APPROVED - Update on drugs!

[GrammyA]

So excited - today got approval for BOTH Solvaldi and Olysio to be provided to me for a 12 week treatment using just these 2 drugs!  As you might recall from my previous posts that my Hep Dr. believes that this combo will be the perfect cocktail for SUCCESS!  Tomorrow marks exactly 1 year since I stopped the last treatment at 24 weeks of Riba, Victrelis and Pegasus.  HORRIBLE side effects, blood transfusions and detectable AGAIN at the post 12 week mark.  It actually took me 6 - 7 months to shed all the side effects and feel normal again.  That was my 2nd attempt to SVR and at 61 years old I am really praying this treatment is indeed the final solution.
I will be the 3rd patient he has doing this same program with many more trying to get approvals from their insurance companies.
I should start within a week and will post updates weekly on how I feel and the journey.
Keep the faith and blessings will often happen!  
Happy Grammy today for sure!!!

[bbj2856]

Hoping you have the best luck Keep praying God bless you and don't give up.

bbj

[Pamelajean1]

WhooHoo!!! So excited for you! Our doctors have the same mindset so hopefully I'll be just a few weeks behind you!
Can't remember...did you test for Q80K? I have....don't have my results back yet but thinking I will ask to do even if I'm positive.
Key for me is that he said I could re-treat when the 'miracle' one pill is approved.
I'm over the moon excited for you....keep us updated!
Blessings!

[GrammyA]

No Q80K test - trying it no matter what those results would have been.... however, my Dr. said that doing the 2 drugs without any others does not require that test.  Just doing what I am told by those wiser then me.  Thanks for the congrats!  Good luck to you also!

[can-do-man]

Congrats to you and your doctor. I agree there's no reason to have the test when one has to treat anyway........ Best to you. The odds are on your side.

[ppmguy]

    wow!!!!  that is exciting to get approval of the two together.  really happy to hear your news.  you have a good dr.  getting approval of sovaldi for geno 1 tx experienced is tough.  

[Jeff88]

Congratulations and SVR to you!
What insurance company do you have?

[JimmyMose]

Congratulations on your approval and hope treatment goes well for you.

I saw your earlier post a couple ?
days ago  "we lost our insurance coverage so the doctor is filing for the drug companies to provide them free of charge"
http://www.medhelp.org/posts/Hepatitis-C/Anyone-know-if-Insurance-will-pay-for-these-new-drugs/show/2058000#post_9814038

So your Doctor got the drug companies to provide them free of charge within a few days.  Wow

The 12 week treatment estimated cost of both drugs full price is $150,000 (Solvaldi $84,000  Olysio $66,000)

To All  If anyone becomes aware of any insurance companies actually covering this OFF label use please reply with info and co pays.  .  

[HectorSF]

Three cheers for you and your doctor!
After doing pegIFN based treatment with Victrelis your gonna love this combo as far side effects and adverse advents are concerned.

I did Sovaldi + Ribavirin and it didn't even feel like I was treating most of the time. I had to look at the undetectable graph line of my viral load to believe it sometimes.

Best of luck to all of you treating with this cocktail.

Cheers!
Hector

[Rangle]

congrats great news..  Is that  trial your doing or regular treatment
good luck

[JimmyMose]

I'm not doing any treatment yet  My reply was to GrammyA. Her doctor prescribed Off label (not trial)

[hepcat1954]

It's your personal decision to do it without a Q80K test.  But you should be aware that Victrelis is a linear protease inhibitor.  Since you failed treatment, you are resistant viruses to protease inhibitors.  Olysio is a protease inhibitor.  I think it's a cyclic protease inhibitor rather than linear.  Will that make a difference for you?  I'm not sure.

However, your doctor is misinformed that the test isn't necessary.  The test should've been offered and you could decline but the test is necessary because you failed a 1st generation protease inhibitor.

I know all about resistant viruses.  I failed incivek based therapy and finally got cured with Sofosbuvir (Sovaldi) and Ledipasvir.  Neither one are protease inhibitors.  

Good luck
HC

...

[Rangle]

I meant to congrat  grammy haven't been around for a while
Hung here during my treatment in 07

health is a funny thing most people don't realize they have it till they start losing it

warmest regards
Rangle

[GrammyA]

My mistake  - my last treatment was with INCIVEK.... NOT Victrelis...... fog brain due to old age.

[pooh55811]

Congratulations on getting approved for treatment! Hopefully this will be your ticket to SVR.

Sounds like your doctor knows what he is doing. I know you are Genotype 1b so I doubt you have to worry about the Q80K polymorphism. It is very rare in Genotype 1b.


OLYSIO (simeprevir)  -  Resistant Variant Q80K polymorphism

"Q80K polymorphism: QUEST-1 and QUEST-2 studies"
"In  the simeprevir QUEST-1 and QUEST-2 studies, researchers reported in QUEST-1 patients with HCV genotype1a had almost 20% less SVR than HCV genotype 1b. Noted, at baseline the mutation Q80K was found in approximately 1/3 of genotype 1a patients. On the contrary, in QUEST-2 this mutation was infrequent and did not impact significantly the SVR rate".

"48 percent of U.S. patients with a HCV genotype 1a  had the Q80K polymorphism at baseline"
"Johnson & Johnson went on to perform an analysis pooling all subjects from the C205, C206, C208, C216, and HPC3007 trials, and found 48 percent of U.S. patients with a HCV genotype 1a  had the Q80K polymorphism at baseline, compared to only 19 percent of patients in Europe. The mutation is almost nonexistent in those with a genotype 1b infection."

http://hepatitiscnewdrugresearch.com/olysiosimeprevir-resistant-variant-q80k.html

Best of luck.

