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]

October 31, 2009
More than 80% of Hepatitis C Patients Treated in Study C208 Achieved an SVR with Telaprevir-Based Regimens

    83% SVR achieved with twice-daily regimen of telaprevir dosed with PEGASYS and ribavirin
    Results highlight the use of response-guided therapy in managing treatment outcomes
    Similar safety and tolerability observed between telaprevir-based regimens dosed either twice daily or three times daily

BOSTON, Oct 31, 2009 (BUSINESS WIRE) -- More than 80 percent of hepatitis C patients in each arm of the Phase 2 Study C208 achieved a sustained viral response (SVR) with a telaprevir-based regimen according to results of an intent-to-treat (ITT) analysis announced today by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX). The data from Study C208 will be presented in an oral presidential plenary session at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which began yesterday in Boston. Telaprevir is a hepatitis C virus (HCV) protease inhibitor being developed by Vertex Pharmaceuticals Incorporated in collaboration with Tibotec and Mitsubishi Tanabe Pharma.

(cont)

[Diana66]

Talking about how to take it, have you seen the latest that taking it twice per day (1,125mg ) instead of 3 times per day is in fact better?

I guess Incivek will update their site shortly. I only wonder if we will need the 30grms of fat with the 3 tablets?

http://hepatitiscresearchandnewsupdates.blogspot.co.nz/2012/10/twice-daily-incivo-telaprevir-in.html#.UH212m_MjjA

[hrsepwrguy]

I'm not going to beat the dead horse, I have produced the science behind the dosage rational, presented to the FDA for telaprevir approval, take it as you wish.

"Is that enough? Maybe!!!!"

Maybe not !!!! WHY TAKE THE RISK, you only get one shot with the PI's and if you fail YOU are the one who still has HEP C

[Diana66]

Guys, not to pour gas on the fire but here is an extract from the Data sheet here in New Zealand:
Telaprevir is orally available, most likely absorbed in the small intestine, with no evidence for absorption in the colon. Maximum plasma concentrations after a single dose of telaprevir are generally achieved after 4 – 5 hours. In vitro studies performed with human Caco-2 cells indicated that telaprevir is a substrate of P-glycoprotein (P-gp).
The exposure to telaprevir was increased by 20% when taken following a high-fat caloric meal (56 g fat, 928 kcal) compared to an intake following a standard normal caloric meal (21 g fat, 533 kcal). When compared to administration following a standard normal caloric meal, exposure (AUC) decreased by 73% when telaprevir was taken on an empty stomach, by 26% following a low-calorie high-protein meal (9 g fat, 260 kcal), and by 39% following a low-calorie low-fat meal (3.6 g fat, 249 kcal). Therefore, telaprevir should be taken with food.

Here is the link: http://www.medsafe.govt.nz/profs/datasheet/i/incivotab.pdf

Which really only shows what I have been told by Jansen's office: that needing to take 20gr of fat is news to them. I am not saying that this might not be the case, I am only saying that the same company gives a very different advice in Autralia and New Zealand. And if this is the case they should put their act together.

From the paragraph above it seems that I need 21grs for 100% availability, 56grs to have a 20% increase

Hence the 237% increase presented in US is certainly a different way to presents results. We all  love statistics and how easy is to manipulate results.

The same paragraph also says that if only 9gr are taken (your one glass of milk and whatever else, exposure will decrease 26%. Is that enough? Maybe!!!! I guess it really depends on how big the person is. You cannot tell me that the same amount is needed for a 50kg person and a 120kg person

[flcyclist]

In your follow up post which disappeared you stated that you grilled your doctor and nurse for at least an hour and they adamantly stated that there’s no need for the 20 gm of fat and they’ve treated many patients over many years.   Unless your treatment team has been directly involved with Incivek trials prior to its release in May 2011, this doesn’t allow much time (1.5 yrs) for any doctor to accumulate data on diet and rates of SVR.    If they were involved in trials and shared their data with you to support this advice, it may bring some credibility to their adamant advice.  If they haven’t been involved in trials, this short interval doesn’t allow enough time to recommend off label advice which could recklessly jeopardize anyone’s success in treatment.   If you failed tx, you would look back and always wonder if this could have impacted the result.  

If you feel comfortable in following this advice, then that’s your call.  But to post this as an encouragement for others to follow this off label advice is wrong and reckless.  This would be akin to saying you’ve never been involved in a car wreck resulting in serious injuries, so why bother putting on the seat belt.  Maybe not the best analogy, but if you want to take a risk, then don’t encourage others to follow.  This is by no means an attempt to attack you in any way - just to correct bad advice.   Good luck to you.  

Take a few minutes to read the good information that hrsepwrguy has kindly provided.

[hrsepwrguy]

The distribution of telaprevir exposures (plotted as the population PK model-predicted average plasma concentrations), are included with the 5th and the 95th percentiles marked as dotted vertical lines. The resulting plot shows a relatively flat CUI indicating that the exposure range of telaprevir obtained from the 750 mg q8h dose in combination with Peg- IFN/RBV results in a good balance between efficacy and safety (Figure 6) The exposure-response relationship for subjects with prior treatment failure from Study 106 showed that the clinical utility index weighted by SVR is relatively flat between the 5th and the 95th percentiles of telaprevir exposure (Figure 7). Furthermore, Phase 3 studies have confirmed that this dose of telaprevir used in combination with Peg-IFN/RBV therapy provides superior SVR rates over those seen with Peg-IFN/RBV therapy alone.

To see the charts follow the link

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562