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5154342 tn?1370274567

ION-1 / ION-2 / ION-3 / LONESTAR / ELECTRON statuses

Hello all:

I thought that it might be helpful to all of us ION-1 / ION-2 / ION-3 / LONESTAR / ELECTRON folks to post an abbreviated synopsis of their HCV and post-treatment clinical trial statuses when they find out something definitive about their viral load, with as much info as they might be willing to share. This is or the benefit of us ION-"X" people so we can see how we are all doing, as well as for the benefit of others waiting and hoping to see whether sofosbuvir plus ledipasvir with or without ribavirin for 8, 12, or 24 weeks will comprise a viable treatment strategy.

I was going to try to start building a list of what I could harvest from this site, but decided that some people may prefer that I not do that, so, if people want to share their ION1/ION2/ION3 (and even ELECTRON and LONESTAR phase 2 studies) HCV status, they can.

I was thinking that, as much as people may be willing to share, that forum name, gender, genotype, liver Bx status prior to start of treatment, in which trial you participated, treatment regimen, whether treatment-experienced or not, whether PI-experienced or not, and since post-treatment viral load is quasi-blinded, whether you got the 24-wk followup invite or the sux2BU notification, or post-treatment private viral load test outcome, or declared cured or relapsed, would be helpful to share with the Community here and provide useful information to them. My status follows this post.

Thanx, all!
174 Responses
5154342 tn?1370274567
who?            still_above_dirt
gender?         M
genotype?       1b
Bx @ start?     stage 3 / grade 4
which trial?    ION-2
regimen?        SOF/LDV without RBV
Tx-experienced? Y
PI-experienced? Y
post-TX status? EOT+12, got 24-wk invite
5154342 tn?1370274567
minor  correction:

regimen?        12-wk SOF/LDV without RBV
Avatar universal
Grateful to be here
Stage 2
Ion 2
Sof/ldv with RIBA
24 weeks
Currently at week 17 of 24
UDL at week 4
Enzymes low end of Normal
Avatar universal
Ok this is a great idea.  Heres my info.

Started May 23rd ION3.  Sofosbuvir and ledipasvir no riba for 12 weeks.  Tomorrow is my last day.

GT1b treatment naive non cirrhotic.  Starting VL 154000.

I have been Und since week 1.  

Tomorrow being last day will have to wait to see when I'm called back in for blood work.   Fingers crossed that I stay und!!!!!

Good luck to everyone on these trials.  I will follow this thread to see how we're all doing.  Kathleen
180992 tn?1383377657
who=            Purplecat
gender=         F
genotype=       1b
Bx @ start=     stage 2 / grade 2  30Jan13
which trial=    ION-2
regimen=        SOF/LDV  12 Weeks  EOT 24April13
Tx-experienced= Y
PI-experienced= N
post-TX status? EOT+12 17Jul13, got 24-wk invite 09Oct13
Avatar universal
Tx naive
ION-1 (UK)
Start of tx: VL 5,000,000
SOF/LDV + RBV 12 weeks EOT 29 July 2013
UND from week 4
Liver enzymes - now normal (ALT 19)
Side effects: insomnia, digestive disorders, fatigue, nausea, slight breathlessness on occasion, slight brain fog/lack of concentration
EOT+4 test 28/8/2013 (blinded)
EOT+12 -  end Oct (not blinded)

Will continue to follow and post when I have news

best of luck to all
Avatar universal
ION 3 - 8 weeks - no Riba
G 1A
VL 4 mil.
UND 2nd week
BX level 3 staging 3 to 4
Enz AST29 ALT18
EOT 8/4/13

Post 4 week blood draw due on 9/3
This is a great idea...our own trial data..will post more when infol available

Wishing everyone SVR forever!
Avatar universal
Maybe useful too if people could post briefly in their summary if they had side effects and which?
Avatar universal
It's been so long I can't remember. Think I was ION1
Started back in Oct 2012
FEMALE - now 58
TX naïve
geno 1a
Stage 0 - 0 fibrosis
VL 14 million
ALT+AST always good

Gilead sofosbuvir/5885 - no riba
24 week arm, but only went as far as 14 weeks
UD week 2
SVR 24 - UNDETECTED as of TODAY!!!!!
Avatar universal
Well done, UKgirl55.
Just got my 12 week treatment blood draw result (NOT EOT 12 week)- still UND, ALT 18. A long wait now for EOT 12 weeks.

