weight based????

[santaclaus]

hi all, just a quick question. i took my 2nd shot las nite and still no sides or any probs 2 worry bout,
im 3a and on 180 peg and 800 riba, i weigh 90.8kg and my hb was 16.2 on thursday.
i jus want 2 know how do i go about getting doc 2 up my riba?
i mentioned it 2 the nurse b4 i seen the doc on thurs and she started talking bout a weight based injection????
its jus that i really want 2 beat it this time around and i feel if i can handle it would be 2 up my riba.

please all ur thoughts are needed.

wayne

[comeagain]

I think its like epiphiny said before fuuuuck those geno 2,3 together studys.

I have my studie papers in front of me and it says its a studie for geno 2.3 how earlier has  been treated 12 to 24 weeks with pegulated interferon and riba and not have become SVR . 100 persons in german and thr noren countries will participate.

Im in a special group for people that from the beginning ( must mean week 12 since no PCR was made until then) has answered with UND and with EOT with UND but then got it back.

Still its g2 g3  2gether when will  they ever learn when will they ever learn where have all the soldiers gone.

[comeagain]

I am in a studie provided by roche the ones how make pegasys why do you think they are given me weightbased riba and let me treat for 48 weeks if its proven tha it will result in a lower SVR chanse.

[epiphiny]

Agreed apache1, people should not change their dosage without their Doctors consent however this is a very interesting discussion.

It's true that without study or research to back up these theories this is purely theoretical but there are current trials being carried out with different arms being given different Riba dosages and length of tx.  

And let's face it, the drug companies are the ones that are carrying out these trials; they wouldn't be doing them if they thought they had perfected the dosing regimes. Of course, due to follow up times, it will be sometime before we have results to put in print.

If the above guidelines were set in stone, why would the drug companies be doing further research?

[apache1]

Marcia,
As you suggested I just looked at my
Pegasys  insert for geno 2 and 3.

Just got this Pegasys box last week from the pharmacy, maybe the next box will have an updated insert ?
Its insert clearly recommends 800 for geno 2 or 3 for 24 wks

Interesting study in the Pegasys Insert ...this is the meat of it for geno 2/3
study # 5 table #3
http://www.rocheusa.com/products/pegasys/pi.pdf
geno 2-3_ 180pegasys flat dose 800 riba                     = 82% svr_ 24 wk treatment
geno 2-3_ 180pegasys wt base1000-1200 riba            = 81% svr _24 wk treatment
geno 2-3_ 180pegasys 800or wt  base 1000-1200 riba = 76% svr  _48wk treatment

There are the regular study disclaimers for lower svr in the fine print of study #5,
age over 40 , African American, Cirrhosis,
overweight, etc

Bottom line....without a study or research to prove it, we are just guessing/hoping, at best imo.

Please, nobody should change their doses from there Dr recommendation because of this post.

[comeagain]

I 2 are in a roche studie for relapsers geno 2, and 3 when started I weighted 89 kg got 1200 riba a day  after 12 weeks weighted 80kg still does that after 38 weeks same riba dose.

ca

[epiphiny]

Thanks for that, made an interesting read and I wholeheartedly agree that weight based is the way to go for G3.  On my first treatment I was on standard 800 and at my beginning weight I was still under dosed by current weight dosing guidelines.  Coupled with the fact that I put on 10kgs during treatment which would have then put me in the upper range for weight dosing.

I imagine the 24 weeks protocol is aimed at treatment naive patients.  In my opinion G3 relapsers and non-responders should be treated as other 'hard to treat' Geno with extended treatment times.

I look forward to the day when we can see some solid study data on this topic - if anyone has any info it would be great to hear about it!

[apache1]

think the .html got truncated in Jim's copy paste

http://www.hivandhepatitis.com/hep_c/news/2008/032808_b.html

[epiphiny]

As a Gt3a previous non-responder the above report really annoys me, and I believe it's high time they stopped putting Gt3 & 2 in the same box as it is becoming very apparent that the Gt2 results are skewing the numbers for Gt3.  

Gt3 is harder to treat that originally thought and while that report may say there is no additional benefit to extending tx to 48 for 3s there IS a distinct trend to do just that now.  What IS missing is good follow up data on these longer treatment times and studies that focus entirely on Gt3.

Perhaps that report is already outdated as weight based for Gt3 is also becoming SOC.

Btw, jmjm, I was unable to follow the 2nd link you posted, error 404, any ideas?

[apache1]

Actually the new FDA label revisions is for the Pegintron, not Pegasys, they are a little different.

Jim, unless I am reading your link wrong, for geno2 or 3, this test does not prove
more than 800 riba flat rate dose is better for svr,
Please correct me if I am wrong.

Interesting that this WIN-R test is the largest test to date in the usa for hep c

"In the first report, Ira Jacobson and colleagues provided overall results for the 5,027 total participants enrolled in WIN-R.

Results

    • Among patients with genotype 2 or 3, SVR rates were not significantly different depending on ribavirin dose (61.8% for weight-based and 59.5% for flat-dose), regardless of treatment duration.

    • Among these patients, 48-week treatment was not superior to the standard 24-week course.

    • Weight-based ribavirin was associated with larger reductions in hemoglobin levels.

    • Other than hemoglobin reductions, safety profiles were similar across the ribavirin dose groups, including the 1400 mg/day group.

