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VX950 VL result update...
Well I just got off the phone with my doctor, and he gave me my 20 week VL unblinding - FINALLY. I've been waiting for this for a long time, and to say the least was very apprehensive about what my results were. So here goes..
First, my starting VL was 14 million, which was a surprise because it usually measures out at about 1.5 million. Oh well, that's life.
At day 8 I was down to "29", which means somewhere between 10 IU/ml and 29 IU/ml.
By day 15 I was UND (less than 10 IU/ml).
I've remained UND since that time, up to and including week 20.
As a quick refresher, I stopped my VX early due to the onset of a bad skin rash caused by the VX. I was on it about 8 (out of 12) weeks before stopping. During this timeframe I was forced to take an extensive course of prednisone (lasting about 40 days) capped off with a big jolt of an intravenous drug called solumedrol. For those who don't know, both prednisone and especially solumedrol are immunosuppressants. They suppress, or curtail your immune system's response so that allergies can be brought under control. Unfortunately, suppressing your immune system is the exact OPPOSITE of what you want to do when you're trying to fight off a viral infection. And that's what IFN does, it stimulates your immune system, so the last thing you'd want to do is to take any drugs that would dilute or lessen this effect. Continued...
First, my starting VL was 14 million, which was a surprise because it usually measures out at about 1.5 million. Oh well, that's life.
At day 8 I was down to "29", which means somewhere between 10 IU/ml and 29 IU/ml.
By day 15 I was UND (less than 10 IU/ml).
I've remained UND since that time, up to and including week 20.
As a quick refresher, I stopped my VX early due to the onset of a bad skin rash caused by the VX. I was on it about 8 (out of 12) weeks before stopping. During this timeframe I was forced to take an extensive course of prednisone (lasting about 40 days) capped off with a big jolt of an intravenous drug called solumedrol. For those who don't know, both prednisone and especially solumedrol are immunosuppressants. They suppress, or curtail your immune system's response so that allergies can be brought under control. Unfortunately, suppressing your immune system is the exact OPPOSITE of what you want to do when you're trying to fight off a viral infection. And that's what IFN does, it stimulates your immune system, so the last thing you'd want to do is to take any drugs that would dilute or lessen this effect. Continued...
It appears it's just the stupid way they chose to report the labs resulting in confusion not just with patients but no doubt with medical teams as well. Bottom line is as long as your labs says you are <30, then you are really < 10 IU/ml. LOL. At least that's my take on all this. The definitive answer of course is to ask someone who actually knows, which apparently isn't as easy as one might think.
Be well.
-- Jim
Be well.
-- Jim
That's definitely the most logical conclusion, no question. I guess I've seen it as a <30IU UND, but reading this as a <10IU qualitative reading is even better.
Appreciate your patience with us on this, Jim. Seeing results published as <10IU/ml using the very same data expressed as <30IU/ml in our reports was the cause of some significant angst!
Appreciate your patience with us on this, Jim. Seeing results published as <10IU/ml using the very same data expressed as <30IU/ml in our reports was the cause of some significant angst!
To simplify, using the three ways APK's trial coordinator has seen the Vertex results reported:
(1) a number, IU/ml for quant values -- means the number given is the number of IU/ml's, example 1.5 IU/ml.
(2) the mystery 29 -- means you are detectible between 30 IU/ml and 10 IU/ml.
(3) <30IU/ml, no HCV RNA detected -- means you are non-detectible down to 10 IU/ml.
(1) a number, IU/ml for quant values -- means the number given is the number of IU/ml's, example 1.5 IU/ml.
(2) the mystery 29 -- means you are detectible between 30 IU/ml and 10 IU/ml.
(3) <30IU/ml, no HCV RNA detected -- means you are non-detectible down to 10 IU/ml.
Forgot to add that this is why no one apparently has ever seen a test report that says "<10 IU/ml". The notation used appears to be simply "no HCV RNA detected". Lordy, lordy.
What I think is this:
Anyone who is non-detectible (per press release) down to 10 IU/ml, is actually non-detectible via two different test processes -- the PCR which goes down to 30 IU/ml and the qualitative which goes down to 10 IU/ml.
Therefore, when the result reads: "<30 IU/ml, no HCV RNA detected", the "<30.." part refers to the PCR and the "no HCV RNA detected" part refers to the qualitative. So in other words, "<30IU/ml, no HCV RNA detected" really means that the individual is non-detectable to the limit of the lower limit test, in this case being <10 IU/ml.
On the other hand, if the person is PCR negative but detectible on the qualitative, the result is simply "29".
