Re treatment of Viral Break-through Patient

[slagle2]

I stated before that I was a responder to SOC treatment eight years ago with Pegasys and generic ribavirin but that is not entirely true.  I was undetectable at 12 weeks and also at 48 weeks but at 24 weeks I had a VL of 212,000.  I used 1200 mg of ribavirin all the way through and a single vial (1cc I think) of the Roche interferon per week the whole time and missed no doses.  I was only tested these three times and six months post TX I was 16,400,000.  Before I treated I was 5,000,000 and now my VL is 3,779,631.  I tolerated the treatment reasonably well.

If I re treat how is the treatment different for a break through patient as opposed to a relapsed responder?  How does this affect the outcome; is there any data?  

The folks on this board are great, I've learned more here in a few days that I learned in the last ten years elsewhere.  I need to know about this as I have a dooctor's appointment this coming Tuesday.  

[slagle2]

That is great news and glad to hear it, it takes lots of will power to get through all that.

[halbev]

I can say is that I was treated 2 times in a row non stop 84 weeks with Int/Riba could get to where I had no VL, but always would be there in qualitative test which means it is there or not.
6 months off and went to Incevik INT/Riba went UND at 4 weeks 8,12 now on 16 and all is good.
I am 1a stage 3 cirrhosis so was hoping this would work,
Seems to have done it! although we all know the is still the possibility of breakthrough, but I have not seen that, if you clear it at 4,8,12 all seems to be good to go. But this is all new but seems to be a great improvement

[slagle2]

That is what I've heard for some time.  On Yahoo Finance there are message boards for different companies listed by their stock symbol. The symbol for Vertex, the Incevik company is VRTX.  For years I followed  the discussion there about the clinical trials for VX950 which was Incevik during the clinical trials phase.  There were some smart biotech guys there and it seemed to me that the VX950 showed great promise.

[halbev]

Oh on with Incevik!!!  much higher they say 86% for relapsed people

[slagle2]

Thanks, its nice to be reminded that even if I had a viral breakthrough which I guess is similar to being a non-responder that with the new PI drugs that there is still maybe a 50% cure rate.

[adamben101]

I don't have the links at hand but all studies about retreatment of those who non-responded to PEG/RIBA AND those who responded and relapsed are that the new tri-cocktails are doing a wonderful job.  I want to say at least 50% or maybe even as high as 70% success rates.  Again, don't quote me.  But it should be easily researchable on here or google.

[slagle2]

Thanks a bunch for the info and I'm going to follow your advice and seek a hepatologist who is familiar with this.  I went to a clinic at Sarasota for a couple of years and was evaluated for clinical trials but decided not to do that because about that time I had to have a hip replacement due to an accident several years earlier.  And thanks for the advice about explaining to the  doc that poor adherence was not a problem.  I did miss (or delayed) by I think five days a single interferon injection but that was after the 212,000 viral breakthrough.  

Another couple of possible anomalies was that there was a time that it is possible I froze two vials of interferon due to a malfunctioning fridge and I always wondered about the generic ribavirin.  The outfit that supplied that was a bit of a rinky-dink operation and I hope someone was watching them.  

The doc I'm seeing now is not a heptologist though he is a great doctor and the closest one to where I live who treats hep C patients but was not involved in the clinical trials.  I see him Tuesday and am looking forward to seeing how the second reading of my biopsy turns out.  Because there had been no progression in fibrosis in ten years he was a bit suspicious of the results from the August biopsy.  

Thanks for your help.

[can-do-man]

Also in the article i posted above was this on just SOC.

In addition, there are some patients who experience viral breakthrough. These patients have undetectable viremia at some point during treatment, but experience an on-treatment viral breakthrough. Viral breakthrough is usually due to poor adherence.

You want to make sure the doctor understands that was not the case for you, as most doctors just assume poor adherence was the cause.

Wishing you the best

[can-do-man]

As i said in the other thread you did have a breakthrough, that said theres not alot on breakthroughs and these new PI's, all though i did find this.

These patients were randomized into 4 arms. The first arm received peginterferon alpha-2a 180 µgs weekly, 1,000–1,200 mg of ribavirin daily, and telaprevir 750 mg 3 times daily for 12 weeks. This was then followed by treatment with peginterferon plus ribavirin for an additional 12 weeks. The second arm received peginterferon, ribavirin, and telaprevir for 24 weeks, followed by peginterferon plus ribavirin for 24 weeks. The third arm received peginterferon and telaprevir for 24 weeks. The fourth arm (control) received standard therapy with peginterferon plus ribavirin for 48 weeks. The overall SVR rates in this study were 51%, 53%, 24%, and 14% in arms 1, 2, 3, and 4, respectively. The SVR rates among prior nonresponders were 39%, 38%, 11%, and 9%, respectively; among prior relapsers, rates were 69%, 76%, 42%, and 20%, respectively; and among patients with prior viral breakthrough while on treatment, rates were 57%, 63%, 36%, and 40%, respectively.
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If it was me i would ask my doctor about doing 48 weeks total, both of these PI's seem pretty close in SVR rates. So what i would want to know sense being a breakthrough patient would i be better of doing Incivek for 12 + 36 or would being on the PI longer maybe give me better odds which would mean 4 week lead in then 44 weeks of Victrelis.

One thing for sure your going to need a very good hepatologist that has been involved with both these drugs during their trials.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2886472/