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no anemia/ no gastric troubles? no rashes?
also, its interesting that a 14 day treatment resulted in a 3 month RNA negative period. seems like SVR to me.
It's an ADD on not a substitute.
anyhow, vx is a great hope for nonresponders. we will all beat this virus yet.
What we know at this point is that VX-950 knocks the virus down VERY fast with almost anyone who takes it. What we don't know is if it will produce SVR (cure). That information should be available within a year. Another reason for people to wait who can afford it.
If things work out in the trials, Vertex potentially will be on the market in about 3 years with trial opportunities for many sooner.
-- Jim
Ron
Vertex is not a stand alone drug, it relies on regular old Peg too. Maybe eventually they will be working on mixing it with something else but for now...it's not really a plan for you I don't think
However Infergen IS indicated especially for non-responders and relapsers.
Have you discussed this?
All the best.
-- Jim
In that trial, side effects seen were those mostly associated with the known side effect profile of IFN.
I think there tends to be confusion, as they have run several different trials. As Jim pointed out, in the US, it is being tested CURRENTLY (not talking about the past or future) with IFN and riba, while in Europe, there will be arms without riba.
You can infer from the abstracts that 950 still works as a mono, but at a slower rate than with IFN, which should be expected.
IMHO, the riba issue is being done to placate the FDA. It doesn't seem there is any evidence that shows riba is going to do a whole lot. After all, it gets 4 logs in 2 weeks by itself, 5.5 logs in 2 weeks with IFN only.
When the time comes, I guarantee I will opt out of the riba, and it won't be an issue as far as I am concerned. But, that is a personal opinion, and no one else should necessarily take that advice for themselves. With Thalassemia minor, I don't see the point of taking riba when my baseline hgb would be around the 12 area.
It does look very promising and could be the "cure" we all hope for but it is extremely unlikely if not impossible for it to be available in " 2 years"
Ron
Beagle
Like to article where VX950 was tested as a monotherapy in Phase IB:
http://www.vrtx.com/Pressreleases2005/pr111105.html
Beagle
My hope is that they can find a solution that helps ALL victims of HCV.
Further, the subject has come up in web casts with analysts (who have raised the issue) about whether or not they could file based on phase 2 data.
In the past, they have said that it is possible, but the data would have to be "transformational", and they mentioned 75% SVR, or something like that IIRC.
They have also said their phase 2 constitutes a filable package. Meaning, it is done like a phase 3 would be. Part of the proof of that is this is a 1000 patient trial, which is the size of many phase 3's.
So, yes, there is a chance (and the company doesn't want to focus on that based on prior web calls).
And yes, there is a timeline for launch. Analysts have put that in their numbers for the company. Can timelines change? Yes, but this has been the basic timeline with minor adjustments for a while.
Keep in mind, this phase 2 was supposed to start earlier than it did, but kept getting delayed. Now we know the reason. Instead of 200 patients for a normal phase 2, this is 1000 patients.
It doesn't.
They don't have the same mechanisms of action, therefore, there is actual efficacy and direct effect from 950. As far as symptoms, the side effect profile has been covered in detail in the trial results, it does not cause anemia, or many of riba symptoms, and has generally been very well tollerated with no SAE's.
Here is an excerpt from the trial with 950 and IFN ONLY:
"A preliminary safety review has been conducted that indicates that the treatment was well tolerated. All patients completed dosing and no serious adverse events were reported. All adverse events in the patients receiving VX-950 alone were reported as mild. Typical interferon-related side effects, of mild to moderate severity, were reported in the patients that received peg-IFN along with VX-950 or placebo. Laboratory-related adverse events of neutropenia in one patient and thrombocytopenia in one patient were reported among the patients who received peg-IFN. Neutropenia and thrombocytopenia have previously been reported in patients receiving peg-IFN alone. It is not known if the two patients in whom these events occurred were also receiving VX-950, because the full safety database has not yet been unblinded. A complete safety analysis will be conducted once the study is fully unblinded."
The sides have been addressed in other publications in greater detail.
Sorry to hear about your relapse. I really am not expecting 950 to be tested without riba in the states, but then again, no one knows what phase 3 would look like.
I really think that if/when this gets approved, it will be with riba. I would choose not to take riba on my own, even if my doc disagrees.
My hgb is normally around 12, was once as high as just under 14, which I hear is unusual for Thal. minor. But, it is usually in the 12-13 range.
Good luck to you, I remembered from a while ago you were treating and had TM, but I was unaware you relapsed, as I miss many threads.
As far as why no rashes were reported from the shorter duration trials: both myself and the other participant who have the rash, had no real rash at 28 days. Only little bumps that just itched a little, that's all. It took longer than that to flower into what it is now. And again, please don't misinterpret this. I most certainly DO NOT know that VX is causing this, nor am I stating that. Just pointing out that just because no rashes or other assorted side effects were not noted in shorter term trials, that doesn't preclude the possibility that something might show up in a trial duration three times longer. (which is true with ANY experimental drug of course) And again, I know of some people in the trial who are not getting the rash and they have been taking it longer than myself. So even if it did cause a rash, it may only be in some people, not everyone.
