Incivek Trial: Ribavirin Stopped because of Anemia

[luckyluss]

Hi All,

My BF is at week 13 on an Incivek trial and  . I haven't seen a case like this so I would like to ask you for your advice:

He is anemic (HGB below 8). He's has been asked by his doctor now to stop Ribavirin completely after several dose reductions (from 1200 to 1000 to 800 to 200).  

We just learned today that he is UND for his 12 weeks and was since week 4 or before.  That is promising so we don't want to jeopardize SVR.

Procrit is not allowed in this trial.  We are thinking that maybe he should quit the trial and continue on his own , with a patient assistance program from the companies that make th Ribavirin and Interferon.  The Procrit may be covered under his french insurance, but not sure of that.

Last possibility is to stay in the trial and accept a transfusion.

Any thoughts?  The last thing we want is for him NOT to cure after an EVR.  Thanks!

[willbb]

sorry ...I re read your post and it looks like he is going to transfuse this coming week...I have never had the pleasure of having one.. hopfully someone else who has will chime in...glad to hear he is staying in the trial

Will

[Trish77]

Sorry, posts crossed over.  So Incivek is done.  Riba is done for now and your b/f is on INF monotherapy until ribavirin resumes.  A one week dosage reduction of ribavirin at this stage is considered manageable (although reduction is different than complete stoppage). I'd want to know how soon the doctor will resume ribavirin after the transfusion.  Your boyfriend's RVR is in his favour.  Good luck.

Trish

[willbb]

luckyluss...thats great...sounds like he is good to go.. and lets hope with Tela out of the mix ..like the doc says HGB. will start to go up and not need to transfuse.

Good luck

Will

[Trish77]

A couple of questions....does the Incivek stop at Week 12 or will he be taking it all the way through to Week 24?  At what hemoglobin level does your boyfriend need to be before the doctor will resume ribavirin and at what dosage?

I would at least go ahead with the trial and accept the transfusion as it will make your boyfriend feel better and get his hemoglobin level up, which will be good no matter which way he decides to go, stay on the trial or go off the trial with PR and Procrit.  That's as much as I'd want to suggest without having the answers to the two questions I asked you.  For example, if Incivek stops at Week 12, then your boyfriend will be on interferon only with no ribavirin, effectively meaning he's on interferon monotherapy until his hemoglobin comes up. So, again, I would at least go for the transfusion to get his hgb up at the least.

In the meantime, just so that you know your possibilities, it would be useful to determine if the option to treat with procrit with Peg / Riba and see if he can roll over seamlessly to continue treatment off the trial.  Do you already have a doctor who's willing to go that route and do you know for sure he can get procrit?  If not, those are unknowns you need to explore before you can decide to step off the trial and I wouldn't wait too long to look into them.  It's not always so easy to stop a trial and roll uninterrupted into treatment and you should find out what your options are.

Good luck with this.

[luckyluss]

Uopdate:  My BF saw his Dr, who will test him again on Monday for his HGB and in all likelihood will do a transfusion that day.  The Dr. siud he wasnt concerned about stopping Riba for a few days because the Telaprevir has already done its job and continuing with Riba and Interferon for the remainder of the 6 months is just like an "insurance policy".

Now that my BF is RVR for real since yesterday offically, the Dr. is much more inclined to keep him on the trial. So we'll stay.  Only 11 weeks left.

He also said the Telaprevir itself causes anemia and since my BF finished with Telaprevir last week, the anemia may subside on its own within a couple of weeks.  So  we hope.  it's been a tough ride so far.

Again thank you for your thoughts and support. I will keep you posted.

Any of you who were transfused- what is it like?

[spectda]

"If it was me ,personally I would continue on with the trial and accept the transfusion as I still believe .leaving a trial once started can have complications down the road. "

+1

[susan400]

Could he get a transfusion from a family member's blood?  Then, stop the Riba for just 1 day and restart it at a lower dose of 600mg?  I'm no doctor, but from past experience, I would be hesitate to leave off the Ribavirin entirely.  It's a necessary component with the Telaprevir treatment.  Susan400

[willbb]

In your original post you said you were considering "quitting the trial" to treat privately with procrit vs. dose reduction.,, however you did mention that they offered him a transfusion....
In you last post you said   I think it will be a good idea to continue privately if they drop him"

If it was me ,personally I would continue on with the trial and accept the transfusion as I still believe .leaving a trial once started can have complications down the road.

However if like you say  it is because they are going to drop him(altho.I don"t understand that as they offered to transfuse)   I would certainly carry on privately with my own doctor ..rather than just be booted to the curb with an RVR in your pocket.

Best

Will

[banarep]

stopping now and getting into other treatment is risky.  can he continue right away or would there be a stoppage of treatment.  if there is a stoppage, then that could hurt his chances all the way.

[banarep]

I was on one of the earlier telaprevir trials.  My riba was cut in half at week 17 from 1200 to 600 for the rest of the trial (31 more weeks) and am still SVR. 19 months after treatment ended.

[FlGuy]

If they are offereing a transfusion. instead of procrit, he should take it.  The main risk is that it might take 18 hours, instead of 12 hours, for him to feel better.

