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Hep C Discussion Forum -> Hep C News -> FDA throws up surprise labelling for Gilead Sciences' hepatitis C treatment Sovaldi
Post Info TOPIC: FDA throws up surprise labelling for Gilead Sciences' hepatitis C treatment Sovaldi
Zlikster


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RE: FDA throws up surprise labelling for Gilead Sciences' hepatitis C treatment Sovaldi
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i can already hear insurance companies screaming (GT1s for 168k $ too? noooooooooo) :)



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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!
Cinnamon Girl


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Hi Matt, yes, that`s an interesting point.  I`ve just been reading through the full prescribing information and as far as I can see this will only apply to people with an HCV-HIV-1 co-infection (see points 8.8, and 14.4), unless I`ve missed something.

This is what it says at the end of section 2.1,` Recommended Dose for Adults`...SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive an interferon based regimen [See Use in Specific Populations (8.8) and Clinical Studies (14.4)]`

It will be interesting to read the results of the poll being conducted by First World, as described in the article, when it`s published tomorrow (Thursday).

Here`s the link to the full prescribing information, pdf format...

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

 



__________________

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.

 

 
Matt Chris


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Hey All

I was reading some of the news in about Sovaldi and this topic about Gilead getting approval for GT-1's being able to either receive treatment for 24 weeks with Ribavirin only or 12 weeks with peg & Riba.

Like the article reads, I don't remember any hard data that suggested that 24 weeks with Riba had high % SVR rates. 

Interesting reading here's the link http://www.firstwordpharma.com/node/1170390#axzz2n2eh1CcY

matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
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