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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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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FDA Draft Guidance for Industry on HCV Virus Infection: Developing Direct-Acting Antiviral Drugs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Draft Guidance for Industry on HCV Virus Infection: Developing Direct-Acting Antiviral Drugs The Food and Drug Administration (FDA) has published draft guidance to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C fro...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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FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1
(Preview)
Oct. 24, 2013 - Janssen Research & Development, LLC (Janssen) announced today that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously (19 to 0) to recommend approval of the investigational protease inhibitor simeprevir (TMC435) admini...
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Cinnamon Girl
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Hepatitis C Trust (UK) pubishes new 'State of the Nation' Policy Report
(Preview)
A new report, published today by The Hepatitis C Trust, has found that hepatitis C is grossly under-prioritised in England. Despite it being curable, only 3% of people receive treatment each year.Charles Gore, Chief Executive of The Hepatitis C Trust, said: "There must be no more excuses for the r...
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Good news for the oldies.
(Preview)
This is an interesting article as it discusses results for the over 65's. Note that the IL28B gene test is quoted, but only using the SNP rs8099917, rather than rs12979860 (commonly used in the USA). See my article on Gene testing in General Information. Also note that all patients were Genotype 1b....
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mallani
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New injection device in UK delivers optimum treatment dose to Hep C patients
(Preview)
Saturday, October 5, 2013. A new injection device, ViraferonPeg Clearclick, has launched in the UK today for hepatitis C patients to accurately titrate and self-administer their weekly dose of ViraferonPeg (peginterferon alfa-2b).The device has been specially designed to maintain dosing fl...
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Cinnamon Girl
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Inactivation of Hepatitis C Virus Infectivity by Human Breast Milk
(Preview)
Inactivation of Hepatitis C Virus Infectivity by Human Breast Milk 30th Sept, 2013. An interesting study that looked at breast milk and the transmission of HCV. The authors concluded that human breast milk has antiviral properties against the hepatitis C virus that prevent the transmission of...
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Cinnamon Girl
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Merck`s patent war with Gilead over sofosbuvir, update
(Preview)
UPDATED: Merck demand triggers expanding patent war with Gilead over sofosbuvir Gilead is rolling out its big legal guns to defend its control of the experimental Hepatitis C drug sofosbuvir,, one of the most valuable therapies in the industry's late-stage pipeline. On Friday the company fired o...
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Telaprevir twice-daily works as well as every eight hours, safe for hep C patients with cirrhosis (news from ASSLD)
(Preview)
Telaprevir twice-daily works as well as every eight hours, safe for hepatitis C patients with cirrhosisNews from ASSLD 2012, provided by NAMThe HCV protease inhibitor telaprevir (Incivo or Incivek) taken twice daily with pegylated interferon plus ribavirin is as likely to produce sustained vi...
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Cinnamon Girl
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October 2013, HCV Advocate newsletter
(Preview)
October 2013, HCV Advocate newsletterhttp://www.hcvadvocate.org/news/newsLetter/2013/advocate1013.html
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Cinnamon Girl
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FDA Panel Review On For Gilead's Sofosbuvir Despite Government Shutdown
(Preview)
Despite FDA shutdown, Gilead still on for high-profile panelsOctober 1, 2013. As of today, the FDA has been virtually halved, and while the mandatory furloughs spelled out by a government shutdown may imperil some of the agency's duties, it appears that drug approvals and reviews will go unmarred...
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Cinnamon Girl
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GSK receives marketing authorisation from the European Commission for Revolade (eltrombopag) for low platelet counts
(Preview)
GSK receives marketing authorisation from the European Commission for additional Revolade (eltrombopag) indication as the first approved treatment for chronic hepatitis C-associated thrombocytopeniaGlaxoSmithKline plc announced today, 24th September, that the European Commission ha...
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Cinnamon Girl
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July 2013 HCV Advocate Newsletter
(Preview)
July 2013 HCV Advocate Newsletterhttp://www.hcvadvocate.org/news/newsLetter/2013/advocate0713.html
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September 2013 HCV Advocate Newsletter
(Preview)
September 2013 HCV Advocate Newsletterhttp://www.hcvadvocate.org/news/newsLetter/2013/advocate0913.html
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Cinnamon Girl
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Can Diet And Exercise Improve Fibrosis - new study
(Preview)
Fibrosis, steatosis and insulin resistance was improved with exercise, low-fat or low-calorie diets in people with HCV according to a recent study in the 2013 August issue of Nutrition Journal.The study establishes the benefits of the low-calorie diet and low-fat diet in management of patient...
