DENIED AGAIN

[m13m]

My appeal was denied again --saying Harvoni does not help people with decompensated cirrhosis. I have HEP C type 1a and cirrhosis and acities .
I ask for treatment for HEP C , my Dr. said I need it.  They say I don't.  Welcome to Oregon. Hopefully Gilead will approve me.
  Did not have question.  Just need a place to get it out.

[flyinlynn]

Ok here are the recommendations from the AASLD for patients with decompensated cirrhosis

http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-decompensated-cirrhosis

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

For patients with decompensated cirrhosis in whom prior sofosbuvir-based treatment has failed, daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) and RBV (initial dose of 600 mg, increased as tolerated) for 24 weeks is an alternative regimen.

[flyinlynn]

I just finished 24 weeks of Harvoni and added Ribavirin later so 15 weeks of that.

I am GT 1a 3 time null responder to interferon based tx and relapsed last year after treating for 12 weeks with Sovaldi / Olysio. I was diagnosed with cirrhosis in 01/08 and have portal hypertension and have had esophageal varicies handed in 2012. Still considered compensated MELD 7 Child "A".

Saying all this because your insurance is full of BULL you need Harvoni worse than anyone you should be at the top of the list!!

As Pooh posted above the recommendations for a patient with cirrhosis is Harvoni and you have good odds of a cure. My insurance treated me your insurance needs to treat you.

Gurrrrr so angry right now

Good luck keep fighting!
Lynn

[m13m]

Thanks everyone  for the info. and the feelings that always  helps!

[hepcandme]

I am so sorry that you are having to deal with this

I hope it is resolved in your favor soon

[pooh55811]

I am sorry you are having to go through all of this. There is no excuse for them denying you treatment. I hope you can get help through Gilead.


From Clinical Care Options:

"Current AASLD/IDSA guidance recommendations for patients with decompensated cirrhosis strongly emphasize that an experienced HCV infection practitioner should be involved in providing therapy, ideally in a liver transplant center, as these patients tend to become ill quickly and therapy is not guaranteed to salvage them from potential complications.[1] Interferon is contraindicated in decompensated cirrhotics for safety reasons, and telaprevir and boceprevir have been shown in the TARGET and CUPIC studies to be very difficult to use in a decompensated cirrhosis population.[10,11]

For genotype 1 and 4 HCV–infected individuals, current data support use of the combination of ledipasvir/sofosbuvir and ribavirin for 12 weeks with possible extension to 24 weeks in the case of previous sofosbuvir failure. Use of ledipasvir/sofosbuvir for 24 weeks is advocated in patients with anemia or a history of ribavirin intolerance. "


SOLAR-1: Ledipasvir/Sofosbuvir With Ribavirin in Patients With Decompensated Cirrhosis

"Earlier studies with decompensated cirrhotic patients used sofosbuvir plus ribavirin for a year and showed that this regimen is tolerable and can improve clinical parameters in this fragile population.[12] However, this regimen is not currently advocated in patients with genotype 1 HCV infection since ledipasvir/sofosbuvir in combination with ribavirin also shows high efficacy in this population. The SOLAR-1 trial investigated the efficacy of 12 or 24 weeks of ledipasvir/sofosbuvir with ribavirin in patients with decompensated cirrhosis.[13]

It is important to note that the initial ribavirin dose is different in a patient with decompensated cirrhosis than it is in one with compensated cirrhosis or no cirrhosis at all. All patients in this study were started at 600 mg ribavirin daily and increased as tolerated to a weight-based dose. Another important element of the SOLAR-1 study design is that patients were stratified by the degree of hepatic impairment as denoted by a CTP score of B or C. Patients with a CTP score of C are at very high risk for clinical decompensation and life-threatening complications.

The most striking result of this trial was a surprisingly high efficacy regardless of duration of treatment. The overall SVR12 rate was 87% with 12 weeks of therapy and 89% with 24 weeks, which are higher than expected for a decompensated population. Efficacy did not vary significantly by CTP score B or C. Subjects with a CTP score of C did have a numerically higher SVR12 rate of 90% after 24 weeks of treatment compared with 86% after 12 weeks of treatment, but a careful look reveals that this was driven not by relapse but by clinical consequences in a relatively small sample, with 1 relapse and 1 death in each arm. This patient population experienced a high rate of adverse events (AEs), but few were treatment-related severe AEs and very few patients discontinued therapy due to AEs. "

[jules2551]

Understand totally I am in the same boat.  Gilead is fighting my insurance company to get them to pay.  Hang in there I know it's frustrating

Jules