Aa
denied :(
Well I was not accepted into the study. They wont accept anyone without a sub-genotype. And the FDA wont accept any retests. So Im out...Im really hoping another one will come along and that I wont have the same problem. This has been a lot harder then I expected. I was diagnosed a year ago and thought I would for sure be "cured" by now. Hopefully soon!!!
My genotyping only have back as genotype 3 - no subtype. Does that mean I don't have one?
My very first VL and geno test were done through Quest Diagnostics, with my regular doctor referring me. The inconclusive genotype tests later on for the study were done through another lab and were the only lab which could do my bloodwork for that trial. After I got rejected for the first trial, I waited about 4-5 months and tested again independently through Quest. They again correctly ID'd the geno. Then we put some pressure on the second trial lab by letting them know that another lab ID'd this already. You might want to do the same thing. Have your regular or trial Dr request more testing through an independent lab. Might work for you too,
Thank you! I did get my hopes up with this one. But there is a reason for everything and this just wasn't meant to be. Hoping and praying another one will come up soon. Although this genotype mystery could possibly be a problem for all studies. If so, well I guess I will cross that bridge when I get there :)
I guess any decision regarding treatment is a personal one and not everyone chooses the same thing. I have been waiting to get into this specific study since December. I researched it as much as possible and also had a friend, who is a biochemist, research it for me as well. There are many reasons why I dont want to use interferon, I wont bore you with them. My hepatologist and his team all agreed an interferon free treatment will be best for me and my circumstances. This specific study does not have a placebo. The patients who have completed this study have had excellent results, some becoming UND in just days, with zero to minimal side effects. I asked many, many questions and knew the pros/cons before signing up for the screening. I would never jump into a study blindfolded.
No, I don't think you're out of line but there are may reasons to search out a trial. I'm not underinsured but I was absolutely frightened of needles and the possible sides from PEG. So I found an all-oral trial. Here's my reasons for choosing that...1) no placebos 2) Four all oral drugs (NS5a inhibitor, protease, polymerase, and Riba) 3) Riba was included 4) Reports of trials using these drugs and less were showing very good results and 5) If the all orals didn't work, there was a rescue arm which kicked in immediately with PEG. So in my doctor's and my view, if the all-orals didn't work, and the PEG didn't work, there really isn't anything in the current SOC at the time or the next generation of meds which would help. As it turned out, I had a breakthrough at week 8, added PEG and am now on week 31 of 48. Been UND since week 4 or 5 of the rescue arm. The irony is that I have to treat for 48 instead of 24, but I haven't had any sides. And if it helps me clear this disease, I'm happy to extend for double the time. Hope that sheds some light on the subject.
Desrt X2 - I agree whole heartedly !
And it seems many folks who do sign up don't Really understand the risks and/or the drugs (because they haven't been proven or disproved) ,sx , control issues etc etc etc ...
And many don't know they should ask a ton of questions before making this decision ..
Very thankful for those brave enough who do sign up .. however .. more than 50% of trial drugs do not make it to market ...
And it seems many folks who do sign up don't Really understand the risks and/or the drugs (because they haven't been proven or disproved) ,sx , control issues etc etc etc ...
And many don't know they should ask a ton of questions before making this decision ..
Very thankful for those brave enough who do sign up .. however .. more than 50% of trial drugs do not make it to market ...
I've never been quite clear why some people are so eager to labrat themselves in a drug trial where they are likely to receive a plaebo, a drug with unknown side effects, or be overdosed or underdosed in the case where a manufacturer is trying to establish a proper dosing regimen.
Sure, for someone who has failed IFN therapy, a drug trial 'might' present a last desperate hope that something diferent might work, but for most, there are plenty of proven, FDA tested protocols that work just fine. Heck, the companies that produce the currently available meds will even subsidize you if you're uninsured/underinsured. A couple days reading on this or any other HCV forum can usually show that most of the horror stories about IFN are way overblown. As for subtype, if I'd waited for a representative sample of 3e genotypes to be tested, I would've died of old age or cirrhosis, take your pick. If you test g1, treat like a g1.
If I'm out of line, I apologize. Please explain why being in a drug trial is such an imperative.
Sure, for someone who has failed IFN therapy, a drug trial 'might' present a last desperate hope that something diferent might work, but for most, there are plenty of proven, FDA tested protocols that work just fine. Heck, the companies that produce the currently available meds will even subsidize you if you're uninsured/underinsured. A couple days reading on this or any other HCV forum can usually show that most of the horror stories about IFN are way overblown. As for subtype, if I'd waited for a representative sample of 3e genotypes to be tested, I would've died of old age or cirrhosis, take your pick. If you test g1, treat like a g1.
If I'm out of line, I apologize. Please explain why being in a drug trial is such an imperative.
The first test with VL 800 and geno 1a was the very first test upon finding out I had the HCV antibodies. Then a year or so went by and when I went for any trial, a new HCV RNA was required with geno test. That's where I started running into issues with not being able to ID the geno. Odd.
I am a bit confused. Why did they keep retesting if the first test told you what you were? (VL of 800 geno 1a) ?
Sub genotype as in 1a or 1b? I had this issue. and yes the first study which I got denied for due to this gave me one or two retests, which also could not come back as conclusive as to 1a or 1b. That was weird considering the very first test I had a year prior was a VL of 800 and a definitive geno of 1a. 3-4 months went by and I got independently tested which came back 1a. Another study came up a few months later and guess what...couldn't ID the genotype. But then the study lab sent the blood off to a more specialized lab (or something) and it came back 1a. So I don't have an explanation but just letting you know it does happen. Good luck!
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