Sovaldi (sofosbuvir) - Full Prescribing Information
JLynch30 said
Dec 11, 2013
Thanks! I have failed a study using the BMS700 before - I am wondering if I am eligible for this medication.
mallani said
Dec 11, 2013
Hi Jill,
Thanks for this.
I don't like the fact that Gilead have set such firm parameters for the management of the Riba anaemia. The statement 'Reduce Ribavirin to 600 mg/day if Hb falls to <10 g/dL, and discontinue Riba if Hb drops to <8.5 g/dL' seems extreme. In the highly litiginous USA, this ties the hands of the Hepatologist. Many patients can manage with a Hb of <10, and why does the Riba reduction have to be so large? Procrit is an accepted management of anaemia, but this is not mentioned. The Victrelis and Incivek Prescribing Information leaves this up to the Hepatologist to manage.
The section about resistant mutations is confusing. They describe only one relapser who had the S282T RAV. The other substitutions mentioned have been discussed and discounted by other researchers. I think there's a lot they either don't know, or are keeping to themselves.
I can't understand why Stopping Rules are not discussed. Does Gilead want to make sure every patient gets at least 12 weeks of Sovaldi? Cheers.
Cinnamon Girl said
Dec 11, 2013
Sovaldi (sofosbuvir) - Full Prescribing Information, from Gilead Sciences.
Thanks! I have failed a study using the BMS700 before - I am wondering if I am eligible for this medication.
Hi Jill,
Thanks for this.
I don't like the fact that Gilead have set such firm parameters for the management of the Riba anaemia. The statement 'Reduce Ribavirin to 600 mg/day if Hb falls to <10 g/dL, and discontinue Riba if Hb drops to <8.5 g/dL' seems extreme. In the highly litiginous USA, this ties the hands of the Hepatologist. Many patients can manage with a Hb of <10, and why does the Riba reduction have to be so large? Procrit is an accepted management of anaemia, but this is not mentioned. The Victrelis and Incivek Prescribing Information leaves this up to the Hepatologist to manage.
The section about resistant mutations is confusing. They describe only one relapser who had the S282T RAV. The other substitutions mentioned have been discussed and discounted by other researchers. I think there's a lot they either don't know, or are keeping to themselves.
I can't understand why Stopping Rules are not discussed. Does Gilead want to make sure every patient gets at least 12 weeks of Sovaldi? Cheers.
Sovaldi (sofosbuvir) - Full Prescribing Information, from Gilead Sciences.
Pdf format...
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf