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New and experimental hepatitis C treatment news

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MSF response to Gilead announcement on inclusion of hepatitis C drug GS-5816 in voluntary licence

GS-5816 is an important anti-hepatitis C compound that, in combination with sofosbuvir, will greatly simplify treatment for developing countries. However, it appears that none of the terms and conditions of the original licence agreement has been changed, meaning that the concerns that MSF has with the licence agreement remain, including the limited geographic scope of the agreement, restrictions on the production and export of active pharmaceutical ingredient, and the inclusion of an ethically and medically controversial and problematic anti-diversion clause.

Published
6 hours ago
From
Médecins Sans Frontières press release
Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. The expanded agreements will allow Gilead’s India-based partners to manufacture GS-5816 and the single tablet regimen of sofosbuvir/GS-5816, once approved, for distribution in 91 developing countries, which together account for 54 percent of the total worldwide population of individuals infected with the hepatitis C virus (HCV).

Published
6 hours ago
From
Gilead press release
How India's Patent Office Destroyed Gilead's Global Game Plan

Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," lawyer Tahir Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug."

Published
19 January 2015
From
Bloomberg Businessweek
Merck speeds up drug-submission plans for hep C, lung cancer

Merck said it planned to file an application with the FDA in the first half of the year for marketing approval for grazoprevir/elbasvir, a new two-drug, single-pill combination to treat hepatitis C.

Published
13 January 2015
From
Reuters
New open-access journal in the rapidly developing field of virus eradication

The Journal of Virus Eradication is a new open-access online and print journal dedicated to the rapidly developing field of virus eradication. It is particularly interested in publishing original research on HIV, hepatitis viruses, HPV, herpes and flu but work on other viruses is also included. The first issue was successfully launched at the HIV and Hepatitis Five Nations Conference in London on 8 December 2014 and is available now on the Journal website: www.viruseradication.com

Published
23 December 2014
From
Mediscript
US FDA approves AbbVie hepatitis C drug, costs $83319 for 12 weeks

U.S. health regulators on Friday approved AbbVie's all-oral treatment for hepatitis C, and the company said the drug would cost $83,319 for a typical 12-week plan, a bit below its huge selling competitor Sovaldi from Gilead Sciences.

Published
20 December 2014
From
Reuters
Daclatasvir for hepatitis C: added benefit not proven

The German Institute for Quality and Efficiency in Health Care (IQWiG) has concluded that data for patients without cirrhosis of the liver who are infected with hepatitis C virus (HCV) genotype 1, and for patients with HCV genotype 4 are not suitable for proving an added benefit of Daklinza (daclatasvir).

Published
11 December 2014
From
German Institute for Quality and Efficiency in Health Care (IQWiG)
Sofosbuvir/ledipasvir cures most previously treated hepatitis C patients with cirrhosis

Difficult-to-treat hepatitis C patients with liver cirrhosis who were not cured with a prior course of first-generation HCV protease inhibitors had a sustained response rate of 96-97%

Published
10 December 2014
By
Liz Highleyman
Sofosbuvir/ledipasvir with ribavirin cures most people with hepatitis C recurrence after liver transplantation

An interferon-free regimen of sofosbuvir plus ledipasvir (Harvoni) taken with ribavirin for 12 or 24 weeks led to sustained virological response in nearly all HCV genotype 1patients with fibrosis

Published
02 December 2014
By
Liz Highleyman
Sofosbuvir + simeprevir shows good results for hepatitis C in real-world use

Regimens containing sofosbuvir (Sovaldi) – including sofosbuvir plus simeprevir (Olysio) – work well for people with hepatitis C genotype 1 in real-world use, which to date has included

Published
02 December 2014
By
Liz Highleyman
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