Sofosbuvir (GS-7977)/Ledipasvir (GS-5885)

[somuchmore2]

Is there any news on this FDA fast track which should be forthcoming in the fall of 2014?

Have any of you 1A Genotype done these yet?

Thanks

[somuchmore2]

Thank you.  I am trying to make certain am up to speed on the latest.  It appears to be my best hope.

[HectorSF]

Gilead filed the NDA (new drug application) for ledipasvir/sofosbuvir (LDV/SOF) February 10, 2014 and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014.

The FDA has also assigned LDV/SOF a Breakthrough Therapy designation. The FDA grants Breakthrough Therapy designation and priority review status to investigational medicines that may offer major advances in treatment over existing options. The data submitted in the NDA are from three Phase III studies, ION-1, ION-2 and ION-3, and support the use of LDV/SOF in adults with genotype 1 HCV infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Around 75% of people infected with HCV in the USA have the genotype 1 strain of the virus.

Sovaldi (SOF) as a single agent was approved by the FDA under the trade name Sovaldi on December 6, 2013.

So expect ledipasvir/sofosbuvir to start being available in November of December after it is added to the formularies of the health insurance companies and distributed to pharmacies.

Hector

[48weeks]

Probably just the couple of hundred who were lucky enough to participate in the trials. The news sounds promising and I'm right there with ya...waiting.