called about a double blind study

[Mary4now]

Hi,
I was just called about a double blind study and received the packet of protocols which i need to delve into.  I have been on their list for 2 yrs. (goes by so fast)
it is with the PI and Telavpravir  
I dont think I want to just do the Ribavarin and Interferon but doesnt look like i have a choice?  I will check this out and then talk to the nurse there to see if there is a study that doesnt include a placebo...... i have geno 1 and dont like the odds to much.
I am also not sure of my grade anymore, because i had my biopsy 2 yrs ago. grade 1 / stage 1
I wonder if it is good to start this take all the tests to see if I am a candidate.
dont like the placebo part...
Mary4now

[Trish77]

Mary, what I didn't see in your trial protocols online - it's usually in the text of your agreement or you have to ask for this information - is the trial's, or your medical team's approach to the use of rescue drugs vs. dosage reduction if your whites or reds take a dive.  I would ask about that simply so that you know what to expect ahead of time if that situation arises rather than get a sudden surprise while you're in the midst of the trial.  Sometimes it's a matter of the trial permitting one thing and your own medical team preferring another so it's good to ask the distinction on what the trial permits and then how your medical team feels about that.

If that's unclear or you have questions about that....please ask.  

[Trish77]

Mary:

Recent presentation on your drugs at AASLD:

http://www.natap.org/2010/AASLD/AASLD_06.htm

This particular article is superb and contains information that explains clinical trials and researching information.  It's good prep for anyone thinking of doing a clinical trial and wanting to research information on the drugs they'll be taking in their trial.  Written in an easily understood manner.  Hope this helps.

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/Making%20sense_10.pdf

[Mary4now]

Susan, hi, I think the PI is a better option for me, and of course i'm concerned that I wont get that arm, (eternal optimist) but I do have a chance & as long as i'm doing well I would continue with whatever I'm doing. your support and information is greatly appreciated.
Thanks Will, its so reassuring to listen to others experience and recommendations based on wisdom and experience.  Whew
Trinity, I am of course hoping to get into the real drug arm, this is where luck, faith, acceptance and courage come in.  Also I love the aspect that I will be supported at the clinic and will be taken care of.  The nurse practitioner kept saying you can back out for any reason.  I will be meeting with the Doctor on the 21st, I think this is the first study they have had here and they are pretty psyched about it. Trinity thank you for your comments and I do hope you benefit from the new drugs soon.

[Trinity4]

I like this study. Since relapse, I haven't explored study possibilities because I don't want to risk getting in the placebo arm but this one caught my eye.  If you're lucky enough to get the new drug combo plus the current SOC that's a win-win.  Unfortunately, they aren't recruiting in my area yet or I would seriously consider this one.

Trinity

[Susan_1a_CC]

I'm on lambda interferon and ribavirin.  The lambda is supposed to replicate the type of interferon that the body makes, and it is thought to only target hepatic cells.  

I haven't read up on your study but why do you think being a 1a would exclude you from PI's?  Good luck on the 21st - do definitely get answers to all of your questions.  

Hopefully, things will become clearer as you proceed down this path.  I would think this situation offers many practice points for your spiritual beliefs.  Funny how wisdom shows up.

[willbb]

Hi Mary....I am still in tx. and things and so far so good for me. Results are blinded for another while so unable to say much on that front.

Sounds like things are moving along for you,with regards to getting your ducks in a row for what looks like is a solid study trial.

Hope it all works out and as you can see the there is good support here as you move ahead.  All the best .

WILL

[Mary4now]

Oh your study sounds good, no placebo, what are the drugs.  
I'm a little concerned that I wont get the PI since I'm genotype 1 and I am not looking forward to just using Interferon and Riba, I guess I'll make that decision after all the tests and see what the liver looks like.  I may wait for the PI's to come out
I'm not sure if I will be discounted if I do not have the right DNA.
I' will find out on the 21st.

Willbb, how did your treatment go, what were the results of the study, this is complicated isnt it?

[Trish77]

If they exclude on that basis without declaring it, then perhaps that's an issue but otherwise I don't see it from a data perspective.  Then the data is interpreted in that light.  No different than doing a trial for Genotype 1 naives with specific exclusion / inclusion criteria or declaring how many African-Americans and what their specific results were, for example.

However, where it might be an issue is if that then excludes the harder to treat persons in general if it becomes an inclusion criteria in general and not due to the outcomes being tested.

[willbb]

In my trial you could agree or not to do the test,however the results were also blinded  until the end of entire study.

[Susan_1a_CC]

The trial I am in is restricted to 1a, CC's, with a known dosage of meds, and no placebos given.  No doubt, if this proves viable, many 1a, cc allele people will have reason to rejoice.  There are other trials running with the same drugs that have all different mixes of genotypes, and drug amounts being given.  I can't make a call on fairness as the information they are gathering I believe will have implications for all.

[nygirl7]

Is it really fair for them to do the IL test on people when they are doing a trial? doesn't that like sway the outcome a bit if they only take the people that they think are going to succeed - I dont get that part at all...well I get it but it still doesnt seem fair to me. how then can they say like it has a 100% SVR rate if they are only taking those who will succeed?

