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ION-1 / ION-2 / ION-3 / LONESTAR / ELECTRON statuses
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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!
Tags: Gilead Sciences trials
173 Comments Post a Comment
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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
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5154342_tn?1370274567
minor  correction:

regimen?        12-wk SOF/LDV without RBV
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Avatar_m_tn
Grateful to be here
M
1a
Stage 2
Ion 2
Sof/ldv with RIBA
24 weeks
Naive
Currently at week 17 of 24
UDL at week 4
Enzymes low end of Normal
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Avatar_f_tn
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
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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
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Avatar_m_tn
Geshmit
F
G1b
Tx naive
non-cirrhotic
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
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Avatar_m_tn
ION 3 - 8 weeks - no Riba
F
G 1A
VL 4 mil.
UND 2nd week
BX level 3 staging 3 to 4
Naive
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!
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Avatar_m_tn
Maybe useful too if people could post briefly in their summary if they had side effects and which?
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Avatar_f_tn
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!!!!!
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Avatar_m_tn
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

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Avatar_m_tn
Observations about side effects
M
1a
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
Insomnia
Irritability
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

Thanks!
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Avatar_m_tn
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
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Avatar_m_tn
What we have never determined is are there side effects from the 5885 without Riba

Anyone?
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Avatar_m_tn
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:-)
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Avatar_m_tn
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?
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Avatar_m_tn
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?

Best
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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.
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Avatar_m_tn
Hi,

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
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Avatar_m_tn
Please anyone?
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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.
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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.
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Avatar_m_tn
Hi

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

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Avatar_m_tn
One last thing - I see there is one other person on ION-1 too: so 2 ION-1 participants in all.
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Avatar_m_tn
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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Avatar_f_tn
They just had their first 4 week eot blood draw and the results are blinded from the clinic and the patient till their 12 week blood draw and i think if you are detected,  you get a letter stating you need to return for a recheck.  so we won't know till about the 12 week results come back if they are SVR or not..I am in ION2 people that were in a 24 week trial..just will be finishing up in about 4 weeks.  It would be great to know how the 8 week people do..we know 12 weeks does the trick, that is why being in the 24 week arm and with RBV *****...

take care..
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Avatar_f_tn
Just thought I would let people know next week is my 4 wk eot.  And I will post the results when I know.  I was in ION3 12 week no riba. I do know another lady in same trial that got the 8 week no riba and she is und after her 4 week eot.  Because they double blinded the trial at the end we have to just hope we don't get a call back to retest after blood work.  Wish more people would start posting results also!!!!  Kathleen
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5154342_tn?1370274567
All the ION2 are 12 or 24 weeks with or without RBV. ION3 and its phase 2 predecessor LONESTAR are 8- or 12-week plans.

I'm thinking that some of the 24-week ION2 folks should be near EOT+4 about now. It's not crystal clear to me, when I read the ION2 informed consent documentation package, whether treatment failures at EOT+4 would be asked to come in for confirmation draws, or would they just wait for EOT+12 to serve as the confirmation draw. I can't speak to ION3's policies.

Fortunately, near as I can tell, that hasn't happened to anyone. I know I would have posted a treatment failure status had it happened to me and I expect anyone else willing to post here would do so, too. The majority of us 12-wk ION2 folks are looking at EOT+24 in October (late October for me), early October for for folks like Renee543 and Latille.

So I'm thinking that any interim results would have to come from folks reporting results from their own privately arranged viral load tests conducted outside of the auspices of these trials. I'm kicking around the idea about seeing if I can get my family care physician to order me up another test for EOT+18 time frame (that's just a few weeks away from now)

Thanks for getting this thread bumped back up topside, I hope that doing so will encourage the appearance of some more status summary reports.
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Avatar_m_tn
Hi

I am still trying to find people who were in the ION 2 who did the 8 wks without Riba.  Are you still UND 4 wks, 8 wks, etc after EOT??  I am in the ION 3 trial but do you think I am going to wait 12 wks tell the trial tells me if I am UND or not???  I already have a script for blood work and I am getting my own blood drawn the next day after my 4 wk eot draw.  My interest are not in the 12 or 24 wks with or without riba, etc.  Just the 8 week.   Thanks you
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Avatar_m_tn
I had my EOT4 test last week (ION-1, 12 weeks, w/riba) but the results are blinded. I'm not sure if I will be asked back to redo a blood draw if the VL results are detectable.
I don't really have anyone to ask right now as my usual NP is away and the clinical research nurse I saw doesn't know much.
I will get my ALT etc results soon though which are not blinded and those may give a clue, but not conclusive. I will post them when I have them.

I'm now 5 weeks post treatment and am convinced the virus has returned - feeling rubbish, with a couple of low-grade infections, digestive disorders, fatigue, aches and pains etc. I was starting to feel better after treatment but have now crashed. I was UND from week 4.

Interested to know if anyone else is feeling or has felt like this after treatment?
thanks
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Avatar_f_tn
Read your consent forms.  It stated in mine that we do not get results back and the clinic doesn't either until week 12 eot.  Then you get letter asking to do a repeat if you are detected.  .  I think after insurance pays is around $20 or $30 for blood test.  I will have my primary dr do blood draw!  Hope we all are svr.
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5154342_tn?1370274567
Hello Quest5245:

You won't find any 8-wk cohort ION2 participants because there are no 8-wk cohorts in that trial. Please refer to http://clinicaltrials.gov/ct2/show/NCT01768286?term=ION2&rank=1 for further information.

Your trial (ION3) and its phase 2 predecessor LONESTAR are the only SOF+LDV±RBV trials of which I am aware that have 8-week cohorts.

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Avatar_m_tn
delighted to see there is activity again here

ION 2
24 w Riba
this week I go for week 20 draw
four more to go

I feel great - exercising again losing a few pounds too:)

plagued with skin rashes & insomnia

I plan to go for my annual physical four weeks after EOT and get complete blood work done

we always knew the blinded 12 weeks was the hardest part

hang in there - after what we have all been through - breathe, think positive
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Avatar_m_tn
Firstly, I'm not in the US and things may vary - I'm also on ION-1. I know we don't get the EOT4 results back and neither does the clinic, (that's the meaning of blinded)but my question was do we get asked to do a repeat blood draw in any event if the sponsor sees that the VL test is detected but without saying it's detected?

And grateful_to_be_here - you're right - we've been thru so much that a few weeks wait is not so bad. In fact, a bit of ignorance is bliss is ok.  It's just the feeling crap and wondering if it's because the virus is blazing back that's hard.

Quest5245 - I think there were a couple of 8 week participants on another thread..maybe take a look and ask them? I did, but haven't seen any updates.
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Avatar_m_tn
this thread will have tremendous value to all of in the coming months.
for me, it's my only support group and place to recieve real time information

I was in the dark for many years before diagnosis - got limited data for the next 13 yrs until I got into ION2

I think patience at this point is paramount

so is sharing information we gather as we finish up

you have to believe some will relapse - and there is no tooth fairy


hang in there
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Avatar_m_tn
Many of us who got the disease before 1990 or so (when diagnosis of and a test for hep C came out instead of non AB) were also in the dark for a time - I know I wasn't officially diagnosed for around 15 years either although we knew there was something wrong with my liver.

