Aa
The importance of taking Ribavirin with fatty foods !
I thought this was important enough to post since some members here may be giving out the wrong information. Also people may confuse taking only Incivek with fatty food and not the Ribavirin. It is just as important to take the Riba with fatty food. Since people take their riba and Incivek at the same time the fatty food will help both meds to be better absorbed.
Let me state this again. Ribavirin is better absorbed with a high fat meal. Like I said there are studies and proven data to back it up. Google " taking ribavirin with fat". Here is one example from PubMed, a well respected website:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1804105/
The component of the final population pharmacokinetic model that describes the absorption phase is complex. Although a standard meal did not affect ribavirin bioavailability (F1), administration of ribavirin with a high-fat meal increased bioavailability by 46% relative to the fasting state. A high-fat meal prolonged the duration of the zero-order input part of the absorption model, with D1 increasing from 0.498 h (fasting and standard meal) to 0.740 h. The type of meal also influenced the first-order input part of the absorption model (Table 1).
Let me state this again. Ribavirin is better absorbed with a high fat meal. Like I said there are studies and proven data to back it up. Google " taking ribavirin with fat". Here is one example from PubMed, a well respected website:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1804105/
The component of the final population pharmacokinetic model that describes the absorption phase is complex. Although a standard meal did not affect ribavirin bioavailability (F1), administration of ribavirin with a high-fat meal increased bioavailability by 46% relative to the fasting state. A high-fat meal prolonged the duration of the zero-order input part of the absorption model, with D1 increasing from 0.498 h (fasting and standard meal) to 0.740 h. The type of meal also influenced the first-order input part of the absorption model (Table 1).
You make some valid points in your last post. Appreciate the input. As usual it comes down to each person & doctors choice.
OC: agreed, frijole posted the same excerpt in another thread. But look also at the "Medication Guide" (page 25)which states "Take Ribasphere (ribavirin, USP) with food." and the "Patient Counseling Information" (page 22) which states "Patients should be advised to take Ribasphere (ribavirin, USP) with food.". No mention of how much fat to take, no mention of fat at all.
The implication is whatever additional absorption can be leveraged by additional fat is neither standardized nor not part of clinical practice,
copyman: I'm just being cranky - maybe too much PB in my last riba dose. No argument that there are perhaps half a dozen studies showing additional rbv absorption with fat. (Also studies showing extra absorption with a low purine diet).
Taking it with fat is part of standard "home brew" remedies, When I remember, I also do this on the assumption that more rbv is better, like trying not to waste any ifn over the 180 dose in each shot. No idea what the effect on rbv dose is, but assume it can't hurt.
However it seems misleading to compare this to the very specific requirement for fat that goes along with inci. For inci half-life is very short and effect of bioavailability on fat is huge. Hence the fat requirement is spelled out in the Patient Information section of the package insert and 20g dose was part of the protocol for all Phase III studies
For rbv none of this is true. As Magnum points out no rbv clinical trial includes a given amount of fat as part of the protocol. The bioavailability effect is much smaller and not well characterized (what's the AUC impact of high fat vs ordinary meal as Ajw points out?). Whatever additional 'boost' results from taking rbv with fat is not part of its clinical practice.
Agreed that if you have to take the fat anyway for inci, you might as well take your rbv with it. However if you're going out of your way to add fat it seems safer to just take more rbv instead of leaving the body to sort out where to stash a few extra thousand calories of 'wrapping'....
The implication is whatever additional absorption can be leveraged by additional fat is neither standardized nor not part of clinical practice,
copyman: I'm just being cranky - maybe too much PB in my last riba dose. No argument that there are perhaps half a dozen studies showing additional rbv absorption with fat. (Also studies showing extra absorption with a low purine diet).
Taking it with fat is part of standard "home brew" remedies, When I remember, I also do this on the assumption that more rbv is better, like trying not to waste any ifn over the 180 dose in each shot. No idea what the effect on rbv dose is, but assume it can't hurt.
However it seems misleading to compare this to the very specific requirement for fat that goes along with inci. For inci half-life is very short and effect of bioavailability on fat is huge. Hence the fat requirement is spelled out in the Patient Information section of the package insert and 20g dose was part of the protocol for all Phase III studies
For rbv none of this is true. As Magnum points out no rbv clinical trial includes a given amount of fat as part of the protocol. The bioavailability effect is much smaller and not well characterized (what's the AUC impact of high fat vs ordinary meal as Ajw points out?). Whatever additional 'boost' results from taking rbv with fat is not part of its clinical practice.
