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544172 tn?1216520164

Non-responder

I need some questions to ask my study Dr. Monday.  I am in the Genotype 1 tx naive Vertex trial (double blinded) so I don't have my lab values.  Week 25 they pulled my meds so I thought that I was in the telaprevir arm; however, I found out yesterday that my Viral count was 2 mil.  ( I was 11mil. when I started).  I know that the viral load does not indicate liver damage and that it fluctuates.  The trial is finished towards the end of Dec. There is a possibility that they will offer telaprevir to the participants.  If I drop out and continue SOC I lose that possibility, but I can't find out if I relapsed after the telaprevir until the end of the trial.  Help! I am brain fogged.
Thanks  
17 Responses
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9648 tn?1290091207
Not sure I understand your post, but I can't think of what the advantage would be of continuing to treat if you have any viral load at 24 weeks of treatment.

VL is  not supposed to fluctuate while on treatment. The drugs are supposed to keep it going down, down, down until it's UND.

Is there a placebo arm you could have been on? If not, and you did get the telaprevir, I'm wondering why it would work if you try it again when it didn't work the first time. I thought the PI's were a one-shot thing.
Helpful - 0
544172 tn?1216520164
The PI's are a one shot thing.....The placebo arm was SOC (with placebo telaprevir)....if I was in that arm...I may still have a shot at SVR with telaprevir.

I am clueless as to what may come next...any input or questions to ask my doctor would be appreciated.
Helpful - 0
179856 tn?1333547362
If you do not clear completely and become UND by week 24 you SHOULD be stopped. Since they have already stopped your meds - this is what they are telling you. You have an extremely high VL for week 25 and it shows that the interferon and ribavirin are NOT working as you are NOT responding. SOC is not working.

I don't kow what your biopsy results say but I assume you do have some time to wait for the PIs to be approved by the FDA.  I do not believe in any way that you will be offered them as an alternative at this point, you need to start completely over at square one but this time you will not be considered tx naive.  You will be considered a non-responder.

They should treat you completely differently next time (more meds, switch interferon's, more riba and add on a PI and Alinia or something too).

The sad fact is (and I am sorry) but the interferon and ribavirin just did not work for you.  If you had a very very low VL at week 24 PERHAPS a doctor could be convinced to let you extend to week 72 and see if that would do it but most likely most wouldn't even offer that.

Personally I cleared completely (UND) somewhere between week 12 and 24 and I still had to extend to week 72 (which is what the studies suggest).  But there just isn't any value for someone who is not responding to continue on meds that obviously just aren't working.

AGain, I am really sorry.  Talk to your doc about Infergen or starting over later with a whole different set of parameters.
Helpful - 0
179856 tn?1333547362
I may still have a shot at SVR with telaprevir.


Yes but you have to completely stop and detox and then start all over again when the PIs are approved by the FDA or find a different trial.  At this point I honestly believe you would be much better off WAITING for the FDA so you can have access to all of your test results as they come up.

As you may know - the closer you get to UND at week 4 the better your chances.  We can't really tell if you NEVER got to UND or if you RELAPSED.

I just realized that. not until they show you those test results will you really know which way it went.

Either way though it's the same outcome and you just might have a better shot with an open access so you can monitor what is going on and perhaps adjust the meds as needed (ie add more riba next time........etc).

Trials are too rigid and you woulnd't be able to alter anything.

Once you have done the PIs though if you fail you will NOT be able to do them again.  So ti is a serious decision to make.
Helpful - 0
Avatar universal
Sorry to hear you did not clear. That stinks that you can't find out what arm you were in. Either way you should not treat beyond 24 weeks if you still have a viral load. Your chances of clearing the virus still being detected at 24 weeks is less then 2%. So it is a no brainer to stop and wait for the PI's in the next few years or get into a non-responder trial sooner. I also have read Vertex is trying to get early FDA approval for Non-Responders.  Best of luck
Helpful - 0
544172 tn?1216520164
Thank you all!!!  

My bx was st2 gr2.  

Just will continue to live as healthy as possible and wait...............