UKgirl55 - may I ask why you only did 14 weeks? You don't have to answer, but I was wondering if it was because of side effects as it's interesting to find out how many suffered from them. Or did Gilead decide that?

thanks and all the very best

Avatar universal
Observations about side effects
24 with Riba
In week 17 of trial

I have no way of quantifying which drug causes sides but:
Runny eyes
Blurred vision
Skin rashes
Heightened herpes out breaks
Greatly diminished cardio capacity
Tire easily

Some say its the result of the Riba

Has anyone on a non Riba arm experienced any of these side effects?

I have never heard that question answered

Avatar universal
Oh yes, I also developed a bad skin rash at week 10 of 12week tx. (w Riba). Gradually faded with use of antihistamine and strong hydrocortisone cream
Avatar universal
What we have never determined is are there side effects from the 5885 without Riba

Avatar universal
I think there are documented potential side effects for the FDC drug such as occasional blood in urine (women), brain fog & digestive disorders, but yes, it would be good to hear 1st hand as part of this micro-trial:-)
Avatar universal
documented sides are a trailing index so to speak. when I entered the trial I couldn't get a straight answer about the sides of RIBA as the documented sides were all in conjunction with Inreferon.

I have a much clearer understanding of the sides of RIBA after being on it for four months, having said that - we are all taking it in conjunction with GS5885.

fifty percent of us are taking just GS5885 so those of us in that arm will be the ones who can differentiate - I would much rther have your input than to wait for them to sift though he data to tell us what they think the sides of GS5885 are.

so - again - any side effects from GS5885 without RIBA?
Avatar universal
I think what the 8 weeks without Riba want to know is anyone in this group achieving SVR 4, SVR 8 SVR 12 SVR 26.   The ION 2 study did 8 weeks with and without Riba but Gilead only publish SVR results as of 8 weeks!  What good is telling about the side effects Sofosbuvir and Ledipasvir it it doesn't work without the Riba?

Anyone here do the ION 2 without the Riba?  Are you still SVR?

180992 tn?1383377657
I think "still above the dirt" was hoping this thread would be more like the great list that Frijole made for  triple TX people and their outcomes.  It seems one can't help but have more questions and discussion around these status posts. Renee's thread is over 600 now so I hope this thread is mostly status rather than discussion or "Still above the dirt" is making list like Frijole did. That said, here are my answers to help those wanting to know more info about NO RIBA group.

Quest5245, I'm ION-2 SVR12 with no riba at this point in time. UKGirl ION-1 no riba made it all the way and is SVR24!

RainM snd Grateful to be here, I had headache, stomach pains, nausea and diarrhea.  I missed one day of work with extreme nausea and stomach pains.  The evening before I had Lasagna.  I then went on diet of no dairy wheat and little fat.  All symptoms stopped and I sailed through the remaining weeks of treatment.  UKgirl was supposed to do 24 weeks with no riba.  At about week 8 she started having nausea. It became so bad she was pulled off treatment week 14.  She is now SVR!

My NP from my clinic said another woman was also having Gastric distress and went on low fat, no dairy and symptoms subsided.  I do not know if UKGirl tried any diet between week 8 and 13 before she was pulled off treatment.  But Gastric problems for a very small percentage seems to be side effect for the No Riba group. Many report headache in very beginning but it subsides. My NP told me many have no reported sides with No ribavirin arms.
Avatar universal

OK.  Let me try to be a bit clearer at what I am trying to find out, maybe someone can help me?   ION 2 had people doing the Sofo & Ledi for 8 weeks, with and without Riba.  But the report Gilead published only gave the SVR status up to 8 weeks post trial for these folks.  I would like to find out if ANYONE that did the 8 weeks without Riba is still SVR?  There is more evidence that 12 wks without the Riba works..  I need to hear more from folks who only did the 8 wks without Riba, please.  Thanks
Avatar universal
Please anyone?
5154342 tn?1370274567
The trial in which you are participating, ION3, and its phase 2 predecessor, LONESTAR, were the only trials that had 8-wk protocols.

