Dosage for Harvoni

[garyc]

61 yrs old
VL 10.5 million
Cirrhosis Stage 4
Genotype 1a
2010 Txt with 48 wks of  Interferon/Rib-NonResponder

Thank God I finally start Harvoni tomorrow. I am so thankful because I really had to fight for this - 2 insurance companies denied me and I finALLY WENT ON STATE INsurance (Medicaid) because paying over $1,000 a month for private insurance became impossible. I was originally denied by Oregon medicaid but I rec'd a letter from Oregon Health Plan (OHP)following last denial saying they had switched me to what is called Open OHP which means I will have a disease manager for special needs. The next day I rec'd approval and tomorrow I start 12 wks of Harvoni plus Ribaviran.  I am very grateful but apprehensive because the Harvoni web site says a person with genotype 1a with cirrhosis and prior txt should be prescribed 24 wks of Harvoni. When I asked my Gastroenterologist's nurse (just this morning) she said she never heard of anyone  receiving an extension for Harvoni and she has NEVER heard of anyone on 24 wks of Harvoni. I find that hard to believe as the dosage and administration guidelines from Gilead call for 24 wks for geno 1a, with cirrhosis and prior txt.  Anyone know anything about this? Has anyone been 1a, cirrhosis 4 and have prior txt and been prescribed only 12 wks of Harvoni.  Can anyone give me some feedback? I am worried 12 wks is not enough.  Thanks garyc

[dragonslayer]

Gary, what was your prior treatment?  Generally, treatment experienced plus cirrhosis  gets 24 wks.. . But youre getting Harvoni Plus Ribavirin.  Do they see thats as a way to shorten your treatment?

[garyc]

Thanks for the response. I had interferon and ribaviran and vl went from 9 million to 2,000 but was back up in months. I have no idea why they are only giving me 12 wks. I was surprised. I know my insurance has its own dosage and admin  guidelines that have 8 wks for trxt naive with no cirrhosis and 12 wks for txt naive with cirrhosis and 12 wks for prior txt with cirrhosis  (they have a note that says a 16 wk. extension can be applied for)  but the pharmacist and gastroenterologist's nurse both said they have never heard of anyone getting an extension. I don't know what they are doing.  I am suppose to take 1 Harvoni per day plus 3 ribaviran. I am calling the dr. tomorrow but there is no way I will get to talk to him but I will try the nurse again. I am quite concerned as this is my shot at getting rid of this disease. I can't see insurance paying for txt with something else, if this doesn't work. 

[KimInTheForest]

Is 3 riba a day ALL the riba you will be taking, gary? Because that is low. The standard (depending on your weight) would be 5 or 6 riba a day - 3 with the harvoni and then a 2nd dose of 2-3 riba later. I have heard some Drs say that just 3 riba a day (600 mg) is a sub-therapeutic dose (i.e., it may not have any effect).

kim

[garyc]

Thanks for your info. I am definitely going to contact everyone, dr., pharmacy, and gilead if needed. This is too important to not have the absolute maximum chance of success and in all the info I have read 24 wks of harvoni gives me that.  You are correct. I just read the bottle and it says 3 riba in morning and 3 in evening. In the middle I take 1 harvoni. thanks garyc

[KimInTheForest]

Hi Gary. Riba keeps some people awake at night (me for example). That problem went away when I moved my 2nd riba dosage up to 4 pm on the advice of my trial nurse. She said the timing of riba is very flexible and it doesn't really matter when in the day we take it, so long as we get the right quantity down the hatch somewhere in each 24-hour cycle. Harvoni does need to be taken at roughly the same time every day. Some people go with mornings (my preference because of the energy boost it gives me), others go with evenings.

Good luck. Sounds like you are doing all the right things to get approved the the duration that will be best for you.

best,
kim

[Lynn K]

Hi Gary

The treatment is normally either 24 weeks of Harvoni or as an option 12 weeks of Harvoni plus Ribavirin for treatment experienced with cirrhosis.

Per the Recommendations for Testing, Managing, and Treating Hepatitis C published by the American Association for the Study of Liver Diseases (AASLD)

http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed

Recommended regimens for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.

Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.

Rating: Class I, Level A

Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 12 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.

Rating: Class I, Level B

In the population with cirrhosis, patients treated for 24 weeks had higher SVR rates than those treated for 12 weeks, supporting the recommendation that HCV treatment–experienced patients with cirrhosis receive 24 weeks of treatment without RBV.

For ION 2 clinical trial results see

https://depts.washington.edu/hepstudy/presentations/uploads/121/ion2ledipasvir_sofosbuvir.pdf


I am a 3 time null responder to interferon based treatment. I relapsed last year after taking Sovaldi and Olysio for 12 weeks. I was diagnosed with liver biopsy with F4 cirrhosis in Jan 2008. I was Child A was Meld 8 but now MELD 7. Compensated cirrhosis low platelet count (90) and had esophageal varicies banded in 2012

I finished 24 weeks of Harvoni and 15 weeks of Ribavirin on May 4th and my 4 week post treatment result on  June 1st was not detected.

Waiting for the big 12 week post test on July 28th to see if I am cured.

Good luck
Lynn

[Debula]

Hi Gary
Lynn basically said it all in her post

I am at stage 4 cirrhosis also and they put me on 24 weeks of Harvoni (no Riba)
So far after 5 weeks of Harvoni the virus is undetected
My understanding was either 12 weeks harvoni with Riba or 24 weeks Harvoni only
My insurance approved 24 weeks Harvoni so that is what I went with

Good luck to you!
Deb