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Author Topic: Dosage for Harvoni  (Read 9802 times)

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Offline garyc

  • Member
  • Posts: 14
  • geno 1a Interferon/Rib in 2010 Failed Cirrhosis-4
Dosage for Harvoni
« on: June 16, 2015, 04:27:40 pm »
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
Have a blessed day. gpc

Offline dragonslayer

  • Member
  • Posts: 873
Re: Dosage for Harvoni
« Reply #1 on: June 16, 2015, 06:52:18 pm »
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?
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline garyc

  • Member
  • Posts: 14
  • geno 1a Interferon/Rib in 2010 Failed Cirrhosis-4
Re: Dosage for Harvoni
« Reply #2 on: June 16, 2015, 10:37:45 pm »
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. 
Have a blessed day. gpc

Offline KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: Dosage for Harvoni
« Reply #3 on: June 17, 2015, 01:27:34 am »
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
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline garyc

  • Member
  • Posts: 14
  • geno 1a Interferon/Rib in 2010 Failed Cirrhosis-4
Re: Dosage for Harvoni
« Reply #4 on: June 17, 2015, 01:49:43 am »
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
Have a blessed day. gpc

Offline KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: Dosage for Harvoni
« Reply #5 on: June 17, 2015, 02:07:55 am »
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 :)
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Dosage for Harvoni
« Reply #6 on: June 17, 2015, 02:49:42 am »
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
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline Debula

  • Member
  • Posts: 257
  • "Your body hears everything your mind says"
Re: Dosage for Harvoni
« Reply #7 on: June 17, 2015, 04:31:51 pm »
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
80's DX: NonA,B
Non responder to Interferon
3/6/2015-GT 1a
VL-1920000 IU/mL
FibroSURE: Fibrosis stage F4 (0.79)
                  Necroinflammat activity A3 Severe (0.75)
AST 88,  ALT 120, Platelets 73
4/16/2015-Started Harvoni (24 weeks)
5/13/2015-4 weeks AST 26, ALT 36 
5/22/2015-5 weeks  VL UND
6/17/2015-9 weeks  VL UND AST 28 ALT 40
7/31/2015-15 weeks VL UND AST 27 ALT 39
9/22 Diagnosed with HCC
10/1-EOT
10/29-SVR4
12/23-SVR12
I AM HEPC FREE! :)

 


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