Aa
why don't we hear from more trial people
I would like to hear the experience from people without cirrhosis and diffenent degrees of liver damage and how they did in trials with 24 and 48 weeks. We never hear from this group of people. It would be nice to know who reach SVR and who didn't without just reading trial information that is so limited as to the individual personal situation and end result. They are out there, how do you find them?
In my study, I attended for drugs first every two weeks, now every four weeks. Some in the study were selected (whether it's random or not, I'm not sure) to have blood drawn 5 hours after taking the meds for levels of the drug.
I was selected for that and have to have that done every 8 weeks.
It's a bit of a pita because the liver centre isn't in the city where I live. But I get to hang out in a cool part of town for 5 hours and shop so... Whatever... ;)
I was selected for that and have to have that done every 8 weeks.
It's a bit of a pita because the liver centre isn't in the city where I live. But I get to hang out in a cool part of town for 5 hours and shop so... Whatever... ;)
The people at the clinic I go to are amazing. I gave her a copy of the Letter to people without hepatitis. She thought it was great and I think they will use it with Newbies with spouses or signifacant others!
i go to my study nurse every friday. she counts my pills and asks about anything going on in my life that may be related to my meds. i get my blood drawn every week and get a detailed printout of my info. she'll call me mid-week to see how i'm doing. i feel very fortunate to have her in my life. i can call her 24/7 if needed. i also love my doctors. there are 3 involved with this study. anything else you'd like to know, let me know. best wishes, belle
p.s. i hope all is good with you.
p.s. i hope all is good with you.
Hello Stream, It is part of the researchers job to separate the wheat from the shaft. We are asked to put down our side effects not to try to second guess the doctor. I also give explanations if I think something is unrelated. EG I woke up with very swollen eyes a couple weeks ago and had some minor vision changes. I reported it but also indicated that I had been hiking in the woods the day before and touching plants and touchng my face and that I had such a reaction a few months ago before treatment. I took it to be an allergy. Perhaps they think so too but they want me to get an eye exam anyway. The purpose of the trial is to study efficacy and safety. As a subject, my job is simply to take the drugs, report on any physical/mental changes during the day and to report for assessments and it is their job to determine what is safe and/or efficacious. They cannot do their job if I don't do mine correctly. Granted there are subjects who violate the parameters. Experience and other research tells the PI what percentage to expect will do this. Much of this is accounted for in statistical equation and by other means. In general, I trust the people in my study and at my site know what they are doing and I just let them do it. I try to be a good subject so they can be good docs.
There have been at least 4 I've seen who are currently treating with Incivek that have not been UND by 4 weeks which disqualifies for an eRVR.
eRVR not going to happen for everyone and neither is SVR. Sad but true.
eRVR not going to happen for everyone and neither is SVR. Sad but true.
Now that was interesting. You are the first person on this forum since I started treatment that didn't reach eRVR by 12 weeks. You said you had a brake through at week 6 and they pulled you.
Good to here that. I was afraid I should have kept it at 1000mg. That 200 makes it all so much easier. What a dream difference.
So really a trial is only as good as the accuracy of the people in it. Something like they way they record side effects. I know every time I talk to the nurse hot line if I said I had something wrong that day they would have reported it as a side effect to the company when maybe it didn't have anything to do with the drug. So I know that I was careful when I talk to them no to give them any insignificant side because I didn't want it recorded as a side effect of the drug when I new it wasn't, but how many people think of that when they are talking about their day and how they are feeling when on treatment?????
For instance the trial data for incivek says 49% of the people in trial received eRVR by 12 weeks. I know there isn't many people on this forum in comparison to the trials, but so far we are seeing maybe 100% of the people on this forum getting eRVR even when they are not adhering to the protocol. missing a dose or having to lower dose whatever the circumstance. It pretty amazing!!!!!
In my study they count the pills. We are given a dosing and side effect daily diary to fill out as well and we have to fill it out. The exact time that we take the dose is entered. It is then handed in periodically and replaced with a new one. We also have to enter whenever we have had to take any other drug and are asked about it. They keep records of flu shots, allergy meds., etc. We record when a side effect started and when it stopped and whether we took anything for it. I usually ask what they recommend I take. For example, my eyes were affected by allergy and I asked what med. they recommend. I asked if it would be ok to put some steroid cream on my lids as I had some from a past problem. PI said fine as it was only a small amount on the skin but no steroid by mouth.