Will see what options my doc has to offer....at least I'm in with the hepatologists at a major teaching facility.
Helpful - 0
Avatar universal
At 24 weeks into it with or with out the telaprevir, I would go with the hail marry and keep my mind and spirit in the game. I would push hard to continue with the SOC asap. This virus is not going to beat you and don’t let it with out a fight. You did respond, granted! But you did respond and if you stop it will come back with a vengeance so don’t let it. Stand on his head and make it spin around until he gives.

geterdone

Helpful - 0
Avatar universal
Hi geter,

I was very susprised to see someone as informed about HCV as you to advise sandbash to continue tx,  even though his VL is 2 mil after 25 weeks.  The only way there could be any positive from continuing tx would be if there was extensive liver damage (stage 4) and that is not the case here.
The fact is that if someone is still positive at 24 weeks they have almost zero chance of clearing the virus. This has been proven with many studies.
One good thing is he is seeing a Hepatologist at a teaching hospital that will be up to date on protocols and no doubt will advise not to continue.
Helpful - 0
Avatar universal
If I drop out and continue SOC I lose that possibility, but I can't find out if I relapsed after the telaprevir until the end of the trial.

Adjustment that would be the point. Treatment naive and telaprevir did not work but the viral load did drop. I do not know what dosage the patient was on but if it were lower than the 180 INF and 1200mg riba it would shed some light on the outcome. Something must be working and heaven forbid that the telaprevir would be the culprit in not allowing the virus to be eradicated by now. Maybe sandbash could shed some light on the particulars of the status. In any event I am hoping that the doctor would allow the patient to continue the SOC at least for the next 6 weeks and see the outcome at that point.

There has been a lot of time and effort put into the TX to just let it just stop without benefit of the doubt, if it were presented.

Yes, the 24 week cut off but this is not the standard SOC.

jasper
Helpful - 0
Avatar universal
I'm curious to know if you had to go thru any dose reductions during your tx???
Helpful - 0
Avatar universal
Hello sorry to here this i assume you have already stopped meds at this point there is no point to continue on soc with viral load 2 million at week 24 i have relapsed 3 times in past once from 72 weeks always been neg by 26 weeks or sooner you may just find you were only on soc you can always reteat after december with a more agressive approach i am on vertex trial from prove 3 rollover arm been neg week 2 have 2 weeks left i dont know if they have rollover on this trial but if not there will be options best of luck
Helpful - 0
Avatar universal
First we don't know if she got telaprevir. I don't think she did. As for her VL dropping to 2 million that is not a big drop at all. Not even a 2 log drop! Actually there is not much of a difference of his starting VL of 10 mil and 25 week VL of 2 mil.  My point is what does she gain from more tx with SOC? It has not worked yet and chances are they would not work with extending tx out to even 72 weeks. Why subject your body to a harsh tx that could result in permanent SX damage.  She sounds like the perfect cadidate for a PI.

I'm in the Vertex study (no placebo in my study).  The only dose in Telaprevir studies is 1200mg riba and 180 pegasys. Unless the study doctor ordered a riba reduction during tx due to low HGB, etc.
Helpful - 0
408795 tn?1324935675
"One good thing is he is seeing a Hepatologist at a teaching hospital that will be up to date on protocols and no doubt will advise not to continue".  

Are you sure the Heptologist will encourage sandbash to discontinue tx?  This is a trial and the doctors are normally paid by the sponsors, so I wouldn't be to sure.  Whatever the case, at this point sandbash needs to be able to walk out.  

sandbash, sorry that happened to you, that really sux.  good luck  

fret
Helpful - 0
544172 tn?1216520164
As you know....this trial does not allow rescue drugs....Most of the time I was on 1000 riba and 180 peg (had dose reductions to 800 riba 135 peg and once had to skip a peg.)  I weigh about 160-165 had problems with anemia and neutropenia.

My results have been blinded but i did make it past the 12 week criteria whatever that must have been.

I can walk out at any time....I will find out more after my appt. next week.
Thank you for your responses.

Helpful - 0
Avatar universal
I am curious as to what are the Placebos used in these trials and does anyone know what is in them?

Jasper
Helpful - 0
Avatar universal
Sandbash, sorry you had reached this outcome but as you know there are options in the waiting, so don’t get down on yourself and if anything you’ll know what to look for in the next round if it should be delayed until then.

Questions, if you wouldn’t mind

How many weeks were you on the 1000/180 before the reduction?
What week did you skip the INF
When was your last shot and riba dose?

jasper
Helpful - 0
544172 tn?1216520164
Turned all my med forms into study (Drats should have copied them)
Wk 9 reduced to 800/135  hgb 9.0
wk 13 skipped INF  neutrophils 350
wk 24 800/180  @ Jan 15th
wk 28 lab check  (non responder)  
I did go back to 100/180 for a few weeks (it always knocked my hgb and anc down)
Helpful - 0
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