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Post Info TOPIC: U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1


Guru

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RE: U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1
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Puzzling, isn`t it.  I can`t see why it`s being given Priority Review either.



__________________

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.

 

 



Senior Member

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Hi Malcolm:

From what they told us at the screening was that they are only talking patients who have not been treated before, and don't have 

cirrhosis.disbelief



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Geno type 1b, F1 vl 640,000 enrolled in Gilead's sofosbuvir/ledipasvir -week 1 66, week 2 <25



Guru

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I have no idea Malcolm,, when they take the peg out, that's when it interest's me.



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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~



Guru

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Hi Jill,

I've poured over the results for Quest-1, Quest-2 and Promise Trials and wonder what I'm missing. Simeprevir has an advantage in being a single pill, but still needs to be used with Peg and Riba. As a second generation NS-3/4A inhibitor, I expected better results than those for Incivek and Victrelis. The same old problems appear and the difference in results for Interleukin 28B variants is more striking. The TT alleles do very poorly. The SVR rates are highly dependent on the Fibrosis score, which is not what we are looking for. The side effects are not well documented but fatigue and rash seem common.

Can anyone explain why this drug deserves Priority Review?



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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



Guru

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U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C

RARITAN, N.J., May 13, 2013 /PRNewswire/ -- Janssen Research & Development announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) 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 with compensated liver disease.

Full news release...

http://www.prnewswire.com/news-releases/us-fda-grants-priority-review-to-simeprevir-tmc435-for-combination-treatment-of-genotype-1-chronic-hepatitis-c-207169391.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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