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Post Info TOPIC: Simeprevir Approved in Canada, for Gen. 1


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Simeprevir Approved in Canada, for Gen. 1
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I just noticed that Simeprevir has now also been approved by FDA in USA.  I pulled out a paragraph from one article that really caught my eye.

"Simeprevir is also being studied in several interferon-free regimens using selected combinations of direct acting antiviral agents with different mechanisms of action. To date, more than 3,700 patients have been treated with simeprevir in clinical trials."

The Merck drug I am on had 98 people in their first Phase 2 trial.  My coordinator was concerned about her people getting a slot in this second Phase 2 trial--maybe 600 slots.  Merck still has Phase 3 trials to complete.  And there are several other new drugs in Phase 2 .  If Simeprevir did 3,700 patients for it's approval by FDA--Just imagine how many people will get the opportunity to do clinical trials in the coming year with all the new drugs being tested.  Those without insurance now have a chance to be treated----IF they are resourceful in checking out this opportunity. And for others there will be the opportunity to treat earlier with the new drugs.

SuziQ  



-- Edited by suziq on Monday 25th of November 2013 02:28:55 PM

__________________

Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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Medivir AB has announced that Health Canada has approved simeprevir for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naļve or who have failed previous interferon therapy (pegylated or non-pegylated) with ribavirin.

Simeprevir received priority review status and is the first treatment for CHC to be approved for once-daily administration with pegylated interferon and ribavirin in Canada.

Full article...

http://hepatitiscnewdrugs.blogspot.co.uk/2013/11/simeprevir-approved-for-hepatitis-c-in.html



__________________

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.

 

 

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