soon to start Harvoni... but

[Magnum]

Saw my transplant doctor yesterday at UCLA Medical Center. Interesting meeting... I mentioned Gilead's Harvoni, which I will be starting soon. He said the protocol is that Medicare, or whatever insurance company will cover it, has to see a current viral load to ensure you have Hepatitis C. He also mentioned that it's not available at CVS, Walgreens, etc., but instead at specialized pharmacies.

Another interesting thing. Since I've failed 5 treatments, I will have to go 24 weeks instead of 12, at an average cost of $170,000. But he said that the cost of testing a person before transplant costs the insurance companies more. I believe him. Before my transplant this past December, I had to undergo 4 days of intense testing from
8 a.m. to 3 p.m. daily. Heart tests, kidney tests, psychiatric tests, MRI's, Cat Scans, Ultrasounds and on and on.

The average cost of a liver transplant is well over $500,000, therefore the insurance company would rather pay out the money to treat with Harvoni than to pay out the money to treat one for a transplant if they don't get cured now and develop Cirrhosis, like I did.

He also asked me, now that I got a second chance in life, if there is one thing I would like to see before I die, what would it be? I thought about if for a minute and said "I would like to see Justin Beiber fall down a flight of stairs".

Magnum

[nan535]

For those interested in what else is in the pipeline soon to be approved:

http://news.bms.com/press-release/bristol-myers-squibb-receives-positive-chmp-opinion-daklinza-daclatasvir-treatment-chr

"Applications for Daklinza-based regimens are also pending in Japan and the U.S. A decision from Japan’s Pharmaceutical and Medical Devices Agency is expected soon, and the U.S. Food and Drug Administration has granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 30, 2014."

It is wonderful to know there are more options to be considered.

Nan

[nan535]

Wishing you a successful treatment. I hope you will keep us posted on your progress.   My husband is waiting to hear from his doctor what are his next steps. As you may know, he too is post transplant with severe recurrent HepC and as a result has cirrhosis again. He relapsed after 24 weeks on Sovaldi and Ribavirin so his doctor is considering carefully whether Harvoni is the answer or if he should wait for another new  treatment expected to be approved in December. (Sovaldi + Daclatasvir)
http://www.hepctrust.org.uk/News_Resources/news/2014/January/Daclatasvir+and+Sofosbuvir+cure+toughest+cases+of+hepatitis+C

The virus comes back much stronger in transplant patients because of the immunosuppressant drugs transplant patients must take. So it is a true blessing that you have access to these new drugs so quickly after your transplant.

Our best wishes for you,
Nan

[Magnum]

Luckily because of my physical disability, I have both Medicare and Medical. The doctor and I don't see a problem, especially since I've had a transplant and common sense says I should treat right away because if the liver becomes very damaged, it will all have been for naught. Stay tuned...

Magnum

[nursehepc]

You made his day...too funny...  

[sue4hula]

Best wishes that the Harvoni is your magic ticket to the cure.  I'll be watching your journey and look forward to more smiles from your humorous comments.  :)

[flyinlynn]

Hi Flower
Also from the prescribing information sheet for Harvoni

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

excerpts:

8.7 Hepatic Impairment
No dosage adjustment of HARVONI is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C). Safety and efficacy of HARVONI have not been established in patients with decompensated cirrhosis [see Clinical Pharmacology (12.3)].

and

Patients with Hepatic Impairment: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative subjects with severe hepatic impairment (Child-Pugh Class C). Ledipasvir plasma exposure (AUC0-inf) was similar in subjects with severe hepatic impairment and control subjects with normal hepatic function. Population pharmacokinetics analysis in HCV-infected subjects indicated that cirrhosis had no clinically relevant effect on the exposure of ledipasvir [see Use in Specific Populations (8.7)].

The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected subjects with moderate and severe hepatic impairment (Child-Pugh Class B and C). Relative to subjects with normal hepatic function, the sofosbuvir AUC0-24 were 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 were 18% and 9% higher, respectively. Population pharmacokinetics analysis in HCV-infected subjects indicated that cirrhosis had no clinically relevant effect on the exposure of sofosbuvir and GS-331007 [see Use in Specific Populations (8.7)].

