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Hope - treatment can work in 24 weeks with cirrhosis?!
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Hope - treatment can work in 24 weeks with cirrhosis?!

Just wanted to share some encouragement to those of you in treatment with Incivek.  My Hepatologist today told me that based on the fact that at 4 weeks I was completely UNdetectable - AND that recent studies have shown that SVR can be achieved at 24 weeks even with cirrhosis --- I might be able to stop at 24 weeks too!  We will watch the numbers as we move forward - but let me tell you since tomorrow will make my 9th week....this is very encouraging indeed!  He is the only true Hepatologist within 3 hours of us and also is a liver transplant surgeon.  He stays on top of this info and I will be grateful should it remove 24 weeks of this pure misery to find good health again.
Just something for some of you to explore with your doctors maybe.
Blessings!
29 Comments Post a Comment
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Avatar_m_tn
"AND that recent studies have shown that SVR can be achieved at 24 weeks even with cirrhosis"

Recent studies? Not sure what he is talking about, would love to see those "recent studies"....... Good luck but I for one don't agree with him.
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Avatar_m_tn

AND that recent studies have shown that SVR can be achieved at 24 weeks even with cirrhosis
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I have never seen  any study that said that.
It may very well be that if you stopped at 24 weeks you would SVR,however keep in mind it is  suggested by the prescribing information  that 48 weeks "may" be better.

If your doctor is willing to gamble this,and you wil lnot second guess your descision if in the unfortunate event you relapse ,,then it "may " be an option to stop at 24 weeks

good luck...

Will

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm

Treatment-naïve patients with cirrhosis who have undetectable HCV-RNA at weeks 4 and 12 of INCIVEK combination treatment may benefit from an additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total)

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Avatar_m_tn
I too would be apprehensive about stopping at 24 weeks.
I have never seen any convincing data supporting cirrhotics stopping at 24.

Whatever you decide - I wish you good luck.

Mike
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179856_tn?1333550962
I'm just posting to be with my boys. Sorry I haven't been here lately. Fashion week...............

I would be very apprehensive. I did 72 weeks just because I never ever wanted to do it again. And I wasnt cirrhotic.

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Avatar_f_tn
If I were you I would do more research on cirrhosis and stopping at 24 weeks.  I have to agree with the crew here. Something you really need to take a look at.  You should post this same question on the Cirrhosis Forum and see what they have to say to!

Jules

(Hey NYgirl...good to see ya :)
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223152_tn?1346981971
I too want to see those studies.

My doctor told me I could probably get away with 36 weeks tx (I am on VIC) since I was UND with a test sensitive to <2IU/mL at the second week of VIC but I chose to do 48.  It isn't that I like pain and suffering.  It is that I cannot bear the thought of doing this again.  I believe in 100% of the meds, 100% of the time and do anything to increase odds.

Hey ny --- me too -- like to post with "my boys".  I have missed you around here lately

bean
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766573_tn?1365170066
Could this possibly have anything to do with the Incivek (telaprevir) product labeling revision in June 2012? I would have to look at older material to see how it is presented. I am not treatment naive or cirrhotic so I don't really focus on that aspect of the literature.

It is this:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm309863.htm

Trial 108 (ADVANCE):
Twenty-one subjects had cirrhosis at baseline and the overall SVR in these subjects was 71% (15/21).
☞ Among subjects with cirrhosis, 43% (9/21)were assigned to 24 weeks of treatment and of those 78% (7/9)achieved SVR.

Also, on the 'complete revised label' it still says:

Treatment-naïve patients with cirrhosis who have undetectable HCV-RNA (Target Not Detected) at weeks 4 and 12 of. INCIVEK combination treatment may benefit from an additional 36 weeks of Peginterferon Alfa and Ribavirin (48 weeks total) [See clinical studies (14.2)] Study 108 Advance


In a nutshell Study 108 (ADVANCE) is this:
http://www.natap.org/2011/HCV/telap_04.htm

All treatment naive:

The 1088 enrolled subjects had a median age of 49 years (range: 18 to 69); 59% of the subjects were male; 23% had a body mass index greater than or equal to 30 kg/m2; 9% were Black; 11% were Hispanic or Latino; 77% had baseline HCV-RNA levels greater than 800,000 IU/mL;
15% had bridging fibrosis;
6% had cirrhosis;
59% had HCV genotype 1a;
and 40% had HCV genotype 1b.