Agreed that if you have to take the fat anyway for inci, you might as well take your rbv with it. However if you're going out of your way to add fat it seems safer to just take more rbv instead of leaving the body to sort out where to stash a few extra thousand calories of 'wrapping'....
I did talk to my Gastro about this fat protocol and as I mentioned before, he said 10 grams of fat with each Riba dosage is fine and cautioned me about weight gain. So I feel that this ongoing discussion will not have an ending. Therefore I personally will make my own choice, thinking back on how wine was bad for you and now a glass per day will extend your life and keep you healthier, and let's not forget the coffee revision. And last but not least, former clinical trials have never suggested fat with Riba and people cleared by the thousands...
Magnum
Magnum
I read and re-read the data provided by both frijole and copyman.
In my opinion and understanding-
The extra absorption of Riba when taken with a high fat meal is when compared to a fasting state.
It is absorbed better with high fat meal vs. if you had an empty stomach.
Just taking it with a regular meal has the same absorption as with a high fat meal.
I personally do not believe the data says anything otherwise.
I suggest reading the data, then talk to your doctor about it, then make your decision.
In my opinion and understanding-
The extra absorption of Riba when taken with a high fat meal is when compared to a fasting state.
It is absorbed better with high fat meal vs. if you had an empty stomach.
Just taking it with a regular meal has the same absorption as with a high fat meal.
I personally do not believe the data says anything otherwise.
I suggest reading the data, then talk to your doctor about it, then make your decision.
Walk into any Wal-Mart and look at the fat people outnumber the normal folks and tell me I'm wrong. Now walk into a Wal-Mart in Tokyo and see the difference. In America, every one person equals the combined weight of two others. In other words, one in three weighs as much as the other two. Even their pets and little kids are fat. It’s all around us, so we now are adjusted to it and doesn’t bother us anymore. Hold on....Hand me another slice of pizza honey.... Okay I’m back.
I'm puzzled by all this turmoil over adding some fat to your meds when we eat pizzas, sodas, hamburgers, ribs, doughnuts, pies, cakes, ice cream, extra butter for your baked potato and such on a regular basis.
So I'm getting bigger with the addition of 40 grams daily of fat with my Riba. More to hold on to on cold Winter nights. After all, on a cold dark Winter's night on a bed you just rolled back the cold sheets on, would you like to curl up next to a skinny Tokyo partner or a warm Wal-Mart hefty with plenty of flesh to keep you warm? Tell the truth or your nose will grow...
Magnum
I'm puzzled by all this turmoil over adding some fat to your meds when we eat pizzas, sodas, hamburgers, ribs, doughnuts, pies, cakes, ice cream, extra butter for your baked potato and such on a regular basis.
So I'm getting bigger with the addition of 40 grams daily of fat with my Riba. More to hold on to on cold Winter nights. After all, on a cold dark Winter's night on a bed you just rolled back the cold sheets on, would you like to curl up next to a skinny Tokyo partner or a warm Wal-Mart hefty with plenty of flesh to keep you warm? Tell the truth or your nose will grow...
Magnum
plus the ribavirin, affects people's sleep, the pegasys nurse told me to take it with my afternoon dose of incivek (2pm).
peace
peace
Hey Magnum, you had me rolling on the floor, funny stuff....."Since this is a country of fat people, a little more fat shouldn't tarnish our image......."
Yes frijole, I took my riba at 6am & 2pm. It is not critical to take the riba exactly every 12 hrs. As long as you get the prescribed amount on a daily basis. You could actually take the full daily dose at one time. The reason it is divided into 2 doses is not to upset your stomach. Riba has such a long half life that there is no effect to taking it at whatever time convenient for you.
