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Post Info TOPIC: Test Results Appreciate Input


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All I can say is WOW!  Jimmy, when you come back SVR12 I am going to be dancing on air.

Hang in there.  Take your mind off of it when you can.  Keep being the excellent Jimmy that you are.



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GT2a, VL 681,500, Less than F1, Treatment Naive

12 wks Sovaldi/Ribavirin, SOT 2/25/16, EOT 5/17/16

UND at 2,4,8 and 12 wks during treatment but ribavirin crazy.

ALT/AST normal EOT

SVR12 8/13/2016!!!!!!!!!  I WON!!

EOT 6 Months 11/12/2016  CURED

 



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Oh I'm not sweating anything. Personally I think I am cured. The 4 week test will be very interesting and that is only three weeks off now. If that comes in UND, I would have to be beyond strange ( wait strike that ),... If week 4 comes in UND, the likelihood of cure is extremely high.

Now if week 4 does come back detected, I will work with the Doctor to perhaps restart 24 weeks of Harvoni in Jan 2017. That would give time between treatments. The study Tig mentioned yesterday shows RAS does not have much of an affect on 12 weeks and zero on 24.

So the Insurance Company will either get very lucky by cutting me in half OR will forfeit the cost of 12 weeks wasted and have to start over kicking themselves for not listening in the first place.

Tig, jumping through hoops is great exercise! LOL !

JimmyK



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."

Tig


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I think that's the best of choices really. You do definitely have them over a barrel right now. This will work out, I'm sure of that, but I'm not happy that you're having to jump through these hoops to accomplish it. I wouldn't be as collected as you seem to be, I stand in awe of your ability to process and apply. I know we'll be celebrating your SVR soon enough, hopefully it'll be according to the original plan.



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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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Well I am not touching it unless my Doctor says to. The first Peer to Peer was not with him on the phone. When I got in their face at CVS they reopened the case and I insisted it only be with Sussman directly.

That happened yesterday.

Just updated from Doctor. 7 days is too great a gap in treatment and we are not going to take the chance. New plan calls for a 4 week blood draw RAV RNA. If detected at that point we will go from there, if not on to SVR12.

Whatever happens now, there will be NO arguments from Insurance. We have them in an interesting position now.

 

LOL Mi Vida Loco eh?



-- Edited by JimmyK on Thursday 14th of July 2016 02:56:17 PM

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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."

Tig


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I would question the RAV (RAS) possibilities and ask that they determine it, regardless of whether you continue or not. Did the subject of Riba come up? I know that's an ugly word, but it may add some punch to the last leg. If they want to start you on 12 more weeks and you come back with some resistant variants, what then? I would want assurance that you will be guaranteed a next round of silver bullets when they arrive at the pharmacy. 

Either that, or you see what happens at EOT +12 and if you're SVR, done deal. If not, they should be willing to provide the appropriate protocol at the appropriate time, without hesitation. JMHO. Sorry you're having to go through this JK. Keep us informed.



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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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Time for a call to the manufacturer, they may be the only ones who can answer the question regarding lapse of time.

Isn't your doc worried about that? (Guess it's all coming down so fast he/ they may not have time to address that yet).

How confusing, but if there's one person who can sort it out, you can JimmyK! smile

 

Do keep us informed ... the all around suspense is killing me.

 

D

 



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63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 



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What about the lapse of time off Harvoni, if somehow you did need the additional Tx (I don't think that's possible but for argument sake), isn't this how RAV's develop?

Surely they are not talking about another 12 weeks of Harvoni, sounds like they are stuck in quicksand and wiggling madly to try to get out. Sounds to me they are in a panic and just trying to avoid a lawsuit. How insanely crazy this is all turning out.

I'm speechless now!

 

Linux



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63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 



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Head nurse is in contact with the Doctor now. I have no idea if I should fill the order and take the stuff with a 7 day gap.



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Urgent Update:

My Doctor did a direct Peer to Peer with their Doctor and they reversed the denial and just added 12 more weeks.

Now what do I do?

This is nuts!

 

JimmyK

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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My nurse will be discussing it with my Doctor next week when they meet.

To be honest another thing I am looking at is Carolyn. She does her SVR12 on 08/20. My SVR04 would be 08/05.

I would still rather hear good news regarding Carolyn before good news about me. Just a thing I have I guess.

We shall see.



