Aa
High Fat and Ribavirin...yes, again
Has anyone found any new info on the “high fat food taken with ribavirin” issue? All I keep finding are supposed "sources" that usually lead back to the same study, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1804105/ and they are repeating or "gleaning" the same inconclusive data from this one study.
Maybe someone knows of a newer study with a professional abstract that was approved for publication? This old one was approved, but it was not a study that researched high fat meals and ribavirin. It clearly states, " Interoccasion variability and food effects were included, but were not the "aim" of the study" and the results state, "Lean body weight was the only covariate with a clinically significant influence on ribavirin pharmacokinetics..."
Thanks
Maybe someone knows of a newer study with a professional abstract that was approved for publication? This old one was approved, but it was not a study that researched high fat meals and ribavirin. It clearly states, " Interoccasion variability and food effects were included, but were not the "aim" of the study" and the results state, "Lean body weight was the only covariate with a clinically significant influence on ribavirin pharmacokinetics..."
Thanks
Hi everyone -
The thread is closed.
Emily
********************** CLOSED THREAD ********************************
NO MORE POSTS, PLEASE
The thread is closed.
Emily
********************** CLOSED THREAD ********************************
NO MORE POSTS, PLEASE
I am certainly no bio-chemist and I don't pretend to know definitively whether or not Riba does a better job while treating if taken with just some food or some fatty food
. It seems that debate has gone on since Riba's inception approx. 10 -11 years ago.
When I joined here and started treating I didn't know if I should do some fat food with the Riba. The two Hepa's counseling me in my trial said ,just to take it with food.
So I looked up some past threads here...there were 756 on (Riba withFat or not).
After reading them over a three day period I deduced that possibly munching down some fat with the riba may help,probably wouldn't hurt as I am not overweight.
Well , unfortunately we have no other way to keep score on how we are doing with Riba ,other than our HGB. (there are currently no commercial tests avail. to us to gauge Riba concentration in the blood.
I took 1200 mg Riba ( I weigh 190) with some fat and low and behold my HGB never budged the whole time I treated ....not even half a point.
I did not clear the virus.Was it because of poor Riba absorption? Don't know and will never know. There were others on here at the time eating Riba with barely a snack and they had there face in the carpet with anemia,some cleared virus ,others didn't.
Point being .it proly doesn't make a lot of sense to scarf down riba with a boatload of fat,however possibly common sense and a bit may help with slowing absorption and even more importantly the food seems to help with relief of some nausea.
Just my cent on a slow evening..
Best..
Will
. It seems that debate has gone on since Riba's inception approx. 10 -11 years ago.
When I joined here and started treating I didn't know if I should do some fat food with the Riba. The two Hepa's counseling me in my trial said ,just to take it with food.
So I looked up some past threads here...there were 756 on (Riba withFat or not).
After reading them over a three day period I deduced that possibly munching down some fat with the riba may help,probably wouldn't hurt as I am not overweight.
Well , unfortunately we have no other way to keep score on how we are doing with Riba ,other than our HGB. (there are currently no commercial tests avail. to us to gauge Riba concentration in the blood.
I took 1200 mg Riba ( I weigh 190) with some fat and low and behold my HGB never budged the whole time I treated ....not even half a point.
I did not clear the virus.Was it because of poor Riba absorption? Don't know and will never know. There were others on here at the time eating Riba with barely a snack and they had there face in the carpet with anemia,some cleared virus ,others didn't.
Point being .it proly doesn't make a lot of sense to scarf down riba with a boatload of fat,however possibly common sense and a bit may help with slowing absorption and even more importantly the food seems to help with relief of some nausea.
Just my cent on a slow evening..
Best..
Will
Where's Em I think we should close this thread. Various posters have revealed the appropriate information. So why continue? JMHO!
You make perfect common sense. My concern is that people are coming up with these high fat intake formulas and possibly hurting rather than helping themselves. Moderation based on your starting lean body mass makes sense, but people who are overweight to begin with have a lesser chance to clear than those who are lean. How sad to keep adding more to one's body fat based on reading a paragraph in an article (one which does not end up in the conclusive info) rather than listening to their doc or the pharm company's dosing directions.
My problem (getting a little OCD here, lol) is that I have professionally worked on committees to review research trying to get published. I play devil's advocate in finding the holes. These are serious documents from which doctors and pharms rely. If writers throw some unproven nonsense in their conclusions/results they risk their professional reputations and as many may know, that is why it takes months to get a professional research abstract published. No study to date has proven one must take riba with high fat. People read that paragraph about fat and draw that conclusion and they should not when in fact the researcher could not.