And how to they know if people are adhering to trial rules. Do you take the pills in front of them or can they tell by your blood work the concentration of the drug. We all know it's hard to remember taking our drugs or we may be so sick we might want to skip a day or maybe some people just don't get the fat with incivek or whatever rule there is for the drug you are taking. Do they go my you results and you word alone. You can't possibly go to a center everyday to take you drugs. Just wondering how accurate the trials information may be or not be. Like I forget who it was, but someone stated they would just call her and tell her to change her dosage and it wouldn't even be the dosage she was taking. How organized are most of the trials?
they lowered my riba to 800 about 2 weeks ago. it's much better for me. i have 3 doctors and the one i saw then couldn't believe i was on 1000 of riba. she said it was too much for me. i have a rash on my back and by my collarbones. at night i take 1/2 benadryl and smother with gold bond lotion. it works pretty good for me. i'm geno 1a with stage 2 fibrosis/ mild inflamation. i will be told at 24 weeks if i can stop or go for 24 more. whatever happens i want to slay this dragon. best wishes...belle
I thought that i would also mention that different things are blinded in trials.
Sometimes you don't know what arm you are in; lets say one arm is placebo or comparator and the other arms have the active new compounds...... but you won't know which arm you get.
Sometimes it could be about treatment issues such as the rash.
Vertex had a phase 3 trial in which you knew you were getting triple therapy, what you didn't know was if you were doing 12 & 12 or 12 & 36; duration.
Some of those trials were very frustrating; since they never told you anything some people in finished 12 & 12 and were finished; a success!!..... others in the trial were stopped (or in theory may have been stopped) due to inadequate response, which means they automatically would stop TX at 24 weeks; they were still detectable. Both the extreme successes and slow responder failures were not told and were stopped at the same time. There was no way to know unless the treatment was stopped due to medical reasons like anemia or rash, or if a person experienced viral breakthough.
Unless people did a private PCR they wouldn't know squat. The original guidelines were that trials were to be blinded until the SOC arms were all in; 48 +24 weeks. I think they may have softened that; way too hard core.
willy
Sometimes you don't know what arm you are in; lets say one arm is placebo or comparator and the other arms have the active new compounds...... but you won't know which arm you get.
Sometimes it could be about treatment issues such as the rash.
Vertex had a phase 3 trial in which you knew you were getting triple therapy, what you didn't know was if you were doing 12 & 12 or 12 & 36; duration.
Some of those trials were very frustrating; since they never told you anything some people in finished 12 & 12 and were finished; a success!!..... others in the trial were stopped (or in theory may have been stopped) due to inadequate response, which means they automatically would stop TX at 24 weeks; they were still detectable. Both the extreme successes and slow responder failures were not told and were stopped at the same time. There was no way to know unless the treatment was stopped due to medical reasons like anemia or rash, or if a person experienced viral breakthough.
Unless people did a private PCR they wouldn't know squat. The original guidelines were that trials were to be blinded until the SOC arms were all in; 48 +24 weeks. I think they may have softened that; way too hard core.
willy
I am not in a trial though. Forgot to mention that. I'm geno 1a with an ILB28 CC and cirrhotic.Waiting for more info before I decide if I'm going the 48 or the 24 weeks
Hi Bella, I'm going on week 14 incivek triple therapy. I did my 12 weeks of incivek. slept through most of it. The week I came off incivek was the week from hell for me, but with my GP gave me an anti anxiety drug until I got to my hep doc the next day. Thought I was going to die felt so bad. My hep Doc lowered my riba 200 mg. and now a week later I'm feeling great. Don't have my energy level back but no sides. Hoping I can keep the Riba at 800 mg. It works nicely for me. I'll find out in about 4 weeks when I get my next labs. From what I understand lowering it after the 12 week undetectable is safe to do. Hope you keep keep doing well. Isn't it nice when the sides let up?
hi there. i'm in the 16th week of a gilead double-blind study. i'm on peg/riba and gs-9451. i was on tegobuvir but it was stopped during week 10. i was und week 8. my sx have been minimal most days but i've had my share of bad days, also. i'll let you know my progress. belle
Im week 22 of Inc trial
geno 1 stage 1-2 CC starting VL 1900...been undetected weeks 4,8, 12
first 4 weeks was easy...weeks 4-12 was hard....Inc makes you feel yucky!! weeks 12-18 was easy....18 - present....tired is my only SX..
It flys by fast!!!
geno 1 stage 1-2 CC starting VL 1900...been undetected weeks 4,8, 12
first 4 weeks was easy...weeks 4-12 was hard....Inc makes you feel yucky!! weeks 12-18 was easy....18 - present....tired is my only SX..
It flys by fast!!!
I'm in phase 3 for BI 20133 (or placebo). It's double blind. I wasn't asked to sign anything stating I wouldn't 'talk'. :)
I believe I'm in week 10 now but I must admit, I've lost track.
I'll get my VL week `1 but what I'm not clear about is if that will be a week 8 VL or if the blood is drawn on week 12 visit for that... Wish I knew! I guess I could make a call but I'm kind of not wanting to know right now if it's the latter.