Yes frijole, I took my riba at 6am & 2pm. It is not critical to take the riba exactly every 12 hrs. As long as you get the prescribed amount on a daily basis. You could actually take the full daily dose at one time. The reason it is divided into 2 doses is not to upset your stomach. Riba has such a long half life that there is no effect to taking it at whatever time convenient for you.
i'm looking at the ribasphere prescribing infomation, see 12.3, it says,
"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 ribavirin was taken with a high-fat meal compared with fasting conditions [see Dosage and Administration (2.1) and Patient Counseling Information (17)]."
http://kadmon.com/files/ribasphere-tablets-pi.pdf
peace
"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 ribavirin was taken with a high-fat meal compared with fasting conditions [see Dosage and Administration (2.1) and Patient Counseling Information (17)]."
http://kadmon.com/files/ribasphere-tablets-pi.pdf
peace
I hate having to get up evry morning 6.30am / 2.30pm / 10.30pm
Setting my phone alarms for to get the medicatiopn Victrelis / Boceprevir for my fiance'
Morning time is very hard for her, at times getting very little sleep in the night and by the time she gets to sleep the alarm goes off and does not want to be disturbed but get her a
1: Fresh Cold Drink
2: A little piece of Choclate pie in which to mix the victrelis capsules in so there is not so much of a bad taste in your mouth, and by putting the capsule in the pie you do not realise you are taking them so much.
Take another hour to get back to sleep!
Has enetered her 12 week on treatment with Victrelis and now come to the stage her blood count is all low.
Setting my phone alarms for to get the medicatiopn Victrelis / Boceprevir for my fiance'
Morning time is very hard for her, at times getting very little sleep in the night and by the time she gets to sleep the alarm goes off and does not want to be disturbed but get her a
1: Fresh Cold Drink
2: A little piece of Choclate pie in which to mix the victrelis capsules in so there is not so much of a bad taste in your mouth, and by putting the capsule in the pie you do not realise you are taking them so much.
Take another hour to get back to sleep!
Has enetered her 12 week on treatment with Victrelis and now come to the stage her blood count is all low.
"I hated getting up every morning at 6am to take 1st dose of Rib & Tel each day. My dose times were 6am, 2pm (both meds) & 10pm (Telap only). In the end it was all worth "
So you took your riba in 8 hour and 16 hour intervals? I would think this would have distorted the bioavailability more than whether they were taken with or without fat. It is my understanding that the riba should be taken the same time each day, approximately 12 hours apart.
I really think we are primarily in agreement here. We should take our riba with some fat. The amount of fat has not been determined.
frijole
So you took your riba in 8 hour and 16 hour intervals? I would think this would have distorted the bioavailability more than whether they were taken with or without fat. It is my understanding that the riba should be taken the same time each day, approximately 12 hours apart.
I really think we are primarily in agreement here. We should take our riba with some fat. The amount of fat has not been determined.
frijole
My pharmacist told me to take RIBA with or without food. I have been taking the morning one with incivek and fat and the afternoon one by itself 12 hours later so I have been concerned about the postings regarding food. Thanks to everyone for all the information. It helps to hear the various viewpoints and bits of data.
I also found something on the fda site (http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111342.pdf) that says if you on pegintron take it with food, if you are intron A, take it with or without food. I am on Pegasus peg interferon alpha 2a which i think is intron A. it may help to take with some food based on the postings but sounds like I am not in a really bad place going into week 4.
I also found something on the fda site (http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111342.pdf) that says if you on pegintron take it with food, if you are intron A, take it with or without food. I am on Pegasus peg interferon alpha 2a which i think is intron A. it may help to take with some food based on the postings but sounds like I am not in a really bad place going into week 4.
I agree. Since this is a country of fat people, a little more fat shouldn't tarnish our image to the rest of the world or diminish the fact that we can eat Kentucky fried chicken with artery clogging batter or drink huge 7-11 Big Gulp sodas with enormous amounts of sugar or cholesterol infested chicken wings, but complain about 40 grams of fat daily added to life saving medicine. I say be fat, be happy and be cured...
Magnum
Magnum
Initially you did say "but for Riba to be effective it should be taken with just as much fat if not more then incivek." I think that was the source for the back and forth debate.. 20g of fat is not a little fat and no where in the FDA patient information does it specify that.
People who are on Incivek will benefit from the fat requirement if they dose ribavirin with the Incivek. If they don't it isn't necessary to add an additional 20 g of fat or more with each ribavirn dose. They can dose riba AM with Incivek and eat a non low fat meal PM and dose the ribavirin. As long as they're eating with food that contains some fat and again, it doesn't have to be 20 g or more, they should be fine.
People who are on Incivek will benefit from the fat requirement if they dose ribavirin with the Incivek. If they don't it isn't necessary to add an additional 20 g of fat or more with each ribavirn dose. They can dose riba AM with Incivek and eat a non low fat meal PM and dose the ribavirin. As long as they're eating with food that contains some fat and again, it doesn't have to be 20 g or more, they should be fine.
