changed mind....again!

I have decided to not go with Inc. and do Vic instead (4 week lead in). I start tx on the 22nd so this is a last min. decision. The anxiety I was having  was unbearable. I could not rap my brain around the 60 grams of fat. I don't eat cheese or bread so that didn't help so after a week of anxiety I talked with doctor and we decided to do the other triple therapy. Now I feel better and not spending so much time with list of fat and searching the stores for what I could possibly eat. I know i have to eat with the Reba dose but she said a snack will do. Does not have to be high fat. Its not that I was afraid of putting on weight, it was more of not being able to do it!  What surprises me the small amount of people on this sight who are doing Inc instead of Vic. Either way, I just want to get this started!

[hondapatches]

I was told that the incivek was mostly for non responders. :( That's me..lol

[kirk8]

I think Vic. is prescribed more.  That may have something to do with less sever side effects or the price tag.  Vic. is about 1/4 the price of Incivek.  The clinical trials indicated that Inc is more effective in non responders/relapses but the difference in naives was small.

[flcyclist]

As the following article mentions, neither drug has been proven superior.  It comes down to patient preference and risk factors.  I haven't read anything about either having an advantage for non-responders, but that might be the case.  If so, it would be good to list a reference for a published trial.  

If I had to do things all over and needed to choose a PI, I'd be leaning toward Vic since I'm a rashy guy and my Hgb hasn't been an issue.  

The following article was posted last month by Diane12855 and is a good read.

http://www.idse.net//ViewArticle.aspx?ses=ogst&d=Hepatitis&d_id=213&i=ISSUE%3a+August+2011&i_id=753&a_id=18862

Best of luck as you begin.  Try not to overthink this stuff.  I know I don't.  hahaha.

[copyman]

Hate to tell you this but for Riba to be effective it should be taken with just as much fat if not more then incivek. This has been proven with data to back it up. My thought was is if I had to take fat with riba anyway I might as well take the incivek at the same time with the same fatty food.

Also one of the main reasons people are doing incivek more is the possibility of only having to treat for 24 weeks. That by itself is a huge factor. The less time these drugs are in your body the better. And of course you will take a lot less fat in 24 weeks vs 48 weeks :)

[beeblessed]

Really?  From the posts I have read since June, there seem to be many more people on INVICEK than on VICTRELIS.  But then, I am only checking this community, so maybe there are more in the Social Community or somewhere else.  The draw of INV is shorter treatment time (typically), while the draw for VIC is less intense sides.  My doc initially had me scheduled for INV but after talking to her colleagues, she discovered that many were having trouble with the sides, particularly -- anal pain and/or bleeding and firey bowels, to the point where they had to stop treatment.  So I am currently on the Pegasys (Interferon) and Ribavirin, then at the beginning of the 5th week, I will add VIC.  Either way, there is a ton of helpful information on what to do about sides for both drugs, and everybody responds differently to tx.

As for the RIBA......To make the morning dose more comfortable.....my training session suggested a "robust" breakfast, to avoid tummy issues since you have been fasting while sleeping (and therefore; your stomach acid is higher and wants to suck up the first thing you give it; and since the RIBA is hard on GI issues.....you want to start off with a bit more food in the mornings).  I found that I was overeating, trying to do this but I have decided/learned that a regular breakfast is good.  So more than a snack.  Hope this helps.  Best to you in tx!

[willing]

>for Riba to be effective it should be taken with just as much fat if not more then incivek.

not true.The food requirements  in  the medication guide for copegus (one of the brand names under which rbv is sold) makes no mention of fat:
"Take COPEGUS with food."
http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=12149#Guide

whereas the language in the inci package insert is explicit about the requirement for 20g of fat/dose.

"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)."
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf

Many pts do opt to take rbv with additional fat, to improve absorption, but this it is not a  requirement (and the need/advisability is controversial).

>one of the main reasons people are doing incivek more is the possibility of only having to treat for 24 weeks
for naives who clear after 4w of PI  both inci and vic specify 24 w of tx. Vic add a 4w lead in, making the total 28 w. The risk of not doing a leadin is potentially pointless exposure to the PI.

What is true however, is that the amount of PI exposure time with inci is never more than 12w and thus always shorter than vic.  

