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telprivar relapse
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telprivar relapse

I posted this morning about my husband being told at wk 24 he had not met the req. to continue in they study or he had e RVR. We know he was non detectable at week seven and have been told up to that point that he was doing "the best in the study" all his levels that they did give to his Dr were great. Monday we went in and was told he relapsed and was only going to do the follow up. I have read all the paperwork from Vertex and do understand that they can stop the treatment for two reasons : one you have relapsed or you have no dectable level in you system and they are just monitoring you for the next 48 wks.  They also say you will remain on treatment for the full 48wks either way unless you are clean.I am not sure if his Dr just said he relapsed at this time because we did get blood work done at 7 wks and told him he was clear by the outside testing. We are getting him tested asap either way. I just don't understand because this is a double blind study and his Dr does not have the actual results....
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Avatar_m_tn
not sure how these things work, but now that your husband has been dismissed from the trial, shouldn't his blood results be available to him immediately? might want to double check on this. also, do you have this week seven results printed out? was a sensitivity of the test? it's fairly uncommon for someone to be UND with a very sensitive test and then have a viral breakthrough during treatment. I certainly don't want to get your hope up, but the best result would be if the test you take now shows him to be UND which may suggest a false positive for some other mixup with the trial blood tests. In that case, if I read this study correctly, he would only have treated 24 weeks anyway, which is already completed. But really just a lot of speculation, what you really want for all of his blood tests from the trial, and a current viral load test. Two tests I'd recommend from quest labs are either : (1) Heptimax; or
(2) HCV RNA QUAL TMA. Both tests are sensitive down to 5 IU/ml. good luck.
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Avatar_f_tn
He was not dismissed he was told he didn't meet the requirements to contine on the drugs which are the standard treament for hep c. He still has to go in to have follow ups and be monitored. His Dr said they are not releasing the test results for him until the end of the trial. Like I said we are going to have his blood drawn outside the group and we did the HCV RNA tests at 7 wks and he was undetectable at that time. I just am haveing a hard time trying to understand how his Dr could say he relapsed with out knowing the blood results or wondering if he is one of the lucky ones that did clear early and has remained clear and that would also explain him being taken off the rest of the standard treatment. Telprivar is supposed to be a 24 week total treament when it finally approved so I am just very confused at this time
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96938_tn?1189803458
Since it was hubby who was given the information, are you sure about how they phrased it?  As you point out, the doc might not have the information to determine relapse.  If it was phrased more like 'hubby did not meet the criteria to continue' that could mean something different entirely.  It does sound like a confusing mystery.
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Avatar_m_tn
now I'm getting a bit confused. Are you saying that your husband was told not to take any more drugs because either (1) he was RVR and therefore only needs to treat 24 weeks, or (2) he didn't meet the requisite viral load drop and therefore is being discontinued because more drugs aren't doing many good. And not because the doctors are blinded, they don't know which of the above categories your husband falls into.

OR are you saying that they are telling you that he simply didn't get the requisite viral response and therefore more drugs aren't doing any good?

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Avatar_m_tn
our posts crossed, but FLGuy and myself are saying the same thing. You really should have a talk with Dr. directly and find out exactly what's going on.
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186344_tn?1278268245
"it's fairly uncommon for someone to be UND with a very sensitive test and then have a viral breakthrough during treatment."

This is true when treating with SOC, but it might not be true when treating with a PI. Say you respond well to the PI, but not to the pegylated interferon and the ribavirin. You might reach UND at first and then when the PI resistant mutations develop, you might have a breakthrough, since you were a null responder to SOC.

Debbie, I sure hope this is not the case with your husband. Just trying to be realistic about the possibility of breakthrough. Sending prayers your way that it all will work out.

Za
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Avatar_f_tn
The paper we got on Monday stated:
This subject did not meet the necessary Week 24 criteria to continue study treatment or had an eRVR. This subject should discontinue all study treatment and continue per protocol.
His Dr was told by us that he was undectable at week 7, this was after we went outside to his personnel Dr. We were also told several times by his study Dr that he was doing the best as far as side effects and maintaing good levels in the blood work that were given to his Dr.I know this a double blind study but at this point there is something that is not right.
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Avatar_m_tn
you could be correct, but I'm unaware of any data to support (or not to support) what you're saying, and yes, I was referring to SOC data which we do have. the more important issue seems to be what exactly is the Dr. trying to communicate. As Florida Guy and I suggest, it may well be better husband was taken off the drugs because he was RVR and therefore doesn't need to treat beyond 24 weeks. That still seems unclear.
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Avatar_f_tn
the test drug is given for the fist 8 to 12 weeks along with the standard drugs peg.-rib. He continued with the standard for the 12 weeks after the telprivar. He passed at week 12 to continue but at week 24 was stopped from taking anything else with his Dr saying he Relapsed. I don't understand that because he was basing it on the letter I posted earlier..
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96938_tn?1189803458
I think that the 'or had eRVR'  part is an important part of that notice and reason to be optimistic.
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Avatar_m_tn
This subject did not meet the necessary Week 24 criteria to continue study treatment or had an eRVR.
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if this is the language they sent you, the writer should be shot, especially if it was not accompanied by a conversation with your doctor. At face value it seems to suggest that your husband has a 50-50 chance of being RVR and therefore is not continuing because the hope is for him to become SVR with only 24 weeks of treatment. Again, you should confirm this with your doctor. Sounds like things may be looking up, hopefully.
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186344_tn?1278268245
I interpret that as either your husband was UND at week 4 and therefore only has to do 24 weeks OR he was detectable at week 24. Since you know your husband was UND at week 7, I would say the chance is great that he also was UND at week 4 and therefore only needs 24 weeks of tx. Looking good in my opinion!
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Avatar_m_tn
If I deciphered correctly, this is how it should have been written:

You should stop all drugs at week 24 because you fell into one of two following groups. unfortunately, because the trial is blinded, we cannot let you know at this point which group you are in.

Group 1: You had a eRVR and therefore we do not believe that you need more than 24 weeks of treatment to be cured.

Group 2: Your viral response did not meet the trial requirements and therefore we are stopping treatment because we do not believe the drugs can cure you.

