Aa
Unexpected physical problems
Wow! I had some whammy stuff happen over the last couple of weeks. I started the riba, interferon and telepravir study on January 9, 2009. Did ok until a little over a week ago. Thursday (3-12-09) I went to have blood drawn, went to pick up my 2 1/2 year old afterward, took her to a mexican restaurant to eat as she likes the refried beans. I ate one cheese enchilada. I started feeling reeaaallll bad inside the restaurant, got out, got the baby strapped into her seat in the van, turned around, puked and the next thing I knew some kid was helping pick me up off the parking lot in the rain as I'd passed smooth out. He and some others tried to confine me and call an ambulance and I freaked out, fought them, raised hell and got out of there. Ended up with the police behind me, who ended up following me the rest of the way home to make sure I made it ok (I was lucky enough to know the officer). My RBC was 7.1 and they did a transfusion. I haven't taken ANY of the meds since then and feel almost alive again but am supposed to start the riba and interferon again tomorrow if the blood they took today warrants it. They won't let me start the telepravir again as the study prohibits it after a break in dosage. Anyone else had any crazy reactions to the study/treatment?
I really have appreated y'alls participation in my post. I don't know what to say from here except that the doc called yesterday (Saturday) and said to do my interferon and to start a reduced dose of riba. If anyone is ever in the Baytown, Texas area (Mont Belvieu) on the east side of Houston look me up ( ***@****). I'm a single dad and i'm sitting here with my sweet little 2 1/2-yr-old interacting and watching Winnie the Pooh over and over until I'm blue in the face. Makes it all worthwhile.
A bright note...the PI drugs are very powerful and effective is eliminating the virus...so you may be make it to SVR still..what are you stats?...low viral loads are minium liver damage before the start of TX helps alot with SVR...and also if your BMI is normal...there still is that chance you may be cured...alto maye not high,but still
Im really sorry this happened.. you must have been in the end of the 10th week.. 2 more weeks the Telaprevir would have been drop anyway.. there is no telling what their going to do.. i hope u reached UND, are still UND and they let you continue with SOC...
Thanks for clarifiying the international protocol re Procrit.
The reason I mentioned the option of treating privately is because it was stated that Telaprevir was stopped because of study protocol.
So, if no Telaprevir and no Epo, then I dont see any more advantage in treating within the trial and in fact I see a disadvantage being the inability to access Procrit. Procrit would be allowed privately along with unblinded blood results.
Of course this assumes that the Telaprevir is indeed dropped and that it's financially and logistically feasible for Gypsy to find a good hepatologist to treat privately with. IF not, then by all means go ahead with the trial doctor -- sans Telaprevir if that is the case -- but I would still go outside the trial for at least some more reality checks in terms of current viral load tests unless the trial is willing to do them now, to identify any breakthough as you mentioned.
The reason I mentioned the option of treating privately is because it was stated that Telaprevir was stopped because of study protocol.
So, if no Telaprevir and no Epo, then I dont see any more advantage in treating within the trial and in fact I see a disadvantage being the inability to access Procrit. Procrit would be allowed privately along with unblinded blood results.
Of course this assumes that the Telaprevir is indeed dropped and that it's financially and logistically feasible for Gypsy to find a good hepatologist to treat privately with. IF not, then by all means go ahead with the trial doctor -- sans Telaprevir if that is the case -- but I would still go outside the trial for at least some more reality checks in terms of current viral load tests unless the trial is willing to do them now, to identify any breakthough as you mentioned.
Sorry, I left out that I didn't take my interferon or Riba anymore beginning last Friday after the incident the day prior on Thursday. I spoke to my medical people on Sunday and they told me then to stop the Telepravir as my RBC was too low and to get the transfusion the next day Monday. So, I've been off of the interferon and ribaviren for one-week and off of the telepravir since a little less. It was all agreed upon/suggested by the medical people.
I figured that was the reason why you got upset...you were proberly more pi.ssed off that anything else,i just wish and hope you can maybe be still UD and maybe be able to keep on a lower dose RIBA as so to keep you on track...
It's an international study ;
http://clinicaltrials.gov/ct2/show/NCT00703118?show_locs=Y#locn
Same rules for all 111 international locations.
