You don't need 20 grms af fat for telepravir

[quayle]

Many times I questioned the clinic nurse And the treating Doctor and they both said it just needs to be taken,with a tall gglass full cream milk or a couple of tablespoons of full cream yougurt,so what has antyone else been told they have to strickly take 20gms of fat.a sI was told that is not the case.

[hrsepwrguy]

Exposure-response analyses, including clinical utility analyses28,29, conducted on data from the Phase 2/3 development programs confirmed that the 750 mg q8h dose and the regimen of telaprevir in combination with Peg-IFN/RBV results in telaprevir exposures that provided a good balance between efficacy and safety.  The clinical utility index (CUI) represents a composite of the exposure-response relationships for both safety and efficacy endpoints by defining the probability of clinical success as the difference between the probability of clinical efficacy and the probability of clinical safety over a range of drug exposures. The CUI from Study 108 represents a composite of the probability of achieving a RVR, preventing viral breakthrough (no VBT), and incurring a Grade 2 or greater hemoglobin decrease (Hgb abnormalities), as a function of model- predicted telaprevir exposure (Figure 6). During the construction of the CUI, the probability of RVR and no VBT are weighted by the percentage of subjects who meet these endpoints and go on to achieve SVR (81% for RVR and 77% for no VBT). The probability of the Hgb abnormalities is weighted by the percentage of subjects that meet this endpoint and fail to achieve SVR (24%). This weighting scheme was implemented to objectively scale the individual endpoint probability curves by their relative importance on the probability of clinical success

(cont)

[hrsepwrguy]

The antiviral activity of different dosages of telaprevir, administered as a suspension formulation, was evaluated in subjects with genotype 1 CHC (Study 101). The antiviral response was evaluated after administration of telaprevir monotherapy administered for 14 days at 450 mg q8h, 750 mg q8h, or 1250 mg q12h (Figure 5A). The greatest reduction in HCV RNA was observed with the 750 mg q8h regimen, which corresponded to the highest exposure to telaprevir. Because no clinically relevant differences were observed in the safety profile of the 3 dose regimens, the 750 mg q8h regimen was further explored in 2 subsequent short-term studies using a tablet formulation with about 1.5- to 2-fold improved exposure to telaprevir (Studies 102 and 103). In these studies, telaprevir 750 mg q8h coadministered with Peg-IFN or Peg-IFN/RBV resulted in further increase in telaprevir exposures and greater HCV RNA reduction compared with telaprevir monotherapy (Figure 5B), as well as suppression of telaprevir-resistant HCV variants. Because the telaprevir 750 mg q8h dose was generally well tolerated and not associated with any SAEs or discontinuations due to AEs, and the short-term efficacy was favorable (all 12 subjects achieved undetectable HCV RNA at Week 4 in Study 102), this regimen was selected for further clinical development, and no further dose-ranging studies were performed.

(cont)

[hrsepwrguy]

5.4 Rationale for Dose Selection As a consequence of its high replicative rate and its error-prone polymerase, HCV exists as a quasispecies. In most subjects, the quasispecies consists predominantly of wild-type virus and minority populations of viral variants with varying levels of resistance to direct-acting antiviral agents, including HCV protease inhibitors such as telaprevir. These variants may have lower level (< 25-fold increase in IC50) or higher level telaprevir resistance. The HCV variants usually exist at a low frequency before the start of treatment because they are less fit (have lower replicative capacity) than wild-type virus.  Two main goals of antiviral therapy applied to the development of telaprevir were (1) to achieve a high enough exposure to inhibit replication of wild-type and lower level resistant variants within an acceptable safety margin, and (2) to maintain this dose for a duration needed to eliminate wild-type and lower level resistant variants in combination with Peg- IFN/RBV treatment. The primary role of telaprevir in a T/PR regimen is to eradicate wild- type and lower level resistant variants, leaving the complementary role of PR to eradicate higher level resistant variants and any remaining lower level resistant variants. Susceptibility of HCV to telaprevir in both treatment-naive subjects and in subjects who have previously failed treatment with Peg-IFN/RBV therapy is expected to be the same.

(cont)

[hrsepwrguy]

The science behind 20 grams of fat with food, it is not a myth, it comes from years of research.

5.3 Food Effect
To achieve optimal exposure, telaprevir should be taken with food. In a Phase 1 study, when compared with administration following a standard normal caloric meal (21 g fat, 533 kcal), exposures (AUC) decreased by an average of 73% when telaprevir was taken in the fasted state, by 39% following a low-calorie low-fat meal (3.6 g fat, 249 kcal), and by 26% following a low-calorie high-protein meal (9 g fat, 260 kcal). The exposure to telaprevir was increased by 20% when taken following a high-fat caloric meal (56 g fat, 928 kcal) compared with an intake following a standard normal caloric meal.  In Phase 2/3 studies, subjects were advised to consume a regular meal or snack (high fat was not required) within 30 minutes prior to dosing with telaprevir. Based on its prescribing information, RBV is also to be dosed with food. Since RBV is administered twice a day and has a long half-life, it was administered with 2 of the 3 daily telaprevir doses in the Phase 2/ 3 studies.

(cont)

[BoceprevirGal]

I just wanted to add, that while our bodies are busy, fighting a virus, we need to pay extra good attention to our nutrition (food)~
   It's like when we were kids, fighting the flu...chicken soup :)  The fat that floats to the top of the soup has always been an old Jewish cold/flu remedy~

[jules2551]

http://www.incivek.com/how-to-take-incivek

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

    Take 2 INCIVEK pills (a dose) 3 times a day
    Eat a meal or snack that contains about 20 grams of fat, within 30 minutes before you take each dose of INCIVEK
    Each dose should be taken 7 to 9 hours apart. Pick the same time each day to make it easier to remember
    INCIVEK must be taken with peginterferon alfa and ribavirin


Always take INCIVEK with food
If you take INCIVEK on an empty stomach, you may not get enough medicine in your blood to clear the virus. That's why it's important to eat a meal or snack that contains fat, within 30 minutes of taking each dose of INCIVEK.

Examples of foods that contain about 20 grams of fat that could be eaten with INCIVEK include*:

    Bagel with cream cheese
    1/2 cup nuts
    3 tablespoons peanut butter
    1 cup ice cream
    2 ounces American or Cheddar cheese
    2 ounces potato chips
    1/2 cup trail mix


Of course, don't eat any foods that you are allergic to. Also, keep in mind any dietary restrictions you may have.

*The food you eat with INCIVEK should NOT be low-fat.