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96938_tn?1189803458
No matter how it turns out please pull up one of these threads and let us know how it turns out. I, for one, am really curious about this.  Good luck to you and hubby!
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Avatar_f_tn
THANK YOU ALL for the in put. I just needed to hear from others that I am not losing my mind and that this might not be as bad as it was put.. The letter from the Dr was exactly as we got . I have the copy. My only defense to his Dr being so  for lack of a better word heartless was he did know that he was neg at 7 wks and just assumed that he must have relapsed. I think it has taken a couple of yrs off  after Monday for the both of us but I am trying to look on the bright side and I do believe that he is clear and we will fine. Again thanks to all here you are Mind and Life savers.....
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186344_tn?1278268245
eRVR must mean early RVR. Could this be RVR even before week 4? I know here in Sweden the hepatitis doctors use the term vRVR, which means "very rapid viral response", and is used for having less than 1000 IU/ml at week 1 (day 7).
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96938_tn?1189803458
Written like a true editor  
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96938_tn?1189803458
I have also heard the term 'super-responder', but don't know the duration for which that applies.
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Avatar_m_tn
like a true editor using voice recognition software that won't let me go back and edit LOL at least you get the point. as to eRVR, yes, these trials usually test viral load well before week 4. I can only assume from the letter, that eRVR is required to stop at 24 weeks as opposed to simply RVR, although I'm sure it's all written down in the trial protocol.
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Avatar_m_tn
reread trial protocol this is a naive trial so i dont have it i know on prove 3 trial wich was also double blinded all viral loads were released to me at 6 months i had to request them they were not offered that is when i realized i was on placebo arm i think you need to speak to doctor again
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186344_tn?1278268245
If your doctor had spoken as clearly to you as Jim did in his suggested letter above, a lot would have been won. It seems to me your doctor was very careless in his interpretation of the letter.

I am thinking chances are good that your husband is SVR already.
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412873_tn?1329178055
You should be given all pcr results from this point on....so the mystery will be over soon.  If it comes back UND....he must have been in one of the Telaprevir arms and is done.  No one in the placebo group has an option to tx for 24 weeks-they all go the full 48-unless there is a viral breakthrough then they are stopped.

If the pcr comes back with a detectable level then you will know at some point he had a breakthrough.  If it were me.....I'd get that pcr as soon as you can....but I'm impatient.

I agree with Jim.....whoever worded that letter needs to be smacked.  Preferably by a bunch of us in the study.

I'm wishing the best for you and your hubby =)
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Avatar_m_tn
the really frightening thing is that her doctor may not actually understand the letter. We've seen similar here before haven't we :(
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412873_tn?1329178055
Clarification......I am referring to the tx-naive double blind study.
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186344_tn?1278268245
A quick look on the internet seems to imply that super responder is the same as RVR.
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Avatar_m_tn
My only defense to his Dr being so  for lack of a better word heartless was he did know that he was neg at 7 wks and just assumed that he must have relapsed.
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why would a relapse if he doesn't have access to the viral load tests? something is wrong in Kansas and you should really talk with him.
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96938_tn?1189803458
This didn't all happen at the University of Miami, did it?  If so, I'm really disappointed.
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Avatar_f_tn
Sorry to disappointment you but that is where the study is being done...
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Avatar_m_tn
actually "eRVR" appears to mean "extended rapid viral response" per here:
http://clinicaltrials.gov/ct2/show/NCT00758043?term=treating+AND+ervr&rank=1

Not exactly sure what that is, but my guess is that perhaps they're giving some leeway with what they consider RVR. Perhaps for example, they might consider UND at week 6 as eRVR but just a guess. Of course the doctor should know -- just thought I'd inject a little humor :)
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96938_tn?1189803458
It's unlike them.
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Avatar_f_tn
We told his study Dr that he was neg at week seven. So all I can think is that he is not understaning the letter and thinking the worst of a relapse after knowing  we had a neg..
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186344_tn?1278268245
I am tempted to make a guess here, that eRVR means UND by week 2. This guess is based on reading a couple of studies where emphasis has been put on even greater success if UND by week 2.

I totally agree with Jim that it is frightening to think that your doctor probably did not understand what the letter said, thereof his reply about relapse.
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Avatar_f_tn
I don't know all I know is that hopefully when the blood work from Monday gets back to his study Dr we get acall and then maybe I can go 6 wks between getting the grey out of my hair instead of every three.. A little humor here...
Another thing is he did pass at week 12  and nothing was said until week 24 so I just don't know really what to make of all of this.. We are getting the blood test done asap but even with that it takes time and time like this is making me crazy...
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186344_tn?1278268245
Extended rapid viral response, huh? Interesting. Wonder what that means.
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Avatar_m_tn
actually, being UND at week two is called an ultra rapid viral response per here:
http://www.hivandhepatitis.com/2007icr/aasld/docs/110907_d.html

The trial probably in question (see my post above) uses eRVR to mean "extended rapid viral response" which could be something else, like UND at week 6 . Or not :)

don't you just love it how they make up their own terms for these trials and then fail to define them so no one knows what they're talking about, even the doctors.
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Avatar_f_tn
I haven't got a clue..  you know I feel for all who have to go throught this it is a really tough thing, not only for the person with it, but for the person helping as best they can get you through it.. Not a good thing for anyone.. But to be told that and to be told that what could be in store for your next treament is even harder for everyone. Doesn't give you much hope after going through everything you just did for 6 months and now you might have to start something new that might be harder to deal with .. Don't want to sound like a whiner but I don't know if I can take another round let alone him take it......
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Avatar_m_tn
I'm signing off but the more I go over it, it sounds like your husband got the best possible letter he could have in this trial. Hopefully, you'll get clarification of that from the doctor's office. It's not, personally I would contact one of the trial coordinators for Vertex. In any event, running your own tests is a solid idea. Just make sure you use a very sensitive test like a couple that I mentioned earlier. Not all of the viral of tests are sensitive.
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Avatar_f_tn
Again thank you I will let you know on this just what happens....
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186344_tn?1278268245
Found it. "Our criteria for eRVR require that the patient have undetectable HCV RNA levels—less than 10 IU/mL—at 4 weeks and again at 12 weeks after the start of treatment."