And that's pretty widespread - and has  been a problem, no testing, no diagnosis, no symptoms for a long time until the disease has taken its toll.

I do have one or two other people I know who got it (at different times, different places, different methods) so I do talk to them, but I'm not in a support group either so this group is valuable to me too.

I was confident at EOT but the way I feel in the last couple of weeks, I'm not so optimistic now.
Yep, we have to wait and see.

best to all
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Avatar_m_tn
Geshmit,

I have heard of some people feeling like crap after ending therapy and I do not know what to think of it. It must be nerve wracking to be blinded to lab results if you experience this.

Can you describe these digestive disorders you are experiencing or the symptoms and how they make you feel?

Are they something new or are they something you have had for years, but lessened while on your clinical trial, only to return when you stopped?

Good luck.

Cheese
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Avatar_m_tn
ION 2
1a
24 w/ RIBA

went for 20 weeke draw today and picked up my last meds.
my 16 week draw had my hemo at 13.5
ALT 10
AST 19
lowest in 13 years!

one more month of the happy orange pills and the evil blue ones.

My study coordinator told me of the 21 patients at EOT one did not return for follow up so he is automatically classifed as relapsed per the study guidelines - no one else has been called back for testing - yet
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Avatar_f_tn
I go for my 20 week draw today too.  I will ask coordinator how many have had call backs.  Last time I saw her she said they have the cure now and that I could have had the 12 week study.  I have 24 weeks sofosbuvir, 5885' and RBV .  27 more days unless Mexico takes my drugs, which at last visit she said they might!,   But that it would be okay if they did.  Glad I get to talk to her today.

Take care!
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Avatar_f_tn
I just got back from 20 week exam.  She said there have been no call backs.  She said when drugs get approved treatment will be 12 weeks and 8 weeks but the 8 week people get Interferon.

I have 25 more days.  She moved up date so i could see dr Oct 1 for my exam.~~~~  so 25 more days and i am done!!  good to know 12 weeks does the job and so does  8  but with Interferon for some I guess.
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Avatar_m_tn
If  Gilead thinks people are going to want to take the sofos & ledi but they will have to take it with riba or inteferon...........Gilead can keep the crap!  They already have proof that 12 wks without riba works on 1a's and no sides.  The question is does sofos & ledi work in 8 wks without the horrible drug riba.  I know of 2 other people on another site..and both of them took sofos and ledi for 12 wks, no riba and are 24 wks SVR!  We already know that in Gilead's prior trial of 8 wks, 95% without riba had SVR 8 (only 1 person had a break through) and the group with 8 wks with riba had a 100% SVR 8 weeks!  Some Lonestar participants should have had VL tests done again either by themself or clinic by now.  Are any of you still SVR???
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Avatar_m_tn
I believe Gilead will combine sofo with whatever the FDA or regulating agency approves.It could have been aspirin

The reason RIBA or Interferon are in the approved cocktails is more about the trial protocol than the effectiveness of sofo and until there is a lot more data collected the clinical facts will be irrelevant.

Gilead is in the business of selling drugs, this one is important to get to market given the costs.

It's not a perfect world - get used to it

many of us believe RIBA & Interferon are poisonous from our personal experience.

The FDA cares not. Had the protocol been different for testing the approved cocktail would be different

and as they say "if grandma had balls she would be grampa"
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Avatar_m_tn
Well I guess your reply solves it.  We should all just bend over and take the poison Gilead, MRK or ABBV and the FDA wants to shove in there (even though data proves Gilead can cure without them) and get cured of Hep C but go on to develope other life long heath diseases from these poison drugs ( RIBA & Interferon)  like diabetis, thyroid, immune and heart problems, etc....just to name a few.  Sounds like a real win win situation for doctors and drug companies.  
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Avatar_m_tn
no question - I agree with you 100%

you have a choice - you can go through life being angry about it

I prefer to be grateful to have been enrolled in this study and given an opportunity
for a cure - I turned down Interferon & RIBA, teleprivir a number of recent studies that included Interferon.

My guess would be most people with HepC have not been diagnosed and if they have they have limited information and no opportunity to be cured in a trial for free as we have.

I prefer not to be angry because the world is not fair and prefer to count my blessings that I may get to push the restart button at 61.


If I relapse I will deal with that - though I prefer to think positive

I hope I havent upset you & if i have i apologize and will not engage you further

Peace
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Avatar_f_tn
The treatments will be much shorter now.  If RBV prescribed it is more doable and at lower doses.  Trial coordinator said only interferon with 8 week treatments in future.  Just do 12 weeks then without interferon and w or wo RBV.  That would be a breeze to do.  I am starting week 21 folks.  23 days to go.

Not bad for a CURE.
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Avatar_m_tn
My post TX treatments: I have had sporadic gut problems over the years, but not constant and not chronic. On treatment, they became much worse: digestive problems, bloating, extreme nausea, constipation and so on. Post tx - I have some of the tx side effects but constantly, unlike pre tx - bloating, gas etc.

To all:

Although pharma, Gilead included, does stand to make squillions from these new drugs, I really believe that it is in their interest to eradicate interferon and the older drugs and they clearly aim to do so. I have known and do know many doctors - hepatologists and others - they have no interest in prescribing old drugs with severe side-effects. My hepatologist can't wait for the day that these new drugs with a high cure and low side effect rate are licensed.

Prescribing clinicians would sincerely love to do away with interferon (and riba) It's government, health services and the insurers are the ones who care less about patient experience and more about protocols and regulations. It's easy to be cynical about pharmaceutical companies, but actually they are the guys who are developing revolutionary treatments and who will save our lives.
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Avatar_m_tn
Geshmit

Thanks for defining your intestinal sides.

I have had intestinal issues for many years (a decade) which often included painful headaches, insomnia sore joint, and they kept getting worse and the symptoms from them more debilitating. I thought I might have some sort of infection, or a "pocket" that got filled up and did not empty.
After seeing doctors about this for years and them not being to find anything of concern, (besides a  "moderate number of diverticulae " ) I had put it all down to HCV.
My symptoms tended to improve while I was on GS-7977/5885 and riba but did not go away completely. If the virus causing this discomfort was gone, why would the symptoms stay?
I became concerned that although VL was UND since week 4, that I would relapse after treatment ended.  And when it did end, within a few days I felt the old symptoms strengthen. Within a week or two after tx I had completely "flared up" to feeling as bad as I did on so many occasions before I started tx and came to the conclusion that the virus was back.
I spoke with my G.P. about my concerns before I stopped tx, and again after when my symptoms flared up. We did some blood work.  ALT / AST remained low. We are now looking into the possibility of parasites, c. difficile, and something else, plus I am to see a gastroenterologist (again) for these symptoms that I have been complaining to gastroenterologists to for the last 10 years.
Maybe they'll find it this time, if it is not HCV.  Maybe I DO have some sort of pocket or slight obstruction. Or maybe all this is just normal for people who have had HCV for several decades, maybe even the flare up is normal, if it happens.
I guess we'll find out after my post tx week 12.