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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JimmyK wrote:

I do appreciate that brother. I am trying to sort out how I would feel. To be UND at 4 weeks and then found detected at 12 would for me be more of a let down that simply going on to 12 and seeing what's up.

I will consider it I assure you.

 

Thanks

 

JimmyK


 This is the exact logic that my PCP used when I asked for an EOT+4. I didn't agree at the time and still think it would have saved me a lot of grief but in my case I hadn't seen UND yet, you have. I didn't push it or insist on the test and just went along with her recommendation (not real happily).

Probably one of those six of one, half dozen of the other in your case.

You ARE cured and we ALL know it ... just a matter of waiting once again.

I do like your plan to just count down to your trip instead ... good thinkin' bro.

 

Dave

 



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63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 

Tig


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I think that was the best decision. The PPV is so high that SVR4 is almost golden. The incidence of relapse is in the same ballpark at EOT+4. I am going out on a sturdy limb and saying if you are still undetected then, open the bubbly!



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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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Tig, I went ahead and made the request. They will probably approve because the Doc is not happy with the Insurance Company right now. LOL

Will advise.

JimmyK

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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I do appreciate that brother. I am trying to sort out how I would feel. To be UND at 4 weeks and then found detected at 12 would for me be more of a let down that simply going on to 12 and seeing what's up.

I will consider it I assure you.

 

Thanks

 

JimmyK



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."

Tig


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However, concordance of SVR results at weeks 4,12 and 24 were determined and were extremely similar. The PPV of 98%+ bodes well for SVR 12 and 24 if SVR4 is achieved. If relapse is to occur, the majority of incidents happens in the first 4 weeks after EOT. Just fuel for thought.....

SVR 4, 12 and 24: Concordance



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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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You know Dave I am simply not going to mess with EOT+4. I could I know that, but the fact is I consider it worthless.

The EOT blood work of course was going to come in UND because on Harvoni once UND you remain that way through treatment. There are no breakthroughs. The CBC's were to me of far more interest and they came in great.

EOT + 12 is the key and I am simply going to forget about it until then. I was in perfect compliance throughout treatment right down to no variance from 5:55A greater than three minutes. I even stopped patchouli oil just in case.

I am pretty calm in all this and absolutely good with leaving this where it belongs. In the Hands of God. I am not one of those who will suppose to answer for Him either. He may say yes and He may say no, either way I am good with it. wink

My count down has shifted now. I have 109 days before boarding The Ship with my Girl, and that has become a more agonizing wait than reporting on any stupid lizard. LOL !

JimmyK wink



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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I knew it, I knew it!!

Congrats JimmyK!  w00t.gif

I hope you get an EOT+4 test too but we KNOW that would/ will be UND.

You got it! Happy for ya!!

 

Dave

 



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63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 



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Prayers are coveted thank you.

Attached is the whole enchilada.

My Neut% came in low but that may be caused by an infection that I got rid of 2 weeks before EOT.

Creatinine is slightly high. My Doc has always attributed that to high muscle mass and Omeprazol combined and has never caused a concern, in particular because kidney function is great.

Those are the only two items not in the normal range. I was even able to bring Glucose back down to earth at 92.

ALT is now 21

AST is now 25

Platelets at 296

And of course the <15 UND findings remain a cause of hope that the 12 weeks did the trick.

Time will tell, but regardless of the outcome, there remains a high indication that the Liver is Happy and has in any case gotten a nice rest. Progression of the F-Score is pretty unlikely so God has been gracious and allowed time to remain on my side in the event of a relapse.

I may well end up in retrospect happy that the treatment period was cut. I certainly don't want to be taking anything other than that which is needed. Harvoni remains a new drug and for all I know there will be a day time commercial sometime around the year 2025 that goes like this;

"Did You Take Harvoni and have your left foot fall off while riding a Harley? If so you may be eligible for compensation! Call 1-800- Ambulance Chase to see if you qualify."

Anyway, the beat goes on, Que Sara Sara and all that and Life Is Beautiful!

JimmyK

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."

Tig


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Outstanding James!! When will they do the next blood draw? Prayers up my Brother....



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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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Good Morning.

Blood Draw from July 8th, one day following EOT remains UND.

This will be an "interesting" 12 weeks.

JimmyK



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Very interesting indeed!

Thanks for keeping us informed Jimmy. By pursuing this you do us all a favor by holding the parties involved accountable for their actions (or inactions as the case may be).

