Thanks Tig.

I like to write so here is the one I just finished to my Doctor.

"Howdy Doc, hope your day has gone better than mine. By now you have likely been informed that I was rejected at screening for the trial. I appreciate that you made the attempt on my behalf more than you will ever know.

I remain on schedule to meet with you in The Woodlands 03/08/16. At that time I would appreciate discussing either Harvoni ( which is my Insurance Companies preferred treatment) or perhaps discussing your below potential recommendation of  SOF/DAC.

The SOF/DAC of course avoids the Ledipasvir in Harvoni which needs some gastric acid to be absorbed into the body.

I do believe in my case that Harvoni if taken while fasting simultaneously first thing in the morning the environment is likely more acidic than with folks who do not have Zollinger Ellison Syndrome. (If I miss a morning dose of Omeprozol generally taken by 6:00 am I am on fire by 5:00 pm.)

I called both Gilead and CVS Specialty Pharmacy. Both confirmed that if taking no more than 20mg of Omeprozol, and provided it was taken simultaneous with the Harvoni, I would be meeting the official dosing guidelines and should present no problem.

Personally I would like to give the Harvoni a shot and I do recognize it is an expensive drug. At the same time, that being the case, I believe CVS Specialty Pharmacy would have a valid reason to block providing Harvoni in my case if Omeprozol were an issue but they do not consider that to be the case IF I followed dosing guidelines.

The big study did produce issues yes but I believe those have since been settled via the fasting and simultaneous usage guidelines.

I believe I can be cured at either 12 or 24 weeks of straight Harvoni without RBV due to being non cirrhotic.

Would love to discuss further 03/08/16 when we meet and God Bless all you do for so many!"

We will see what he has to say. The only reason he has avoided Harvoni is my usage of Omeprozol. I believe however he is relying more on initial studies as opposed to the most recent. In my mind there is no way an Insurance Company would approve an expensive medication like Harvoini if they were able to point to, "....oh we know that guy he takes Omeprozol, no way." Fact is however that is not the case. they prefer to approve Harvoni so ....

I am no Doctor and that is a fact, but I do know how to read and comprehend.

JimmyK

Sorry to hear that, Jimmy. That must be super dissapointing. I honestly don't know a lot about the options out there because up to this point I didn't have any hope for a cure, but I do have hope now, for myself and for you. Something will come out soon that will be everything that you need. 

Sorry to hear about that Jimmy, but your need for Omeprazol trumps that section of track. You'll get what you need when the right option comes along and it will. I know you have the faith and it won't let you down. I guess now we're going to have to go shopping for the next biggest sniper rifle, the one offering the double dragon load. I know a distributor, he, he, he!! Keep your spirits high and don't let this keep you down any longer than it has. The fight shall continue and your family here is in it to win it, right along with you...

Greetings,

Just back from screening and I was rejected due to use of Omeprozol.

Train ticket was refundable so no problem there.

<sigh>

JimmyK

Wow that`s great news, Jimmy, I`m just catching up with this.

Best of luck with the screening process on Monday, keep us posted.. 

Howdy Tig I appreciate you my friend.

Just feels kind of odd that Houston is "Not Yet Recruiting" but they are calling me in for it.

Please honor the strike through and give me time to rephrase.

YAHOO! Congrats on the continuing good news Jimmy. I'm sure Gilead's interest stems from the V Pak failure and of course, seeing to it that you destroy your Dragon. Maybe that could be your Dragon's name, Red or Red Rooster? Either way, it's going down!

Congrats Jimmy!

Glad to hear it ... !

Dave

Update:

I just got called in to do the screening Monday the 22nd. The nurse said Gilead, "...was very interested in getting me into this study."

Ok now what the heck is that supposed to mean? Makes me feel like some kind of redhea... Oh wait.

JimmyK

Ha, the Velpatasvir pills even look streamlined like a magic bullet ...

New shirt is the bomb! Thanks Jimmy!

We are the velpatasvir poster children!

This shirt has the Eye of The Dragon in the center surrounded by Sof /Vel.

Nasty lil lizard be gone now.

Brother you wish is an honor to grant.

It was a V-Pak Shirt and no refunds!

