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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!
Viral load was 16,000 at week 1 and <650 at week 2, using a not so sensitive test. I had it reversed in my post above.
re fluctuating viral load --
A false positive is always a possiblity but another is the possiblity that this is just the way the virus behaves if you test it frequently enough. In other words, it just keeps getting knocked down, then coming up for air, then knocked down, etc, and hopefully stays down for good. If that is what is going on then the next viral load test is critical although I don't think you have anything to worry about.
Like those in the Vertex trials, I also was tested frequently for viral load -- every week in my case -- until I became non-detectible. It went something like this: week 1: <650 week 2: 16,000;
week 3: 40; week 4: 55; week 5: 100; and week 6; <5 (non-detectible). As you can imagine, I was sweating bullets between week 4 and 6, but it turned out OK. Although my doctor brought up the notion of false positives, I don't think so. My feeling is that this is the way the virus manifest itself in my case either as a natural course of events or perhaps because of having to go off riba for a week around week 2. In any event, I don't think enough folks have been tested weekly -- or even more often like with the Vertex trials -- to come to a conclusion on this up and down thing at very low levels.
re Cholesterol
LOL. Sounds like something I might have done with the Ben and Jerry's if I was in Mre's shoes, however, not only was I unaware of the study when I started treatment but my cholesterol was over 200 anyway, so no need. I also seriously wonder if artificially jacking up your cholesterol would benefit or not, as opposed to just having a naturally elevated total cholesterol or LDL. Should it work, then we could call it the B&N Therapy -- pre-dosing with Ben and Jerry's -- but I really don't think it would help. I'll also add that my understanding is that the studies were *pre* treatment and not during treatment. Like some, but unlike many, my cholesterol signficantly dropped once I began treatment, almost from week 1. It dropped from around 220 to as low as 130-140, regardless of the fact that my treatment diet was cholesterol laden. This drop in cholesterol then was a function of interferon, nothing to do with SVR in my case. From what I understand, the virus and LDL share the same receptor. So, you would think that my cholesterol would have gone up during treatment, but again, it didn't. A lot we still don't know, or at least I don't know.
re Oxymatrine
First, I know nothing about it other than what has been posted here. With no disrespect to anyone, I'm just leery of adding anything to SOC that hasn't either been trialed or that someone treating patients can't vouch for in terms of seeing a successful result. So far neither of those scenarios have been posted here. That said, I'm sure if I was still treating and worried about a slower response, I'd look into it. However, if I had an RVR or even EVR, I'd probably be reluctant to add anything to a mix that apparently was working. I had to cross this bridge myself half way into treatment with a biologic called Enbrel that was recommended for my psoriasis. Unlike other systemtics, Enbrel supposedly wasn't liver toxic and in fact one preliminary study suggested it might help SVR. Still, given my RVR, I was reluctant to add another immunosuppresive to the mix and didn't. I'm sure Oxymatrine works on a different mechanism, but again, if it ain't broke, don't fix it, and if treatment seems to be working, don't change things. At least that's how I approached things almost to the point of being superstitious near the end in terms of riba, diet and all sorts of things.
A false positive is always a possiblity but another is the possiblity that this is just the way the virus behaves if you test it frequently enough. In other words, it just keeps getting knocked down, then coming up for air, then knocked down, etc, and hopefully stays down for good. If that is what is going on then the next viral load test is critical although I don't think you have anything to worry about.
Like those in the Vertex trials, I also was tested frequently for viral load -- every week in my case -- until I became non-detectible. It went something like this: week 1: <650 week 2: 16,000;
week 3: 40; week 4: 55; week 5: 100; and week 6; <5 (non-detectible). As you can imagine, I was sweating bullets between week 4 and 6, but it turned out OK. Although my doctor brought up the notion of false positives, I don't think so. My feeling is that this is the way the virus manifest itself in my case either as a natural course of events or perhaps because of having to go off riba for a week around week 2. In any event, I don't think enough folks have been tested weekly -- or even more often like with the Vertex trials -- to come to a conclusion on this up and down thing at very low levels.
re Cholesterol
LOL. Sounds like something I might have done with the Ben and Jerry's if I was in Mre's shoes, however, not only was I unaware of the study when I started treatment but my cholesterol was over 200 anyway, so no need. I also seriously wonder if artificially jacking up your cholesterol would benefit or not, as opposed to just having a naturally elevated total cholesterol or LDL. Should it work, then we could call it the B&N Therapy -- pre-dosing with Ben and Jerry's -- but I really don't think it would help. I'll also add that my understanding is that the studies were *pre* treatment and not during treatment. Like some, but unlike many, my cholesterol signficantly dropped once I began treatment, almost from week 1. It dropped from around 220 to as low as 130-140, regardless of the fact that my treatment diet was cholesterol laden. This drop in cholesterol then was a function of interferon, nothing to do with SVR in my case. From what I understand, the virus and LDL share the same receptor. So, you would think that my cholesterol would have gone up during treatment, but again, it didn't. A lot we still don't know, or at least I don't know.