[Magnum]

I'm on Victrelis and feel 90% normal. No Anemia, no anger, just a medicine taste in my mouth. Tic Tac. Partial responder. As for the fat with Riba, doc said 10 grams is enough. Get it from organic peanut butter. 48 weeks in the course of a lifetime is nothing. At least no horrendous rash from Incivek. Spoke to lab tech at Merck who said if partials don’t clear after 12 weeks, they could clear after 6 months, so don’t give up too easily...

Magnum

[willbb]

Spoke to lab tech at Merck who said if partials don’t clear after 12 weeks, they could clear after 6 months, so don’t give up too easily...
---------------------------------------------------------------------------------------------------------------------------------
That may be ...keeping in mind the labeling says  if>100 at 12 weeks   or still DET at 6 months  to discontinue per futility protocol .

Possibly this tech may not agree with the company's labeling?

[copyman]

Wow, I thought everyone knew this to be very true. Guess not. Just so any newbies get the RIGHT information here it is again.

Let me state this again. Ribavirin is better absorbed with a high fat meal. Like I said there are studies and proven data to back it up. Google " taking ribavirin with fat". Here is one example from PubMed, a well respected website:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1804105/

The component of the final population pharmacokinetic model that describes the absorption phase is complex. Although a standard meal did not affect ribavirin bioavailability (F1), administration of ribavirin with a high-fat meal increased bioavailability by 46% relative to the fasting state. A high-fat meal prolonged the duration of the zero-order input part of the absorption model, with D1 increasing from 0.498 h (fasting and standard meal) to 0.740 h. The type of meal also influenced the first-order input part of the absorption model (Table 1).

[hrsepwrguy]

Ok now I'm confused, I am in a study of concentration controlled ribavirin dosing.

http://clinicaltrials.gov/ct2/show/NCT01097395?term=hepatitis+c+AND+colorado&rank=1

When I went in for my first day, for them to run the AUC 0-12 (11 blood draws) I was made to show up in a fasking state and was not allowed anything to eat until 5 hrs after my first dose of ribavirin, not once has the hep c research team at UC Denver told me I needed to take riba with fat, they have stongly suggested that I take the tela with 20 grams of fat but only needed to take riba with food to avoid nausea. So my thought is this, who do I believe people on the internet, who I know have done tons of research on the matter or the hep c research team at UC Denver who knows exactly how my body is absorbing the riba based on AUC 0-12 after my first dose.

[willing]

"not once has the hep c research team at UC Denver told me I needed to take riba with fat"

no such recommendation was made because no package insert for the drug requires it. As noted above many pts opt to take rbv with fat to increase absorption but this is a 'home brew' remedy aimed at increasing rnv concentration. Other, equivalent home brew remedies are a low purine diet (purines and rbv compete for the same molecules for transport from the gut to the blood stream) and simply taking a higher rbv dose.

Unlike the fat requirement for inci, none of these home-brew remedies are  required/recommended . Searching the mh  archives will show much discussion/controversy on the topic.

A key factor is the dramatic difference in the additional absorption effect induced by a high fat meal, For rbv bioavailability increases "46% relative to the fasting state" whereas for inci it increases 330% relative to fasting (from the quotes above).

The claim that rbv, to be effective, requires as much if not more fat than inci is nonsense,

[lynda607]

"The claim that rbv, to be effective, requires as much if not more fat than inci is nonsense,"

Totally agree.

[curiouslady1]

I hope you guys get this all figured out soon.  

[can-do-man]

""The claim that rbv, to be effective, requires as much if not more fat than inci is nonsense"

100% agree

[copyman]

LOL. home brew? read the studies make your own decision. Perhaps this is why some people clear the virus and some don't.  Not a chance I want to take.

[shanro]

Agreed!  If there's a way to make any of this more effective regardless of prescription labeling... sign me up!!!  I'd rather be fat and hep free than skinny with hep C!!!

[lynda607]

Ribavirin dose optimization is not ultimately achieved through a high fat diet.  It may be helpful but primarily it has to do with how well the body metabolizes the ribavirin and how well plasma ribavirin concentrations are maintained.  Dosage can play a significant role in this.

