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Hep C Discussion Forum -> Clinical Trial Participants -> Think I might have gotten a trial!!!!! Questions….
Post Info TOPIC: Think I might have gotten a trial!!!!! Questions….
Milliganus


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RE: Think I might have gotten a trial!!!!! Questions….
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Thanks so much Tig, very useful info.  I'm ready to do the happy dance, but waiting till I get the official acceptance.  I was crying on the phone though to the RN at Scripps who is helping me.  I've waited 35 years for this.  You all know the feeling.  I'm unable to put it into words.

 

Thanks for all your encouragement.



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
Tig


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 Hi Marcy,

Congratulations on being accepted for that study! You're lucky because I believe these studies will begin to wane due to the actual use of these two drugs as an "off label" treatment. Fewer and fewer opportunities for study inclusion (this combo) will occur in the near future I think. So your timing is perfect for this.  It's an excellent combination and your chances of success (SVR) are extremely high. The Q80K polymorphism (info links below) is something that can be tested for and if you're on a trial, they will certainly test you for it. It's a reason you don't need to worry about though. The Q80K pm affects those being treated with one of the three Polymerase Inhibitors, Incivek. Victrelis or Olysio along with Interferon and Ribavirin. The addition of Sovaldi (Sofosbuvir) mitigates the Q80K issue, so you don't need to worry about it. Approximately 1/3 of the GT 1's have this polymorphism according to reports. 

I think you've got a very good reason to stand up and do your version (whatever it is) of the "Happy Dance"!!!! A hep C free future is in the cards for you, woot!! Good luck...

Tig

Olysio and the Resistant Q80K Polymorphism

Polymorphism Screening

 



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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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Milliganus


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Called out to Scripps today and talked with them about the upcoming Janssen Optimist-1 clinical trial (NCT02114177).  Sounds like they are going to accept me.  It will start in May in California.  We are currently in Colorado with a child with a broken arm.  No problem to travel though.  All of you have more experience than me with this, so I'd really appreciate your input on this trial for my genotype.

The trial is a randomized 8 or 12 week 2 pill a day, Sofosbusvir (400mg) & Simeprevir (150mg).  No Riba or Inf.  Data from the phase 2 Cosmo study for my genotype 1a is below.  My question is:

1.  These studies talk about "poly morphisms".  Don't know what that is.

2.  For my genotype (info in signature), are the chances good I will achieve SVR with either the 8 or 12?

3.  Since I'm currently treatment naive, if these don't work, will I then be at a disadvantage for other trials in the future?

Just trying to get all the info I can before we travel 1200 miles for this.  Very excited but want to be informed.  As many of you know, we travel full-time in our RV so I don't have a regular doctor.

Any help will be much appreciated!!

 

EASL Final Data:  Cosmo 2 

SVR12 Among Patients with Genotype 1 HCV and Advanced Liver Fibrosis in Cohort 2 of the COSMOS Study*
12 Weeks of Treatment
Regimen
Simeprevir/
Sofosbuvir (%)
Simeprevir/
Sofosbuvir
+ Ribavirin (%)
Overall
93
93
Genotype 1a HCV without the Q80K polymorphism
88
93
Genotype 1a HCV with the Q80K polymorphism
100
88
Genotype 1b HCV
100
100
IL28B CT
100
93
IL28B TT
100
88
METAVIR 
86
91
 
 
 
 
 
SVR12 Among Patient Subgroups with Genotype 1 HCV and METAVIR Scores of F0-F2 in Cohort 1 of the COSMOS Study*
12 Weeks of Treatment
Regimen
Simeprevir/
Sofosbuvir (%)
Simeprevir/Sofosbuvir + Ribavirin (%)
IL28B CT
100
100
IL28B TT
67
83
METAVIR F2
100
94


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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
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