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Hep C Discussion Forum -> Hep C News -> Gilead applies for FDA approval for sofosbuvir & velpatasvir combination treatment
Post Info TOPIC: Gilead applies for FDA approval for sofosbuvir & velpatasvir combination treatment
Cinnamon Girl


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Gilead applies for FDA approval for sofosbuvir & velpatasvir combination treatment
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On September 21, 2015 Gilead submitted their Phase 3 data of a once-daily combination of sofosbuvir (polymerase inhibitor) and velpatasvir (NS5A inhibitor) with and without ribavirin to treat genotype 1 through 6 patients to the FDA for marketing approval.

Patients with decompensated cirrhosis were treated with sofosbuvir plus velpatasvir and ribavirin.  The treatment duration was 12 or 24 weeks.

The FDA has designated the combination as Breakthrough Therapy. The designation will speed up the drug approval process. This combination will be approved in 2016.

 

Link to article, including data from the phase 3 `Astral` clinical trials...

http://hepatitiscadvocate.blogspot.co.uk/2015/11/gilead-applies-for-fda-approval-by-alan.html



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
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Hep C Discussion Forum -> Hep C News -> Gilead applies for FDA approval for sofosbuvir & velpatasvir combination treatment
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