Telaprevir Trial: Refused Procrit but Dose Reduction in Half: Is That Dangerous?

[luckyluss]

Hi,  Next in the treatment journey:  At 10 weeks, my BF is anemic, is in the Telaprevir / Incivek Trial.  He's getting weaker by the day with constant dizziness, now he can hardly stay up.  The Dr. has prescribed last week a dose reduction of Riba from 1200 to 1000.  At that time his HGB was 9.6.  Now seeing the anemia is getting worse, he told him to reduce to 600. I dont have the latest lab results yet.  The Dr. told him Procrit was forbidden in this trial.

Now I'm getting scared of 2 things:
1. that his SVR may be now in jeopardy although he started with RVR at wks (we did our own PCR)
2. that it keeps getting worse and gets taken out of the trial

Also: He has infections in his mouth, throat. Anyone can chime in with experiences or advice?  Thanks!

[luckyluss]

Thanks - just curious, how come you did 48 weeks if you were UND at day 20?

[Isobella]

Sorry to hear of your BFs anemia.  I was in a Telaprevir trial and UND at day 20.  At week 7 my peg was reduced to half for about 6 weeks.  I did 12/48 and am still UND almost 2 years later.  I realize youu're asking about riba, but my point is that having the RVR and the added punch of incevik....I think the odds are in his favor.  

I also once gave myself the full dose and then did a "oops, I forgot to reduce, sorry" afterwards.  

I did make a back up plan with an out of study doc during that time, though.  At least that way I could have continued SOC if I got dumped from the trial.  My insurance wouldn't have covered it, but I figured I would deal with that issue after my SVR came in.

Good luck to you both

Isobella

[luckyluss]

He was not detected at a few days before 4 weeks with a <50 PCR test his private Dr. did, which I know is not the most accurate but still counts.  Right? Is that considered UND?

Now waiting on the 12-week visit next week, and then hope that we can hear that there are only 3 months of treatment left!  And Incivek will be over too in any case.

[lapis]

Hi, sorry to hear your BF's having such a hard time.  Just wanted to share my experience as well.  I developed anemia at 3 wks on triple tx.  Out of the 24 wks I did tx, I was dose-reduced to 600mg Riba for a total of 7 wks.  I was worried after reading on this forum that Riba shouldn't be reduced but it seems less important with the PI's, at least with INC.  And it seems that anemia is actually a good sign on tx, that the drugs are working.  He'll be ok as long as his Hgb gets back to 10.  It feels like crap but it gets better when the INC is discontinued at 12 wks.  At what week was he UND?

Hang in there!  Wishing you the best...
Lapis

[luckyluss]

Thanks for your thoughts and support.  We're in a trial because he really needed to get treated and didn't have health insurance (except a French coverage that covers basic stuff for expats), and at that time Telaprevir hadn't been approved yet. So it is a blessing he was able to get these meds for free. I will say that the trial people are nice but rather unhelpful, they never have any advice on how to manage a troublesome side effect except for the anemia - hence the dose reduction.  All the other info, including doing your own PCR, what to ask for at he Dr's, etc, I found here.

If things dont improve, I thought of asking for patient assistance program for the rest of the time on SOC, but will wait and see what's up next week.  I will keep you posted.

[Willy50]

In general, riba doses are to be avoided, especially in the first 12 weeks.  At this point you are nearly now past the 12 weeks.

Further, you're in a trial; it's part of the deal; no rescue drugs (in this one anyway).  Not much any way around it.  You can drop out of the trial and see if you can continue w/out missing a beat, then see if insurance will pick up procrit, but it may or may not.  Out of pocket you may need to sell the farm, it's kinda pricey.

Chances are you will have coasted through the telaprevir phase and when you hit the 2 part SOC phase your anemia will improve/ body adjust some.

I guess I'm saying that you may be fine in the trial from this point on, although treatment may still be very hard.  It is different for everybody and different each time even.  Triple therapy is harder than SOC, but at this point the worst may almost be over......

willy

[paen53]

I did 72 weeks like nygirl and the mouth ulcers were the bane of the last half of tx, but were one of the first to disappear. MM helped to numb the pain, but not make them go away. Ended up having to eat mainly soft foods - chilled applesauce was my go-to food - also yogurt seemed to help. If you're having probs with ANC's, watch for infections.

Good luck with the PCR next week!! Keep us posted and hang in there, both of you, Pam

[nygirl7]

The Magic Mouthwash didn't work for me, the ulcers on my tongue drove me crazy the whole 72 weeks of treatment - thankfully though about 2 weeks after treatment they were all gone. They are caused by the interferon so you can see once it is out of the body they'll go away.

The anemia just s.u.c.k.s. sorry that he is experiencing it.  If you know a hemotologist you might be able to get the procrit that way - why is he doing a tela trial when it's already been approved by the FDA???

[luckyluss]

Thank you all for your responses.  Next week is the 12 weeks PCR and we'll know whether he's in for 6 months or 1 year.  How long did you all treat for? It seems like when a side effect goes away, another one goes to replace it...the Magic Mouthwash helped some, not much.  Thank you though for your encouragements!

[copyman]

I was also in a Telaprevir study and reduced riba at 13 weeks because of anemia.  I had done my own pcr's and knew I was clear since 3 weeks. I only reduced for a few weeks that when HGB came back up I went back to full dose. I ended up being cured.
If dose reduction is done after 10 weeks or more you have built up enough the riba which has very long half life and stays in system for a long time. Chances are this will have no effect on chances of being cured.
Better to dose reduce then get thrown out of trial for anemia.
He will feel much better after a few days of lower riba. Once that HGB starts climbing back up he will feel like a new man.
He should get back on the full dose as soon as possible.

Best of luck

[Tippyclubb]

I was in a Telaprevir trial two years ago and no rescue drugs were allowed.  I started out taking 1000 of Riba but in my 12th week I was Riba reduced to 600 for 6 weeks, and then they increased it to 800 for 5 weeks.  It took 11 weeks of Riba reduction for my hgb to rise over 10.  Like you I was very concerned the reduction would jeopardized my SVR, but it did not.  I was UND by week four and remain that way two years later.

[can-do-man]

Theres some stuff the doctor can order its called around here 'magic mouthwash' that should help with the mouth and throat issues, nobody likes the dose reductions but sense its a trial not much can be done there. Hopefully it brings up his hgb and they increase his dose again soon. Being he was RVR data has shown his odds are still good, from prior trials people being forced to stop was quite low do to anemia......... Hang tough!

cando