Treatment being stop

Well looks like I'm going to be taken off the IdealStudy.  I didn't make the 2 load drop, missing it by 30,000.
Started 1a v-load 7 mill, my 12 week test returned I'm now at 100,000.  They want me at 70,000.
I see my dr. this monday, I'm to take my last dose of meds sunday nite.
I don't even know what to say here on the forum, I'm at a lost for words.  Can anyone of you put a smile back on my face?
Looking for hope.
Diana

[scruffy]

Diana, that is a very big drop in viral load-it just does'nt meet their test standards. Is there any way you can continue the treatment and simply extend the time of treating? You have shown that you are responding to treatment. Good luck to you-others will answer you with more useful avenues to pursue to continue treatment. frank

[whoaisme]

The Infergen study (Intermune)is still open for non-responders or as we prefer slow responders....but first check to see if your doc will continue treating you "off study". You were responding and it is still early in the game. I wouldn't rush right into a daily infergen protocol without trying to continue with the peg/riba --either company  (Schlering or Roche) first...good luck

[Kanzou]

I am sorry to hear that you were dropped after making such good progress. Which study were you on - Pegasus w/Copegus or Peg-intron w/Rebotol, or were you on the different dose comparison study? I'm a 1a about to start tx and don't know which one yet.

It sounds like Schering-Plough wants granduer results to publicize even though it looks like you would clear but not as fast as they desire. It doesn't surprise me a bit of a drug firm more interested in the bottom line and publicity than curing someone who is ill. What a shame.

Have you discussed this w/your physician to see if he/she would agree to having you continue with your treatment and he/she would monitor your progress?

I do hope things work out for the better for you. Keep fighting and don't give in.

[bon_vivant]

:(
I am sorry to hear this news... I am sure you are feeling pretty devistated & over-whelmed right now...

But Don't Give Up Yet.... There is Still Inferen

I don't know "Where" you are located at.... but I do know that there is still hope for Non-responders, & Slow-responders..... & The Infergen Studies Are Active, & In Place....

You are responding, you just didn't meet that particular studies criteria....

I wish I were more knowledgable on that subject so I could furture assist you, & I am sure others will come along that can.... but don't ever give up...

I know this is discouraging... but it's not the end...

Easier said than done... but try not to fret or loose hope!
Vicki

[poolcue]

I'm on the Peg-Intron w/Rebotol.  You are correct it is the Schering-Plough.  I'm 47,125lbs. I believe I'm a weight base study.
My meds 0.28 peg and 800mg reb.  they dose reduce me to 600mg reb. and from what I have read on this forum do your  BEST NOT TO BE DOSE REDUCED.  I wish you good luck & health with your tx.  I agree with you I think I have made progress with good results. Hopefully when I talk to my dr. monday he will do something to continue my tx. but I'm on contract.  So I'm guessing that I will have to wait until all my follow-ups are done before the dr. will do anything.  Its great to have it paid for.
But I must play by their rules.  If I had been on my insurance I think the tx would continue??? maybe not.
Diana

[poolcue]

Hi Vicki,
I'm in Fl. I moved here just for the tx. my home is in Indiana.  Hubby & I have been traveling back and forth so that I can do the tx.
Thanks for the input on Infergen study.
Diana

[cuteus]

Hey Diana, Vic reminded me of some study that was recruiting non or slow responders, maybe you can jump right into one of the kind.
That was one big viral load decrease, but they are set in their own numbers. You are a responder and should take advantage of this before the virus mutates into a ahrd to beat bug. Someone here mentioned their PCP monitored their tx when they lost their GI.
Insurance would not have stopped tx if no 2 log drop, mine didn't. it has to do with how the dr words his letters to the insurance and the codes used. TRY to continue somehow, somewhere.

clinicaltrials.gov

[TnHepGuy_]

<u>poolcue</u> - I'm sorry you had to wait so long before you were given the Procrit. A Hg level of 9.4 can be extremely intolerable, at best. And if it is your WBC that dropped to 0.93, then that is a rather low level that doctors do not prefer to see. In each case, if you were not part of the IDEAL study and were under the care of a proactive doctor, chances are that you would not have been allowed to reach so low points and earlier intervention with both Procrit and Neupogen would have taken place - thereby allowing you both symptomatic relief and the opportunity to continue at full dose.