Agree with you about what the FDA requires on inserts. But don't believe everything you read on packet inserts. The same way every drug insert has "if you have liver damage consult your physician before using". Much of it is generic information.
No reason to go back and forth about this subject. There is "PROVEN" hard core data to back up absorption of ribavirin with fatty foods. Not sure what the big deal is.
As important as taking weight based riba is why not increase the chance of absorption by adding some fat when taking the dose. Not saying you have to eat a cup of lard with it just a little fat.
No reason to go back and forth about this subject. There is "PROVEN" hard core data to back up absorption of ribavirin with fatty foods. Not sure what the big deal is.
As important as taking weight based riba is why not increase the chance of absorption by adding some fat when taking the dose. Not saying you have to eat a cup of lard with it just a little fat.
to *really* increase bioavailabilty never mind peanut butter - dissolve the tablets (they are water soluble) and inject them!
There is a simple way to confirm whether you need to take your rbv pills with a given amount of fat: check the "Patient Information" section of the package insert. The FDA tightly regulates the language in the package insert that accompanies medication.
There is a simple way to confirm whether you need to take your rbv pills with a given amount of fat: check the "Patient Information" section of the package insert. The FDA tightly regulates the language in the package insert that accompanies medication.
"actually, i've been told to take the Riba with 20 grams of fat per dose, which would be 60 grams per day..."
Since your doing Incivek and its taken three times a day where the riba is only taken twice a day it would be the incivek they are talking about as it does require 20 grams per dose.
Good luck starting tx, you will do fine.
Since your doing Incivek and its taken three times a day where the riba is only taken twice a day it would be the incivek they are talking about as it does require 20 grams per dose.
Good luck starting tx, you will do fine.
Still no one can explain to me why on my past four attempts since 1999, never was there mention by my Gastro, Hepatologist or manufacturer of fat embelishing the effect of Ribavirin absorption. After all, it's been around longer than that. Anyone?
actually, i've been told to take the Riba with 20 grams of fat per dose, which would be 60 grams per day... it is a lot, and i'm concerned about gaining unnecessary weight, but there are lots of "good" fats, i.e., avocados, smoothies with full fat organic yogurts and fruit, almond butter and/or peanut butter, organic granola (I make my own), organic eggs, etc. I don't plan to eat fast food at all -- don't eat it now, don't intend to eat it just for the fat content...
it says on the label of my meds to take with food, and specifically, not low fat foods... my problem is going to be eating so early in the morning... i'm not a morning person and eating 30 minutes before taking the meds is going to be an adjustment for me... :(
wish me luck -- i start on Tuesday, with my first injection on Friday.... yea, i'll be a member of the Friday Night Dart Club...lol
we're all in this together, and I, for one, am so grateful I found this forum -- I've gained so much from everyone's experience, strength and hope... I'm truly inspired and hopeful... :)
Thanks, Karen
it says on the label of my meds to take with food, and specifically, not low fat foods... my problem is going to be eating so early in the morning... i'm not a morning person and eating 30 minutes before taking the meds is going to be an adjustment for me... :(
wish me luck -- i start on Tuesday, with my first injection on Friday.... yea, i'll be a member of the Friday Night Dart Club...lol
we're all in this together, and I, for one, am so grateful I found this forum -- I've gained so much from everyone's experience, strength and hope... I'm truly inspired and hopeful... :)
Thanks, Karen
This topic keeps coming up and I had saved this to my hard drive so here it is again..
frijole
July 2011
Hi Susan ..I was doing some looking back at some threads recently myself on this issue and...something COWriter posted seemed to make as much sense on this topic as anything I had read. Don"t know if you saw it or not...and if not hope it is helpful
Will..
....
Should you take the Ribavirin with a high fat meal to increase the concentration????
Every time I hear people tell a newbie to take the Riba with a HIGH FAT MEAL or to eat all the ice cream they want, I cringe. So I decided to look into it. Please feel free to jump in. All comments welcome even if you don't agree with me.
First of all, let's see what the drug company means by "a high-fat meal"....( 53.8 gramsof FAT, 31.6 gramsof Protein, and 57.4 grams of Carbohydrate. A total of 841 calories per meal).
