Hepatitis C Community
5885/7977 w/o RBV 12-wks
About This Community:

This forum is for questions about medical issues and research aspects of Hepatitis C such as, questions about being newly diagnosed, questions about current treatments, information and participation in discussions about research studies and clinical trials related to Hepatitis. If you would like to communicate with other people who have been touched by Hepatitis, please visit our new Hepatitis Social/Living with Hepatitis forum

Font Size:
A
A
A
Background:
Blank
Blank
Blank
Blank Blank

5885/7977 w/o RBV 12-wks

How are people doing on this combination? (5885/7977 w/o RBV 12-wks)

Does it work without riba?
Tags: Gilead, 7977, Sofosbuvir, 5885, GT1, naive
19 Comments Post a Comment
Blank
317787_tn?1373214989
Hello, welcome to the forum, while I have not taken this combination I believe there are others who are on it and have done well.  I hope someone comes on soon to help you.  You can also do a search.  There is a block right next to post a questions where you can search.  I will try as well and if I find something will send it to you
Dee
Blank
2135877_tn?1381864726
The 12-week was cancelled.  I was told by a nurse (and a letter from Gilead) that it was in part because of objections from the FDA.  All 12-week ION-2 study members w/o RIBA were moved over to the 24-week w/o RIBA group.

I finish the 12-week w/ RIBA on Wednesday.  
Blank
Avatar_m_tn
What about the naive patients who received 7977/5885 without RBV in ION-1?
Blank
Avatar_f_tn
NO, ABSOLUTELY NOT!  The current treatment is Ribavirin and Interferon A... for genotype 1 and then there is Incevik and another new cure (name, can't remember) that is added for 12 wks. along with the Ribavirin and Interferon-A.  I've had 3 treatments, one with the Incevik 'cure' & and will soon test 1 yr. later to see if I'm still without the virus.  Treatment was incredibly debilitating.  
Blank
2135877_tn?1381864726
I think (but I'm really not sure) that the ION-1 early results are why the ION-2 12-week w/o RIBA was cancelled.

But don't quote me.  They said something like "Due to the results of the earlier study, etc etc."
Blank
Avatar_m_tn
see this thread, on the other side; social

http://www.medhelp.org/posts/Hepatitis-Social/7985-Gilead-trail-stopping-at-12-weeks-no-riba-ION-2/show/1933105

I don't quite understand it and afraid to try to explain it but I *may* (and maybe not) be able to get an explanation, or maybe it will become more clear.

I was kind of....inferring .....that the trial was extended to be on the safe side...... but due to trial results (from a different trial, ION1?) that they changed their minds, the average response (response or cure rate?  I dunno) was over 75%, they had that data, so anyone who had not treated 12 weeks could stop at 12 weeks, but if they had treated beyond and we into the 24 week would sty the course.  Gilead wants data in 12 or 24 week bundles; not 14 week and 16 and a half weeks.  Make sense? The data will be more clear if it is 12 or 24 weeks.

My guess is that they were erring to be on the safe side (in extending), but when the data came in it looked like those in the 12 week arm w/ no riba had a good enough result that they hit a pre-defined stopping point/success point of over 75%.  (I am inferring this meant SVR 4, not mere response)

Since ION 1 started in call it Nov 1 that would give 12 weeks and 4 weeks for a SVR 4.  Data probably just came in.  Not enough time for a SVR12.

This is just my guess, NOT my assertion of what is going on.

willy
Blank
Avatar_m_tn
I had heard that the first 200 patients in ION-1 were cirrhotics; so I was wondering that without riba, the 7977/5885 combination may not work for these patients - hence why this combination was withdrawn from from ION-2.  The question is whether the 7977/5885 without riba for 12 weeks wil work in naive non-cirrhotic patients!
Blank
Avatar_m_tn
Thanks - this supports my theory - that for 12 weeks, 7977/5885 will require riba
Blank
Avatar_m_tn
I have to disagree on a few points.  You *could* be right, but I doubt it.

ION 1 was open to naives only.  Cirrhotics were not excluded but the trial could only include 20% cirrhotics in the entire trial.  I'm not a math guy but 200 trial participants in a 800 total trial would seem to me to be about 25%.  

I also have to wonder.......just who exactly would know that all 200 people were cirrhotic?  No trial participant..... no doctor would know unless they all are furiously comparing information which is supposed to be blinded.

I think I doubt your source,

I'm not trying to be rough on you but I don't think it is a good tor accurate theory.

It would also seem to me that IF all these people were cirrhotic and that 12 weeks w/o riba wouldn't work...... if the evidence supported that (which I doubt, but supposing...), then I would think that they would want to try to extend the period of treatment to 24 weeks.  What does one learn by under treating patients that you know will relapse?  I would think if they knew they would relapse w/ only 12 weeks they would extend them and see if 24 weeks *would* work.
....but from what I understand they did not extend and they did assert a 75% success rate was hit.

