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On Treatment question about telaprevir , reply much appreciated
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On Treatment question about telaprevir , reply much appreciated

Hi I have on the triple therapy  , peg , rib , telaprevir now for just over 3 weeks ,
My question is with telaprevir and the 20 grams of fat , I usually have a meal or snack with 20 to 30 grams of fat with each dose of telaprevir , sometimes when I am on the road for work , I may stop at maccas and have a quarter pounder and fries which comes to about 50 grams of fat ,  is that okay ? that amount of fat to be taken with teleprevir ?
Replies appreciated .
13 Comments Post a Comment
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1747881_tn?1358189534
Fat increases the amount telaprevir your body absorbs, yes it is ok
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Avatar_f_tn
I found the more fat the better my side effects were...good luck with treatment.
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Avatar_m_tn
I drank a  glass of "whole" milk with the pills. No where near 20 grams of fat but still worked. Studies have shown fat helps absorption of Telap so it is best to take with some fat, if possible. But I think it is somewhat over stated, the same way drinking half of body weight in OZ's of water.
There have been no studies of drinking water. As a matter of fact some top hep docs think to much water dilutes the meds making less effective.
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1747881_tn?1358189534
Effects of Food on Oral Absorption  

The systemic exposure (AUC) to telaprevir was increased by 237% when telaprevir was administered with a standard fat meal (containing 533 kcal and 21 g fat) compared to when telaprevir was administered under fasting conditions. In addition, the type of meal significantly affects exposure to telaprevir. Relative to fasting, when telaprevir was administered with a low-fat meal (249 kcal, 3.6 g fat) and a high-fat meal (928 kcal, 56 g fat), the systemic exposure (AUC) to telaprevir was increased by approximately 117% and 330%, respectively. Doses of INCIVEK were administered within 30 minutes of completing a meal or snack containing approximately 20 grams of fat in the Phase 3 trials. Therefore, INCIVEK should always be taken with food (not low fat)

How should I take INCIVEK?  

Take INCIVEK exactly as your healthcare provider tells you. Your healthcare provider will tell you how much INCIVEK to take and when to take it.  

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.

20 grams of fat = better safe than sorry, why risk it
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3093770_tn?1389742726
The funny part though is the Telaprevir safety sheet does not mention the amount of fat. In fact when I called them I have been told that this is news to them. Although they recommend some fat!!!!

So I was and still am really confused!! The nurse and the doctor are mentioning the 20gr of fat though.

But then I wonder myself: why would I want 200% more? The meds are calculated for standard so increasing by 330% is not necessarly a good thing.

Is there any study showing if the 20-30 gr fat counted for more SVRs then let's say a 10grm fat  meal?
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1747881_tn?1358189534
The info above is straight out of the vertex prescribing information sheet

when telaprevir was administered with a low-fat meal (249 kcal, 3.6 g fat)
the systemic exposure (AUC) to telaprevir was increased by approximately  117%

when telaprevir was administered a high-fat meal (928 kcal, 56 g fat), the systemic exposure (AUC) to telaprevir was increased by approximately 330%

20 grams of fat = better safe than sorry, why risk it ?
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1747881_tn?1358189534
There are not any stats that I am aware of on SVR rates based on fat consumption with telaprevir, it only says that the AUC (area under the curve) systemic exposure is increased.

How much systemic exposure is needed ? Good question, but I'm pretty sure they took that into consideration when they wrote the prescribing info.
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1747881_tn?1358189534
If you really want to get into the pharmacology of telaprevir follow the link it's in section 5, there are a lot of graphs that don't copy and paste

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562
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766573_tn?1365170066
Hey I remember you! Looks like you decided to take care of your commitments before you treated. Anywho, the huge fold out prescription insert ("Full Prescribing Information and Medication Guide) that comes in the blue & white box of Incivek says take with food (not low in fat) but elsewhere on the same fold out it says to eat a meal or snack that contains about 20 grams of fat.

Wow that FDA link is a huge file but there is lots of good info .

Here is the section about fat but the one below it is even more interesting. It explains how Incivek is developed to attack the wild-type and lower level resistant variants.....leaving the complimentary role of Peg/Riba to eradicate the ...rest (it gets more detailed but I don't want to totally hijack your thread).


http://www.medhelp.org/user_photos/show/307232?personal_page_id=1282072

Anyway it's like hrsepwrguy says, "Why chance it?"

Oh here is the page from the Incvek web site (that alarm clock never used to be there)
http://www.incivek.com/how-to-take-incivek

Maccas? I like that. Man I am getting old. Back in the day it was "Mickey D's."

Best of luck ♫
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1856046_tn?1330240845
Yeah, I agree with hp too!

And if you can eat more, I say go for it. Glad you aren't suffering the nausea and can eat at all!

That fda link to the Realize C216 study that hp posted has a lot of good info in it too.

Chris
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Avatar_m_tn
Thank you for some great responses , so far I feel okay a little brain fog , little tired and a few head aches but besides that I feel fine .
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184420_tn?1326743408
hang in !!!!!!!!!!
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Avatar_m_tn
These drugs are a huge commitment and there is alot at stake.
I'm pleased the "milk" worked for you but please don't suggest to others they do the same.
There is a specific reason the drug company wants you to take the fast with the drugs. The systemic exposure to telaprevir was increased by 237%.
who doesnt want that? It's not to make things harder for us.
12 weeks of fat is a small price to pay for a life free of hcv
I was diligent with my fat, measuring with every dose.
I'll never be able to eat hagen daz vanilla ice cream again but
I am now 7 months post treatment and "cured"
Stick with the outlined program!
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