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Hep C Discussion Forum -> Hep C News -> Phase 3 trials evaluating Simeprevir and Sofosbuvir have been initiated.
Post Info TOPIC: Phase 3 trials evaluating Simeprevir and Sofosbuvir have been initiated.
Matt Chris


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RE: Phase 3 trials evaluating Simeprevir and Sofosbuvir have been initiated.
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Hey Gracie

Getting into a trial is easier if you live within driving distance, but you can fly or move their for a short term.

The key to getting in a study is getting an appointment with the doctor that is sponsoring the study for the drug company. In the US they most of the time they list the study locations at Clinicaltrials.gov ( just search by Hepatitis C and the drug companies name)

I am watching them all the time and they have new ones all the time.

matt

   



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
Gracie


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How does one go about getting into these trials? They say they are in Canada as well. Do you have to live near a doctor who is running the trial?



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  1. Gracie

1A. Previously treated non responder Rebetron in 2000 And Incevik in 2014 with a breakthrough at week 12. Fibroscan 15.5. VL 6,000,000. Finished 24 weeks harvoni on Dec. 19, 2015. SVR. Latest Fibroscan 8.8.
Cinnamon Girl


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Hi Tig, yes exactly, and I wonder why it`s taken them so long?  It`s great news anyway, and let`s hope the initiation of these phase 3 trials helps to make things a lot easier for everyone doing or hoping to do, the currently `off label` treatment of Sovaldi/Olysio.  And hopefully the completed data will lead to FDA approval for this drug combo as a treatment in its own right.



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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.

 

 
Tig


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Hopefully a completed and successful phase 3 study will put an end to the notion that since there were no completed phase 3 Cosmos trials, the third month denials of the current off label use of Sov/Oly will cease. (Silly a reason as it is!) I guess we can say this is finally an indication that the horse was finally put back in front of the cart...

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Cinnamon Girl


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Press Release, 2 April 2014, Stockholm, Sweden - Medivir AB today announces that two phase III trials are recruiting patients to examine the efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in treatment-naļve and treatment-experienced patients with and without cirrhosis."

"Positive safety and efficacy results have previously been demonstrated in genotype 1 HCV infected patients with the interferon- and ribavirin free combination of simeprevir and sofosbuvir in the phase II COSMOS study. The OPTIMIST trials aim to further consolidate these data and to explore a shorter treatment duration of eight weeks to potentially further simplify this promising treatment option," says Charlotte Edenius, EVP Development, Medivir AB

The combination of simeprevir and sofosbuvir was previously evaluated in the phase II COSMOS trial.

The final cohort 1 study results (SVR12) in patients without fibrosis or cirrhosis (METAVIR score of F0-2) and the interim cohort 2 study results (SVR4) in patients with fibrosis or cirrhosis (METAVIR score of F3-4) from the COSMOS study were presented at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting 2013 in Washington, D.C.

Final cohort 2 results (SVR12) have been accepted for presentation at the European Association for the Study of the Liver (EASL) International Liver Congress 2014 on April 12.

Full details...

http://hepatitiscnewdrugs.blogspot.co.uk/2014/04/phase-3-trials-evaluating-simeprevir.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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