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13495566 tn?1431029924

HARVONI package insert ?

Does anybody have the package insert that comes with HARVONI- section 8.7 -says not proven to  help cirrhosis. That is one of my denial reasons--I don't know if it says that. Trying to find out.
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683231 tn?1467323017
With decompensated cirrhosis stopping any additional progression from hep c is of utmost importance.

If you should end up needing a liver transplant at least you won't have hep c to attack your new liver. I have seen the statement that hep c post transplant can come "roaring back with a vengeance" to attack your new liver. Some have cirrhosis again as soon as 5 years post transplant.

Harvoni does not cure liver disease it can cure hepatitis c. Liver transplant does not cure hepatitis c but will replace a failing liver with a new healthy organ.

Good luck
Lynn
Helpful - 0
13495566 tn?1431029924
thanks for DR. name --I just tried for a referral  to a different DR. in same office they denied me. I will call  this DR. and see what they say.  
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Avatar universal
From what I gather there are a few holes here. One is that you don't have confidence in the doc you are about to see. I say get an appointment with Dr Flora at Oregon Clinic Gateway and they'll set you up. He's known nationally and is on the front lines. He takes your insurance. He's a Gastro and has one of the top teams in the nation helping people clear from HCV.
Get your PCP (primary care physician) to give you a referral if it's required by Insurance.
Helpful - 0
13495566 tn?1431029924
I have had hep 44 years no problems-  drank all those years regularly-had gallbladder  problems that's where all this started. think I have alcohol cirrhosis not HEP C cirrhosis--don't know enough. Doctors here are not up on it.
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13495566 tn?1431029924
The doctor in Florida said decompensated .  The one that tried to give me interferion- don't have her papers anymore. Doctors here said ct scan showed  acities and irregular cirrhotic contour of liver-nodularity and increased echogenicity of liver--EGD showed esophageal  varices-- One of my primary P.A. requested  Harvorni --the hepatoligst said nothing just went with it-I was hoping she would say if it was right or wrong--all she said I was bad off. Ordered no blood tests. I see her again June 4 --Not sure what ask her? Hopefully she is better this time.
Helpful - 0
13495566 tn?1431029924
I had my gallbladder removed DR. said he saw cirrhosis on my liver-5 years ago --3 years ago I swelled up--  emergency said acities got spirolatone-i have been on it since--stop 6 months ago to see what would happen --started to retain fluid quickly--had lots cbc tests  last 10 years-. had high alt and ast numbers quit drinking 5 yrs ago numbers are now low. Always had low platelets.  ALT 18--AST 40--creatinine1.01-bun/crea ratio 13.9. albumin 3--globulin 2.5-total bilirubin total 0.9==ptl 69--. I have had four primarys in one year..went to Hepatolist one appointment--she said  I was bad off -order ultra sound--ct scan-  enlarge spleen- mild acities--specialist  appointments 6 months apart- that's all get. Don't know any of those other tests.
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2059648 tn?1439766665
Ready=Reading.    Push post and it changes what you typed.  

Best to you
Helpful - 0
2059648 tn?1439766665
Ready back through your posts you stated you have "decompensated" cirrhosis.   I agree with JimmyMose.   More info is needed to offer a non-medical opinion.  

http://www.aidsmap.com/Sofosbuvir-based-therapy-effective-for-hepatitis-C-patients-with-decompensated-cirrhosis/page/2967397/
Helpful - 0
Avatar universal
Do you know or have you ask your doctor what your METAVIR F score is Stage F0 up to F4 and Grade 0-4 or A0 to A3?
Ask what tests were the basis of this diagnosis
blood results indirect markers, examination, biopsy, Ultrasound:
If F4  What is your (CTP) classification A, B, or C

Have you had any of these Blood test within the few months  If so please post them or ask for them.
Alanine transaminase (ALT)
Alanine transaminase (ALT)
Platelet count
Creatinine (µmol/L)
Total bilirubin (µmol/L)
Serum albumin (g/L)
Prothrombin time/international normalized ratio (INR)
Do any other blood test items show high or low out of the reference range?