It kind of matters who made the descision to stop the telaprevir-best not to decide anything unilateraly 'cos if you step out of line you are 'dirty data' so to speak.
Also we don't know when this person commenced telaprevir as half of those who get the real drug get a four week placebo lead in.
This is all a bit regretable as I don't know how 'treating privately' would interface with Vertex providing the SOC drugs.
My instinct would be to resume SOC asap and hope that some benefit had been derived from the telaprevir experience.
Once this person gets breakthrough it's the end of the waltz anyway.
http://clinicaltrials.gov/ct2/show/NCT00703118?show_locs=Y#locn
Same rules for all 111 international locations.
It kind of matters who made the descision to stop the telaprevir-best not to decide anything unilateraly 'cos if you step out of line you are 'dirty data' so to speak.
Also we don't know when this person commenced telaprevir as half of those who get the real drug get a four week placebo lead in.
This is all a bit regretable as I don't know how 'treating privately' would interface with Vertex providing the SOC drugs.
My instinct would be to resume SOC asap and hope that some benefit had been derived from the telaprevir experience.
Once this person gets breakthrough it's the end of the waltz anyway.
I did the combo (riba & interferon) about 6 to 6 1/2 yrs ago and was taken off as a non-responder after 6-months. I'd gotten too sick and elected to reduce the riba on my own. As a result, my count went back up. This time around, my liver function tests and biopsy did not look bad but I requested to participate in the study as I am 52-yrs-old and the treatment is not going to get any easier. The study prohibits rescue drugs such as procrit, I've asked for it. The results are blinded but I was told during my blood draw today that they should be able to find something out in a couple of weeks since my study participation is changing due to the recent problems. I am participating in the study through a renouned liver specialists group in Houston. I have the utmost confidence in them as they have seemed to be on top of things. They've been monitoring my RBC and it went from 8.4 two-weeks ago to 8.1 then 7.1 withing a few days. At 8.4 they sent me to the hospital for a transfusion but the hospital wouldn't do it saying the risk-VS- benefits factor doesn't warrant it until in the low 7's or less. They got me right back in for the transfusion at the 7.1 discovery. They are supposed to call me tomorrow after seeing today's blood draw results to tell me to start the interferon and riba again or not. As far as wigging out after passing out, I think I was just delirious and when the people tried to "make me" wait on an ambulance and tried to block me in, it triggered my fight response. I've never been much of one to comply with someone trying to tell me I have to do something. Used to be quite the wild and ...let's just say WILD type. Been clean and sober for almost 25-years though (8-4-84). I sincerely appreciate your responses.
Is that UK Telaprevir trials or all? I ask because I thought some here were allowed Procrit but that may have been with Boceprevir, havent really been following the new trial protocols that closely.
He does say "They won't let me start the telepravir again as the study prohibits it after a break in dosage' -- so if true, then it really doesn't matter if they took him off the Telaprevir or he did it himself because going forward it sounds like they won't let him go back on it. If so, and if no Procrit, then maybe he's better off treating privately. What do you think?
All the best,
-- Jim
He does say "They won't let me start the telepravir again as the study prohibits it after a break in dosage' -- so if true, then it really doesn't matter if they took him off the Telaprevir or he did it himself because going forward it sounds like they won't let him go back on it. If so, and if no Procrit, then maybe he's better off treating privately. What do you think?
All the best,
-- Jim
To those who have asked I would like to confirm that procrit or similar are not permitted in the current telaprevir trial.
This is because Vertex want clean data on the effect of telaprevir on haemoglobin level.
Blood transfusions are however permitted.
I am surprised that this person had reached hgb of 7.1 without intervention by her study doctor as the trial protocol requires very frequent blood draws.
As someone else noted,it is not clear in this case whether the suspension of telaprevir was unilateral on the part of the patient or was enacted by the trial sponsor.
This is because Vertex want clean data on the effect of telaprevir on haemoglobin level.
Blood transfusions are however permitted.
I am surprised that this person had reached hgb of 7.1 without intervention by her study doctor as the trial protocol requires very frequent blood draws.
As someone else noted,it is not clear in this case whether the suspension of telaprevir was unilateral on the part of the patient or was enacted by the trial sponsor.
