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Latest news on VX-950
Among 74 patients given VX-950 for whom data were available at the end of 12 weeks, 88 percent had undetectable levels of the virus. That compared with 52 percent of those in the group that received only interferon and ribavirin.
[...]
Despite its apparent better potency, 9 percent of patients taking VX-950 dropped out of the latest study due to adverse events, including rash, gastrointestinal disorders and anemia -- compared to only 3 percent taking the standard dual therapy.
http://tinyurl.com/ydkred
[...]
Despite its apparent better potency, 9 percent of patients taking VX-950 dropped out of the latest study due to adverse events, including rash, gastrointestinal disorders and anemia -- compared to only 3 percent taking the standard dual therapy.
http://tinyurl.com/ydkred
My Week 20 draw was on Friday, rather than the following Monday which is the usual day. So, the PCR has been a week today. They expect it in next week, which is week 22.
The tx period question is a judgement call.
Based on conventional SOC data, 48 weeks of tx is a safer choice that should provide the best chance of SVR.
The big question is if adding 12 weeks of VX in combo with SOC enables a higher SVR rate for geno 1 [which would be a great result] or a shorter tx period, or both. Nobody knows that answer today, but the Prove 1 data should provide more clarity.
I'm going with the 12 + 12 of arm B, in part because I feel obligated to do my part for the trial, and in part because another 24 weeks of tx by choice seems like masochism.
The folks here who do 72 weeks and double stints of SOC deserve respect. Its not easy for anyone, and truly brutal for many. Hopefully, the new wave of drugs will reduce the tx period with a higher chance of SVR. If this VX trial, and the people in it, contribute even a little to that end then its all worthwhile and its well and truly about time heppers got a decent break.
The tx period question is a judgement call.
Based on conventional SOC data, 48 weeks of tx is a safer choice that should provide the best chance of SVR.
The big question is if adding 12 weeks of VX in combo with SOC enables a higher SVR rate for geno 1 [which would be a great result] or a shorter tx period, or both. Nobody knows that answer today, but the Prove 1 data should provide more clarity.
I'm going with the 12 + 12 of arm B, in part because I feel obligated to do my part for the trial, and in part because another 24 weeks of tx by choice seems like masochism.
The folks here who do 72 weeks and double stints of SOC deserve respect. Its not easy for anyone, and truly brutal for many. Hopefully, the new wave of drugs will reduce the tx period with a higher chance of SVR. If this VX trial, and the people in it, contribute even a little to that end then its all worthwhile and its well and truly about time heppers got a decent break.
Thanks for updating us. I appreciate knowing what your experience was. Hopefully ours will be similar. Your week 20 was 12/4, if memory serves, so it did take them perhaps a week longer to give you gruop info, it seems. And, if your blood was drawn 12/8 and you get info around 12/20, that's not too far off from what we were promised. That's a good omen.
Just curious. Based on the fact that we have no svr data from vertex, did you consider going on to 48? We do have studies indicating that 1a/1b rvr's may be able to treat successfully for 24 weeks, but I not believe that theory has been widely tested. We, of course, would be the testers. I want to do my part for the good of mankind and all that but not sure I am that noble. What's your take on this, when you get a chance. Have a great trip, pleasure i hope, and we'll talk to you soon.
We all appreciate your feedback, not just because you're ahead of us, but we value your insight as well.
Thank you, CHarlotte
Just curious. Based on the fact that we have no svr data from vertex, did you consider going on to 48? We do have studies indicating that 1a/1b rvr's may be able to treat successfully for 24 weeks, but I not believe that theory has been widely tested. We, of course, would be the testers. I want to do my part for the good of mankind and all that but not sure I am that noble. What's your take on this, when you get a chance. Have a great trip, pleasure i hope, and we'll talk to you soon.
We all appreciate your feedback, not just because you're ahead of us, but we value your insight as well.
Thank you, CHarlotte
Sorry - I'm out of the country this week so access to the [un]real world is patchy.
I only have one data point for the unblinding process.
- Arm data was emailed to me immediately it became available on Monday.
