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Post Info TOPIC: SVR Chances - am I being misled?


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RE: SVR Chances - am I being misled?
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Thank you Mallani,

A wealth of info - I wish the medical staff I work with was this helpful!

Gary



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Genotype 3A. Failed Peg and Ribivarin about 2006. Currently UND after 1 month Sovaldi and Ribavirin.



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Hi Gary,

That's good about your AST/ALT ratio. At least you know what to look for now.

RVR is usually determined by the Phase 3 Trials. For SOC and Incivek triple, this is defined as Undetectable HCV RNA after 4 weeks of treatment. For the Victrelis triple, this is at 8 weeks. For the new DAA's, little has been said about RVR. Until advised otherwise, this should be assumed to be after 4 weeks Rx.

The SVR rates quoted to patients are usually established during Phase 3 Trials. Quite often, these are modified after practice in 'the real world'. For the Incivek and Victrelis triples, the VA published revised SVR rates, and each Hepatologist will develop his own figures, based on experience.

Cirrhosis is a histological diagnosis, based on disruption of liver architecture, fibrous bands and scars, and regenerative nodule formation. Liver biopsy will identify this. When Fibroscan was first used in 2008, patients had both a liver biopsy and a Fibroscan. This allowed the prediction of cirrhosis using the Fibroscan reading ( usually above 17 kPa). Cirrhosis also has a typical Lab. profile, mostly based on ALP, albumin, platelet count and Prothrombin time. Some Hepatologists diagnose cirrhosis, based on these findings. However, some well-compensated cirrhotics do not develop these Lab abnormalities. Depending on a number of factors, patients can live a normal life with compensated cirrhosis for many years. However, it is progressive, and unless the cause ( in our case HCV) is removed, decompensated cirrhosis or HCC will eventually develop.

Re your question about Rx-experienced patients. This mostly applied to previous Interferon treatments. If you had previous SOC and were a non-responder, your SVR chances were less. If a partial responder, SVR chances were better. If a responder but relapser, chances of SVR were better still, and close to the Rx-naive rates. These days, with the new DAA's and Interferon-free, I don't think it makes much difference. 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 LTChaos,

Thanks for sharing this. I think one of the Gurus said at this point it would not be indicated for me. But I am sure others will find your info useful, thanks for posting!

Gary



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Genotype 3A. Failed Peg and Ribivarin about 2006. Currently UND after 1 month Sovaldi and Ribavirin.



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Gary, Are you close to Canada?  I found a place that does the Fibroscan, in Toronto.     I was thinking of taking a trip to Niagara Falls, and maybe heading over to Toronto to have one done.  My PA doesn't think it is indicated, and didn't recommend a biopsy either, so if I do this it will be purely for my own peace of mind.

I really don't know if the place I found is reputable or not, but they advertise $100 for the test.    http://www.liverscan.ca/  It almost seems to good to be true, and I am a natural skeptic.  



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GT 2  VL on 10/23/13 7.2 Million; AST 55;ALT 79;AFP 3.2; Started 12 weeks Riba/Sovaldi 2/2/14 - Results Undetectable at 12 weeks!  



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Latest note from my NP responding to my question about SVR chances:

"We do not have a Fibroscan yet
You are correct that treatment experienced cirrhotic g3 patients had response rates of 60%, but you are a previous relapsing responder and relapsing responders behave similar to treatment naive patients."

Is this credible?

(And sorry to seem skeptical. This is my 2nd try at TX)

Gary



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Genotype 3A. Failed Peg and Ribivarin about 2006. Currently UND after 1 month Sovaldi and Ribavirin.



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Doh. So sorry. Looking again at the last lab test, my AST was 86. Alt was 92.  I guess I said it backwards before.

Mallani I am really encouraged by your success given your circumstances. A few questions:

1) Your RVR (Rapid Virological Response?). Can you define when this event occurs? (I never heard of it till now).

2) How are the figures about subsequent SVR chance calculated and by who?

3) I accept that I have cirrhosis. As I understand it, this is scaring of the liver. I would assume that the more scaring, the worse for liver function.  And the inverse of course.  Can you help me understand why my thought here is incorrect, in light of your 'no degree of cirrhosis' comment?

(I'm not challenging you. just trying to learn. thank you).

Gary



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Genotype 3A. Failed Peg and Ribivarin about 2006. Currently UND after 1 month Sovaldi and Ribavirin.



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Hi Gary,

Jill's comments are spot on, as usual. You either have cirrhosis or you don't. You can't have 'mild cirrhosis', 'early cirrhosis'  or 'a degree of cirrhosis'. This should have been established before treatment, either by biopsy or Fibroscan. A Fibroscan now will not give an accurate reading. The fact that the AST/ALT ratio is >1 suggests cirrhosis. Also Geno 3 has a more rapid progression to cirrhosis, particularly if combining with alcohol. Anyway, you can't change things now, so be optimistic and go with the flow. However, if you assume you have cirrhosis, the Riba reduction is less desirable.  As a 1b cirrhotic, I was initially given a 60% SVR chance, which rose to 70-80% after my RVR. Cheers.



__________________

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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Thanks, and I agree about your liver enzyme levels not being too much cause for concern.  One thing I noticed is that your AST level is a bit higher than your ALT and it`s usually the other way around.  That could be an indication of cirrhosis, although you`d need to have that confirmed by a fibroscan test as the liver enzyme levels can fluctuate quite a lot from time to time anyway.

Even if you do have cirrhosis you`ll still have to do the same duration of treatment so it doesn`t make a lot of difference, although I can understand your concern about reducing the dose of Ribavirin if it becomes necessary.   Let`s hope it doesn`t come to that anyway, best of luck!