Wow that is so scary I'm so sorry to hear this happened to you. Be CAREFUL on stairs and stuff - if they won't let you have Epo how can they let you back on the riba then how can you get SVR! Have you treated before or you just starting out tx naive on a trial? If so you might want to rethink that and see if you can get into a hep doc and do SOC so that you are able to have the rescue meds. I could not have made it through tx without them myself, I completely understand because I fainted in the shower (OK not as drastic as mexican food making me faint but...I know that feeling and it's horrible! ;) (just kidding)
Nightmare!!! but at least you were ok and the police made sure you and your child were looked after. You must live in a wonderful town for them to be so helpful. In the end that was the most important part and thank God it didn't happen while you were driving or carrying the baby on stairs or something.
I wish you all the best and will be looking to see what happens!
Nightmare!!! but at least you were ok and the police made sure you and your child were looked after. You must live in a wonderful town for them to be so helpful. In the end that was the most important part and thank God it didn't happen while you were driving or carrying the baby on stairs or something.
I wish you all the best and will be looking to see what happens!
Did they put you on Procrit (epo) to help with anemia in the future? Is it allowed in your trial?
If they wont give you any more Telaprevir, and they won't allow Procrit, and if finances allow -- then you might want to get a consult with a liver specialist (hepatologist) outside of the trial to re-evaluate where you're at and then have the option to continue on with helper drugs like Procrit.
Hope you feel better soon.
-- Jim
If they wont give you any more Telaprevir, and they won't allow Procrit, and if finances allow -- then you might want to get a consult with a liver specialist (hepatologist) outside of the trial to re-evaluate where you're at and then have the option to continue on with helper drugs like Procrit.
Hope you feel better soon.
-- Jim
I would venture that you are in the final tx failures study with Telaprevir? (or are you in the final naives trial?)
You didn't make it clear when or that you stopped dosing TVR or how long the discontinuation was, whether it was your idea, theirs, ect.
That is too bad that you cannot continue with triple therapy and that you had a disruption in dosing and therefore an end to triple dosing regimen.
I would do a private PCR to see where you stand. Am I correct that they will not share the results with you because they are blinded?
I have to wonder why they let your reds get down so low? Have you done a reduction in RBV or IFN or still on full dose? Am I correct that they do not allow "rescue drugs" in the trial or can you say?
Kind of late but I wonder if they had either allowed rescue drugs or if they had simply cut back on your riba...... you would not have needed the transfusion and you might still be on all 3 drugs.
GET a PCR and see where you sit. IF you are undetectable you may need to stay that way even if it takes going on rescue drugs, trial or no trial. If you have detectable HCV RNA at this point you may be unlikely to clear especially if your riba is reduced.
You may discuss your private PCR results with your doctors and see what they think; what is your best course of action?
That is my reaction. Sorry that it is not upbeat. It is possible that you have cleared and may maintain that status and SVR from this point however. As mentioned; if you are *clear* work hard to maintain that status.
best,
willy
You didn't make it clear when or that you stopped dosing TVR or how long the discontinuation was, whether it was your idea, theirs, ect.
That is too bad that you cannot continue with triple therapy and that you had a disruption in dosing and therefore an end to triple dosing regimen.
I would do a private PCR to see where you stand. Am I correct that they will not share the results with you because they are blinded?
I have to wonder why they let your reds get down so low? Have you done a reduction in RBV or IFN or still on full dose? Am I correct that they do not allow "rescue drugs" in the trial or can you say?
Kind of late but I wonder if they had either allowed rescue drugs or if they had simply cut back on your riba...... you would not have needed the transfusion and you might still be on all 3 drugs.
GET a PCR and see where you sit. IF you are undetectable you may need to stay that way even if it takes going on rescue drugs, trial or no trial. If you have detectable HCV RNA at this point you may be unlikely to clear especially if your riba is reduced.
You may discuss your private PCR results with your doctors and see what they think; what is your best course of action?
That is my reaction. Sorry that it is not upbeat. It is possible that you have cleared and may maintain that status and SVR from this point however. As mentioned; if you are *clear* work hard to maintain that status.
best,
willy
That is one heavy duty experience,sorry to hear that,you say you freaked out and stuff,was it because of the drugs?...did the drugs cause the mad reaction?
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