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Post Info TOPIC: Harvoni..new treatment???
Brian1412


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RE: Harvoni..new treatment???
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should I be  nudging in this direction?  While I am comfortable and thankfull  for  my DR, and the Grant etc, I am still  wary about the  institution itself



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Ro


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Thanks Taz!  Hoping for the best on this wild ride......



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Tig


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HARVONI® (ledipasvir and sofosbuvir) tablets, for oral use Initial U.S. Approval: 2014

-------------------------------INDICATIONS AND USAGE-------------------------

HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults (1 )

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf



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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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angelseven


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harvoni is only approved for 1a and 1b as i understand it

 



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
Huey


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sorry i did not realize Harvoni was approved for 2's,  I was using old protocol .

The Sovaldi works on the 2's but the Harvoni out preformed it in test. so it is supposed to be better.  Good Luck!!


I also thought you was a 2a . confused with someone else.   lol. :)


-- Edited by Huey on Wednesday 22nd of October 2014 02:56:23 AM



-- Edited by Huey on Wednesday 22nd of October 2014 02:58:43 AM

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  HCV Genotype 3a , now Psot-Tx was on S/riba. First VL was 5.8 mil on 7-5-13 then "und" at 3.8 weeks. 06/13/14 still und. off meds 3 days back on 7/29 Last pill 08/10/14 SVR+4

 
angelseven


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Well Gilead called cigna and they were told Harvoni had not been added to their formulary and i called and talked to a supervisor and they told me it had not been added so i don't think anyone is really lying.... maybe solvaldi is approved.. but Harvoni has non been added



-- Edited by angelseven on Wednesday 22nd of October 2014 02:56:38 AM

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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
TazKat


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Good luck Ro!! this stuff has come soooo very far & I am soooo glad. I had bcbs with the incevik & the sovaldi. so hopefully everything will work out just perfectly. I sure hope so!!!! Happy Trails.& the plus not all that nastiness that the former treatments hae been. just terrible stuff..

Peace Out & thinking & praying for u!!

Taz



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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..

 

 
Huey


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angelseven wrote:

Thanks, for this info, I am just going to go into my doctors appointment November 5th and let them figure it out,  they are the experts at this stuff,  Cigna told me and Gilead it might be added to their formulary  in 2 to 4 weeks and to check with them weekly

 

Thanks for your assistance and have a great day,

 

Connie

I had CIGNA ,, and they paid for my Sovaldi, and i was on it for 24 weeks.  It is already on there formulary someone is lying to you.  It may be Genotype specific though, mine is a 3 and after all these new DAA's came out, I still would have had to had the same treatment .



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  HCV Genotype 3a , now Psot-Tx was on S/riba. First VL was 5.8 mil on 7-5-13 then "und" at 3.8 weeks. 06/13/14 still und. off meds 3 days back on 7/29 Last pill 08/10/14 SVR+4

 
angelseven


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Thanks, for this info, I am just going to go into my doctors appointment November 5th and let them figure it out,  they are the experts at this stuff,  Cigna told me and Gilead it might be added to their formulary  in 2 to 4 weeks and to check with them weekly

 

Thanks for your assistance and have a great day,

 

Connie



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
Tig


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One thing I did see is Cigna seems to offer some coverage options and it will be worth you asking your doctor to check out. The 2015 Cigna formulary I found did not have Harvoni or Sovaldi listed. But Cigna does list Sovaldi as a Tier 5 availability via their Medicare formulary. I read that if the Medicare formulary has it available, your doctor can request it be provided across all Cigna plans but they have to specifically ask, if you are turned down by your non Medicare plan. So it's worth investigating when Harvoni comes available.

http://www.cigna.com/iwov-resources/medicare-2015/docs/formulary-ea-pdp-a.pdf

Tig



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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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angelseven


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what about Cigna, i could not find anything



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
Tig


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 I was able to search a number of insurance formularies via links through our friend Google. I wasn't able to find any BCBS carriers that listed it available yet. That doesn't mean much, if they want to cover it they will, all in time. There seem to be so many formularies out there, it's amazing! Angel7, you mentioned Aetna and I was impressed that one, they have 10 different formularies and they have Harvoni approved (with preapproval) on every list. So I think it's going to be slow to get off the ground for some, but they'll come around. I hope that happens soon, everyone has waited for this opportunity long enough! Good luck...

Tig



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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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angelseven


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hey, keep us updated!!!  Good luck, i hope you get the meds fast... my appointment is not until november 5th but i have done all my premliminary work so it won't make any difference if i go any earlier as the insurance company says it could take 2 to 4 weeks to add to formulary and to check weekly... Looks like medicaid and some supplement got a guys right away that is on a facebook support group, i am just ready to get going before i change my mind  hehehe



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
Matt Chris


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Hello Ro

Welcome to the forum, you have found a good place to follow the latest real world developments of patients on "Harvoni" 

We actually have a thread for members that want to follow Harvoni developments that might be useful to you.

Folllow this link --- http://hepcfriends.activeboard.com/t58762824/all-aboard-for-the-harvoni-treatment-train-enjoy-the-ride-fo/

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! 
Groupergetter


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Hi Star, hope we don't get too much runaround from the insurance companies.  My docs said I was in the first group of 10 they prescribed for.  I got a call from Express Scripts saying they had the prescription but none of the records they needed for the prior auth.  I know my doc's PA sent it, she is very efficient.  Harvoni doesn't appear to be on my insurance companies formulary as well.  I was hoping to get meds within 2 weeks but at this point that is questionable.  Good luck with getting yours filled.  Hope we all find SVR.  



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.
angelseven


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thanks for that info!!!