http://74.125.77.132/search?q=cache:9TdwIHvylTkJ:apps.shareholder.com/sec/viewerContent.aspx%3Fcompanyid%3DVRTX%26docid%3D5723986+vertex+eRVR&hl=sv&ct=clnk&cd=3&gl=se
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Avatar_m_tn
from what I've read, 24 weeks is all you really want, you don't want to have to do 48 weeks with an RVR. At least I wouldn't. Consider your husband lucky, except for the confusing communication part. And please do update us as it will make our day if things turn out the way they appear.
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96938_tn?1189803458
Don't make me read the whole thing...what dose the 'e' mean?  Exceptional, extra-special, excellent, early.......?
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186344_tn?1278268245
Extended, just like Jim said.
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Avatar_m_tn
good hit. Of course they couldn't have just said," UND at both week 4 and week 12"
Nah. eRVR so much sexier than so much more confusing LOL
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96938_tn?1189803458
OK, thanks.
Next Question...what is that plant in the background of your picture?
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Avatar_f_tn
All I can say for sure is he had undectable levels at week 7 and that is what I am going to base my hopes on and the fact that there were some people in the group that were stopping at 24 wks because they had no dectable levels and they are clean....

Thank you to all for your input and for making me feel so much more optimistic about his. You don't know how much it means to the both of us.. I will post as soon as we know God bless and thanks
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186344_tn?1278268245
Extended RVR sounds to me like they are saying you got an RVR at week 4 and then you did not have a breakthrough by week 12. Important to know when you are on the PI, I bet.

Have to sign off too now. Good luck, Deb and husband.
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388154_tn?1306365291
to even make it more confusing where did that week 7 came from!!!
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Avatar_m_tn
Important to know when you are on the PI, I bet.

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think you're reading too much into it LOL. My bet is that the vast majority of the week 4 UNDS remain UND and the week 12 test is just a marker/formality. For example, I was UND at week SLrvr (slighly late rvr LOL) at week six, but I was also tested at week 12. No one expected the week 12 test to be anything but UND. Given that Debs husband was UND at week 7, I'd say things are really looking good.
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96938_tn?1189803458
I think they went outside the trial to a personal doctor.

Maybe you know, CA.  What kind of plant is that in the background of Zazza's picture?  May be you planted it.
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186344_tn?1278268245
SLrvr - LOL - ROTFL

FlGuy, this is the second time you ask this question! Last time, a long time ago, I called my mom and looked  the plant up in Wikipedia and posted it, but you must not have seen my answer! Now, of course, I have forgotten. But I believe Pro knows because he said these plants grow around his place as well. I will ask him and get back to you. I'll send you a note so you won't miss it this time!
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96938_tn?1189803458
Thanks. I did miss your reply but I think of it every time I see you post.  Isn't it nice that you are associated with a pretty plant?  The reason I ask is because I have something similar near my house.
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186344_tn?1278268245
I think it is sweet of you. I sent Pro an email already. I always have problem remembering names of plants. Guess I am better at math than biology. I will try to find that Wikipedia page again. I remember it was interesting and had beautiful pictures. The picture is taken at my mom's country house, that is why I called her last time.
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Avatar_f_tn
week 7 came when we went outside the study to his own Dr and got his blood tested. It was non dectectable then
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186344_tn?1278268245
That week 7 test was a smart move. That is why you can feel pretty relaxed by now. OK, SVR is too early to say, but UND at EOT seems to be within your reach.
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Avatar_f_tn
sorry for the delay.. my husband is still taking this bad and he is out of town so phone conversations to keep him optomistic are really important. We should hear something from his study Dr tomorrow or Fri the latest. I am trying to keep an open mind and believe that he is fine and clean.This whole thing is just so hard to deal with and then to not have the information you need or to not have the Dr know how to read the paperwork is really hard. I do appreciate all the time and answers from everyone it really does help to be able to talk to people who understand and have the objective opinions that you find here. THANKS AGAIN TO ALL
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568322_tn?1370169040
What day exactly was Week 24?  Because it takes several days to get the results from the viral load.  So if week 24 was on Monday, then the viral load was due that day, right?  And they couldn't have had those results.  

There's one more reason that could have caused termination.  You went outside the study protocol and had a viral load test done at week 7.....and told the doctor about it.   If the doctor reported it to the drug company (which he should have), they could have chosen to end your husband's participation for protocol violation.  But they wouldn't tell him he relapsed.  They would just say he doesn't meet the criteria to continue.  

Co
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Avatar_m_tn
I'm in the Telaprevir study and this is how I interpret what you are saying. Even though your hubby may have been UNDE at week 7 by your own privite PCR he was not RVR at week 4 and also at 24 weeks was still detectable. The SOC protocol is to stop if still detectable at 24 weeks so this is why I think they are saying to stop.As a matter of fact I think this is the only way they will remove you from study, and of course for labs tanking. I hope I'm wrong. The only thing the study team sees is the bloodwork so they can monitor for anemia, etc. They are blinded to the VL's throughout study. The otherws have givin you some sound advice about getting your own PCR ASAP! Best of luck

PS,  since this hits close to home with me being in the Telaprevir study can you please post your hubby's stats, i.e. age, bx stage, starting VL, etc,etc. Thanks
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Avatar_n_tn
Vertex might have been annoyed in that scenario,but don't think they would terminate.
The name of the game is to get as many SVR's as possible and dumping one would be a tick in the withdrawal box,so not good for them,
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Avatar_m_tn
I'ts the week 12 test that determines continuation or not (eRVR see above) not the week 24 test, as you're suggesting -- see link above to trial protocool.  I'm pretty sure it's as Zazza and I concluded and nothing to do with the week 7 test. It's OK to test outside of trial protocol.
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Avatar_m_tn
no, read trial protocol, see above. they will also stop you if eRVR, simply meaning that they think 24 weeks is enough treatment given the viral response. they will also test against a 48 week group but personally, I'd prefer to be in the 24 week group that RVRd like her husband appeared to
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Avatar_m_tn
Folks might want to read what appears to be the actual trial protocol before reaching any conclusions:

