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Hep C Discussion Forum -> On Treatment -> Trial fell thru.....
Post Info TOPIC: Trial fell thru.....
suziq


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RE: Trial fell thru.....
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Hi Marcy,

I did not get my first trial either. That particular Gilead trial was not taking people with cirrhosis.  But Gilead did do my first biopsy since 2000 for me free.  My trial coordinator kept looking for me and I got a Merck trial last August--started in Sept  Age and cirrhosis not a problem with that trial.

I did NOT find the trial experience stressful.  Got regular viral load tests and lots of monitoring and attention, so I knew how the meds were working for me.  The coordinator was very comfortable with spending time with the participants and listening to whatever we were experiencing.  Thank goodness the double blind studies were ending by then.  Those would have been stressful for me.

Think I'm the only one posting on this forum that has done a Merck trial.  Everyone (100%) at my center reached SVR.  The coordinator said the one in my nationwide group that did not reach SVR appeared to be non-compliant from almost the beginning.  They measure the level of meds in your blood at each visit. 

I do think my age sort of intrigued my coordinator so she really kept me in mind as the center received new trials.  My general health was/is good and my diabetes was/is under control.  Fatigue and a little brain fog seemed to be my only symptoms of Hep C after all those years of virus.  I thought those were probably age issues BUT, now, 18 weeks post treatment, the fatigue is gone but I am still a little foggy in the area of short term memory.  Names, and sometimes words, just seem to float around while I search for them.  I definitely need a timer when baking.  Naps are a thing of the past.  I first reached UND last October so no virus in my blood for about seven months now. First time in about 48 years.

With all the new meds, I am sure that whatever is right for you is or will be available soon.  I do know it is very disappointing to have a trial fall through.  I was certainly disappointed when Gilead refused me on my first attempt to do a trial.  And there was nothing FDA approved back then.

I wish you success in getting treatment soon.  Just hang in there.  SVR is right around the corner.

SuziQ

 

 



__________________

Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR
Isiscat2011


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Hi Marcy:

HepC can effect more than our livers--pretty much all of our systems--and those sure sound like HepC symptoms, don't they?   Ok, now I get why you feel the urgency to treat asap.  I do think getting rid of the virus will improve, or with a little luck, even relieve you of those symptoms.  I'm counting on getting some energy back myself so I hope this is the case. 

Treating with your own physician would probably be much easier on you.  While clinical trials can be very valuable they can also be very taxing.  Also, if you can wait you would be treating with drugs that have already passed certain safety and efficacy standards (not a guarantee but less risk involved).  

Were I in your situation I would wait, and in the meantime, find a good doctor who would be willing to go to bat for you with the insurance company in the event BCBS initially denies your request.  If possible talk with a few docs (and talk with their nurses and/or support staff too).  You will get a good idea of which doc would be best for you.  What I would be looking for in a doc is: HepC tx experience, willingness to deal with the insurance company, and if possible someone you like/feel comfortable with.  You don't necessarily need the doc with the most liver experience since your liver is good.  An infectious disease doc might fit the bill as well.  

As soon as there are a few more drug options available (in addition to the Sov/Led combo) insurance will become a non-issue.  That should be happening in 2015. Sounds like a long time but it will go fast especially if you are busy lining things up.   

I wish you all the best.  Let us know what you decide.  

 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Milliganus


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Isiscat2011

I ignored it for many years but about the last 5 years I am experiencing ever increasing fatigue, terrible mouth sores, higher alt and iron levels.  brain fog and fatigue mainly though.  I can barely get thru the day anymore.  So, even tho my liver appears to be,ok, the virus is taking a toll on other parts of the body.

 

thanks for your input



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
Isiscat2011


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Hi Marcy:

Your liver is in great shape.  Clearly the HepC is having very little impact on your liver since you have had it for a good 40 years and you have no fibrosis. Statistically you are far more likely to die of something unrelated to liver disease.  In all likelihood it would take many years for you to even progress to cirrhosis, and even if you eventually did progress to cirrhosis, you would probably live many more years with a well functioning liver.  Your odds of ever developing liver cancer as the result of HepC are exceedingly low.