Cheese.
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Avatar_m_tn
Thanks for your input.

let me know what transpires with difficile etc tests.

My gut-related sides were much worse with treatment.

I expect to find out  my ALT/AST results over the next week or so for EOT +4 weeks. All in all I was chosen for ION-1 as a potentially successful candidate, which is how they like to choose us - no cirrhosis (although I do have fibrosis), treatment naive (I had refused interferon tx for nearly 10 years), in a good position to comply with treatment regs and hospital appts/tests.

So if anyone on my hospital trial (16 overall, 4 arms, 12 & 24 wk w & w/o RBV) has a good chance, there's no reason why it shouldn't be me. But maybe other conditions come crawling out of the woodwork after living with HCV for so long. I have had a couple of infections this past couple of weeks - a family member who is a hematologist said that after taking anti-virals of any kind, I was bound to feel worse with infections than I would if I these toxins weren't in my system, and that I was still immuno-compromised, so hopefully, that's it.  

I will post my liver enzyme results just as soon as I have them.
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that makes a lot of sense - with luck and the right lifestyle I would like to think I will be able to cleanse the toxins over time.

The evolution of how I have felt since diagnosed is complicated & I don't pretend to understand what was HVC, gastro issues or a bad day.

I have days when I feel like lousy now - I find pushing myself and going to the gym or for a run really helps.

I am counting down the days - 24 to go :)

then I can focus on my fitness

reset at 61 yrs old!
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Has anyone experienced difficulty with swallowing food?  Like today I had scrambled eggs ...they did not want to go down.  But then I ate Honey Nut Cheerios with half & half and it went down fine.  Most food goes down as long as I chew carefully but some just seem to sit there and I have to get it up.  I have and had hep C for 40 years could this be a problem steming from the disease?.  Still waiting for my EOT +4 blood results.  Has anyone else had this type of digestive issues?  One I get my EOT + 4 results, will post.
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I just wondered if anyone else had bad gastro issues since treatment.

My symptoms have now got so bad (6th week post tx) that I am going to get in touch with my trial nurse tomorrow, with a view to getting tests for whatever.

I never had symptoms like this before tx and as a couple of you have some sort of digestive issues, I was wondering if this was on a wider scale after treatment and if possibly one of the drugs was causing this, or whether another factor was to blame.

thanks all
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As promised, my EOT +4 week liver enzyme results (VL blinded):
ALT & AST:  13, 16 (not sure which is which, but either way is good) - the lowest ever! So while it's not definitive in any way, it could be indicative and at least my liver is in good shape.

Hospital nurse said that my gastro symptoms are not liver related...

Six weeks to go until my 12 week EOT tests.

What happened to all of you who said you were doing a private HCV test? Any results?
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Got an independent "EOT+17.85" VL test four days ago. The independent EOT+6 that I had gotten took 8 days to get the results back. Stand by...
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i am 55 years old male caucasian geno 1a for last 30+ years with f3 fibrosis but no other medical complications.
i am on week 18 of 24 trialing sofosbuvir/ledipasvir fdc pill with no ribavirin.
i have been undetectable for viral load since week six and was still undectable on week 16 at my last blood draw.
i have had no noticable adverse side effects and many positive side effects such as less fatigue,more energy,better concentration.i have felt better since week one of starting the treatment.
i am happy to have been chosen for the 24 week arm without ribavirin as i think all the adverse sides are coming from riba and,as i have had hep c for a long time i think i have less chance of relapsing than treating for just 12.
has anybody got eot +24 week results yet?
good luck to all,david
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They have set review date for October 25 now for Sofosbuvir!!  Give me your thoughts please on if this will move up date for FDA approval.  We will have a lot of answers to our questions now...And I have heard 2015 for 2885 to be approved!  I think they want to know about long term safety issues on the 5885.  I have 15 more days and then I am done...can't wait...  was 1B had 24 weeks RBV, Sofosbuvir and 5885.  

Wanting SVR for all and no sides...Wishing the best for everyone... :)  Gilead's (GILD) Sofosbuvir FDA Panel Review Date Set for October 25th
September 13, 2013 9:08 AM EDT

4160-01-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Antiviral Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Antiviral Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on October 25, 2013, from 8 a.m. to 5 p.m.

Location: Sheraton Silver Spring Hotel, Cypress Ballroom, 8777 Georgia Ave., Silver Spring, MD. The hotel phone number is 301-589-0800.

Contact Person: Karen Abraham-Burrell, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: ***@**** or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).

A notice in the Federal Register about last minute modifica

- See more at: http://hepatitiscresearchandnewsupdates.blogspot.com/2013/09/gilead-gild-sofosbuvir-fda-panel-review.html#sthash.b5TAXc1M.dpuf
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Sorry to point this out, but isn't this a thread for our status reports during and post TX? Don't get me wrong - this is great news for all.
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I think we're all waiting for results from EOT 12 weeks, never mind +24 weeks. And we all seem to be pretty much in the same boat, time wise, both in the US and the UK.

I have another six weeks to go until my EOT +12 weeks (EOT 4 weeks test is blinded). However, a friend of mine did sofosbuvir (only, no ledipasvir) w riba for 24 weeks (geno 3, treatment experienced) and he just got his EOT 12 weeks results - still SVR.

My understanding from reading the info out there is that if you clear the virus during treatment, you'll most likely still be SVR until the end of treatment.The relapse, if it's to come, will come after treatment. That's the big test.
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M
1a
Stage 2
Ion 2
Sof/ldv with RIBA
24 weeks
Naive
UDL at week 4
Enzymes low end of Normal


15 days to EOT

feeling better than I have in 15 yrs. exercising regularly, have lost 7 lbs over the past month

I am prepared for the next 3 months of silence during which I will go for complete Hepatic panel from my internist.
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2135877_tn?1381864726
who?            Eki
gender?         M
genotype?       1a
Bx @ start?     stage 3
which trial?    ION-2
regimen?        SOF/LDV with RBV - 12 weeks
Tx-experienced? Y
PI-experienced? Y
post-TX status? EOT+12, got 24-wk invite
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Good for you Eki !

Your news gives all of us in this trial hope, especially those like me, who still feel sick.

Cheese
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thank you very much - that's the data we are all waiting for

should be much more forthcoming over the coming months!
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Awesome!  Thanks for posting and keeping us informed!  

