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Author Topic: Daklinza + Solvaldi for Genotype 1  (Read 13275 times)

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Offline FutureThinker

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  • Posts: 711
  • Onward and upward!
Daklinza + Solvaldi for Genotype 1
« on: December 22, 2015, 10:16:20 am »
Is anyone taking this combo for Genotype 1? It's typically for GT 3 but is recently being recommended for GT1.  Insurance denied Harvoni, so this one might get approved.  Thanks for any info.
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline jakas

  • Member
  • Posts: 265
Re: Daklinza + Solvaldi for Genotype 1
« Reply #1 on: December 22, 2015, 11:53:45 am »
not taking it here but I know it works very well
M/57 yrs.
Contracted (Unknown) 10-20-30 yrs back ??
Treatment Naive
Geno 1a&1b
VL  17+ million
ALT 200+, AST 170+
Fibroscan F4 ( 26+ kpa ) on 8th Dec. 2105
Started Tx 11th Dec.2015 ( 12 wks. Gilead Harvoni)
7/1/2016 :Viral Load|<25 UND.
23/1/2016: ALT 34 , AST 35, ALP 143
8 week NO labs done
EOT:03.03.2016 ( 84 pills eaten )
ALT 26, ALP 124, BIL .54
V/L <25 UND E.O.T.
4 weeks E.O.T. V/L UND::: SVR 4
SVR 12 and  SVR 24 on 16/8/16
Fibro 24.5kpa 23/05/16
SVR 63 05/17
Fibro 17.03.2020 kpa 6.3

Offline Joe NM

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  • Posts: 46
Re: Daklinza + Solvaldi for Genotype 1
« Reply #2 on: December 22, 2015, 03:37:57 pm »
It's one of the recommended treatments, per the treatment guidelines: http://www.hcvguidelines.org/node/72. Makes sense, since Daklinza is supposed to work on any genotype, so Sovaldi + Daklinza should work as well as Sovaldi + Ledipasvir (otherwise known as Harvoni). If insurance denies this (I hope they don't!!!), then you could try for Viekira Pak (plus ribavirin for 1a, no ribavirin for 1b)...if insurance denies a Prior Authorization and an Appeal for THAT, the drug company has a Patient Assistance program called 'proCeed' that can get you the medications for free...unlike the makers of Sovaldi and Daklinza. https://www.viekira.com/.
HCV Case Manager
Type-1 diabetic
Connoisseur of battling insurance companies, and when that fails resorting to 'Sample Pharmacies' and sneaking insulin back from Mexico to survive.
Kindred spirit/admirer of all on this forum!
Here to help in any way I can!
EVERYONE DESERVES A CURE!

Offline FutureThinker

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  • Onward and upward!
Re: Daklinza + Solvaldi for Genotype 1
« Reply #3 on: December 22, 2015, 06:10:53 pm »
Thanks, Joe NM --- I saw that this combo is now on the recommended treatments, just wondering if anyone is having insurance issues as with the Harvoni.  I went through 2 appeals and Harvoni was still denied.  Trying not to have to take the RIBA (required with the Viekira for GT1a), so this one may be possible for me to start treatment, finally! This is a relatively new addition for GT1, so also wondering re: side effects, etc.
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline Coach Mike

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  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: Daklinza + Solvaldi for Genotype 1
« Reply #4 on: December 23, 2015, 09:38:15 am »
Did you take your appeal to the independent external review you are guaranteed under the Affordable Care Act. That is how I got my Harvoni approved. It works.
Also, Dr. Freeman at fixhepc.com is conducting a huge e trial for 3000+ people.
It's called REDEMPTION.
Coach Mike
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: Daklinza + Solvaldi for Genotype 1
« Reply #5 on: December 23, 2015, 07:47:18 pm »
Coach Mike --- Thanks for the info. I have the IMR forms, but my doctor is now recommending the Daklinza hoping my insurance may cover.  We also considered resubmitting for Harvoni, and if denied, then doing the IMR.  I see there is some info in this forum from people taking the  Daklinza w/ other GTs, but it seems this drug combo is relatively new. I'll also look at the info on the trial.  Thanks! FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline HEPful Guy

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  • Posts: 13
Re: Daklinza + Solvaldi for Genotype 1
« Reply #6 on: December 24, 2015, 09:55:50 pm »
What insurance company do you have and/or who is it through?

