
22 Nov. 2013 - The European Medicines Agency`s Committee for Medicinal Products for Human Use (CHMP) has given an opinion on the use of daclatasvir in combination with sofosbuvir in the treatment of chronic (long-term) hepatitis C virus (HCV) infection, in a compassionate-use programme.The rec...
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Cinnamon Girl
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Simeprevir Approved in Canada, for Gen. 1
(Preview)
Medivir AB has announced that Health Canada has approved simeprevir for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have fai...
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Cinnamon Girl
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`OLYSIO` (Simeprevir) Receives FDA Approval
(Preview)
November 22, 2013 - `OLYSIO` (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C OLYSIO is the first once-daily protease inhibitor approved for the treatment of chronic hepatitis C in a combination antiviral regimen for adults with compensated liver disease T...
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Cinnamon Girl
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Generic Sofosbuvir in India? Maybe!
(Preview)
http://www.msfaccess.org/about-us/media-room/press-releases/gilead-attempt-secure-patent-hepatitis-c-drug-opposed-india
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Zlikster
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(CHMP), the scientific committee of the European Medicines Agency Green Lights SOFOSBUVIR
(Preview)
Hey All as noted by SuziQ Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on sofosbuvir. This will have great ramifications for all upcoming and existing/ current competing Meds. The Gilead s...
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Matt Chris
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Summary of Nov 2013 Liver Meeting
(Preview)
Hi guys, This is a summary of most abstracts presented at the recent Liver Meeting. The mind boggles. http://www.natap.org/2013/AASLD/AASLD_40.htm
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mallani
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One Shot and You're Cured
(Preview)
Just happened to see a new clinical trial for the latest new innovation while cruising thru clinicaltrials.com for a friend. It is trial # NCT 01899092. It is a first time trial on people. Check it out and dream of what may be possible. I had only read about it as a Duke University study. These new me...
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suziq
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What Is The Minimum costs to produce Hepatitis C Direct Acting Antivirals
(Preview)
http://hepatitiscnewdrugs.blogspot.co.uk/2013/11/aasld-sofosbuvirsimeprevir-what-is.html-- Edited by Karen on Wednesday 13th of November 2013 02:07:00 PM
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Karen
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Fixed-dose sofosbuvir/ledipasvir with or without ribavirin cures most genotype 1 patients, LONESTAR study
(Preview)
Fixed-dose sofosbuvir/ledipasvir with or without ribavirin cures most genotype 1 hepatitis C patients, LONESTAR study shows`At least 95% of newly treated people with genotype 1 hepatitis C and prior non-responders achieved sustained virological response using a fixed-dose combination of s...
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Cinnamon Girl
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Gilead Announces New SVR Data for Sofosbuvir-Based Regimens in Genotype 3 infected Patients
(Preview)
Nov. 2, 2013. Gilead Sciences announced results from two studies, the Phase 3 VALENCE study and the Phase 2 LONESTAR-2 study, evaluating the investigational once-daily nucleotide analogue sofosbuvir for the treatment of chronic hep C virus infection among patients infected with genotype 3. Th...
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Cinnamon Girl
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November 2013 HVC Advocate Newletter
(Preview)
http://www.hcvadvocate.org/news/newsLetter/2013/advocate1113.html#4
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Cinnamon Girl
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FDA Advisory Committee Supports Approval of Gilead’s Sofosbuvir for Chronic Hepatitis C Infection
(Preview)
Oct. 25, 2013. Gilead Sciences today announced that the Antiviral Drugs Advisory Committee of the US FDA has voted unanimously (15-0) that the available data support approval of the once-daily nucleotide analogue sofosbuvir in combination with ribavirin for the treatment of chronic hepatitis...
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Cinnamon Girl
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Sofosbuvir use in Europe
(Preview)
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/10/WC500153144.pdf
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rebeca
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FDA Draft Guidance for Industry on HCV Virus Infection: Developing Direct-Acting Antiviral Drugs
(Preview)
Draft Guidance for Industry on HCV Virus Infection: Developing Direct-Acting Antiviral Drugs The Food and Drug Administration (FDA) has published draft guidance to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C fro...
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Cinnamon Girl
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Merck Receives Breakthrough Therapy Designation for MK-5172/MK-8742
(Preview)
Merck Receives Breakthrough Therapy Designation for MK-5172/MK-8742 This is one of the fast rising new HCV drug combos that will likely be the next most studied 2nd generation DAA that has high resistants to mutations. The MK-1572 is made up of NS3/4A protease inhibitor, and MK-8742, an investig...
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Matt Chris
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