[hrsepwrguy]

" If there's a way to make any of this more effective regardless of prescription labeling... sign me up!!! "

Really then why are you second guessing your doctor on thier version incivek protocol

[hrsepwrguy]

Thank you for the clarification on the issue.

[shanro]

because it is better to be safe than sorry...

I haven't seen any research proving that it's bad to take riba with high fat, but there's research that it may be beneficial.  It seems that this is still being studied...  So why not just take the riba with high fat which won't do any harm..

as far as second guessing my doctor, the incivek protocol was studied... and in my opinion I'd rather be safe then sorry...

[hrsepwrguy]

Ribavirin has been around for a few more years and has been through all of the studies if not more than incivek, yet the label still doesn't call for fat intake before dose but the incivek does and how do you know that you are not absorbing to much riba which must be bad for you or they would say take 2000 mg's a day just to make sure you get enough. Riba is a major cause in hgb decline so maybe to much is not a good thing, but I guess maybe it is better to be safe than sorry right.

[Magnum]

In the past 4 treatment attempts, fat with Riba was never mentioned.

Magnum

[Magnum]

In the past 4 treatment attempts, fat with Riba was never mentioned.

Magnum

[willbb]

Oh look..the centuries old (well since 2001 anyway) argument about fat with Riba again.

"Bioavailability"  means the portion of a dose that reaches circulation.  Higher fat food will slow absorption of most drugs(including Riba)   ..but will not have much effect on "bioavailability"

In the Schering Plough study Riba was given with no regard to food, and concluded because uf uncertainty about effects of food they said it may be prudent to take Riba  "with food"       it said nothing about  "high fat food"

For those of you on Inci..it is mostly moot anyway as I would imagine you are taking the Riba at or about the same time as Inci and the fat is adequate ....for those on Vic   because "some fat" may increase "bioavailability  a little fat with the Riba can"t hurt ...however nothing to stress over....according to the company that makes it and most knowledgeable Hepa"s

Will

[flcyclist]

Hey brianmo,  I bet you didn't expect your post to turn into a Riba and fat vs no fat debate. lol

Based on the studies I've read I try to have some additional fat with each meal taken with Riba.  I don't obsess about how much or if I forget, but figure it won't hurt.  

[willbb]

I try to have some additional fat with each meal taken with Riba.  I don't obsess about how much or if I forget, but figure it won't hurt.  

Perfect :)

[shanro]

i'm having some brain fog/wallowing issues right now and the mention of having to indulge in fattening food sounded comforting so I went with that.... with the brain fog I thought I was arguing my point well but with bs... so i will openly admit now that i don't what the hell i'm talking about right now... LOL... i think i'll quietly step away from this discussion now...

[frijole]

'What surprises me the small amount of people on this sight who are doing Inc instead of Vic'

Okay, I admit to being a little anal but I have started a spreadsheet of people starting therapy since May.  I have missed a lot but it looks like INC - 30, VIC - 8.

My Ribashere labeling says this under Clincal Pharmcology - Pharmacokinetics:
"Effect of Food on Absorption of Ribavirn - Bioavailability of a single oral dose of ribavirin was increased by co-administration with a high-fat meal.  The absorption was slowed (T max was doubled) and the AUC 0-192h and C max increased by 42% and 66% respectively, when the ribavirin was taken with a high-fat meal rather than fasting."

So the absorption is better with a high-fat meal but the absorption is slowed down (over fasting).  It is far more important  for trough ribavirin plasma concentrations to be reached. And it takes about 12 WEEKS for that to happen.   In the long run take food or not -- I think taking all of your doses and taking them close to 12 hours apart is more important.

One of the biggest differences between ribavirin and incevik is the half-life.  The half-life of a single dose of ribavirn is 120-170 hours.  The half life of Incevik 9-11 hours according to the FDA advisory committee briefing document (page 4)  The only way to keep INC in the system is to take it every 8 hours or so.  The fat helps with that maximum short-term bioavailability.  With the ribavirin, overall, we just need to keep it going in our system and let it build up -- with or without fat.

