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Post Info TOPIC: Janssen Submits Application to FDA for Simeprevir (TMC435) for Combo Tx of Gen 1 (with peg +riba)


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RE: Janssen Submits Application to FDA for Simeprevir (TMC435) for Combo Tx of Gen 1 (with peg +riba)
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Not alone at all I stopped 3rd time in January and I still reak of it. After 3 times I don't think it works for me Others make it but I didn't  It's pills or nothing.

Bills



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.



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I will never take interferon drug ever again. And i know i am not alone.



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58 yo..Relapsed in 99 and again in 2004. Started triple therapy with Victrelis July 22,2012.  genotype 1a. week 8,12,16,24 VL Undetectable..E.O.T -- 6-22-2013,,,EOT + 24., UND. 

SVR !!!

 

~Bob~



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Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C

-- Filing Based on Phase 3 Data in Treatment-Naļve and Treatment-Experienced Patients with Compensated Liver Disease --

Raritan, N.J., March 28, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients.

Full aritcle...

http://www.prnewswire.com/news-releases/janssen-submits-new-drug-application-to-us-fda-for-simeprevir-tmc435-for-combination-treatment-of-adult-patients-with-genotype-1-chronic-hepatitis-c-200501671.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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