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New and experimental hepatitis C treatment news

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Fair Pricing Coalition Disappointed by the High Price of New Janssen Hepatitis C Drug Olysio (simeprevir)

Janssen has set the wholesale acquisition cost, (WAC) for a single 12-week course of Olysio at $66,360. Though this is in parity with current HCV PIs, the FPC believes that all HCV drugs are priced too high. The WAC price of Olysio represents only part of the cost of an anti-HCV regimen, including at least $18,000 in WAC costs of interferon and ribavirin, plus the additional cost of the NS3 Q80K polymorphism screening test recommended by the FDA for all patients before initiating Olysio therapy.

Published
29 November 2013
From
Fair Pricing Coalition
Gilead responds over India patent pressure on HCV drug

Fresh from picking up a positive opinion in Europe for sofosbuvir, Gilead Sciences is facing a battle to get patent protection in India for its much-touted new hepatitis C drug.

Published
27 November 2013
From
PharmaTimes
Faldaprevir effective across patient sub-groups with several baseline characteristics associated with treatment outcomes

The experimental hepatitis C virus (HCV) protease inhibitor is efficacious across a range of subgroups, according to research presented to the recent Liver Meeting 2013, the 64th annual

Published
27 November 2013
By
Michael Carter
Meeting report of the International multi-stakeholders meeting on the compassionate use of HCV treatment

On 19-20 June 2013, the European AIDS Treatment Group (EATG) and the European Liver Patients Association (ELPA) organised a meeting, dedicated to “Pathways to provide access to novel HCV compounds to people for whom they are yet not authorised, but who have no alternative treatments”.

Published
26 November 2013
From
EATG
European Medicines Agency advises on compassionate use of daclatasvir

Opinion concerns use in combination with sofosbuvir in patients with chronic hepatitis C in urgent need of therapy to prevent progression of liver disease.

Published
26 November 2013
From
European Medicines Agency
Indian health activists move to prevent Gilead’s drug patent

Indian health activists are seeking to prevent Gilead from patenting its new treatment for Hepatitis C in the country in a fresh battle over affordable access to medicine.

Published
26 November 2013
From
Financial Times
FDA approves new treatment for hepatitis C virus

The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.

Published
23 November 2013
From
US FDA
European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C

Sofosbuvir is the first representative of a new class of antivirals that act as inhibitors of an essential enzyme of HCV, the NS5B ribonucleic acid polymerase. This medicine provides the first interferon-free treatment option for chronic hepatitis C.

Published
22 November 2013
From
European Medicines Agency
Faldaprevir safe and effective in HCV treatment-experienced patients

The investigational hepatitis C virus (HCV) protease inhibitor faldaprevir is a safe and effective treatment for people who did not respond to a previous course of HCV treatment,

Published
22 November 2013
By
Michael Carter
AbbVie reports 96% cure rate for interferon-free hepatitis C regimen in phase 3 study

An interferon-free combination of three drugs plus ribavirin achieved a sustained virologic response (SVR12) in 96% of previously untreated patients with genotype 1 hepatitis C infection, AbbVie

Published
18 November 2013
By
Keith Alcorn

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