I am so sorry to hear you are coping with this all over rash issue. o the doctors have no clue? What is it like? I know it is hard to describe a rash, but it sounds like all over re bumps that itch? Do I have that right? Does it hurt? Cause any other symptoms? I agree with you and was told something similar by my doctor that there is no "riba rash" it is a catch all for various skin issues that crop up but it is not one particular rash cause by riba. How simply awful this must be for you. I hope the prednisone works out and you get some relief soon.
thanks so much for volunteering to be a "guinea pig" for us all.
www.valeant.com
With my thalessemia minor there were times in the past that my HGB was 14 but the norm of the last few years appears to be 11.0-12.0. Before starting tx it was 11.0. For me the anemia was the worse sxs and having 2 transfusions to stay on tx. The procrit didn't really help me until near the end when I was taking 60,000 units every 5 days. Can't wait to hear you got to SVR, it will prove there is a cure for people like us.
Beagle
What does it mean? Anyone's guess so far, it may not be caused by VX at all. But so far no one has been able to explain to me what's going on with this rash, or what it's likely origin is. Bottomline is that VX *IS* and remains an experimental drug, don't forget that. I've fully come to realize I'm a guinea pig, make no mistake about it. Maybe a willing and carefully monitored guinea pig, but a GP nonetheless. So extreme enthusiasm based on VX's performance in trials leading up to the current trial should be tempered with patience and realism. No one knows for certain yet what this drug is going to do in terms of improving SVR odds OR if it will be largely tolerable by most people for periods of time longer than 28 days of dosage. This rash has really been something. I never knew what true suffering was until I had this, and believe me I've been in some miserable spots before. And I had to go on prednisone to control it, which lowers the effectiveness of IFN/riba, and now am left hanging wondering if I'm immunologically "standing on my shoelaces" as a consequence of that. Anyway, everyone should keep it in mind before we start counting all our chickens before they're hatched. I'm still optimistic about VX950, and it's only natural for all of us to be so hopeful, but please just try and reserve over exuberance and temper your expectations with what we all know as "the real world".
I had no idea that you were suffering that much. Truthfully I feel like quite the baby because I made a HUGE deal of the RibaRash when it developed (I am still scarred from it so it wasn't nothing but it certainly wasn't anything as bad as you have).
I just have to say good luck on your journey one more time. I hope that nothing else comes up and that they do figure something out. I'm sorry that they had to put you on the Pred - that totally totally SUCKS - has it at least helped at all?
Debby
couldn't think of a nickname, I posted to you in this thread about 4 - 6 posts above, about your thalaasemia.
Beagle
Ideally VX950 will not have side effects of any consequence but if it does, a rash isn't the end of the world. Unless you are the one that has the rash of course, then it can be consuming.
However, I think every medicine there is has sides, because these chemicals are foreign to the body. I have been told certain meds (allergy for example) are well-tolerated and shouldn't cause symptoms. For me, they have. One a long time ago was supposed to cause drowsiness, instead, it wound me up. Sometimes I wish I had that allergy med in the house lol.
Just another reason to hope for as short as possible. After all, these are all chemicals, and I know no one wants to take them a day longer than they have to.
Having said all of the above, there are sides with 950, SGP's, and all of them.
Don't worry buddy, we're not askin.....like Clinton's military -- Don't ask; Don't tell.
I don't know about your doctor, but skin issues have been mentioned in here for a very long time, with SOC.
Mr B,
I was once very hopeful about viramadine, but it now has had 2 trials where it didn't quite meet its endpoint.
I know it still does show activity, and may still be a player, but I think the trial results of late haven't been as anticipated. From a theoretical standpoint, the fewer the drugs needed the better of course. But, there is a lot of data that needs to be seen with everything, and the 950 trial in Europe without riba might shed some light on some questions.
A rash doesn't necessarily mean anything at this point however he is in the trial and he knows of at least one other participant that has the same odd rash. Time will tell. If he is on VX950, his rash and need for prednisone will be noted in the data. I know everyone wants it to be problem free and available soon but as he points out, we don't know enough yet to say one way or the other. He makes a good point when he says that the rash wasnt seen in the other trial group BUT he has been on it longer than 28 days they were on it. Anyone who has taken SOC knows that it can take time before side effects rear their head.
I now have Vertiligo (white patches on my skin) and it is spreading. It may not be the VX950 that caused the rash -- something to consider.
I still am experienceing severe itching, especially after a shower which tends to last 20-30 minutes..but no real rash now.
I hope they let you stay on it without the Riba.
I personally hate Riba!
Best of luck to you.
Beagle
Hope this helps, take care.
If you're still experiencing the nightmarish itching, I'm taking Atarax which is a potent antihistamine commonly prescribed for these types of rashes. As long as I take it regularly, it seems to hold the creepy crawlies at bay...although it spaces you out pretty bad. But still, I'll take the spaciness over the itching any day. Hope you're doing well otherwise, please stay in touch and let us know how you're making out. Best of luck, and here's to an SVR for all of us.
Hope you continue to do well and we end up with SVR...I would love to be able to donate my liver to my beautiful daughter...she seems to be on the verge of transplant..
Good Luck,
Jodi
ribavirin is a broad spectrum antiviral that is also used for influenza. unfortunately, hcv patients take it for much longer than do patients with other illnesses. i guess thats what makse the side effects worse.
VX is a narrow spectrum antiviral thats supposed to work only for HCV. naturally, a specialized medicatino will be more effective, and have lesser side effects.
personally i believe it will be used without riba once it comes out.