I'm guessing one Kimberly is currently shaking in her little Chicago boots realizing what a HUGE mistake writing that ill conceived letter was.

Please do let us know of any further developments ...

 

Thanks for all you do JimmyK,

Dave



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63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 



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Wow.  Very cool, Jimmy. Glad you didn't stand down.  Rights are rights and bureaucrats are not welcome to amend them.

Thanks, pal.

 



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GT2a, VL 681,500, Less than F1, Treatment Naive

12 wks Sovaldi/Ribavirin, SOT 2/25/16, EOT 5/17/16

UND at 2,4,8 and 12 wks during treatment but ribavirin crazy.

ALT/AST normal EOT

SVR12 8/13/2016!!!!!!!!!  I WON!!

EOT 6 Months 11/12/2016  CURED

 



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So she has a doctorate in Pharmacology.  She can't sign off letters as "MD".  That's misrepresentation.  If one was so inclined one could report her to the governing body for pharmacists in the US and she would have sanctions placed on her license.  

To say that she was summarising a doctor's comments without making this clear is also ethically dubious.

But best to leave it be.  You'll be cured by the treatment you've just had.  And, if not, you have the next one in the bag.  With all the ammo you have they would have to pull out all the stops to avoid a complaint.



-- Edited by Pablito on Monday 11th of July 2016 07:14:45 PM

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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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Oh Chris, I do not deserve such kind words but I most assuredly thank you for them.

I want to pause to remind all, before I was a Christian, I was not. If I were to receive a fraction of what I deserve I could not stand, yet by the grace of God, I do.

It's all good and the thought of being able to help others, is for me, the absolute victory through it all.

Patience is a virtue and I am in the learning stage.

All is well.

JimmyK



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Jimmy,  RC just pointed out I need to get caught up... I LOVE your ZEAL!!!   I used to be in the insurance business and specifically Health Insurance.   When our clients had problems with medical claims I had many a battle with the adjusters and claims CSR's.    I just loved a good battle every once in while.   I used to write letters and always a carbon copy to the State Insurance Commissioners Office when necessary.     You are exactly right you are helping others in your "Pursuit".   Thanks for sharing .......I just love your spirit and attitude too.......... after all it is all in Gods hands and in HIS time.   God Bless !   Chris



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F 63,  1b  1974, no cirrhosis, fibro scan 5.8 F0-F1,fibro test .37 ,V/L 702987, ALT 90, AST 75.  ABBVIE Topaz II on 10-30-14 Viekira Pak no RIBA , EOT 1-22-15 SVR, ALT 37, AST 29, 4-15-15 SVR12 - fibro test .22,  1-21-16 SVR 52 ,  1-21-17 SVR 104! 1-21-18 SVR 3 years ,2020 5 years, 2022 7 years!



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LOL what a bunch of Maroons!

OK I tracked Kim down with the assistance of Re-Buy and got her on the phone. She admitted to penning the letter which she said was a recap from what the Doctor had said. So I asked for the name of the Doctor and she was not sure she was allowed to release that. I said... "What?... You do realize your letter is signed off using the title of a Dr but not the name, and without the name it is assumed that you used that title." I think I got her attention there.

She then referred to a peer to peer discussion which, "..included Dr, Diller.."

I asked at that point, "So who is Dr, Diller?" She said, "Is that not your Doctor?" To which I answered, "Yes, that is NOT my Doctor."

I was kind but remained firm I wanted all data used to deny my case. I also specifically want the name of the Doctor who said I should be on Zepatier and Sovaldi when there is no data other than don't combine these two out there. I believe I got a whiff of sweat at that point as she announced she was reopening the case.

I then told her that if the case is reopened it is with the understanding I took my last does of Harvoni on 07/07/16. Even if some miracle were to happen and they somehow wanted to ship another 12 weeks, I am not touching it without direct approval from Dr. Sussman and no one else.

At this point I have to assume the gap in therapy may be too great to continue and I am ok with that. I am actually more interested in making the right moves now in the event of a relapse. This sort of thing may well lead to an agreement that they will seek the SVR-12 but if not achieved there will be no argument on re-treatment. I am very cool with that.

More to come in the never ending saga of...

The Adventures of JimmyK!

Hiyo Silver...Away!

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Thanks Re-Buy and yes that is her. Shame she signed off as an MD because she is not. Going to go after this one.

