Hep C Discussion Forum

sofi moore · Veteran Member

RE: ION-3 trial

HR · Senior Member

Hi Sofi

i tried to copy and paste it as well and had no luck. Mine says exactly the same thing yours does. We are getting close. Hang in there

sofi moore · Veteran Member

Hi all,

What I signed says that for three months post treatment, neither me nor my doc will know if HCV is detected. However, if it is detected at 3 months you will be informed and must return one to two weeks later for another blood draw to confirm it is still present in your blood. If it is not detected then you return at 24 weeks post treatment and then study is over. Then it says if you are still UND at 24 weeks then they will be interested in following up with you for three years but new paperwork will be required.

I tried to copy and paste from the pdf but I couldn't, but that is what it says.

I hate these drugs. I am having to take time off because it hurts to walk and I have bruises and hives and some odd growth...I am calling my doctor's office tomorrow to schedule an appointment. I want a full examination of my legs. I am thinking of stopping the ribavirin.

Karen · Senior Member

Hi RH...nothing like that.

I have learned quickly about trials. After my first couple of visits I realized I was not "their patient", just the number that I write on my survey each visit.. It is about information gathering. They expect you to continue seeing your regular doctor and I guess we should feel fortune that they share what they share.

HR · Senior Member

Hey Karen

On your trial is there a clause in there that states after your 12 week test (after meds) that if you have hcv in your blood you will be called in and told you hcv?

take care

RH

Karen · Senior Member

Just skimmed through the last several postings...In regard to the Gilead trial paperwork and confirmed by the study nurse, once the drug stops, test results for follow-up labs will NOT be shared with them or the patient. 4-12-24 week follow-ups.

HR · Senior Member

Your welcome Misfis.

Socal, we are going to make it through this buddy. I'm glad you brought this up. I really wasn't paying too much attention at the start of treatment about how things would take place after we finished our meds. I was too concerned about what the hell these drugs were going to make me feel like.

Malcom, how many phase III trials does a drug have to go through to get a chance at FDA approval? It seems like once ION-3 is complete they should submit to FDA? Or will they wait and do more trials with more complex patients and get it all in at once? Just curious on your thoughts about this.

take care everyone

RH

Caryn · Senior Member

mallani wrote:
Hi ION-3 Triallists,
Don't be surprised if Gilead sit on the results for the Sofos/Led combo for a while. They are concentrating on getting Sofosbuvir approved for Geno 1 with Peg and Riba. They obviously want this to be used to get Doctors used to using Sofosbuvir. If they release data showing Sofos/Led is much better for Geno 1's, obviously many patients would wait for Ledispavir to be approved, which may take another 2 years.

Malcolm this sounds right. My doctor told me I would be on sofosbuvir and interferon. My nurse said that I would not be taking ribaviran, but I will wait to talk to the dr about that at my december appt. he said it would possibly be shorter duration, possibly 12 weeks total.

Misfis · Veteran Member

Thanks, Ckncali, and Rh, that does explain things, and makes sense.

Rose · Member

Hi, it is pretty strange that the first 2 studies have been so quite about the post treatment results. What you said Malcolm makes sense. Beyond the lives of the trail participants, is the business of pharmacies and marketing the drugs. In addition don't they have a marketing meeting coming up in Nov? That would be the place to show case to the market the long term benefits . Or another though is that the first time they were tooo quick to post results on a previous study and the Gilead shares tanked.
At any rate we are where we are, hoping for the best.

Sofi and ckncali I'm sorry to hear that the Riba is taking its toll on you guys. You are both so kind and supportive It makes me sad to hear how you are suffering with it. I truly hope you get some relief soon. It's almost over.

Ckncali · Veteran Member

Hey Guys, I asked a lot of questions about this topic at my baseline and this is what I was told. We will be given the VL results from all the blood draws up until EOT. After EOT At the 4 week blood draw if you do not get a call to come back for a retest you can make the assumption that you are UND. After EOT At the 12 week blood draw if you get a call to schedule your six month blood draw and you do not get asked to come back for a retest you can assume you are still UND. Either at your six month blood draw or after it you will be given the opportunity to enter a 3 year trial where you will be tested every six months. If you are still UND at your six month they will not call to retest you and will ask you to signup for this 3 year trial. If you are detected at six months then you will be called back for a retest and you would not be asked to join the three year trial.