My problem (getting a little OCD here, lol) is that I have professionally worked on committees to review research trying to get published. I play devil's advocate in finding the holes. These are serious documents from which doctors and pharms rely. If writers throw some unproven nonsense in their conclusions/results they risk their professional reputations and as many may know, that is why it takes months to get a professional research abstract published. No study to date has proven one must take riba with high fat. People read that paragraph about fat and draw that conclusion and they should not when in fact the researcher could not.
I just notice that I feel better, with less side-effects, to be eating fresh healthy meals, thru-out the day. When I get an empty stomach, I feel sick and dizzy, and have a psych side-effect that is akin mild paranoia...I've always been healthy before this hit me, and I've never had to take any medication before.
So, I pop the pills, eat my yogurt, and anything else that seems appetizing, which is a challenge at this point- I have maintained the same weight, now that i'm on triple tx, although I did lose weight with the intitial lead in. I feel strongest at a healthy weight, not over-weight or under, etc
So, I pop the pills, eat my yogurt, and anything else that seems appetizing, which is a challenge at this point- I have maintained the same weight, now that i'm on triple tx, although I did lose weight with the intitial lead in. I feel strongest at a healthy weight, not over-weight or under, etc
As stated below the clinical relevance of the results from this "single dose study" is unknown. It only recommends to take ribavirin with food in order to achieve optimal ribavirin plasma concentrations. If it recommended a high fat diet, I'd think it would clearly state that on the label. However, based on some of this information, I've always thought adding some additional fat might help. Again, I never worried about how much fat and didn't sweat it. I'm on the lean side anyway and didn't want to lose too much weight during tx.
"The bioavailability of a single oral 600 mg dose Copegus was increased by coadministration of a high fat meal. The ribavirin exposure parameters of AUC(0-192h) and Cmax increased by 42% and 66%, respectively, when Copegus was taken with a high fat breakfast compared to being taken in the fasted state. The clinical relevance of results from this single dose study is unknown. Ribavirin exposure after multiple dosing when taken with food was comparable in patients receiving peginterferon alfa-2a and Copegus and interferon alfa-2b and ribavirin. In order to achieve optimal ribavirin plasma concentrations, it is recommended to take ribavirin with food."
http://www.medicines.ie/medicine/3007/SPC/Copegus+200mg+Film-coated+Tablets/
"The bioavailability of a single oral 600 mg dose Copegus was increased by coadministration of a high fat meal. The ribavirin exposure parameters of AUC(0-192h) and Cmax increased by 42% and 66%, respectively, when Copegus was taken with a high fat breakfast compared to being taken in the fasted state. The clinical relevance of results from this single dose study is unknown. Ribavirin exposure after multiple dosing when taken with food was comparable in patients receiving peginterferon alfa-2a and Copegus and interferon alfa-2b and ribavirin. In order to achieve optimal ribavirin plasma concentrations, it is recommended to take ribavirin with food."
http://www.medicines.ie/medicine/3007/SPC/Copegus+200mg+Film-coated+Tablets/
Re: "I've yet to see a "data bite" that discredits the published information."
The isolated "data bites" I refer to are the stuff like this:
"Effect of Food on Absorption of Ribavirin
Bioavailability of a single oral dose of ribavirin was increased by co-administration with a high-fat meal. The
absorption was slowed (Tmax was doubled) and the AUC0-192h and Cmax increased by 42% and 66%, respectively,
when COPEGUS was taken with a high-fat meal compared with fasting conditions [see Dosage and
Administration (2.1) and Patient Counseling Information (17)]. "
Then follow the "[see Dosage and
Administration (2.1) and Patient Counseling Information (17)]. " and you will not be told to take the med with a high fat meal.
It does not discredit published information. There is no published info directing one to "take riba with high fat" to discredit. That's the whole point. No doc or pharm takes this incidental data bite and tells patients to "take riba with high fat". The data is not conclusive.
What is your published information that directs patients to take riba with fat? The “data bites” posted so far do not.
I’m over and out on this. It’s a sequential logic thing. See what hrsepwrguy posted, read your dosing directions….it’s not in there and for good reason. No one seems to be able to produce a direct quote that says "take with a high fat meal". They are assuming/gleaning that from the "data bite", but the professional community is not. It only verifies to take with food.
The isolated "data bites" I refer to are the stuff like this:
"Effect of Food on Absorption of Ribavirin
Bioavailability of a single oral dose of ribavirin was increased by co-administration with a high-fat meal. The
absorption was slowed (Tmax was doubled) and the AUC0-192h and Cmax increased by 42% and 66%, respectively,
when COPEGUS was taken with a high-fat meal compared with fasting conditions [see Dosage and
Administration (2.1) and Patient Counseling Information (17)]. "
Then follow the "[see Dosage and
Administration (2.1) and Patient Counseling Information (17)]. " and you will not be told to take the med with a high fat meal.