http://clinicaltrials.gov/ct2/show/NCT00758043?term=treating+AND+ervr&rank=1
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Avatar_m_tn
btw definition of eRVR is UND at both weeks 4 and 12.
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Avatar_f_tn
We were told by his study Dr Mon. to go outside the study and get his blood tested. He had to be undectable at week 12 to continue  and was and then, at the what would have been the start of week 25, was told to stop all drugs.. It is just the wording of the letter and the what I think is the interpritation that has me so sick.( Sorry for bad spelling)
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568322_tn?1370169040
"That week 7 test was a smart move."
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Telling the doctor about it was not.  When you sign a consent, you agree to abide by their rules.  Having blood tests outside of the study is a protocol violation.  If the Study Coordinator or the Investigator find out about it, it is their duty to report it to the study sponsor.  If the study sponsor allows the patient to stay in the study, they have to write an "exclusion" or "amendment" to the protocol so that they can cover what the patient did and submit it to the IRB (Institutional Review Board).  Because if that's not done and the FDA somehow finds out about it, they'll be in trouble.  

Co
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Avatar_m_tn
Having blood tests outside of the study is a protocol violation.
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Not necessarily true. Depends on trial and I'm pretty sure Vertex allows outside testing it's just that they will only test per protocol
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Avatar_f_tn
We didn't actually admit to having it done.. I know that is bad on My part. I asked his Dr what the results might be. I had taken the patient info off the top and gave it to him. He then said the person did not have the virus. It was not until later that I told him it was my husbands results. After reading the consent form it does NOT say anywhere that you cannot get the test done or tell the Dr about it.
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Avatar_m_tn
if neg before week 4 and at 12 done week 24
if neg week 4 to 12 go to 48
if placebo arm i believe min 2 log drop week 12 go to 24 if neg 24 go to48
anytime viral brekthrough done
on prove 3 had 3 log drop week 12 week 20 under 30 detected week 24 neg went full 48 relapsed
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Avatar_f_tn
you are right.. we can test they can only use their results to hand over to the FDA. It still would not exclude him from continuing the test. Bad wording and miscommuntcation is to blame here I think. His Dr would not know he relapsed unless he had access to his viril loads and the rest of the blood work. THAT would be against protocol.....
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Avatar_f_tn
When was the first time you disclosed your outside testing to anyone associated with the trial? Was it before the doc told your husband about  finishing tx at 24? Or was it  only afterwards?
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Avatar_f_tn
I am totally lost on what you are saying ........very bad with texting too LOL...
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Avatar_f_tn
was disclosed "Off the record" before he was told about finishing at wwk 24
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Avatar_f_tn
Stats for my Husband: 53- Naive for treatment ,3-4 stage for liver disease, found out 9 yrs ago had hep-c
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Avatar_f_tn
So you're just going to have to wait, since it could be one or the other in respect to why he stopped at 24.

The doc doesn't appear to know what's going on, so I wouldn't take his 'relapse' talk to heart (not that anyone can be level-headed in such an ambiguous situation).  

BTW, did the doc break protocol by saying you 'relapsed' when he was required to not specify anything other than what was in the letter?

I'm with Zazza and the others who feel hopeful.
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Avatar_m_tn
if viris was neg at week 4 or sooner and then again at week 12 and remained that to week 24 done with treatment
if viris neg between week 4 and 12 and remains so you go to 48
if on placebe must have 2 log drop week 12 or done then must be neg week 24 or done
any viral break through you our done i hope i have explained it i am a little brain dead right now in week 17 i dont think would drop you for your own testing i was told to reduce rib after dec 30 test and took some advice given here and had my own cbc done wich i gave to hospital  never dose reduced any was able to carry on
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Avatar_m_tn
your husband could very well been neg week there is another here same trial as you went fron 10 million to neg i believe week 3
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Avatar_f_tn
Thank you... keep up with what you think is right for you.. 9 yrs ago when my husband was fist diag. the treatment was three shots a week and alot more riba. than now so do what you feel is right for you. He started at 202 lbs and is now at 170lbs they never wanted to change his meds. Keep up the good work.

Not to blow smoke up my own butt ----my Hubby's Dr wanted to know what I was doing for him to keep him so healthy. said he did the best out of the whole group when it came to keeping his "good" levels up. Let me know if I can give you any "tips" and all the best for you in getting to neg....
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Avatar_f_tn
the scary part for him was his viral load was " Very" low yet he was border line for stage 4 liver disease. What I have learned is that the faster you respond the greater your success rate for cure. I know that he passed the protocol for week 12 also it is just strange how they word things and how they keep you in the dark for s much of this but if the telprivar works then it will be worth it for so many people.. I wish you all the luck in the world and anyone else going through this
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Avatar_m_tn
thank i may need some tips i also treated with intro 3 shots week t rib i found it nastier then this i am very lucky this time around my neighbour is a nurse and comes over every tuesday to give me my shot and stepson does all grocery shopping even cooks me dinner 3 times week  be well deb try not to stress
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Avatar_f_tn
kinda makes you feel like a mushroom keep you in the dark and feed you alot of s**t.
Make sure you eat well it is so important..Drink alot of water and if you can find it drink the orange vitiamin water it helps keep your immune system up.

