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.

[quayle]

Thanks BoceoravirGal,
                       That's what the doctor and Nurse said to me Just have a tall
glass of full cream milk,or an Avacado they just said when you eat wbefore taking it make sure you have some food woth full fat,not skim or low fat,she said two rich creamy biscuits would do,But I eat too much already so I don't see any problem.

[BoceprevirGal]

  I think all should be fine then, a glass of milk, and a handful of peanuts, would cover it. Nuts and avocados have good fat in them.
  Good luck with your Treatment, and I'll be here, to lend you support/encouragement.
  Have you started yet, and if not, make sure to get a loud alarm, and set it to go off every 8 hrs, for your Incivek dose. I used my cell phone, with a rly annoying jingle. Once my Treatment was over, I couldn't figure out how to get the alarm to stop going off (my husband set it for me) and so I stopped paying my ph bill onthat phone, lol)
  The virus is tricky, so you cant miss even a dose~ good luck

[quayle]

I know well to take it with food but 15grms of fat is fine I'm not takin any pills during treatment on an empty stomach.

[quayle]

I did not say that not to eat fat with it btumy Dr.heptologist,Who has treated thousands and thousandss over ten years,has perscribed thousands of scripts for five years talks with the reps who visit the clinic said it not,nessesary to take 20grms evrytime you take telepravir it just that you take a reasonable amount,so You'll excuse me if I take his word over yours sorry

[uncledudeness]

yes you do need 20 grams of fat with Incivek....................i'm glad we settled that.....just sayin

[BoceprevirGal]

  Just to cover all bases, I ate like a pig.  I always had a yogurt, everytime I took my meds, and a sandwhich, and a glass of milk. Then I would take a walk. I found eating and walking helped to combat any weird, nauseous or dizzy feelings, I was having.
  

[hrsepwrguy]

Straight out of janssens incivo booklet

http://www.medhelp.org/user_photos/show/308364?personal_page_id=2257209

http://www.hepcnomads.co.uk/Incivo/Diet_and_Lifestyle_Booklet_incivo.pdf

[willbb]

Wow....40 posts  on what to take Inci with ?

  Possibly try 20 grams of fat for best results. (as per instuctions) as HPG has said...


Will

[hrsepwrguy]

I guess anything is worth a shot, but if you fail with these drugs, you can't just go back and follow the instructions :) So my advice to all is to follow the instructions.

Have a great day

[copyman]

FYI, Me taking the pills with whole milk was not that I took a "risk" or just got lucky. This came from a leading Hepatologist in Boston. I wasn't able to keep the pills down with fat. Taking with milk was an "alternative" that worked.

I'm not suggesting for anyone to take with just milk. But rather then not taking them at all you can drink milk instead.

Actually with this resilient virus I will take some luck as well :-)

[Diana66]

Yep, this one is from 2012, not sure why they needed to repeat it (and they do have different results as well, lower than the ones you have posted and probably morea realistic. Still, 74% is good :)

Janssen Research & Development Infectious Diseases - Diagnostics BVBA (Janssen) will present results from the OPTIMIZE Phase 3 trial for INCIVO® (telaprevir), during a late-breaking poster presentation at the 63rd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston (http://www.aasld.org/lm2012). The study, which was completed in September, investigates the efficacy and safety of the twice-daily dosing (BID) of telaprevir versus dosing every eight hours (q8h) in people chronically infected with genotype-1 hepatitis C virus (HCV) who had not been previously treated.[1]


The results demonstrated that BID dosing of telaprevir 1,125mg in combination with peginterferon alfa and ribavirin (PR), achieved similar cure rates, also known as sustained virological response (SVR12) to q8h dosing of telaprevir 750mg (74.3% versus 72.8%), thereby meeting its primary objective of non-inferiority versus q8h dosing.[1] The safety and tolerability of telaprevir was comparable across dosing arms and consistent with previous studies. The most common adverse events experienced were fatigue, pruritus, anemia, nausea and rash.[

[hrsepwrguy]

Study C208 explored telaprevir-based regimens dosed either every 12 hours (q12h; twice daily) or every eight hours (q8h; three times daily) combined with either peg-IFN-alfa-2a (PEGASYS(R)) or peg-IFN-alfa-2b (PEGINTRON(R)) and ribavirin (RBV), for 12 weeks followed by an additional 12 weeks of peg-IFN and RBV in a response-guided trial design that included 161 treatment-naïve patients (intent-to-treat analysis) with genotype 1 hepatitis C virus (HCV) infection. Across the four arms, SVR rates were 82 and 83 percent in patients treated with the every 12 hour telaprevir-based regimen (PEGINTRON and PEGASYS, respectively) and 81 and 85 percent in patients treated with the every 8 hour regimen (PEGINTRON and PEGASYS, respectively). For the majority of patients, these SVR rates were obtained with a 24-week telaprevir-based regimen.

"With high SVR rates and similar safety outcomes between the twice-daily and three-times-daily treatment groups, the results from this exploratory study support the future evaluation of telaprevir-based regimens dosed twice daily," said Professor Patrick Marcellin, M.D., from Beaujon Hospital in Clichy, France. "These results also highlight the potential future role for response-guided therapy with the goal of improving treatment outcomes and potentially shortening the duration of therapy for the majority of patients."

Study C208 Results                         RVR* SVR**
TVR (q12h/peg-IFN alfa-2a/RBV) (n=40)  83% (n=33)        83% (n=33)
TVR (q12h/peg-IFN alfa-2b/RBV) (n=39)  67% (n=26)     82% (n=32)
TVR (q8h/peg-IFN alfa-2a/RBV) (n=40)    80% (n=32)     85% (n=34)
TVR (q8h/peg-IFN alfa-2b/RBV) (n=42)    69% (n=29)     81% (n=34)

* Rapid Viral Response: Undetectable HCV RNA at week 4

** Sustained Viral Response: Undetectable HCV RNA 24 weeks after the end of treatment

alfa-2a: PEGASYS

alfa-2b: PEGINTRON

(cont) at the following link

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=420611

[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

[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.