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Hep C Discussion Forum -> General Discussion -> I'm back and happy
Post Info TOPIC: I'm back and happy
mallani


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RE: I'm back and happy
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Hi Laura,

I'm very happy for you and Tom. I hope you can get Insurance to approve the Sovaldi/Ledipasvir and he can be rid of this virus. Keep us informed. Fantastic!



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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
Cinnamon Girl


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It`s ok, Laura, you`re not losing it...we can`t see people`s signature lines when we have the reply box open, for some reason!  It`s quite annoying actually when we`re typing a reply and want to refer to someone`s details.  It often catches me out!  smile



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
tomyboy


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What is wrong with me....you do have a signature line.  I'm losing it. Sorry everyone, that's what I get from posting at work!!!



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Geno type 1,��after 20 YEARS Harvoni finally arrived....after six prior treatments...�Began harvoni for 24 weeks.....30 days viral count....STILL 0.......Tom now HEP C and Cancer FREE

tomyboy


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Thank you Isiscat for the responding and to you C girl. Your always there with something positive to say. Isiscat,  Please keep us posted as your progress with your approval.   We plan on scheduling with his local gastro doctor here and get the ball moving.  I'd like to be prepared with any necessary information so this can go smoothly. You don't have a signature line and I am curious as to know what geno type you are.  All the best of luck to you....October is right around the corner......smile



__________________

Geno type 1,��after 20 YEARS Harvoni finally arrived....after six prior treatments...�Began harvoni for 24 weeks.....30 days viral count....STILL 0.......Tom now HEP C and Cancer FREE

Isiscat2011


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Hi Laura:

I just wanted to congratulate you and your husband on this wonderful victory.  The all oral treatment, Sovaldi/Ledipasvir, will be approved on October 10th, and I would expect that your husband will be able to get it with no significant problems.

As far as when to begin the insurance paperwork I am looking into that myself and will let you know whatever I find out.  I too am planning to begin the S/L combo in October.  By all accounts this tx is a winner!  Your husband should be able to get rid of this virus once and for all and with very minimal side effects. He is due for some good luck and it sounds like it has already started.  Best wishes to you.  

 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Cinnamon Girl


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Yes, that`s right, Laura, it`s a combination of the 2 drugs in one pill.  Whether it will be marketed under another name apart from Sovaldi/Ledipasvir once it`s received FDA approval we don`t yet know, so maybe that`s what your doctors meant.  

I really hope Tom can do this treatment and I can`t see any reason why he shouldn`t, especially with his treatment history.  The clinical trial results have been outstanding and you have every reason to be excited!  smile

 



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
tomyboy


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  • whooops sorry, I just read link and see that the two were colated into one pill....I jumped the gun. Sorry, and THANK YOU!!!!


__________________

Geno type 1,��after 20 YEARS Harvoni finally arrived....after six prior treatments...�Began harvoni for 24 weeks.....30 days viral count....STILL 0.......Tom now HEP C and Cancer FREE

tomyboy


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Thanks Tig for the info and cinnamon girl for the links.  I will check them out.  Tig, I think that is what the doc in the city was more or less stating.  Get the ball moving early in case of problems.  But just as you said, due to his previous failures and return of the hep C after treatment, he should definitely be a candidate.  I only pray it does work for him.  I really don't think Tom could take another disappointing blow of his viral count returning when the treament stops.  Doctor made it appear that this "new" treatment was only going to be "ONE" pill.  I have heard of the double combo you are speaking about.  Is there something even newer on the horizon?  Both doctors reported there wasn't even a name for it yet.  Am I crazy and we misunderstood them?  I don't think we did.  I'm going to check out the links now and see if they sound familiar.  We are very excited. 



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Geno type 1,��after 20 YEARS Harvoni finally arrived....after six prior treatments...�Began harvoni for 24 weeks.....30 days viral count....STILL 0.......Tom now HEP C and Cancer FREE

Tig


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Hello,

I'd like to share in the congrats for the great news as well! That's such a blessing. I hope Tom can get the approval to stop the chemo, that will be such a treat for him! As Jill mentioned, the treatment you are  referring to is the Gilead combo of Sovaldi and Ledispavir (S/L). All indications point to a nearly 100% effective protocol across many reports. Not only effective, it does it with few SFX. Doesn't get much better than that!