Offline FutureThinker

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  • Onward and upward!
Re: Daklinza + Solvaldi for Genotype 1
« Reply #7 on: December 26, 2015, 12:04:28 pm »
BCBS, which is requiring fibrosis of F3 or higher to approve treatment.  I prefer not  to wait till I get to that point, obviously!
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline HEPful Guy

  • Member
  • Posts: 13
Re: Daklinza + Solvaldi for Genotype 1
« Reply #8 on: December 26, 2015, 02:59:28 pm »
May want to try to get approved at the beginning of the year as a lot of BCBS plans are removing fibrosis requirement or reducing it to F2 for approval.

Offline FutureThinker

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  • Posts: 711
  • Onward and upward!
Re: Daklinza + Solvaldi for Genotype 1
« Reply #9 on: December 27, 2015, 02:55:14 pm »
WOW, that's fantastic news, if it's true!!! How do you know about this, as it affects a lot of people! I was reading last night about new drugs in the pipeline and see that Gilead has put in for approval of Velpatasvir as of Oct. 28th, and the Astral studies were very promising. So, next year may be "the year" for many of us, as new drugs get on the market and if you are correct, the F3+ requirement is removed.

Please expand on this info re: fibrosis stage requirements!  Thanks, FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline HEPful Guy

  • Member
  • Posts: 13
Re: Daklinza + Solvaldi for Genotype 1
« Reply #10 on: December 27, 2015, 05:32:40 pm »
I'm a Pharmacist that works with doctors office's to help patients get approved for these types of therapies. I know for our state, BCBS has recently lowered their Fibrosis requirement to include F2 patients. Some of the surrounding states are also rumored to be decreasing their Fibrosis staging requirement at the beginning of the year as well, or to remove it completely. January 1st is a huge time for insurance plans as a lot of insurances reevaluate their policy on the drugs and/or therapies they are going to cover. Hopefully your BCBS plan is lowering their requirement, keep in mind not all states are doing this. There is a possibility that some states could even tighten their criteria for treatment and move up to F3/F4 only. But most of the states surrounding me are loosening their criteria.

A majority of plans basically use Fibrosis staging as their sole criteria for treatment. This is due to the AASLD placing patients at different "categories" for urgency of treatment. http://www.hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy-box-summary-recommendations-when-and-whom-initiate.  Obviously patients with the most severe complications of HepC such as F3/F4 fibrosis are highest priority for treatment due to the higher likelihood of severe complications such as liver failure, transplant or HCC. Unfortunately, a lot of insurances use this list to say "well, patients that aren't meeting Highest priority criteria per AASLD don't need to be treated yet" and have inappropriately used the guidelines to limit treatment to save money. When in reality all the AASLD was doing is telling clinicians, "hey, these are the type of patients that could die soon if left untreated or the virus complications will progress at a faster rate than other patients.

Like I said though, this may not be indicative of your plan. With an F3/F4 plan such as yours, their policy and procedures for HepC can only get better, not worse. If you were my patient, I would retry getting you approved for Harvoni or Viekira (whatever their preferred product is) at the beginning of the year.  My guess is that your plan wont pay for Sovaldi + Daklinza regardless of your Fibrosis staging, as its almost double the cost of Harvoni or Viekira and < the same efficacy.
« Last Edit: December 27, 2015, 05:34:18 pm by HEPful Guy »

Offline FutureThinker

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  • Posts: 711
  • Onward and upward!
Re: Daklinza + Solvaldi for Genotype 1
« Reply #11 on: January 01, 2016, 03:34:49 pm »
Thanks for the info.  I agree, now that I've looked more into the Daklinza info, it is more expensive than Harvoni so it is doubtful that BCBS will cover. Not sure why my MD thinks they may. I also agree in how the insurance cos have been using the AASLD guidelines, and I noticed the newer guidelines since the 11/15 meeting have changed their wording somewhat re: F1-2 patients. I need to go look at my insurance's Specialty drug list to see if Daklinza is even on it at this point.  And, as I mentioned in my last post, the new Gilead drug application adds more to think about.

Lots to think about in this new year! Thanks again, FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: Daklinza + Solvaldi for Genotype 1
« Reply #12 on: January 01, 2016, 03:44:32 pm »
Just saw on another topic on this forum that one person's insurance approved the Daklinza but not the Solvaldi.......... perhaps that is what my doctor was referring to when it was said that my insurance might pay for this.  Doesn't help much, though, when the Solvaldi is $80,000.  FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline jakas