JimmyK



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Kimberly Menard-Gates Pharm.D 

Chicago area

may be the one you are looking for. 



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64 yr old male. Geno 1B. Fibroscan-20.9 Peg/Interferon in 2005 no luck. Started 24 week Harvoni on May 11

After 24 weeks of Harvoni 

ALT-18

AST-18

Platelets-103

Viral Count-UNDETECTED !! :)



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Tig I feel quite confident that the 12 weeks did the trick. At this point I am not sweating the next 80 days to SVR-12. (No I am not counting either, I did such a nice job on my tracker I am auto informed. LOL)

At this point, I cannot lay claim to the pioneering nature we have all taken if I do not speak up. It is not likely to in any way benefit me but hopefully if I shake things up a bit, those that follow will have a better time of it.

They absolutely now have a problem. The letter took credit for coming from;

"MD Board Certified in Gastroenterology." It left out the name but I was able with the help of CVS to dig it up. I have yet to find a MD that cannot be shown through a Web search including board actions, sanctions, credits, etc.

I do believe in this case they have messed with the wrong Cowboy and this is not where the Cowboy rides away. wink

This was supposed to happen to me so I could protect others. Plain and simple. I will be cured I know, but others will not have to go through what I have to get there.

 

JimmyK



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."

Tig


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You go Jimmy!



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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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Oh man it just keeps getting better.

I was in contact with the Pharmacy this morning. I questioned the letter in particular the "Medical decision" that I needed to be on Zepatier with Sovaldi. I pointed out that the two have a drug interaction and that there are is no test data to support that "Doctor's" recommendation.

Then I noted that there was no name for the Doctor and I wanted it.

After some digging they came up with Kimberly Menard-Gates. I asked if they had further information on her and I could tell the girl on the phone was doing the same thing I was. A web search for the name associated with an MD.

ZIP

I could further tell from her voice that did not sit well with the girl I was speaking to. By the way, she was great!

So I have left a note with my Doctor along with the name of the person who penned the denial on behalf of the Insurance Company and that she did so laying claim to be a MD. I pointed out the clear errors including recommendations for combining drugs that have no studies other than to determine that there is a negative drug interaction as well as the reference to Harvoni as a mono-therapy which it is not.

To be honest, one of my main purposes for posting all of this is to stress to the Family here that knowledge is incredibly important and one should not leave it to the powers that be for us to sheepishly follow. Each of us needs to know what we are doing and why we are doing it. It may feel boring to read up and consider studies but we all need to properly equip ourselves. A soldier goes into battle prepared as should we and we are not simply fighting for self, but also for those who will be right behind us.

 

Regards

 

JimmyK



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Hi Jimmy!!     WOW what a denial letter?   No matter what happens you will get cured, you know that.  They have guaranteed you a third if needed. That should sit well with you. I understand your feelings about Carolyn getting cured, My Ragdoll cured between my first and second failure. It really helped me to get over my first failure. God works in great ways- if I had not gotten into the first trial my Ragdoll would not have gotten a trial offer. Our wives are cured- It can't get much better than that.    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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Hi Dave,

As I believe you know I deal with Contracts for a living. I am pretty well trained and not half bad at finding weak links and taking advantage of them where contractual agreements are concerned.

As to the validity of their findings, as stated, I already know they have made a huge series of mistakes. They could have simply stated that the guidelines in cases such as mine support a 12 week protocol and left it at that. It would not have been something anyone could have argued against, and as far as ending treatment at 12 weeks the outcome would have been the same.

However they were so anxious to win the appeal, they made some serious errors.

Sovaldi Cost 12 weeks is $84,000

Zepatier Cost 12 weeks in $65,520

Throw in Ribavirin and well past the $150k mark for 12 weeks.

Harvoni is $94,500 for the same 12 weeks.

In that they put what they said I should be on in writing it will be hard for them to back away from that in the case of the need for me to retreat.

With regard to Zepatier the following warning is stated;

"Zepatier may have reduced therapeutic effects or adverse reactions due to drug interactions. Avoid strong CYP3A4 inducers and inhibitors."

Also of note is table 9;

Table 9: Drug Interactions: Changes in Pharmacokinetics for Co-Administered Drug in the Presence of Elbasvir, Grazoprevir, or Co-Administered Elbasvir and Grazoprevir.

