The remarkably high cure rates being reported with the newest hepatitis C drugs are only likely to be used by a tiny percentage of people who need them.
30 January 2015 | HIV i-Base
We, the undersigned, are organizations of people living with hepatitis C virus (HCV), HIV, and our allies. We believe in equitable access to life-saving treatment for all who need it. We write to express our indignation over Gilead’s pricing and licensing policies for the HCV drug, sofosbuvir.
30 January 2015 | Petitionbuzz
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.
27 January 2015 | Médecins Sans Frontières press release
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).
27 January 2015 | Gilead press release
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."
19 January 2015 | Bloomberg Businessweek
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.
13 January 2015 | Reuters
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
23 December 2014 | Mediscript
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.
20 December 2014 | Reuters
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).
11 December 2014 | German Institute for Quality and Efficiency in Health Care (IQWiG)
Bristol-Myers said the FDA has asked it for data involving use of daclatasvir with other drugs, and that the company is in discussions with the agency about the scope of the required information.
27 November 2014 | Reuters