I have never seen anything about the amount of fat and nothing on 20 grams for riba.

frijole

[frijole]

Lynda
"Ribavirin dose optimization is not ultimately achieved through a high fat diet.  It may be helpful but primarily it has to do with how well the body metabolizes the ribavirin and how well plasma ribavirin concentrations are maintained.  Dosage can play a significant role in this. "

Exactly - you are able to put this in concise words oh so well!  We know if that riba is working, when we get anemic.  In reverse, there have been members -- bill1954 and fishdoc -- who have been riba resistent (whose hgb never dropped significantly).  The way they solved the problem was NOT eating more fat, but upping the riba dose

frjiole

[frijole]

"I was told that the incivek was mostly for non responders. :( That's me..lol "

I think this is totally false.  I think you could succeed with either one

[willbb]

Okay, I admit to being a little anal but I have started a spreadsheet of people starting therapy since May.  I have missed a lot but it looks like INC - 30, VIC - 8.
--------------------------------------------------------------------------------------------------------
lol..it is good sometimes good to keep score  :)

To new folks..frjole"s advice will be invaluable  to you going forward ..with her knowledge of HCV and tx.

[frijole]

I am really glad you are doing so well.  What was your start date and what was your VL at the end of the lead in and after 4 weeks of VIC (if you are there yet)

[Magnum]

As the doctor pointed out on my blood work results visit Tuesday, it's not necessary for 20 grams of fat, and warned me about weight gain. I've been on treatment almost 6 weeks and put on 6 pounds. So let's see, I'm pretty good with math, 48 weeks = 48 lbs.....

No, I can't agree with the 20 grams. I will take my chances with 10 grams, and let's not forget that this fat protocol was mandated to be taken with Ribavirin without Victrelis or Incivek Now that those have been added to patients, is this fat thing necessary? A question that will raise debates, perplex even scientists and especially some patients.

So far in this treatment plan (one month traditional lead-in and 9 days Victrelis), I notice the constant medicinal taste in my mouth. I will add that the doctor has me on Prevacid as I developed acid reflux after adding Victrelis. It’s well under control now..

Surprisingly enough, I still do 12 laps in the pool daily, no lip sores (first week, yes), not ready to strangle anyone, hair not falling out, not losing weight (quite the contrary), good humor. What's right with this picture?

Here's something: The nurse who works for the company that sends my meds is very well aware of patients’ reactions regarding agonies, as well as successes. She pointed out that attitude is everything, and she’s right. In fact after I told her how good I feel under this bombardment, she said “I told you so”.

I for one, never think I’m on treatment. I keep very occupied writing my new screenplay, doing things around the house, working on new songs, etc... and the only time I think about treatment is when the alarm goes off to take the meds. Otherwise, it’s up to you. 48 weeks = 48 lbs....?

Magnum

[willing]

frijole:nice post - made me go back and dig up the "patient information"  section for my ribasphere rx : "Take this medicine with food". As with the copegus directions above, no mention of fat.

the main  point, nicely summarized by lynda, is not that taking fat won't improve rbv absorption  (it will) or that adequate rbv is not a key factor in svr (it is) but that adjusting rbv levels with avocadoes and peanut butter is   not the best way to do the job. Given that we are saturated with rbv within a few weeks  of  tx,  AUC rather than Cmax or absorption time  from  single dose measurement is the relevant stat. (and what's the AUC difference relative to an ordinary meal?).

Strange thing is that though there is unanimous agreement about the importance of rbv, what constitutes an "optimal"  rbv dose is still very murky. Serum  concentration is hard to measure in the US  (though possibly available through trial NCT01097395 at UC Denver) and is still missing reliable comparison points. This leaves weight (at least 13-14 mg/kg) and Hgb decline (at least 3 units of Hgb drop - from rbv, not PI).

Not a very optimal definition of optimal...

[willing]

>I still do 12 laps in the pool daily,
wow! On a good day I sometimes  manage 12 'laps' up and down my drive way....

[can-do-man]

"Okay, I admit to being a little anal"

Nothing wrong with that girl, if for some reason your not happy with having a little one may i suggest eating alot of fat????.....:)

[Magnum]

Viral count after one month lead-in 2,325,024 to 652.332. This means I'm a partial responder. Doc is happy with this. I will add that the ALT (62) and AST (58) readings have been the lowest in 17 years since diagnosed.

