Is treatment like antibiotics - I have missed many doses of telaprevir & Ribavirin

[MelonLiver]

HI,

I hate to ask a question about every little worry, but I read that heppers are worried about becoming resistant, or mutations. I had a rough first 3 days and managed somehow to only take one dose (rather than three) of Telaprevir per day on average.
I think this has a lot to do with some kind of 'brain fog' because I swore that I had taken my telaprevir pills 3Xs a day, but when I looked at the pill box, I had only popped out 2 pills x3 over 3 days.
This is an average of once a day!
If telaprevir works like antibiotics, then you take them 3Xs a day to keep up the level in your blood and to not do that, well, thats what leads to resistance and mutations.

I know 3 days isn't forever, but I  read that someone had a viral load of 8 million and got it down to 30 in the first week!?!
If this is the case, it would seem that messing up my first three days could be important.

I'm not irresponsible, I was really in a fog after my Interferon injection, and after staying awake for 48hrs, I passed out for 24hrs, not taking ANY meds that day.

I am going to do my best, best, best to get everything smooth and on track, but I just want to know if anyone thinks that taking the telaprevir or the Ribavirin only once or twice a day for three days could effect the chance that it attacks the virus straight from the get-go?

Please don't think me indifferent by not taking the meds, I really believed I had taken them, and even wrote down that I had, but when I looked, the pills were still there.
I am feeling more coherent now (3days after Interferon) so I hope this doesn't happen again next shot I take.

btw, I know you should have some support, like family or something, but I live in Paris and I only have one person who can even help me, and they will not come to my house, just call by phone (whihc I *hallucinated was someone singing when it rang)

*I know hallucinating sounds severe, but it was a half-asleep while in this confused state, not a 'waking hallucination'

Thanks for any input, I hope I'm making sense when I write :)

[HCA]

The protocol for Telaprevir is very strictly every eight hours.
It is impossible for any of us to speculate what degree of compromise may have resulted.
You are obviously in a Phase 3 trial.
Inform the study nurse as soon as possible.
This does not mean that your treatment will not succeed but it is obviously not helpful.
Don't panic-continue with the treatment but stay on the ball................

[nygirl7]

wow I really hate to tell you but it's crucial you take all of the doses of all of the meds.  You absolutely must be compliant throughout treatment to have any chance of success. And at best then it's a 50/50 thing for a geno1.

They say if you take 80% of the meds 80% of the time ... that that is as absolutely the bottom limit that you can possibly do with having any chance of getting to SVR. The first week is the week you get the biggest reaction out of the medications - yet you haven't really taken them?
'
You have to take the riba twice a day every single day.  
You have to take the shot on the same day every week.  

Sorry ML some will explain it much better than I can while I"m at work and busy but I'd say your chances of success are really pretty slim with this happening. The beginning 12 weeks are absolutely crucial.....and you've already missed so many doses Im not sure if it would be better to stop and regroup and then start again later.

Can't you put on an alarm to remind you about them or have someone responsible call you at breakfast and dinner?  I had to treat for 72 weeks and a few times I got confused and double took them but even with passing out for giant clips at a time I always woke up to take the meds, even if I had to set the alarm on Saturday because I knew I might sleep through the breakfast portion.

I mean seriously it's a hard enough fight to get to SVR but if you don't take the meds you certainly CANT get there.

Good luck.

[MelonLiver]

Like I said, I really didn't MEAN to do this.
I cannot explain to how absolutely out of it I was. I honestly believed I was awake (and I did set an alarm) and took the medication. Like I said also, I even didn't answer the phone because I was so confused, I thought the phone was someone singing to me.

This is NOT a case of me not caring enough, I was sincerely OUT-OF-IT.

So I can't really make that clear enough, nor can I take it back, but I do want to clarify, since you've said:

"I'd say your chances of success are really pretty slim with this happening. The beginning 12 weeks are absolutely crucial.....and you've already missed so many doses Im not sure if it would be better to stop and regroup and then start again later."

Well, I don't know if you are right that it might be better to stop, but when you say I have missed "so many doses", you do realize this is between Wednesday night and Friday afternoon. So thats not actually three days. I calculated it and it turns out to be about 2 days by hours.
So in 48hrs, for example, I should have taken the telaprevir 6 X's but I only took it 3
For the Ribavirin, I missed one of my two daily doses and took two pills instead of 3 the next time I took it.

Do you think that would ruin the crucial 12 weeks you're talking about?
48hrs of being out of it and messing up my dosing?