- VL info is verbal at present. The results of all PCRs taken during the trial will be provided when the results of the week 20 PCR are received. This was straight from Vertex, so it should be reliable information. The week 20 PCR draw was taken Friday last, so we should get the packet mid next week.
Thats all I know at present, but will update if anything new emerges.
I only have one data point for the unblinding process.
- Arm data was emailed to me immediately it became available on Monday.
- VL info is verbal at present. The results of all PCRs taken during the trial will be provided when the results of the week 20 PCR are received. This was straight from Vertex, so it should be reliable information. The week 20 PCR draw was taken Friday last, so we should get the packet mid next week.
Thats all I know at present, but will update if anything new emerges.
Hi Chuck, I have been thinking about you. Good luck with your treatment, Lets us know what happens. I will be unblinded very soon, the 27th at the latest. Have a nice holiday. Pam
Congratulations !!!!I'm so happy for you.Apk said( all that matters now is holding UND status for the next 12 months)I Think you will do fine. I will post my findings the 27th. Crsrph, How have you been? any news on your treatment. Pam
Way to go, that is super news you wiped tht huge VL out so fast!
Congrats on the unblinding and being in the arm you hoped for!
Keep on keepin on and have a nice holiday
Congrats on the unblinding and being in the arm you hoped for!
Keep on keepin on and have a nice holiday
Congratulations on your awesome news! I'm so happy for you...You must be ecstatic! It must feel like winning the lottery to know you'll be done tx'ing soon. I'm keeping my fingers crossed that you'll hold on to UND forever! Good luck!
Hi Beebs. Welcome. Glad you found this site.
The best way to find out if you are a candidate for Vertex (or any upcoming trial with any of the newer drugs being tested) is to get under the care of good hep doc who participates in research or is very familiar with it and can refer you to (or tell you about) a hep doc who is at a site where trials are being conducted.
They are recruiting now for VX950 (and many others too) and will be in the future, probably, but you have to meet certain criteria to be picked. They automatically exclude certain patients right off the bat based on "exclusion criteria". Some of that information is the drug manufacturer site or at www.clinicaltrials.org (but some of it is not, or it needs to be further defined to you by a doctor who is doing research for the drug.) Ask a doctor to help you.
As far as the rash with VX-950 and whether a patient in a trial is pulled (or whether they drop out on their own), either can happen - they can be pulled due to complications, such as hematologic disorders, skin disorders (rash), GI disorder, or they can drop out on their own at any time they want to.
Best of luck.
The best way to find out if you are a candidate for Vertex (or any upcoming trial with any of the newer drugs being tested) is to get under the care of good hep doc who participates in research or is very familiar with it and can refer you to (or tell you about) a hep doc who is at a site where trials are being conducted.
They are recruiting now for VX950 (and many others too) and will be in the future, probably, but you have to meet certain criteria to be picked. They automatically exclude certain patients right off the bat based on "exclusion criteria". Some of that information is the drug manufacturer site or at www.clinicaltrials.org (but some of it is not, or it needs to be further defined to you by a doctor who is doing research for the drug.) Ask a doctor to help you.
As far as the rash with VX-950 and whether a patient in a trial is pulled (or whether they drop out on their own), either can happen - they can be pulled due to complications, such as hematologic disorders, skin disorders (rash), GI disorder, or they can drop out on their own at any time they want to.
Best of luck.
oh for sure - their VX720 knocked their investors for a loop. I'm intersted in it mostly for me and hep c (but for other reasons, too), and it took a d*** beating yesterday! It's been a risky one, but a good one, I think, but - it's on schedule to kick out and sell if it doesn't start behaving !!
Awesome!!!!!!! So, you were undedected at 2 weeks. Your baseline starting load was 27M, as in at one of your screenings and/or right before treatment. So, you went from 27M to un in 2 weeks. Amazing.
Can you help us understand a little bit about how the unblinding process works as we all seem to be getting conflicting information from our studies. You had your week 20 visit last Monday, correct. From then, how long did it take you to get your group assignment and viral loads. Was it in writing or did they give it to you verbally? Sorry about all the questions, but nobody in my study seems to know for sure, even after checking with the monitor. It just seems to be a really confusing process. Did you find it to be so? I'm at 20 in less than 2 weeks, and would really like to know what to expect.