re Oxymatrine
First, I know nothing about it other than what has been posted here. With no disrespect to anyone, I'm just leery of adding anything to SOC that hasn't either been trialed or that someone treating patients can't vouch for in terms of seeing a successful result. So far neither of those scenarios have been posted here. That said, I'm sure if I was still treating and worried about a slower response, I'd look into it. However, if I had an RVR or even EVR, I'd probably be reluctant to add anything to a mix that apparently was working. I had to cross this bridge myself half way into treatment with a biologic called Enbrel that was recommended for my psoriasis. Unlike other systemtics, Enbrel supposedly wasn't liver toxic and in fact one preliminary study suggested it might help SVR. Still, given my RVR, I was reluctant to add another immunosuppresive to the mix and didn't. I'm sure Oxymatrine works on a different mechanism, but again, if it ain't broke, don't fix it, and if treatment seems to be working, don't change things. At least that's how I approached things almost to the point of being superstitious near the end in terms of riba, diet and all sorts of things.
sAID: Anyway, just prior to starting treatment I started wolfing down Ben and Jerry's, pepperoni pizza, hamburgers, fried clams, french fries, donuts, buttery pancakes, whole milk, whatever!
Hey............you took my fab diet advice! :)
Seriously I eat like that but I just have a little tiny bit of what I want - and I've stayed skinny and have perfect cholesterol. I watch other people who suffer through salad after salad after cottage cheese disgustingness - and taking pill after pill for their problem.
I think honestly - all good things in MODERATION are just how it was meant to be.
(So...down with another pint of B&J, Cherry Garcia for me!)
hee hee hee (hey the only fun part about treatment was eating all the ice cream that I could!)
Hey............you took my fab diet advice! :)
Seriously I eat like that but I just have a little tiny bit of what I want - and I've stayed skinny and have perfect cholesterol. I watch other people who suffer through salad after salad after cottage cheese disgustingness - and taking pill after pill for their problem.
I think honestly - all good things in MODERATION are just how it was meant to be.
(So...down with another pint of B&J, Cherry Garcia for me!)
hee hee hee (hey the only fun part about treatment was eating all the ice cream that I could!)
I think jim summed up your results pretty well. Good to see you responded strongly at first, but then sorry to see the mixed and somewhat ambiguous results later on. Hard to say what the best course of action would be at this point. But since you say you're basically feeling fine, then like you said at the very least finish out the 48 weeks as long as you remain UND. Another thing is, is that I'm just a little skeptical of all the "29's" we've been seeing. A 29 means you were detectable with a value somewhere between 10 IU/ml and 30 IU/ml. PDS had one at her day 85 visit just like you did. But she was UND nearly all the way up to it and the entire time after it. In our doctor's view, she probably scored a false positive, which he says definitely happens from time to time. Plus when viewed within the context of her particular consistently UND responses both before and after suggests it may be a false positive. Especially when viewed in conjunction with the fact that a viral breakthrough is usually a distinct event that will cause a much larger viral load to be detected than something between 10-30 IU/ml.
Unfortunately in your case though, these 29's have flickered on and off all along during the latter part of your testing (leading up to today). If these "29" data points are accurate, it looks to me like you're consistently remaining infected at a low level varying between UND (<10 IU/ml) and 30 IU/ml. Since this appears to be the case (according to these alternating on and off 29's), this apparently consistent (so far anyway) low level viral presence should be able to be detected using the supersensitive LabCorp PCR test that goes down to 2 IU/ml. Myself and PDS both got this test to verify we were indeed negative. HR also recommended this test because it is processed at the top lab in the US, which is held to the very highest standards of accuracy/quality control. I would definitely schedule a series of at least 2 or 3 of these offstudy tests and have the blood drawn on the same day as your scheduled study visits. That way if another one of these damned 29's rears its ugly head, you'll have a definitive referee to resolve if these are legitimate positives or not. If one or more of the next 29(s) turns out to be bogus, then that should bolster your confidence that at least some of your previous 29's may have been false + too. If the 2 copy test vindicates the 29(s), then at least you'll truly know where you stand with your treatment.