....HCV Antiviral

 
GS-331007Sofosbuvir 400 mg single-doseEBR + GZR50 mg + 200 mg once daily161.13 (1.05, 1.21)0.87 (0.78, 0.96)1.53 (1.43, 1.63)
SofosbuvirSofosbuvir 400 mg single-doseEBR + GZR50 mg + 200 mg once daily162.43 (2.12, 2.79)2.27 (1.72, 2.99)

--

 

Whoops!

Their unnamed Doctor said I was supposed to be on Zepatier, Sovaldi and Ribovirin. But Zepatier does not go with Sovaldi as far as I can tell.

By putting it in writing they have committed to a $150k 12 week course as opposed to a $94,500 course.

Personally I think that puts me in a good position if re-treatment is required. I could insist on their recommendation which would cost them $150k, and it would be very hard for them to refuse the recommendation of the guy they used to win the appeal. If they later balked it would clearly establish they were not giving my case and honest assessment.

Faced with that, they would likely be more reasonable with a 24 week re-treatment with Harvoni some time after my planned cruise.

I am absolutely certain I could make them want this letter to go away and I am sure I could be convinced to make that happen. Everything is after all, negotiable. ;)

In the mean time I am highly confident that the 12 weeks I have just completed are sufficient and will lead to the desired results. If not I am kind of happy that they have so badly blundered, in writing, in the manner in which they have so I don't have to worry about what they will say if I need to do a round three.

If this were Texas Hold Um, they just dealt me a straight Flush. wink

 

JimmyK



__________________

Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Hi Jimmy,

Feels like one of those "What's wrong with this picture?" puzzles.

A heck of lot, obviously. My guess is that from an insurance standpoint it's a denial that (in their minds) is unlikely to be questioned considering the fact they stopped the medication days ago and are just now telling you about it. (They've already gotten their way and they just needed Bozo to write some mumbo jumbo to satisfy their need to do so). What a batch of blithering idiots they are.

My take on your Harvoni treatment is that indeed, you were UNDETECTED at wk 4, in a day or two you will get lab results indicating UNDETECTED at EOT. In 12 weeks you will be UNDETECTED once more and announced OFFICIALLY as SVR, done, cured amen.

This letter is, for lack of any better possible word, Stupid. It's certainly unprofessional and apparently completely false other than the fact that you have been denied 12 more weeks of Harvoni.

The letter in no way effects or diminishes the fact that you are right on track and headed straight for the SVR station directly ahead.

I see nothing for you to worry about (not even in the slightest) and would be tempted, myself, to try to get a copy of the original insurance Co. denial and present it to the proper regularity authorities to bring to light the insurance company's gross negligence. (Without doing a little research I'm not sure if that's the Attorney General, the Insurance Commissioner or who it is but I'm sure there is one. (That's not the Riba talking, that just me). I'd do it, if for no other reason to hold the Insurance Co. accountable for their actions and to try to prevent this type of denial "straw argument" from being thrown about so recklessly. You are already cured, I have absolutely no doubt about that, but others less able to understand the system, the processes etc should not be getting this type of BS letter to deny them of being cured of HCV.

 

Be Well,

Dave



__________________

63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 



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Hiya SF,

To be honest, my situation is for the good of those who read it. If I am to be used a messenger of how one acts who believes in God then it is to and for His Glory.

Some folks have faith that God will cure them. I have faith that He is to be honored regardless of the answer received.

My prayer is that Carolyn first be healed and then me. In both cases that prayer is in accordance with His will.

My perseverance and positive attitude is not a product of me. It is a simple matter of being good with whatever God decides. In fact that is my only fear of Riba. It tends to take over and dictate my thoughts and not in a particularly positive way.

Right now, I'm cool and well convinced things are going as they should. wink

JimmyK



__________________

Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Jimmy,

This is enough to make peoples heads spin. I don't understand .. or maybe I do how the system can be so messed up. I do agree with you that UND at 4 weeks speaks volumes for a protocol they say is wrong.  Now that you are EOT, we are patiently waiting for that test result.

This should be the magic bullet this time but your perseverance and positive attitude is incredible. I admire you as I am sure many others do for your resolve.

Lets see what the next few days bring although I believe we all know what it is.