Hi C !

I am still waiting more formal information but due to recruiting sites and the fact both Clear Lake and San Antonio are active recruiters but Houston is not, I believe it must be NCT02607735.

Like I mentioned however, until I have the first pill in hand I will remain in a wait and see mode.

Reminds me of being at an Airport and being on stand by.

;) JimmyK

Yep! Were waitin', waitin', waitin', I'd rather be rollin', rollin', rollin!

Hey, you stole my "Lucinda" mantra !! ... "what will be, will be - and we shall see" ... that was about as positive a one I could muster!

Mallani previously stated some good info re: sof/vel and GS-9857 to both you and I.

IS your trial the "exact same" one as my wannabe one (or one of the ones tkflex36 and webtomas have already started)? Do you happen to have your trial NCT#? Seems to be 3 NCT#'s going (all very similar tho) - a little curious that. As far as I know, mine is NCT02639338, specified cirrhotic and GT3.

Yes, Gilead seems to be trying for a "better" NS5A "replication complex inhibitor" with velpa (formerly GS-5816). On the mysterious (with or without) "GS-9857" added ... there is little detail searchable on this "NS3/4A protease inhibitor", all I could find was that it is also something Gilead wishes to be a "better" NS3/4A protease inhibitor. I think I read GS-9857 was more "pan", a "Pico-Molar" inhibitor, active for 1b and 3a's, but perhaps less potent in 3a's?

And that's all she wrote!

I may have some of the facts wrong, so don't quote me - let me know if you find out anything more informative about "our drugs" please. Would appreciate it.

Saddle up? yeehaw? Your pal, C

Howdy C  < Like the way that sounds.

Going for the whole enchilada, ... with GS-9857. 

This is easy for me as I don't pack. I just go.

I learned a long time ago. If it does not fit in a saddle bag, ya don't need it.

The only thing about it being a "trial" is they get to tell me what to do and that combined with no Omeprozol sounds like a bad mix.

Fortunately my Doctor is somewhat of a brain guy. So all I have to do is ask a simple question and he will go read a book and then write two.  LOL In all honesty I am very grateful for him. He does tend to dig some before arriving at the place best suited. To be honest if I don't make the trial, I may well wait for the release anyway. This one looks like the best of all options with the most promising results in cases like mine.

I think Gilead intends for this to be ABBV's nemesis and it is designed to clean up behind ABBV and watch them push it in just that fashion.  

For me things are rather fluid. I intend this time to explore all options and weigh each carefully. At the point I say ok this time I will be certain and simply look forward to the ride.

Not speaking ill of it at all but for me the V-Pak ride was more of a "sure ok why not?" This time I want to read everything I can get my hands on. Pros and Cons with each until I scream Uncle, lay it on me.

I think I have landed but until a pill crosses my lips.... we shall see.

JimmyK

Concentrate JimmyK, concentrate!

Think ... velpa, velpa, velpa!

Do not be distracted by any of us gals trying to banter you into place!

If you could just pleeeease stop spinning around in the train station, packing and re-packing your every available drug regime suitcase, and land in one spot, we could get you the right shirt ordered! heeheeheee whee!

umm, btw, which velpa seat have you picked out fer yersef, IF this IS your final train route choice? With or without GS-9857?? - THAT is the question. 

Your pal (and possible fellow velpa train passenger), Canuck 

Yo Lin Zantac is not a PPI so I will let you know how that works out for me. Been on the Omeprozol for years so should be a good test case.

That is if I remember to respond.

Despicable.

Ok thanks...

But what were we talking about?

Zit Damn fool I tell ya.

Oh yea!   https://www.youtube.com/watch?v=Mv6_6Si-530

... just saw that too Tig, not comforting, I've been taking Omeprazole for years and unless they come up with an option I can't see that changing.

Hey Jimmy,

Might be a good time to change medication anyway. I received this in the mail today.....

Dementia and PPI's

Howdy Canuck,

Man talk about a turn of events for me. I was informed this morning by my Doc that he has recommended me for the exact same trial.

Coordinator called me right afterwards and asked me if I was willing to dump Omeprozol for Zantac. I told her no problem and she said ok hang tight I am submitting your name for the trial.