The scheme above explains all discrepensies to me. Whether it's correct or not should be checked with either study personnel or the lab itself. Then, they should shoot whoever is in charge of notating the tests on these reports and try it all over again in plain English :)
-- Jim
Anyone who is non-detectible (per press release) down to 10 IU/ml, is actually non-detectible via two different test processes -- the PCR which goes down to 30 IU/ml and the qualitative which goes down to 10 IU/ml.
Therefore, when the result reads: "<30 IU/ml, no HCV RNA detected", the "<30.." part refers to the PCR and the "no HCV RNA detected" part refers to the qualitative. So in other words, "<30IU/ml, no HCV RNA detected" really means that the individual is non-detectable to the limit of the lower limit test, in this case being <10 IU/ml.
On the other hand, if the person is PCR negative but detectible on the qualitative, the result is simply "29".
The scheme above explains all discrepensies to me. Whether it's correct or not should be checked with either study personnel or the lab itself. Then, they should shoot whoever is in charge of notating the tests on these reports and try it all over again in plain English :)
-- Jim
Jim said,"Did anyone see a test report that said, "< 10 IU/ml" or did you all see either ">30 IU/ml" or "29" ? Because if no one saw "<10 IU/ml" written on their report, I might have an idea on the discrepencies."
Based on what we have heard here, and what my trial coord has seen, all VL summaries have been expressed as HCV RNA PCR Taqman RUO CL, followed by:
- a number, IU/ml for quant values
- the mystery 29
- <30IU/ml, no HCV RNA detected
Have not heard of anyone in the trail who has a <xxIU/ml value other than 30.
FWIW, my trial coord is following up on this when she is up at Vertex in a week for Prove 3 briefings.
Based on what we have heard here, and what my trial coord has seen, all VL summaries have been expressed as HCV RNA PCR Taqman RUO CL, followed by:
- a number, IU/ml for quant values
- the mystery 29
- <30IU/ml, no HCV RNA detected
Have not heard of anyone in the trail who has a <xxIU/ml value other than 30.
FWIW, my trial coord is following up on this when she is up at Vertex in a week for Prove 3 briefings.
I agree that Vertex is not riba from all that I've seen...in just the small sample groups, what 8 or 9 out of 10 clear very quickly with Vertex? Riba does not have those numbers...as for the rest, I agree that more shall be revealed...
"Have not heard of anyone in the trail who has a ..."
which should have read, "Have not heard of anyone in the trial who has a single result expressed as <10IU/ml."
which should have read, "Have not heard of anyone in the trial who has a single result expressed as <10IU/ml."
I'm doing very well, thanks! I'm taking shot 19 today and will have my week-20 visit in a couple of weeks. I'm fortunate that I haven't had the awful side effects endured by you and mremeet (and many others). I'm glad to hear that your doc believes the 29 was a false positive.
I guess I was just pointing out the grey areas that exist in the screening criteria that can give some wiggle room - to the benefit or detriment of the patient trying to get in. In my case, the pathologist's reading declared that I had "evolving cirrhosis" which automatically excluded me from the study. However, in the opinion of the Dr. that was an "overcall" - who read it more as a stage 2 than 3, w/ fibrosis. I felt that the doctor and study nurse worked on my behalf to help me get into the study. On the other hand, I read on another forum that a person was excluded because he said he had a beer in the last 12 months. It seems there's more to selecting a trial participant than labwork.
I guess I was just pointing out the grey areas that exist in the screening criteria that can give some wiggle room - to the benefit or detriment of the patient trying to get in. In my case, the pathologist's reading declared that I had "evolving cirrhosis" which automatically excluded me from the study. However, in the opinion of the Dr. that was an "overcall" - who read it more as a stage 2 than 3, w/ fibrosis. I felt that the doctor and study nurse worked on my behalf to help me get into the study. On the other hand, I read on another forum that a person was excluded because he said he had a beer in the last 12 months. It seems there's more to selecting a trial participant than labwork.
Hi, I hope you're sailing right along, you're at week 12 or 13 now? Anyway, I don't think we'll ever know exactly what all those "cherry picking" criteria are but I don't quite think that they deliberately pick "the best patients posible to achieve success". If that were the case, they may have excluded patients such as myself with a notoriously high vl or APK with a vl of 28M. Mine was 27M a month before start of treatment but had gone down to 15M on the first day of dosing. Why would they have included PLN or APK, both with F-3 livers. Granted, they did exclude anyone whose liver was beyond F3, to my knowledge. So, I'll agree with you that there's bound to be some "cherry picking" but it can't be far and wide or they wouldn't be able to get away with that. THese trials are under close scrunity and they do have to enroll a wide range of subjects with varying degrees of fibrosis, vl, combination genotypes, etc.