 

SF

 



__________________

65 yo, GT1A, , Cirrhosis, F-Scan F4 33.5, TX Naive Harvoni 12 wks

SOT 2/9/16 / ALT 187 AST 114 VL 2.3M.    POSTS

EOT 5/2/16  ALT 35/ AST/25  platlets 126 C/B VL UND

EOT +12 7/26/16  ALT 25 /AST 22/ ALP 83  platlets 129 C/B VL UND

EOT + 24 10/18/16 ALT 27/ AST 20/ ALP 71 platlets 153 C UND

 * SVR *



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Hi Pablito,

Well to be honest, I am not expecting compassion to be high on the list of Insurance Companies. CVS is simply relaying the data in the denial letter from the Insurance folks.

In fact they appear to be quoting the letter and messed up. If you notice they completed the first paragraph with, "MD Board Certified in Gastroenterology 7/1/2016." Seems they forgot to put the name of the Doctor who wrote the response and bears that title.

Also the top 1/3rd of the letter speaks to the testing that is recommended but then goes on to state the results from my testing that was submitted prior to and along with their initial approval. That was constructed by a less than stellar writer. The reference to the guidelines from the AASLD is a case of pseudo intelligence given the fact that they clearly have the results of those tests in front of them. Someone who did not need to plead before The Wizard of Oz for a brain would have simply stated , "Based on the results of your reported resistance associated variants...."

Further, Zepatier as we all know was just released 7 months ago. Personally I can't find any data where it is used in a combination with Sovaldi. As far as the reference to, "based on limited data", that is an understatement to say the least.

This is where it gets interesting. They say, ".... the AASLD guidelines would not support an extension of Harvoni mono-therapy under any circumstances."

Now just sit back and think about that statement for a moment. It implies that it would support initial treatment with Harvoni (12 weeks) but not extended treatment. Otherwise it needed to say simply the guidelines do not support Harvoni treatment period. And how can they say what guidelines would not support under any circumstances? Guidelines either do or don't and they are somewhat black and white. Guidelines are not people, they are results of studies. The statement made was not very intelligent.

Can anyone here find AASLD Guidelines that supports the use of Zepatier with Sovaldi and Ribavirin, in the case of someone who has failed V-Pack and produced both NS5a and NS3 RAV's?

One better, can anyone find Zepatier in combination with Sovaldi? That is other than Zepatier VS, Sovaldi.

If those guidelines cannot be found, then the entire letter is a straw man designed to avoid the high cost of extended Harvoni Treatment. 

If Harvoni in my case is so taboo, how do they explain being UND at 4 weeks?

We have all seen Court cases where Doctors on opposing sides do not agree. In my humble opinion The Insurance Company has found some Doctor, unnamed in their response, whose sole job is to assist in cost saving denials.

It is not the writer of the letter that needed to use compassion, but us for him as he lacks a brain.

They should have signed it Dr. Dumass.

LOL. No worries. The 12 weeks of Harvoni will work, or we will go for round three, once again, AFTER the cruise. ;)

Syd no worries about this messing with my head. It is actually rather reassuring that the guy who denied me is an idiot. LOL

JimmyK

 

 

 



__________________

Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Bloody hell, Jimmy.  That's one awful letter; written without an ounce of compassion in it.

I know you are a very cool-headed customer and you need to draw on this here.  I still think there's hope here.  I appreciate the general science around DAAs is robust, but when one gets into re-treatements and, in particular, RAVs I believe the science becomes less well-established.  Like you say: you were UND at week 4.  Even if that UND was a few copies present (but below the cut-point for detection) you had 8 weeks to ensure that these stragglers were zapped.

Pablo

 



__________________

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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Gosh Jimmy, that letter brings playing with your head to a whole new level. 

I personally believe that the 12 week Harvini will work.

what I cant understand is that they are basically telling you that the 12 weeks you have just been through was a stuff up. Are "they" holding themselves accountable? Who are they? If they are not accountable who is? It seems like an extraordinary way to weazil out of an obligation. How cruel is that too??  Increasing your worry as you wait for 12 weeks EOT. 

I know you will have already taken this and shaped it with your thoughts so it is palatable.

We all love you Jimmy K, admire you endlessly, feel confident you have the dragon licked and want to stomp on someone's head on your behalf.

Syd

 

 



__________________

Contracted Hep C 1969. Genome Type 2, treatment naive. Began 12 week RIBA/sof/Dac on 12/11/15. Cirrhosis. VL before treatment 4m. Treatment extended another 12 weeks without Riba. No virus detected at 9 weeks.



