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Post Info TOPIC: ACCESS TO TRIAL DRUGS IN A COMPASSIONATE PROGRAM


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RE: ACCESS TO TRIAL DRUGS IN A COMPASSIONATE PROGRAM
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Hi all-- I'm not looking for a trial at this time. Pablito thanks for the help but those trials are out of the country (USA). What I am interested in is -- will the drug companys let a person get the drugs that are still in trials and not fda approved . My understanding is that Abbvie will look at this question on a case by case scenario, and has in the past supplied the study drug. Just wondering if gilead had a program like this?   RC



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 M-64) 3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18   



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And here are 3 more trials you might fancy...

Link 1

Link 2  (G3 only)

Link 3

 

 

 



-- Edited by Pablito on Thursday 30th of June 2016 11:55:18 AM

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44 y.o. male, HCV G4 since 1996, F-scan score 9, F2, Failed prior I/R, finished sof/vel/vox 8 weeks 5/16, pre-treatment VL 2 million, EOT UND, EOT+4 UND, EOT+12 UND.



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I've pasted the contact details below.  I've just noticed that they are only recruiting G1 patients.  What genotype are you?

Contact: Eleanor Wilson, MD410-706-1710ewilson@ihv.umaryland.edu 
Contact: Jennifer Hoffmann, MSN/MPH410-706-0294jhoffmann@som.umaryland.edu 


Locations
United States, Maryland
Institute of Human VirologyRecruiting
Baltimore, Maryland, United States, 21201 
Contact: Eleanor Wilson, MD    410-706-1710    ewilson@ihv.umaryland.edu    
Contact: Jennifer Hoffmann, MSN/MPH    410-706-0294    jhoffmann@ihv.umaryland.edu    



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44 y.o. male, HCV G4 since 1996, F-scan score 9, F2, Failed prior I/R, finished sof/vel/vox 8 weeks 5/16, pre-treatment VL 2 million, EOT UND, EOT+4 UND, EOT+12 UND.



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Hi Robert

Bear in mind when searching for sof/vel/vox trials that vox is likely to be called GS-9857.

When I put "GS-9857" into the search engine Wendy recommended a bunch of trials came up but only one is actively recruiting.  Here is the link

It's based in Maryland.  I don't know where this is but I know it's in the US and you are in the US.  There's a link for the contact numbers in the link above.

I'd get on to them right away.

Please bear in mind that in the exclusion criteria they mention "other significant health problems".  I hope this doesn't include HCC, but I know this is was an exclusion criterion for the sof/vel/vox trial I did.

Pablo

 



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44 y.o. male, HCV G4 since 1996, F-scan score 9, F2, Failed prior I/R, finished sof/vel/vox 8 weeks 5/16, pre-treatment VL 2 million, EOT UND, EOT+4 UND, EOT+12 UND.

Tig


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You know, my thought on this RC, is to ask your oncologist and hepatologist if they can intervene on your behalf. They will be in the know of whom is in charge of these large trial programs. A phone call by them may find a trial director that has an immediate opening that you can slip into. Your case would be right at the top of "interesting" for them. Seeing how these drugs perform and how the virus reacts in your particular situation has to be something they would like to investigate. Just another thought!



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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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Thanks, I will start pounding on the Gilead door next week after I see the intervention Radiologist about my three little friends camping out in my liver.  RC



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 M-64) 3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18   



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Found this RC.....To learn more about the clinical trials that are underway and to find out if a study is enrolling patients in your area, please visit www.clinicaltrials.gov or call 1-(800) GILEAD-5 (800-445-3235) between 8:00 a.m. and 5:00 p.m. Pacific Time.

Since what you are looking for just came out this week, it may not be on the site yet, I agree with Canuck...call em. What have you go to lose. 



