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Concerned about Dosing
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Concerned about Dosing

I'm five shots into SOC and a few days into the blue pills (Boceprevir or placebo) and I'm at the point where I'm beginning to worry about things. (Probably time for a walk, really.) But, I wanted to run my SOC dosage by everyone because I'm feeling like it's pretty low EVEN THOUGH I did check it somewhere (at Schering-Plough?) and it did check out. Still, I'm the only 1 I've ever seen who is getting less than 1000 mgs of ribavirin. Here's what I'm taking:

.4 of 120 mcg peg-intron redipen (96 mcg)
800 mgs of ribavirin
12 blue pills

I weighed somewhere between 138 and 143 at the beginning of tx. I'm about 5' 3 1/2".

Thoughts? Or just tell me to go take that walk and leave it alone . . .
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19 Comments Post a Comment
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96938_tn?1189803458
If the standard weigh-based doses are 13-15 mg Riba per Kg and Peg at 1.5 mcg of Peg per Kg, you are only a hair less on both.  I think it's part of the risk/reward aspect with trials.  On one hand you are getting free meds and the 'new stuff' on the block and a lot of attention.  On the other hand, there is less of a possibility for treatment 'stylizing' and things like rescue drugs might not be available.  Now, if the meds were height-based and not weight-based you'd be right on the mark.  Your a little person, ain't ya?
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9648_tn?1290094807
Thanks for the laugh. I've always felt BIG because I'm the tallest woman in the family. And I used to be much thinner before I had two kids and middle-age set in.

My trial does allow rescue drugs (and they provide them) so there shouldn't be any dose reductions. That's a good thing.

I'm just obsessing because I'm not happy with my first VL counts. Even though I know there's nothing that I can do about them. Even though I know that if I have the real thing (and not the placebo) I have a great chance.

Thanks for "weighing in" on this. ;)
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Avatar_m_tn
Why don't you bring up the numbers FLGuy supplied and ask your med team to consider increasing dosage.
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9648_tn?1290094807
Seems unlikely she would go with that. She showed me the charts she was using to establish the dosage when I first started. And my weight has been decreasing. I'm down to about 61 kg now.
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Avatar_m_tn
I also tried to squeeze an extra riba out of my doctor, no cando, cando. Its not like when i was on SOC........... You getting a nasty taste from them blue monsters? They can be down right nasty at times.
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Avatar_m_tn
I was always shown a riba chart by my NP that was outdated. Fortunatly I had researched it out prior and called her on it. She didn't admit that the chart was outdated but did allow me to increase my dose.
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9648_tn?1290094807
jmjm--I will def look into that then. I was assuming she was showing me a protocol sheet from the trial, but who knows.

can-do--Yes, the blue ones are Most Foul. I'm not getting metallic, though. Should I be worried that they taste like someone's old sneakers that have been mouldering underground for at least ten years instead? (Should I be worried that I can even guess what that would taste like?)
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577132_tn?1314270126
Yes I would be worried if I knew what buried ten year old sneakers tasted like!
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Avatar_m_tn
(Should I be worried that I can even guess what that would taste like?) ..... UHHH YES:)

I really don't know if its a metallic taste, its just a down right nasty after taste. A word of advice, i had cotton mouth one morning when i took one, it got stuck, well all a big gulp of water did was help it dissolve BEFORE it went down. I've only made that mistake once.
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9648_tn?1290094807
I admit it. I'm a writer. I have a very active imaginary life. I also have a younger brother who was prone to burying things in sand at the beach, the backyard, etc.

I almost got a pill stuck this morning. There was a moment of true panic when I realized what that could lead to.

Maybe I do have the real thing. That would be marvelous (especially considering how disgusting they after-taste).
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408795_tn?1324939275
If I were you I would leave the dosage issue alone.  I trusted my clinic nurses fully, there not gonna do anything that would chance you failing tx.  As far as the blue bombers go, just keeping up with taking all those a day and keeping the count right is like a small job in itself.lol  One thing I've read about in your case is not being able to get blood test results.  I was always able to get mine whenever I asked.  Of course I realize that you most likely can't do anything about that, but I think it's a big crock that they said the sponsor/Schering Plough are the only ones who are privy to that information b/c it's a double blind study.  The clinical trial site has to know when your HgB drops a significant amount, so they can drop your Riba one capsule and start you on Procrit.  Sounds like you're doing fine, I remember a small young lady who was on tx a few months ago and they dropped dosage levels on both as the amounts were just kicking her bum.  The idea that everyone has to start at the same level, just doesn't hold true alot of times.  Sure if you're able to handle it then that's fine, but when a one hundred pound lady is getting the same dosage as a two hundred pound man, it just doesn't seem right.  Just my opinion of course, but I prefer the idea of weight based tx.  The blue bombers took me from 2 million something in my 4th wk, to 118 in my 5th week.  That drop was only 1 wk of the blue bombers.  I didn't know about the massive drop until later, but I had to drop out for personal reasons.  In my personal situation I don't regret having to stop, even being so close to UND, I'll have to try another day.    Good luck and God Bless
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9648_tn?1290094807
Thanks for your advise. No kidding about keeping up with taking everything. I found a calendar and I'm making notes as the day goes along. Water too. That's really helping. And if--for some reason--the information doesn't transmit to them (did you have to use one of these dumb Palm Treo's too?)--I'll still have the data.

At any rate, I did *finally* get my all my numbers from the nurse the last time I saw here and will continue to get all my testing information as the trial progresses.