Willows may be right about them using even more strict criteria for picking non-responders and that the non-responder group may be smaller than we'd like. I don't know the answer to that but would love to ask my doctor when I see him in the next week or so.
Willows may be right about them using even more strict criteria for picking non-responders and that the non-responder group may be smaller than we'd like. I don't know the answer to that but would love to ask my doctor when I see him in the next week or so.
Nick, you might be the first Prove 2 subject we've seen on the board, so welcome! I'm a Prove 1, now finished 24 weeks after a starting VL of 28.4m and UND around day 15. This stuff hits the rascals hard!
The first few weeks of the trial are surreal, given its all new and slightly confusing. The blinding ads an element of mystery, of course. The SX are a movable feast, and very difficult to predict. Aside from a nasty rash and HGB that bounced along the bottom around 10.0, mine were not too bad.
Please keep us posted on you progress. You will nail the SVR in 12, right?
The first few weeks of the trial are surreal, given its all new and slightly confusing. The blinding ads an element of mystery, of course. The SX are a movable feast, and very difficult to predict. Aside from a nasty rash and HGB that bounced along the bottom around 10.0, mine were not too bad.
Please keep us posted on you progress. You will nail the SVR in 12, right?
mremeet - Congratulations on your awesome news. You certainly deserve this after all the pain and agony you've been through. Hope you're feeling well! SVR all the way!
nick - Good luck with the Prove 2 trial. The blood draws should become easier - they seem to take a lot more in the very beginning of dosing. Of course your study may be a little different than ours since you're only doing twelve weeks (and w/out riba). Best wishes for success - please keep us posted.
pds / willows- I believe there is "cherry-picking" going on when screening patients for clinical trials (not necessarily during the randomization process). They are going to pick the best patient's possible to achieve success. I was originally excluded from the study and missed my dosing start date due to a discrepancy in my biopsy (the doctor disagreed with the pathologist's reading and I eventually got in after they filed additional paperwork). (It remains to be seen whether I'm really getting the study drug). Another person failed to get in because their veins weren't good enough to handle the blood work. They can find all sorts of reasons if they don't believe you're a good candidate.
nick - Good luck with the Prove 2 trial. The blood draws should become easier - they seem to take a lot more in the very beginning of dosing. Of course your study may be a little different than ours since you're only doing twelve weeks (and w/out riba). Best wishes for success - please keep us posted.
pds / willows- I believe there is "cherry-picking" going on when screening patients for clinical trials (not necessarily during the randomization process). They are going to pick the best patient's possible to achieve success. I was originally excluded from the study and missed my dosing start date due to a discrepancy in my biopsy (the doctor disagreed with the pathologist's reading and I eventually got in after they filed additional paperwork). (It remains to be seen whether I'm really getting the study drug). Another person failed to get in because their veins weren't good enough to handle the blood work. They can find all sorts of reasons if they don't believe you're a good candidate.
Congratulations mremeet!You must be feeling out of this world!
For new kids on the block like me, reading your post, makes me feel that there is a lot of hope yet for an easier cure...
Best wishes
Shastri
For new kids on the block like me, reading your post, makes me feel that there is a lot of hope yet for an easier cure...
Best wishes
Shastri
About the cherry picking...those were my doctor's words, actually kind of a warning to me, he didn't want me to get too disappointed if I wasn't accepted. He says my vl breakthru at 24 weeks does not make me the optimal "non-responder" and his experience was telling him there would not be as many non-responders in the prove 3 trial as one like me would think.
He has much experience in testing HIV drugs, says HCV drugs are following many of the same routines, so I tended to believe him. It will be refreshing if he is wrong and a hard to treat person like me could get picked for a trial. Like jmjm said, I will be a nice pest and just keep trying. I can be cordial, while I'm whining about wanting to try their meds. Cross your fingers.
p.s. geno 1 stage 3 grade 2 vl 2,500,00 right now. Started in 2002 at 4,000,000 went down to 10,000 at 12 weeks (never und), went back up to 800,000 at 24 weeks. Saw two docs, both said to stop tx, never a word about increasing either drug. I do not think it would have made a difference.
Perhaps my doc is over cautious, I do not think so, other docs have said the same about my profile, the least exposure I have to IFN, the better. Some folks just don't respond to IFN, which is another way of saying the virus can mutate around the signals from the IFN. So I cross my fingers for VX or another one being tried...HCV 796. At this point, I will try either one. It will feel good to feel bad from taking new drugs along with IFN, which will make me feel good that I am feeling bad from it. HA! Sounds crazy, Hep C has given me a crazy streak, but I hide it well.
