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Hep C Discussion Forum -> On Treatment -> 48 weeks vs 24, based on what the doctor makes the decision?
Post Info TOPIC: 48 weeks vs 24, based on what the doctor makes the decision?
mallani


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RE: 48 weeks vs 24, based on what the doctor makes the decision?
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As hepatologists treat more and more patients with the antiproteases, I would expect some fine tuning of the Rx periods laid down by the protocols from the trials. I am yet to see any published material.

The longer we take these drugs, the more the chance of longterm damage to extrahepatic systems. However, we want the length of Rx protocol that will give us the best chance of SVR. The factors that influence Rx length have already been mentioned. However with cirrhotics, the 48 week Rx length appears set in stone. I am a previous relapser, have achieved sRVR, but still have to do the full 48 weeks ( 44 weeks of Victrelis). The trials did not split cirrhotics into categories. Certainly, from the trials, the SVR figures for 36 weeks Rx were much lower than the 48 weeks ones. I hope that soon there will be enough data for additional protocols.



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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
Margo


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Uval951 wrote:

Congratulations, Rita. It's great news.

Thank you!

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
Uval951


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Congratulations, Rita. It's great news.



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Gen. 1b. 1st Tx in 2003 Rib/Peg. Biopsy F3-F4; 2nd Tx started 2/28/12, Pegasys+RibaPak+Victrelis for 48 weeks. VL: 260,000 (starting), 125,600 (4 weeks), UND-weeks 6-45.EOT 1/7/13 after 45 full weeks. Post Tx 4,12,24 weeks -UND  SVR!
Margo


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Update: since the virus has been UND at weeks 4,8 and 12, I will be only doing 24 weeks! Regardless of me relapsing last time.

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
Margo


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Thank you, very informative.

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
Uval951


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 A few more response category:

Response

Definition

SVR

HCV RNA undetectable by sensitive assay 24 wks after treatment end

RVR

HCV RNA undetectable at Wk 4

EVR

> 2 log10 IU/mL reduction in HCV RNA at Wk 12

cEVR

HCV RNA detectable at Wk 4, but undetectable at Wk 12

Null response

HCV RNA decline < 2 log10 IU/mL from baseline at Wk 12

Partial response

HCV RNA decline > 2 log10 IU/mL from baseline at Wk 12, but HCV RNA detectable at Wks 12 and 24

Viral breakthrough

HCV RNA detectable at any time during treatment after being undetectable

Relapse

HCV RNA detectable after withdrawing treatment in a patient who was undetectable at end of treatment

New response categories with PI-based therapy

eRVR with boceprevir

HCV RNA undetectable at Wks 8 and 24 of therapy

eRVR with telaprevir

HCV RNA undetectable at Wks 4 and 12 of triple therapy

Week 8 response

Among boceprevir-treated patients, HCV RNA undetectable at Wk 8 of the overall treatment course (ie, after 4 wks of pegIFN/RBV lead-in and 4 wks of triple therapy)

Lead-in RVR

HCV RNA undetectable at Wk 4 for patients who had a pegIFN/RBV lead-in phase of therapy



-- Edited by Uval951 on Sunday 8th of July 2012 04:14:16 PM

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Gen. 1b. 1st Tx in 2003 Rib/Peg. Biopsy F3-F4; 2nd Tx started 2/28/12, Pegasys+RibaPak+Victrelis for 48 weeks. VL: 260,000 (starting), 125,600 (4 weeks), UND-weeks 6-45.EOT 1/7/13 after 45 full weeks. Post Tx 4,12,24 weeks -UND  SVR!
Margo


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My doctor still haven't made his decision for how many weeks he wants me to continue. I guess after my 12 week blood work I will know, I'll keep you informed.

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
LanaiSurferGirl


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The triple treatment is so new and there isn't a ton of research to support a decision either way.  My doc and I both agreed to play it more conservative but if you can stick it out through 24 weeks you have made a big difference...anything extra is gravy and most likely improves your chance of beating the hep c! :)



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geno 1a, mother & brother also hep c +...mom got a blood transfusion and passed it along.  Started tx with incivik 11/23/11 and brother started 2/8/2012.  Both of us und. at 4,8,12 and me at 24.  I am going 36 wks and brother is going 48 weeks.
kannon


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I feel a little lucky in that I can be an active member of treatment planning with my doctor. My doctor doesn't have a whole lot of experience with these new meds. I've been doing a lot of research on my own.  At the same time it would be nice to have someone with more knowledge and experience working with me. 

 

One question I have is: when Invicek collected their stats from the clinical trials, were the participants treated using the regimen they suggest using now (If the virus is und at weeks 4 and 12 then you may only need 24 total weeks of treatment. 12/triple and 12 peg/riba.