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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.

 

 



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Cinnamon Girl wrote:

Hi again, yes, I did miss your edit earlier!  And yes, I did read your previous posts and the thread you referred to.

An ultrasound scan won`t necessarily detect fibrosis or cirrhosis, but there is an alternative to a biopsy, called a `fibroscan` which was approved by the US FDA last year.  It`s not quite as reliable as a biopsy in some ways but has certain advantages, mainly that it`s a non-invasive procedure.  Here`s some information about it, from the Hep C Advocate website...

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/fibroscan.pdf#search=%22fibroscan%22

Apart from your viral load, do you have any recent lab results for your liver enzymes (ALT and AST)? 


Wow, what a wealth of information you have! Thank you again, I just forward a Q to my NP about the fibroscan for me. 

Oddly I am getting my weekly CBC results sent to me and Quest did not send the baseline. I am working on that. So the last ALT and AST I have a paper copy of are > 1yr old but were 86 and 92 respectively. I do remember being told recently that my current ranges were not a big worry - they did not seem concerned about those levels for me.

 

 



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Genotype 3A. Failed Peg and Ribivarin about 2006. Currently UND after 1 month Sovaldi and Ribavirin.



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Hi again, yes, I did miss your edit earlier!  And yes, I did read your previous posts and the thread you referred to.

An ultrasound scan won`t necessarily detect fibrosis or cirrhosis, but there is an alternative to a biopsy, called a `fibroscan` which was approved by the US FDA last year.  It`s not quite as reliable as a biopsy in some ways but has certain advantages, mainly that it`s a non-invasive procedure.  Here`s some information about it, from the Hep C Advocate website...

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/fibroscan.pdf#search=%22fibroscan%22

Apart from your viral load, do you have any recent lab results for your liver enzymes (ALT and AST)? 



__________________

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.

 

 



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You've been a great help, thank you! (You may have missed my edit on the previous post, I just did it when you posted).

By the way is there anything available now to get find the stage of liver damage from fibrosis without a biopsy? Maybe a new scan? I am loathe to ever let someone do that to me again (no anesthetic -  I will remember the pain and shock till my last day).



-- Edited by hepcsurvivor on Sunday 2nd of February 2014 02:01:18 PM



-- Edited by hepcsurvivor on Sunday 2nd of February 2014 02:14:34 PM

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Genotype 3A. Failed Peg and Ribivarin about 2006. Currently UND after 1 month Sovaldi and Ribavirin.



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Ok, well that`s unfortunate.  It`s just that you either have cirrhosis or you don`t as far as the staging goes.  I was just wondering if maybe you had some degree of `fibrosis` rather than `cirrhosis` as such. 

I don`t think I can really comment on that then if you don`t have access to your records, although maybe your NP does?  Certainly if you do have cirrhosis then that will lower your chances of success, going by the chart, and I agree that it does indicate the importance of trying to stay on the full dose of Ribavirin, if possible. 

Sorry I can`t help you more! 



__________________

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.

 

 



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Cinnamon Girl wrote:

Hi again, hepcsurvivor, I`ve had a look and I see what you mean about the lower percentage success rates for cirrhotic patients. 

When you say you have `some degree of Cirrhosis` are you basing that on a recent biopsy result?  And if so, do you know what the actual stage was?  That would be very helpful information, thanks. 


Gosh I wish I knew. I had a biopsy like....2005ish? All I recall is that there was an indication of Cirrhosis. Then we moved, the Doctor retired...anyway I can't get the records now

Edit: Prior to the end of 1999 I drank more booz than I should have on a regular basis. I quite totally when I found out about the Hep C. I mention this because it could have contributed to some Cirrhosis.

Now combine that with my current basline VL of 170,000 (yup its that low) and I may allow myself to believe that perhaps the Cirrhosis didn't advance much more.

My initial post from a few years ago explains why the VL is so low. It turned out to be quite controversial (the post) and was locked. Not trying to start that up again, just thought you might be curious bout the VL.

 

Thank You!



-- Edited by hepcsurvivor on Sunday 2nd of February 2014 01:51:44 PM



-- Edited by hepcsurvivor on Sunday 2nd of February 2014 02:14:07 PM

__________________

Genotype 3A. Failed Peg and Ribivarin about 2006. Currently UND after 1 month Sovaldi and Ribavirin.



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Hi again, hepcsurvivor, I`ve had a look and I see what you mean about the lower percentage success rates for cirrhotic patients. 

When you say you have `some degree of Cirrhosis` are you basing that on a recent biopsy result?  And if so, do you know what the actual stage was?  That would be very helpful information, thanks. 



__________________

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.

 

 



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Hi,

Here is a note I just sent my NP (perhaps I should have posted here 1st LOL). I do have some degree of Cirrhosis.

********************************

Question: When I came to see Dr <name>I believe I was quoted either 80-85% SVR for my case. (Can't recall which).

(Link to gilead data provided by Cinnamon Girl in my last post).

Please take a gander at this:

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

Table 17 SVR Rates for Selected Subgroup by Genotype in Study VALENCE
Treatment-experienced
Cirrhotic 60% < < < This is me, right?
Non-cirrhotic 85%

Per this table under the full dosage, am I at 85%, or 60% per this study?
This question may become more relevant if we need to talk about reducing Ribavirin later.

********************************

When I tried TX last time with Riba/Interferon I was given some rosy numbers that didn't pan out. I am wondering if its happening again - or (hopefully) I am missing something?

Thank you,

Gary

 



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Genotype 3A. Failed Peg and Ribivarin about 2006. Currently UND after 1 month Sovaldi and Ribavirin.

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