Anybody please give me your opinions. I have set all the alarms and asked for help to make sure that it doesn't happen again, but I can't take back the couple of days of being out of it. They are gone. :(

[portann]

Get yourself an Ironman triatholon watch, set the three alarms and wear it constantly, and close to your ear when you're sleeping.  Don't turn off the alarm until you see yourself putting the meds in your mouth. You can't count on your Blackberry or laptop the same way as a watch on your wrist. You said your parents are helping you out. Get them to phone you on Skype to insure you're on track. In a couple of weeks, you'll get the hang of it.

Do your best to follow the protocol from now on but please, please, please, inform the trial immediately. So many people are counting on the most accurate conclusions possible and this may mistakenly influence the outcome.    

[nygirl7]

I calculated it and it turns out to be about 2 days by hours.


Yeah that's really really REALLY too long to miss your meds - but I think you have to really realize this already.  There is a reason even that we have to take the riba twice a day - let alone not for almost three days!  That's WAY over 12 hours!

I can't imagine anyone here thinking that three days worth of meds not be taken is not a problem.  Report it to your study nurse immediately you really have to at this point.

Nobody can tell you you have not hurt your chances, I'm sorry.

[Fl_Gator]

I am in the trial same trial. I was told that missing a dose could result in mutation. You should be having bloodwork done every week for the first 4 weeks and every other week for then next 8. If there is any hint of mutation you will be pulled off of the meds.

Gator

[NJDrummer]

Wow. I never heard of this mutation stuff.  Just another thing to add to my worry list..

Melon...no need to be so defensive...you posted about missing doses and people are sharing their thoughts with you..Rather than getting defensive, just do your best to step your game up.  I made a microsoft word pad detail of the day I took my first meds and the times that way I don't forget...also wrote in on calender...

If you are that out of it...get a notepad next to your meds so you can jot down when you are taking them so you don't have to rely on memory.

[MelonLiver]

LET ME START OVER:

I had a 48hr period - not 3day, as I cleared up already.
In that period I missed what amounts to 1 Ribavirin dose and two telaprevir doses.

I was very much out of it and it could be a possible strong reaction coupled with some other factors that I don't want to drag out, but believe me, I am doing everything I can to make sure the circumstances don't repeat.

I wanted some helpful advice and I always welcome honest talk and opinions.
However, if it were me, I wouldn't want to be responsible for making someone feel hopeless about their situation.
People go through a lot mentally, enough that they are studying the link with Interferon and suicide. In these circumstances, I don't think it's needed to really pound home how hopeless someone is based on some missed doses.

i take my life and this treatment, as well as everyones situation, very seriously, and I care just as much as the next person. I would like to get and give constructive and uplifting advice and also be real, but not seal someones fate based on my amateur opinion.

As for missing a dose will cause mutation, well I guess I am dealing with different ideas here in France, because it ws explained to me that if I am late for a dose, simply ignore it and take the next one, because double dosing wasn't worth it.
I can't see why they'd say that if would cause a mutation.

I'm sure people mean well, but try not to get frustrated with human situations and be supportive, as I will be with you given the chance.

Thanks  

[meNtoby]

If it is different in France, and you believe it will be alright, why are you asking for opinions on the mistake?  All you can do now is call the study nurse.  Maybe she will tell you that you were given the "sugar" pills, and not to worry about it.  

[sunqueen]

My gosh, I'm confused.  We went from maybe messing up few first days of tx to SVR. Maybe I need a shot and a nap.

[Bobby1952]

   I am confused too. If this person is SVR why did they even post about missing dosages? Weird ! Everyone was concerned about this person and they are SVR.

Bobby

[Isobella]

I'm with you sunqueen :-)

Melon:  I am in the same study also-week 9.  I was given 3 different devices for timers and drug diaries that are mandatory to fill out.  So that pretty much takes the quess work out of it for me.....tho at my appt last Wednesday, when I handed in my empty pill card--there was a dose still in it.  My nurse and I about fell over!  Not good...I have no excuse why I did that.  She told me that after 4 hours, you have to skip the dose.  

You really do need to call your study nurse immediately and let them know what is going on.  Because this drug is so new, while promising-there is an unknown so really all we can do here on the forum is speculate. It is known though that timing is crucial.  Post their response, so that way we will all learn :-)

I truly wish you the best and do keep us posted.

Isobella

[Isobella]

I know this has to be tough on you...being in another country without a strong support net.  

If ya get overwhelmed and need to talk...feel free to pm me anytime. I know there is a time difference between us, but I am usually lurking around somewhere.  

Do, please keep me updated.  :-)

Isobella

[ladywhy]

Hey...you made a mistake..now it's time to move on and catch up with your nurse. I hope all goes well.
I know little about the trials but I do know how these meds can mess with your head...it's real important to talk to the nurse about that too.
I also know how hard it is to do this tx alone..... though at the same time...I can't imagine having to deal with many people at this point.
God has gotten me through....alot...
it seems like I have been doing it forever, actually 19 mos.
Like Isobella, I feel for you...pm anytime.... I would like to help.
Yonne

[ladywhy]

oops, that's Yvonne (lol)

[cigaso]

Hey gator girl get rid of the gator ****. It's very offensive!!! I don't care what pagan god  you worship.