Good to hear from you & I'm glad you're back wherever you've been.
Char
Can you help us understand a little bit about how the unblinding process works as we all seem to be getting conflicting information from our studies. You had your week 20 visit last Monday, correct. From then, how long did it take you to get your group assignment and viral loads. Was it in writing or did they give it to you verbally? Sorry about all the questions, but nobody in my study seems to know for sure, even after checking with the monitor. It just seems to be a really confusing process. Did you find it to be so? I'm at 20 in less than 2 weeks, and would really like to know what to expect.
Good to hear from you & I'm glad you're back wherever you've been.
Char
New to this forum and finding it very informative. Excited about what I have been reading about VX 950. I noticed the reference to the rash as reason for discontinuance and wonder if this is up to the patient to decide, or does the rash just mean a quick ticket out regardless. I ask because I have recently started acupuncture to try and help my symptoms (I also have cryoglobulinemia) and in the course of my tx I developed a severe rash on my lower body. My Chinese doctor felt that was a normal and acceptable reaction, as so many toxins can be released through the skin, so I kept up with the treatments. Now, a few weeks later, the rash is gone and my symptoms are much improved. And this makes me wonder if the rash that so many people get on interferon/ribavirin isn't maybe just the body's way of sluffing off the toxins that the liver hasn't taken care of. Could it actually be a positive sign that things are improving?
Anyway, just a thought.
Does anyone know if they are still recruiting for the trials?
Anyway, just a thought.
Does anyone know if they are still recruiting for the trials?
As far as the dropout rates is concerned, it is quite low compared to the 20% dropout rate for 48 weeks SOC. Here is what a recent Smith Barney article said:
If we extrapolate the 9% discontinuation rate, we estimate the final discontinuation rate will
be in the low double digits for 12 weeks of therapy. Such a discontinuation rate would be inline
with the ~12-21% discontinuation rate for the standard of care at 48 weeks.
If we extrapolate the 9% discontinuation rate, we estimate the final discontinuation rate will
be in the low double digits for 12 weeks of therapy. Such a discontinuation rate would be inline
with the ~12-21% discontinuation rate for the standard of care at 48 weeks.
You hit the other nail right on the head!! Those 88% are still on SOC, so the real test of VX is when they pull the INF and then go 6 months, have a PCR and then we, us sacred money making, warrior mode, best information gathering Hep C folks will know the true value of VX.
I still love the HOPE part tho. For me, stage three, viral mutations abounding, the view of HOPE beats the hell out of looking at the face of "no other options". So today, I am very kewl. My itty bitty 200 shares is getting whooped tho, but it ain't nothing compared to living with the virus. So it is all good.
I still love the HOPE part tho. For me, stage three, viral mutations abounding, the view of HOPE beats the hell out of looking at the face of "no other options". So today, I am very kewl. My itty bitty 200 shares is getting whooped tho, but it ain't nothing compared to living with the virus. So it is all good.
I'm stage 3 too. No WAY you know we don't want this to succeed - I'm just a little bit hesitant to get too excited YET. There have come other drugs before Vertex....and hope and FAITH are too different things. ;)
Anyway - I think you have a good stock position and would hang on to it long term. I mean really they have some many irons in the fire and if any ONE of them pay off you could do SO FANTASTIC! I am ALWAYS optomiistic about things like THAT! :)
I wish I had a few play bucks that I could throw in there but I'm as broke as the brokest single mom. So see - as to where I come to work...you play the market and we both eat! :)
If you don't absolutely HAVE to work while doing treatment...why bother? Heck NO if I had a lot of money I'd be at home...you can count on it! I am glad I kept going just cause that in itself kept me going but.......sleeping late and napping if I need to...WOWOWOWOWOW! ;)
Anyway - I think you have a good stock position and would hang on to it long term. I mean really they have some many irons in the fire and if any ONE of them pay off you could do SO FANTASTIC! I am ALWAYS optomiistic about things like THAT! :)
I wish I had a few play bucks that I could throw in there but I'm as broke as the brokest single mom. So see - as to where I come to work...you play the market and we both eat! :)
If you don't absolutely HAVE to work while doing treatment...why bother? Heck NO if I had a lot of money I'd be at home...you can count on it! I am glad I kept going just cause that in itself kept me going but.......sleeping late and napping if I need to...WOWOWOWOWOW! ;)
Well, you are still my hero for being able to work. And we aren't really rich enough for me to stay home, second income is missed badly by the kids still in college.