I said, "You mean the one that is accepting folks in Clear Lake and San Antonio?" She replied, "Why yes, sounds like you enjoy reading." I assured her I did but reminded here this is Houston. To which she responded, "Then that would make you first right?"

I was stunned with the banter which I am used to being in control of and got nailed by a girl!

I thought I really need to recover here somehow...

So I said, "Yes I guess I would be first then, does that mean I get a free lunch?" To which she responded quickly, "Dude this is Houston not Canada." 

Ok ok I made that last part up but not the trial. We may well be on the same train my friend. 

JimmyK

I was afraid you'd say that.

Hmmm, taking stock - you are probably right!

But buck up, you have gotten rid of 3 of the velpa shirts, and maybe you can wear a 4th yourself? C 

Rats, are you sure?

Now I am stuck with two dozen t-shirts that likely won't sell.

Hey JimmyK,

So glad you asked! ... it was definitely NOT low fat, low cal, and likely too high in iron (for me anyway), contained refined food products, high carbs, sugar, salt. I was so unprepared/surprized/flabbergasted at this offer of a "free" and delivered lunch, that I did not know what to choose, no menu, she just said "what would you like?", I guess ... had I thought it out better (low blood sugar moment), if I had said lobster, or steak and eggs, it might have come? In default, I just went with the maitre d's suggestions for the dumbstruck - Tim Hortons, Subway Sandwich, and some other establishment choice I forget now. It hit the spot anyway, as I was depleted, and as a bonus I felt like they thought it was OK for me to cheat on my diet. It came with coffee, juice (I should have asked for dessert and maybe a smoothie as well eh) and it WAS hot, but I can vouch for this, if it this ever happens to you, don't eat it in the actual exam room off the examination table like I did. 

Any other questions?  

Your pal, Canuck

Greetings,

Generally speaking we prefer a few more details.

So what did you have for lunch?

JimmyK

Whal,

WEDS - We jumps in the wagon and skidaddle down to the big city, and overnight it at some cheap motel the night before my big day with the doc. Fasted that night for the lab work the next morning.

THURS - Dutifully (highly motivated) I show up just a wee bit early for my date - (LOL try like over an hour early!) Had to hesitate outside for a bit, not wanting to appear toooo overly-eager, eh (desperate one might think?!). Hard for me in my state to look exactly bight eyed and bushy-tailed, but as I "caved" into my anticipatory zeal (and went in only a 1/2 hour early), I hoped I would appear only as one of the earnest and willing!

Spent quite-some-time there - going from room to room, area to area, office to office for ECG, fibroscan, bloodletting, exams and interviews. Down about a quart of blood, glad they didn't ask for too much urine, as by that time i was out of spare fluid and calories. Get this ... they bought and brought me lunch (as soon as the lab work was finally finished!!) - I was floored! They were certainly super nice to me.

I was really hoping (being that this was my second visit to the doc to talk about getting in the sofo/velpa trial) that he would actually "say" whether I was in (or not) - but alas, it must be true what they say - all good things take time!

I DID get that trial consent form signed in blood tho. Next visit (2 more weeks), before I can get confirmation.

They and I will wait (they more patiently than I) for the "newest" test results to return. A lot of these tests I have already had done within the last 6 months by an associate doc, but, whatever it is that is required, I am more than happy to comply.

Only thing I learned "fer sure" is that they ARE very nice, and will help me, that I lost 5 lbs., I am no shorter, lunch was good, and that my fibroscans (4 months apart) "technically" appear to have gone from F3/12kPa to F4/12.6kPa - give 'er take a little. Whal, ya know what they say about them fatty old 3a's eh?, bad reputation for being difficult. 

Boy, they sure treated me well though, and just LIKE I am already in the trial! 

FRI - Home again, home again ... to wait some more, sigh. Maybe only 14 more sleeps! My chauffeur says he is "driving Ms. Crazy".  C

Welcome Canuck.  The trial your looking at is a good one.  Gilead will take care of you!  They pick up the stragglers  ( trial treatment failures).  I'm one and they put me back into a redosing trial and it looks like it worked. RC

Ok, I promised to do the best I could and I am true to my word. That said;

1) The size has been adjusted and prior to final shipping I am assured the variety is sufficient to cover anyone from a Pygmy to Paul Bunyan.