Again, congrats to you. Do not worry about the 29. Live and breath, calm and happy, makes the virus mad, keeps it away.
Night.
Willow
He has much experience in testing HIV drugs, says HCV drugs are following many of the same routines, so I tended to believe him. It will be refreshing if he is wrong and a hard to treat person like me could get picked for a trial. Like jmjm said, I will be a nice pest and just keep trying. I can be cordial, while I'm whining about wanting to try their meds. Cross your fingers.
p.s. geno 1 stage 3 grade 2 vl 2,500,00 right now. Started in 2002 at 4,000,000 went down to 10,000 at 12 weeks (never und), went back up to 800,000 at 24 weeks. Saw two docs, both said to stop tx, never a word about increasing either drug. I do not think it would have made a difference.
Perhaps my doc is over cautious, I do not think so, other docs have said the same about my profile, the least exposure I have to IFN, the better. Some folks just don't respond to IFN, which is another way of saying the virus can mutate around the signals from the IFN. So I cross my fingers for VX or another one being tried...HCV 796. At this point, I will try either one. It will feel good to feel bad from taking new drugs along with IFN, which will make me feel good that I am feeling bad from it. HA! Sounds crazy, Hep C has given me a crazy streak, but I hide it well.
Again, congrats to you. Do not worry about the 29. Live and breath, calm and happy, makes the virus mad, keeps it away.
Night.
Willow
Hey, you haven't let anybody down!! You did good, girl, anybody who can do one shot of IFN and not run away, yelling and screaming belongs in my hall of fame. The whole virus, with its acronyms, tests, side effects, percentage of chances, on and on with the lack of information we all have to deal with, MAKES ME CRAZY. So, you take a rest and then find something that brings you much joy. You have taken a trip that the normal person could not even imagine.
We talk to each other here about stuff that makes normal folks just kind of shudder and shake and then walk away, feeling bad that they are glad they are not US. I think it is too easy to forget what bad asses we are. We live in the mouth of the dragon. Everyday. I, for one, find some comfort in the fact that I can remain sane, positive, inventive, happy and challenged, all the while, this virus is chompin on my liver. My mind is definitely way ruling over my body, you do the same and find your own happy dance, girl!!
Willow
We talk to each other here about stuff that makes normal folks just kind of shudder and shake and then walk away, feeling bad that they are glad they are not US. I think it is too easy to forget what bad asses we are. We live in the mouth of the dragon. Everyday. I, for one, find some comfort in the fact that I can remain sane, positive, inventive, happy and challenged, all the while, this virus is chompin on my liver. My mind is definitely way ruling over my body, you do the same and find your own happy dance, girl!!
Willow
That is FANTASTIC news.
I tend to think Foreseegoods thinking is awesome - use the VX to knock it out hard and fast and then INF and riba to do the search and destroy.
Of course the most AWESOME would be a drug we don't have to do SOC with....................in time :)
GREAT Meet I am so happy for you and no mystery about that.
I tend to think Foreseegoods thinking is awesome - use the VX to knock it out hard and fast and then INF and riba to do the search and destroy.
Of course the most AWESOME would be a drug we don't have to do SOC with....................in time :)
GREAT Meet I am so happy for you and no mystery about that.
If you have a health related concern with edamame (soy beans) then you can express it here. Or do you just not like how it tastes ? I always thought soybeans were healthy in moderation although they often oversalt the edamane in restaurants which I consciously often forget to tell them not to :)
-- Jim
-- Jim
wow, what great news...thanks for sharing, your the first vx950 person i ever met, and with such exciting results...many of my non-responding and relapsing friends now have hope for svr....
an inspiration!
michelle
an inspiration!
michelle
not to mention the gas...lordy lordy...okay, now Goof will be on this, sheesh....
OK so we don't agree on ***** and edamame. You still like Sushi right? You're still avoiding treatment right ? LOL.
-- Jim
-- Jim
Congratulations! That is wonderful that you kicked it out so quickly! I also like Foresee's idea and yessss Kathy needs in this trial and another one that I would love to see in the trial is Susan400. Susan,,,you haven't done yet,,,have you?
Back to you mremeet,,,,Amazing! From 14 mil to 0 in 2 weeks!!!!
Back to you mremeet,,,,Amazing! From 14 mil to 0 in 2 weeks!!!!
I'm almost more excited about your news than I was mine. Your numbers are awesome!!! Just talked to Pam....we are both so psyched!!!!!!!!!!!!!!!!
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