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5154342 tn?1370270967

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!
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Avatar universal
awesome results!

I went for my 12 week eot draw last week and my study coordinator (my angel) told me she would be receiving a letter in two weeks & while not very specific I assume it would the 12 week SVR letter. She said she would call when she got it.

My most recent blood work was very promising on an overall level
liver enzymes were at12 yr record lows for me low end of normal
Hemo back up over 16
white blood cells in normal range another record for me

I have been experiencing some neuropathy in my in my feet but since I think we are all a little gun shy I am really not sure if its a side effect or unrelated. I had been running on the beach which I have curtailed for now & plan to seek alternative cardio & see a doc for diagnosis

all in all I feel great - lot of energy and renewed confidence.

went a bought a new to me race car for Christmas - 1970 911s, renewed my licenses to race in historics (where I belong at my age) and am planning my season..

who would have thunk it at 61?
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Avatar universal
thanks for opening the link I posted;-)

happy new year to you too.
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Avatar universal
http://www.gilead.com/news/press-releases/2013/12/gilead-announces-svr12-rates-from-three-phase-3-studies-evaluating-a-oncedaily-fixeddose-combination-of-sofosbuvir-and-ledipasvir-for-genotype-1-hepatitis-c-patients?mode=print

(per the link provided by Geshmit)

"Of the 1,518 patients randomized to the 12-week arms of ION-1 and to all arms of ION-2 and ION-3, 1,456 patients (95.9 percent) achieved the primary efficacy endpoint of SVR12. Of the 62 patients (4.1 percent) who failed to achieve SVR12, 36 patients (2.4 percent) experienced virologic failure: 35 due to relapse and only one patient due to on-treatment breakthrough (with documented non-compliance). Twenty-six patients (1.7 percent) were lost to follow-up or withdrew consent.

Fewer adverse events were observed in the RBV-free, fixed-dose combination arms compared to the RBV-containing arms in all ION studies. Adverse events observed in those taking the SOF/LDV tablet were generally mild and included fatigue and headache. In the RBV-containing arms of the ION studies, the most common adverse events were fatigue, headache, nausea and insomnia. Anemia, which is a common side effect associated with RBV, was reported in 0.5 percent of patients in the SOF/LDV arms versus 9.2 percent of patients in the RBV-containing arms. Less than 1 percent of patients in the studies discontinued treatment due to treatment-emergent adverse events."

================
If you check out natap they usually  have great presentations with nice graphics.
For instance check this out.  AE chart at bottom of the "page";

http://www.natap.org/2013/hepDART/hepDART_10.htm

====================
please also note.......I have yet to see AE results ever list tinnitus or neuropathy.  Perhaps they are not...."adverse" enough, ,,,,,,,,,,,,,,,,,,,,,,,,but nerve damage/tinnitus is quite often serious and permanent, whereas drug induced forms of anemia are almost always transitory.......

I do not understand, but it seems to be something that I witness.

happy new year....

willy

Helpful - 0
Avatar universal
Another reason to be grateful.
The cost of the drugs we've been given for free is likely to be prohibitive...

http://vaccinenewsdaily.com/medical_countermeasures/329106-new-hcv-drug-could-cost-1000-per-pill/
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Avatar universal
Hi again

Try this link from Gilead's website - it mentions sides. Gilead is publishing its results on its site, so good to take a look there

http://www.gilead.com/news/press-releases/2013/12/gilead-announces-svr12-rates-from-three-phase-3-studies-evaluating-a-oncedaily-fixeddose-combination-of-sofosbuvir-and-ledipasvir-for-genotype-1-hepatitis-c-patients?mode=print
Helpful - 0
Avatar universal
I will have to look for a link. I have the trial results in hard copy that someone printed out for me from a medical publication - I couldn't access the full version online But will have a look. Perhaps Willy50's link has it?
Helpful - 0
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