Congratulations, you are cured!
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That is great and promising news. You must be over the moon. Hope it's that way for the rest of us who are waiting...

all the very best
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I hope we are all cured on these trials, and I don't want to be the party pooper, but shouldn't we wait a bit longer until we declare we are cured? Someone on these threads did a long trial of SOF + RBV without LDV - was SVR early on until week 47 (yes, a long trial or maybe off  label treatment) when he relapsed. So perhaps we shouldn't be too optimistic just yet.
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Geshmit,
The circumstances leave us with not many choices especially for hard to treat gt 1's who do not do well with peg inf. There are so many lovely DAAs coming down the pike that I would imagine it would helpful to get a head start by enrolling in any study that is feasible. Having the opportunity to be evaluated by a team of liver specialists would be great. I'm hoping to get approval after 5 hour screening at NIH with cirrhosis is turning out to be like walking very tight rope. New symptoms appear on a regular basis and just found out NIH is not screening until November - January. Oh well, it would be worth to at least go to the screening and see what happens. I cannot afford to see a hepatologist and pay out of pocket at this time Kaiser is all I can barely afford.   The study will be 8 weeks of sofos/ledipasvir fixed dose combo plus - gs9451 or gs9669.  Do you know much about gs9451 and gs9669?  I think NIH is confirming with J. Hopkins to make sure I was a null responder to inf/riba study back in 1999.   Anyway, just read your post and want to say good luck to you on your EOT results. It sounds very promising.    
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Sorry I know nothing about gs9451 and gs9669, but my guess is that Gilead is trying to shorten treatment times as much as poss - they know that 8 weeks of SOF + LDV is not sufficient and probably want to wipe out RBV and keep all treatment drugs under their own roof. Also RBV is an old drug with documented side effects.

So the company is developing new drugs which would complement their others. As far as licensing goes, they won't approve Gilead's 8 week oral regimen without interferon, cos the duration hasn't proved sufficient. So Gilead is developing alternatives.

Of course, this is by no means medical  opinion, but merely a logical estimate based on my understanding of what I've read so far.

Good luck with it
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* * * NEW INFO * * * NEW INFO * * * NEW INFO * * *

I had a second private viral load test conducted independently of the ION2 trial, at 17 wks 6 days post-EOT. It took twelve days to get my test results back.

who?             still_above_dirt
gender?          M
race?            caucasian
age?             58
genotype?        1b
Bx before start? stage 3 / grade 4 mid-2011
which trial?     ION-2
regimen?         12wk SOF/LDV without RBV
Tx-experienced?  Y
PI-experienced?  Y
post-TX status?
                 test: Labcorp NGI Quantasure, test #140639
                 claimed LLoQ/LLoD: 2IU/ml
                 time of sample collection: EOT+17.857wks
                 outcome: still less than 2IU/ml (undetectable)
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Can we also include viral loads on the data?
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great news. but not clear on one thing - is less than 21U/ml und or simply less than 21U/ml ? (not that I'm trying to spoil the party, just devil's advocate).

penn1023 - My viral load was either 5,000,000 or 8,000,000 at the start of treatment - can't remember now, but it's been higher in the past - it went down to 45 after 1 week of tx, then 27 after two weeks tx, then UND at 4wks tx.
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5154342_tn?1370274567
It is "2 iu/ml" not "21 u/ml"

This test's LLoD is 2iu/ml. Less than the lower limit of detection is considered undetectable. For whatever reason, Labcorp's test reports never say "undetectable" like Gilead's did. Probably had some corporate lawyer tell 'em that they couldn't say "undetected".
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5154342_tn?1370274567
I don't remember where I was at start of treatment. I think around 2,500,000 to 3,500,000 or thereabouts.

I do remember that I had roughly a 4 log drop by end of week 1 of treatment, was detectable but less than 25 at both weeks 2 and 4, and finally made undetectable at week 6.
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5154342_tn?1370274567
Also,I believe that the general consensus of hepatologist professionals is that actual viral load is not indicative of the extent of liver damage, but that looking at rates of decrease in viral load as treatment progresses is a useful parameter to gauge the efficacy of treatment, e.g., my 4-log drop by SOT+1 was good news.
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180992_tn?1383377657
Had my yearly physical 17Sep and my primary care GP did a HCV PCR test early before my Gilead test date of 09Oct. Just got results emailed today that is Undetected!!! EOT 21 I'm still UND. Wow weeeee. I was 12 weeks 7977/5885 NO RIBA arm. I will post official after I receive Gilead EOT 24 . My GP says 3 weeks I'm still going to be UND, not to worry. I'm almost there.
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1815939_tn?1377995399
That is great news. Congratulations!
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Wish list:

Boy, it woluld be nice to have 7977/5885 and 9451 the protease as insurance.
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Fantastic news and reassuring for the rest of us.

all the best
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Where did you get your info that Sofos and Ledpasvir DO NOT WORK IN 8 WEEKS WITHOUT RBV???????????????  I would really like to see your proof and you should have proof before you make such statements.

Pls provide the proof.

Thanks
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- I don't like your aggressive tone and I'm not getting into an argument.
The fact that Gilead will go for FDA for 8 weeks tx only with INT says a lot. Scour this site, take a look at Gilead's own info - reach your own conclusions.

As I said before, my opinions are my own and not scientific And  I'll say it again: SOF/LDV will not be licensed for 8 weeks without INT. My opinion, of course. But I think that it is probably because it doesn't work.
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what I should have said was: it is probably because it doesn't work as well as longer treatments.
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None of us have the facts yet, but come October 26 it will all be public.  My coordinator said for the 8 week treatments, they will be adding interferon.  It might be because it is such a shorter time frame and some would need it in order to be cured???.  I believe if you are a certain ethnic race you might need it more in order to rid the disease i have read.  in just weeks we will all have the facts in.  i finish in 4 days....24 weeks ...rbv, 5885 and sofie.  CAN'T WAIT...  cleared at 3 or 4 weeks..Matt how are you doing?????   wish yu would write me and let me know...     take care all...as long as there are no long term results of being on these meds for such a long time, the ride wasn't too bad....:)
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we are almost there my friend - the time flew by. Oct 2 is my last day
24 sob with riba

I too have been udl  since week 4

I was told in one on my first day by the head trial doc, who has treated me for 14 yrs that the first round to be approved would include Interferon - that was six months ago - his comment was that it was part of the original protocols and that while it made no sense Gilead would go to market with what the FDA approved & it would take time to get the treatment approved without Inter. He also said there would be a big battle amongst the parties about how it would be paid for - meaning between the insurance companies and the drug companies.

I would like to offer that his is the last place there should be any confrontation - yes I am speaking to you Quest5245 - chill and learn from the dialogue - this is a long road for many of us and we are all we have to share with - this place offers us the chance to share leading edge information - not debate the merits of the drug companies or the FDA

this is about us - and our experience - much more valuable to me than personally than any official report released

I miss Matt too - I hope you are doing well wherever you may be these days.

peace

its almost over for me - I hope
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agreed, exactly what I meant. There are some harder to treat groups, (such as Afro-Caribbeans, especially males) and Gilead is striving for SVR success for all, not failure.

To grateful_to_be_here

agreed too.

It would be nice to have some LONESTAR participants (and a few more others) on this thread though.

I don't know Matt but I think I saw on another thread that he was taking a break from this site - I may be mistaken  though. Maybe send him a personal message?

Only 4 weeks to go until my post Tx 12 week results...I haven't bothered with an independent PCR test - the time is passing quickly enough.

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Hey how are you doing now that you are almost 12 weeks DONE with treatment?   Let us know!

3 more days and I am done!

Can't wait till this report comes from the FDA on Gilead  out to public October 26!  I just have heard we get better and better from another site.

