Aa
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...
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.
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