If it's detectable at either week 4 or 12 then you may do 48 total weeks of treatment: 12/triple and 36 peg/riba) 

I wonder if it might be more beneficial and increase your chances of achieving a SVR if you continue treatment for 48 weeks versus 24, even though the virus was undetectable at 4 and 12. 



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Margo


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Thank you Kannon, great explanation. I was UND at 4 and 8 weeks, I hope for 24 weeks.

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
kannon


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Keep us informed. Sounds like treatment is working well for you Margo.



-- Edited by kannon on Saturday 7th of July 2012 09:13:58 PM

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kannon


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That's what I was thinking (48 weeks would increase the odds of achieving a SVR). It would be nice to have some stats to compare the groups (und at 4 and 12 broken into 3 groups based on length of treatment, 24, 36 and 48). I know you run the risk of developing autoimmune disorders and other nasty side effects the longer you take the peg/riba, which should be considered in the decision making process. 



-- Edited by kannon on Saturday 7th of July 2012 09:08:47 PM

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kannon


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If you relapsed, then you are, at least a partial responder.

I'm assuming you are taking triple therapy with incevik. Based on the info from the pharma company: If the virus is und at weeks 4 and 12 then you may only need 24 total weeks of treatment. 12/triple and 12 peg/riba.

If it's detectable at either week 4 or 12 then you may do 48 total weeks of treatment: 12/triple and 36 peg/riba.

If you have cirrhosis, it is recommended that you have 48 weeks of treatment - 12/triple and 36 peg/riba.. 



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Margo


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Sunrise747 wrote:

Whats a difference between the tru relapser and partial responder?

A relapser goes the full treatment duration with all their prescribed viral load tests at undetectable.  But then, sometime after treatment ends, the virus become detectable again.  Usually this is discovered at the 3 or 6-month post-treatment test. 

A partial responder either gest ssome of their VL tests to undetectable but not all of them.  Or they get much lower VL counts than they had before starting treatment but not all the way to undetectable.  In other words they did respond to treatment to a significant degree but 100%.

A non-responder shows only minor improvement (or none at all) in their viral load counts during treatment.

 

So that makes me a non- responder? I relapsed at the very end of my treatment.

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
TazKat


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TazKat wrote:

i don't know what happened to me. i did 32 weeks, had to get off to meds out of system so i can get this bad tooth pulled.. i relapsed i think b4 i ever got off the interferon & riba..  sucks....................Taz

 i am a genotype 1   had done  interferon three times.. not sure i want to put that stuff back into my body.. Taz

 

i

 



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TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
TazKat


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i don't know what happened to me. i did 32 weeks, had to get off to meds out of system so i can get this bad tooth pulled.. i relapsed i think b4 i ever got off the interferon & riba..  sucks....................



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TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
Sunrise747


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Whats a difference between the tru relapser and partial responder?

A relapser goes the full treatment duration with all their prescribed viral load tests at undetectable.  But then, sometime after treatment ends, the virus become detectable again.  Usually this is discovered at the 3 or 6-month post-treatment test. 

A partial responder either gest ssome of their VL tests to undetectable but not all of them.  Or they get much lower VL counts than they had before starting treatment but not all the way to undetectable.  In other words they did respond to treatment to a significant degree but 100%.

A non-responder shows only minor improvement (or none at all) in their viral load counts during treatment.

 



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Geno 1B Relapser 2001. Started Incivek 12-16-11. 57 yr old male.  Last biopsy 2000 -stage 3 fibrosis. UND Wk4, 12, 18, 26.  Did 34 weeks.  Still UND at 12-wks post.
Margo


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Sunrise747 wrote:

I saw Dr Brown for years.  Best doc ever.  Knows more about Hep C than most anybody because he has hundreds of C patients.  If you are a true relapser (as opposed to a partial responder), remain negative on all required VL tests, and do not have cirrhosis then 24 weeks is typical (Incivek). 

 Thanks, I hope so too. I am not rushing my doctor to make a descision, I just hope it would be the right one. Whats a difference between the tru relapser and partial responder?



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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
Sunrise747


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I saw Dr Brown for years.  Best doc ever.  Knows more about Hep C than most anybody because he has hundreds of C patients.  If you are a true relapser (as opposed to a partial responder), remain negative on all required VL tests, and do not have cirrhosis then 24 weeks is typical (Incivek). 



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Geno 1B Relapser 2001. Started Incivek 12-16-11. 57 yr old male.  Last biopsy 2000 -stage 3 fibrosis. UND Wk4, 12, 18, 26.  Did 34 weeks.  Still UND at 12-wks post.
Margo


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Uval951 wrote:

He should be great. We saw Dr. Brown, but just for consultation. Monthly we go to local hepatologist.

