Accepted for pre screen of clinical study, need advice

Hey guys need your advice, I have been accepted for pre screening for this study...Since I have no experience with the meds used in therapy I need your input on whether or not to pursue it...



The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PEG-Intron 1.5

[HepCinLA]

I believe this is the Ideal study the same one I'll be going into.

Unfortunately I don't think you get a choice as to which drug you can take (it's random).  So you'll either get Pegasys or Peg Intron.  If you get put on Peg, you won't know if you're on the high or low dosage.

The good thing that it is a study so they tend to monitor you very closely.

[1fairygirl]

Beth,
You get to stay in Canada and do this, right?  It sounds like this may be an answer to your problem of where to treat.  Also, what level of care you get while treating.  The problem could be if you don't get a high enough dose to get svr.  Keep us posted on your thoughts with doing this.  Good luck!
Smiles, Sue

[v eggie dip]

no, this study is in North Carolina at Duke University Medical School...I would have to live with my daughter and she is about 220 miles away, but at least it is a way I can get care back home and don't have to deal with this sub standard health care sysytem in Ontario...In these studies do they want you to have scheduled appointments on a weekly basis or monthly?  I was wondering about that because it is so far away, like blood work etc...They probably want to use their own labs too...

Lots to think about....Thanks for your input

[1fairygirl]

Beth,
Sorry to hear that it's in the states.  You were thinking about treating here, anyway, though and this would help so you wouldn't have to worry about expenses or getting medical coverage.  Will they cover for all meds for sides during treatment?  Yes, it is a lot to think about.  So nice to have your sister there for you, but also hard to be gone for a year.  Until later,
Smiles, Sue

[jmjm530]

The pro's are: (1) financial; (2) good supervision; (3) helping to collect data.

The con's are: (2) You may get stuck in the low dose group that they know in advance will have a lower SVR; (3) The study may not allow intervention with Procrit or Neupogen thus increasing the chance of either decreased dose or early termination; (4) treatment options (blood tests/doses/treatment length)are less individualized since you have to follow certain protocols.

[HepCinLA]

If this is the Ideal study (and I think it is just check out the website www.idealstudy.com) you will have to do scheduled visits.  There is the initial exam, chest x-ray, ekg.  Then you have shot one at the doctors office.  You come in two weeks after that, and then on a monthly basis.  
I believe you are able to take Procit but only after your hemoglobin drops below 10.
Your doctor's visits, bloodwork, meds are all paid for except anything that falls outside the scope of hepatitis.  For example you will need to get AD's, birth control, etc paid for thru your own insurance.
Did you ever find out your VL?  If your VL is very low and you are not extremely overweight then I think you will still be okay with the lower dosage of Peg in terms of reaching SVR.  
The idealstudy website also has a list of participating hospitals.  Maybe you can find one that is a little closer to you.
Good luck!

[friole]

That is good news.  I hope you will be able to work out all the details.  You have done a lot of leg work in the last couple of weeks!
Kathy

[jmjm530]

Yes, in most cases it could cover a two-log drop, but being non-detectible at 12 weeks gives more predictive information per certain studies and that really requires a sensitive PCR <50. No big deal if someone didn't get one, just more information to work with if you do. Certainly, you'd want your week 48 test (and six month follow-up) to be as sensitive as possible to make sure you really cleared the virus.

CT Scans, MRI's, and Ultrasounds are better for liver cancer screening, not to stage fibrosis/cirrhosis. Because I'm a stage 3, I alternate ultrasound and CT scan every 6 months. MRI's produce good pictures as well but have more radiation so probably not a good idea if you're going to be doing a lot of them.

For staging, the alternative to needle biopsy are newer blood tests like Fibrosure and a European x-ray type of device called Fibroscan. I believe a study showed that in combination they were more accurate than used alone.

-- Jim

[v eggie dip]

yes I had been researching a way to get home for treatment for days and this is the first promising thing I have found...However, it is far away and it is a gamble with the chance of getting reduced meds...I am genotype 1A so that is a big deciding factor...

[chellski]

wow - lots to think about.   jmjm weighed the pro's & cons's but still a big decision.  good thing you can stay with your daughter.   (btw: in everyone's post, i'm saying to myself whats so ideal about this study?....duh!)
beth - i'll say a prayer and hope you're able to make a decision without too much stress or worry...maybe something will come along to make the decision easier....good luck and be well...
<3 michelle

[v eggie dip]

thanks michelle

[iceboy]

Sorry to jump in. just a quick question. You where saying yesterday about the roche amplicore (600/800.000) that is was not satisfactory for week 12, 24 and 48. I understand why for the 24 and 48, but cant it cover the 2 log drop on week 12?

Also, can scans and x-rays replace totally the needle biopsy? all the best.

[mawg]

This is the Ideal Study.  (I know cause, I 'flunked out').  

Here's what I know:

1) You will receive treatment--no placebo in the trial.  Which treatment will be 'luck of the draw'.  2 out of 3 are the S-P drugs.

2) The treatment drugs/supplies are supplied by the study.

3) Any 'extra' drugs (anti-depressants, Procrit, Neupogen) are NOT paid for by the study.

4) All labs are paid for, by the study.  The results are very slow back to you.  (I think--because of the long chain of parties within the study).

5) You must have a 2-log drop in VL by week 12 or you will be dropped by the study.  This is what happened to me (1.8 drop) but it was for the best 'cause the SX were grinding me into the dirt.

6) The study has a 6-month follow-up--if you SRV or not (just had my last lab work in July)


So, the price is right .... the rest is just-okay.

Good Luck!
mawg

[rearfang]

That sounds like the IDEAL study. (I mean that's what it is called, not that its so wonderful!) Is that the one? If so, I almost went through that, but Roche's Pegassist program came through for me at the last minute. (I went through two screenings and was literally 2 days from starting when I found out I would be covered under Pegassist.) I believe they want to see you every 2 weeks for about 6 weeks, then once a month. I don't recall exactly, but it seems to me that I would be able to go to my own labs for bloodwork. I had asked about Procrit/Neupogen, etc... and they told me that they would first go for a dosage reduction, but would rx the meds if necessary (sounded backwards to me!). Anyway, hope this helps. Good luck and let us know how you fare.
Lauren

[motox829]

I am 7 weeks post tx.  I went through the Ideal Study and all I can say is it was rough, but worth it.  I was Type 1.  I was issued Pegaysys .5mg and copegesus 1000mg.  I have been hep c negative since week 4 of tx and received results Friday and I am still (-)!!!!  Only time will tell if it is gone for good.