53.8 grams FAT = 482 calories. If you have 2 high fat meals a day to take your Riba, that would give you a total of 1682 calories.....and 964 calories would be from fat. That means that over 50% of the total calories would come from fat. Considering that only 30% of a person's total calories each day should come from fat, that would be a very unhealthy diet.
Diabetics are usually allowed a total of 1800 calories a day. So that means that after eating the two high fat meals, they'll have 118 calories left to cover one more meal and two snacks....which may cause their blood sugar to be out of control.
What are you guys going to eat to make your meal "high fat"? Did you say TWO tablespoons of peanut butter? Hmmm.....that's only 16 grams of fat.....so you'll have to eat at least 6 tablespoons. Or a Big Mac, fries and 2 tablespoons of peanut butter.....Twice a day!
What they're suggesting is ridiculous and unhealthy. Having some fat with your meal is fine, but do you really need 54 grams????
To help you decide, I did a little research on the effects of food on Riba bioavailability.....
(The quotes come from published data on Riba pharmacokinetics. Sources listed below)
"Bioavailability" means the portion of the dose that reaches the systemic circulation. When a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered orally, its bioavailability decreases because not all of it is absorbed. So 70% bioavailability means that, from the dose you took, 70% of it reached systemic circulation.
"Two studies have been carried out to assess the effect of food (ie, a high-fat breakfast) on the bioavailability of a SINGLE oral dose of ribavirin. An initial study by ICN Pharmaceuticals, Inc. showed MINOR EFFECTS on bioavailability, but a 33% increase in Tmax (Time to Maximum Concentration)"
In other words, a high-fat breakfast (54 grams of fat) slowed the absorption of Ribavirin by 33%. It took 33% longer to reach the maximum concentration and had only a minor effect on bioavailability. So according to that study, eating a high fat meal had no benefit.
"A subsequent study by Schering-Plough demonstrated more substantial increases in bioavailability: food increased the AUC (Area Under the Curve) and Cmax (Maximum Concentration) by 70% compared to the FASTING population, and Tmax (Mean Time to Maximum Concentration) which is usually 1.5 hours was more than doubled."
So that means that compared to people who were fasting, eating a high fat meal (54 grams of fat), increased the maximum concentration of Riba by 70% but it took twice as long to do it. Ribavirin is rapidly absorbed following oral administration. The time to reach the Maximum Concentration of Riba after taking a single oral dose is usually 1.5 hours. After a high fat meal, it took over 3 hours to reach the maximum concentration.....but bioavailability is more important than absorption time.
"Although both studies consistently showed that food slowed the absorption of ribavirin, the extent to which food affected ribavirin bioavailability differed widely between the studies."
That's right, one study showed that a high fat meal had no effect on bioavailability and the other one showed that it did.....if you ate 54 grams of fat.....as compared to people who ate nothing. That means that we don't know whether bioavailability would be 69% or 71% or whatever if people eat a regular, non high-fat meal because they didn't look at that. They compared people who ate a high fat meal to people who ate nothing.
"It is also UNKNOWN whether any food effect might be altered by the type of meal consumed (eg, high versus low fat), IF A FOOD EFFECT WOULD STILL BE EVIDENT UPON MULTIPLE DOSING OF RIBAVIRIN, and, finally, what clinical implications the food effect might have. It should be noted that in the pivotal Schering-Plough clinical efficacy studies, ribavirin was administered without regard to food. Because of the uncertainty about the effects of food, it may be prudent for patients to TAKE RIBAVIRIN WITH FOOD."
Notice how it DOES NOT say HIGH FAT food.....just food.
But 70% concentration sounds so impressive, doesn't it? But remember....that was after taking ONE SINGLE DOSE of Riba. Taking multiple doses is totally different. You cannot predict what the bioavailability will be after taking multiple doses from looking at what happened after taking ONE DOSE.
"The fact that the multiple-dose ribavirin half-life (298 hours) is considerably longer than the single-dose half-life (79 hours) MEANS THAT IT IS NOT POSSIBLE TO PREDICT MULTIPLE-DOSE RIBAVIRIN PHARMACOKINETIC PARAMETERS BASED ON SINGLE-DOSE PARAMETERS. This has implications for interpretation of food effect pharmacokinetic data."
In other words, the data from the two high fat meal studies pertains to those of you who are planning on taking ONLY ONE Ribavirin dose....
