Olysio +Sovaldi for stage 4 cirrhosis patients

[glair]

I have had Hep C since 1973, gone through 3 tx the last one being the triple tx about 3 years ago. I had such an adverse reaction to either the ribavirin or interferon that I had to discontinue after one week and was in the hospital for 3-4 days.
I'm excited about the new tx with Olysio and Sovaldi but was turned down by Medicare because I have compensated cirrhosis and they say these drugs have not been approved to treat that stage of cirrhosis. I have appealed but again was turned down.
Has anyone else on the Forum had this experience? My doctor seems to think that by 2015 the FDA will approve this treatment for my condition. Any feedback would be appreciated. Thanks

[glair]

Thanks to all of you for your responses to my question. My doctor is a hepatologist with the University of Alabama @ Birmingham (UAB) Medical Center. I trust his judgment in these as he has been involved in several of the experimental treatments.
I have BC/BS secondary insurance and it may be that they are part of the problem although the denial letters I have received have been from Medicare Generation.
I am genotype 1a and don't think I have been tested for the Q80k mutation. This is the first I've heard of it. I've been on the liver transplant list for several years now but my MELD scores are not high enough for the transplant. My score fluctuates between 18-13.
I copied some of the research you mentioned in your posts and have forwarded that to my doctor.
Thanks,
George

[Sarah1949]

I have cirrhosis and was just recently approved for Sovaldi but denied for Olysio because I had not tested for q80k. I have Original Medicare with Express Scripts in Oregon. I'm still waiting for my q80k test results before appealing.
Good luck!

[HectorSF]

The only reason you have been turn down must be your doctor's office doesn't know how to correctly apply for approval for S/O. Having cirrhosis you should not be forced to use a lesser effective treatment especially one that has interferon in it. Interferon is known to have the potential of causing decompensation or even liver failure.
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June 4, 2014

Medicare Backs Off Restrictions Against Sovaldi/Olysio for Hep C
Reversing a previous stance, Medicare is now adhering to guidelines recommending Sovaldi (sofosbuvir) and Olysio (simeprevir) combination treatment for people with genotype 1 of hepatitis C, allowing for reimbursement of the pricey therapy, NPR.com reports. Medicare changed its policy based upon an Arizona resident named Walter Bianco who has been living with the virus for four decades and who has significant liver damage, yet who was twice denied Medicare coverage for the Sovaldi/Olysio combination therapy.

In January, the American Association for the Study of Liver Diseases (AASLD) recommended 12 weeks of Sovaldi and Olysio plus ribavirin for those with genotype 1 of hep C who are ineligible to take interferon (which many argue includes those who simply do not want to take the injectable interferon and experience its onerous side effects). While this combination has not yet been approved by the U.S. Food and Drug Administration—an application is pending—Sean Cavanaugh, deputy administrator of the Centers for Medicare and Medicaid Services, said in a statement that Medicare would now follow the AASLD guidelines."
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Call your nearest liver transplant center and ask to be referred to a local gastroenterologist or hepatologist who is aware of the latest treatments and how to get insurance approval for patients with cirrhosis who are most in need of treatment.

You also need to be tested if you are genotype 1a for the Q80k mutation. Note this treatment has never been tested in anyone who treated with a Protease inhibitor.
The SVR rate for cirrhotics was 86% Simeprevir/Sofosbuvir and 91% for Simeprevir/Sofosbuvir + Ribavirin in the COSMOS trials.
Regardless will treating no further damage will be done to your liver during the 8 or so weeks you are undetectable. In the worse case your liver disease won't have gotten worse and there will be new and better treatment available if you should relapse after treating.

Waiting for new treatments to be available in November or December you run the risk of decompensation and irreversible liver damage that will result in the need for a liver transplant with or without an active hepatitis C. All people infected with hep C that are on liver transplant waiting lists who are healthy enough are treating now. Don't be one of the last people that waited too long to treat there hep C and as a result need to be transplanted.

If not this treatment then do the Sovaldi + ribavirin for 24 weeks to stop further damage to your liver.
Get treated now and keep your own parts (liver).

Good luck!
Hector

[flyinlynn]

Hi again

I just noticed you did triple therapy with either telaprevir or boceprevir I would assume.

That could be the problem

from the AASLD guidelines

A recommendation for simeprevir use for patients with previous telaprevir or boceprevir exposure not provided due to potential risk of preexistant resistance to protease inhibitor treatment.

The good news is there are new meds to be released later this year. One of them is Sovaldi combined with Ledipasvir in a single dose combo pill. It is supposed to be approved by October 10th and should be available a month or 2 later. They have been having great results with this medicine.

If you are still compensated you hopefully will have enough time for the newest meds. But as you have cirrhosis time is very important. Others here will know more than me about what triple therapy non responder options are regarding Sovaldi Olysio.

I never had telaprevir or boceprevir as by the time it became available I already had cirrhosis. Being a 3 time null responder my doctor felt the risk of decompensation was greater then the odds of the treatment working for me.

Lynn

[flyinlynn]

Hi Glair

Is you doctor a hepatologist or at least a gastroenterologist experienced with hep C patients because from what you said he does not sound like he is up to date with the current treatment

I would try to get incontact with a human at medicare that does not sound correct at all!

Many or us here have treaten with Sovaldi Olysio who have cirrhosis including myself but my coverage was through my insurance at work.

Many here were initially turned down usually there is a form that needs to be faxed with answers from your doctor and that is generally what has been the problem.

Here is a link to the prescribing information for Sovaldi followed by some selected excerpts

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

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

*SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection

Also the current Recommendations for Testing, Managing,
and Treating Hepatitis C by the American Association for the Study of Liver Diseases AASLD

Note: Sovaldi=sofosbuvir Olysio=simeprevir
http://www.hcvguidelines.org/sites/default/files/full_report.pdf

Recommended regimen for HCV genotype 1 PEG/RBV (without an HCV protease inhibitor) nonresponder patients:

Daily sofosbuvir (400 mg) plus simeprevir (150 mg), with or without weight-based RBV (1000 mg [<75
kg] to 1200 mg [≥75 kg]) for 12 weeks is recommended for retreatment of HCV genotype 1 infection,
regardless of subtype or IFN eligibility

Treatment-naive patients with compensated cirrhosis, including those with hepatocellular carcinoma,
should receive the same treatment as recommended for patients without cirrhosis.

Have a read of this material and have a conversation with your doctor

Good luck
Lynn