What are my options now?

[Diana66]

I pretty much threw up everything yesterday: 2 doses of Telaprevir plus my evening Riba. It took 90 seconds to have the tablets out. I have taken yesterday: Ondensatrone, Buccastem, Ginger, Anti nausea homeopathic spray, sea sickness bracelets. None of them worked.At least I did not throw up my 3 Riba yesterday morning. So today is 8.05, didn't take yet any tablets, didn't take Tela last nigh or today at 6.30 am. I am getting ready to try and eat something and go for Riba again. I am still very nauseous and stomach is quite upset, not to mentioned the headache. Gall bladder feels a bit better though

I was able to drink a bit of soya milk through the night. Yesterday I couldn't even hold the water down.

So what are my options now?

[Dannyboi7]

Sorry to hear about this whole mess Diana,hope it works out for you.

[hrsepwrguy]

Sorry the # didn't work for you, I know you are NZ but was hopng that the human side of the equation was more important than the money side, I guess not which is a shame.

Wishing you all the best

[Diana66]

ok, I have tried the hot line and they are not allowed to take international calls... duuuh....

The service is only for US.. as we here in other side of the world do not put money in their pockets..

She could not comment at all on nausea symptoms, she did not know anything about the length is taking for the drug to get into the blood stream...

All good, Mon here so will have access to the nurse and the doctor today. After checking more material, is seems that resistance is referred more into the context of someone retreating after that person did not achieve SVR.

Even with that appears to be a difference between Genotype 1a and 1b. 1a creates resistance easier than 1b (something with one nucleotide versus 2 nucleotides needing to change )

[Ironpony]

I was pretty sick the whole time on Inc and had to change everything I ate often. If I smelled peanut butter I was running to the bathroom.  

I also found that if I woke up and took my zofran too close to my fat feeding I would get sick before I even took the Incivek...So I messed around with the times and between that and finding the right foods I made it through.

This is probably a really stupid question...I am just curious...Is there any rules against someone in Diana's position doing Vic later if she has to stop Incivek now and continues on Peg/riba?    

Diana I am sorry you are feeling so sick, I hope everything works out for you...I do suggest calling this 24 hr vertex number Hrspwguy provided.



Laura




Good luck to you

[hrsepwrguy]

"I had more like 5 doses. One full day with 3 and second day with one lost after 4 hours and another one went to the floor in 3 hours"

Clinical Pharmacology
The pharmacokinetic and pharmacokinetic/pharmacodynamic characteristics of telaprevir have been studied since the start of the clinical development program. Telaprevir is orally bioavailable and should be administered with food for improved exposure. After a single dose, the terminal elimination half-life is approximately 4 hours, and
at steady state, the effective half life is about 9 to 11 hours.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562

I think it would be safe to say she absorbed the meds of all 5 doses

[hrsepwrguy]

Common side effects of INCIVEK in combination with peginterferon alfa and ribavirin include:
itching
-----nausea------
diarrhea
-----vomiting-----
anal or rectal problems, including: hemorrhoids discomfort or burning around or near the anus itching around or near the anus
taste changes
tiredness

http://pi.vrtx.com/files/usmedguide_telaprevir.pdf

[hrsepwrguy]

855-546-2483 is nurse 24/7 hotline

Call this number and choose option 2, leave your number and a nurse will be in touch with you within 30 min, I tried it and it works.

Have a great day

[can-do-man]

I read people here say that this reaction is not normal with incivek but yet they seem to think that was the problem....... Could somebody clue me in please?

[Diana66]

Tried to call Vertex on the number you posted but is not a 24/7. Is only an 8am to 8pm Eastern time Monday to Friday

Looks like I have to go with what was recommended it.

[orphanedhawk]

The reason to call Vertex is you may not be the only person with this reaction.
They may have better suggestions than your doctor who is not as experienced with the medicine as they obviously are. The other reason, is if your reaction was unusual, they need to be told.

I should remind you that not everyone will remember that you are in New Zealand. We tend to think everyone on here is from the US unless they remind us.

Good luck with going forward, whatever you do:o

[Diana66]

Why call Vertex? I guess I am not trusting the advice I got here. Yes, the doctor suggested to have a 2 weeks lead and then reintroduce Telaprevir. I had more like 5 doses. One full day with 3 and second day with one lost after 4 hours and another one went to the floor in 3 hours
They want to see how I respond to Interferon and Riba and if my body settles. I had no nausea today and I managed to hold down the Riba in the morning. I am not really great but is ok.

But from what you guys are saying restarting Tela is not really a possibility as it is never recommended to be restarted. I know that the doctor said is ok but they treated only another 9 people and none of them had this reaction.

For some reason I think that all the fatty food was the reason for the sickness. I think I went a bit overboard having lots of fats and my gall bladder was just not happy. Today all is like nothing ever happened!!!!

I think I desperately want to believe that I can restart Tela now. As for calling the US number, well it is always good to know another opinion and challenge the doctor

[can-do-man]

I am really surprised that they don't mention the Interferon as the main side effect is flu like symptoms that include nausea and vomiting and mainly occur within the first 24 hours of the shot. Plus add that this was your first shot on top of it.........

[Diana66]

Well it is weekend here in NZ and everything is closed. I called Incivek in NZ on Fri and the only thing they said is that they will write down my side effects in their database and that they might contact my doctor to follow up...Idiots!!! I will try to call US line

The specialist nurse called the doctor yesterday and he said that since I took it only one day I should stop it and have a 2 weeks lead, see how I go and then reintroduce it once my body settles. Crazy???? This is very unusual..