Fat is a good source of energy and we all need some fat in our diet. For somebody on treatment who has lost lots of weight and can't afford to loose any more, the recommendation is certainly to eat whatever they can tolerate and that includes fat. If it means survival, it's better to eat junk than to eat nothing at all. At that point, getting calories is the important thing, doesn't matter where they come from.
I have no problem with people having some fat with their Riba. But I can't agree with suggesting people starting treatment eat 54 grams of fat twice a day as suggested by the study (especially if they're already obese) to MAYBE increase Riba bioavailability. Not when multiple dosing may already be doing that. Not when up to two thirds of them may have insulin resistance and many of them have fatty liver.
A high fat diet promotes oxidative stress, fatty liver, high blood sugar, an increase in CYP2E1, cytokine-induced beta-cell death, hepatic insulin resistance and hyperinsulinemia. All the things that lower SVR.
When you become insensitive to insulin (Insulin Resistance), the pancreas increases its production of insulin....so you end up with too much insulin (hyperinsulinemia).....And large levels of insulin, MAKE INTERFERON INEFFECTIVE....and at that point, Riba bioavailability will no longer matter.
As always, the choice is yours.
frijole
July 2011
Hi Susan ..I was doing some looking back at some threads recently myself on this issue and...something COWriter posted seemed to make as much sense on this topic as anything I had read. Don"t know if you saw it or not...and if not hope it is helpful
Will..
....
Should you take the Ribavirin with a high fat meal to increase the concentration????
Every time I hear people tell a newbie to take the Riba with a HIGH FAT MEAL or to eat all the ice cream they want, I cringe. So I decided to look into it. Please feel free to jump in. All comments welcome even if you don't agree with me.
First of all, let's see what the drug company means by "a high-fat meal"....( 53.8 gramsof FAT, 31.6 gramsof Protein, and 57.4 grams of Carbohydrate. A total of 841 calories per meal).
53.8 grams FAT = 482 calories. If you have 2 high fat meals a day to take your Riba, that would give you a total of 1682 calories.....and 964 calories would be from fat. That means that over 50% of the total calories would come from fat. Considering that only 30% of a person's total calories each day should come from fat, that would be a very unhealthy diet.
Diabetics are usually allowed a total of 1800 calories a day. So that means that after eating the two high fat meals, they'll have 118 calories left to cover one more meal and two snacks....which may cause their blood sugar to be out of control.
What are you guys going to eat to make your meal "high fat"? Did you say TWO tablespoons of peanut butter? Hmmm.....that's only 16 grams of fat.....so you'll have to eat at least 6 tablespoons. Or a Big Mac, fries and 2 tablespoons of peanut butter.....Twice a day!
What they're suggesting is ridiculous and unhealthy. Having some fat with your meal is fine, but do you really need 54 grams????
To help you decide, I did a little research on the effects of food on Riba bioavailability.....
(The quotes come from published data on Riba pharmacokinetics. Sources listed below)
"Bioavailability" means the portion of the dose that reaches the systemic circulation. When a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered orally, its bioavailability decreases because not all of it is absorbed. So 70% bioavailability means that, from the dose you took, 70% of it reached systemic circulation.
"Two studies have been carried out to assess the effect of food (ie, a high-fat breakfast) on the bioavailability of a SINGLE oral dose of ribavirin. An initial study by ICN Pharmaceuticals, Inc. showed MINOR EFFECTS on bioavailability, but a 33% increase in Tmax (Time to Maximum Concentration)"
In other words, a high-fat breakfast (54 grams of fat) slowed the absorption of Ribavirin by 33%. It took 33% longer to reach the maximum concentration and had only a minor effect on bioavailability. So according to that study, eating a high fat meal had no benefit.
"A subsequent study by Schering-Plough demonstrated more substantial increases in bioavailability: food increased the AUC (Area Under the Curve) and Cmax (Maximum Concentration) by 70% compared to the FASTING population, and Tmax (Mean Time to Maximum Concentration) which is usually 1.5 hours was more than doubled."
So that means that compared to people who were fasting, eating a high fat meal (54 grams of fat), increased the maximum concentration of Riba by 70% but it took twice as long to do it. Ribavirin is rapidly absorbed following oral administration. The time to reach the Maximum Concentration of Riba after taking a single oral dose is usually 1.5 hours. After a high fat meal, it took over 3 hours to reach the maximum concentration.....but bioavailability is more important than absorption time.