However, there were small numbers of subjects enrolled in some key subgroups. In the T12/PR group:

· Twenty-one subjects had cirrhosis at baseline and the overall SVR in these subjects was 62% (13/21).
☞ Among subjects with cirrhosis, 43% (9/21) achieved an eRVR and of those 78% (7/9) achieved SVR.

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s004lbl.pdf

__________________________

The other one mentioned on the FDA Labeling Revision is Trial 111 (ILLUMINATE)

    Sixty-one (11%) of subjects had cirrhosis at baseline. Among subjects with cirrhosis, 30 (49%) achieved an eRVR: 18 were randomized to T12/PR24 and 12 to T12/PR48.

Not sure I like the odds on this one:
☞ The SVR rates were 61% (11/18) for the T12/PR24 group and 92% (11/12) for the T12/PR48 group.
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Avatar_m_tn
I believe it is true with Incivik. I also had a Hepatologist tell me basically the same thing.  4 week test is the key. If Und at 4,8,12,16 then 24 weeks has same SVR results as 48 weeks. Only difference is your body doesn't take a beating from the harsh drugs for additional 24 weeks.

There may be benefit besides SVR to someone with cirrhosis extending beyond 24 weeks. Interferon can give the liver a much needed break. Sometimes even regressing the liver damage.
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Avatar_m_tn
"There may be benefit besides SVR to someone with cirrhosis extending beyond 24 weeks. Interferon can give the liver a much needed break. Sometimes even regressing the liver damage."

What??? Oh my
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Avatar_f_tn
Thank you copyman for your posting - for a minute there I was thinking my DH and I must have heard him wrong.  Yes, obviously if I am walking through treatment as a normal human at week 24 I could not imagine why I would choose to stop.  In the meantime - I gives me hope to take it now day by day as all I want is to get out of the bed once in a while.

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Avatar_m_tn
the following is from the Incivek (telaprevir) product labeling revision in June 2012. seems like it would be hard for a doc who knows their patient has cirrhosis to recommend less than 48 weeks. however,  i was told by a reliable source that 24 weeks is the practice with cirrhotics in Europe who are UND at week 4 and 12. anyone else hear this?

Treatment-naïve patients with cirrhosis who have undetectable HCV RNA (Target Not Detected) at weeks 4 and 12 of INCIVEK combination treatment may benefit from an additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total) [see Clinical Studies (14.2)].

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s004lbl.pdf?source=govdelivery

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Avatar_f_tn
Thanks for all the info as always - you are the fruit bowl of knowledge my friends.
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190885_tn?1333029491
you should feel a lot better mentally post incivek....make sure not to miss any incivek....tx will be way more tolerable after the pl...having bad symptoms can be good in the long run...hang in there....billy
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Avatar_m_tn
Since there is a risk for those of us with cirrhosis to even do treatment and causing our liver to become worse what makes you think that a doctor would extend treatment past SVR to improve our livers, sorry but interferon is NOT a friend of ours in no way. SVR yes.

Grammy best to you in whatever you decide, its your life and your decision.
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1280753_tn?1367761532
i was told the same thing; 48 weeks. i started tx with incivek...wow let's see....6 days ago...wooohoo only 47.1428571 weeks left..( i had to use a calculator and i still think i got it wrong )....since i am a responder/relapser, i couldn't imagine not doing the full 48, being that i am stage 4. good luck
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Avatar_m_tn
Yes interferon could be detrimental to some with cirrhosis but when there is no other options interferon can give the liver a break. Of course being closely monitored by a doc that has treated many liver patients (preferably a Hepatologist)

There has even been cases of the patient regressing in liver damage after several months on a maintenance dose of INF.

