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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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Hepatitis C Trust (UK) pubishes new 'State of the Nation' Policy Report
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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.
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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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New injection device in UK delivers optimum treatment dose to Hep C patients
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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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Inactivation of Hepatitis C Virus Infectivity by Human Breast Milk
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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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Merck`s patent war with Gilead over sofosbuvir, update
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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)
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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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October 2013, HCV Advocate newsletter
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October 2013, HCV Advocate newsletterhttp://www.hcvadvocate.org/news/newsLetter/2013/advocate1013.html
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FDA Panel Review On For Gilead's Sofosbuvir Despite Government Shutdown
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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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GSK receives marketing authorisation from the European Commission for Revolade (eltrombopag) for low platelet counts
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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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July 2013 HCV Advocate Newsletter
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July 2013 HCV Advocate Newsletterhttp://www.hcvadvocate.org/news/newsLetter/2013/advocate0713.html
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September 2013 HCV Advocate Newsletter
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September 2013 HCV Advocate Newsletterhttp://www.hcvadvocate.org/news/newsLetter/2013/advocate0913.html
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Can Diet And Exercise Improve Fibrosis - new study
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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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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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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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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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An update on Victrelis
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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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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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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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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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New Drugs Pipeline, overview from the Hep C Trust
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New Drugs Pipelinearticle...http://www.hepctrust.org.uk/News_Resources/news/2013/July/New+drugs+pipeline
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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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SVR12 vs SVR24
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http://www.hepctrust.org.uk/News_Resources/news/2013/June/Is+SVR12+As+Good+As+SVR24
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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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New York State Legislature passes bill requiring doctors to offer hep C tests to baby boomers
(Preview)
New York State Legislature passes bill requiring doctors to offer hepatitis C tests to baby boomers Thursday, June 20, 2013 Baby boomers in New York will be offered screening tests for hepatitis C when they visit a doctor or hospital under a bill passed by the state Legislature today. The bill requir...
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FDA Approves Abbott Test for Identifying Hep C Genotypes
(Preview)
Thursday, June 20, 2013 FDA Approves Abbott Test for Identifying Hepatitis C Genotypes The U.S. Food and Drug Administration has approved a test manufactured by Abbott Laboratories (ABT) that identifies the genotype of hepatitis C virus, or HCV, that a patient is carrying, helping health-care p...
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The FDA Makes Hepatitis C a Priority
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The FDA Makes Hepatitis C a Priority Recognizing that investigational drugs from three pharmaceutical companies show advantages over existing hepatitis C therapies, the FDA has sped up its development and review process for the therapies.With pharmaceutical companies clamoring to bring to m...
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Blood Tests for Fibrosis Diagnosis in Hep C...new study
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Blood testing can accurately identify clinically significant fibrosis and cirrhosis in people with hepatitis C virus (HCV) infection and may be an alternative to liver biopsy in some patients, a new study found.The analysis of 172 studies comparing various blood tests to biopsy in HCV patients r...
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Video - Naim Alkhouri, MD, discusses interferon-free regimens for HCV
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ORLANDO, Fla. - Naim Alkhouri, MD, of the Digestive Disease Institute at the Cleveland Clinic, provides his perspective on interferon-free therapies for hepatitis C at Digestive Disease Week 2013.Alkhouri cites encouraging data from trials of sofosbuvir and ribavirin in patients with HCV ge...
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