[MelonLiver]

To basically address all the responses:

Thanks for your input, and I get the message loud and clear that it is very important and serious when doses are missed.

Thats all I needed to know.

To this comment:
"If it is different in France, and you believe it will be alright, why are you asking for opinions on the mistake? "

I never said I 'know' it will be alright, I simply am saying that giving me the feedback that it's something to be concerned about is enough. I don't need it to be beaten over my head and told I should give up hope because there's no chance it could work for me now (and that was said, read the earlier posts)

So far from "knowing" it will be alright, I just am saying that with the fact that I can do nothing but my best to make sure I don't miss anymore doses, I would like to have positive attitude and "try to believe it will work out"
-- This is different than believing it will be fine as in I didn't want opinions - just trying to be a positive thinker since I can't turn back the clock.

The thing about France having a different idea was just an observation in response to someone saying they were told that a single missed dose will cause a mutation.
I simply said that the doctors and nurses here gave me a different impression.

I think I joined this group at an emotional time.

I appreciate the feedback, I asked because I wanted to know, I accept what was said, and now I am trying to make the best of the days ahead.

Thats all :)

[jmjm530]

1. Tell your study coordinator
2. Come up with a different system as your current system is not working. Can you get help from a friend or family member? What about a log book? This is used by truck drivers and will wake the dead: http://www.the-perfect-present.com/Pages_SCRM/Screamin_Meanie.html

[Marcia2202]

Jim,

The way I understood is that she missed her doses because she had such a strong reaction to the first shot, couldn't sleep for 48 hours, then crashed with her alarm next to her pillow and didn't wake up for 24 hours. Even when the phone rang, she thought someone was humming or singing. She was in a complete fog for 2 days or so. She also logged taking her meds, but somehow didn't take them.

I think the screaming meanie would have probably been the only thing which could have helped.

She is in a foreign country with no relatives at all and has only 1 person who is willing to check on her and that is ONLY by phone. And probably if it's convenient.That is practically like having no one at all.

It looks like she is alright now, but I am actually worried for what will happen after the next shot and I will ask her to give me her number if she wants to. We are in the same time zone and it will be nothing for me to call and be insisting... the friend calling in might not realize the importance of it.

[Marcia2202]

If you want me to call you, especially on days of your shot and afterward, I'll be glad to do so. I have skype and call all over the world with it. It costs nothing to call to France, US, and a whole bunch of other countries with skype. Cheaper than a local call for me here. So don't worry about that. And it won't be any trouble for me either, as I am at home all the time.  You can give me your meds schedule and I check up on you every 8 hours or more on those days you need it. We can pm each other about the details.

Marcia

[jmjm530]

I think the screaming meanie would have probably been the only thing which could have helped.
-------------------
Yes, it would have gotten her up but given all she said, only a person physically there would have made a difference. Phone support only works if the person at the other end both hears the phone, picks it up and processes the information properly. Missing the trial drug AND ribavirin for several days early in treatment is not a very good sign. She really needs someone physically around and if that is not possible then the real possiblity exists that treatment will fail.

[Marcia2202]

Well, let's hope she will not have the same reaction to the second shot. If not she could maybe ask the hospital to send a nurse or to be admitted for a few days after each shot, until they ease up. It is impossible to know how one will react, especially after the first shot.

Marcia

[Trish77]

You absolutely should be reporting your reaction to your interferon to your trial team.  If you are in a fog that severe for a full 48 hours after the injection and then passing out for 24 hours and missing your dosage they need to be aware of it BEFORE you take your next dose so that they can work WITH you to take proactive measures or perhaps assess your suitability for these drugs.  Side effects and reactions to the drugs are monitored stringently on a trial and recorded and become part of the data.  Adherence to the dosages is also very important and your trial team needs to be aware of ALL of this.  It's not enough to hope that the next dose goes better.  The early stages of the trial are particularly critical both from a data, adherence and outcome perspective and I would inform your team and work with them on this.  They may have strategies that will help also.  My two cents worth.

Trish

[Kristina538]

Having experienced major sleep deprivation in my first week of txing, I can appreciate how 'out of it'; your were after your first shot.   I could hardly function and hardly think, I was fragile, exhausted and very stressed.

I've had slight brain fog since and feel a little 'once removed' occasionally, but nothing compared with how I was without sleep.   I was very pleased my partner and son were around or I wouldn't have known what I was doing.   Once I had some sleep meds everything improved to a level I could cope with.