Lastly, Kalio has fairly recently added a supplement to her regimen named Oxymatrine. Oxymatrine is a derivative of the sophora root, an herb used in traditional Chinese medicine (TCM). According to several Chinese studies, oxymatrine has been shown to very significantly lower HCV viral loads; even to UND levels in some people. It also supposedly has anti-fibrotic properties. Normally I'm very skeptical of such claims, especially when there are no corresponding western studies (that I know of) to help correlate the Chinese claims (yes, I'm a bit of a xenophobe when it comes to unvetted TCM claims). On the other hand, and I don't want to speak for HR or misrepresent what his stance on Oxymatrine is, but I have seen him express at least some optimism for this substance. He made no claims it would cure, nor did he outright endorse it, but I believe he definitely believes it is a substance that is worth investigating further. And as you probably know, he's pretty uniquely qualified to provide a well informed opinion on such a thing. If the Oxymatrine truly does have antiviral properties, the possibility of adding oxymatrine to IFN/riba therapy could very well tip the balance and finish off those last "29'er" holdouts. And if it truly does possess antifibrotic properties, then obviously you'd also benefit from that as well.
Of course if you did decide to take oxymatrine, you'd probably have to discontinue from the study. Although you never know, they might let you take it - they might assume it would be ineffective as an antiviral agent. Also, apparently it has a very safe side effect profile, so that shouldn't pose a problem. But even if you did have to discontinue from the study in order to ("legally") take oxymatrine, if you know your virus is managing to consistently hang in there at low levels, then what do you have to lose? I'd definitely take it and see if it would help. Who knows, it might make all the difference. Talk to Kalio or HR to learn more if you're interested, also you can just google it and check it out for yourself.
Oh, and one more thing, and sorry to be so long winded. But I have been maintaining a high cholesterol level throughout my entire treatment. There was a compelling study published shortly before starting on this trial that strongly suggests that those that maintain high cholesterol, especially high LDL cholesterol (i.e. the "bad" type) are significantly more likely to achieve SVR than those with low cholesterol. And this study didn't just suggest some vague and statistically weak correlation between slightly higher SVR rates and high LDL cholesterol, it was fairly definitive. And the population sample size was a couple hundred people too, so it wasn't a study based on small numbers (which would statistically be much less meaningful). Plus this study was premised on previous studies that also suggested this same relationship between SVR rates and cholesterol. And they had an apparently logical and sensible theory explaining why high LDL cholesterol levels would help to interfere with viral activity during treatment.
Anyway, just prior to starting treatment I started wolfing down Ben and Jerry's, pepperoni pizza, hamburgers, fried clams, french fries, donuts, buttery pancakes, whole milk, whatever! And man I achieved my goal. At one point my cholesterol was 285, and I don't recall offhand what my LDL was, but it was quite high, I'm sure it was in the "I've fallen and I can't get up" zone (lol). And I've maintained my cholesterol above 225 pretty much the whole time, with the exception of my last test which showed 195 (I couldn't stand whole milk anymore, so I suspect my move to 2% accounted for the drop). I can't know exactly what role my elevated cholesterol might have played in my good response rate, but I often wonder if it made the difference for me. Especially during my time of crisis when I had stopped the VX, interrupted my riba and was taking prednisone all at the same time. I thought for sure I would of had a viral breakthrough during that troubled and vulnerable timeframe, but it didn't happen. Was it my disgustingly fat laden diet that saved me?? Who knows, but it might have.
I know you're a healthy and active person who exercises and takes care of yourself. I'm not advising you to ruin your diet because of the obvious negative consequences of a high cholesterol diet. But speaking for myself, I'm willing to take the risk temporarily with the thought that I'll clean up my act and return to skim milk and roasted skinless chicken after completing this treatment.
Keep us posted on your progress, take care.
Unfortunately in your case though, these 29's have flickered on and off all along during the latter part of your testing (leading up to today). If these "29" data points are accurate, it looks to me like you're consistently remaining infected at a low level varying between UND (<10 IU/ml) and 30 IU/ml. Since this appears to be the case (according to these alternating on and off 29's), this apparently consistent (so far anyway) low level viral presence should be able to be detected using the supersensitive LabCorp PCR test that goes down to 2 IU/ml. Myself and PDS both got this test to verify we were indeed negative. HR also recommended this test because it is processed at the top lab in the US, which is held to the very highest standards of accuracy/quality control. I would definitely schedule a series of at least 2 or 3 of these offstudy tests and have the blood drawn on the same day as your scheduled study visits. That way if another one of these damned 29's rears its ugly head, you'll have a definitive referee to resolve if these are legitimate positives or not. If one or more of the next 29(s) turns out to be bogus, then that should bolster your confidence that at least some of your previous 29's may have been false + too. If the 2 copy test vindicates the 29(s), then at least you'll truly know where you stand with your treatment.
