good musings...that's why I'm really glad for the postings of the participants...they are very helpful to the rest of us in my view...thanks for keeping up with this, much appreciated...
I haven't heard much on the NM283 study that is underway either. I think they must be cracking down on privacy issues.
I am in Prove 3. Most patients started mid April to mid May and the blind won't be lifted until the 24th week for any individual patients.
There are two arms that are 24 weeks and two that are 48 weeks. We won't find out which arm we are in until the 24th week. In the interim, we are told our liver functions - Alt 80 at start of treatment, 30 at week 1. Nothing else so far.
Most of us are experiencing the usual side effects with anemia being the worst of them so far. It is early for any of us to get the VX rash which I think turns up about the 7th week if at all. I am just completing week 7 and no rash except the usual riba rash so far.
Thanks for the info. This sure is a long process
hi upbeat. i'm in wk 43 of 48, prove 1. i don't expect any data from vertex till september or so, that data should be on the prove 1, 24 week group.
I'm stopping tonight at week 41, will let you know what happens as time goes by. If I manage to pull an SVR out of my hat, I'd interpret that as a good sign. I stopped my VX about 4 weeks early and took a ton of immunosuppressants to deal with my rash (immunosuppressants tend to counteract the effects of interferon). I was also (and remain) on reduced ribavirin for much of my treatment. Plus I'm cutting my cycle short by 7 weeks. So if I manage to pull an SVR out of my hat, I think that's yet more good anecdotal evidence the VX really adds bran to your corn flakes. But really, press releases aside, I think we know enough at this point ot make some basic observations:
1. VX does, repeat - DOES substantially help to get rid of the virus when dosed with IFN and ribavirin in the vast majority who take all three. There is no doubt about that.
2. VX does add significantly to the side effect profile when dosed with IFN+riba, especially in terms of rash. Still, speaking as someone who got the worst of the rash, even then it can offer something very substantial to your treatment strategy. You just gotta be able to recognize its onset early, stay on top of it with appropriate treatment strategies and stop the VX in time to keep it from taking on freight train proportions (whilst preserving/deriving its initial up front viral slamming benefit).
3. A bit early to say for sure, but I feel confident in saying that I believe that telaprevir+IFN+riba (full doses) will reliably shorten type 1 treatment cycles to 24 weeks, and possibly much shorter for those who are ultra-responders (like PLN who started with a low VL and cleared by day 4).
4. I also feel SVR rates will be significantly improved, even with a 24 week treatment cycle. For those who get the full dose of all drugs (including ribavirin), I'd guess on average the SVR rate will be increased from ~50% upwards to 75% or so (give or take 10%). I wouldn't be surprised a lick to see it come in at 85% though (again assuming full dosage).
5. Treatment without ribavirin is more cloudy. Some will be able to clear without ribavirin (on IFN and VX alone), but I definitely think the SVR reliability of only IFN+VX will be much lower than that of IFN+VX alone. Not enough info to know for sure, but I'm skeptical that treatment without ribavirin will achieve the kind of performance most people would feel comfortable with, especially with ribavirin at their disposal.
6. I'm guessing telaprevir will get its FDA approval sooner or later. VX950 is big medicine, too effective to ignore considering how many people this disease kills. The only caveat is if they suddenly find out VX950 makes your wang fall off 72 weeks after taking it (that'd be my luck).
Those are the basics as I know them, your mileage may vary. If you're waiting for this one to come to market, I'd remain "upbeat" about it.