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Unblinded VL results - any opinions?
FOr those of you who have been following us vx trial participants, I thought I would share my unblinded vl results and ask your opinions on whether I should be concerned. As it turns out, I'm in the placebo arm, so my results aren't nearly as interesting as most of the others. It seems I'm not really much of a labrat after all, just a regular patient treating w/ standard meds. I've been fortunate that I haven't experienced any dose reductions or debilitating side effects. In fact I feel pretty normal, which is great; however it appears I didn't quite meet the hallmark of a rapid responder. While I'm thrilled to be currently UND,I didn't really make it by week 4. Here are the numbers:
PreTreatment:
June '06 8,000,000+ (off-study)
07/28/06 3,070,000 TaqMan-RUO-CL
08/05/06 6,400,000 TaqMan-Exp-RUO-CL
PostTreatment:
Day 1 3,830,000 TaqMan-RUO-CL
Day 4 17500 TaqMan-RUO-CL
Day 8 16900 TaqMan-RUO-CL
Day 15 5348 TaqMan-RUO-CL
Day 22 1280 TaqMan-RUO-CL
Day 29 318 TaqMan-RUO-CL
Day 57 29 TaqMan-RUO-CL
Day 71 <30 IU/mL TaqMan-Exp-RUO-CL
Day 85(preDose) 29 TaqMan-RUO-CL
Day 85(post) <30 IU/mL TaqMan-RUO-CL
Week 16 29 TaqMan-RUO-CL
Week 20 <30 IU/mL TaqMan-RUO-CL
I need to go back and re-read all of the posts regarding the significance of the 29. But there it is!
PreTreatment:
June '06 8,000,000+ (off-study)
07/28/06 3,070,000 TaqMan-RUO-CL
08/05/06 6,400,000 TaqMan-Exp-RUO-CL
PostTreatment:
Day 1 3,830,000 TaqMan-RUO-CL
Day 4 17500 TaqMan-RUO-CL
Day 8 16900 TaqMan-RUO-CL
Day 15 5348 TaqMan-RUO-CL
Day 22 1280 TaqMan-RUO-CL
Day 29 318 TaqMan-RUO-CL
Day 57 29 TaqMan-RUO-CL
Day 71 <30 IU/mL TaqMan-Exp-RUO-CL
Day 85(preDose) 29 TaqMan-RUO-CL
Day 85(post) <30 IU/mL TaqMan-RUO-CL
Week 16 29 TaqMan-RUO-CL
Week 20 <30 IU/mL TaqMan-RUO-CL
I need to go back and re-read all of the posts regarding the significance of the 29. But there it is!
mremeet - thanks a million for your response and for clarifying the information on oxymatrine. As I said, I'll have to do further research on that subject. Coincidentally, my study nurse just called a little while ago and I asked her about the "29"'s that were popping up on my labs and she said don't worry about it, they happen all the time in some patients. Maybe she said that to make me feel better...but it worked, and now I intend not to worry about it!
lab: my study nurse just called a little while ago and I asked her about the "29"'s that were popping up on my labs and she said don't worry about it, they happen all the time in some patients.
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I know you've got other stuff on your plate but I would find the above answer
*extremely* unsatisfactory, be it from a nurse or my doctor. What exactly does she mean it "happens all the time"? That statement means nothing to me other than either the nurse was patronizing you or is simply ignorant what is going on. Also, did you or Mre get clarification from your doctors like APK did, regarding the signficance of "29". My understanding is that it only means one thing -- that you are detectible somewhere between 10 and 30 IU/ml. From some of the posts I've read here, I'm beginning to think that some of the study staff are confused as to what it means. This to me is beyond the pale but then again not much surprises me anymore. If I were in the study group, personally I wouldn't rest until I knew exactly what it meant if it meant knocking on Bolger's door. Lack of clarity in a viral load test is totally unacceptable unless you resign yourself to literally be a guinea pig as opposed to a human being who is able to participate in their own treatment. Regarding Oxymatrine again, I still go back to "don't rock the boat" if things are working unless you are *very* sure what you're doing. Kalio is Kalio, not you, and she is also re-treating after what appeared to be either a true viral breakthrough or most probably a relapse. Your case is diffferent.
