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Author Topic: Does anyone know when GS-5816 is going to be FDA approved in the U.S.?  (Read 5802 times)

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Offline Dawnmh

  • Member
  • Posts: 6
Just trying to find out when GS-5816 is going to be approved or if anyone knows if it will even be approved here first?????  I know they are allowing poorer countries to use this drug, but when does America?  Thanks ahead of time.

Offline charly8

  • Member
  • Posts: 113
It is in Phase III so probably within a year.  I would like to know as well.  Its hard to tell.
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline Dawnmh

  • Member
  • Posts: 6
Thanks so much, I hope so.  I wonder if they'll approve it for all GT's in this country.  That is something they may NOT do.

 


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