I know the Dr kept telling me he wanted to talk to me after the study because my other half did better than everyone else so he wanted to know what I did for him. That being said. If you want I have my own ideas as to what to eat and what to do to make it as easy for you as it can be. Let me know if you need anything ***@**** it probably the best way to get me.. Good luck
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Avatar_f_tn
The only way you are going to know for sure before the end of the trial, which won't be for some time yet is to get another PCR and its results as soon as possible. If it comes back und, you'll know he responded, if not perhaps you can convince your Doc to put him back on tx with peg intron immediately.
I find it confusing that your husband was on Telaprivir for that long, the study calls for it to be given only for 12 weeks. If he did only recieve Telepravir for 12 weeks and a further 12 weeks of SOC, he would have been in the active comparator arm and there is a good chance that he was taken off tx at this time because he remains undetectable.
Evangaline
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Avatar_m_tn
thats what i think
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Avatar_m_tn
If he did only recieve Telepravir for 12 weeks and a further 12 weeks of SOC, he would have been in the active comparator arm and there is a good chance that he was taken off tx at this time because he remains undetectable.
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This is the most likely scenario.
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Avatar_f_tn
I know what you are saying ,we are trying to get his blood tested but he is out of state and we need to make sure we get it done right. In th teleprivar study you don't know which drugs you are given. He may or may not have gotten the test drug at all. But with the test result at week 7 we are believing that he got it. It will be a weight off our shoulders to know either way once he gets some sort of blood results and then we can take it to the next level. His Dr. on Monday refused to let him continue on the standard treatment and said we had to return all unused drugs. At this point it is a hurry up and wait. Unfortunately....
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Avatar_f_tn
You are a saint if anyone can make someone use their brain and not let the negitive things take over it is you......I think I agree with you totally and I know in my heart you are right. Sometimes we tend to let people confuse us to what we know is righ... I do feel so much better
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Avatar_m_tn
Debbie: He may or may not have gotten the test drug at all.
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Debbie, Is this your husband's study? If so, EVERYONE in the study gets the treatment drugs. There is no placebo. I'm not being overly optimistic, I've just read the study protocol.

http://clinicaltrials.gov/ct2/show/NCT00758043?term=treating+AND+ervr&rank=1
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if monday was 24 week test would not have viral loads possibly week takes longer for mine if neg week 20 they would tell him quit week 24 regardless if test not back it would not matter if neg he would quit if pos he would quit  if placebo arm would need results before told either way  
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Avatar_f_tn
As far as I understand and as it reads in the Informed consent form there were to be three groups one received the standard treatment and placebo-- one group 8 wks teleprivar and standard---one group 12 wks telepivar and standard treatment....Rapid response was what they were looking for the sooner the better as it was said to us... We know for sure he was clean at 7 wks. he met the criteria for weesk 4 and 12.... after that at weeks what would actually be the first injection of his 25 shot he was told he " did not met the neccary Week 24 criteria to continue study treatment or had an eRVR. This subject should discontinue all study treament and continue per protocol
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Avatar_f_tn
If you really read the protocol it states that if you were undectable at wk 24 you stopped treatment. they cover themslves by also stating in the next paragraph that the study Dr can stop treatment after wk 24...
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Seems very probable to me that the dude was stopped because he's UND and did enough. Not to put too fine a point on it, but a VL recorded while on the drugs is a breathrough, not a relapse.

Breakthroughs on PI's alone are common. That's why the poison was added back into the cocktail. Debbie - my crystal ball sees Crystal... Crystal champagne for you and your dude when you get the good news.  Good luck.
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thanks so much for you well wishes I just wish you really had a chrystal ball cuz I have alot of questions
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My 2 cents.

The doctor cannot tell you the viral loads.  They can only run the trial as Vertex contracted for them to do and your hubby agreed to do when he signed the consent form.

I think a lot of this has come from fuzzy communication.  The first thread said relapse and suggested that the trial end was due to the relapse.  I think it was suggested at the end of that thread of the POSSIBILITY that the trial ended simply because the hubby was done dosing and in an arm which only went 24 weeks; not a failure at all.

None of us know; only the doctor or NP can tell you in the special way that they must that hubby is done for one reason or another.  Either hubby or both of you needs to get the message clearly....as clearly as they are able to tell you.  You understand that they are NOT permitted to tell you certain things, as it would unblind the study.  You need to be very careful to understand what they tell you and not misinterpret it.

Rebounding in the middle of a study may mean no continuation of treatment.
Being in the 12 or 8 week triple therapy arm and being randomised into a 24 week total treatment time means the same thing; no continued treatment after 24 weeks.  You see....the end result is the same but there is a hell of a difference isn't there?  Complete failure versus a likelihood of success probably on par with 90-95% (if one eRVR'ed).  

One other thing that I'd warn you about is that the reason that these trials are blinded is that they don't want people unblinding the trials.
That means..... you should probably not be posting such information if and when you get it.  That is part of the agreement that hubby signed.  

Lastly, I would also suggest not naming names or hospital locations for obvious reasons.  These trials can be a wonderful thing but one has to take care of them.  

Everybody has had good input but I think that some of this may have been avoided with a little more clarity about what was actually communicated.  (and having said that I don't know what was communicated)

By the way..... this didn't happen in other trials since the blinding process is longer and more complete in this trial.....or so I believe I understood. Other trials were unblinded as people went along; not immediately but maybe in 12 week increments.  This one is to remain (or the origional intent was) blinded until the SOC arm ends  (that's about either 12 or 18 months if they figure waiting for 6 month PCR's) which will place a lot more stress upon the participants (and I'd also guess the doctors as well).

Sorry if this sounds like scolding a little bit but you have to be careful what to reveal/post here.  I have a feeling that you will be able to deduce where he sits fairly soon.  

A private PVR will show if he is positive or not.

If he was clear at 7 weeks but experienced viral breakthru (as proven by the PCR)..... there probably isn't much that can be done except stop TX.

IF he was clear at 7 weeks and is clear at 24 weeks I'd venture a guess that you are in good shape, eh?

How many more options are there?

best,
Willy
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well I understand your reasoning here but I did not sign the agreement and actually to be honest-- whether or not I say where the treatment took place is not even on my mind. It is my and only my opinion that the way in which it was handled---- it was WRONG... I know that by going outside the trial was not what they wanted but then again what they subject you to in reguards to what you go through during the treament is not at all what they tell you to expect. The actual percentage and what you as an individuale go through are not what is on paper. I know that as the "caretaker" for lack of a better word go through is just as hard as what the patient is going through without the actual symptoms.

I guess for lack of a better way of putting it I have been put through hell for the last few days and I think that there is a better way of putting it to patients without Ripping their guts out to say they failed. Especially when you have nothing to base it on.. And you want me to be careful as to where I say he was treated. Please let them come to me and say I did something wrong then we will see....

you seem to know enough to know that the next round of treatment for people who fail the protease inhibitor is not what you want to look forward to....
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In the first naive trial the 2 triple therapy courses of treatment were to be a total of 24 weeks.  IF the patient were a slow responder then the doctor could continue treatment (it would be SOC; not any form of triple therapy) for up to another 24 weeks.  the doctors could stop TX during that period for reasons either medical need or simply because the patient wasn't responding.