<u>ASmile4U</u> - the amount of Peg-Intron is determined in a weight-based dosing strategy (as opposed to Pegasys, which is a 'one-size-fits-all' amount of 180 ug) and is usually stated in a 'per/kilogram' amount. The IDEAL study uses two differing levels of Peg-Intron: a lower 1.0 ug/kg amount and a higher 1.5 ug/kg amount. As for your dosage, if you look at this <a href="http://www.curascript.com/wbdchar.shtml">chart</a> you'll see that you're on an amount listed for a body weight of 76-85 kg/166-187 lbs (which also states a coinciding riba amount of 1,000 mg.).

As far as your doc stating that a 4 week PCR is not accurate, I'm assuming he means as a predictor of SVR. Well, if that's the case, he's far off-base on that one and need look no further than <a href="http://www.natap.org/2005/HCV/060605_01.htm">Ferencia</a> for confirmation: (from the study) "<i>The likelihood of achieving an SVR was highest in patients who had an RVR at week 4.</i>"

If he's referring to the accuracy of the test itself at week #4, then he's even more off-base, since it's the exact same test that is given at any point in time to measure viral load.


Best to you in your upcoming PCR results.


TnHepGuy

[poolcue]

Thanks for bringing up the 1.5 ug or 1.0 ug.
I'm reading my consent form now and it looks to me that you are right.  Here is how it reads:
Comparison of PEG-Intron 1.5ug/kg/wk Plus REBETOL vs PEG-Intron 1ug/kg/wk Plus REBETOL vs PEGASYS 180 ug/wk Plus COPEGUS.

I had to ask to be put on Procrit 3 weeks ago.  My red blood started around 13 & drop to 9.4 when I ask for it.  It's now at 12.8
I just found out ( I think this is my white cell count) at sometime during the tx was .93 and is now at 1.41

Do you think its possible that I'm a high risk study being that my counts are on the low end ?
Diana

[ASmile4U]

After reading the info you posted on Peg_Intron standard dosing, I went and looked at the packaging on my Peg_Intron Redi-Pens.  I was curious where I fell in with the standard because I am unsure of whether I am at a high or low dose.  The package says 120 ug/0.5 ml. The u in ug is almost like a backwards p.  I take the full 0.5 ml.  Am I misunderstanding something or am I on a really high dose?  I also take 1000 mg of Riba which appears to be the norm.  I'm a 1a with a VL of 1.9.  Was just curious, I go next week for my 12 week PCR, my doc refused to do one at 4 weeks  saying the results were not accurate any sooner than 12 weeks.  I have a feeling we may have a long visit once the results are in if I am not clear.

[TnHepGuy_]

I hope you don't think you are a non-responder - you most certainly are.

As being part of this study you weren't given the best treatment plan: 1.) by being on sub-optimal doses of both interferon and riba to begin with, and (secondarily) 2.)by them not intervening prior to your dose reduction.

The interferon amount you state of 0.28 seems to be far below the beginning IDEAL study amounts of either 1.5 ug. or 1.0 ug. of Peg_Intron. And standard non-trial dosing of riba these days is 1,000 mg., whereas you were started on only 800 mg. - then reduced from there.

I would say that if you were given the standard amounts of each drug to begin with, your odds of hitting the 2-log mark - and perhaps even being serum clear - by week #12 would have improved dramatically. That being the case, I wouldn't clasify you as a 'slow-responder', and most certainly not a tx-failure. The only 'failure' here has been in under-dosing of your tx. You won't know what your 'true' status is until you are given the proper tx.