The problems people have experienced with the off label treatment of Sovaldi and Olysio (S/O), will hopefully not be experienced with S/L. People applying for S/O have often been denied their first attempt to approve and we have discovered that it required an initial application and subsequent appeal to facilitate the final approval from insurance. I think a lot of the force driving the initial denial was due to the cost involved, including the fact the combo was made by two seperate manufacturers. Fortunately that shouldn't be an issue with S/L. But considering the cost is anticipated to be quite high, there may be some initial hesitation by insurance carriers. But with Tom's history, it seems obvious to me that the need and requirement are there.

So my advice would be to have your doctor apply for approval of the S/L combo as soon as the FDA approves it for sale/distribution. If the odd circumstance of insurance denial comes to pass, you will be ahead of the game and will be immediately prepared to file the initial appeal. With the S/O denials recently, we have seen several approvals immediately after an appeal was submitted. So it may simply be a process the insurance companies are insisting on as a means to control costs. Our goal is to understand the rules of the game and be ready to play! I'm sure in the end, Tom will be approved and life will be good for all of you!! That's the plan, right? Right! Good luck...

Tig



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Tig

68yo 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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TazKat


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wonderful news!!! so happy for u guys!!!!! smile



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TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
Cinnamon Girl


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HI Laura, great to hear your news, how wonderful that Tom is still completely clear of cancer, I`m so pleased for you both!

The new drug combo you mention sounds like the fixed dose combo of Sovaldi and Ledipasvir which is expected to be approved by the U.S FDA on or about 10th October this year.  Many people are anxiously waiting for this treatment to become available because of the high success rates it`s shown in clinical trials.  Here`s a link telling you a bit more about it...

http://hepatitiscnewdrugs.blogspot.co.uk/2014/04/gilead-announces-us-fda-priority-review.html

And some details of the clinical trial results...

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/Phase_3_Genotype_1_SOF-LDV.pdf

Please send our congratulations to Tom, and thanks for sharing this news, Laura, you do a great job posting here and keeping us updated, and it`s great to hear that things are working out so well. 

I`m not too familiar with the insurance issues but I`m sure some of our American members will be able to advise you of the best way to approach it.

Wishing you both all the very best of luck, keep in touch and do let us know how it goes.  Jill x

 

 



-- Edited by Cinnamon Girl on Friday 27th of June 2014 03:27:27 PM

__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
tomyboy


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Hi all from Laura and Tom.  Went back to Mt Sinai for Tom's liver CT scan on 6/19, exactly one year to the day he had the liver resection and  cancer removed.  His liver is still clean of cancer and doctor's report they want Tom to start the "newest" hep c  treatment this fall.  They don't even know the name of the pill yet, but they report it will be approved by the FDA  and clinical results have been awesome.  We both are pretty stoked about this.  Now we  hope Tom's oncologist will approve and agree to  stop his oral chemothereapy at the end of Sept, give him a month of taking nothing, and begin the one pill treatment for hep C in November. He can't be on both treatments at the same time.   It amazes me at how different the "newest"  treatments have become.  Like you all know, this is exciting news for Tom as he has failed at four previous treatments and has had huge disappointments. This treatment sounds promising and we are very excited.  Good to see many people here have been succeeding in beating it tooooo!!!  Thanks for all the support although I find it difficult to stop in as often as I would like.  Tom sends his regards too Question, doctor in city told Tom to see his gastro doc here and begin the process of insurance approval  at the end of August as it takes quite a while for the insurance to approve the treatment.  Has anyone had an issue with this?  They feel Tom definitiely fits the criteria, i.e., failed at numerous previous treatments and is a geno type 1. Any informaion would be helpful.  ......best to all of you and will keep you posted when he begins his treatment, please pray for him.



__________________

Geno type 1,��after 20 YEARS Harvoni finally arrived....after six prior treatments...�Began harvoni for 24 weeks.....30 days viral count....STILL 0.......Tom now HEP C and Cancer FREE

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