clinical trial & riba

[joy5116]

I'm contemplating a clinical trial that has riba in 4 of the 9 arms.  My question to the PA was: "If I develop hemolytic anemia how will it addressed?"  Her reposnse was we will "probably" stop the riba.  While I didn't think to ask now am wondering in a doubleblinded study how does one know which drug is riba or would they stop all meds?
I'm not exactly getting cold feet but wondering if I should wait.  I have HCV over 40 years and am f-2.
Time keeps on slippin into the future...
Joy5116

[UKgirl55]

Forgot to address your question though. If you're worried about the Riba, a good thing to remember is this...Riba will lower your blood levels, but that's how they tell it's working. It's the INF that stops the body from naturally reproducing red blood cells. Without the INF, your body should automatically kick in and produce more red blood cells. It's not to say that your levels won't drop...just hopefully not as much. This is how it was explained to me when I screened for a trial (which I decided not to do) earlier this year. If I were to do this trial I would WANT the Riba in the arm. I'm more concerned about the 7977 and 938 taken together. What have they said about that? These are two powerful drugs.

[UKgirl55]

Oh, I know this dilemma only too well Joy! I'm right there with you!

[joy5116]

This is for Quantum.  I have followed PSI-7977 since before it's first trial run and it sounds very promising the addition of PSI-938 for resistant mutations sounds good also but it's a risk not knowing which arm you'll end up in.
Big decision...because waiting presents it's own risks.

[UKgirl55]

If you don't mind sharing....what trial is this for?

[joy5116]

These people seem absolutely wonderful as well.  They made me feel very comfortable.  I was told we will NOT (unlike other trials), be given the VL numbers throughout and that the drugs will packaged so they will not know which is which.  It sounds much stricter in that respect but as for staff, PA nurses, doc, etc it is a great staff and I couldn't ask for more in that respect.  They are caringand considerate.
My question is simply around the riba.
Thanks so much,
Joy

[SusieS2010]

In the new arm of the Quantum (I think) trial, the ribavirin arm has a placebo 50% of the time. The Pharmasset drug 7977 is defiinitely given. At some point it will be unblinded and if a patient does not get the ribavirn and does not respond then they are given the ribavirin. Hopefully, because 7977 has a very high resistance barrier, that won't be a problem.

[belle19]

i'm in a clinical trial.  they told me i'm on peg/riba for sure but not sure if i'm on a placebo in addition or a protease inhibitor.  my numbers are great.  i get blood work every week.  i was anemic so they lowered the riba dose.  i'm in week 19 and i've been UND since week 8.  i have one of the top liver doctors.  my study nurse is great.  i have nothing but good things to say about my care. i've had hepc for 37 years and i am f-2.  good luck with whatever you decide on.  belle

[Bill1954]

Without reviewing the particulars of your trial, the interferon and ribavirin components are generally identified and guaranteed. The trial drugs are, on the other hand, often double blinded.

There are a number of disadvantages to trial participation that need to be balanced against the obvious benefits; it’s not always a simple equation, unfortunately. Good luck with your decisions-

--Bill