I believe I'm in week 10 now but I must admit, I've lost track.
I'll get my VL week `1 but what I'm not clear about is if that will be a week 8 VL or if the blood is drawn on week 12 visit for that... Wish I knew! I guess I could make a call but I'm kind of not wanting to know right now if it's the latter.
I think it is up to the mods to determine what is fair or not fair or what is useful or not or what other people with other diseases on other forums wish or want or need in terms of internet tools and communications. My inquiry was not about whether it is a good idea or not. It was about whether others would be interested. At this point, it does seem as though there is little interest in this idea at least with the people who have decided to respond to the query this afternoon. Nevertheless, hopefully, people will post information that is potentially helpful to others either through a thread with a clear subject title or in a journal that can easily be accessed by interested others. I very vigorously disagree with the idea that there is little interest in trials now that the tele/boce trials are over. And that "most people" want to take the triple. I get quite a few back channel requests for information and have seen interest generated in the regular forum esp for trials which do not include SOC. But that is only the people who have been able to find out that there are alternatives for them. The flurry of interest has only been generated in the past two months re the all-oral trials which have only gotten underway within the past little while. I think it will only increase.
Well I would tx as long as I had to so I did not have to do it again. And I probally would not be thinking that way if I had sx... My trial always has more paper work for me to sign lately (there changing the rules???) Now they are looking for late relapse. I guess later than the usual. And maybe they might be looking for mutant or occult virus. Dont know Im usually with out me spects and cant see what Im signing.
My thoughts are maybe you should go 48 wks just incase. since there already looking for later than usual relapses in de trials. Oh also I agree. They do look for the healthiest folks in the trials. Not fair.But it will rule out some reasons for failure. Lets say you and I went in I got a good ticker you got a bad one. you die ya had a bad ticker ;-)..we both die and WOW must be something wrong with their study drug. because I was only 21 and had a good ticker ;-)... Have a good day and I hope your 48 wks flies by as mine did... Ps ins. might not want to pay for second go around too. well gotta go feed a gut ;p) ginger
My thoughts are maybe you should go 48 wks just incase. since there already looking for later than usual relapses in de trials. Oh also I agree. They do look for the healthiest folks in the trials. Not fair.But it will rule out some reasons for failure. Lets say you and I went in I got a good ticker you got a bad one. you die ya had a bad ticker ;-)..we both die and WOW must be something wrong with their study drug. because I was only 21 and had a good ticker ;-)... Have a good day and I hope your 48 wks flies by as mine did... Ps ins. might not want to pay for second go around too. well gotta go feed a gut ;p) ginger
Hi, wonderful story and so happy for you. I'm not in a trial. I am on triple therapy with incivek. I finished the incivek and reach my first and very important goal ervr. I was undetectable all the way through to my 12 week and now am finishing up my last 12 weeks with riba and interferon.
They do recommend the 48 weeks for me and I guess I'm looking for answers to justify my wanting to cut treatment to 24 weeks. I feel I have a good chance of permanent SVR because of my ILB28 cc , first time treating and the fact that I responded quickly and everything is right on target. I'm just looking for answer as to why some people clear permanently and some will relapse. I know in trials they don't use people who aren't in the best of health so in some ways I feel trials don't give the rest of us a fear and adequate percentage of our SVR. I looking for the latest data to that comes out and that only through people who have been through trials. Although I am feeling so well the longer I am off of the incivek that maybe the 48 won't be so bad. There is a part of me that wonders how much damage the extra time will do to our livers. We know damage can start to reverse but no until off therapy. we have never heard of damage reversing while on therapy. Which in my mind if we could find out that 24 weeks is just or almost as good it may be better to go that route.Thanks for you reply, your story is quite amazing and I wish you much luck and health going foward.
They do recommend the 48 weeks for me and I guess I'm looking for answers to justify my wanting to cut treatment to 24 weeks. I feel I have a good chance of permanent SVR because of my ILB28 cc , first time treating and the fact that I responded quickly and everything is right on target. I'm just looking for answer as to why some people clear permanently and some will relapse. I know in trials they don't use people who aren't in the best of health so in some ways I feel trials don't give the rest of us a fear and adequate percentage of our SVR. I looking for the latest data to that comes out and that only through people who have been through trials. Although I am feeling so well the longer I am off of the incivek that maybe the 48 won't be so bad. There is a part of me that wonders how much damage the extra time will do to our livers. We know damage can start to reverse but no until off therapy. we have never heard of damage reversing while on therapy. Which in my mind if we could find out that 24 weeks is just or almost as good it may be better to go that route.Thanks for you reply, your story is quite amazing and I wish you much luck and health going foward.
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