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Wendy 53 y/o, DX 1994, geno 1A F1

1999 TX 1 - Inter -non responder 2001 TX 2 - Peg + Riba - viral load tripled and taken off

T3:  Harvoni 12 weeks Sept. 19, 2015 ALT 41 AST 30 VL 541800 UND at EOT and SVR 24 ALT 18 AST 26 platelets 223

 



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RC,

ASK everyone!! Repeatedly!, starting with ALL your docs, and ALL the staff you have recently met, every team member, everyone you were introduced to, and all of their support staff (perhaps even their support staff that you did NOT get to meet yet). Get the office heirarcy phone lists.

ASK, and keep asking, the ones you know (and their staff that you may not know yet) the same question and request, until they are sick of you asking, ask by phone, by fax, by email, in person, AND, do the same inquiries directly as you can with all the differing names you can find for Gilead. Aside from you (directly contacting all the Gilead people you can find), ask all your docs as well, all members of the "team", and their staff, to make inquiries of Gilead on your behalf, "request" they make inquiries on your behalf. Follow it up, with later inquiries, of the same people to whom you have evoked even a luke warm response with, "if they have found out yet, about your "request" to find out -"how can I get vox now please?".

Make it known to everyone of them, (your OLD docs and OLD staff), AND, the new docs and staff, that that's what you want and need - AND ask them "HOW" am I going to get vox, for my treatment, now, not next year! Please will you find out for me, from Gilead, how they can make this haapen for me and my provider!

Keep inquiring everywhere (to any involved or "in the know" party), have them "notice you" pursuing it so ardently, employ your wife's assistance, tag team like. Leave no stone unturned.

Write a long letter or email to the (sussed out) most appropriate senior person you can find at Gilead, address it to (both) them AND Gileads "Compassionate Programme" dept. (as one), asking for what you want/explain it all, (even if you know and see they have no "Compassionate Programme")!!!

I tried EVERYTHING to succeed getting into my trial, tig even made me brave enough to contact Gilead directly, I only gave that (contacting Gilead directly) one feeble attempt, and I will never know whether it had any intended effect to my favour, or not (I kind of doubt it - I got back a kind of standard "re-direct" answer from them, referring me back to my care provider), oh well, but, it was worth my one lac lustre attempt. Who knows, you might just have better luck than I did, in actually having a real "advising discussion" with some humane-being at Gilead, AND, you could probably do a better job of it (trying to make effective contact with Gilead) than I did!.

I, with little shame, jumped from one doc to another, inquired of many others (different outfits), until I narrowed my best choice of "an in" to one outfit, then I pursued some of the head clinical trial nurses, some of whom were reeeally VERY nice and understanding human beings who could see how obvious my desperation was to get into a sof/vel trial (anybody's sof/vel trial!) - I do believe it was mostly them (the two different clinical nurses, at the two differing outfits) "talking shop" to one another about this desperate G3a phoning them, and then one (in particular) who ended up helping me to finally get my foot in the correct door faster (or at least "in time") before all the (few) trial seats were gone. Turned out, I was already at the right door, but I was not about to leave any of my stones "unturned", just in case! Back-up, insurance.

I might have just been spinning my wheels, all for nothing, and perhaps just good fortune would have got me there anyway, but, I REALLY DO suspect my "obvious to them" activities/communications/actions (to ardently show my wishes), did help!!

You should ask everyone, push, you never know what might help! Trying cannot hurt.

 



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Hi All--  Lets say you have a liver in pretty bad shape, and you have been on two treatments that failed you.Now let's say a new combo drug was just approved yesterday (sof-Vel) but you felt like you needed to hit the virus in three spots instead of just two, and the third drug was in trials and was proven in the trials to be very effective when used with the sof-Vel. The third drug in trials (VOX) won't be out until next year mid summer? GILEAD is the drug mfg.Has anyone heard of a program with gilead where you can get access to drugs in trials?

Abbvie dose have a program they call compassionate access to trial drugs, but I can't find anything on Gilead.     Thanks.  RC



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 M-64) 3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18   

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