It was the SECOND phase 3 naives trial in which patients were randomized into 24 and 48 week groups (not the this one).

So....in this trial all successful triple therapy participants would stop at week 24.
Only placebo arms and slow responders would continue beyond 24 weeks.
It may be an uncommon use of the words and wording but......

If you don't "meet the criteria to continue" that might mean that you cleared and have stayed clear; since only SOC arms and the triple therapy slow responders can continue beyond the 24 week mark.

Does that make sense to you?  I don't know what they said but this is one more spin on it....just different wording of what has been suggested earlier.

best,
willy
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I do know what you are saying but all I have been through since Monday and the total inhability of the Dr to give any answer beyond you relapsed, has been a hard thing to take..
I do consider myself to be a reasonably intellegent person but that comment coming out of left field so to speak was mind blowing to say the least.
You can put so many "twist" on things to have it come out the way you want it can blow your mind. I do understand that he may be one of the " LUCKY" ones that achieved a rapid response and maintained a undetectable viral load. That is what not only vertex wants but as a patient you also want that. The options as to what you are left with if you did in fact receive the real drug are not something that I would wish on anyone. But then again what choice are people left with.. I have gone through a gambit of emotions from wanting to die for him to feeling like I have lost my mind to anger, to wanting to fight like no one has ever thought of.
At this point I don't care if by me saying where he received treatment is a big deal--- no one should have to go through this and if it means me bringing this to peoples attention and them changing the wording then so be it. My hope for him and anyone else going through this or any other type of treatment for this is that they get the type of treament they deserve and not just be treated like like some type of lab rat.
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Part of what I'm saying is that I don't want you stressing without need.

The vast majority of success cases in the Vertex trials will all have to stop at week 24; only the slow responders and SOC patients can continue beyond....at  least as I understand it.

I guess my question is if you are sure they said he failed....or you are interpreting that?  I can kind of imagine the state that you are in.  I've been in a similar frame of mind when I was DX'ed or while waiting for results of my kids PCR's.  A week is a long time to wait; an eternity.

All that I am suggesting is the possibility that this could be good news and not bad news.  All I am asking is that he get back with the doctor and make sure of which it is.  I have a feeling that only the successes will be shut down at week 24.  IF a person "failed" I don't even know if they will tell them that at the time.  For that reason I am wondering if he was actually told that he failed TX.  

If he was a slow responder he would continue treating.

If he has experienced a breakthrough they may not tell you but you can determine it via outside testing.  If he experienced a breakthough I'd guess that he is done treating no matter what.

Does this help or is it making you feel worse?  I feel as though what I have communicated may mean some hope..... but if they flat out says he failed TX then I haven't much more to add.

I'm sorry that this is stressful but it is not yet clear to me that he "failed".

best,
Willy
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you have been at this all day and  nite  get some rest no worries best wishes good nite
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I am sorry to be taking this out on you there is no excuse for this and I do apoligize. When we went into his appt. on Mon. his Dr. told him he had relapsed and was to stop all ************** meaning the rib. and the alpha inter. We went outside the test study at 7 wks and had his blood work done at that time we were told his was a 0--- no detection of the virus in his blood. this was told to his Dr. at one point "off" the record.  This was several weeks ago seeing he was told to stop treatment at the start of 25 wks.

It is stressful and as a parent and grandparent my heart goes out to you I know what it is like to wait I had to wait 5 day for cancer results and I do know what that can do to you..

I know they can not tell him much in order to keep this a blind study but I also know there are better ways of dealing with these types of things..

Again I do apoligise for my total lack of patience with you but this and finding out my Mom is dying in less than three days is a bit much for anyone to take.. Please forgive me...
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Thankyou for the concern but I started this before work and now I think after all you might be right.... I think I need some sleep it has been a long 4 days......Thanks
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Avatar_m_tn
You wrote;
"the total inability of the Dr to give any answer beyond you relapsed"
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If that is what they said then I don't think there is much room for many interpretations.

Get the PCR and prove it yourself.  If there is a viral breakthrough there are several possibilities

12 weeks of triple therapy  followed by 12 weeks of SOC yields about a 70% SVR rate.  that means about 30% fail.

In all likelihood 8 week triple therapy arm may have a lower success rate..... but we don't know that.  8 weeks may be as effective as 12 but could see a lower drop out rate.  We don't know yet.  Assume a 30% failure rate here too just for ease.  Any of the failures may be have less success with treating with PI's in the future; we don't really now about that yet.
The third group could be SOC null responders or breakthroughs that they decide not to treat into the extended arm.  He may be a part of that group as well.  In his case if he is in the SOC arm you have proven that he is a responder and in all likelihood if he had been on a triple therapy arm he may have had success.  That means if he were to treat with PI's the next time he may be fine.

I am very interested.... trying to explain things.  If he failed it is of course a tough thing, a scary thing but it in all likelihood is not the end.  

These trials are tough.  The blinding process makes them very tough and this one has a VERY long blind period.  I hope that you are not in the dark much longer.  I will float out the possibility that once you know more you will feel better.  Not knowing is very hard.

I've got to turn in; work tomorrow but just wanted to see if I could make some things more clear.  I may not be able to make them better.  If I could.....

best.....

Willy
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Avatar_m_tn
And don't worry..... I took no offense.  I understand that this is a tough period for you.

I am also very sorry to hear about your mom.  I just lost a friend my age a few months ago to cancer.

No worries...there is nothing to apologise for.

