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Avatar universal

Terminated from trial at week 10

I just got some bad news with my week 8 HCV RNA result. Was instructed to stop treatment due to my poor response. I also learned I am not eligible for the open label retreatment as I got at least one of the study drugs. I was in the Gilead trial NCT01225380. Not sure if I got both the GS9190 (polymerase inhibitor) and GS9256 (protease inhibitor), or just the GS9256. Go for my early termination visit for the trial on July 7 and made a appointment with my GI doc for July 15.

Not sure what my options are or what I will do next.
Ed

Baseline VL 5460000 log 6.74
Week 1  VL 8980      log 3.95
Week 2  VL 22100     log 4.30
Week 4  VL 173000   log 5.24
Week 8  VL 588000   log 5.77
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Avatar universal

sorry to hear about the failed attemt in a trial.

As far as what the next step is... they will continue to monitor you in the trial..until your normal end date,. you will not be able to take treatment again until  your results are unblinded(so you and your team know what they gave you) ..Resistance profiles ..hopfully will be made avail.(talk to them about this) and then you will be able to treat again.  with what is the same question many of us are  wondering.. most likely  another class of DAA or  a combination of.. Daa"s....

Good luck..

Will
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408795 tn?1324935675
Terrible, sorry to hear bad news like that!!  Maybe you will find out what the problem was in a couple weeks.  Looks like you had at least one day with the trial drug but you don't know for sure yet either.  Too early to tell yet but keep us posted, we can all learn something together.  good luck bro.

Hey, be sure and ask alot of questions because it just don't seem right that they let you take one of the study drugs,  Even one study drug could exclude you from future clinical trials.  Not fair to you at all, meaning maybe they should have stayed on top of your tests a little better, I don't know.    
Helpful - 0
374652 tn?1494811435
Im sorry to hear your results, I do hope after your study is unblinded that you will have some options.
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Avatar universal
a likely cause of failure is that you were on triple tx with GS9256 (without GS9190) and had inadequate ifn response to clear the variants resistant to the PI. This is the most common source of failure with triple tx. Had you not been in the trial, I'm not sure many physicians would have continued from w4 to w8. The increase in VL from w2 to w4 was a  loud warning bell.

The upcoming  termination interview is a rare opportunity. It is in your interest to try and get as much information as possible about sequencing tests done at w4 and w8. In particular, do the w8 results indicate your dominant viral sequence now includes  GS9256 resistant variants? If the failed tx simply caused an enrichment of resistant variants these will hopefully die out over time. However if the dominant strain you are left with includes NS3/4A resistance, future tx with a drug in that class will likely not be effective.

Try to walk away with  a written commitment to release sequencing results to your provider!
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Avatar universal
I was on at least three, maybe four. Pegasys, Ribavirin and in addition  not sure if I got both the GS9190 (polymerase inhibitor) and GS9256 (protease inhibitor), or just the GS9256
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Avatar universal
Sorry.

Question were you on triple drugs and if so which one?
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1658980 tn?1330711550
Ed:
I'm sorry that things did not work out well for you.  I'd be interested to learn what is discussed at your termination interview.  In looking over the trial protocol, from what I can see, they will test you for resistance then and possibly enter you in the Resistance Substudy at that time.  Either way, it sux for you and I'm sorry.  Hang in there.
Debra
Helpful - 0
Avatar universal
Could termination result because of resistance discerned from the testing?

Is "poor response" synonymous with resistance?

Wouldn't one need the sequencing records (as well as the the drugs used) to determine next steps?  (See my post to the thread about what to ask before signing on for a trial --  "Can I get a commitment to receive any sequencing (population and clonal if available) results done on my virus in the case of failure?"  Seems like this ties into the threads on DAA combos and resistance.

Please post about what you leearn and do.

BTB
Helpful - 0
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