"Although both studies consistently showed that food slowed the absorption of ribavirin, the extent to which food affected ribavirin bioavailability differed widely between the studies."
That's right, one study showed that a high fat meal had no effect on bioavailability and the other one showed that it did.....if you ate 54 grams of fat.....as compared to people who ate nothing. That means that we don't know whether bioavailability would be 69% or 71% or whatever if people eat a regular, non high-fat meal because they didn't look at that. They compared people who ate a high fat meal to people who ate nothing.
"It is also UNKNOWN whether any food effect might be altered by the type of meal consumed (eg, high versus low fat), IF A FOOD EFFECT WOULD STILL BE EVIDENT UPON MULTIPLE DOSING OF RIBAVIRIN, and, finally, what clinical implications the food effect might have. It should be noted that in the pivotal Schering-Plough clinical efficacy studies, ribavirin was administered without regard to food. Because of the uncertainty about the effects of food, it may be prudent for patients to TAKE RIBAVIRIN WITH FOOD."
Notice how it DOES NOT say HIGH FAT food.....just food.
But 70% concentration sounds so impressive, doesn't it? But remember....that was after taking ONE SINGLE DOSE of Riba. Taking multiple doses is totally different. You cannot predict what the bioavailability will be after taking multiple doses from looking at what happened after taking ONE DOSE.
"The fact that the multiple-dose ribavirin half-life (298 hours) is considerably longer than the single-dose half-life (79 hours) MEANS THAT IT IS NOT POSSIBLE TO PREDICT MULTIPLE-DOSE RIBAVIRIN PHARMACOKINETIC PARAMETERS BASED ON SINGLE-DOSE PARAMETERS. This has implications for interpretation of food effect pharmacokinetic data."
In other words, the data from the two high fat meal studies pertains to those of you who are planning on taking ONLY ONE Ribavirin dose....
Fat is a good source of energy and we all need some fat in our diet. For somebody on treatment who has lost lots of weight and can't afford to loose any more, the recommendation is certainly to eat whatever they can tolerate and that includes fat. If it means survival, it's better to eat junk than to eat nothing at all. At that point, getting calories is the important thing, doesn't matter where they come from.
I have no problem with people having some fat with their Riba. But I can't agree with suggesting people starting treatment eat 54 grams of fat twice a day as suggested by the study (especially if they're already obese) to MAYBE increase Riba bioavailability. Not when multiple dosing may already be doing that. Not when up to two thirds of them may have insulin resistance and many of them have fatty liver.
A high fat diet promotes oxidative stress, fatty liver, high blood sugar, an increase in CYP2E1, cytokine-induced beta-cell death, hepatic insulin resistance and hyperinsulinemia. All the things that lower SVR.
When you become insensitive to insulin (Insulin Resistance), the pancreas increases its production of insulin....so you end up with too much insulin (hyperinsulinemia).....And large levels of insulin, MAKE INTERFERON INEFFECTIVE....and at that point, Riba bioavailability will no longer matter.
As always, the choice is yours.
Thanks....I will probably take incevik at 6am , 2pm, and 10 pm and double up the first two doses with the riba - I think it will make it easier to take them together and perhaps as you say, not affect sleeping as much. And hopefully we can all say it is worth it ;)
It is ok to take the riba with the Incivek. When I treated I took the riba and telap together 2 x's a day then telaprevir 3rd dose by itself. I hated getting up every morning at 6am to take 1st dose of Rib & Tel each day. My dose times were 6am, 2pm (both meds) & 10pm (Telap only). In the end it was all worth it :)
In a way there already is, called "the most viewed health pages". Never went over to big though, got bogged down with to much junk.
I agree totally, flcyclist! Great idea.
@ ginger...I take my Incivek and Riba together. I also have no problems sleeping at all. My last dose of Riba is at 2:30 pm.
I was told it was okay to take them together and for the reasons that copyman stated, it makes perfect sense.
@ ginger...I take my Incivek and Riba together. I also have no problems sleeping at all. My last dose of Riba is at 2:30 pm.
I was told it was okay to take them together and for the reasons that copyman stated, it makes perfect sense.
I agree with Fly. There needs to be an area for general information and I would go futher, an area to post esp helpful links eg slide shows about drug mechanisms etc.
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