You mentioned you had Ascites in the Cirrhosis of the Liver Community link in prior reply

Do you currently have or have ask doctor
Ascites None, Mild or Moderate to Severe
Hepatic encephalopathy None,  Grade I–II (or suppressed with medication) or Grade III–IV (or refractory)

With correct answers some maybe be better able to offer their non-medical opinon
Helpful - 0
2059648 tn?1439766665
Hope the above is helpful
Helpful - 0
2059648 tn?1439766665
If you do have cirrhosis and Hepatitis C then you are at the top of the list for treatment.  Below is a link to whom treatment is afforded.

http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy

By everything that you have said on this thread and another it sounds like you don't have cirrhosis.  It sounds like your have fibrosis of the liver.  If that is true then its a very good chance your are being denied treatment.  

What exactly is your test results that confirmed you have cirrhosis?  Are you currently drinking alcohol?  Apparently, some insurance companies
are testing for drugs and alcohol before treatment.  

How this is helpful
Helpful - 0
13495566 tn?1431029924
I know I have to treat HEP C. I would like to do it the right way the first time. I am seeing a Hepatoligst--the only one that I can see though Oregon health care --I have requested a different one  and was denied. How experienced she is I do not know-- these meds. is another thing that does not seem right. Also on tests  they say I do not need. That I read, I should have.  But are denied. They say I am not sick enough for HEP C treatment. That my problem is (manageable) cirrhosis. And can be treated with diet and diaretics.  In Florida When I was diagnosed  5 years ago they try to give me Interferion for free. And tried to scare me into it. I refused. And I think that was the right choice. So I am unsure now what to believe.
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Avatar universal
Of course it's proven by the HCV general population who's cirrhosis has stopped progressing, after being treated to eradicate the virus and staying svr. I know the Insurance Company is going by medical codes for approvals. You didn't fit the code. You might want to find out the correct medical code and go from there. Call the Insurance company to find out what's missing on the request for approval. Sometimes not everyone of the docs team and the Insurance Co are on the same page. It sounds like someone mislabeled it-goofed by labeling the treatment as something for cirrhosis though it's actually for killing the deadly HCV virus, which is where the focus should be. Cirrhosis is an aside and has little to do with killing the virus through treatment. Don't give up. Keep going. There is an even newer cocktail that is having great success. It's in trial now. Your day will come. I hope it's soon.
Helpful - 0
Avatar universal
section 8.7
Safety and efficacy of HARVONI have not been established in patients with decompensated cirrhosis.  

I read your post mentioning Ascites
http://www.medhelp.org/posts/Cirrhosis-of-the-Liver/hep-c-and-cirrhosis-/show/2572232

What type of doctor has prescribed Harrvoni? You should be seeing a gastroenterologist /hepatoligst experienced in decompensated cirrhosis preferably in a liver transport center   Have you been told Child Turcotte Pugh (CTP) classification of the severity of cirrhosis  Ascites would indicate Class B or C  Do you have a MELD score?

A a gastroenterologist /hepatoligst experienced in HCV treatment with decompensated cirrhosis can best decide if Harvoni may benefit you and present the best reasons to insurance.

Best wishes for getting treatment and the best outcome .

These links will provide info on HCV treatment with decompensated cirrhosis
http://hepatitiscnewdrugs.blogspot.com/2015/04/hepatitisgileads-harvoni-and-sovaldi.html

AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C.

http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-decompensated-cirrhosis
accessed May 17, 2015

Patients with HCV genotype 1 or 4 with decompensated cirrhosis (moderate or severe hepatic impairment; Child Turcotte Pugh [CTP] class B or C) should be referred to a medical practitioner with expertise in that condition (ideally in a liver transplant center).
Rating: Class I, Level C

Recommended regimen for patients with decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C) who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma. This regimen should be used only by highly experienced HCV practitioners.
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) and RBV (initial dose of 600 mg, increased as tolerated) for 12 weeks is recommended for patients with decompensated cirrhosis.

Rating: Class IIb, Level C

For patients with decompensated cirrhosis and anemia or RBV intolerance, daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended.

Rating: Class IIb, Level C
Helpful - 0
6708370 tn?1471490210
Here it is:

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

If you do not address your Hep C, your liver disease will worsen. That is just common fact

http://hepc.liverfoundation.org/what-is-hepatitis-c/what-can-happen-complications-of-hep-c/
Helpful - 0
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