So even if they do not tell you the results directly you can make these assumptions about what the results are by whether or not you are asked to retest. This was explained to me exactly as I stated above by my trial coordinator. She did not tell me anything about how long the results would be blinded but guaranteed me that I would be able to know I was still UND if I was never asked to retest.

HR · Senior Member

Page 8 in OUR study consent form reads

For 3 months after you stop taking any study drug(s),you and your study doctor will NOT be allowed to know if you still have HCV in your blood. Instead, if HCV is NOT found in your blood after the 12 week (3 month) follow up visit,you will be asked by your study doctor to return for the 24 week (6 month) follow-up visit. Altrnatively, if HCV IS found in your blood after the 12 week follow-up visit, then a return visit within 1-2 weeks to confirm this test result may be necessary and you will then be told that you are still infected with HCV.

Long story short- we will not know if we reach SVR 4 and 12 until they schedule our 24 week test...If they schedule a test 1-2 weeks after we go in for our 12 week check up we know we have HCV in our blood.

RH

Misfis · Veteran Member

Thanks RH, I think a number of us will be waiting with bated breath to hear what you find out.

HR · Senior Member

I will find out tomorrow whether or not this is fact or fiction

Misfis · Veteran Member

I mean, I know that as a clinical trial participant, you are kind of at the mercy of the trial, if you choose to continue it. I guess I just don't like what we are told to expect changing like that. Other than having total choice as to whether we continue or not, we don't have the same rights to information as we would if we were patients paying, or having our insurance company paying.

Misfis · Veteran Member

Hmmm, Socal, I thought it was odd that the last time I went in, the EOT 12 week thing about that being the time when UND meant "cured" for all intents and purposes, was suddenly changed to 24 weeks. Maybe next time it will be 48 weeks or more. Call me paranoid..... or maybe not.

socalbeatnik · Veteran Member

It makes no sense to me as well. I told her i would go to my private doctor and get them. She also said to expand a little on conversation i had with her today. She said that they wouldnt know but there would be some signs if there is a problem with a patient, that they may call them and ask for another blood draw to be done or something along those lines. very strange maybe i'll look at the contract and see if there is anything in there regarding this.

Misfis · Veteran Member

Yes, but shouldn't that be our choice?

Misfis · Veteran Member

Yeah, I find that hard to believe, too. I have a colleague who knows someone who is also on the gilead trial, who has already finished. From what I understand, she is getting the results of her post treatment blood draws, but I will definitely be asking my research asst about this next Wednesday when I go down and get my next blood draw. That will be my 8 week draw of my 12 week sof/led treatment. I encourage others to ask the same question! Yes, we need to be our own advocates!

mallani · Guru

Hi ION-3 Triallists,

Don't be surprised if Gilead sit on the results for the Sofos/Led combo for a while. They are concentrating on getting Sofosbuvir approved for Geno 1 with Peg and Riba. They obviously want this to be used to get Doctors used to using Sofosbuvir. If they release data showing Sofos/Led is much better for Geno 1's, obviously many patients would wait for Ledispavir to be approved, which may take another 2 years.

HR · Senior Member

I do not believe that one bit.

I can think of numerous reasons why this would be idiotic. Not just for the patient but for Gilead as well.

socalbeatnik · Veteran Member

I just got back from my 6 week visit, all is fine. They did say i had developed anemia but that i would be fine again after treatment with the meds stopped, 2 more weeks. However i did ask about what the procedure would be after the medication and she told me that i would than have monthly visits for blood work. She told me that Gilead will keep the results blind for 14 months and that they would not even know the results. What is that all about? I cant believe that we will not know how we are doing for over a year. I will not be comfortable with that. I told her i will go to my own private doctor and get my own results before i wait a year from Gilead to find out. Has anybody heard anything about this, not get results on your condition?