[luckyluss]

My BF was actually UND before 4 weeks (minus 2 days when we did the PCR).  He was UND with a <50 PCR sensitivity.  We learned yesterday that he's still UND and will do 24 weeks wich is great news.  

He is in a trial and he was indeed getting INCIVEK for sure.

Now, should we accept a transfusion? What are the risks?  

At what point of lowering/stopping Riba will his SVR be compromised? I couldnt find any thing online for his case where one is RVR/ EVR and treated with Incivek.

We'll see the study doctor later today and willl keep you posted.  I think it will be a good idea to continue privately if they drop him.  ven though this is a major hospital they dont seem very committed to this cure.  They threatened to take him off ealier because he was complaining about feeling angry.

If all fails I want to have plan B  in place, provate dr. with patient assistance program.  His chances of SVR being that he was RVR are quite good as I unerstand so i'm not that concerned about resistance.

Thanks a million for the support.  Any feedback from those who had transfusion and/or dose reduciotn will be helpful.

[spectda]

I had a point in my Victrelis trial where I considered stopping and continuing with SOC. I spoke with my trial doc who agreed to treat me privately if I went that direction and was honest with me about what he felt would give me the best chance.

I had a friend in the same trial who felt that her doctor was giving her advice that favored the  pharmaceutical companies search for data. Maybe your doc will be honest with you about which direction will be best.
-Dave

[willbb]

Hi Dave.
ha ...I think I may be the one misguided :) as I didn"t know there was no placebo Inc trials going on...Certainly ,as you mention getting the Riba is important ...I was just thinking of my own trial however. and as you know results aren"t always what we hope for...so was just considering things being somewhat complicated down the road for the OP  if they were to have a less than stellar result.

Good to see you Dave...
Will

[spectda]

Hi Will-
I may definately be wrong but I think there is no trial involving Incivek currently where there is an Incivek placebo. I think there is a dosing study (twice vs three times daily) and there may be some trials involving other DAAs. Also if at week 13 they would they would no longer be getting the Incivek.

If it was me I would rather risk not having the info in favor of having definite ribavirin. On the other hand as the wise Cando mentioned it might be too late for adding procrit and more ribavirin.

I am far from an expert or a medical professional so of course this is only my personal thoughts and they may be clearly misguided.
-Dave

[willbb]

"That's exactly what I would do. Your insurance company will most likely approve the procrit quickly, it's less expensive then a transfusion. "

I may not be so quick as my good friend Dave to do this.....given the questions we asked of you above...there are some implications you need to consider.

!) do you know in fact from your own PCR that you were UND. at wee4 so that you know exactly when to stop (week 24 or 48) ? your new doc will not get this info from the trial
2) Do you know that you were definitely getting Tela? They will not tell you till the end .
3) You or your new treating doc will  not be getting any data on any of your results(other than what you currently have) until the end of the entire trial...possibly not for a couple of years.
4)If you happen to have a breakthrough. or relapse..who will do the resistance testing ?

Just some thoughts to think very carefully about..

Good luck
Will

[can-do-man]

They put you in a tough spot there, leaving the trial now and going on your own might not help to much, your below 8 on your HGB already, procrit takes awhile.

Sense you were already dose reducing for some time and it kept dropping i would guess the Incivek was playing a big part in the drop also. If the study will allow you a transfusion that might be your only hope for now. You should be off the Incivek now lets hope your HGB rises very quick and you get back to full dose on your riba.

This is one reason why i worry about treating with Incivek, if they are not going to allow procrit it could effect someone tx wise big time......... Best to you

[spectda]

"Procrit is not allowed in this trial.  We are thinking that maybe he should quit the trial and continue on his own , with a patient assistance program from the companies that make th Ribavirin and Interferon.  The Procrit may be covered under his french insurance, but not sure of that."

That's exactly what I would do. Your insurance company will most likely approve the procrit quickly, it's less expensive then a transfusion.

-Dave

[crossroadsec]

Congratulations on the SVR rate! woohoo! I'd def stay on with UND. Low platelets are draining, and if they offer a transfusion, that would be awesome. I'm sure he's gonna be tired if they don't get him one. I had one last year. I'd take one a month if they let me. I'm gonna watch your posts with interest. Best wishes in making all these choices. Karen

[FlGuy]

After 12 weeks in the trial did they say he'd do 24 or 48 weeks? (you previously said they would tell you at week 12). In addition you said he was getting private PCRs.  If it was me I'd stay on the trial, especially if they were to re-introduce riba, based on hgb gains, and if he continues to be UND in those private PCRs.

[willbb]

Sorry to hear about the BF still struggling witht the anemia.He must feel quite poorly with a HGB. of 8. To what level does the trial protocol go before they will transfuse?

In this trial you mentioned in an earlier post that he is getting Tela for sure...is that correct? Also you say he was UND. at week 4 ..however you say in an earlier post with your oown private PCR done he was at 50. this is probably not UND (RVR) so he would have to do 48 weeks . or did the trial PCR at week 4 say he was UND  at week 4 therefore only has to do 24 weeks?

If you could add a little more info. it would be helpful...

Best ..

Will