You take care!
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Hi - thanks for asking.

I've been having constant gut problems I never had before, which started around a month after the end of treatment - hospital says it's nothing to do with treatment.

It's annoying the hell out of me...having tests at the moment but nothing so far. It's like I finally may have got rid of one plague, but what have I got in its place??

So my feelings about Hep C are clouded by this new phenomenon at the moment....

I have more energy though but my gut symptoms are constant, so I'm worried.

You have a bit of a wait now, but the time passes quickly...
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Wow I am so sorry you are having a new problem now.  That doesn't sound good at all.  It's a chance we all took being on a trial with drugs never used before.   Hopefully it will pass and not develop into a big issue.   Take care!
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EOT today :)
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Here we go!  1b CT relapser from IVF/riba in 2007.  ION2 with riba for 12 weeks.  Sxs include some gastro issues,dry eyes, anemia. All resolved. Just got 6 month EOT results and I AM CLEAR!!!
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1815939_tn?1377995399
Great news. Congratulations!
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Avatar_m_tn
great news!
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IMPORTANT:

Since around a month after EOT I've been having some serious gastro issues - constant stomach rumbling, wind, flatulence, constipation etc. Hospital says it's nothing to do with treatment, but after seeing a gastro specialist today, he suspects that treatment may well have caused this.

I really need to know if anyone else on these trials has also experienced such symptoms - unknown to me prior to TX. They actually began while on the trial, subsided for around a month, then erupted and have since got worse.

I'm about to start some gastro tests - waiting for 3 month EOT blood test next week but in the meantime, my ALT is great - 16 and the lowest ever.

many thanks
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I was on ION-2.  I haven't had any issues.

Sorry I can't help you.
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180992_tn?1383377657
Yes I had these GI issues first few weeks of treatment plus headache, but went on colitis type of diet with no dairy for rest of treatment and then was fine.  Added a little cheese and yogurt back into my diet over the last few weeks and doing fine, I waited well after EOT before having especially cheese. I got my official SVR yesterday so its only up from here. Try a colitis type of diet for awhile, your GI will probably recommend this.    
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180992_tn?1383377657
ION-2 group ,SVR EOT24, now in 3 year follow up study for tracking. .
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There is some terminology I'll have to learn to know what some of you are talking about. I guess these trials are for all different kinds of variations. I found out just this afternoon that after 48weeks of triple therapy(Incivek) I relapsed so I am obviously very interested in all of your experiences. I'm Gen type 1a, prior to my relapse on triple therapy I was a non-responder to two other treatments. I have not had a biopsy in 9 years, I am a 53 year old male. Does anyone have any idea of when some of these treatments will become blessed by the cdc. I'm not sure which one I would get on seems like maybe the one with the 3 drugs Led+Sos+Rib not sure. Have a great one, hope you don't mind my crashing your post.
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Great news! Hopefully for all of us on these trials too. You must be ecstatic.

The GI symptoms I am talking about have been since a month EOT too. I finished treatment nearly 12 weeks ago.

To 48weeks: sorry to hear about your relapses. I'm not sure when these treatments will become available in the US (I am in the UK) maybe someone else in the US can answer. The trials we have been doing have been randomized - that is some of have been randomly selected for Sof+Led with or without Rib.

As far as I can understand, FDA approved treatments with these drugs will initially include Interferon. I'm not sure how it will be for treatment experienced. You may want to follow Gilead, who makes these new drugs, by looking at their press releases on www.gilead.com.

As far as biopsies are concerned, I haven't had a biopsy for 10 years - for this trial I only needed a Fibroscan.

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Well, I have my 12 week EOT blood draw tomorrow - results a couple of weeks later. Watch this space.

I hope others will report their results here too, and haven't disappeared. I think it's vital for us all to know - even if we relapse. For many of us, if not all, this is our only way of knowing if these drugs work, and on whom.
So please don't disappear.
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FYI - some of Gilead's results and new treatment updates will apparently be published at the upcoming American Association for the Study of Liver Diseases meeting, to be held in Washington DC Nov 1 - 5 2013, with some info (not sure what) released to the public, via the press from  Nov 2. Probably worth following.

http://www.aasld.org/livermeeting/Pages/default.aspx

On a personal note, I had my  EOT 12 week blood draw yesterday - so a nail-biting wait for a couple of weeks to see if I'm on the 24 week follow up or I'm dumped on the SX2BU list! Clinic was  keen to point out that if I'm on the SX2BU list, I will be kept on a register for new trials/meds. Let's hope I won't be on that list.

Btw more people on these trials are posting their results on Renee543's thread, so worth taking a look there too. But please do post here too.
think this is the link:
http://www.medhelp.org/posts/Hepatitis-C/Starting-Sofosbuvir-GS-5885/show/1875802?page=1
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Hi, I was in the ION 3 trial, on the 12 week sofosbuvir/ledispavir without the riba.  My 12 week EOT blood draw will be on November 13th.  I was genotype 1A, naive (no previous treatment) and had stage 1 to 2 liver damage.  I've had hep c probably since my early twenties, but was just diagnosed in October of 2009.  I'm eager to be a part of this forum and to see what happens with everyone else who was part of this Gilead clinical trial.
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RIP Lou Reed. Another victim.
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Avatar_m_tn
I guess it is my turn to post positive news.

Ion-2, GS-7977+GS-5885 with Ribavirin. 24 week dosing.
I have been scheduled for a week 24 post EOT follow-up.

This is amazing news.  I thought a recent flare-up of "symptoms" was indication I had relapsed.
I guess the body has lots of new things to adjust to now that the virus is not detectable. An immune system with decades of frustration may be one of them.

Best wishes to all.

Cheese



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I too have some good news - and another happy Gilead customer.

My 12 week post treatment blood draw showed I have cleared the virus (ION-1, 12 week tx w riba) and I have my 24 week post tx date in my diary.

Wooo hooo. These drugs do work...

Cheesegrater - fabulous news for you too. Well done! As I've posted, I have had gut issues which we're investigating - I think it's tx related, with the body adjusting, but who knows. I hope we both get to the bottom of our conditions now we're rid of the virus.
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5154342_tn?1370274567
* * * UPDATE * * *

who?                still_above_dirt
gender?            M
race?                caucasian
age?                 59
genotype?         1b
Bx before start? stage 3 / grade 4 mid-2011
which trial?        ION-2
regimen?           12wk SOF/LDV without RBV
Tx-experienced? Y
PI-experienced? Y
post-TX status?  * * * attained SVR24 * * *
                       
It is my understanding that, statistically speaking, this means that there is now only a 1% chance of of relapse.

After decades of infection, all of us infectees are now more at risk of developing nasty things like liver cancer, than is the general population at large. So I guess occasional ultrasounds and/or biopsies and/or fibroscans are in my future periodically for the next several years. They should be in everybody else's future, too. I can live with that future.