Be well,
-- Jim
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I know you've got other stuff on your plate but I would find the above answer
*extremely* unsatisfactory, be it from a nurse or my doctor. What exactly does she mean it "happens all the time"? That statement means nothing to me other than either the nurse was patronizing you or is simply ignorant what is going on. Also, did you or Mre get clarification from your doctors like APK did, regarding the signficance of "29". My understanding is that it only means one thing -- that you are detectible somewhere between 10 and 30 IU/ml. From some of the posts I've read here, I'm beginning to think that some of the study staff are confused as to what it means. This to me is beyond the pale but then again not much surprises me anymore. If I were in the study group, personally I wouldn't rest until I knew exactly what it meant if it meant knocking on Bolger's door. Lack of clarity in a viral load test is totally unacceptable unless you resign yourself to literally be a guinea pig as opposed to a human being who is able to participate in their own treatment. Regarding Oxymatrine again, I still go back to "don't rock the boat" if things are working unless you are *very* sure what you're doing. Kalio is Kalio, not you, and she is also re-treating after what appeared to be either a true viral breakthrough or most probably a relapse. Your case is diffferent.
Be well,
-- Jim
What jim told you about how it may be possible that the viral load may simply fluctuate at very low levels in some people who later go on to SVR may be true. I was speaking with my doctor about the significance of the "29's" (I had one too btw) and he basically said the same thing. He said that the original testing/trials for peg IFN with and without ribavirin several years ago were conducted with a test that only went down to <615 IU/ml. And since that was true, he said it's quite possible that many of the patients who were testing "UND" back then and later went on to SVR, could have actually had some form of low level viral presence below 615 IU/ml during much of their treatment while testing "UND". There's no way to know now of course, but it's important to remember the profound difference in sensitivity between our tests (that go down to 10 IU/ml) and the older much less sensitive tests which were used to build the statistical database that's commonly referenced today when discussing likelihood of SVR when "UND" - we have to remember that UND at <615 IU/ml and UND at <10 IU/ml ain't the same thing!
As far as oxymatrine is concerned, I'm certainly no expert on the subject. I've just read dribs and drabs here and there about it fairly recently. I don't want to speak for HR, but from what I've heard you should probably not take it as a monotherapy (unless you're SVR already and are taking it for anti-fibrotic effects). The maximal effect you might derive from oxymatrine would occur if you were taking it in conjuction with other antiviral drugs like IFN and riba as a triple combo therapy. Ideally, you'd want to take all of these drugs up front simultaneously to whack the virus with everything you've got all at once. This way the viral population would be collapsed as rapidly as possible, which thereby thwarts the virus' ability to breed mutants (which differ meaningfully from the parent virus) that might be capable of later resisting the effects of the various drugs (and reducing your chances for an SVR). The virus' most powerful mechanism for survival is its incredibly huge breeding stock (roughly a trillion copies in most people), combined with its short life cycle and relatively unstable genetic structure. If you can annihilate the vast majority of the breeding stock in a blitzkrieged assault right up front, then you close the window on that most powerful adaptive mechanism the virus has for surviving a multivariable drug and immune system onslaught. A rapid viral decline is definitely thought to be critical in avoiding drug resistance and maximizing chances of SVR.
Anyway, in your situation you're not at the beginning of treatment and are already UND (essentially). So it's just a little unclear to me how possibly beneficial it might be at this point. However, off the cuff if it truly does have effective antiviral properties, then I'd certainly think it could definitely lend a hand to the IFN/riba in putting the cooties down for good. Obviously your virus (what's left of it) is oxymatrine naive, so it should be sensitive to it. Plus the breeding stock has been brought down to a very low level, so I would think the production of adaptive mutants in response to oxymatrine would be very minimal, especially with IFN and ribavirin still on the job (and apparently working well).
