virus relapse

Hi Everybody,I wanted to update on my progress with the Roche trial.My trial nurse just called and told me the virus is back.That was my 30 day post checkup.I cleared in 4 weeks so my hopes were high.I am dealing with it the best I can.But I knew what my chances were.

[silentlamb]

*HUG*  

Keep trying....

[Gee704]

{{{{{{{Terca}}}}}}} Sorry to hear your news.

Which Roche trial were you in?

[Diane12855]

I'm so sorry to hear that. I imagine you thought as I did that by clearing so soon in treatment you didn't have anything to worry about.

Hang in there.

Diane

[terca]

I was in the R05024048 trial

[nygirl7]

Oh God I'm so sorry, I really thought you had this thing beat too by clearing so early. This just ***** I'm so very very sorry for you.
Deb

[spectda]

i am very sorry to hear this news. I am sure it's a very difficult time for you. How did the trial work regarding time treating, lead in, soc? Did you receive the trial drug along with the riba and INF? Do you know you got the real drug and not the placebo?
- Dave

[Trinity4]

Looks like treatment duration was only six months too and the trial people said they were getting 80% SVR rates.  I'll bet terca got the placebo but you know we're going to see more and more failures as time goes on even with the protease inhibitors because that's the way it goes.

Trin  

[terca]

I was treated for 24 weeks because I cleared at 4 weeks.My trial nurse told me I was given the real drug.If I wasnt given the real drug they would not have stopped me at 24 weeks.They are giving the ones that were given the placebo and they relapse a chance to take the real drug.Since I was given the real drug I am out of options at this point.  

[spectda]

Did you start with the real drug andriba and inf?  Was there a lead in with soc? Are you geno 1?

[susan400]

I am so sorry, don't know what else I can say to make you feel any better.  I can say that I know the disappointment you are feeling as I've had many such feelings in my TX history.  Hugs (( ))   Susan400

[portann]

Hi Terca,

I'm really sorry to hear your news. :(

Epi (Epiphiny) was on a similar trial with the same polymerase inhibitor R05024048. I'll PM her about this and maybe she'll weigh in.

Interestingly, she was a geno-3 (a G-3 typically treats for 24 weeks on SOC ) but she treated for 48 weeks, including 8 weeks with the trial drug and 180mcg interferon and 1200 riba. I think this was due to her having been a previous non-responder.

You probably know that without the study drug factored in, reaching RVR is not sufficient for a G-1 to halve treatment time. You would have also needed a low starting viral load, less than 400, 000 IU/ml, which wasn't your case.

So it looks like this polymerase didn't work here, G-1, high starting viral load, cutting treatment time in half.

Do you know how many others with high starting load, RVR and the polymerase went on to SVR?

Is it for sure that you were taking riba or could you have had a riba placebo?

I know you'll regroup like so many other members here who persevered until they SVR'ed.

In the meantime, I hope you feel better quickly and enjoy those grandchildren.

Hang in and your turn to post SVR will come along soon.

In the meantime, best wishes and big hugs.

Susan



  

[spectda]

This is very difficult news for you after going through tx. Although I am sure today is not the day you want to treat again, It seems to me that you have options. From what I have read, the fact that the drug is a polymerase inhibitor rather then a protease inhibitor should mean that resistance will not be an issue in the future. If you had a lead in without soc, and even if you did not, you were rvr. I would imagine that there is a good chance that soc might have cured you if you had gone 48 weeks. I think you have an excellent chance of svr with longer treatment.

I know that's not on todays agenda, but I think there is hope. I am very sorry that you are going through this painful experience.
- Dave

[mikesimon]

I am sorry about your results.
I wish you well.
Mike

[epiphiny]

Hi there, I am so sorry to hear this news.

I was on the phase 1a trials for this drug, also achieved RVR and was scheduled to stop at 24 weeks.  As I was a previous non-responder (Geno 3A) I fought very hard to continue treatment past the 24 weeks and ended up going the full 48 weeks of standard combo treatment after the trial finished. I did have a minor blip with a breakthrough after study drug finished and after a riba reduction due to anemia but was able to get back to UND when my riba dose was raised again. All these factors were part of my decision to prolong treatment.

First of all - did they give you a Viral Load count when they gave you your results on the phone? I don't want to raise your hopes BUT it is possible to get a false reading and if the VL is pretty minimal this may be the case for you.  I think NYGirl has had this experience. and will be able to go into more detail.

Also would you mind posting the dosages of INF/Riba and study drug you received? And did you have to take any riba reductions to due to low hbg? I know you probably don't want to think about such things today but it is important to know this info so that your treatment can be modified if/when you decide to treat again.

First things first tho - what was the VL reading from your latest test?  Also, I would be inclined to request another test. Mistakes can and do happen.

My thoughts are with you :)

Epi.

[skersj]

I am at a loss for words but my heart goes out to you.

[jt57]

I feel your disappointment!  We fight this battle so hard, feel we have it beat, then WHAM!  Been there.  But you can't give up.  There are options.  Get yourself together, get strong again, have a life for awhile!!!!!!!!    And then exercise your  options, because you do have them

I am so sorry.  I am taking my 24th shot tomorrow.  rvr at 4 wks  1b.   praying this is it for me...but you never know.   I relapsed last time..

Hang in there.