I hope you can speak with your nurse who will be able to tell you statistically where you lie;  try not to stress, you CAN do this and CARRY on until you get advice from your medical team.   God bless..

JmJm/Marcia  -   You are speaking in 'third person' lol - did you notice??   I think 48 hours without sleep is more sleep deprivation than 'shot reaction'?....   I don't know whether mine was from the riba or because my thyroid jumped up (within limits but it did jump)... but the lack of quality sleep was an absolute killer for cognitive function for me....

[geterdone]

How do you feel now with taking your interferon? Don’t much care about what you missed but what is happening now. I went through a similar experience when first starting treatment with two shots in the same week and not much recollection of except it was Tuesday morning before being some what coherent again. It is very hard to explain what happened during that time; like being displaced in time between two worlds, although I didn’t pass out it sure felt like it. How do you explain that to the doc and even more so trying to get him to understand? That was the first and only time it happened during my treatment, good luck going forward and please consider taking Marcia up on her offer to keep contact with you and keep posting here it is a life line.

jasper

[Trish77]

"How do you explain that to the doc and even more so trying to get him to understand? "

I'm sure there's a way, jasper.  On a trial it's important to have adverse effects recorded, in my opinion.  Particularly if it identifies a trend. Certainly the rash issue with Telaprevir was identified that way.  I know my trial co-ordinator is meticulous about those things and it's definitely one of the considerations when evaluating whether one goes into a trial.  I personally feel there's a certain amount of responsibility on the part of trial participants when you sign on that line and it's knowing where to draw that line.  

[geterdone]

Agree 100% if your in a trial, and am sure they will follow up very closely given the circumstances. In my case, I was not in a trial and treating with a GI doctor who was more interested in his female patient’s experiences than what I was trying to relate, my bad but live and learn.

jasper  

[Marcia2202]

FYI, Melon did her 1st shot on Wednesday the 24th. So she just started treatment a few days ago.

marcia

[geterdone]

The 24th of Sept? if so, the missed doses are not too much to be concerned about in that the interferon can be caulked up as a pre dose.

Thanks! was not sure how soon Melon started treatment. I am kind of cringing here given Melon’s reaction to her first INF shot after getting a glimpse here of her last shot. I know now this is not a normal reaction from my own experience and just a tad concerned here for her.

jasper

[Marcia2202]

So am I. I hope she will chime in soon.

marcia

[Marcia2202]

Are you alright?

Marcia

[Fl_Gator]

Really? you must be an Ohio State fan.

[gonzoreno]

dear melonliver ,please ,please, do not be a fool, i did three and of half years
of standard interferon+riba, peg-intron+riba, double doses of peg-intron for 6
months, all kinds of supplaments (dr. approved) like amandadine, i injected
a inch long needle almost to the bone full of vitamin c for awhile.. the lowest
my viral load at the end was 160,000, they did not have telepravir then....telepravirs
first clinical trial cleared the virus in two to three days, don't worry everybody hallusinate's
(see's thing's that are not there) DO EXACTLY WHAT THEY SAY UNLESS YOU WANT  TO WAIT FOR A LIVER TRANSPLANT, DON'T WHINE YOU HAVE A BETTER
CHANCE THAN ANYONE TO CLEAR IT, if you can't sleep get your doc to give you some ambian you will get a good buzz when you sleep, but ambian IS ADDICTIVE             hang in there you don't have so bad.....GONZORENO

[jackal80]

Hey if you think thats bad...... I missed 3 months of ribavirin, because of forgetting. I never forgot the interferon, i always poked myself on fridays, sometimes, i'd be away from home and have to take it saturday or even thursday. I'm horrible with pills. always have been. no alarm clocks worked for me, cuz i would just shut it off when it'd go off. I'm SVR and have been for a year. So don't worry about explaining yourself to everyone. I am a nurse and every liver and every body is different. Everyone has a different viral load, and some are sicker than others. Some lead a "fast" kind of life and therefore cannot seem to maintain svr. I got Hep C from grabbing my biker dads razor when i had to shave my legs before goin out on a date. NICE DAD. LEAVE YOUR RAZOR OUT SO YOUR TEEN DAUGHER CAN USE IT AND GET A DISEASE AT 18 YEARS OLD. Can you tell i'm bitter. 9 years later i find out i have hep c and asked if i shared razors or toothbrushes. yup, only did with my dad that one time!!!! I had an 8million viral load at 27, and now at 29 i'm a nurse, and i'm free so far. Dont worry about it. If your SVR your good to go for now. It was hard for me to remember all those meds. I worked full time, went to school full time, was a wife and mother. I was gone 89 hours a week, going thru the horrible side affects while working, going to school, being a mom, being sick, losing my hair, being a wife, studying, sleeping, and hating everyone. Just take your meds as soon as you remember, never double dose, and ur fine.