If you're interested, I would investigate it further and discuss it with both HR and Kalio. Kalio was knee deep in treatment when she started taking it not too long ago. Last I heard she was saying she felt alot better after taking it and was doing well. Plus I haven't seen her here much lately, so maybe it's allowed her to become more active?? I'd definitely talk to her and learn more about it. I've been meaning to do the same too, although like I said I remain somewhat skeptical for the reasons previously cited.
You ask about what would constitute a viral breakthrough in the trial: I probed this issue with my study nurse prior to being unblinded, and basically she didn't know. But from what I gathered, you could experience a viral reappearance of some magnitude and still not be "unblinded" or discontinued. The breakthrough would have to reach some undetermined level in order for the treatment to be considered a failure (and so be discontinued). But now that you're unblinded, will the doctor consider another 29 a breakthrough? That depends on the doctor, but I don't think so (largely for the reasons cited above in reference to the old 615 IU/ml tests). I would think they'd want to continue you, and I'd probably want to continue as long as I was tolerating treatment well (like you are). But I'd seriously consider taking the oxymatrine though.
Also, here's a link to the cholesterol study and increased SVR rates in case you're interested in looking it over. Take care...
http://www.natap.org/2006/HCV/080806_02.htm
As far as oxymatrine is concerned, I'm certainly no expert on the subject. I've just read dribs and drabs here and there about it fairly recently. I don't want to speak for HR, but from what I've heard you should probably not take it as a monotherapy (unless you're SVR already and are taking it for anti-fibrotic effects). The maximal effect you might derive from oxymatrine would occur if you were taking it in conjuction with other antiviral drugs like IFN and riba as a triple combo therapy. Ideally, you'd want to take all of these drugs up front simultaneously to whack the virus with everything you've got all at once. This way the viral population would be collapsed as rapidly as possible, which thereby thwarts the virus' ability to breed mutants (which differ meaningfully from the parent virus) that might be capable of later resisting the effects of the various drugs (and reducing your chances for an SVR). The virus' most powerful mechanism for survival is its incredibly huge breeding stock (roughly a trillion copies in most people), combined with its short life cycle and relatively unstable genetic structure. If you can annihilate the vast majority of the breeding stock in a blitzkrieged assault right up front, then you close the window on that most powerful adaptive mechanism the virus has for surviving a multivariable drug and immune system onslaught. A rapid viral decline is definitely thought to be critical in avoiding drug resistance and maximizing chances of SVR.
Anyway, in your situation you're not at the beginning of treatment and are already UND (essentially). So it's just a little unclear to me how possibly beneficial it might be at this point. However, off the cuff if it truly does have effective antiviral properties, then I'd certainly think it could definitely lend a hand to the IFN/riba in putting the cooties down for good. Obviously your virus (what's left of it) is oxymatrine naive, so it should be sensitive to it. Plus the breeding stock has been brought down to a very low level, so I would think the production of adaptive mutants in response to oxymatrine would be very minimal, especially with IFN and ribavirin still on the job (and apparently working well).
If you're interested, I would investigate it further and discuss it with both HR and Kalio. Kalio was knee deep in treatment when she started taking it not too long ago. Last I heard she was saying she felt alot better after taking it and was doing well. Plus I haven't seen her here much lately, so maybe it's allowed her to become more active?? I'd definitely talk to her and learn more about it. I've been meaning to do the same too, although like I said I remain somewhat skeptical for the reasons previously cited.
You ask about what would constitute a viral breakthrough in the trial: I probed this issue with my study nurse prior to being unblinded, and basically she didn't know. But from what I gathered, you could experience a viral reappearance of some magnitude and still not be "unblinded" or discontinued. The breakthrough would have to reach some undetermined level in order for the treatment to be considered a failure (and so be discontinued). But now that you're unblinded, will the doctor consider another 29 a breakthrough? That depends on the doctor, but I don't think so (largely for the reasons cited above in reference to the old 615 IU/ml tests). I would think they'd want to continue you, and I'd probably want to continue as long as I was tolerating treatment well (like you are). But I'd seriously consider taking the oxymatrine though.