[Sovaldi13Newbie]

I remember you from a long time ago here and you were always up and amusing. I really wish the best for you, you are QUITE the Warrior and deserve a break!!!! This Sovaldi just SVR'd me and my hopes that it will do the same for you!

[Magnum]

Interesting to note that many tests prior to my transplant and prior to all 5 treatments, the viral load was never higher than 3.2 million. Just got the results from Friday's test. After the successful transplant 10 months ago, it is now 5 million. Someone did mention to me that the virus comes on with a vengeance many times after transplants. Go figure. However, I will be put on Harvoni as soon as the prior authorization is completed. And the beat goes on...

Magnum

[Flowerchild700]

Thank  You!

[Flowerchild700]

Thank you it does. But, I'm not really sure how sick I am. I sure have been feeling a lot worse than I have in the past. But, all the blood test they have run are about the same. I'm thinking it might be something wrong that has nothing to do with Cirrhosis or Hep C. I don't have to worry about it now until Nov.18. I just rescheduled my appointment, they were suppose to start me on some type of treatment, I'm not sure what kind it is.  

[Aquisi]

Hi Jenney, this is the patient information for Harvoni.
DOSAGE AND ADMINISTRATION-----------------------
 Recommended dosage: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food (2.1)
 Recommended treatment duration (2.1):
 Treatment-naïve with or without cirrhosis: 12 weeks
 Treatment-experienced without cirrhosis: 12 weeks
 Treatment-experienced with cirrhosis: 24 weeks
 A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease (2.2)

My understanding is that cirrhosis is ESLD(end stage liver disease)
Best wishes to you
Charlie
PS Magnum, you have a good attitude.

[Magnum]

Just got off the phone with my transplant doctor's assistant with this very question. She said that he is treating people with Cirrhosis with the new drug. I asked her about end stage Cirrhosis. She replied that it depends on how sick they are...

Hope this helps some. Best to talk to a Hepatologist or Transplant doctor.
Good luck...

Magnum

[Flowerchild700]

I just wondered does anyone know whether Harvoni is safe for someone with end stage cirrhosis?

Jenny

[Dee1956]

I am so happy to hear you will be getting on the new Harvoni, that is great news.
As said above, your time has come.  We will all be rooting for you, cheering you on.  I had to use a Specialty Pharmacy when on Incivek.  I think many had to use the same.  Some were still able to use their local pharmacy but not many.  In my case, Aetna had their own specialty pharmacy so I was transferred from one to the other half way through tx.
Again, really happy for you, Dee

[susan400]

You are TOOO funny.  Now a teenage girl would probably be crushed, but... o well.   I think that if you could use it, maybe the Gilead's Patient Access Network (PAN) foundation, may be able to help you?  Have you looked into it?  For me, since I am on a Medicare Advantage Part D plan, and also have my husband's prescription drug coverage.., I was told that I could choose which drug coverage I want but that I could use both under the Medicare Advantage (PPO/HMO) Part D coverage agreement.  Since the Part D coverage was so lousy and the coverage my husband's plan under Cigna was superb, I chose Cigna.  Since I wasn't using the Medicare Part D plan for the Sovaldi/Peg/Riba, I was able to use the PAN.  My husband's insurance picked up about 80% of the cost of the 3 drugs and the PAN picked up the remainder, so I ended up with a $0   co-pay.  Which for me, I was ecstatic about that.  For many of my other treatments (except for the 4 clinical trials), all the other 6 treatments had HUGE co-pays that my husband and I had to find a way to cover.  So, I did not feel guilty about having a $0 co-pay, not one bit!  Anyway, I would hope that somehow, you could get some assistance with PAN.  Susan400

[flyinlynn]

Too funny thanks for the laugh!

:-)

[Ekkiemom]

Gotta love the last paragraph, you have quite a sense of humor...God bless you and keep you strong on your new treatment. We are all here for you!
Take care Magnum :)

[Livelife777]

Very funny Magnum!
Would like to wish you well for your upcoming Tx.
Do believe its finally YOUR time to beat this Beast once and for all.
Take Care
....Kim