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Cinnamon Girl
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First study of benefits of SVR using triple Rx
(Preview)
Hi all, There have been countless studies reporting the results of SVR using Peg. and Riba. This is the first report I have seen of the SVR benefits using triple Rx. As DAA's have only been around for a short time, obviously the numbers are small, but the results are reassuring. http://www.natap.org...
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mallani
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New approach to HCV treatment
(Preview)
Hi all, I've been following an Australian Company called Benitec Pharma, and their work on gene silencing. After a difficult time with the lawyers, they are now starting Trials for a novel approach to HCV eradication. They are using a drug called TT-034, which is a ddRNAi (DNA-directed RNA interfac...
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mallani
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China over-rides patent
(Preview)
Hi all, This is an interesting article. This will almost certainly apply to the new HCV DAA's. India and Indonesia will probably do the same. It may be the way that affordable HCV care reaches these countries, for those who are not rich enough to travel to the USA. I have always just walked into a phar...
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mallani
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An update on Victrelis
(Preview)
With all the new DAA's, it is easy to forget the first antiproteases. If you're not in the USA, have a read of the Victrelis results, recently reworked and re-presented. If you were a prior relapser to Peg and Riba, SVR rates of close to 100% can be expected. Sure, there are side effects, but these result...
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mallani
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Hep C gen1 with low viral load and rapid virologic response to peg/riba obviates a protease inhibitor
(Preview)
Hepatitis C genotype 1 virus with low viral load and rapid virologic response to peginterferon/ribavirin obviates a protease inhibitor Given the high side-effect profile of the current HCV protease combination therapy, it is good to know that there are some genotype 1 patients who can be cured wi...
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Cinnamon Girl
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Pegylated interferon now included on WHO (World Heath Organisation) Model Essential Medicines List
(Preview)
Hepatitis treatment debuts on WHO Model Essential Medicines ListJuly 2013 For the first time, the WHO`s Model Essential Medicines List - a globally agreed list that helps individual nations identify priority medicines for their citizens - now includes pegylated interferon. The application to...
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Cinnamon Girl
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NICE (UK) draft guidance recommends drugs to treat chronic hepatitis C in children and young people
(Preview)
NICE (the National Institute for health and Care Excellence) draft guidance recommends drugs to treat chronic hepatitis C in children and young peopleIn a draft guidance published 17th July 2013 NICE recommends peginterferon alfa in combination with ribavirin as an option for treating chronic...
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Cinnamon Girl
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New Drugs Pipeline, overview from the Hep C Trust
(Preview)
New Drugs Pipelinearticle...http://www.hepctrust.org.uk/News_Resources/news/2013/July/New+drugs+pipeline
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Cinnamon Girl
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hemopurifier
(Preview)
http://www.prnewswire.com/news-releases/aethlon-medical-announces-fda-approval-of-ide-to-treat-hepatitis-c-hcv-patients-212905971.html
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hiatus
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SVR12 vs SVR24
(Preview)
http://www.hepctrust.org.uk/News_Resources/news/2013/June/Is+SVR12+As+Good+As+SVR24
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mallani
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Interferon-free combo Faldaprevir and Deleobuvir with ribavirin achieves 95% cure rate in geno 1b
(Preview)
Faldaprevir and deleobuvir with ribavirin achieves 95% cure rate in geno 1bInterferon-free combo faldaprevir+ and deleobuvir+ (BI 207127)/ribavirin achieves 95% viral cure rates in genotype-1b hepatitis C patientsNew data from Boehringer Ingelheim`s interferon-free SOUND-C3 study were...
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Simeprevir and Sofosbuvir Likely Approved by 2014 - Clinical/Ethical/Pharmacoeconomic Dilemmas Loom
(Preview)
Both Simeprevir and Sofosbuvir Likely Approved by 2014 - Clinical/Ethical/Pharmacoeconomic Dilemmas Loom As expected, simeprevir, and now also sofosbuvir, are being given "priority review" by the FDA. With the 6-month rule under the Prescription Drug User Fee Act...that means there`s a goo...
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