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Steve76


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Okay, they are going to give me 12 weeks of Harvoni Plus Ribavirin.  Not sure how I feel about this,  really would like to get the standard treatment.

 

I found this study that wasn't so optimistic when treating f4 with Harvoni/Ribavirin for 12 weeks.  ION 2 Study

 

High SVR12 rates were also observed in patients with and without cirrhosis for both the 12 and 24-week treatment groups. In treatment-experienced patients with cirrhosis, the SVR12 rates were numerically lower in the 12-week groups with values of 86.4% with Harvoni and 81.8% with Harvoni + RBV when compared to the 24-week treatment groups who reported SVR12 of 100.0%. In the non-cirrhotic groups, the 12 and 24-week treatment groups, in the presence and absence of RBV, all produced high SVR12 rates (95 to 100%). The SVR rates in cirrhotic and non-cirrhotic patients who previously failed treatment with PegIFN/RBV or PI + PegINF/RBV were similar to the overall SVR12 of Harvoni 12-and 24-Week treatment duration in the presence and absence of RBV.

Although the addition of RBV to the Harvoni regimen did not enhance the observed SVR12 rate in both non-cirrhotic and cirrhotic patients, the extension of treatment duration of Harvoni from 12 to 24 weeks had a modest increase in non-cirrhotics and a numerically more significant increase in the cirrhotic group [for example (e.g.) increased from 86% to 100%]. On the basis of these results, a 24-week treatment duration was therefore recommended in the Harvoni Product Monograph for treatment-experienced cirrhotic patients in the absence of RBV.

 

I suspect this push to use 12 weeks harvoni/ribavirin is about cost rather than real results.  Unfortunately I have a fight on my hands now.

Link below.

  Here is the link,  http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2015_harvoni_173180-eng.php

 

Really base on this I might a well just do 12 weeks Harvoni and forget about Ribavirin.  I see some Insurers are pushing this now, but it is really irresponsible and driven by profits IMO.

 

 



-- Edited by Steve76 on Monday 5th of October 2015 05:25:37 PM



-- Edited by Steve76 on Monday 5th of October 2015 06:13:21 PM

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Groupergetter


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Welcome Steve,  from another who has been through some of what you are experiencing.  This is a great forum.  Take some time to read through threads, lot's of good info and shared knowledge.  Whatever happens with the length of your tx, hoping you find SVR.



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.
Cinnamon Girl


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Hi Gracie, RAVs (Resistance Associated Variants) are mutations in the Hep C virus which become resistant to certain drugs.   Malcolm did a post on NS-5A RAVs, you might find it helpful to have a read through this thread...

http://hepcfriends.activeboard.com/t59321988/ravs-at-the-ns-5-site/A

 

Hi Steve, welcome from me too, glad to have you here.

Wishing you the best of luck with this, I also agree that 24 weeks would be a more suitable treatment duration for you  You want to have the best possible chance of a successful outcome.



-- Edited by Cinnamon Girl on Monday 5th of October 2015 12:57:21 PM

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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Gracie


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What causes the NS5A Ravs? 

 



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  1. Gracie

1A. Previously treated non responder Rebetron in 2000 And Incevik in 2014 with a breakthrough at week 12. Fibroscan 15.5. VL 6,000,000. Finished 24 weeks harvoni on Dec. 19, 2015. SVR. Latest Fibroscan 8.8.
Tig


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You're correct Matt, I should've used a better explanation regarding the RAV's that may present following Tx failure. I recall now a discussion we had recently on this. I believe there is definitely fuel for thought on long term NS5A RAV's in the sector of patients that actually fail as a result of those 5A RAV's. Which leads me to wonder, why do they continue to omit pre treatment RAV screening in the majority of new DAA protocols? Costs or lack of understanding the impact they may have? As you know they were required in the trials. If they tested and found them pre treatment, then certainly, selecting a more effective protocol is the better choice or deferring treatment if nothing else is recommended or available.

With the extremely high rates of success of the current DAA treatments, if these RAV tests were performed prior to Tx and discovered (giving time to reevaluate protocol) I believe the rates of SVR would even be higher. Another consideration, I believe, is as our concern indicates, too short a treatment protocol that fails to provide satisfactory results, may be responsible in the development of some RAV's. Pre screening, proper medication and the duration of treatment would go a long way in reducing RAV induced failures. This is my interpretation and opinion only. There is so much data supporting various sides of the discussion, like all protocols before it, the proof tends to present itself well after the fact. I think great strides could be made if more attention to pre treatment RAV screening were accomplished. Thanks, good discussion!



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Matt Chris


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Hey Steve

Great to have you as a member of the forum, you have found a good place.

Being a follow cirrhotic and relapsed on a 12 weeks ABBVIE protocol in a clinical trial the 24 weeks of Harvoni IMO is the correct call.

Your doctor is the one that needs to be convinced. i am going to respectfully disagree with Tig about the ramifications if you were to relapse from RAV's. if you end up NS-3 or NS-4 Rav's no problem but if you end up with NS-5 mutations / RAV's they have been known to last many years. The good news is Abbvie has in development 2nd generation DAA''s that will address patients that have NS-5 RAV's. Abbvie will be revealing the early clinical trial data on these DAA's ABT-493 and ABT-530 in the Nov. at the AASLD convention.

Steve convince your doctor and then the insurance company should follow suit.