For me the event suggests a level of success not failure.  Furthermore, it is possible you are basing your theory on facts that really are not yet known and just could be "false facts".

This could change soon.  EASL is this weekend and some data could very well be released. Until then I remain hopeful.

If I were to guess, not all groups may be treated w/o riba in 12 weeks but I think it is possible that some will.

The thing I don't quite grasp is asserting a response curve from TX naives to guide the treatment of past TX failures, which I believe will tend to be a sicker, harder to treat group.  The only way I would consider it would be if the 12 week without riba was very successful in naives.

I really don't know, wish I did. I think many people are wondering.

willy
Blank
Avatar_m_tn
Hi - thanks for the comments - i just re-read my post and also disagree with myself :)

I have searched for data on 7977/5885 without RBV and cant find any - there is data with RBV - so my suspicions were aroused, because if this combination worked without RBV, then why aren't we being told.

One pill once a day - no RBV or IFN - that would be something!

If someone has any ideas please chime in!
Blank
Avatar_m_tn
I was referring to 12 weeks in the above post - 24 weeks may be OK without RBV
Blank
Avatar_f_tn
I am in ION-2 and in my 8th week.  Last week, I was told by my trial nurse (who showed me a letter from Gilead) that 12 week w/o Riba was OK, which meant I had 4 weeks left.  

Which study are you in and do you have a copy of the Gilead  letter? I can get mine if necessary.

I'm trying to figure out why they're telling folks two different things??
Blank
2135877_tn?1381864726
I do not have a copy of it.  They just showed it to me at the appointment.  And to be honest, I didn't even really read it.  The PA just summarized it for me and showed me highlights, so it's possible that she misinterpreted it.

Wait, are you on 12 week w/o riba?  You would be the only one I know of.  They specifically said they transitioned all the 12 week w/o riba to 24 week at my site.
Blank
Avatar_m_tn
I was just randomized in last week and it appeared that a 12 week no riba arm was still on the table. (for ION-1's)

Some of this is simply pure trial design. They set a trial up to differentiate results, so generally trials get set up and you play out the cards you are dealt; simple.

ION-1 was supposed to be reflexive; the back end, the final 600 were supposed to be influenced but the results of the first 200.

I am at a loss about how or why one trial would reflexively affect a different trial, such as ION -1 altering the course/duration of ION-2.

It's probably better to just wait and we will hear more. There are so many different possibilities. I hope that it works out.  We may hear some results at EASL this weekend.

willy
Blank
Avatar_f_tn
yes I'm on 12 week no riba -- ION-2.  My site is Nashville... where is yours?

i don't understand the difference between sites.

One other person on 12 week no riba heard the same thing as I did:

http://www.medhelp.org/posts/Hepatitis-Social/7985-Gilead-trail-stopping-at-12-weeks-no-riba-ION-2/show/1933105
Blank
2135877_tn?1381864726
San Diego.  I have an appointment tomorrow.  I'll ask what's going on.
Blank
180992_tn?1383377657
12 week ion-2 that were moved to 24 week have now been moved back to 12 week because of results of ION-1.   They met their protocol of75% or better and thus have moved us all back to 12 week no Riba.    
Blank
2135877_tn?1381864726
OK, yes purplecat...that's what my study nurse said this morning, almost word for word.  It was a replacement study nurse that told me the opposite thing while the regular one was on vacation.  Honestly, I didn't pay too much attention to it, since I was on the 12-week with RIBA (just finished today.)

As far as my status....I keep floating back and forth between <25 and und.  Unfortunately, I think I'm liable to relapse, but we'll have to wait for the 12-week post treatment test to be sure.
Blank
Avatar_f_tn
Thanks guys! This has been extremely helpful....I wish you all the best of luck! :) :)

I've also been looking into a few different combinations and I've been told that the data from LONESTAR of 7977 + 5885 has been really good, has anyone heard anything about that?
Blank
Post a Comment
To
Blank
Weight Tracker
Weight Tracker
Start Tracking Now
Hepatitis C Community Resources
RSS Expert Activity
469720_tn?1388149949
Blank
Abdominal Aortic Aneurysm-treatable... Blank
Oct 04 by Lee Kirksey, MDBlank
242532_tn?1269553979
Blank
The 3 Essentials to Ending Emotiona...
Sep 18 by Roger Gould, M.D.Blank
242532_tn?1269553979
Blank
Control Emotional Eating with this ...
Sep 04 by Roger Gould, M.D.Blank
Top Hepatitis Answerers
Avatar_f_tn
Blank
Livelife777
Avatar_m_tn
Blank
can-do-man
IN
179856_tn?1333550962
Blank
nygirl7
Planet Earth, CT
476246_tn?1418874514
Blank
Marcia2202
Copenhagen, Denmark
Avatar_f_tn
Blank
patra_
DeLand, FL
1815939_tn?1377995399
Blank
pooh55811