Willy
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I'm still confused about the 7 week PCR and why it was done.  I did a trial this year PI and PCR'd every week for 4 and then fortnightly to week 8 and one at 12.  If UND at 4 or before (eRVR) then why was the week 7 necessary?  Bad doctoring, bloody disgraceful communication, but extremely common with busy research facilities.  Fingers crossed that tx was terminated due to RVR and only needing 24 weeks as per protocol.  He could roll over to SOC and do another 24 weeks??.  A PCR now is so crucial. Best of luck and hope everything turns out SVR. Emi
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I was going by the consent form in my study which seems to be different. I'm in the "open label" study where everyone gets telaprevir for 12 weeks. The way I read my consent form is they will use week 4,12 & 24 week pcr;s to dertermine continuation. You can be randomized to 48 weeks even if you are RVR at 4 and still UNDE at 12 & 24 weeks. If you still have detectable virus anyrtime up to 24 weeks you continue to 48 weeks regardless. But "everyone" stops at 24 weeks if virus still present. They will not even consider a pcr from another lab, only their cettified contracted lab.
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Debbie,

I'm sorry to hear about your mother's imminent death. Maybe this is contributing more than anything else to your flurry of emotions. Shouldn't you be spending time with her in her final three days instead of single-mindedly worrying about your boyfriend?

Since you imply you yourself are a grandmother, your consolation is that she's lived a long life and is a great-grandmother.

What does your boyfriend say about all this? I know you've been looking after him devotedly but was he there at the meeting when you say the doctor said he 'relapsed'? Does your boyfriend agree with you that this is exactly what the doctor said?

I find it puzzling because

1) the doctor was bound to say nothing at all and
2) he doesn't know, anyway and
3) he would have used the term,  'breakthrough',  not 'relapse'.

So maybe your boyfriend and you need to both confirm what he said because he was supposed to have said no such thing and frankly couldn't have known. It's either his mistake or yours, so first get to the bottom of that.

Does your boyfriend share the same anger and sense of grievance about the trial that you do? Is he equally willing to bad-mouth it publicly and break the terms of agreement? Did he sign the agreement or did you sign it together? Does he know you are disclosing personal information about him in a public forum that could unblind a blind study?

Personally, I think you are overstepping your rights unless he fully agrees with your point of view about trashing the trial. He should have taken the time to understand what he signed up for and maybe he did. I wish he would weigh in.

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I am sorry to be taking this out on you there is no excuse for this and I do apoligize. When we went into his appt. on Mon. his Dr. told him he had relapsed and was to stop all ************** meaning the rib. and the alpha inter. We went outside the test study at 7 wks and had his blood work done at that time we were told his was a 0--- no detection of the virus in his blood. this was told to his Dr. at one point "off" the record.  This was several weeks ago seeing he was told to stop treatment at the start of 25 wks. "

Two different things:

Deb, you have to find out the sensitivity of the test that you got OUTside of the test study - if perhaps say it was a test that tested to <615 but the trial test went to <50 - if he had a count of 400 then he would 'appear' to have been UND for the 615 test but not really be.........but by the <50 test he would come back positive.  This is a VERYimportant part of the equation that you need to find out.  You should be able to just call the outside folks and ask them what was the sensitivity of the test?

It happened to me which is why I know it is possible.....had my doctor not gotten me a sensitive test my 411 at week four would have appeared to be a true UND but it was not. so later if I had a higher sensitivity at say week 10 but the first test came back UND <615....I would have been shown to HAVE HAD BREAKTHROUGH when in reality I was never truly UND at all, so it's not a RELAPSE. Relapse is for AFTER treatment is over.

Unfortunately I doubt the doctor would say that he had RELAPSE/BREAKTRHOUGH if he had not, but I would want to retest that test just to make sure somehow it wasn't a false positive and that the scenario above is not what happened.

Good luck.....one way or the other find out what the sensitivity of that 7 week test was that should maybe give you a hint of what is going on? There is a big difference between breakthrough (meds stop working) and relapse (virus comes back after drugs are discontinued and the person was never TRULY UND at all)

Deb

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Avatar_f_tn
Your mother is dying within the next two days.  Wouldn't it make more sense to put your boyfriend's situation on the back burner while you spend time with her?

He's a 1A, treating for the first time. The results are what they are, despite the confusion and trial secrecy.  Last minute emergency testing will not change the results. The cards are dealt and you've done your best. Pat yourself on the back for looking after him so well.

Front and center is that your mother is dying within the next two days. She needs you. Your boyfriend will understand if you set aside your perceived urgency of his situation to be with her instead. Sensitive testing can surely wait - it won't impact the outcome since the outcome is a fait accompli.

A mother only dies once.
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I sent you a note and hope you read it. To everyone else I am NOT trashing the study. I have been involved with it since day one. I know what the Dr said and How he said it. These studies are a wonderful thing and desperately needed. I am just upset with the handling of it. As far as breaking the terms of agreement you are wrong. I didn't sign anything and I am not trashing it. I was aking questions of people because the Dr could not answer mine. Do not assume you know my situation and where or not I am a Grandmother and where I need to be spending my time and with whom... I did say she was dying I did not say in three days. The three days came by finding out she is ill and getting the info exactly the way I first stated by his Dr. Two bad things in three days. My husband is also concerned as anyone in these groups about relapse. And I am not unblinding the blind study I am tring to get some information that is all
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Avatar_m_tn
i agree with portan well said god bless hope you can find peace
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debbie i just wanna suport you in this stress youve been in, theres is no exuse for the doc to say your husband has relapsed in that unclear way which he probably hasn`t (relapsed that is) anyway.

I my self know what it is to recive such a message "you have relapsed" .

Chock and stress noone who hasn´t been there not even can imagen.

And about if you should have unblinded any studie I think its very unsensetiv to even mention this to you in this stressful time.

If somebody wants to warn educate others about it they cold very well open a thread about not to  unblind studies in a couple of days  when this have calmed down a little for you.

I don´t know what i would have done if it was me how have been treated the way you have been.

Slapping is the least for that doc in my opinion, and about what you have said here on forum you have nothing to apologise for, some others owe you instead in my opinion.

ca

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Avatar_m_tn
To put an optimistic spin on things, if someone from the trial, or from Vertex is reading this -- and I hope they are -- perhaps they will put more of an emphasis on clearer communications not only between doctors and patients, but between the trial organizers and the doctors who actually run the trials.

This is not the first time we've seen massive confusion in and trials run by Vertex. And the confusion, as often as not, has been with the doctors and their staff, not just the patients. It's one thing when a patient here posted on understand this or that blood result. It's quite another thing when the NP who runs a study also doesn't appear to understand.