It does not discredit published information. There is no published info directing one to "take riba with high fat" to discredit. That's the whole point. No doc or pharm takes this incidental data bite and tells patients to "take riba with high fat". The data is not conclusive.
What is your published information that directs patients to take riba with fat? The “data bites” posted so far do not.
I’m over and out on this. It’s a sequential logic thing. See what hrsepwrguy posted, read your dosing directions….it’s not in there and for good reason. No one seems to be able to produce a direct quote that says "take with a high fat meal". They are assuming/gleaning that from the "data bite", but the professional community is not. It only verifies to take with food.
Thanks for your input. It seems to verify what the studies verify....which is NO definitive clinical significance that has doctors or pharms directing patients to "take riba with a high fat meal". It's just not there. There is no reason to ask a patient to increase their body fat content at the risk of lowering their chance for clearance. IDK, I don't get why some people don't get the point of this issue. Maybe I'm not explaining it properly. :)
I can't remember if it's mentioned in the Q&A fda transcripts or not..One could read it and check
http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3909t1.htm
http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3909t1.htm
My POV is that everything is relative.
Modern medicine works on a one size fits all ideology.
They do not take into account our differences be they our physical make ups, our diet, environmental factors, stress levels, etc.
I ate more fat but I was also trying not to lose more weight.
Maybe not scientific but I firmly believe to go by what your instincts say is right for you.
Modern medicine works on a one size fits all ideology.
They do not take into account our differences be they our physical make ups, our diet, environmental factors, stress levels, etc.
I ate more fat but I was also trying not to lose more weight.
Maybe not scientific but I firmly believe to go by what your instincts say is right for you.
I have the same Ribashpere literature....if you find where it says to take with high fat, please let me know. I have been sent so many links that supposedly back up the urban legend only to find it's not in there. Lots and lots of reading that goes nowhere, lol. I guess people have different styles of reading comprehension.....
Thanks
Thanks
To each their own, I've yet to see a "data bite" that discredits the published information. Although I may have missed where you or others have posted a link to such. Hey, I'm just a carpenter, to be honest, I'd occasionally take riba with just coffee.
I understand that you don’t understand, but in a nutshell the point is that doctors and pharms are not taking the info you and others keep providing, and telling patients to “take riba with high fat”. The “data bite” is in the guide and other studies, but not even the pharm who related that info recognizes it’s significance. If they did, they would clearly state in the directions, “to take with a high fat meal”? They don't for good reason.
If that is good enough documentation for someone to adjust the dosing directions (contrary to the dosing guide or the doctor), so be it, it is their choice, their judgment.
The concern is that people who think they are getting a "leg up" by erroneously interpreting research data could actually be interfering with the real documented research and “clinically significant lean body weight covariate” by making themselves less lean (i.e., by eating more fat when they are not told to do so).
One thing we know for sure is that the leaner one is, the higher the chance of clearing HCV. Some people are actually packing on more pounds over months by increasing their fat intake per the urban legend “formulas” which is just like shooting themselves in the foot.
If that is good enough documentation for someone to adjust the dosing directions (contrary to the dosing guide or the doctor), so be it, it is their choice, their judgment.
The concern is that people who think they are getting a "leg up" by erroneously interpreting research data could actually be interfering with the real documented research and “clinically significant lean body weight covariate” by making themselves less lean (i.e., by eating more fat when they are not told to do so).
One thing we know for sure is that the leaner one is, the higher the chance of clearing HCV. Some people are actually packing on more pounds over months by increasing their fat intake per the urban legend “formulas” which is just like shooting themselves in the foot.
I am in a concentration controlled ribavirin study
http://clinicaltrials.gov/ct2/show/NCT01097395?term=NCT01097395&rank=1
Not once has the tx team at UC Denver told me to take riba (the drug they are studying) with fat only to take with food. On my first day when they were checking how well my body absorbed the riba so they could adjust it to the levels they were looking for, I had to show up fasting and take the pills on an empty stomach, I asked why and was told there was not enough valid info out there on long term effects of taking riba with high fat meals, apparently I absorb the riba just fine without food because I was never adjusted from standard wt based dosing and am in group 2 which is the dose adjustment group.
http://clinicaltrials.gov/ct2/show/NCT01097395?term=NCT01097395&rank=1
Not once has the tx team at UC Denver told me to take riba (the drug they are studying) with fat only to take with food. On my first day when they were checking how well my body absorbed the riba so they could adjust it to the levels they were looking for, I had to show up fasting and take the pills on an empty stomach, I asked why and was told there was not enough valid info out there on long term effects of taking riba with high fat meals, apparently I absorb the riba just fine without food because I was never adjusted from standard wt based dosing and am in group 2 which is the dose adjustment group.