  • Member
  • Posts: 265
Re: Daklinza + Solvaldi for Genotype 1
« Reply #13 on: January 01, 2016, 04:50:59 pm »
Here is my 2 cents:
13 months back on a flight from Asia had terrible chills, fever and bad liver pain with bloating. Anyway got home and somehow knew it was the Hepc causing this. It was high time to get treated. We dont have insurances in my country similar to the US but the law states that Hepc MUST be treated with state money and EVRYONE MUST BE TREATED.
Cutting the story short the doctor refused sovaldi or harvoni. They advised peginterferon + ribavirin without any fibroscan done or anything like that.
I refused.
Travelled again to Asia fibro done it was in the range 10-15 kpa. The doc there said F3 fibrosis wait for Harvoni its coming or take sovaldi, peg interf. and ribavirin.
I needed time.
Back home it took 6 months to get a new fibroscan BUT I HAD DECIDED I was going to Bangladesh or India to get that Harvoni if they Doc still had problems to give me Gilead Harvoni at home. My country does not allow import of medicines by post or courier.
The cost of generic Harvoni which works as good as the original costs JUST $ 1200 for 12 weeks by DHL from India. Thats 84 orange tabs :D. The US does allow import for 3 months for personal use.

In my case the EU put out the law that all F3/F4 MUST BE TREATED ON PRIORITY.
My fibroscan showed 26 kpa V/Load 900000, the doctor could not refuse. I got the 3 months of Harvoni, I was surprised. Its been 22 days I am on it.

So I hope you got my drift if the US insurers are acting bitchy just go elsewhere. Its really possible. The Indian companies are licenced by Gilead and you need just 12 weeks with the low fibro you have.
There is also a Pharmas market at fixhepc site, check it out if you decide to import it.

So HAPPY NEW YEAR and God bless. Wishing you well and hoping to see you get well soon :)

I am not a native English speaker so please excuse my language  :P
« Last Edit: January 01, 2016, 04:54:38 pm by jakas »
M/57 yrs.
Contracted (Unknown) 10-20-30 yrs back ??
Treatment Naive
Geno 1a&1b
VL  17+ million
ALT 200+, AST 170+
Fibroscan F4 ( 26+ kpa ) on 8th Dec. 2105
Started Tx 11th Dec.2015 ( 12 wks. Gilead Harvoni)
7/1/2016 :Viral Load|<25 UND.
23/1/2016: ALT 34 , AST 35, ALP 143
8 week NO labs done
EOT:03.03.2016 ( 84 pills eaten )
ALT 26, ALP 124, BIL .54
V/L <25 UND E.O.T.
4 weeks E.O.T. V/L UND::: SVR 4
SVR 12 and  SVR 24 on 16/8/16
Fibro 24.5kpa 23/05/16
SVR 63 05/17
Fibro 17.03.2020 kpa 6.3

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: Daklinza + Solvaldi for Genotype 1
« Reply #14 on: January 08, 2016, 12:40:19 pm »
Thanks for all the info and thank goodness you are in treatment!!  I just saw last night that the FDA intends to make an approval decision on the new Gilead drug (SOF and VEL) by/on June 28th........ I think I'm going to call Gilead and discuss my situation with them and get a bit more info on this new combo.  Since Solvaldi is in it, I'm guessing it's going to be $$$$$$, but I'm going to find out.

Happy new year to you, too, and let's hope with possibly 4 drugs on the market for GT1 that this will be a good year for many of us.  FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: Daklinza + Solvaldi for Genotype 1
« Reply #15 on: January 08, 2016, 12:46:07 pm »
Hi,
One can get Twinvir shipped to the U.S. from a trusted source for $1000 for 12 weeks.
CM
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: Daklinza + Solvaldi for Genotype 1
« Reply #16 on: January 11, 2016, 05:53:38 pm »
Hey Coach Mike, Came across some of your other postings under "Just going to Buy Harvoni" last spring when you were fighting SO hard to get treatment -- very inspiring!!!  At any rate, I am going the IMR route for Harvoni, so I'll post again in the near future when that battle is decided. It just shouldn't be this hard to get treatment for a confirmed medical condition in the USA....... FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: Daklinza + Solvaldi for Genotype 1
« Reply #17 on: January 11, 2016, 07:12:16 pm »
Wow,
This has been a journey!!
My experience pales, however, to those pioneers like Lucinda and others who went through the "interferon" era.
I was very fortunate. Many people have not been.
We have an effective cure now.
No one should have to fight to get it.
Period.
But, if you DO have to fight, or just prefer to, fight like hell.
CM
« Last Edit: January 11, 2016, 07:15:02 pm by Coach Mike »
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: Daklinza + Solvaldi for Genotype 1
« Reply #18 on: February 11, 2016, 04:21:28 pm »
So the answer to my original question came yesterday from the FDA: Daklinza + Solvadi is now approved for GT 1, along with 3. Very good news!! This is gonna be the year......... FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

 


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