2) Long Sleeves are not a problem as can be herein shown.

3) The request for a "Turtle Neck" was made but I was informed we ran out of stock of those back in 1967 along with all Tye Dyed Patterns.

4) We made every attempt to provide in wool but the sheep are presently on strike and there is no eminent meeting of the minds at the table.

DISCLAIMER:

As a supplier of unique BS we cannot be held to all requests made however we will make every reasonable attempt to honor any and all requests. In this particular case, our Agent reported back that he was actually laughed at and beat up by a flock of Sheep at the request for (a) the Turtle Neck at which point the laughter began and then (b) beat up and ridiculed as a"SCAB" at the request for wool.

At any rate, having done my utmost to welcome a new Brother I humbly present you with your new shirt.

JimmyK

You did notice the word "free" right?

LOL! I will see what I can do.

Hey, JimmyK - Belly LOL.

Wrong size. I need long sleeves, turtle neck, preferably wool. Thanks, C 

Greetings and Welcome.

Here is your free new member shirt.

Please wear with a coat as it is cold out there!

Bla Hahah

JimmyK

Welcome and know that you found a terrific bunch of folks here. The knowledge, support and smiles are invaluable. 

Hi Canuck,

Welcome to the Forum!!

Good luck with getting on the trial, that's a great opportunity.

Here's a little different view of the Velpatasvir Structure, I was finally able to see the 3D image using another browser.

The Avatar you have is great, just wanted to give you another option. Once I get my mind set, I can't stop messing with something like this until I get it, I'm a stubborn ol' cuss sometimes.

The attached image location is  http://files.activeboard.com/1846118?AWSAccessKeyId=1XXJBWHKN0QBQS6TGPG2&Expires=1455753600&Signature=rFp4lsNEAugKtuC9TVfaHSWZYWE%3D

Dave

Thank you everyone for the welcome.

My very same concerns and questions too (mallani) - what drugs WILL I be able to go to IF I DO require re-treatment (after these short treatments of either SOF/VEL 12 wks., or SOF/VEL/GS-9857 8 wks.)

Considering my potential pre-existing impediments to effective treatment outcome (just being a GT3a, ready built for certain RAV's, poorly perfused hard fatty F3, higher VL and iron load, hemochromatosis/polycythemia, etc.), it might have been better had I been in one of the earlier SOF/VEL trials (less the RBV that I would be reluctant to do!) - taking SOF/VEL alone at the prior trial lengths that were 16 wks. long. But, the SOF/VEL success rates remain looking high even at the 8/12 week regimes.

I get no choices in this trial now, yet I have some concerns about the short 8 and 12 wk. arms, and about the rationale/wisdom of the added NS3/4A (GS-9857) to the 8 wk. arm, especially in the case that re-treatment is required.

I just cannot get my head around why they do not pre-test for RAVs/RAV potentials prior to treatment decisions - (initial costs versus potential costs of negative outcomes.)

Should I post my (pre) pre-trial labs (bloods in last 6 months of work-up) for baseline background, before I start posting the trial labs? Does anyone have a "good guess" at "what next" re-treatment drugs might be left for me to use, should I require them?

Thanks all of you for being here for me. Canuck

Hello Canuck,

You have certainly come to the right place for information and friends to be here for you in any way they can. Good luck getting into the trial and waiting is just so hard. I have been waiting for nearly 7 months but hope to start treatment in a week approximately.

It's nice to see yet another Canadian here. Fingers crossed and high hopes that we all achieve SVR eh?

Hello Canuck, welcome!l

I really hope you`ll be accepted into this trial and wish you all the best of luck.  Please let us know when you hear, I know you`re counting down the days!  Great to hear that you`re already familiar with how the forum works, we`re glad to have you here with us.  As you`re already found out, this is a very friendly group so make yourself at home.

We`ll be looking forward to hearing more from you!  

And by the way, what you`ve written in your signature and your bio is just right.. thanks, that`s very helpful. 

Welcome To The Family!

That is what we are and that is what you are now!