I wouldn't switch him, I usually go to the best, especially this treatment. Doctors dont usually see patients already on treatment for seco d opinions. Thanks anyway :)

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
Uval951


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He should be great. We saw Dr. Brown, but just for consultation. Monthly we go to local hepatologist.



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Gen. 1b. 1st Tx in 2003 Rib/Peg. Biopsy F3-F4; 2nd Tx started 2/28/12, Pegasys+RibaPak+Victrelis for 48 weeks. VL: 260,000 (starting), 125,600 (4 weeks), UND-weeks 6-45.EOT 1/7/13 after 45 full weeks. Post Tx 4,12,24 weeks -UND  SVR!
Margo


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Uval951 wrote:

Margo, you live in NYC and have good opportunity for professional second opinion about your Tx duration. This week I met a professor of NewYork-Presbyterian (The University Hospital of Colombia and Cornel, Center of study Hepatitis C) and he changed some my minds about Tx. They have own experiance in triple Tx in many years trials. It's much better of standard protocols of medicine producers, used regular hepatologists.

You just started the Tx and have time for detail schedule how will be healthy.



-- Edited by Uval951 on Thursday 28th of June 2012 07:28:40 PM

I go to Columbia university Dr. Magun, he is excellent. Who do you have in mind? I was just wondering for my own curiosity what factors do they look at.

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
Margo


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Thank you kiwi, I really hope so. I did 11 months last time, don't want to repeat that again...

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
Uval951


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Margo, you live in NYC and have good opportunity for professional second opinion about your Tx duration. This week I met a professor of NewYork-Presbyterian (The University Hospital of Colombia and Cornel, Center of study Hepatitis C) and he changed some my minds about Tx. They have own experiance in triple Tx in many years trials. It's much better of standard protocols of medicine producers, used regular hepatologists.

You just started the Tx and have time for detail schedule how will be healthy.



-- Edited by Uval951 on Thursday 28th of June 2012 07:28:40 PM

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Gen. 1b. 1st Tx in 2003 Rib/Peg. Biopsy F3-F4; 2nd Tx started 2/28/12, Pegasys+RibaPak+Victrelis for 48 weeks. VL: 260,000 (starting), 125,600 (4 weeks), UND-weeks 6-45.EOT 1/7/13 after 45 full weeks. Post Tx 4,12,24 weeks -UND  SVR!
kiwi


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Margo wrote:

So it's not whether you relapsed before or not?

 i was told, if you are not detected at 4 weeks, you only had to do 24 weeks treatment.  otherwise its the 48 weeks long haul.... im on riba/peg. but that seems to be protocol...

i was still detectable at 4 weeks, so its 48 weeks for this kiwi. ah well.

good luck whatever they decide mate

 



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kiwi. genotype 1. started pegasus and riba on 10 nov. VL 17.6 million. (4 weeks VL 1368)  week 15 UNDETECTED... :)
Phil G


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The way I read the Victrelis info is that previous partial responders or relapsers go 36 weeks on 3 meds if undetected at week 8. If detected at week 8, add another 12 weeks of just peg/riba for 48 weeks total. With compensated cirrhosis, its 48 weeks on 3 meds. Don't know about Incivek.



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Geno 1A, VL 1.9 mm, SOT 12/2/11 - Pegintron/Ribavirin/Victrelis, UND since wk 8, EOT 6/15/12 (28 wks), SVR 11/30/12
Margo


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So it's not whether you relapsed before or not?

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
mallani


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The clinical trials for Incivik and Victrelis have given a clear indication as to what length of Rx gives the best chance of SVR.  EVR's ( as you are ) usually need 24-28 weeks unless you are cirrhotic. Alan is correct, hepatologists should base their decision on that information.



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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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Probably he will use the recommendations of the drug manufacturer based on the results of the trials. A doctor that prescribes outside of those recommendations does so at his own peril.

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Geno 1A  Started Pegasys/Ribavirin/Incivek Nov. 20, 2011 .  Completed July 28, 2012 (36 weeks). For a treatment history, see:  https://jshare.johnshopkins.edu/xythoswfs/webview/_xy-9921874_1

SVR on January 14, 2013!!
Margo


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My doctor is still not sure if I will only need 24 weeks or the whole 9 yards, because I relapsed last time, but was UND at week 4 this time. He told me he still has to think about what's right for me. I'm just wondering on what information he will make the decision?

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Geno 1b, relapsed in 2009 a week before my treatment was to be over. Started triple therapy on April 28th, 2012. UND at week 4,8,12,24,3 months post tx.
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