May this drug combo ultimately prove its efficacy and cure us all, lab rats and all the people still waiting for a treatment that will work for them.
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WOW awesome, this is great news, congratulations!!
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Why would we be more at risk???? The hep c is gone, we were very much before, at high risk of liver cancer, I would think now we will be at much less risk of liver cancer.
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5154342_tn?1370274567
I'm not a doctor or a life/health insurance actuary, but let me proffer what I think might be a plausible analogy:

If a person smokes two packs of cigarettes a day for 40 years, I think that the general consensus would be that they are in a higher risk pool to develop lung cancer than the general population at large, whether they quit smoking or not, wouldn't you agree?

So if a person has severe fibrosis because his liver has been under attack for 20-45 years, just because the hep c virus is now all of a sudden gone doesn't mean that the groundwork for other bad things to happen hasn't been established. Doesn't mean we're all doomed, but I bet we're in a higher risk pool of unfavorable hepatic things happening to us than is the general population at large. I agree we should be at less risk than those that have not treated or continue to fail treatments. Maybe you didn't pick up on my intent for using the phrase "...than is the general population at large" in my previous post? That wasn't meant to imply "the general hep c population".

And, FWIW, I can't think of any other reason why my hepatologist would recommend that I should come in for ultrasounds and biopsies and fibroscans and bloodwork every six months for years to comes. That was the impetus behind the comment.
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First of all let me congratulate you on SVR!! The wicked old witch is dead! I've been asked by Gilead and I know others have also, to continue with a 3 year study.  I will be going into the lab every 6 months for the next 3 years for testing.  I will know after my first appointment Dec 30 of what exactly they want to follow. If one has advance stage of fibrosis that puts you at higher risk for Cancer.  My HepC doctor also wants to follow me with AFP and possible sonograms.  Once I know what Gilead is going to be doing for follow through for free, then my HepC doctor said to contact him for appointment in early 2014 to discuss if I need any further follow through from him these next 3 years. My HepC doctor said to keep sending him copies of all my Gilead tests.  I am a stage 2 and you are stage 3, so we have to continue health care because of our fibrotic livers.
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1week since week 12 eot lab work, hoping my research group doesnt call. I did the 8week sof/led + riba with little issues. I was stage 2 grade 1 on biopsy prior to study. I have had hcv gen 1a for probably 30+ years since blood transfusion in 1978. Viral load was 12,000,000 before study and was < 220 in week 1 and und week 2. Liver enzymes normal at week 3. Hoping like the rest that we all be UND at week 12 and 24. Everyone hang in there and if this doesnt work something better is always in development.

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In my trial lthe 12 week EOT wasn't blinded, and I got my results just over a week after my blood draw.

Following a big liver meeting in Washington Gilead released interim results for 8 and 12 week sof/led with and without riba - the with riba arm achieved 100% SVR while the non riba group were 95% - so it looks good for you. You don't say if you were treatment naive or not...but it looks that riba arms are doing a little better.
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Avatar_m_tn
sorry, i got your username wrong.

To all

The published results were from the LONESTAR trial - the predecessor of ION-1, 2 & 3 and were for 8 and 12 weeks.
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Avatar_m_tn
I was tx naive when I started. But good to hear the iterim reports, thanks for the info, greatly appreciated.
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...and they were for 12 week EOT SVR
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Got my notice from study group. I work in same hospital where group is located so I went in and they told me the good news of SVR 12 weeks with invite to EOT24 week test. I am blown away.
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Congratulations! Wishing you SVR.
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who?                    HepCat    
gender?               Female
age?                    59  
genotype?           1a
Bx @ start?         stage 2
starting VL?         500,000 IU/mL
which trial?          ION-2
regimen?             12 weeks, Sofosbuvir + Ledipasvir FDC, no Riba
when treated?     Feb - May 2013
Tx-experienced? Y
PI-experienced?  Y (failed triple with Incivek Nov 2012)
post-TX status?   SVR24 as of Nov 1, 2013
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I disagree Geshmit.  The 8 week Lonestar study doesn't even have interferon.

Treatment                  Treatment Duration  Population                         Results
Sofosbuvir + ledipasvir   8 weeks GT 1 treatment-naïve 95% (19/20)   SVR 8
Sofosbuvir + ledipasvir   8 weeks GT 1 treatment-naïve 100% (21/21) SVR 8
        + RBV  

They're trying to find out if 8 weeks is as effective as 12.
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Ooops, sorry I meant SVR 12, not SVR 8.
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180992_tn?1383377657
another SVR with no Riba and a 1A, wow, great news. Congratulations!!
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And a cheerful congrats to you too!
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Avatar_m_tn
Yes, I know what the LONESTAR trial is and that they're assessing 8 week treatments. I've read the results and all the relevant info. And what they show is that without riba is not as effective as with by 5%, which is exactly what I meant. 95% success without riba; 100% with (8 weeks tx) .

Congrats to you too.

Enjoy the winter



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Sorry Geshmit.  I was trying to post to ALL but can't figure it out.
Just wanted post results for everyone to see that are interested.
I was in ION3, treatment naive,  1B,  bx grade 2 stage 0.  I had the
sofosbuvir and ledipasvir no riba for 12 weeks.  I just received my
EOT 12 weeks and am still clear so onward to the 24 wks mark.
Good luck to everyone on these trials!!!!!!!!!!Kathleen
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Avatar_m_tn

Great news. Congrats. I have my 24 week EOT test in Jan 2014, so we're around the same place. These drugs really are the business -

You just type ALL when you want a msg to go to all....

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Hello, I'm so happy for you. I have a similar story. Am I bad to ask if a glass of wine is ok again ? :-)
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No you are not bad, my coordinator said I can have wine since I had no scarring on my liver and my liver was and is healthy.   If you have scarring  you should not have it though.   Ask your dr!
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It's been very quiet here lately. I am going my 12 week draw after EOT next week. Any news on relapse in the study?

I have to assume no news is good news but. . .

Could we all be cured?
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Avatar_f_tn
That is what coordinator said, no news is good news.  Due to holidays here, I have my blood draw tomorrow-12 week draw rot, although is actually only 11.3 week.   If we get apt for 24 week eot we are cured w/o a doubt!  I don't think there have been any relapses.
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Same draw for me on the 26th.

I figured no news was good news it's just  been awfully quiet here so I wanted to ask. This forum has been a great support group and source of information over the past year.

Thanks
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Avatar_m_tn
According to my NP you have to flunk both 4 and 12 week PCR's to get a call back.  I tested early Dec and have heard nothing.  
Yet.  : )

On the balance of things almost all 12 and 24 week w/ riba are 95%+ cure rates, some seeing 99%.  

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

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I had my blood work yesterday.  Coordinator said she will get letter from Gillead saying make apt for 24 week test if I show up undetected.  She made apt for me March 14 for my 24 week test though.   I said please email me if u get that letter, I want to KNOW it too, she said ok will email u, it will be w/in 2 weeks.  

It is quiet here .   Did you talk to Matt?
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How has everyone been?   Any lasting effects of treatments?

I still have tinnitus, slightly.  My neck still creaks sometimes too, but it's all livable and t think will go away eventually.   Going for a physical after January 1!