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Tig56 wrote:

Did they test you for the NS5A/B and NS3/4 RAV's Jimmy? If you mentioned it previously, it has slipped my mind.


 Yes they did and I believe they are posted in this thread. They had all the data when they approved me so this will be interesting if I fail.

UPDATE EDIT: Yup page 4 of this thread. As mentioned the NS5A is M28 and that one has a slight resistance to the Led in Harvoni. But in that I was/an UND at 4 weeks, not much of a problem.

We will see, and after all I am a weirdo so... LOL

 

I do also understand that they tend to look for ways to save money. The mention, "per physician review", but that is a rather generic term.

Also they mention "..Harvoni mono therapy.." which is interesting in that Harvoni is not a single drug and that is how mono therapy is defined.

I guess we will find out if the 12 did it or not in 12 weeks.

 

JimmyK



-- Edited by JimmyK on Saturday 9th of July 2016 07:23:54 PM

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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Whoa Jimmy!  This is getting weird.  How did they determine you were on the wrong treatment?  Sorry to say that I have no advice or information to add, just my amazement at your tenacity and ability to remain calm.  You are right.  You'll get this one way or another.  Of course I'm hoping that its SVR12 will be the way..  

This is shocking information.  I'm sure you'll keep us posted.  

I sure am glad you're here.

 



__________________

GT2a, VL 681,500, Less than F1, Treatment Naive

12 wks Sovaldi/Ribavirin, SOT 2/25/16, EOT 5/17/16

UND at 2,4,8 and 12 wks during treatment but ribavirin crazy.

ALT/AST normal EOT

SVR12 8/13/2016!!!!!!!!!  I WON!!

EOT 6 Months 11/12/2016  CURED

 

Tig


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Did they test you for the NS5A/B and NS3/4 RAV's Jimmy? If you mentioned it previously, it has slipped my mind.



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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!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

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I trust your doc more than I trust the pharmacy. And personally, I would rather be a lab monkey than a lab rat. And we both know who's in charge and it is His plan......

hugz,

wendy



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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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Greetings,

Well I just got the official denial documents from Caremark Specialty. The denial has an interesting twist to  it. It was not the length of time they contested. What they came up with is that Harvoni is not a the proper treatment plan in my case...period.

They said I am supposed to be on Zepatier with Sovaldi and Ribavirin although they did not specify for how long.

So I suppose if I fail, they already know what the next chapter will bring. However this could get very interesting and begs the question, why was I approved in the first place then? The Dr. prescribed it and Insurance approved it so how was it initially approved if it is the wrong protocol?

I am not sweating it even if I do fail as re treatment, based on their screw up is a given. LOL

Also of interest is the question, what if I come in SVR-12? How can it be then said it was the wrong protocol?

Geeze now I feel like a lab monkey. wink

The saga continues...

 

JimmyK

 

 



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Yes life is good! I got to sleep in this morning until 6:00am!

 

LOL



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Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Hey Jimmy and mrs.  

Zero pills, Zero loads, just the way it should be. Really nice!

Life IS good! biggrin Love, sis



__________________

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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One more thing Jimmy, We will want you to post a video of you putting the rooster on the Christmas tree this year. What a Christmas blessing that will be!  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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Hi Jimmy.  So this morning at 5:55 the last pill went down the hatch!!  Every time one of us reach EOT all of us get a little better. My friend you have been through the ringer, after your breakthrough on Viekira-Pak W/RIBA  you stood up blew off the dust and dug right back into treatment and look at you now!!  You were UND 3 weeks into Harvoni, that's 9 weeks UND on treatment-  You got it done this time. That's not even mentioning your wife's treatment succes during your second treatment. Some of us just half to work a little harder to get it done, and you got it done!  Can't wait to see the post treatment results come in, we will all be celebrating with you and Carolyn.  Thanks for all your support, Chris and I have been helped along so many times by your feedback. Thank you! RC



__________________

 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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Canuck wrote:

Ah, I see!

At 4 AM I don't read fine print so good, do I? heehee.



 Well in that yours still states;

"Waiting for SOF/VEL with or without GS-9857 trial - NCT02639338." I suppose I understand. LOL



__________________

Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."



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Ah, I see!

At 4 AM I don't read fine print so good, do I? heehee.

So, nice, you will have nuttin to do at 5:55 then!

Feels good when you can finally quit drugs, eh?

2 more sleeps! yay! biggrin C.



__________________

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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