Jean

[GSDgirl]

I am so sorry to hear of your results.  Good Luck in the future

Denise

[terca]

Thank you so much for all your kind words.It is nice to know I am not going through this alone.I did start on the trial drug with riba and inf.The trial drug was stopped at 8 weeks.I started on 180mg of inf and 1000 mg of riba and I am not sure what the mg of trial drug was.I took 1 pill of trial drug twice a day.The riba was later reduced to 800mg and then to 600 mg because of severe anemia.My trial nurse told me today my viral reading was 160,000.I have 1 question for somebody.Could someone tell how bad my liver is with a biopsy of stage 2 and grade 4.My doctor says it is not too bad.But I know how doctors sugar coat things sometime.I am not looking forward to going through this again.

[Trinity4]

Stage 1 indicates enlargement of the portal areas by fibrosis; stage 2 indicates fibrosis extending out from the portal areas with rare bridges between portal areas; stage 3 indicates many bridges of fibrosis that link up portal and central areas of the liver; and stage 4 indicates cirrhosis.

Your doctor is correct.  Stage 2 is not that bad and you have time to wait for newer treatments.  I don't relish the idea of having to treat again either but what else can we do?  Your liver had a nice 6 month break, mine had an 18 month break.  Things will get back in perspective, you'll pick up where you left off and one day both of us will beat this bas-tard disease down.  

Wishing you a speedy recovery,
Trinity

[Magnum]

There will be more and more solutions and drugs coming out now that Merck and Schering have started the race. The race after all, is about money. And who is more adapt at grabbing the most money possible than banks, oil companies and pharmaceutical companies. Not trying to be critical here, but the race is on. Hang in there. There may well be drugs without the awful and most times brutal side effects in the not so distant future. I'm waiting along with you and the rest of us...

Magnum

[RCM829]

Hi there-

I really do feel your disappointment - right in the pit of my stomach. I want you to know how proud of you I am for giving this your best try. I just know you will evenutally reach SVR...

As you probably know, stage 2 is considered somewhere in the middle of the spectrum. You have mild to moderate fibrosis but it has not yet "bridged", otherwise you would be staged at 3. I believe the grade is the amount of inflammation. At the time of your last biopsy, you liver appears to be have been quite inflamed. Perhaps someone else can expand on this  more but I wanted to extend my best wishes nontheless.

Take care - we're all thinking of you.

[RCM829]

Thanks Trinity, our posts must have crossed at about the same time but you explained the stages in better detail than I.

[sunqueen]

I'm very sorry and wish you success next time.

[Cory255]

That's terrible news Terca.  I'm so sorry.  Good news is you responded to the meds, and maybe next time you can switch to something stronger.  

Cory

[meakea]

I am sorry...truly very sorry for the relapse.  I wish you the best as you go forward in making a plan...  

[spectda]

I think your riba reductions and not treating for 48 weeks was the culprit. Were you not allowed procrit ? You had such a great initial response that you will probably be successful in the future. Also since the drug was a polymerase inhibitor, I think you are still able to treat with telaprevir or boceprevir without issue. Treat for 48 weeks next time and insure the doc will use the rescue drugs rather then dose reduction. When you are over the shock and ready to try again, I think there is real hope. This tx is hell, and going through it twice is tough, but you will conquer it!

Be Well - Dave

[copyman]

Sorry for the news.

I don't think it had anything to do with stopping at 24 weeks. As other studies have shown 24 weeks is all that is needed, even for G1's. telaprevir had even better SVR rates then 48 weeks, 92% with only 24 weeks of the PI. All PI's kill the virus within days if not hours. It is the Interferon & riba that have to "train" the immune system to keep the virus gone. I think you can still try Telaprevir when available in about a year.
Hang in there.

[WriteItDown]

So sorry to hear this!  It really s**ks. I agree with copyman -- and you can still do Telaprevir when it comes out.

[Cory255]

This is the first I've heard of a relapse with a polymearse inhibitor.  Again, I'm sorry for the news.  I also agree waiting for Telaprevir to be a good idea.  

Cory

[mk_]

Will be done next time, keep trying.
A poem to share with all-
----------------------------------------------------------------------------------------------
>Let me escape

Let me escape,
Be free, (wind for my tree and water for my flowers ),
Live self for self,
And drown the gods in me,
Or crush their viper heads beneath my foot.

No space, no space, you say,
But you'll not keep me in
Although your cage is strong.
My strength shall sap your own;
I'll cut through your dark cloud
To see the sun myself,
Pale and decayed, an ugly growth.

{Dylan Thomas}

[zrjl]

So sorry to hear this. I haven't been on in awhile. I'm a little over halfway in 72 weeks of treatment. I think we started about the same time.
Hang in there - there is so much hope on the horizon!
Hugs, and strength.

[Upbeat]

Do you know if you have IR or outright diabetes?

[IAmTheWalrus]

Bad news! I am so sorry to hear it. If you were in the placebo arm of the study, maybe you will get the chance to treat with the trial drug later. It seems like that has been done in other trials. As a fellow relapser, I really sympathize with. I hope you will weather this storm and have good health coming.

Brent

[positude]

Terca;

I know we all saddened to hear this and you must be heartbroken over the news, but you know that there are many others who have gone through it and have now conquered the demon virus, don't give up. And for what it's worth, I would wait for the Telapravir if it were me. We will all be thinking about you.

(Insert a "GIANT HUG" here.)
Pos.

[Bali05]

I feel for you.
They were recommending this trial to me before I started
and I  had decided to go for it but was than declined by Roche.

There are many people who had to give tx  a second  or more tries
and are SVR today.

it`s the old..... pick youself up , dust yourself of..... kind of thing.

Please keep us posted with your next battle plans.