studies

[summer7799]

I have been given 5 studies to choose from. They are all different and Im feeling a little overwhelmed. How should I choose? What questions should I ask?

[gonnabhepcfree]

I do know that my study is opening sometime soon for geno 1A naive ..PSI 7977 and BMS 790052.  I my vl was over 6 million and was und in seven days.  I had some MINOR  fatigue in the first several weeks and that's about it. If I had to pick today a study out of five I would pick mine.  Good luck with whatever you decifde feel free to message me anytime.

[willbb]

It would be difficult for anyone here to go through all the trials and give you advice on what you should do. As I mentioned above this  is what your doctor should be doing.

I would  just add this also.   You are young,treatment naive(never treated before) with only moderate fibrosis and the CC allele.
The two drugs  currently approved for HCV therapy  have shown to be extremely effective for somebody with those circumstances.

In the telaprivir trial and ad-hoc analysis was done with patients with the CC allele and the SVR rates were 90% and went to 95% if you have a early response(UND. at 4 weeks)
There is no better success rates when treating HCV than that.
Yes ..it involves Inf  and one of the new drugs,however you would most likely treat for just 24 weeks.

A trial may be something to consider ,there are some drugs being experimented with right now that have shown good early results,however always keep in mind  the only reason to do HCV therapy is to eradicate the virus and to SVR and the treatment that is available to you being 90 -95% .... it gets no better than that.

Just some thoughts..
Will

http://hepatitiscnewdrugs.blogspot.com/2011/05/hepatitis-ctelaprevir-ups-response.html

SVR rates among patients with the CC allele were 90% with 12-week telaprevir plus PR, 84% with 8-week telaprevir plus PR, and 64% with PR alone.
"
Rapid virologic response (RVR) rate, defined as undetectable HCV RNA at week 4, and eRVR, defined as undetectable HCV RNA at weeks 4 and 12, were improved with the telaprevir-based regimens across all IL-28B genotypes, compared to PR alone.

The RVR rates in patients with the CC allele were 84% with the 12-week telaprevir regimen plus PR Most eRVR patients achieved SVR to telaprevir with PR in all allele groups: CC at 95%,

[curiouslady1]

Awesome being in DC with NIH and all the rest!  

The important component is the name or number of the drugs involved.  You can google the drugs by name or number to get a sense of their track record.  You can use the archives here to find out who has done the drugs.  People on this forum are good about posting if they have had a breakthrough on trial drugs or relapsed, when they reached UND and what sort of side effects they are experiencing .  

One element that might also be important for you (I know it is for a lot of people) is whether it is an open trial or blinded.  If it is open label, you will know what you are getting and what it is REALLY doing to your body all along the way (not just symptoms which could be exaggerated).  I found this to be really important for me.  

[Advocate1955]

Another forum member, specda, posted a link to this information about understanding clinical trials.  I posted in my journal:
http://www.medhelp.org/user_journals/show/332520/Clinical-Trials-and-Medical-Research-in-Hep-C
Advocate1955

[summer7799]

Any volunteers who might want to read over my study info? I can e mail it to you... :)

[summer7799]

Karen,
Not offended at all! Im the first to admit that I have no idea what Im doing or what any of this means. Thats why Im here! :) Sometimes I think forget the whole study thing. Just treat the regular way and get on with it. Just want to make the best choice...

[summer7799]

The Dr who Im seeing is head of the liver disease center at Mercy Hospital. He is the director and oversees all the trials. They do a lot of studies and trials at once. He told me I would be a good candidate for 5 of them. He gave me all the info for each so I could read them over. I can go in to see the study coordinator to go over each one to pick which one i want to do. Once I pick one, I have to go thru screening and be accepted in. If denied, I can apply for a different one. The first one is all oral, no interferon. Its free and they pay me $. But they can add interferon at some point if your not responding. The 2nd study is the normal triple drugs..riba, interferon, incivek. The other 3 are riba/interferon and a 3rd mystery drug that is not approved in the US or anywhere else. So I think I will go in to see the coordinator. I just want to have a list of questions prepared. I keep hearing about rescue drugs..what is that?

[JAY0914]

I think if you can afford it i would do one of the FDA approved PI s...at least your not held to rules of no procrit or neupogen in case your blood crashes and can stay in the game to kill the dragon..plus you know your getting the real stuff instead of the possibility of a placebo...good luck

[crossroadsec]

I'm with Will, you need someone with experience to guide you. There are some on this forum who have treated, had cirrhossis for years, or are just good at deciphering medical terminology.
Idk about you, but I am NOT one of those people. I inform myself as much as possible and am happy to see you doing the same. But this is a huge amount of information.
Be watching for some of our resident experts to help you to know what questions to ask and give you some good links.
I hope you're not offended. I don't mean to imply you're not intelligent. Yikes! But 5 studies would be hard for anyone.
Good luck sister! xoxo Karen :)

[willbb]

I am  just wondering..did one doctor give you the option of doing  one of 5 different studies?
That Does seem like it may be a bit overwhelming.
Was there good guidance on his/her part and full explanation of all the pros and cons of each? Was each one explained in full detail and were recommendations made?

Will

[willbb]

If you know what trials they are specifically  ,it may help people to comment on what they are familiar with.
In the meantime this was posted awhile ago by Dave(spectda) on things to think about and questions to ask when considering a trial.

This was before any of the all oral trials ,so some of the responses may be a little outdated,however maybe some good points to ponder.

Best..
Will

http://www.medhelp.org/posts/Hepatitis-C/Things-to-ask-before-participating-in-a-trial/show/1497138

[can-do-man]

Hi, i would want to know which ones have the best track record so far, what phase are they in? The later might be better. Do they allow rescue drugs, are there placebo arms and if there is do they have a rollover plan for the real thing. What are their cut off levels........... These are just a few things, do your homework. Being in a thrial study can be good, just read the fine print.

Good luck