That is based on standard wt based dosing
In the ribavirin concentration controlled arm those with an AUC0-12h > 7000 or < 3000 ng*hr/mL will have their doses adjusted to a target AUC0-12h of approximately 5000 ng*hr/mL.
I as well as 18 of 20 subjects reach that level while taking in a fasting state as far as the other 2 subject I'm not sure if they have been adjusted up or down but I do know it is not done with food
I had this exact conversation with my study doc due to this subject being brought up here who is a teaching PharmD and study doc for a ribavirin concentration controlled study she told me the reason that I have to have my ribavirin levels checked while in a fasking state to check the my blood levels of riba is because there are no suffient study data to compare to otherwise. She does suggest I follow the package insert and take it with food as recommended.
I guess to be technically correct, it is the bioavailability of the Ribavirin which is increased because the absorption of the medication, when taken with a high fat meal, is slowed.
This is the paragraph which states that Ribavirin absorption is increased if taken with a high fat meal.
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 tablets were taken with a high-fat meal compared with fasting conditions [see Dosage and Administration (2.1) and Patient Counseling Information (17)]."
Here is the link to this page:
http://www.drugs.com/pro/ribavirin.html
5885 and 9451 are the Gilead trail meds.
The reason we eat with the ribavirn is to increase absorption, not nausea. You are supposed to eat a normal meal that contains some fat. I see no reason why you can't do your riba at 10 and 8:30-- or maybe 8:30 and 8:30-- with your meals. If you take your riba at 8:30 with a meal, I don't think it will have much effect on your sleeping.
What are the 5885 and 9451 - are those trial drugs? If they are you will just have to ask your trial coordinator about whether food is needed for absorption.
As pjhep said, if you take Incevik you need quite a bit of fat. If you take Victrelis, you just need a snack and it does not need to contain fat -- but you don't seem to be taking either or these.
frijole
Nowhine is correct you don,t have to take it exactly 12 hrs apart due to the half life of riba, I take mine @ around 7 am with a snack and around 5 or 6 pm whenever I eat dinner, study doc for a riba study told me that was just fine
I think the main reason is to alleviate nausea. I have taken this stuff with little food and it seems harder on the stomach. For me it is easier to take the meds during your regular routine of eating your meals. I have almost forgot to take the PM riba because I wasn't home and didn't have meds with me, but I knew it was dinner time and also riba time, so I had to go home to get meds. If you throw in another scheduling it may be harder to stay on track. Remember we will be taking this stuff for 24-48 weeks. Check with your trail folks but I think you should be able to take your meds when you eat (dine) at 10 and 8:30ish. Don't know when you go to sleep but the stuff gives me the jitters for a few hours after I take it. Hang in there the first shot is the worst. I start week 6 tomorrow and so far the sides are very managable. Hang tough and stay positive. Prayers for you to get SVR. Keep us posted.
if you are on incivek you need to take it with 20 grams of fat 3 times a day if you are just taking Riba just a snack with it
The package insert simply says take with food , no designation as to how much or what, follow the link to see more on the subject.
http://www.medhelp.org/posts/Hepatitis-C/Starting-Week-12-on-INC---THEN-WHAT-/show/1637168