Play the market? You give me more credit than I deserve, I do NOT play, the market is full of mean, backstabbing men who don't care about a cure, just the money they can make. I can't find one person who has any ethics. No, I just read a lot, mostly on the computer and then share the info with the hubby. He plays with 401K, not exactly plays, he is very serious, but we are both feeling the urgent need to try to make up for the loss of my income.
Ain't this virus some piece of work? Right now there are folks trading on the hope that the drugs from Vertex fail and publications who are blaming the 9% that dropped out, no kudos to the 91% that hung tough, thru the rash, the bellyache, the whole nine yards. And you, toughing out extra weeks to insure SVR, damn, I will be truly happy when the rest of the world understands what the hell Hep C is truly about.
You can tell I am sick today. I am usually not so negative or frustrated. Being sick suxs. I think the market made me sick today, but the report from Vertex was still good. I'm gonna go wash the dishes and remember what the real world is like. You take extra good care of yourself, single moms who work hard are angels without their wings yet. I admire you.
Play the market? You give me more credit than I deserve, I do NOT play, the market is full of mean, backstabbing men who don't care about a cure, just the money they can make. I can't find one person who has any ethics. No, I just read a lot, mostly on the computer and then share the info with the hubby. He plays with 401K, not exactly plays, he is very serious, but we are both feeling the urgent need to try to make up for the loss of my income.
Ain't this virus some piece of work? Right now there are folks trading on the hope that the drugs from Vertex fail and publications who are blaming the 9% that dropped out, no kudos to the 91% that hung tough, thru the rash, the bellyache, the whole nine yards. And you, toughing out extra weeks to insure SVR, damn, I will be truly happy when the rest of the world understands what the hell Hep C is truly about.
You can tell I am sick today. I am usually not so negative or frustrated. Being sick suxs. I think the market made me sick today, but the report from Vertex was still good. I'm gonna go wash the dishes and remember what the real world is like. You take extra good care of yourself, single moms who work hard are angels without their wings yet. I admire you.
Everyday I wake up above ground is a new chance to try and be a good girl. You made me laugh. My bad habit is swearing too much and I'm not doing a very good job today.
I see you mentioned you are in the Tele biz. Can you say the Company? I'm with bellsouth, soon to be at&t.
Dana
Dana
Maybe someone can help me, why only 74 people? Is this only group D? All arms have been done the 12 weeks vx for sometime now. I just did shot 20 monday, I go the 19th for my week 20 labs, and I get unblinded the 27th, would be sooner but my study nurse will not be back untill then. APK, any news???
My study had 7 slots open for this study, I know 2 droped out, one because she has no ins and the study will not help with sides,you must go to your pcp, she was having eye and skin problems. I just tx my 4th uti, more bactrin. Pam
New York Woman,
You are so right about the stock price. It has been getting thrashed all week by s.o.b.'s who hoped the drug would fail. That is the nature of the market, those folks are there to make money, we are just the money makers for them.
I follow the stocks for my husband, who is pretty smart about it all, but we are not rich, by any means. He's working his tiny butt off to try and make enuff for two of us to retire on, as I do not have the huevos that you do, I could not continue working. Panic, fatigue, you know, the usual crud.
But I have learned real things about Vertex, it is not a company all about just one drug. MD Anderson Hospital in Houston, which is fairly big league, just came out with very good results on a cancer drug that Vertex is working on. And Vertex got paid $15 mil today for the FACTS about VX950 from a large pharma that it is working with. So things are rolling along for Vertex, rocky as hell this week, but the stock price has nothing to do with the small success of VX. In a long term view, there is good news abounding, for me, for Vertex, for all of us.
