Hep C Discussion Forum

Members Login
Username 
 
Password 
    Remember Me  
Chatbox
Please log in to join the chat!
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


Guru

Status: Offline
Posts: 791
Date:
RE: FDA throws up surprise labelling for Gilead Sciences' hepatitis C treatment Sovaldi
Permalink  
 

i can already hear insurance companies screaming (GT1s for 168k $ too? noooooooooo) :)



__________________

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


Guru

Status: Offline
Posts: 5629
Date:
Permalink  
 

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


Guru

Status: Offline
Posts: 1782
Date:
Permalink  
 

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



__________________

"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! 
Page 1 of 1  sorted by
 
Quick Reply

Please log in to post quick replies.
Hep C Discussion Forum -> Hep C News -> FDA throws up surprise labelling for Gilead Sciences' hepatitis C treatment Sovaldi
Legal Disclaimer:

THIS FORUM, IT'S OWNERS, ADMINISTRATORS, MODERATORS AND MEMBERS DO NOT AT ANY TIME GIVE MEDICAL ADVICE AND IN ALL CASES REFER ANYONE HERE TO SEEK APPROPRIATE MEDICAL ADVICE FROM THEIR DOCTOR.