Clinical trial GS-7977 and BMS-790052

[katla]

I started this clinical trial yesterday, 12 weeks, all oral. (NCT01359644)

There were two arms -  one with and one without Ribavirin. My arm is (unfortunatley) without.

I know some people here are contemplating and/or screening for this trial. I'd love to keep in touch and exchange feedback.

Good health to all...

Kat

[1oftheclub222]

is this for  GT 2 or 3?

[katla]

It's for gt 1, 2 and 3; I'm 1A.

http://clinicaltrials.gov/ct2/show/NCT01359644?term=NCT01359644&rank=1

[Jimeeboy]

I had my biopsy today. If I am Stage 3 or less I'm in. I find out next week.

Was today day -1 or day 1 for you?

Please let us know how it goes.  

[UKgirl55]

Glad to see you got in Katla. Keep us posted. Did you have to stay there for eight hours yesterday? When do they tell you the results of your first blood tests?

[co1251]

Best of luck to you Kat!  Please keep us posted as to how you're doing, side effects if any..etc.  The earlier arms of this trial were for 24 weeks and they've just finished up - people on a different forum who were on this trial said they had minimal sides, ie, fatigue, headache but nothing serious and their AST/ALT went to normal levels within the first week or so.  And everyone achieved UD within the first 3-4 weeks!  The results of the 24 week arms are to be presented next month as EASL and from everything we've read, the results should be great!  
Just to clarify, the 12 wk arm that you're on was added later as an amendment to the 24 wk BMS/PSI trial and is only for 1a's and 1b's, either treatment naive or null responders to triple therapy.  The good news is that if it turns out the 12 wk duration isn't long enough and there's relapse after tx ends, you should be able to re-treat with 7977 in the future because it has such a high barrier to resistance. (Just read they are re-treating the G1 nulls who relapsed after 12 wks 7977 + Riba with 7977 + another DAA and hopefully that will do the trick for them to SVR)
Wishing you all the best!
CO1251

[tanya24]

Best of luck Katla! I have definitely decided to start this 12 wk. psi7977 and bms790052 w or w/o riba trial next week as offered! We will keep in touch and post for others!!

[co1251]

Good luck to you too Tanya!  Please let us know if you're a 1a or 1b and if you're tx naive or a null responder to triple therapy so we can keep track of how each type is doing.  Thanks!

[dointime]

"The good news is that if it turns out the 12 wk duration isn't long enough and there's relapse after tx ends, you should be able to re-treat with 7977 in the future because it has such a high barrier to resistance. (Just read they are re-treating the G1 nulls who relapsed after 12 wks 7977 + Riba with 7977 + another DAA and hopefully that will do the trick for them to SVR)"

This sounds great, however as nobody has ever re-treated with 7977 so far it is not yet proven that it will be ok.  So I think that is not something to count on yet.  If it is tested and proven it will be as big a result as finding the combo that works.  After all, who's not going to do the tx if there's nothing to lose from it.  I'd do 3 months and not worry about a relapse if I could just turn around and do 6 months the next time.    

Great input co1251, thanks.
dointime

      

[co1251]

Anytime, dointime!

[katla]

Jimeeboy- today was day 2. And good luck with the biopsy.

UKgirl- Yesterday I was there for 8 hrs.; blood tests every couple of hours.

co1251- I think you're right. The clinicaltrials.gov site listed gt 1,2 3.

Tanya- good luck...so glad you'll be around to compare notes with.

dointime- I agree with you. The trial doctor reluctantly admitted that not only is the possibility of ever retreating with 7977 an unknown, the possibility of becoming resistant to ANY type of future treatment is unknown...hence all my anxiety.

Well, I am relieved to have found some brothers/sisters in arms....

[UKgirl55]

The resistance factor is an unknown, but the fact that they are going to re-treat the nulls that relapsed says a lot about what they must already know.

[Jimeeboy]

Thanks.

Good luck to you.  Day 3 tomorrow. Short visit....lol

[co1251]

Would you mind telling us your initial viral load and what happened to your VL #'s after taking your first dose at the various time intervals when you find out?  Thanks!

[gonnabhepcfree]

Congratulations!  I felt the same way when I didn't get into the Riba arm and my coordinator said? "Why Riba has all it's own side effects"  made me feel a little better.  I will be going for my two months labs next Thurs to make sure I am still UD and then four more to go.  I am excited for you.  Everyone at my site cleared early and as far as I know have stayed that way.  ( I ask at every appt)  

[katla]

co1251- I will absolutely post as I get the results.

gonnabhepfree- that's exactly what I was told when I expressed my disappointment. I'm not really worried at becoming UND quickly as I believe it's likely; I'm very concerned about maintaining that. Good luck to you.