Tig · Admin

I'm curious if you have any individual requirements set by the study group? Were there any demands placed on you to complete the program(s) before you could make demands from them? I'd be checking that fine print so you can be best prepared with questions of your own. You're you own best advocate! Good luck, I hope you're all feeling better soon!

Matt Chris · Guru

Hello all ION-3 Participants

You are wise in sticky it out through the end with your doctors guidance because you would never want to look back and wish you would have. It would leave such a incomplete picture of what if's in your mind.

Its really not that long in comparison to standard treatment, though the mental battle is still the same. A runner in a race always looks to the end and it keep his mind in the right place so he can finish and collect the prize.

Keep the vision.

Matt

Ckncali · Veteran Member

Hi Everyone,

RH, thank you for your kind words and encouragement.

Socal, I hope you are feeling better and thank you for responding. Sounds like you only have two weeks left. Almost to the finish line.

Sofi, I think out of all of us you are suffering the most and I am so sorry for what you are going through. is it possible for you to stay on the RIBA but perhaps lower it to help improve your symptoms? Did they offer you that option? Can they send you to a rheumatologist to make sure there is not something going on that could cause ongoing problems? I think they have an obligation to refer and pay for you to go to a specialist to check you out when you have symptoms as serious as you are having. Just because it is not life threatening does not mean it is ok, I would insist on being seen by a specialist like a rheumatologist if I could hardly walk and was suffering as much as you are. They have an obligation to do that. Please insist on it and reconsider other options.

Can anyone else who has gone through a clinical trial give Sofi some advice here?

socalbeatnik · Veteran Member

We have come this far Sofi, what the hell think i'll ride it out also. I go tomorrow for my 6 week to the study blood bank. Well glad to hear you feel good enough to keep on keeping on. Your a real trooper.

sofi moore · Veteran Member

Hey all,

You can come off of Ribavirin and stay on the other drug. It is in the handbook. My nurse and doctor finally examined my legs. This is because I struggle walking which was immediately obvious. Nothing going on with me is life threatening and all the pain and inflammation and lumps and whatever else should clear up after I am off the ribavirin. The study doc finally blamed the ribavirin for all my symptoms. They also offered to take me off ribavirin but said I could stay on the study drug--they referred to their handbook and it is an option. I opted to keep the riba since there is only two weeks left. It is like I have rheumatoid arthritis and a whole lot of rashes/hives/welts/cysts who knows. Sigh....I hope I don't regret this decision. I may need a walker to help me. I sure hope it stops as soon as the riba stops.

sofi moore · Veteran Member

Ckncali, Complain away. Let it all out. That sounds horrible. I am miserable and depressed, too, and refusing more medication to treat my various side effects. Let's hope that as soon as we stop putting this poison in our bodies that all this will clear up fast. I am thinking of you, thinking healing thoughts for us all.

socalbeatnik · Veteran Member

Sorry to hear about your reactions to the meds Ckncali sounds like pure hell. I cant find the reason to complain about any reactions i may be experiencing after reading your post and what you are going through. Feel awful for you. Really hope the doctors can figure out something to ease your sysmtoms soon. Only 2 weeks left here for us i believe. I will be glad to get off of them as well especially the Riba. My body feels very weak at this point and the meds are taking a uncomfortable effect on me as well is all i will say, anemia has set in on me and have got to take it easy for the most part or i get dizzy or faintish. Really hope you feel better and glad you have someone watching you. Take care keep us posted.

HR · Senior Member

Sorry about your side effects. It really sounds like the RIBA can be hard on some people. Hang in there as you are almost done.

Take care

RH

Ckncali · Veteran Member

Hi Everyone,

Sorry to complain but I am having such a hard time. My mouth is so full of canker sores even drinking water is excruciating pain, also same problem on but. Had to go to PC doc, have a new viral infection and she gave me anti viral med and ointment and magic mouth wash for it. Sat. Night had severe reaction after taking the new antiviral med, got bright flashing zigzag lights in my vision and could not see anything but the flashes for 30 minutes, had to cover my eyes. It was an occular migraine but more severe than any one i have ever had Before. My body just can't handle all these medications. Am afraid to drive a car now In case the vision problem happens again.

