Hep C Discussion Forum

Members Login
Username 
 
Password 
    Remember Me  
Chatbox
Please log in to join the chat!
Hep C Discussion Forum -> Knowledge/Info Section -> Sovaldi (sofosbuvir) - Full Prescribing Information
Post Info TOPIC: Sovaldi (sofosbuvir) - Full Prescribing Information
JLynch30


Senior Member

Status: Offline
Posts: 292
Date:
RE: Sovaldi (sofosbuvir) - Full Prescribing Information
Permalink  
 

Thanks! I have failed a study using the BMS700 before - I am wondering if I am eligible for this medication.



__________________

John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 
mallani


Guru

Status: Offline
Posts: 3398
Date:
Permalink  
 

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.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
Cinnamon Girl


Guru

Status: Offline
Posts: 5629
Date:
Permalink  
 

Sovaldi (sofosbuvir) - Full Prescribing Information, from Gilead Sciences.

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.

 

 
Page 1 of 1  sorted by
 
Quick Reply

Please log in to post quick replies.
Hep C Discussion Forum -> Knowledge/Info Section -> Sovaldi (sofosbuvir) - Full Prescribing Information
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.