Lastly, Kalio has fairly recently added a supplement to her regimen named Oxymatrine. Oxymatrine is a derivative of the sophora root, an herb used in traditional Chinese medicine (TCM). According to several Chinese studies, oxymatrine has been shown to very significantly lower HCV viral loads; even to UND levels in some people. It also supposedly has anti-fibrotic properties. Normally I'm very skeptical of such claims, especially when there are no corresponding western studies (that I know of) to help correlate the Chinese claims (yes, I'm a bit of a xenophobe when it comes to unvetted TCM claims). On the other hand, and I don't want to speak for HR or misrepresent what his stance on Oxymatrine is, but I have seen him express at least some optimism for this substance. He made no claims it would cure, nor did he outright endorse it, but I believe he definitely believes it is a substance that is worth investigating further. And as you probably know, he's pretty uniquely qualified to provide a well informed opinion on such a thing. If the Oxymatrine truly does have antiviral properties, the possibility of adding oxymatrine to IFN/riba therapy could very well tip the balance and finish off those last "29'er" holdouts. And if it truly does possess antifibrotic properties, then obviously you'd also benefit from that as well.
Of course if you did decide to take oxymatrine, you'd probably have to discontinue from the study. Although you never know, they might let you take it - they might assume it would be ineffective as an antiviral agent. Also, apparently it has a very safe side effect profile, so that shouldn't pose a problem. But even if you did have to discontinue from the study in order to ("legally") take oxymatrine, if you know your virus is managing to consistently hang in there at low levels, then what do you have to lose? I'd definitely take it and see if it would help. Who knows, it might make all the difference. Talk to Kalio or HR to learn more if you're interested, also you can just google it and check it out for yourself.
Oh, and one more thing, and sorry to be so long winded. But I have been maintaining a high cholesterol level throughout my entire treatment. There was a compelling study published shortly before starting on this trial that strongly suggests that those that maintain high cholesterol, especially high LDL cholesterol (i.e. the "bad" type) are significantly more likely to achieve SVR than those with low cholesterol. And this study didn't just suggest some vague and statistically weak correlation between slightly higher SVR rates and high LDL cholesterol, it was fairly definitive. And the population sample size was a couple hundred people too, so it wasn't a study based on small numbers (which would statistically be much less meaningful). Plus this study was premised on previous studies that also suggested this same relationship between SVR rates and cholesterol. And they had an apparently logical and sensible theory explaining why high LDL cholesterol levels would help to interfere with viral activity during treatment.
Anyway, just prior to starting treatment I started wolfing down Ben and Jerry's, pepperoni pizza, hamburgers, fried clams, french fries, donuts, buttery pancakes, whole milk, whatever! And man I achieved my goal. At one point my cholesterol was 285, and I don't recall offhand what my LDL was, but it was quite high, I'm sure it was in the "I've fallen and I can't get up" zone (lol). And I've maintained my cholesterol above 225 pretty much the whole time, with the exception of my last test which showed 195 (I couldn't stand whole milk anymore, so I suspect my move to 2% accounted for the drop). I can't know exactly what role my elevated cholesterol might have played in my good response rate, but I often wonder if it made the difference for me. Especially during my time of crisis when I had stopped the VX, interrupted my riba and was taking prednisone all at the same time. I thought for sure I would of had a viral breakthrough during that troubled and vulnerable timeframe, but it didn't happen. Was it my disgustingly fat laden diet that saved me?? Who knows, but it might have.
I know you're a healthy and active person who exercises and takes care of yourself. I'm not advising you to ruin your diet because of the obvious negative consequences of a high cholesterol diet. But speaking for myself, I'm willing to take the risk temporarily with the thought that I'll clean up my act and return to skim milk and roasted skinless chicken after completing this treatment.
Keep us posted on your progress, take care.
Don't know your pre-tx hgb, but 12.9 is pretty decent on tx, therefore you might discuss with your doctor bumping it up to 1200 to give you a little more oomph since you were still detectible at week 12. Keep in mind some more side effects might follow but you could always drop back to 1000 or even go on epo if allowed. He'll probably tell you that extra riba doesn't help so late in the game but maybe he will be open if you bring up the fact you were still detectible at week 12 again. I assume they will still test you monthly for viral load. If you do get "29" again -- and I doubt you will -- probably time to seriously reassess.
Thanks nygirl. 72 weeks must seem like a lifetime doesn't it? I'm only on week 22 so it's hard for me to imagine that. You must be done soon?
I'm just going to keep plugging along and try not to check the calendar (LOL) and see what the monthly vl tests bring.
I'm just going to keep plugging along and try not to check the calendar (LOL) and see what the monthly vl tests bring.
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