:)
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Avatar_m_tn
I still have gastro issues which started during treatment, and then just go worse -  but slightly improved now. My 24 week EOT test is mid-Jan. However there have been results published on the web by Gilead on IONs 1,2&3 trials - 95.9% success rate, which is excellent for most of us.
The trials with ribavirin came out best - but that's only a 4.1% failure rate among around 1500 patients - a few disappeared from follow-up.

But someone must be in the 4.1%...still it's not many.

Seasons greetings to all and a happy and healthy New Year



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Avatar_m_tn
One other indication is that I am still programed in for a 24 week EOT appointment.  
If you flunk the tests there is no 24 week follow-up.

I was seen by a ENT (for my tinnitus) and an neurologist (for what I believe to be something like neuropathy).  I am still waiting to hear back and so I am still holding back on my suppositions.  I'll just wait.

Overall...... I still have tinnitus. It seems relatively unchanged.

My greatest concern is the neuropathy; the cause and the prognosis.  Will I get better, stay the same or is there a potential for it getting worse w/ time, age, etc?

In general I do not believe that I am getting worse, but like hearing......
.... if things happen slowly I think one can lose a fair amount and not realize it.

RE the poor relapsers....
One thing that strikes me is that some group...... no matter what regimen they take...... it seems as though the strongest therapies (whether Gilead or Abbvie) are not quite enough.  
So there may be a group of super nulls..... the nullest of the nulls.....
or rather
....there just be one viral sub-species that sneaks through and needs yet one more compound which blocks it. I would venture that both companies already know the answer to that one. They will have a profile of the failures and see what  geno sub type, virus subspecies, staging etc most impacts upon the small group which failed this go-round.  They have come remarkably close to 100% and I assume they can bridge that gap.

Merry Christmas all....
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Avatar_m_tn
It just might be that  MAYBE, the virus gets into an area of the body that is more or less shielded from the meds or does not absorb the meds. It does not have to be a super variant, all it has to do is remain hidden and remain viable until end of treatment.

Cheese
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Avatar_m_tn
Or maybe they will be happy with the 95.9%. No treatment ever has a 100% success rate - not for cancer or any other potentially fatal disease. The IONs 1,2 and 3 including cirrhotics, tx exp and traditionally hard to treat groups.

In any case, yes I agree that Gilead etc will continually look  for new compounds, but for the time being, to get the drugs licensed and out there this success rate is sufficient...otherwise they will have to embark on a series of new and expensive trials, which they won't do. They've cracked it with the ION group.

There's also the sofosbuvir (now called Sovaldi) w or w/out riba trials for genos 2 &3 which showed a 85% +- success rate - so they'll have to work on that one, although this rate was sufficient to get it through the FDA.. Geno 3 has become very stubborn, what g1 was known for - not responding to tx.

seasons greetings to all
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sorry - one more thing. Gilead already has another compound - can't remember the name of it which they are using in some trials....I think one person on this thread (or maybe the other one?) was starting it...
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Wishing all of you SVR.
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This is an extract from one of the financial publications: (sofosbuvir is now called Sovaldi) - there have been loads of reports over these past few weeks.

"Perhaps no study caused investors’ jaws to hit the floor harder this week than Gilead Sciences, Inc. (NASDAQ:GILD) three late-stage trials involving its recently FDA-approved hepatitis-C drug Sovaldi in combination with ledipasvir. The three trials demonstrated a sustained virologic response (an elimination of all detectable levels of disease) of between 93.1% and 99.1% in the most common type of hepatitis-C, but also the toughest to treat, genotype 1. Even more astounding, the treatment-naïve arm without the use of a ribavirin delivered a 94% SVR in just eight weeks!  What all this means is that Sovaldi could wind up giving AbbVie Inc (NYSE:ABBV)‘s direct-acting antiviral combo a run for its money in treating genotype 1 patients, especially from a factor of convenience (one pill versus up to six for AbbVie’s combo). I still believe there’s plenty of room in the hepatitis-C marketplace for two blockbuster drugs and am thrilled to see such rapid progress being made."
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Thanx for posting that link (your Dec 20 post) summarizing the ION "X" trials' SVR12 data on this thread. Wonder if they'll post SVR24 data?
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I doubt they have the SVR24 data yet, but hopefully they will post. And what interests me is whether there are relapses from 12 week EOT to 24 EOT. That we don't know yet but they say that SVR12 is their primary endpoint.

have a great Xmas and may 2014 be the year of mass SVR
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Avatar_f_tn
I, too, have apt for 24 week test that was made when I had 11.3 lab done.  Coordinator said she gets letter stating I can come back for 24 week lab In about 2 weeks -----that letter hopefully goes out to her!  I said please let me know to confirm it for my peace of mind and Joy in knowing that.  She said she would.

Merry Christmas all!
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5154342_tn?1370274567
Merry Christmas and Happy New Year to you as well!

Here's one data point for you -- no relapse here -- I'm on the long term registry study GS-US-248-0122 and my baseline at EOT+26 was still undetectable. Will be checked every 6 mos thru summer 2016.

And I'm thinkin' that 2014 will indeed be the year of mass SVR.
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Well I got my confirmation, undetected!  Next is the 24 week test then done!   I was hoping they would be checking me for 3 years.  We shall see.

Happy new year 2014!
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First off.....congrats!!!  I have seen very few relapse and I think you can take that 12 week to be virtually synonymous with a SVR-24.

I kinda got a similar confirmation, really no confirmation, just the lack of a call back for a back up PCR and the next scheduled 24 week PCR appointment. That's as much as this trial site will give.  I don't mind since I pretty much knew it based upon the 12 weeks w/ riba results and my early response to TX.

I have not been on a friendly basis with my doctor since I have been pushing fairly hard about my remaining AE's; post TX sides. I am afraid that it seems to be the classic response. They seem bugged that I am not just grateful about the SVR (not true, I am), and they just want to move on..... cure some more people, not deal with any post TX issues.......which are problematic, difficult to define, diagnose or treat...... and the results of which take too long to be very attractive to treating physicians.
Haha; I also am no joy to deal with and it is a less happy conversation than the "you're cured" talk.  : )

Generally speaking.....I am fine.... OK..... but I am not as well as those who did shorter treatments or those without ribavirin.  I believe over time I may improve, but the changes since ending TX have been relatively slight.  I remain hopeful that by spring I will have more confidence in the trajectory of my recovery.

(PS>>>>>and no..... the opportunity to talk about Matt never came up)

Happy new year to all......

willy
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I still have creaky neck and tinnitus from being on the meds for such a long time and my bones sometimes make noises when I get up etc, I think those are sides too.  I think after 24 weeks eot they will be less so I am hoping anyway.  I am betting Matt is okay.   He quit the meds by 14 weeks all of them, he was a smart guy!  We should have but out of fear I did sofi for 23.5 and RBV WAY too long.   Unfortunately we can't change that, just pray we stay cured and the sides go away!

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My doc and nurse were also decidedly uncooperative about my post TX issues. My new gastro is convinced they're related and wonders how they can think otherwise.; They've improved but I'm still not right.