These trials use some very powerful drugs, and while we as patients potentially benefit from the drugs being tested, we are also offering ourselves up as guinea pigs for the drug companies. But the fact is we're not guinea pigs, we're real human beings with children and families, and we should be treated that way, especially in a drug trial setting.

-- Jim
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Thank you and everyone for thier well wishes in ALL of this. I didn't mean to come off bitter or angey---upset yes. but I am still hopeful for my husband and also for my mother. It is just alot to take in in such a short time and the not having educated answers are the worst- I understand the Dr's position and I do after beating my brain and reading over and over everything for the study and talking to people here and others that it very well can be a good thing and his Dr may be wrong or just misinformed at this time. It just is what it is and only time will tell. Again Thank you all
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Avatar_m_tn
Sometimes I really don't think medical professionals -- the doctors or nurses -- have any conception of how much their their communications can make in a person's life. I'm sure all of us have been in a position at one time or another where a simple phone call -- maybe five minutes out of the doctors time -- would have been enough to clarify an important issue that has caused us significant stress. And why is it that it is so often so hard to get that phone call, to get that five minutes? They should understand that they went to medical school, we did not. So if you have to explain things twice, or even three times, or in a simpler manner, then that should be part of their job. And if they can't do it, they're not doing their job. What we see here are all too often or medical professionals not doing their jobs.
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Avatar_m_tn
This thread takes too long to load.  : )  

Jim; I was rather impressed when Vertex announced way back that this entire trial was to remain blinded the entire time; even for the SOC component.  I don't know if current plans call for it remaining blind until SOC dosing ends or the ultimate end; 6 month PCR's for the SOC control group.  Please note..... I said that I was impressed.....not that I agreed with the decision. : )  I'll tell you....Wall Street was not impressed with that call; the stock promptly started dropping in value (about 16 months ago).  Why?  It seems that Wall Street doesn't just want to plunk down the investment dollar without some occasional feedback as to how the drug is doing.  The fact that Vertex decided to design the trial this way could be in some way to assure compliance in the strictest standards with what the FDA requires for approval.  Hey; they may be going over the top but they are trying to run a very tight trial.  It's one reason that no rescue drugs were allowed in Phase 2 where other companies DID allow them.  The intent is to get FDA approval ASAP and to minimize as many obstacles as possible to that goal.  I'm merely trying to point out that blinding of these trials is required and the more that they are unblinded the more that the trial is undermined.

I'm not sure exactly in what way a doctor can reveal some information if it runs counter to the trial design.  For the sake of argument if a doctor somehow did and that information made its way here it would probably not be a good thing.

I think that a certain level of discretion is required here.

I don't know exactly what was communicated .....and so it does not seem fair to judge a doctor or the trial process.  I think it does seem safe to suggest the PCR or further communication with the doctors but since none of us really knows what happened.....exactly.... it seems prudent to reserve judgement.

I also happen to believe that some discretion in leaving out information where one may be straddling the edge of compliance is a good policy.  I think it protects both parties more; both the doctor/facility and the treating trial participant.

Sorry, it's a touchy situation but I think actions (such as a private PCR) or further communications will bring it into focus relatively easily and quickly.  

best,
Willy

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Avatar_m_tn
I didn't mean to leave the impression that the doctor should reveal anything that he was not authorized to. It's apparent from the lonely this thread, but from others, as well as my own personal experience, the doctor patient communication is often abysmal, not to mention the the written communication Debbie received from the trial. It could've been written in simple to understand English, which may have answered all the questions were not discussing. A doctor can still take the time to explain the situation clearly, even if he cannot divulge certain results.

Jim
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Avatar_f_tn
I agree with you totally. the Dr does not have info so for him to assume that the only reason he is stopping was because of a relapse was wrong. It was his interpretation of the letter but if you read the study it isn't much clearer. It could have been said that there are several reasons you are stopping , this is what they are and lets hope for the best.. That would at least give you hope and not take the wind out of your sails totally. Especially for the person that has just completed the drugs. Doing that alone is tough enough...
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"by jmjm530

Sometimes I really don't think medical professionals -- the doctors or nurses -- have any conception of how much their their communications can make in a person's life."

I think its important with doctors to cut them a bit of slack. Lets face it, many of them have spent most of their lives studying - instead of socializing like the rest of us. Additionally, they have to put up with sick people all the time. While in an ideal world we would have wonderful, well socialized individuals as doctors, if we had that, and they had spent all their time trying to become that, then they probably would have the knowledge to know what they are ****.
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Avatar_f_tn
I must say somethiing in Jim's defense..... Dr's don't have to be the most soialized people in the world but  a little compasionate would help.. They are not in the feild because they hate what they do just a teacher picks teaching. They do it because they want to and it is not all work and books for them always they do believe it or not have wonderful social lives-- at least the Dr's I personnally know I again can't speak for every one but compassion is something some need to work on..
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"Especially for the person that has just completed the drugs. Doing that alone is tough enough..."

This is so true. After I completed tx I needed a month or so just to feel the relief of being off the drugs. First after that was I ready to take a peek at what the results of my efforts on tx might be. Putting so much effort and time into a result unknown is scary, and I needed to rebuild some mental and physical strength first in case the result was not good.

I truly sympathize with you and your husband. But I also believe there will be a happy ending for you, and that is what is most important. You said he had a low baseline viral load, and the majority of these patients do get SVR as long as they get a proper treatment in accordance to their treatment response.
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Avatar_m_tn
moa: I think its important with doctors to cut them a bit of slack. Lets face it, many of them have spent most of their lives studying - instead of socializing like the rest of us. Additionally, they have to put up with sick people all the time.
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I don't know about this. I've had some good friends who were docs. Even dated several. And they seemed to socialize just fine. I suppose life would be easier for them if none of us were sick, but then how would they afford the big homes and fancy cars? I'm sure many going to the profession because it's helping profession, and honestly, that's not why most of my peers went into the profession, at least not the ones I got to know. It was very simple. They spend X. amount of time in school and they came out with a big fat salary for life. Nothing wrong with that, I'm just saying stand a little more time dealing with patients needs, you know earn that salary.
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