 

matt      



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
Tig


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Hi Steve,

Even if you failed Harvoni, the RAV's aren't long term if you develop them and treatment can be repeated without concern for resistance. The Viekira protocol is another excellent option and of course the new Sovaldi and GS 5816 due to be released is another. Merck has some offerings in the pipeline, so IF your choice is limited to 12 weeks and it's approved, I wouldn't turn it down, but insist on the addition of Riba. The rates of success at 12 weeks w/cirrhosis aren't as high as 24 obviously but still respectable, but given a choice, I'd want 24... Good luck!



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Steve76


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The mono therapy did nada, zilch, zero for me. The AASLD guidelines show INF as qualifying for being treatment experienced. The relapse rate is higher for the 12 week treatment for people like me. Failing Harvoni's 12 week treatment leaves very few options that are good. I appreciate the reply and help though, thanks.

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bubble


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Steve, The mono therapy did help lower your VL I am sure. Your an F4 like me. I did the Pegasus trip and relapsed after stopping at 46 weeks.   I am 1a. Did Vikera-pac/riba  for twelve weeks. Please post your stats. You don't need 24 IMO.



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60 yrs. Geno1b 2001. 9mil. VL. �Failed Post Riba/Peg tx. 2006 46 weeks. Diagnosed 1A 2015(?) F3 fibr. 225k VL. Vikera/Riba 12 weeks 3/20/2015. "Undetected" start to finish. Undetected 1yr post tx.
Gracie


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Yes, takes you down quite a bit. Still a good chance at approximately 86% that you would reach SVR, but with 24 weeks, its in the 90's. Try and get the 24, or if they insist on 12, ask for RIBA too, as that increases the SVR rates with 12 weeks.



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  1. Gracie

1A. Previously treated non responder Rebetron in 2000 And Incevik in 2014 with a breakthrough at week 12. Fibroscan 15.5. VL 6,000,000. Finished 24 weeks harvoni on Dec. 19, 2015. SVR. Latest Fibroscan 8.8.
mallani


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Hi and welcome Steve,

I agree you need 24 weeks of treatment. INSIST that you are NOT Rx-naive. Good luck. Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
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Hi Steve.

 I would think you qualify for 24 weeks and I don't blame you for wanting that being that your fibrosis is F4 level and previously treated with INF. Unless you doctor has another reason for only 12 weeks I would certainly discuss this further with him. He should want the added insurance against future relapse also. How long did you treat with the INF regimen? Please let us know any further information. Welcome to the forum!



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60 yo, geno 1a, Dx 1994 HCV-HIV co-inf, Dx 2013 decompensated cirrhosis
Tx #1 - 24wks Sov+Riba /SOT 7-24-2014/UND@EOT/DETECTED@EOT+16 wks
Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52 = SVR

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Tig


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Steve,

I want to add one item that will change this treatment duration from 24 weeks to 12 and that is the addition of weight based Ribavirin to the protocol. I would get this clearly explained by your physician. It could be a game changer!

 

"ION-2: In this phase 3 trial, 440 treatment-experienced patients with genotype 1 chronic hepatitis C infection, with or without cirrhosis, received a 12- or 24-week treatment with fixed- dose combination ledipasvir-sofosbuvir, with or without ribavirin. The SVR12 rate with 12 weeks of ledipasvir-sofosbuvir was 94% without ribavirin and 96% with ribavirin; with 24 weeks of therapy the SVR12 rates were 99%, with or without ribavirin. Patients with cirrhosis who received 12 weeks of therapy had lower SVR rates than patients without cirrhosis. In addition patients with cirrhosis had higher SVR rates with 24 weeks of ledipasvir-sofosbuvir than with 12 weeks (100% versus 86%)."



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Tig


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Hi Steve,

Welcome to the forum. I agree that with the information you provided, assuming you are a genotype 1A or 1B with cirrhosis (F4) and previously treated, the recommended course of treatment using Harvoni alone is 24 weeks. Some additional information on your genotype, viral load and any known lab values is helpful when providing opinions. Has your doctor discussed your available options? There are a few currently available that are very effective and new ones on the horizon. 

If we can provide any help or information, don't hesitate to ask. I'm glad you found us!

Here's the reference I used:

"Recommended regimen for Genotype 1a or 1b, with compensated cirrhosis Ledipasvir-Sofosbuvir

Fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) once daily for 24 weeks"

 http://www.hepatitisc.uw.edu/pdf/treatment-infection/treatment-genotype-1/core-concept/all

 



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Steve76


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I need help with  some information.  I was treated in 97 with mono therapy Iterferon alone, did not work. Did not try anything else...fast forward to 2015.  Heard about new treatment went through lots of test including Fibrscan (F4) Blood work normal except Alt and  AST.  Ultrasound came back normal as well. 

 

Doctor is telling me I am treatment naive even though I had Interferon mono therapy.  I am afraid I am going to get the 12 weeks rather than the 24 weeks of Harvoni.

 

The AASLD Guidelines  http://www.hcvguidelines.org/node/71  "Initial Treatment of HCV Infection includes patients with chronic hepatitis C who have not been previously treated with IFN, PEG-IFN, RBV, or any HCV direct-acting antiviral (DAA) agent, whether experimental, investigational, or US Food and Drug Administration (FDA) approved.

I am worried about getting the 12 week dosing and then relapsing,  it appears to me the 24 week course is the way to go. 

Anyone have any experience or insight thanks.

 

 



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