Again, I am so very happy to have you all here with me on this...kat

[UKgirl55]

You're going to get sick of us asking how you're doing ;-))

[tanya24]

My genotype is 1a, vl 13 million, il28b type c/c, tx naive.

Here is a copy/paste from a paragraph on resistance I found interesting from the following site (understanding resistance link):

http://hepatitiscnewdrugresearch.com/chronic-hcv-symptoms.html site.

Dr. Burack: If patients stop therapy under those circumstances do those mutations go away?

Dr. Flamm: That's a great question. We don't have a lot of long-term information on this, but patients in the HCV protease inhibitor trials who failed therapy and have resistance-associated variants have been followed over the long term. The final data have not been presented, but from the preliminary reports it appears that the vast majority of patients lose the resistance-associated variants in less than 2 years and the wild type returns. Again, there are limitations to resistance testing. We can only detect resistance-associated variants if they occur at a certain prevalence in the patient. The preliminary information tells us that these resistance-associated variants seem to disappear over the relative short-term.

[co1251]

Thanks for sharing your starting profile stats, Tanya!  Those VL #'s are gonna drop quickly once you start tx!
Re: resistance - The big difference with 7977 vs other DAAs is its high barrier to resistance - 7977 has never had viral breakthrough in any study to date, whereas it's not uncommon for there to be vl brkthru with the lower resistance barrier DAA's such as protease inhibitors and NS5a's. If you go to Gilead's website, you can listen to webcasts of various recent healthcare conference presentations they've made and in the February 2012 one in which they discuss the G1 nulls relapse after 12 wks of 7977 + Riba, they state they are immediately doing resistance testing on these nulls to see if they developed resistance to 7977 and if no resistance is found, the nulls can be re-treated with 7977.  In the March 6 webcast for the Cowen Healthcare Conf., Gilead states that they've now completed resistance testing on some of the nulls who relapsed (it's apparently a long and difficult testing process) and no resistance to 7977 was found!  So at the CROI Conf. this week, Gilead stated that they would be re-treating the nulls who relapsed with 7977 plus another DAA to see if the extra firepower of the add'l DAA added to 7977 would be sufficient for G1 nulls to achieve SVR.  Given all this, think you don't have to worry too much about developing resistance to 7977 and being able to re-treat with it again.  
What day next wk do you start and find out if you'll have Riba or not?  We're all excited for you!

[Jimeeboy]

Wow, that's very cool info about 7977.  I hope I get on it.  Thanks.

[tanya24]

Thanks for the new resistance update. That's great news! I am hoping to lower that vl!

I call on Monday to get my start date. I will find out on my first day if I have Riba or not. I think that the trial has apparently changed perimeters according to the clinical.gov site ( NCT# NCT01359644) and info another lady had posted about a potential change on a different site. It appears the trial has changed from a set 12 wks. to 12 to 24 based on each individuals response. I read the update today when getting the Nct# for someone else. The short 12 week flat time made me anxious..so more great news it seems!!

[tanya24]

I may have misread and mixed up info. from someone else. I just scrolled further down the trial info. Maybe it is 12 "and" 24 wks.trial.  Sorry for the wishful miscommunication.

[co1251]

Hey Tanya, I'd also read that about the possibility of your 12 wk trial being modified to be response guided as well but that is not official and has not happened.  And it's my understanding that if this change in the trial protocol were to be made official, it would be triggered in the highly unlikely event that one does not respond sufficiently or rapidly enough to the drug combo (which has not happened to anyone in the prior 24 wk trial of this combo among naives nor in the 12 wk trial among G1 nulls w/ 7977+Riba only). Think this potential protocol amendment may primarily be intended as protection/fallback for the nulls to triple therapy on this 12 wk study since this will be the first study of this drug combo among nulls and they possibly might need longer tx duration, espec. if they're in the arm without Riba.  And if naives were to relapse soon after finishing the 12 weeks with this combo, it's likely that no resistance to 7977 would be found and that re-treatment with 7977 + Riba for an add'l 12 or 24 weeks would then be possible.  You're on a great trial with excellent drugs that have proven to be extremely potent with minimal sides plus the potential to re-treat with 7977 so you can relax, you're sitting pretty!  Keep us posted!

[tanya24]

Thanks for the much needed encouragement and information! I going try to relax until I start and quit chronically researching. Things are starting to jumble in my head at this point. Pre jitters I guess.So...from here on out...positivity until I start!! I will keep you all posted.Thanks again.

[scratchinghead]

love this stuff.
thank you