When I had sides during tx, they were the same, giving me the impression they believed them to be psychosomatic. However now Gilead has published its topline results from the trial, they specifically mention sides and adverse events...

My 24 EOT test is in 2-3 weeks....fingers xd.

HNY to you too
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Can you post a link to the specific sides and adverse events?
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Avatar_m_tn
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?
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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
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Avatar_m_tn
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_m_tn
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

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Avatar_m_tn
thanks for opening the link I posted;-)

happy new year to you too.
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Avatar_m_tn
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_f_tn
Wonderful news!  Congratulations!  Gives hope to the rest  who continue to struggle with the effects of this terrible virus.

Enjoy your new Hep C free  life.

Nan
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the end of a long hard road.....

got the call today 12 week EOT - SVR !!!!!!!



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excellent. thanx for posting your SVR12 outcome. One last hurdle for you to jump -- EOT+24 -- fortunately,that hurdle is only six inches high -- only looks high when you're 12 wks away -- I think you'll clear it.
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RE: your Dec 29th post

Once you go in for your EOT+24, they will probably be asking you if you would like to participate in the long term study. I can't remember if you were ION2 or not, but at least for me, which I presume encompassed any ION2, that study is GS-US-248-0122. I don't even think that the study is ION2 or ION-anything specific; it's just a 3yr SVR followup for anything Gilead.
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Avatar_m_tn
Not sure if they're doing 3 yr follow ups in the UK. My family member who did a sofosbuvir+riba trial (VALENCE?) for G3 was not offered the follow up opportunity after his clear EOT 24 test

My EOT 24 (ION 1) test is in a couple of weeks, so I'll ask then. Interested to see if this is just a US-centric thing.
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I definitely would want to participate even though it is a drive to Chicago !   I told coordinator that I would if they wanted me to.  Although I guess we could tell our primary dr to order a viral load test a year later if we so wanted to have one done.  

Stay well.

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I spent 13yrs being "monitored" before the trial & would welcome another three now that I am  "cured"
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Well, I just got my 24 week post tx results and I'm still SVR.

Reminder: 12 weeks sof+led w riba
G1b

Have signed up for 3 year follow up study.

These trials are really the bomb!

Good luck to all
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Congratulation! Enjoy your new Hep C free life.
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Avatar_f_tn
Just got my results.  SVR 24.  Yippee!!!

I did the ION 3 12wks  no riba.

Kathleen
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Avatar_m_tn
Jan 2014, achieved SVR 24.

24 weeks 7977+5885 and Riba.

It has not cured all my ills, but there is a welcome improvement.

Cheese.
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Avatar_m_tn
Congratulations to both of you

Cheese - it hasn't cured all my ills either, but at least we've got rid of the disease which could have killed us. I don't know your other ills, but it's a huge achievement!

I think that recovery is gradual...

G
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5154342_tn?1370274567
it's been about 60 days since I visited this site and posted anything here last. I have just been scanning over those more recent posts and just want to say how happy I am for everyone who has been achieving SVR24 and how much I appreciate everyone having posted their interim and SVR results here for us all, and others, to see, as we have journeyed down this path.

There is light at the end of the tunnel, and it;'s not the one you see while on your deathbed!

Thank you, all.
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Avatar_m_tn
Went for 24 week EOT yesterday & I am awaiting results of the draw. Presumably I will be getting a letter soon.
Signed up for 3 yr follow study.
Feel pretty darn good
Back pain & neuropathy but manageable
Geno 1a
24 weeks Sobo & RIBA
Was undetectable week 4

Competed in Sebring support race this weekend in vintage HSR -  p2 in class :) not bad for an old guy in an old car.

Life is good
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great info as i was searching for the ion info last night at clinical trials..and found nothing published.

good for all of you!
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Avatar_f_tn
I had my 24  week eot done too 3 days ago and am waiting for email on results.  I, too, am signed up for  3 year follow up.  Feeling great but have cough that is going around and am on a 5 day course of prednisone.   Definitely have more energy even though I have this cough.  Waiting for spring --we have had a brutal winter this year.   Ugh!

Take care all.  :)
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Avatar_m_tn
All good news so far. results seem to be coming in now. I did the ION-1 - 12 weeks so my results were earlier than some who did 24 weeks.

Gibsongal - there is loads of info online about these trials - try looking at the pharma company's website - their press releases (www.gilead.com) or just type in to Google -  Gilead ION trial
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Avatar_f_tn
I got my results in 4 days...still undetected at 24 weeks so definitely considered cured and signed up for 3 year study follow up!

All good news!

Take care everyone!
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Avatar_m_tn
24 EOT results!

yeah!

blood draw was Monday, the called Friday afternoon.

I am so relieved - its over :)

best to all of you and I am truly grateful for all the support, nurturing and caring from all of you - my friends

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Avatar_m_tn
that's great - so pleased for you. We all have every reason to be grateful...to everyone on here - but firstly, the doctors/nurses who invited us to join this trial (in my case, cajoled me somewhat) and looked after us, and  Gilead, for developing these drugs.

In the UK, I have learned, there is no way I would have been able to get them (when ledipasvir is licensed) as they will probably only give them to people who are severely cirrhotic initially, unless we pay the full price ($60,000 for sofosbuvir alone for 3 months). So interferon tx will remain standard tx for some time...

I have only mild fibrosis, fortunately, and my hepatologist said that my liver will probably get better over time if I look after it. For those of you with cirrhosis, he did a study which showed that many cirrhotics can reverse the damage over a few years after the hep C is cured.

Let those great results keep rolling in....



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So true - when I was diagnosed 15 yrs ago I was lost. Had I not had the good fortune to get an introduction into liver specialist at UM in 2000 I am quite sure my fate would have been very different & while the time is almost here for many it is still a journey with large barriers along the way - for the foreseeable future.

My doctor tells me my liver will heal over time & I have to say my energy levels accede any I can remember in adult life.  I think I may well have contracted the disease when I was 18 & I am now 61.
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I moved house and hospital. My old hepatologist tried to persuade me to do interferon (for 48 weeks) - had I done it and failed, I would not have been eligible for this trial (ION-1 was for treatment-naive only).

My new hepatologist was very understanding when I told him I didn't want to do interferon, and kept me on the alert for new trials. I waited for more than a year, maybe two - then got a call in April 2013 from the nurse specialist, who persuaded me to at least to undergo screening for the trial. I was more than hesitant, but when I passed screening, my hepatologist persuaded me to do the trial - saying there were no sides (which there were, for me) and this was my best bet for years to come. He was absolutely right.

I've had gut issues since the trial, but hopefully they are improving, and I now see a gastro, who is ruling out anything serious.

I imagine that the cost of this treatment will be a barrier to many in the US too.
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Avatar_m_tn
early on I made a conscious decision not to be treated with interferon & ribavirin - I followed the developments of other drugs including vertex while  waited. Along the way I tried Chinese herbs for a few years, watched my diet and had regular blood work.

I turned down several  other trials that included interferon and finally this one cam long.aythe riba was nasty - anemia, mood swings and insomnia - but tolerable.

today I have some neuropothy in my feet which I have no evidence that was caused by the drugs -
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