In conclusion, the study authors wrote, "Pegylated interferon alfa-2b plus weight-based ribavirin is more effective than flat-dose ribavirin, particularly in genotype 1 patients, providing equivalent efficacy across all weight groups."

They added that, "For genotype 2/3 patients, 24 weeks of treatment with flat-dose ribavirin is adequate; no evidence of additional benefit of extending treatment to 48 weeks was demonstrated."

[Marcia2202]

okay I just saw, 1a...

[Marcia2202]

you are taking 17mg/kg  if you would put up your dose to 1000mg that would be almost 21mg/kg... that would in my opinion be too high... and you have already cleared.

What genotype are you again? I forgot.

[helpnikki]

I weigh 48.18... 44 yrs old and cleared in 8 wks- on 800mg daily ... can I take more? Where can I find that information?

[santaclaus]

i think wat ur taking is ok as long as u can handle it, im tryin 2 push 4 1200 - 1400 as 800 is not enough 4 me. as u can see everything seems ok and my hb is high

[Marcia2202]

You weigh 59kg. That means that you are getting almost 17mg/kg which is a nice dose. With 800mg, you would be getting 13.5mg/kg. I would say it is better to get a little bit more than less, if you are able to take it and if your doctors allow it.

I would have liked to have 1000mg, but my doctor didn't agree. I weigh 56kg. Maybe I would have cleared by 4 weeks, if I had gotten it.

At least, if you will ever have to have a dosage reduction, it will be reduced to the 'normal' dose. It's seems good to me to have a buffer like that!

Good luck with treatment.

God bless,

Marcia

[LindaC1207]

Odd, my weight is around 130 lbs and I'm taking 1000 mgs a day of Ribaviran.  Now if someone who weighs 140 lbs only takes 800 mgs a day, aren't I taking too much?  Just curious, it doesn't seem to be affecting me in negative way, YET, who's to say what will happen down the road a ways, just want to make sure I'm on the right amount, even though more is probably better, correct?

Linda

[santaclaus]

before tx  8/9/08                                         wk 1 23/9/08
hb  16.4                                                    16.2
pcv .453                                                    .444
rbc 5.22                                                     5.12
mcv 86.7                                                    86.8
mch 31.4                                                   31.6
hpo .1                                                        .1
wbc 11.19 h                                               7.59
platelets 258                                              246
neutrophils 6.32                                         3.76
lymphocyte 3.44                                        2.44
monocytes .65                                          .58
eosinophils .40                                          .43 h  
basophils .10                                             .08

[Marcia2202]

great info...

Do you know what age they are referring to as younger and older? What was the heading of the report/study/article. If you can't remember, I'll try find the it on CCO.

marcia

[frijole]

A couple of other ribavirn factoids from Clinical Care Options --

weight based ribavirin is 13.3mg/kg @ day
high dosed weight based ribavirin is 15.2mg/kg @ day

Also this interesting fact:

"Some studies indicate that ribavirin dose maintenance is particularly important in older patients, such that younger patients are more likely to achieve sustained virologic response (SVR) if ribavirin dosage is decreased later in therapy, whereas older patients are less likely to achieve SVR if ribavirin is reduced or discontinued

In hepatitis C virus (HCV) genotype 1 infection, individuals of younger age may be able to reduce ribavirin dosage after 24 weeks for severe adverse effects without significantly affecting their likelihood of SVR, whereas doing so in older patients may result in a reduced chance of SVR"

[santaclaus]

i will try and get all details on monday when i ring the roche nurse and post here.
thanx wayne

[Marcia2202]

Thanks for the link it is the first time I see it spelled out that precise. This report is for genotype 1. I have seen that Berg suggests different calculations for geno1 (15mg/kg) and geno 2 &3 (ca 12mg/kg)

    • < 65 kg (about 140 lb): 800 mg/day;
    • 65 to 84 kg (about 185 lb): 1000 mg/day;
    • 85 to 104 kg (about 225 lb): 1200 mg/day;
    • 105-125 kg (about 275 lb): 1400 mg/day.

(This is what my doctor might be going after... I only weigh 56kg. The only time I have ever weighed 65, was when I was 9 months pregnant with my twins.)

[Trish77]

If you have a link to the trial details online, I'd be interested to read them.  

Talk to your nurse asap about the riba increase and good luck.  Let us know how it goes, please.

Trish

[santaclaus]

i know the trial im in is been conducted in several countries and prob the same as you, but im defo goin 2 try and get more riba, especialy as i think i can handle more.
i read of people gettin sides from injection 2 which i feel nothing and as for riba the same.
i jus want 2 get this right 1st time round.
wayne

[santaclaus]

im not 2 sure wat my hb was b4 tx, but it is 16.2 1 week in. im getting copys of my results on thurs so ill be able 2 post more.
but as i said above 800 is doin nothing 4 me, dont feel any different and would like 2 try more.

[Trish77]

If you're in a trial, they probably have set dosages for your ribavirin however I'm surprised they have you at 800mg at your weight.  I'm in a Roche trial and I'm at 1200mg a day at less weight than you and a female.  Are there different arms in your trial or does everybody get this same dosage of ribavirin?

If you have a choice, I'd back Jim up and say go with the 1400 as long as you're able to tolerate it .. whatever increase you can get, the sooner the better.  Your interferon sound like it's already where it should be so perhaps your nurse is talking about weight-based dosages for your ribavirin and I hope so .. that would be better.

Interested to know how this turns out for you.

Trish