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Hep C Discussion Forum -> On Treatment -> IDX719 anyone know what this new med is?
Post Info TOPIC: IDX719 anyone know what this new med is?
mallani


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RE: IDX719 anyone know what this new med is?
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Hi Marcy,

I'd be careful using the 'statins', particularly Simvastatin.  Although it is effective in LDL control, liver damage and muscle damage are well known side effects. I'd give it a miss until the HCV is sorted out. Cheers.



__________________

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
Milliganus


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FYI info...RE: IDX719 anyone know what this new med is?
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Just for everyones info, the trial center for the IDX719 trial called & told me that since I'm on Simvastatin (20mg) that I'm ineligible for this particular trial as it could interfere with results.  My old doc put me on it "preventative" so I plan to go off it for future trials just in case.  I had decided not to do this trial anyway.  5 meds and none of them proven for my genotype anyway.  

 

All your great information and advice played into my decision.  Thanks. again.



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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
Milliganus


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RE: IDX719 anyone know what this new med is?
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Matt--sorry bout that.   Foggy brain wink

The 5 drugs in this study are IDX719(samatasvir), simeprevir, ribavirin, TMC647055, Ritonavir.    After reading everyones posts, I don't think I'm going to be to quick to jump on this one..



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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
suziq


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Hi Marcy,

Read Jill's post of the January HCV Advocate Newsletter.  That is where I saw all the new drugs in development listed.  I am sure there will be plenty of trials in the coming year. You can subscribe to the newsletter as well.

 I only did the Merck trial because my clinic coordinator had been a part of the earlier trial and assured me I was getting "a really good trial"  All of her people reached SVR, but she could not tell me that until the results were announced at the Liver conference in Nov.  She cannot even share how others on my trial are doing. 

You can turn down a trial and still remain on the list for other upcoming trials at a testing center.   You can contact my center in Arlington Texas and ask about upcoming trials at that center.

SuziQ 



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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
suziq


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The Merck trial is called C-Worthy.  It is a combo of MK5172 and MK8742.  It is clinical trial NCT01717326.  It is not recruiting as it is finishing up the current trial and will probably recruit for Phase III after the data is compiled sometime this Spring.  The 18 week arm (the longest arm) finishes next week. It has to do a Phase III trial for FDA approval, so sometime soon.

SuziQ



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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
Matt Chris


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Hello Marcy

I am some what confused about which drugs are included in this trial in Fl.

In your first part of the thread you listed  (IDX719, sofobusvir & ribavirin) But in your second you listed the trial info with five Meds none of which include Sofosbuvir.

Can you clarify ?

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! 
Milliganus


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SuziQ,

Thanks..what is the name of the Merck trial you were on?  



-- Edited by Milliganus on Tuesday 7th of January 2014 02:38:19 AM

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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
suziq


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Hi Marcy,

Merck has not started it's phase III trials yet.  It had excellent results for Genotype 1a.  I've been UND since week 4. In the earlier phase 2 study 97 out of 98 reached SVR.  If you have doubts, there will be other trials this coming year.  You are in an excellent position to wait for the best. I am sure several companies will be announcing trials for the coming year in the next few weeks.  I just read a summary of new meds still in trials.  I'll see if I can find it and post it. 

SuziQ 



__________________

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
mallani


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Hi Marcy,

I understand your dilemma. The Helix-1 Trial was back in early 2013, and I haven't seen any results. Could you ask about that?  Also, the initial Trials were only for Rx-naive Geno 1b's.  If the results were great, I don't understand why they added TMC647055, Ritonavir and Ribavirin.  I would certainly want to see some progress data.

With Geno 1a, and your C/T, G/T polymorphisms you certainly want the best chance of SVR. Best of luck!



__________________

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
Milliganus


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Thanks for the info Mallani.  This is the first trial that I may be called for.   I'm apprehensive that I've missed the good phase III trials for the medications that work best for my genotype of 1a.  I don't know how discriminating I should be because I really want my best chance at a cure.  I'm retired and live in a motorhome and can travel anywhere in the country at any time.

Any feedback on how selective I should be with clinical trial offers?

 

Thanks for any and all suggestions.



__________________

Marcy

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


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Hi Marcy,

As Tig said, IDX719 is Samatasvir, a NS-5A inhibitor from Idenix Rharmaceuticals Inc. They have run the Helix-1 and Helix-2 Trials, but have not published any results that I have seen.  The Trials are ongoing, and they are mixing it with other DAA's like Olysio and TMC647055.  I haven't seen it used with Sovaldi.

Here is a link to the Samatasvir info:

http://www.natap.org/2013/HCV/013113_03.htm

I suspect the results aren't that great, and new Trials with Ribavirin are expected.   They also use Ritonavir to boost the blood levels. Personally, I don't think much of TMC647055 as it is a non-nucleoside NS-5B inhibitor, not in the same class as Sovaldi.   I think there are better Trials about but that's only IMHO.  Cheers.



__________________

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
Milliganus


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The trial number is NCT01852604.  I took this out of the listing on ClinicalTrails.gov.  It looks like there will be 5 meds.  Is that common to have that many?  

Experimental: Group C (genotypes 1a, 1b)

Weeks 1-12 = IDX719 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily plus RTV 30 mg once daily, plus RBV (dosing weight-based, according to product label) twice daily

Weeks 1-12 = IDX719 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily, plus RTV 30 mg once daily, plus RBV (dosing weight-based, according to product label) twice daily

Drug: IDX719

IDX719 will be supplied as 25 mg and 50 mg tablets.

Drug: simeprevir

Simeprevir will be supplied as 75 and 150 mg capsules.

Drug: ribavirin

Ribavirin will be supplied as 200 mg tablets.

Drug: TMC647055

TMC647055 will be supplied as 150 mg capsules.

Drug: ritonavir

 

Ritonavir will be supplied as 80 mg/mL oral solution.



-- Edited by Milliganus on Monday 6th of January 2014 11:39:42 PM



-- Edited by Milliganus on Monday 6th of January 2014 11:49:58 PM

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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,

I'm going to do some research on this, so I don't have much info yet. This report gives some limited data on current and upcoming study plans. The drug is from Idenix Pharmaceuticals, Samatasvir (IDX719). Here's a link to their website: 

http://www.idenix.com/hcv/drug.html

Tig



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Tig

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Milliganus


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Hi all,

I got a call from a trial center in Florida that I might be able to get into for a triple combo of IDX719, sofobusvir & ribavirin.  It is a 12 week trial.  I'm excited, but trying to hold back cause I haven't been accepted yet.  Do any of you know what the IDX719 is?  How can I get more information?  Since I haven't had treatment before, (genotype 1a) I want to try and get in a trial that may actually work!

 

Any help is appreciated.

 

Thanks!



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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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