You are so right about the stock price. It has been getting thrashed all week by s.o.b.'s who hoped the drug would fail. That is the nature of the market, those folks are there to make money, we are just the money makers for them.
I follow the stocks for my husband, who is pretty smart about it all, but we are not rich, by any means. He's working his tiny butt off to try and make enuff for two of us to retire on, as I do not have the huevos that you do, I could not continue working. Panic, fatigue, you know, the usual crud.
But I have learned real things about Vertex, it is not a company all about just one drug. MD Anderson Hospital in Houston, which is fairly big league, just came out with very good results on a cancer drug that Vertex is working on. And Vertex got paid $15 mil today for the FACTS about VX950 from a large pharma that it is working with. So things are rolling along for Vertex, rocky as hell this week, but the stock price has nothing to do with the small success of VX. In a long term view, there is good news abounding, for me, for Vertex, for all of us.
pam - Got your message, glad to hear you're doing well. Hang in there for the unblinding, we both know you were gettin' the good stuff. I think you're gonna make your SVR in flying colors, so keep the faith. I really think you're well on your way to the promised land!
As far as Vertex only reporting on the results of only 74 VX dosed patients (out of a total of 175 receiving VX950): I think all that means is that the data they're presenting was sampled before all VX dosing patients had completed their 12 full weeks. In other words, this data was sampled sometime in the past (probably a few weeks ago) when only 74 of the VX dosed group (out of the total of 175) had completed their full initial 12 weeks of dosing. So this means that 101 were still not completed with their 12 week cycle before this data was sampled (and subsequently presented in their press release), and so that's why they were left out.
At least I THINK that's what it means!! ;) I agree it's a little ambiguous. I also would like to know if the 9% they mention quit altogether, or if that means they only stopped the VX.
Hope you're doing well. In the meantime keep on keepin' on, I definitely think you're gonna make it!
As far as Vertex only reporting on the results of only 74 VX dosed patients (out of a total of 175 receiving VX950): I think all that means is that the data they're presenting was sampled before all VX dosing patients had completed their 12 full weeks. In other words, this data was sampled sometime in the past (probably a few weeks ago) when only 74 of the VX dosed group (out of the total of 175) had completed their full initial 12 weeks of dosing. So this means that 101 were still not completed with their 12 week cycle before this data was sampled (and subsequently presented in their press release), and so that's why they were left out.
At least I THINK that's what it means!! ;) I agree it's a little ambiguous. I also would like to know if the 9% they mention quit altogether, or if that means they only stopped the VX.
Hope you're doing well. In the meantime keep on keepin' on, I definitely think you're gonna make it!
Oh yeah another thing I forgot to mention is that I don't think Vertex would be including anyone amongst the VX groups that stopped taking the VX early due to sides and/or who may have required IFN and/or riba dose reductions and/or who may have taken a drug that might skew the viral response (i.e. immunosuppressants like prednisone/solumedrol). So this would exclude the data from myself, PDS and even you for example (because of your reduced riba). The 74 they discuss are described as taking VX950 and peg/riba during their 12 weeks, so I think this means they are only reporting what the viral response was for those that maintained full doses of everything all the way through the 12 weeks. This would also make the results look better (without actually lying), which would be good for their stock price too.
But, again they're pretty vague and leave quite a bit to our imaginations. But I'm satisfied that the VX definitely adds to viral response.
But, again they're pretty vague and leave quite a bit to our imaginations. But I'm satisfied that the VX definitely adds to viral response.
hey rev you posted above that you would not want to post any personal info for fear of enemies but the way you been lately you have NO enemies. not what i think matters but your posts have been great and i know you have and will help a lot of people if you continue to share your wealth of knowledge.
PS, i would never share any personal info even if i was the most liked person in a forum. way to dangerous!
PS, i would never share any personal info even if i was the most liked person in a forum. way to dangerous!
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