FDA throws up surprise labelling for Gilead Sciences' hepatitis C treatment Sovaldi
Zlikster said
Dec 11, 2013
i can already hear insurance companies screaming (GT1s for 168k $ too? noooooooooo) :)
Cinnamon Girl said
Dec 11, 2013
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...
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.
i can already hear insurance companies screaming (GT1s for 168k $ too? noooooooooo) :)
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
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