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
angelseven


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my insurance company, cigna ,does not even have it on their formulary yet... is it on blue Cross Blue shield formulary??  I know it is on Aetna



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
Ro


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Isiscat, you are so right!  The doctor said the same thing in regards to the Abbvie combo.

I was moved to #1 spot on her list of 85 priority patients, so here is hoping Blue Cross does not hold me back.

Tomorrow as soon as approval is announced my info is turned in for Ins. approval...fingers crossed!

 



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Dzdayscomin


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I never had either Riba or interf. but i assure you this I s going to be nothing like that, and if it's how they say,  you may not even feel like like ur on tx , especially having had to deal with the old SOC drugs.

Go get em we are very anxious just to hear your good reports!

Happy treating......Duane



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53yr M 1a acq 12/83 cirr pre tx MELD 17  tx nv diag 1/29/12  tx S/O 3/5/14  trans list.

EOT 5/28/14 UND 6/12/14 SVR 8/29/14 MELD 14 dx HCC 9/5/2014 tumor ablation 9/24/14

In the 10K lakes State It's not about us but those around us.
Ro


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Thanks all!  I truly am anticipating going on treatment...a bit apprehensive..and hoping blue cross will be cooperative...

My appointment is Wednesday, FDA approval is supposed to be Friday.. hoping to be in the system SOON!

It does sound easy compared to the interferon/riba then infergen/riba; and the incivik triple therapy I have been on in the past.

I will be watching board for input and will keep you all posted!

Again thank you so very much for the feedback!

 



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Gator Man


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Hi Ro:

I couldn't agree more with Isiscat or Duane. I jumped at Sovaldi/Olysio last December because my doctor thought there would be more resistance from health insurance if I delayed for a few months. Not sure what would have happened with insurance if I had waited , but I took the chance and am now SVR.



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Geno 1b, compensated cirrhotic, 54 yo, prior null responder. Pre tx VL approx 595,000, tx with Sovaldi/Olysio (no Riba) started 1/8/14. VL 40 @ 2 weeks, UND @ 4 weeks. Still UND @ EOT + 1 year.

Gator Man SVR12, Dragon 0, Final Score.
Isiscat2011


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P.S.  When I say jump, Ro, I mean jump fast!  The reason I say this is that the Abbvie combo should be approved in December which will give insurance providers an option.  If Abbvie is priced lower payers will wish to approve it instead. 

While the Abbvie combo should be comparable in efficacy it is expected to have greater side effects and tx experienced 1as will probably be taking Riba with it. 



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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.
Isiscat2011


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Hi Ro:

My advice is to follow your instinct to jump at the chance.  As a cirrhotic you don't want to wait around; this is the one.  Cirrhotics will have priority insurance approval so that shouldn't be a problem.  As Duane noted, the fact that your doc's office contacted you is awesome, and a strong indicator that they are on top of your medical needs and care.  

Try not to worry about past dissapointments with tx.  This tx should have minimal side effects and will be successful for most people.  Assuming the accuracy of the clinical trial data, as well as what we have seen here, it isn't comparable to the Interferon treatments either in terms of side effects or efficacy.

The only question mark I see is how long should you treat?  The 95% clinical trial results did not apply to cirrhotics who treated for 12 weeks.  The SVR rates were about 10% lower for cirrhotics unless they treated for 24 weeks.  This isn't something that needs to be resolved right this minute, however.  I would talk to my doc about it and just keep it in mind for the moment.   

Btw, this is the tx that I and many others (especially tx experienced 1as) have been waiting for.  Don't be scared.  There will be many others here on the same tx with 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.
Dzdayscomin


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If it is what they are billing it to be , i'd be getting after it ASAP so insurance can quibble, and cry, deny, then relent and approve.

It should be the highest success rate and most easily tolerated tx to date.

And the fact your Dr. called you...to get you going on it early,  well that's just awesome,  because that means they are actively reviewing your file and know their patients and their needs.

I'd be happy, not worried.....I don't know what treatments you failed on but if it is a interferon / riba tx these meds are nothing like that.

I'm gonna say get ready to be HEP C free in 6 months.....

 

Duane !



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53yr M 1a acq 12/83 cirr pre tx MELD 17  tx nv diag 1/29/12  tx S/O 3/5/14  trans list.

EOT 5/28/14 UND 6/12/14 SVR 8/29/14 MELD 14 dx HCC 9/5/2014 tumor ablation 9/24/14

In the 10K lakes State It's not about us but those around us.
Tig


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Hi Ro,

Word is Harvoni will be released on Oct 10th. It's the latest silver bullet drug from Gilead and will be priced high at a rumored cost of $100-125 K for a 12 week course of treatment. Not a bad profit margin for a single pill per day protocol. That's going to make Harvoni one of the most valuable items by weight in the world! The SVR success rates are said to be 95-100% across the study data released to date. Also said to be a low side effect therapy as well. There are a lot of crossed fingers out here! If you have any specific questions, let us know. Good luck on your treatment, please let us know a little more about your Tx as you progress with it! Good luck...

Tig



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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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Ro


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Just received a call from my doctor to schedule an appointment this week as the new treatment Harvoni ((Ledipasivir/Sofosbuvir in 1 pill) is to be approved on Oct 10 and they believe I am a candidate.  As a 2 time non-responder, geno 1A with Q8k morph, and chirrotic liver, I am overwhelmed with digesting this information.  I have tried to follow it as it was researched...but am so confused...I want to jump at the chance of 1 pill daily with minimal to no side effects and greater than 95% cure rate...but have been disappointed in the past.... would truly appreciate any thoughts, questions, etc.  

went for bloodwork today, doctor appoointment Wednesday...

Thank you so very much for any and all input...



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