The next night got a sudden sinking feeling where felt like I could not move, it was horrible. Almost went to ER but finally felt a little better. Going back to doctor today. Stopped taking the new med for the mouth sores because of reaction. My husband has to stay home from work to take care of me. My bedroom is like a hospital room with all the meds and alarms. Can't eat hardly anything for days but for some reason gaining weight when I am not hardly eating. So depressed. Mouth sores just keep multiplying and getting worse.

Rose · Member

Wonderful news on the 4wk UND, RH!

I received 2 wk lab results and still UND. My AST and ALT have also dropped into the teens.
Your right Ckncali, about the HepB vaccine reaction, that must of been it because the last couple of days have been a lot better.

Sofi- hang in there :) Sounds like you have 3 doctors looking out for you and they aren't worried.. those are pretty odds. There are some pretty good yoga relaxing poses/techniques on you tube that you might want to look up for your "Sofitime"

HR · Senior Member

Thank you all !!!

This forum is priceless.

Dillo · Senior Member

sofi moore wrote:
Hello Dillo,

I don't have insurance. I am member of a clinic here that goes on a sliding scale and they really are usually great. My ultrasound on the right leg and even my liver biopsy a few years ago was free. However, I feel like the doc thinks I'm crazy and so does the study nurse and doc, and since I don't have insurance, I can't just go to another doc. I hope I am just crazy. I am sure if they check me thoroughly and tell me I am ok, a new symptom will surface and I will be convinced that it is serious and drive them crazy again. One of my good friends joked with me before I started the study, about how crazy I am and how much I hate taking medicine, and how I was going to freak out a lot--well, that friend knows me well. I keep telling myself that I am being crazy and then I think "but what if I'm not and this is real," and then I panic. I am 8 years clean/sober whichever word you prefer, but being an addictive person already makes me obsess, plus I am a writer--and writers are super obsessive--so I am doubly obsessive. I need to go meditate.... And oh yeah, my boyfriend deserves an award for his patience with me through this. I cried and hung up on him twice today. I am usually not this crazy!

Sofi

I don't know Sofi I don't think your crazy, we all can be obsessive but it hurts us in the long run. If your on a Riba arm well....that adds to the emotions. It's easy for me to say slow down...breathe...meditate.. but it is you who has to make it or whatever calms the anxieties work. Talk to the Doctor..ask questions...why is it they don"t think it's what you think? Listen to the reasoning. Give it a chance and if it still doesn't work for you your only other choice might be getting another opinion or letting it ride until the end of the trial. Can't be that much longer no?

Congrats RH & Misfis. The UND's are sweet ;)

Matt Chris · Guru

Way to go RH

You will never forget this day, so soak it up in your memory

Matt

Ckncali · Veteran Member

Hey RH, Good Job! Congratulations! Enjoy the moment. Ain't it sweet.

Tig · Admin

Good stuff RH! Much luck in the future smile

socalbeatnik · Veteran Member

Great News RH......

Misfis · Veteran Member

Great to hear!!

Biggyb · Guru

RH wrote:
Hello Everyone,
I just got the call. My 4 week VL is UND.

Great news RH,

HR · Senior Member

Hello Everyone,

I just got the call. My 4 week VL is UND.

I guess I got lucky because my body is really not experiencing any side effects. I am doing the exact same things now as I did before treatment. Sometimes I even forget I am on the meds. Hopefully someday they will have a treatment with no side effects for everyone. You better believe they are working on it as everyone of the pharmas that are in this race want a piece of the pie.

Take care

RH

Ckncali · Veteran Member

Congratulations Misfis on going UND. I think you are on the 12 week plan so that gives you a full 8 weeks for the drugs to search and destroy any strays hiding out. That is great news.