There are lots of posts related to this topic with many quotes & data:
http://www.medhelp.org/posts/Hepatitis-C/The-importance-of-taking-Ribavirin-with-fatty-foods-/show/1590954
Anywho, interestingly enough, Ribasphere sent my whole Med kit. They are the ones who sent me the pill case, a timer, the shot disposal kit (which easily re-opens!) and lots of other stuff. Most of the literature is dated 2011 so perhaps later I will plow through the "Dosage & Administration" section just to see if it says what seems to be quoted here and just about every where else on the Internet.
I'm sure it does and I am not trying to be contradictory; I just thought I read that it was absorbancy compared to fasting conditions & a regular meal not quite so high in fat. I don't know, I am not questioning anyone here, it is just that 58 grams seems like a lot - even compared to the total 60 grams fort the Incivek (or 20 grams of fat per dose).
http://www.medhelp.org/posts/Hepatitis-C/The-importance-of-taking-Ribavirin-with-fatty-foods-/show/1590954
Anywho, interestingly enough, Ribasphere sent my whole Med kit. They are the ones who sent me the pill case, a timer, the shot disposal kit (which easily re-opens!) and lots of other stuff. Most of the literature is dated 2011 so perhaps later I will plow through the "Dosage & Administration" section just to see if it says what seems to be quoted here and just about every where else on the Internet.
I'm sure it does and I am not trying to be contradictory; I just thought I read that it was absorbancy compared to fasting conditions & a regular meal not quite so high in fat. I don't know, I am not questioning anyone here, it is just that 58 grams seems like a lot - even compared to the total 60 grams fort the Incivek (or 20 grams of fat per dose).
"Both AUCtf and Cmax increased by 70% when REBETOL Capsules were administered with a high-fat meal (841 kcal, 53.8 g fat, 31.6 g protein, and
57.4 g carbohydrate) in a single. . ."
____________________________________________--
Wow, really? 53.8 g of fat (?!) for *one* high fat meal?
57.4 g carbohydrate) in a single. . ."
____________________________________________--
Wow, really? 53.8 g of fat (?!) for *one* high fat meal?
I found that 2 donuts with my 800mg morning dose of riba, and dinner with my 800mg evening dose worked well for me. Over 4000 riba pills later..svr..:>)
a 72 weeker dinosaur, Pro
a 72 weeker dinosaur, Pro
Thank you for this, I hadn't heard about the high fat with Copegus, but I tend to have pizza after my shot, coincidentally.
I found myself losing weight, in the beginning of treatment, because food seemed to turn me off, initially, I lost 10 lbs the first month, which scared me, and made me feel frail. That's when I began my organic peanut-butter on tortilla routine, which brought me back to my normal, and healthy weight~
I found myself losing weight, in the beginning of treatment, because food seemed to turn me off, initially, I lost 10 lbs the first month, which scared me, and made me feel frail. That's when I began my organic peanut-butter on tortilla routine, which brought me back to my normal, and healthy weight~
It's not an urban myth as are other things on here recently. I'm glad Pro posted up the links.
"Effect of Food on Absorption of Ribavirin
Bioavailability of a single oral dose of ribavirin was increased by co-administration with a high-fat meal. The
absorption was slowed (Tmax was doubled) and the AUC0-192h and Cmax increased by 42% and 66%, respectively,
when COPEGUS was taken with a high-fat meal compared with fasting conditions [see Dosage and
Administration (2.1) and Patient Counseling Information (17)]. "
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s023lbl.pdf
Bioavailability of a single oral dose of ribavirin was increased by co-administration with a high-fat meal. The
absorption was slowed (Tmax was doubled) and the AUC0-192h and Cmax increased by 42% and 66%, respectively,
when COPEGUS was taken with a high-fat meal compared with fasting conditions [see Dosage and
Administration (2.1) and Patient Counseling Information (17)]. "
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s023lbl.pdf
Not sure what is so difficult to understand?
"Effect of Food on Absorption of Ribavirin
Both AUCtf and Cmax increased by 70% when REBETOL Capsules were administered with a high-fat meal (841 kcal, 53.8 g fat, 31.6 g protein, and
57.4 g carbohydrate) in a single-dose pharmacokinetic study [see Dosage and Administration (2)]."
http://www.spfiles.com/pirebetol.pdf
"Effect of Food on Absorption of Ribavirin
Both AUCtf and Cmax increased by 70% when REBETOL Capsules were administered with a high-fat meal (841 kcal, 53.8 g fat, 31.6 g protein, and
57.4 g carbohydrate) in a single-dose pharmacokinetic study [see Dosage and Administration (2)]."
http://www.spfiles.com/pirebetol.pdf
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