ION2 (the one in which I am/was participating) is 12- and 24-wk for tx-exp (http://clinicaltrials.gov/ct2/show/NCT01768286). My group, 12wk no RBV, was, for a short time, extended out to 24-wks, but they rolled us back to 12wks before any of us got to the 12-wk point in our treatment; clinicaltrials.gov website has never updated group 3 info to reflect that we reverted back to 12wk regimen, so that website's info is incorrect in that respect.

KathHall and yourself appear to be the only folks in ION3 following this thread at the moment and neither of you have made it to EOT+4 yet, much less be able to report post-EOT SVR data yet. You'll probably have to do your own independent VL tests like I did, before EOT+24 follow-up blood draw, if you want to find out any interim statuses. Anybody else on ION3, if following this thread at all, is probably holding off posting here until they have some actual post-EOT SVR data to report.

As a sidenote, it appears we only have one known ION1 participant following this thread, too.

Regrettably, it would appear that no LONESTAR participants are following this thread, because there are no posts here from them.
5154342 tn?1370274567
I would like to thank purplecat for attempting to steer this thread a bit back on track. I am not against people posting here, by all means that is for what this thread was set up and I want people to do so. But I am hoping to keep the vast majority of posts' formats closer to the style adopted by the several initial posts. My thought was, that way, people could refer here, and see a succinct and compact list of interim SOF+LDV±RBV data for various gender, genotype, naïvetté-vs-tx/pi-exp, and tx duration combinations. The addition of reporting one's side effects is a good idea, I think, and I welcome that addition to the "template".

I would suggest that specific questions to others be best handled by private message, and specific questions to the Community at Lartge be handled as a new topic. Reason being, as a comparative example, Renee543's "Big Thread" (as of this posting, has 619 comments after her initial Jan 8th post! Wow!), while loaded with lots of good discussion, is difficult (for me, anyways) to harvest information out of there like what I am hoping will be presented here, in a very concise manner and format.

Do keep those status reports of gender, genotype, Bx findings and date, prior tx status, trial and tx regimen, baseline and interim VL data, side effects, other important data items that you deem fit to include and that I have overlooked suggesting to include (like I did with baseline VL and side effects) (e.g., age? race? IL-28B genotype?) and most importantly, post-EOT SVR data; coming. Please! Based on the very limited data set reported here, these trials look promising for us.

Side effects update for me, BTW, in case anybody is interested for their own comparative purposes: My SX didn't manifest themselves until after I got off treatment. My liver freqin' hurts today big time and my digestive tract has been a mess for 14-15 wks. And I'm gettin' fat -- have put on 15 lbs since EOT, even tho'  I'm on a "cheatin' vegan" diet. But hey, I was SVR12, I think.
Avatar universal

I don't wish to digress and promise to keep this thread on track for EOT status, but first:
1) I'm the only one on ION-1 on this thread maybe cos these trials have just begun in the UK for G1 tx-naive individuals with no ION-2 and 3 yet.
Trials for  Tx-exp  G2 & 3 started in the UK around 8 months ago with SOF w/wo RIBA, 12 or 24 weeks.

2) Side effects rationale: I was told at the start of the trial that there weren't any. When I first reported sides, they were treated with a bemused disbelief by the nurses until they were either told off by my hepatologist (and lead trial investigator, who is wonderful) or realized that I was a sane, otherwise healthy, non-hypochondriac with no co-morbidities, and started to treat them seriously. When I developed a severe skin rash, it was highly visible so they saw it for themselves.

It was the nurses whose attitude annoyed me; my hepatologist admitted that his trial was small and not definitive re sides, so it was important to know if anyone experienced any and  to report all to Gilead for worldwide comparison. Hence I thought it useful .to compare sides here, from the "horses' mouth" so to speak....

And hey, still_above_dirt, maybe you're getting fat cos your liver is
healthy:-) Be careful:-)...I've put on a couple of pounds too since EOT-.better start working out again.

OK back to EOT stuff, promise.

best to all

Avatar universal
One last thing - I see there is one other person on ION-1 too: so 2 ION-1 participants in all.
Avatar universal
What happened to ION 2 people who were on the 8 weeks of Sofos+Ledi without Riba????   Are you still undetected??? Or do you all have a gag order and/or life threats if you talk?

Hoping to hear from one of you.  Otherwise, we should assume the trial did not work and you are still positive HCV.
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