[GrammyA]

Pooh - you and so many others are a wealth of knowledge.... thank you for always sharing with us less educated ones. Yes, I am 1b with cirrhosis.
Grammy

[willbb]

This statement by hepcat.........

"But you should be aware that Victrelis is a linear protease inhibitor.  Since you failed treatment, you are resistant viruses to protease inhibitors.  Olysio is a protease inhibitor....

May be a little too definitive with saying ""you are resistant",,however there is a test (sited below)to find out  as this is still a relatively unknow factor for those that failed with a protease type drug...iresgardless of the Q80 mutation.

Given that there will one of the NS5a inhibitors on the market within the next little while,and that in combination with "sovaldi" you know definitively you "do not have any resistance  to  ..(if indeed there may be  a resistance to the protease now )..personally I would ask my physician to consider running  the test  I site below  before proceeding ... JM thoughts......

Best of luck to you..
Will


HCV GenoSure NS3/4A analyzes the genetic sequence for the non-structural proteins NS3 and NS4A of HCV genotypes 1a and 1b that encode for an enzyme essential to viral replication. The assay detects mutations in NS3 and NS4A and specifically identifies those associated with boceprevir and telaprevir resistance.

Recommendations recently developed by the HCV Drug Resistance Advisory Group emphasize the value of resistance testing at treatment baseline and failure in support of the development and clinical evaluation of new drug candidates. In HIV, the routine use of resistance testing to guide antiviral drug treatment is established in clinical practice. In response to the recent and future availability of DAA agents, some experts anticipate that drug resistance testing will provide similar value to the clinical management of HCV infection.

http://hepatitiscnewdrugs.blogspot.com/search/label/protease%20inhibitor-%20%28NS3%2F4A%29%20Drug%20Resistance%20Test

[willbb]

I noticed you did Inci and not Vic  however this is still the same class of drug...

Best ..
Will

[hepcat1954]

The updated Genosure test is for all know resistant variants, Q80K included.  Grammy has resistant variants.  The only unanswered question is which ones.

[willbb]

HC  & Grammy

I would tend to agree with that and that is why I suggested the OP chat with her physician about possibly having the  the 'Genosure" test prior to proceeding with another protease and further discussion about  Sovaldi in combination a Ns5a drug (hopfully aprroved soon),,however there is also the urgency of chirrosis  present.

However given the  uncertaintly of known time for variants to return to "wild type virus"  my comment to you about  being possibly..... "too definitive " a statement

Grammy..... best of luck with this....

Will

[flyinlynn]

Hi all
I am Geno 1A null responder w/cirrhosis meld 7 last treatment was with pegintron and ribavirin. The Dr did not want me to try 3 drug combo as probably would not work and could cause me to decompensate.Basically too much risk for too little chance of success.

In regards to the discussion about Q80K is that something I should ask my Dr about on my next check next month?

I am hoping to get on Sofosbuvir/Ledipasvir combo if/when approved but have been thinking about the off label use Sovaldi-Olysio if I can get my drug coverage to buy off on it but am concerned about the implications of the Q80K.

Dont want to blow a good opportunity for cure by being pre mature treating, but don't want to risk decompensation while waiting for the new combo either.

AND GOOD LUCK to GrammyA!!!

[Upbeat]

Who is paying for these drugs?  I am playing the game with BCBS right now and they don't want to pay for one drug much less both

[Faithdove]

I too would like to know if the two drugs will be covered for "off-label" use together.

[can-do-man]

I need to maybe back track that response I gave you sense I see your a geno type 1a... Yes you should check with your Doctor when you see him. Wishing you the best

"Q80K polymorphism: QUEST-1 and QUEST-2 studies"
"In  the simeprevir QUEST-1 and QUEST-2 studies, researchers reported in QUEST-1 patients with HCV genotype1a had almost 20% less SVR than HCV genotype 1b. Noted, at baseline the mutation Q80K was found in approximately 1/3 of genotype 1a patients. On the contrary, in QUEST-2 this mutation was infrequent and did not impact significantly the SVR rate".

"48 percent of U.S. patients with a HCV genotype 1a  had the Q80K polymorphism at baseline"
"Johnson & Johnson went on to perform an analysis pooling all subjects from the C205, C206, C208, C216, and HPC3007 trials, and found 48 percent of U.S. patients with a HCV genotype 1a  had the Q80K polymorphism at baseline, compared to only 19 percent of patients in Europe. The mutation is almost nonexistent in those with a genotype 1b infection."

http://hepatitiscnewdrugresearch.com/olysiosimeprevir-resistant-variant-q80k.html

[GrammyA]

To answer the money question - here is what I know.  My drugs will be free and provided by the drug companies direct because I qualified with no insurance and only SS Disability income.  However, my doctor has 2 on this off label combo and they both were covered by Aetna Insurance.  He has others struggling with various insurance companies that are saying NO!  BCBS is the worse when it comes to a fast yes.  Once the drugs are added to the formularies for each insurance company they will be available.  Some companied LOCK down the formulary lists on an annual basis and will not add new drugs until the next year.  Others can be convinced by the doctors that it is needed immediately and perhaps get a special acceptance.  
Also, YES this is Off Label...... 2 pills per day only.... Sovaldi and Olysio.