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Hep C Discussion Forum -> General Discussion -> Gileads plans
Post Info TOPIC: Gileads plans
JIme


Guru

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RE: Gileads plans
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If they want to make some real money they need to make a deal with BMS.

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jim

GT1a, St2 Lv2 last biopsy 2002, VL  11.4m,  start triple tx 9/30/11

VL 470 @4wks.....VL 22,000 @8wks  stopped tx

Round 2-  Started 3/16/12   PSI-7977, BMS-790052, Riba Undetectable day 14

Did 24 weeks Still UND 12 weeks post tx, SVR24!!!!!!! 2/14/13

 

 

 

 

 
mallani


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It appears that Gilead will try to fast-track sofosbuvir, to try to get FDA approval in late 2013 or early 2014.  However, this will only be for sofos. + Ribavirin for Geno 2 and 3, and sofos. +Peg + Riba for Geno 1. While I can understand the need to generate some revenue, I'm not sure the Hepatology community, and Stock Market will be thrilled by this. Unless there are marked changes in the SVR rates in the next Phase3 trial results, the SVR rate for Geno 2 and 3 will be ~70%, and the SVR rate for the Geno1's will be ~ 65% overall.

What we need is approval for GS-5885, but this will take another 12 months extra.

Abbott may leapfrog Gilead if the Phase3 trial results continue to be as promising. Unfortunately Abbott's regime contains an NS3 inhibitor, so previous Rx with Incivek and Victrelis will be an exclusion.



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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
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