Sofi, I am sorry you are having such a rough time. The RIBA really causes the anxiety to seem unbearable at times. I can't believe your trial folks say your symptoms are not from the drugs. My trial doc told me all my symptoms were from the drugs. You are not crazy to think that. The vertigo sounds scary, can you get your clinic to check you out on the vertigo? If it continues someone should make sure it is not something serious. Hang in there, it will soon be over.

Rose,I wonder if you reacted to the hepb vaccine, especially if your symptoms were soon after. I vaguely remember having some kind of reaction to that vaccine.

Socal, it does seem like watching a comedy unfold. We all appear to be going crazier and crazier the longer we are on these drugs. The gift that just keeps on giving. maybe stepping back and laughing at ourselves is in order. Have fun in Las Vegas.

sofi moore · Veteran Member

Hello Dillo,

I don't have insurance. I am member of a clinic here that goes on a sliding scale and they really are usually great. My ultrasound on the right leg and even my liver biopsy a few years ago was free. However, I feel like the doc thinks I'm crazy and so does the study nurse and doc, and since I don't have insurance, I can't just go to another doc. I hope I am just crazy. I am sure if they check me thoroughly and tell me I am ok, a new symptom will surface and I will be convinced that it is serious and drive them crazy again. One of my good friends joked with me before I started the study, about how crazy I am and how much I hate taking medicine, and how I was going to freak out a lot--well, that friend knows me well. I keep telling myself that I am being crazy and then I think "but what if I'm not and this is real," and then I panic. I am 8 years clean/sober whichever word you prefer, but being an addictive person already makes me obsess, plus I am a writer--and writers are super obsessive--so I am doubly obsessive. I need to go meditate.... And oh yeah, my boyfriend deserves an award for his patience with me through this. I cried and hung up on him twice today. I am usually not this crazy!

Sofi

sofi moore · Veteran Member

Congrats Misfis!!! Yay!!! And I would be even more insane without this forum...

All the concern about the data for the previous trials 12 week post treatment results-- my paper work says that me nor my doc will be allowed to know my results at 3 months post treatment. So I guess we have a long wait from 8 weeks to 24 weeks to know we are still good. I am wondering if that is the same for the previous trial.

I still have vertigo. I have to wear compression hose. My left leg swells ridiculously and this is the leg without the knot. And I get all in my head and think "they need to ultrasound the left leg. Oh God, I have a blood clot in the left leg." I never even considered blood clots until the doc sent me to the hospital yesterday. I can't wait to be my normal less neurotic self. I am already mildly neurotic and obsessive and hyper vigilante about the way meds affect me--so these meds have made me super nutty. My boyfriend says every night at nine thirty I think I am dying. It's 9:36, and I am thinking my left leg has a blood clot...so he is right...I am ok, just insane. Thank you all for being here and listening. On the plus side, my joint and muscle pain was much better today. And Socal, it is like an insane comedy!

Ckncali, I'm sorry about all your fever and chills and shortness of breath. When I am exhausted, my breath feels shallow but I haven't had fever and chills. I hope it clears up soon and you feel better. The study nurse specifically told me no hair loss but you and Socal prove otherwise.

Rose, I haven't had any pains. Sometimes my chest feels a little tight but I live in the South and it is hot and humid and everyone's chest feels a little tight so I haven't worried about that. Have you told your study doc? I would let them know. Even though they are not super talkative, I'm sure they would do something if it were necessary.

Thanks All,

Sofi

HR · Senior Member

Great news Misfis!!!! I had my 6 week draw today as well. I thought our EOT was 12 weeks post treatment.

At any rate, great job on the UND!! Keep doing what you're doing.

Take care

Misfis · Veteran Member

Hi All, just got back from my 6 week blood draw and got two lab results. Second week was >25, and 4th week was UND. I"m thrilled, but the research asst says the real acid test is UND after 24 weeks. I thought it was 12, but apparently not.

Sorry to hear about all the rib side effects. Sounds like they can be really wicked. But on the bright side, maybe this will give you a better chance of kicking the virus for good. It will be interesting to see down the line if there is any difference between the group that had the three drugs vs the ones of us that had just the sof/led. And also if the 8 week vs 12 week treatment makes any difference.