JimmyK

Hi Canuk,

whatever arm you get on, Velpatasvir seems to be amazing NS5A inhibitor (eager to see results compared to Daclatasvir). Seems Gilead is now testing this, already proven to be a new standard, combo Sof+Vel for 12weeks vs shorter tx with added GS-9857 (as NS3/4A inhibitor). Apparently below 8 weeks is no go. Think they had Phase I/II trial 6 vs 8 weeks already and 8 weeks for triple combo is minimum.

keeps us posted! :)

best

Hi Canuck,

Best of luck getting into the Trial. These are GREAT drugs.

If you get the 8 week arm, ask about re-treatment if you relapse. With a FibroScan of 12, I'm hoping you get the 12 week arm. Cheers.

Hello all,

I am in BC Canada, thus why I have been using the handle "Canuck".

I am new to the site, and have been meaning to "properly" introduce myself to all of you, and intend to share more. Up until now, I have not posted much, I have mostly just been reading the site, learning and asking questions. I have reached out, met and conversed with a few of the members by private messaging and outside emails though, and I have already received nothing but kindness, very helpful information, support and encouragement all round.

I have been learning much (from all of you) and the posts, and I am very happy to be here. I am very glad for this site. The private messages and emails I have received have been very important to me, and I do appreciate all the kind help I have received.

I have been riveted on posts, info and treatments for GT3's - so noted "tkflex36's" and "webtomass's" posts immediately, as their SOF/VEL/GS-9857 trials are related to the trial that I have been trying to get into.  Only 9 more sleeps!!! - and then I should know better (after my next appointment) whether it looks like I have succeeded in getting in. I am very hopeful about getting in, and in the drugs. I have been working hard for months trying to get myself poised to be in this position. With limited treatment options available to me, this was the best bet I could find and hope for.

Each of my assessment and treatment appointments necessitates travelling 4+ hours, one way, and an overnight motel stay, but I will be glad for every minute and mile it takes to achieve the goal.

My trial would be:  NCT02639338 (other name: "GS-US-367-1173") - it outlines 2 arms - the "triple" SOF/VEL/GS-9857 for 8 weeks, OR the "double" SOF/VEL (alone) for 12 weeks, AND it "specifies" that it IS for GT3's, TN to prior DAA's, or TE to interferon, AND Cirrhotics. (People ARE "referring" to my trial as "Polaris III", but I have not actually seen the name "Polaris III" printed anywhere in the trial descriptor.)

"tkflex36's" trial is: NCT02607800, and has the SAME (other name: "GS-US-367-1173") as my trial does - his outlines 2 arms - the exact same "double" or "triple" drug combinations, and lengths, as in my trial, AND it "specifies" it IS for TN to prior DAA's, or TE to interferon (BUT, it does NOT say it excludes certain GT's, nor does it say it includes cirrhotics). His trial IS called "Polaris II", printed right in the title.

"webcomass's" trial is: NCT02607735, and has the SAME (other name: "GS-US-367-1173") as found in both the trials above. It also states it's name "Polaris I", right in the title. But this trial differs somewhat from the other two trials, in that of the 3 arms (one arm being 12 weeks "placebo", and 2 arms being both 12 weeks of the "triple" drugs) there is NO "double" SOF/VEL alone, AND, NO 8 week lengths). This trial, unlike the others, DOES specify it IS for TE, but does NOT say it excludes certain GT's, nor does it say it includes cirrhotics.

So, I assume "webtomas" is in his trial as a GT4 (mostly because his trial IS for DAA TE's), and that I am over in the trial for G3's (mostly because I fit the parameters of being a GT3, TN and cirrhotic), and "tkflex36" who happens to be a GT3,  got in his particular trial (because he fits the parameters of being TN, but not cirrhotic)?

I have now (only recently) created my "signature" line and have added some further info for my "bio". Please feel free to make suggestions as to how I should best be posting anything at all. I am not great at computer stuff.

If I succeed in getting into my trial, then i think "webtomass" and "tkflex36" and myself are the only ones who are testing out SOF/VEL(+-)GS-9857 in this website!? I am looking forward to sharing info about these trials.

Canuck