[Mary4now]

Tibetan Medicine is a combination of Ayurvedic, chinese and tibetan, they are actually very good at GI disorders and the doctor I use teaches at Naropa Institute in Boulder, shes western, but speaks, writes tibetan her husband is a Tibetan doctor.  She cannot cure Hep C, but can work with the overall health of the liver.  I am a practicing Buddhist so it fits very well into my life,
The Dala Lama from what I have heard no longer eats meat, many Tibetans eat meat.  I eat chicken and fish,
I got my first appointment for screening on the 21st of Dec. and the nurse practitioner told me I am #4 of 5, so I will move forward.  The nurse practitioner said I can back out any time if I need to, its so nice to have a choice, we shall see how much of a choice i have after the tests.
Thank you all very much.
Mary4now

[Susan_1a_CC]

Your comment about Tibetan Medicine (what is that?) made me think of one of life's ironies.  The dali lama has some strange blood dyscrasia that actually requires that he eat red meat on occasion - go figure ;).

[Mary4now]

Thanks so much, I called yesterday, and  I will call again today since they open earlier today.
what a group of people you are
I was semi content with living with this disease for the time being, I have had no symptoms that I know of, cept tired sometimes, ( old age and minor depression I think ) and I have been happy with the Tibetan Medicine,clean lifestyle,  but a chance to rid the body of this virus is invaluable.
I feel like Typhoid Mary half the time and sometimes seeing how difficult this disease is for so many people is frightening and makes me feel helpless.  I cant tell you how lucky I feel and I pray for those who are suffering and hope they can get the help they need.
I agree with you advice and we shall see, i will most definitely keep you posted.  

[Susan_1a_CC]

Please let us know if you get in and keep us posted.  I am very hopeful for you, and excited about this trial.

[Mary4now]

THANK YOU !!!!!

[spectda]

This does appear to be a very good choice of trials to participate in. The combination soc plus GS 9190, a polymerase inhibitor, in combination with GS 9256, a protease inhibitor should really limit the possibility of resistance.

Good luck with the screening process,
Dave

[Mary4now]

Thank you so much for your help, I will call the clinic today and start the preliminaries, they seem like a nice group there.  
Andiamo, what I  meant was ( I'm not sure ) after the preliminaries if I'm accepted I can choose to back out.  I'm actually thinking this is a good way for me to get all the information about my current status, and if I'm happy with my care, my understanding of the study, drugs i will go forward.  Also, they do say in the protocols that if you cannot tolerate the drugs you can drop out.  Not that I would, I have just heard horror and not horror stories and I dont know where I would fit,  I would just have to see.  I feel I am in a better position (emotionally) to treat right now.  I would do my best to follow through with everything.  and thank you for reminding me about the resistance.
Thank you again for the valuable information and the support, I really dont have anyone here to talk with this about right now.  I'm pretty much alone, have a couple good friends, who have their own problems, but are very caring.  and my 87 yr old mom with her own concerns.  so thanks,,,,,
much grateful

[Susan_1a_CC]

My personal opinion:  The doctor, lead presenter all of the studies on Vertex worldwide, who discovered the IL28B marker, who now works (as senior VP) at Gilead, will likely be overseeing this trial.  I wouldn't walk, I'd run into this trial.  In fact, if I weren't already in a trial I'd be trying to get into this one.  If you need reassurance just google Dr. John McHutchison.  Believe me, he's brilliant and dedicated.

[willbb]

Keep going thru your testing phase. It will give you valuable info. not the least of which is your biopsy result,no need at this point to put any of that off.

In the meantime it gives you time like the others have said to do more research on this particular study.  When you have all the results from your tests(including biopsy) and have had a chance to do your research,along with the help of the good folks here,then you can make an informed decision,when that time arrives

WILL

[Andiamo1]

"This article goes on to say 100% SVR with both PI's and SOC.  I have some looking into, I have to look further because I may be able to start the process and then back out if I want to. "

I am not sure what you mean by backing out.  Are you saying you might back out before you start the therapy or are you saying you might start the trial and then back out?

It is very important not to drop out of the trial once you start the drug regimen.  You could end up with resistant strains if you do that while you are taking the PIs in combo.

[blondie717]

I was going to fire my GI, he is fired, I just havnt told him.sometimes what I mean to say , dose not get said right on paper. Try again? I asked my old Gi for a IL28. I have good insurance todate.  He said he did not think a test like that should be a deciding factor on weather or not to tx. (I did) He did not say wait for new drug's or offer tx. (just a vit E). after our 2nd meeting he told me to get on the internet (I told him I dont have a computer or know how to get on the internet) I could go on, but this is Mary's thread...I did get the IL28 test preformed. But the clinical trial Im in did that for their own use..I will never know the results of that test.  Good luck Mary4now. I hope you get a great trial...Your in good hands here! sorry if I confused you

[Trish77]

Mary, no need to be sorry.  Now that we've got that sorted...we know what we're talking about!!

Honestly, I wouldn't worry about waiting another day.  I'd carry on and go through with the testing.  They can also decline you as well as you can decline them.  The trial looks good enough on the outset to be worth going through the preliminary testing.  You have a 33% chance of getting a double PI with SOC, a 66% chance of getting a PI with SOC and a 33% chance of getting the control arm.  It's a Phase IIb trial and even from a dull memory, I recall a bit of buzz about these drugs.  So I'd say carry on with your preliminaries while you check this out.  For someone waiting for Telaprevir and Boceprevir to come through...I'd say this is a good bet.  I do also recall that the resistance profiles were different so you're not shooting yourself in the foot there either.  Don't quote me on that....will read up and others will comment...but that's what I'm thinking.  Would have waited to say that but you're making a decision with regards to tomorrow so ... offering the opinion that you just continue with your preliminaries, for what it's worth.

Trish

[Mary4now]

Maybe I will call the clinic tomorrow and tell them I need another day