Socal, I agree with you about how there is a wealth of information to be had just talking to other people who are on this trial via the forum. I think the research people have to be objective and kind of blank slate-ish because of the nature of research studies. I'd hate to think that they are that blase just by nature. Mine is not so bad, actually. But there is nothing like sharing with a good group of people all going through the same experience---a true on line Support Group.

.

Dillo · Senior Member

You BF must know when it's sofithirty then ;) I don't know why they wouldn't ultrasound your leg if you can get it approved. Probably have to have a Doctor seperate from the trial approve it. They did one to both mine with less to go on years ago.

-- Edited by Dillo on Thursday 11th of July 2013 04:29:40 AM

-- Edited by Dillo on Thursday 11th of July 2013 04:33:12 AM

Rose · Member

Thanks! I'm thrilled about the UND. I'm glad I didn't pass up this chance to get in the study. Originally I considered waiting for an FDA approved drug. But couldn't image that now, even with the side affects.

Sofi and Socal that's good news that the scares didn't turn into set backs for you.

Ckncali- thanks for asking.. yes I'm having side affects now, yesterday was the worst. I was like a crazy lady. I was due for for my 3rd vaccine in the 3 shot series for hepB. I totally forgot about it, its been 5 months since the last one. I contacted the trail nurse who emailed Gilead - they gave permission for it.

But last night it was either all in my head, physical reaction, Riba rage (I hadn't experienced that before ) but.. next thing you know I'm up doing spring cleaning at mid night and throwing mops and brooms around, then crying, then cleaning cabinets, then crying..ect.. I finally fell off to sleep around 3am and up at 6am crying about what still needed to be cleaned, I was such a mess. Also getting small rash like bumps on my elbows and shins. Dull pressure almost painful in my heart and liver, is any one else experiencing that? That side affect is the one that scares me the most.

Take care

sofi moore · Veteran Member

Hey,

I don't think they know what the knot is. The ultra sound tech contradicted the doctor. I don't think anyone knows what is really going on. And today, I have vertigo. Everything is slightly moving and I am not calling anyone because it seems that no one really takes it seriously or answers my questions or ever figures anything out. The study people seem to act like nothing is a side effect but my primary care doctor says ribavirin wreaks havoc on the immune system and effects can vary person to person and only the "common" ones are reported. I am really scared at this point. My body is not ok.

I'm sorry that you have a rash in one of the worst places. I haven't noticed any hair loss but I have really thick long hair that has needed a cut for awhile, so it could be happening and I just haven't noticed. I hope we all heal soon.

Ckncali · Veteran Member

Hi Guys and Gals,

Sofi, Glad you don't have a blood clot. Sorry you had to go through that. Wow, RIBA causes swollen blood vessels, is there anything this drug doesn't cause? It can be dangerous to wear your contacts when your eyes are extremely dry because it can cause an abrasion. Please don't wear the contacts, it isn't worth it. My eyes have gotten so dry and irritated and am noticing some foggy, unclear vision. Sure hope it goes away after this is over.

Socal, that is great that you get to continue and your HMG is still in the normal range even though very low. Have you tried vitamin b12? I would get a high dose b12 sublingual which could give you a boost. My trial doc approved it and a b complex vitamin might help too with the fatigue.

I have some new symptoms. I now have an a$$ rash with a painful welt. This is my only rash and it would have to be there. Oh well. Had fever and chills yesterday and lethargic. Got more mouth sores. My hair has been shedding but not alarMing yet. Really noticing some shortness of breath like I have to catch my breath unexpectedly rather frequently. Have cut way back on exercising. Try to do an evening walk much shorter than my usual five miler. Cannot stand the heat and really avoid being outside in the sun. I do really miss being able to go out and do my long walks, they kept my spirits up.

I also have been looking for updates on Gilead ?Lonestar trial. seems like they should have posted a PR on 12 week results a while back. Kind of has me worried that they haven't announced it yet.

Hope you guys are feeling as well as you can and are keeping your spirits up.

Take care

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