If your doctor allows you to continue forward, you need to ask him to switch you to full dose amounts of both the interferon (i.e. - 1.5 ug. of Peg-Intron or 180 ug. of Pegasys) and 1,000 mg. riba, and have him order PCR's every 4 weeks until you show clear. And make sure that he would be willing to start you on Procrit and/or Neupogen <b>before</b> dose reduction becomes an issue. If he's not agreeable, before you begin tx again take the time to find a new doctor who will work on your behalf - one who realizes that as being part of this study, you weren't given the best shot available.


Best to you.


TnHepGuy

[ASmile4U]

Thank you so much for the valuable information.  I have never seen the Peg_Intron dose chart before.  Wondering if the doc will lower my dose now that I have lost 20#'s and I now fall into the .4  catagory.  Suppose I could eat really well prior to my visit!  

Yes, my doc does not believe the 4 week PCR is a predictor of SVR and refused to test any earlier than 12 weeks.  He made it clear from the beginning of tx that he would not test at 4, 8 or even 10 weeks, because he felt the optimal time to test was 12 weeks.  I am amazed at all the differences in opinions with the docs.  So far, I have been very comfortable with my doc and his decisions, however I do need to consider what's best for me. At my last visit, (9 weeks) I made it clear, if I was not clear at 12 weeks that I had no intention of stopping tx and expected him to take me at least to week 24, testing PCR every 4 weeks and from whatever week I actually cleared, I would do a minimum of 36 weeks from that point.  He seemed to agree with what I said and stated, without going into detail, that there are other options depending on the results. I am hopeful he is flexible as well as aggressive.  I'll soon find out.  My platelets have been very low since week 2 so I don't really know how flexible he'll be.   Had to do some serious convincing to remain on tx for the time being.  I'll go next week, a little more educated and opinionated and see where that gets me.  Once again, thank you, I very much appreciate your help.  Hoping that next week when I'm doing shot 13 the doc calls and tells me I'm clear... :)

[desert woman]

My husband was taken off of treatment a month ago (PegIntron, Ribavarin) because after the 6 and 9 month PCR tests it showed his viral load climbing again.  We talked to his doctor about increasing the riba but he wouldn't do it.  My husband was taking 800 mg of riba a day, not enough for his body weight of 176 pounds.  We had to find another doctor willing to treat my husband with Pegasys and the correct dosage of riba.  We are still waiting for an approval from the insurance company on the new meds.  After 9 months of treatment and all the side effects my sweetie went through, it makes me angry that the first doctor wouldn't work with my husband on treatment options.  There are doctors who aren't willing to treat the patient as an individual but as a statistic, and especially with the side effects of hep C treatment, that's a shame.  The wonderful people on this message board have lots of important info to share.  I hope your doctor comes through for you.

desert woman

[poolcue]

Can you supply me with a list of the lab work the dr. test for in the 12th week and the high/low range for me.
1a- 125lbs female.  Or a link.
This way when I see the dr. I can better understand what he is talking about.
I'm willing to bet its been a post here before sorry just one more time please.
Diana

[TnHepGuy_]

The things to pay closest attention to in your most recent round of testing are:

- Viral Load - (which you already know is at 100,000)

- White Blood Cell Count (WBC) - doctors begin to get concerned when it's in the <u>1.5</u> or below range

- Absolute Neutrophil Count (ANC)  - concern around <u>750</u>

- Hemoglobin (Hg) - concern around <u>10</u>

- Hematocrit (Hct) - concern around <u>30</u>

- Platelets (PLT) - concern around <u>50,000</u>


The above listed 'concern' figures are a generalization; some doctors will intervene at higher amounts - some at lower amounts.

<a href="http://janis7hepc.com/monitoring_our_blood_work_while.htm">Here's</a> a site with some good info on blood testing and monitoring while on tx.

And <a href="http://janis7hepc.com/">here</a> is their home page.


TnHepGuy

[poolcue]

Thank you
Diana

[poolcue]

Sorry that your husband was taken off tx.  I know it must be just as hard on you seeing his virals going up.  I sure hope your insurance will give him approval to continue tx and not take to long.  Maybe his sides won't be as bad if the ins. acts quickly.
Good luck
Diana