Also, here's a link to the cholesterol study and increased SVR rates in case you're interested in looking it over. Take care...
http://www.natap.org/2006/HCV/080806_02.htm
Tallahassee - Thanks for the warning! Guess I won't take that extra pill without permission. As for the oxymatrine, I may end up trying that myself if this doesn't work out. Good luck to you, I hope it helps!
mremeet: I just wanted to make a correction to my previous post to you. Where I said "LDL - usually around 70-80" - I meant HDL....where I said "friend of mine w/acute hcv for years" I meant "chronic hcv"...Even though I'm not exactly sure how my liver is doing, I know that my brain is being fried!
mremeet: I just wanted to make a correction to my previous post to you. Where I said "LDL - usually around 70-80" - I meant HDL....where I said "friend of mine w/acute hcv for years" I meant "chronic hcv"...Even though I'm not exactly sure how my liver is doing, I know that my brain is being fried!
Lab: When I was in study with riba in 1995-96, I noticed the extra pills too. Since it is was obvious to me that my viral load does not decrease as other patient's viral loads, I started taking an extra pill of riba every day (of cause, I did not know at that time if I was in riba or placebo arm)....
Well, at the end of the study they requested to return all my extra pills ... Apparently, the study people gave us extra pills just in case... I had to confess to my study nurse that I was taking extra pills...
They did not remove me from the study... but I'm not sure if the study nurse actually reported me to the Dr. I think she felt sorry that I'm not responding well...
Oxymatrine: I started taking it too (from 1/12/07)... I don't know what to do but I'm hoping to increase my chance for SVR ... I guess I'm becoming desperate :)
NYgirl: Congratulations on completion of 72 weeks of treatment!! You inspired me to look for approval of treatment extension. Thank you for your constant inspiration and support!! I think, I hope that you will have SVR!!!! Wishing you (and everybody on this forum) all the best!!
Well, at the end of the study they requested to return all my extra pills ... Apparently, the study people gave us extra pills just in case... I had to confess to my study nurse that I was taking extra pills...
They did not remove me from the study... but I'm not sure if the study nurse actually reported me to the Dr. I think she felt sorry that I'm not responding well...
Oxymatrine: I started taking it too (from 1/12/07)... I don't know what to do but I'm hoping to increase my chance for SVR ... I guess I'm becoming desperate :)
NYgirl: Congratulations on completion of 72 weeks of treatment!! You inspired me to look for approval of treatment extension. Thank you for your constant inspiration and support!! I think, I hope that you will have SVR!!!! Wishing you (and everybody on this forum) all the best!!
Boy, wish I had those cholesterol numbers -- just hope in your case it isn't associated with liver damage. Contacting HR or one of the Fibroscan study centers might be an excellent idea. I had a scan mid-treatment myself and it helped me to decide how long to treat.
Except for some lingering skin problems, most of my other sfx -- GERD, sinus, ear problems, infections, etc -- are either gone or close to. What does remain is a lot of fatigue and lack of initiative and drive. Because of that, and my high cholesterol and tri's post treatment, I decided to change my diet a few days ago, so will try more of a "zone" diet -- less carbs, more proteins. Maybe that will help as my doctor just admitted that Interferon can make the metabolic syndrome worse and that appears to be the case with me.
Be well and good luck with tx,
-- Jim
Except for some lingering skin problems, most of my other sfx -- GERD, sinus, ear problems, infections, etc -- are either gone or close to. What does remain is a lot of fatigue and lack of initiative and drive. Because of that, and my high cholesterol and tri's post treatment, I decided to change my diet a few days ago, so will try more of a "zone" diet -- less carbs, more proteins. Maybe that will help as my doctor just admitted that Interferon can make the metabolic syndrome worse and that appears to be the case with me.
Be well and good luck with tx,
-- Jim
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