If you recall the near death scenario with the Infergen overdosing, the AST was 377 and ALT 368. Bilirubin 2.2. (scary considering the high point being 0.3)... Any higher and I would not be writing this....

AFP marker went down from 24 to 17. It’s been as high as 34. Bilirubin slightly elevated (to be expected). Plateletes at 66 (acceptable), and a good mental and physical attitude helps a lot. Naturally, some med marijuana is a catalyst for at least keeping the sleep cycle regular as well as hunger (hope I don't get attacked again), and so on it goes. I will see in 3 weeks the count, now that Victrelis has been added. Aside from acid reflux, I see virtually no added side effects after adding Victrelis...

Magnum

[lynda607]

It would have more encouraging if you'd seen a better response to P/R than a .56 log drop in the 4 week lead in.  Did your doctor discuss any of the info below?  Regardless of the stats, hoping triple is the winning ticket for you.

Subjects Who Failed Previous Therapy with Peginterferon Alfa and Ribavirin

In subjects who were previous relapsers and partial responders evaluated in RESPOND-2, interferon responsiveness (defined as greater than or equal to 1-log10 decline in viral load at TW4) was predictive of SVR. VICTRELIS-treated subjects who demonstrated interferon responsiveness at TW4 achieved SVR rates of 74% (81/110) in VICTRELIS-RGT arm and 79% (90/114) in VICTRELIS-PR48 arm, compared to 27% (18/67) in subjects treated with PegIntron/REBETOL. VICTRELIS-treated subjects who demonstrated poor interferon responsiveness (defined as less than 1-log10 decline in viral load at TW4) achieved SVR rates of 33% (15/46) in VICTRELIS-RGT arm and 34% (15/44) in VICTRELIS-PR48 arm,compared to 0% (0/12) in subjects treated with PegIntron/REBETOL.

  

[Magnum]

He's very well aware of my past 4 failed treatments, but we're treading in undiscovered territory with Victrelis. Interestingly, he said if that doesn't work, we then switch over to Incivek. There are no more choices after that. Wait until the newer drugs come out? That’s a good question. My liver functions have always been normal, so who can predict the future?

Keep in mind that the pharmacist at Merck told me that partial responders have had miraculous results with Victrelis. I certainly hope so. These horse capsules at 12 a day should kill anything smaller than a cat. It’s been very hot here in Las Vegas, which doesn’t help the sides when it comes to sudden nausea attacks. Thankfully they only last a few torturous moments. It’s been so hot here that the chickens have been laying hard boiled eggs... Stay tuned...

Magnum

[GoofyDad]

"Okay, I admit to being a little anal"

Careful. Family website.

[frijole]

It is far more important  for trough ribavirin plasma concentrations to be reached. And it takes about 12 WEEKS for that to happen

errata - read the labeling wrong ---- it does not take 12 weeks for maxium serum concentration. -- That was the length of the study, duh --- anyway it is 3-4 weeks to reach max

Now, goof -- what's this about a family website........
can-do -- you old icecream pusher you......


magnum - oh yes, I remember well your foray into infergen.  We almost lost you! THis has just got to be the one.   I too wish your lead-in VL were better but it is what it is.  I am pulling for you ----- what is your screenplay about?????

willing -- I really need a translator when I read this stuff -- max t, AUR blah blah blah - it is a very different world trying to "cipher" it all out.

frijole

[susan400]

Well guys/gals, I've treated too many times to count and I only heard about this Riba/fat thing on about the past 3 TX's, the rest of them, it was just 'take it with food'.  It doesn't matter to me one way or another because I didn't clear on any of the 10(or 11 TX's-if you include the 1 maintenance TX I did), with or w/o a fatty/Riba meal.  This last TX was only SOC since I got the placebo and at this time, I have practically no response to SOC and that was with a fatty/Riba administration.   So, you can take what you want from that.  I feel that if you're going to clear-if it's meant to be-you'll clear..., if not, then, oh well, it wasn't the right TX for you at this time.  I just wish I got get the right TX/time w/fatty foods, or w/o fatty food.  It's the Hep C drugs that are what's important.  I don't really think it has that much to do with what you're eating, whether you're a vegan, or a meat eater, or a purine eater, or a non-purine eater...    That's my opinion and it's mine and you don't have to agree with it, that's okay...

Susan400