Thanks for the update. In the states I believe they started with treatment naive, it appears from what you say the opposite in Europe.
I'm interested in the "rule of thumb" you mention where treatment extends from 3 to 4 times the amount of time it takes to get non-detectible. Do you have any more information on this?
I believe I've heard this before but maybe it's just a Vertex rule of thumb and wondering how they came up with it, since I don't believe the trials have gone to SVR yet.
For example, I'm a geno 1 and cleared at week 6. By the "rule of thumb" formula, that means I would only have to treat 18 or 24 weeks. And while a European commission has adopted a 24-week program for selected geno 1's, the operative word is "selcted". They had to clear by week 4 and have a pre-tx viral load under 600,000.
That said, I really am rooting for this new drug. If their formulations are correct and half went undetectible within two weeks, then that half will only need to be treated in 30-60 days. Wow!
WOW! anybody have any idea how long the trial will last and if all goes well, when to expect FDA approval. I just tested posivtive for hep c and confirmed genotype 1a. Depending on liver biopsy, I was considering tx next September. If this drug could be an option I would considering waiting another 6 months to a year.
actually, the first trial was in Europe also, as none have started yet in the states. That is scheduled to happen by the end of the year though. According to their web cast yesterday, this second study will be all treatment naive patients (they gave a reason, I don't remember what it was). The first one did have many non-responders in it. Maybe this has all treatment naive because they want to measure it where there wouldn't have been any resistance to interferon (just my guess). I guess it makes sense too, since the first one was the opposite.
That rule of thumb is interesting, and I had not heard it until I have heard them talk about it. They point to studies that show EVR can have shorter treatment times-geno 2's who clear at 4 weeks, treat for 3 months, and maintain SVR. They also point out the established medical opinion that undetectable at week 12 requires 48 weeks of therapy. They only plan to use 950 in conjunction with the best antivirals in the market or in testing, and right now, that is still interferon. I guess it doesn't make sense to use it with anything but no. 1. It also sounds to me like ribavirin might not be used, and I think that in itself is big. I am sure you can testify to the hell that can cause.
To make the "wow" bigger, it probably is not a leap to hypothesize that the results with the additive (and possibly synergistic) benefits of interferon could not only improve those numbers, but should happen even faster. I can't wait to see that data in a few months. I have to be careful with my expectations though, but then again, the first results were quite dramtic. I don't know if I mentioned this before, but the lead scientist for BILN 2061 is now employed by them, and has been pushing this drug vigorously the last couple of years. He may not have developed it, but he has been pushing it.
this is the only forum I have seen the time line of 950 being so aggresive, I sure hope you're right..I am waiting for that drug....Other forums say 10 years to have anything available other than interferon/riba...I can't wait 10 years and am taking a gamble on Vertex....
If we all chip in perhaps we can start our bubble boy commune somewhere in Europe eventually and get in on this if the States don't get their act together. ;-)
Just kidding. This is just such huge news.
You know I think if they tested everyone in the good old USA and found out what the REAL number of people with HCV are...they would somehow get their butts in gear and find some serious funding and we'd have a cure in no time.
I forgot to add that they also stated that the improvement in LFT's was faster than seen with any current drug, or drug in development. Basically, inflamation was substantially reduced very rapidly.