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Deciding on Entering a Clinical Trail Study

by mari74, Mar 11, 2007 12:00AM
There will be 5 groups to be in...

Group 1..receives Peg & Riba for 6 mos + 6 mos more ...
         no "New"  medicines.

Group 2..Peg & Riba for 6 mos, if positive then add Protease(Spelling it right or wrong?)for 6 + months.

Group 3..Peg + Riba+ New Drug(Protease) for a total of 7 mos.

Group 4..Peg + Riba for 4 weeks, then Peg + Riba + New Drug for 6   mos.

Group 5..Peg + Riba for 4 weeks, then Pega + Riba for 44 weeks.

The hospital will put in a the group they feel you need.  The drugs are suppose to be the real.

I do have insurance, BSBC, but still undecided if a trial study is worth it. And if they will really be given the real medicine.  I cannot take that chance, because of the condition of my liver.
Member Comments (5)

by FL_Gal, Mar 11, 2007 12:00AM
To: mari74
It sounds like the control is group 1, and what they are testing is when and how many weeks to add the protease inhibitor.  If in fact there is no Placebo group, I don't see the down side, except that groups 3 and 4 are shorter treatments overall.

What genotype are you?

by Kalio1, Mar 11, 2007 12:00AM
To: mari
Im not sure I'd take the risk of not having rescue drugs available or being in one of the arms that isn't an ideal dose. You have insurance and their are patient assistance programs to help with the costs also,I have BCBS also and Commitment to Care picks up my drug costs.They have agreed to cover me for both treatments, this one is 72 weeks long. That saved me a fortune in copays.
If you stay out of a trial you could tailor your treatment to YOUR needs and not to fit the parameters of a trial. You could also use rescue drugs and manipulate the length of treatment and your dosages should that become necessary if you find the right doctor who will treat aggressively.
You are adding an additional risk when you are adding a trial drug, the risks are yet to be known, so that adds another wild card.

by mari74, Mar 11, 2007 12:00AM
I am genotype 1.  
I had a liver biosy 2 -3 weeks ago and it said I have Stage 1 Cirrohosis.  
Man, what a blow! I still can't believe it....

by FlGuy, Mar 11, 2007 12:00AM
To: Mari
What's the study drug?

by Kalio1, Mar 11, 2007 12:00AM
To: mari
Yes, I remember. I know the feeling. It's scary but you have a good shot at improving your liver condition treating. I'd be leery of doing a trial because of the limitations. Im sure your main goal is to rid yourself of this virus attacking your liver and in a trial you limit your treating options somewhat.
Keep in mind that some people can reverse that liver damage to some extent with treatment, even for those of us in the early stages of cirrhosis. Stay positive!
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