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Expect Sofosbuvir end of 2013
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Expect Sofosbuvir end of 2013

Read this press release about Sofosbuvir from Gilead...

http://www.gilead.com/pr_1786260

You'll see at the top of the article (under the heading), it says:

-- Initial Regulatory Filings Planned for Q2 2013 --

They have fast-tracked Sofosbuvir so it should take a maximum of 6 months for FDA approval. It is to be for Genotype 2 Tx in combo with Riba.

I expect the combo of Sofosbuvir + Ledipasvir to go to FDA by end of this year and get approval by mid 2014, but that's speculation only. That will be for Genotype 1.

A new dawn will soon be here for those who suffer from HCV.
Tags: Sofosbuvir, Gilead
9 Comments Post a Comment
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2203249_tn?1338994046
Such good news! This has made my day :-). Thank u for this post!
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3097131_tn?1357088481
That is very good news!!
I'm GT 1a and the  Sofosbuvir w/ the triple therapy just Cured me..SVR

~Country
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Avatar_f_tn
Did you have it with Riba & Ledispavir?
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3097131_tn?1357088481
No..it was with INF and Riba..
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Avatar_m_tn
How were you able to get into a trial?  Were you treatment naive?  Or had you previously failed a treatment with Peg-Ifn?  I can't get into a trial because I don't fall into either category.  Had prior treatment with just plain interferon and ribavirin.  Arghhhh.
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Avatar_m_tn
how many weeks were you taking the meds?
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163305_tn?1333672171
This is hopeful but past experience tells us to be cautious.
Nobody knows how long it will actually take the FDA to approve anything.
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Avatar_m_tn
More Sofosbuvir news Early 2Q Done

Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C   4-8-2013
http://www.gilead.com/news/press-releases/2013/4/gilead-submits-new-drug-application-to-us-fda-for-sofosbuvir-for-the-treatment-of-hepatitis-c

HCV Treatment — No More Room for Interferonologists?
http://www.nejm.org/doi/full/10.1056/NEJMe1303818
What are we to conclude from these studies? The low incidence of side effects, the relatively short duration of treatment, and the pangenotypic properties of the drugs are strong selling points of a sofosbuvir–ribavirin regimen and will probably lower the threshold for HCV treatment for both patients and physicians. The likely next step is to combine sofosbuvir with other direct-acting antivirals to enhance its potency. Is the interferonologist down and out? I do not think so, but it is surely time for reeducation.
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Avatar_f_tn
@OC, Since Sofosbuvir is fast tracked by the FDA, it will be approved or rejected in 6 months.

@JimmyMose, yes they need to combine Sofosuvir with another DAA to increase effectiveness.  Currently, they're combining it with Ledipasvir, a NS5A inhibitor, with quite good results...
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