That's really good to hear how well you did with the blue bombers. I've got everything crossed. I'm five weeks in now, and the numbers I have from starting and week 2 are not impressive at all. Hoping (because of the foul taste) that I've got the real thing, and hoping that they kick some serious virus butt.
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408795_tn?1324939275
Yes I had the Palm Treo, glad you're finally getting your blood tests results.  I have no doubt that those blue bombers work.  I think it would be a little late to ask for an upgrade on your meds.  I was never truly impressed with my numbers until my 4th wk to my 5th wk.  My VL took a drastic beating from those blue bombers and incidentally the only sx's I got from the blue bombers was gas, gross inhuman gas.lol    good luck    
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Avatar_n_tn
unfortunately underdosing is one of the risks of trial vs post-approval.

agreed that your mg/kg numbers look reasonable for both drugs, but on the other hand.. a lot of protocols go for 1000 for <75kg.
Jacobson has a recent review on the subject:
"Optimal dose of peginterferon and ribavirin for treatment of chronic hepatitis C."
http://www.ncbi.nlm.nih.gov/pubmed/18637069

which no doubt includes the stats from the recent weight-based studies.
Might be worth comparing that with your dr's chart

Also since you're part of a study, you might be able to settle any argument with your dr by getting her to run a plasma HPLC assay - ultimately that's the factor that correlates with outcome:

"Prediction of sustained virological response by ribavirin plasma concentration at week 4 of therapy in hepatitis C virus genotype 1 patients."
http://www.ncbi.nlm.nih.gov/pubmed/18672540
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Avatar_m_tn
Willing: Also since you're part of a study, you might be able to settle any argument with your dr by getting her to run a plasmaPlasma amino acids HPLC assay - ultimately that's the factorFactor ix complex that correlates with outcome:
------------
Study or no study,  as of two years ago there was no HPLC testing in this country accessible by patients. Possibly this has changed but I have yet to hear of anyone getting one and several have posted interest here. In fact, I daresay most doctors won't even know what you're talking about. Conceptionally, however, I do agree with you. In fact I planned on flying to Sweden myself for that same test but a tanking hgb made that academic as I was maxed out for me.

All the best,

-- Jim
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Avatar_f_tn
That dosage seems a little on the low side.  I'd be checking if your NP is going by a flat dosage ribavirin chart or a weight-based dosage (WBD) ribavirin chart.  For Schering-Plough and at that weight, I'm thinking you'd be better off at 1000mg of Riba.  That's my humble opinion on it.  An article on the differences in results between FD and WBD, just in case that's what she's going by.

http://www.medscape.com/viewarticle/563799

As long as you can handle it .. and the earlier the better...the extra riba is a good thing and if you want to up it, no harm in at least asking and advocating for it.

And it wouldn't be a trial chart she's going by for your riba dosage if the trial mandates SOC to go with your blue bombers.  You should be getting the dosage that SOC would require for your riba, trial or no.  I don't think your boceprevir trial plays with the riba dosages, does it?

Good luck to you.

Trish
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Avatar_n_tn
I'd assume tests for study participants are not limited to those offered by commercial labs, eg you'd have a  hard time finding a commercial lab to run a sequencing test but these are done routinely in the PI trials.

BTW, it seems that in addition to HPLC there are 4 other types of assays for measuring concentration
http://www.ncbi.nlm.nih.gov/pubmed/17628382

Of course, a trip to Sweden may trump the lot.
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408795_tn?1324939275
This wasn't the exact study I was looking for, but it's close enough.  By all means if it totally bothers you to be on weight based dosages, go ahead and ask your tx team.  good luck  

Peginterferon alfa-2a relapse rates depend on weight-based ribavirin dosage in HCV-infected patients with genotype 1: Results of a retrospective evaluation.

Zopf S, Herold C,
Hahn EG, Ganslmayer M.
Medical Department 1, Hepatology and Gastroenterology, Friedrich-Alexander University of Erlangen, Germany.

Objective. The cumulative dosage of ribavirin per kilogram of body-weight prevents relapse and thus is a significant predictor of sustained virological response (SVR). Comparison of peginterferon (peg-IFN) alfa-2b/ribavirin and peg-IFN alfa-2a/ribavirin shows that the rates of SVR are similar, but the rates of relapse are significantly lower under the peg-IFN alfa-2b regimen. Depending on the weight-based ribavirin dose, patients with >105 kg reach a maximum of 13.2 mg/kg body-weight ribavirin in the peg-IFN alfa-2b regimen as opposed to only 11.3 mg/kg in the peg-IFN alfa-2a regimen. The aim of these investigations was to determine relapse rates in a retrospective analysis of 98 patients chronically infected with hepatitis C virus (HCV) genotype (GT) 1 in relation to the weight-based ribavirin dose. Material and methods. All patients completed treatment with peg-IFN alfa-2a/ribavirin (1000 mg/d or 1200 mg/d for patients weighing /=75 kg) for 48 weeks. Classification of a low ribavirin dose with /=13.2 mg/kg were compared with those with a dose /=13.2 mg/kg (n=84) showed a relapse rate of 19.0% in contrast to 71.4% in patients with a ribavirin dose of /=13.2 mg/kg ribavirin dosed group (59.5% versus 28.6%). Conclusions. Weight-adapted ribavirin dosing in combination with peg-IFN alfa-2a to avoid giving low doses of ribavirin should be evaluated. This will minimize relapse, especially in HCV GT 1 patients.

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Avatar_m_tn
I'm basing my statements on both my own efforts and efforts of others to obtain (unsuccessfully) HPLC testing in this country. The doctors I asked were involved in multiple trials and barely even knew of the existance of these tests. It's possible that has changed in the last couple of years (I doubt it :) ) and just wanted to give a heads up before someone felt that they weren't getting available tests. Of course, I recommend anyone giving it the ole' American try. I did and would again, including flying to Sweden if I had to treat again with SOC which I never would again given the new drugs soon becoming available.
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