I don;t know but I was told that the incivek would only work with fat. Something about incivek using the fat to disolve. maybe can't give you the stats on it but I know I hate it I have never put so much food into my body. But only 6 weeks to go.
From the Vertex Prescribing Guidlines. I'd say increasing the exposore of Incivek by 237% with 20 grams is excellent proof.
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).
Everyone that i know...which is about 7 people that were on the trial, all dleared and were asked to stay on a regular diet, specifically were requested to NOT do " Fat Free " they have all been SVR for over 5 1/2 years, most cleared in the first week to week &. 1/2. Just wanted to see if anyone had solid evidence for this dietary requirement.
Those are numbers that are posted, I understand, I guess what I'm trying to find out from trials is exactly what people were doing this 60 gram fat diet verses those that didn't that cleared. Just curious, Carolyn
Telaprevir was trialed for many years so they must have compiled much information during that time and determined the drug is more beneficial and obviously yielded higher SVR rates if taken with 20 grams of fat.
It will be well worth the inconvenience - 12 wks and that's it.
This is the Vertex submission to the FDA. You might want to slog through it and see if you can find something.
Not a doc but I was told that the fat increases how much of the Tela is in your system and also helps to slow absorption to make it work better for us. I am not happy about the high fat diet but I am not happy with HCV so am doing whatever they tell me :) One day, I guess I did not eat enough fat and I got sick and lost my meds