My question is: Why would you even consider subjecting yourself to a clinical trial using experimental drugs that are being tested on you?  I appreciate the emotional issues associated with carrying around an infectious disease.   But, I'm talking about rational, fact based, reasons.  I ask this question with respect and it is not my intention to antagonize.  

How is your health aside from your liver? 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Milliganus


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jimbob wrote:


I don't know where you live but I've read about few others on here that have traveled a state or two away for clinical trials. Would something like this be feasible for you? You are probably only looking at a 12 week trial, so the number of trips might be affordable. That may be your plan already, I don't know.

 We actually live in our RV so I can go anywhere!



-- Edited by Milliganus on Thursday 15th of May 2014 01:50:31 AM

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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
jimbob


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Marcy--
I think Tig's advice is sound, as usual. It appears you have time to wait, so that's a big plus.
I don't know where you live but I've read about few others on here that have traveled a state or two away for clinical trials. Would something like this be feasible for you? You are probably only looking at a 12 week trial, so the number of trips might be affordable. That may be your plan already, I don't know.
Best wishes Marcy. Chin up, and keep looking.

jimbob



-- Edited by jimbob on Thursday 15th of May 2014 01:18:07 AM

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jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.
Milliganus


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Thanks all!  I discovered this trial thru ClinicalTrials.gov.  I keep a close eye on it, but it seems like most of the stuff they are posting now is very specific, special case type of stuff.  



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
longld


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Marcy,

   I am on BCBS and was approved .... took my dr putting together a good package and finally a conf call between doctors - also helps if your dr is a transplant doctor imho.  Best of Luck, you are about my age and hope you can get treatment before any real liver damage occurs.



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62 Yrs Old, CHC Geno 3, Cirrhosis, Kidney Transplant (13 yrs), On Sovaldi/Riba Treatment (24 week) since Feb 01,2014

Viral Load 7M on 1/8/2014,  UND at EOT 7/18/2014
Tig


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Hi Marcy,

I'm sorry to hear that you won't be able to move forward with this trial. I'm sure you were anxious to get this started. Try to not let it discourage you too much. There are so many opportunities now and it seems like they're adding more and more every month. I think your best course of action is to keep researching the clinical trial database. How were you introduced to the trial you were recently denied? I'd keep that avenue open by all means. Is there a need to be on a trial for financial reasons or are you seeking other than SOC treatments? The authorizations by private insurers (like BCBS) will be handled differently next year I'm sure. The denials should be fewer and farther in between once Ledispavir and some of the other new drugs gain approval.

Considering your current liver health, I think you've got time to wait, not only for the next best thing available, but the confusion will also lessen.  If I'm reading your signature stats correctly, your IL28B is a CT allele, right? That makes you a poor candidate for Interferon. Even with Sovaldi, with that allele, to prescribe Interferon would be a poor decision in my opinion. It also aids you when any request is put forward by your doctor for treatment with the new drugs. I know that one of the biggest considerations made by BCBS is not only cost of meds, but likelihood of future costs when a treatment request is submitted. They don't typically have a problem spending money, even for off label approaches when the rates of success are high and an indication of future savings accompany the requests. It's so important to get involved with your doctor when submitting a request, even if it's the first request. If you can provide your doctor with ample data that supports his/her request, it gets noticed. From experience, many doctors don't spend the time to research and/or compile a list of reasons why one treatment should be considered over another. Eventually they might (will) but often not until there has been a denial or two put between you and your requested (desired) course of treatment. I've found that BCBS listens to Prime Therapeutics. They are the pharmacy benefit manager for BCBS and all requests for Rx treatment go through their offices. I've had good results when dealing with them over the years and think that they pay attention when handed a well thought out request. It's worth putting together an appeal packet, before the appeal!! Good luck...

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Milliganus


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cry

The  Jansen solvadi/olysio trail I was hoping to jump on looks like the FDA is changing up to only include certain people groups, so I'm out.  Very disappointed, but still hoping to maybe get on Mercks next iteration of C-worthy, however the trial center says FDA May do the same with this one.

 

I'm tempted to just wait till next year when the new drugs are approved, but I'm concerned I won't get insurance approval (BC/BS) since I'my treatment naive and never done Interferon.

 

any thoughts on this???



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
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