I called the specialist pharmacy and they said that I am their only patient and they do not have much info. They had only another 9 people treated here with triple under some Early access program but their meds came directly from Jansen..

Anyway, after throwing up more last night and having the worst bitter taste coming from God knows where, I managed to get a few hours sleep drinking a little bit more soya milk through the nigh. In the morning, I managed to get one hard boiled egg with a piece of brad and with mustard and got my 3 Riba with absolutely no problem. But that is now 3 doses missed on Tela.

I still wonder why did he say that I can reintroduce it in couple of weeks?

[BoceprevirGal]

Good job on keeping down the soy milk, Dianna.  
You know what I found? That most of my Tx side effects did tend to rove and change frequently, so please dont expect this nausea/vomit reaction to be a constant pattern.
   The trick sometimes is, to have a well balanced meal, and hold it down. After that, I always padded all my meds with food, and completeley avoided ever having a completely empty stomach. But everybody is different with that. Just stay positive, and a little walk and fresh air would help my nauaea, so you may want to try that.  Anything appetizing that you can keep down would be helpful at this point.

[Dawn703]

I agree with Hector on all aspects of what he wrote, and you should call vertex. I feel you should keep trying, as others have said the first three weeks are the worse and the beginning of incivek very important.

[HectorSF]

The first thing I would do is call Vertex's nursing support. Telling them what is happening. Perhaps they have some ideas. I am sure you are not the first with this issue.

Vertex GPS:
Guidance & Patient Support

1-855-VERTEX-GPS (1-855-837-8394)
www.VertexGPS.com
At Vertex Pharmaceuticals, we know that treatment can be difficult. That's why we created Vertex GPS. This service brings together financial services, free 24/7 nurse support, and materials with information about hepatitis C.

24/7 Nurse Support
Registered nurses are available 24 hours a day, 7 days a week when patients call the toll-free Vertex GPS number.

With nurse support, your patients can:
Talk with a registered nurse to get information about hepatitis C
Learn why talking to their provider is important and get tips for good communication with their healthcare team
Request a Patient Starter Kit
Ask a registered nurse to check in from time to time
Have these services translated into more than 90 languages

****The support line nurses will not provide individual patient care or medical advice.
--------------------------------------------------------------------------------------
You really need to start taking your telaprevir or 3 drug treatment will be finished very soon. If you are treatment naive you could try 2 drug treatment. But if you are genotype 1, you are looking at 48 weeks of treatment. Is it worth it. Only you can say.
Do you have to treat?
Do you  have stage 3 or 4 liver disease?
If not you might want to wait a couple for non-interferon treatment that does have these side effects. (Assuming trials are successful).

I know others have said some other people have switched to Boceprevir but I have never seen data on it or what the odds would be.

Right now if at all possible you have to find a way to keep the meds down soon or treatment will be over. Of course as we all know the Direct Acting Antiviral drug should never be stopped.
------------------------------------------------------------------------------------------
How should I take INCIVEK?

 Take INCIVEK 3 times a day. Each dose should be taken 7 to 9 hours apart.  Eat a meal or snack that contains about 20 grams of fat, within 30 minutes before you take each dose of INCIVEK. Talk to your healthcare provider about examples of foods that you can eat that contain about 20 grams of fat. Always take INCIVEK with food.

 If you miss a dose within 4 hours of when you usually take it, take your dose with food as soon as possible.  

 If you miss a dose and it is more than 4 hours after the time you usually take it, skip that dose only and take the next dose
at your normal dosing schedule.

 Do not stop taking INCIVEK unless your healthcare provider tells you to.  If you think there is a reason to stop taking
INCIVEK, talk to your healthcare provider before doing so.

 If your healthcare provider tells you to stop taking INCIVEK, you should not start taking it again even if the reason for
stopping goes away.

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for
Vertex Pharmaceuticals Incorporated
Cambridge, MA 02139
Revised June 2012
©2012 Vertex Pharmaceuticals Incorporated
---------------------------------------------------------------------------------
You started treatment a few days ago I believe? This is when the direct acting antiviral drugs work. Starting and stop will make the telaprevir ineffective. It is now working on the wild virus and close mutations when you don't take the med it allows them to replicate more. So depending on how you respond to interferon will determine if those can still be repressed. It is a dangerous situation because the treatment is not being optimized in treating you hepatitis C. Maybe you will respond anyway but most people need all part of treatment to be successful to achieve SVR.

Phase 1 - DDA + interferon act on the wild virus and mutants.
Phase 2 Interferon and Riba keep viral load undetectable
Phase 2 virus is undetectable for long enough that it doesn't start replicating again when treatment is stopped.

Good luck to you!
Hector

[can-do-man]

You either have to take the telaprevir or not, one cannot play with it. Please read the guidelines on it..........

[Diana66]

Thank you for the tips. But I already missed 2 Telaprevir doses. How is that going to work?

[nightbeacon]

I would occasionally lose all my pills for no patterned reason - so I'd encourage you to keep trying.  Check with your doctor, but if you cut the pills in half and take them with 10g fat every 1.5-2 hours, perhaps you'll hold it down.  Just an idea; I never had to do that. Feel better and good luck!