I'm an advocate of shorter treatments unless absolutely necessary. Cirrhotics are one example who may need longer TX. But not all of them.
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Avatar_f_tn
There have been studies done that clearly show (I don't have them on file so can't provide them at this time) that treatment of HCV compensated cirrhosis with a regimen of low-dose pegylated interferon monotherapy is no longer considered an efficient mode of therapy in slowing down the progression of cirrhosis.  In other words, currently most hepatologists have thrown maintenance interferon for cirrhotics out the window like they did  extending SOC to 72 wks because there was minimal or no benefit. They just don't do it anymore.

The bottom line in all this is Grammy A needs to do 48 wks because that treatment duration provides optimal results for those with cirrhosis.  
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317787_tn?1373214989
Hi I was a previous relapser with the beginning of cirrhosis in 2008
When I was starting the tx ins Sept 2011 Incivek, Peg, Riba my doc said that as long as I was UND at 4 and 12 weeks he would have me do 24 weeks.
I am now 7 months post tx and am SVR

The literature on Incivek said prior relapsers would do 24 weeks and that an additional 24 weeks "MAY" help people with cirrhosis.

I wish you the best.
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317787_tn?1373214989
me again, read everyone else's replies and wanted to say that in addition to the above that I wrote

My doctor said that he was not putting my liver through an additional 24 weeks of tx if it wasn't necessary.
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Avatar_f_tn
THANK YOU!!!!!
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1084115_tn?1385232189
what is with partial resonders to soc with cirrhosis who were UND at week 4?

my doc wanted me doing 48 weeks because i was a partial responder to soc with begiing of cirrhosis.
i was UND at week 4(now in week 41,and the week 40 pcr was still UND).but i wanted to be on the safe side thats why iam with my docs opinion to do 48 weeks instead of 24.
iam from europe..
i think it would drive me crazy if i did 24 weeks and then relapsed..
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1084115_tn?1385232189
what i wanted to ask is,i am a prior partial responders and not treatment naive.
thats why iam doing 48 weeks.
do you people think i could have stopped also at 24 weeks,because i was UND at week 4?
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Avatar_f_tn
That's the thing rex, treatment is brutal and we only want to do it one time.  The key is what provides "optimal" results.  Of course there will always be cirrhotics who are are lucky enough to SVR after 24 weeks but I've seen a number of them who have relapsed after 24 wks with Incivek.  It all boils down to whether you're willing to take a chance.  eRVR is no guarantee of SVR, under the best of circumstances.  
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1084115_tn?1385232189
so you think iam not wrong doing 48 weeks?
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Avatar_f_tn
I don't view it in the context of right or wrong which as why I keep referring to the word "optimal".  As a cirrhotic, that data shows that optimally treated patients have the best chance of SVR.
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Avatar_m_tn
The " optimal chance " as corragio so  correctly puts it  is the only way to view the treatment time frame  IMO.

If a chirrotic happens to relapse then the hope is only that "Big Pharma " can outrace the fibrosis progression with something newer and better. This may still be years away.  For the sake of doing the full prescribed suggested regime is this worth the risk?

Every one needs to weight that individually....

Will
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Avatar_f_tn
My husband had treated 2X before, was a partial responder, and has beginning Cirrhosis.  His hepatologist, who practices at a large transplant center/research university, said "We know you will be doing 48 weeks" when she started him on triple tx with Incivek.  We understood this to be due to the fact that he has Cirrhosis.
Advocate1955
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1084115_tn?1385232189
My point is,do 48 weeks treatment more damage to the liver than 24?  i still think that when i can minimize the risk of relapse with 48 weeks then 48 weeks is optimal for me.
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317787_tn?1373214989
Hi thanks for that information.  I noticed that the June 2012 wording has changed, it used to say (in regards to tx naive and prior replapsers) that an additional 36 weeks (after 4 and 12 weeks UND) may benefit.

Now it says "tx naive with cirrhosis may benefit" so I would think that information is changing faster then company can keep up with.

I am SVR after doing 24 weeks and did what my doctor told me to do.  I think that is the key.
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