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VX-950 combo trial starts in Europe

VRTX announced yesterday that the combo trial of 950 and interferon has started in Europe. This is in geno. 1 treatment naive patients, as opposed to the other trial which had many which failed current treatment. 8 will receive 750 mg 3x daily, 8 750 3x daily plus interferon, and 4 interferon only. Expect top line results early in the first quarter of next year. An IND will be filed with the FDA in the next few weeks to start Phase II in the states here by the end of the year, which will be combo treatment.
For a refresher, VX-950 alone dosed 3x daily at 750 mg saw a mean 4.4 log drop in 2 weeks. Half went undetectable between days 11 and 14. Rule of thumb is that complete treatment should take 3-4 times as long as it took to go undetectable, which is why trials are so short. Also, this trial will use the pill formulation instead of the oral suspension in the prior trial. The pill has shown greater bioavailability. The prior trial it was taken on an empty stomach. They said something (webcast is archived, I need to go back and listen again) about this being taken with food which increased blood concentrations 2-3 times.
A 3 month monotherapy trial is planned for early next year.  

Prudential is hosting a call at 1:30 ET today with a co-author to some abstracts on Schering's drug and VX-950 using AASLD info. I am not a client of theirs, so I won't know what happens unless someone posts it on the VRTX message board.

Feel free to hijack this thread.
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Avatar universal
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!

-- Jim
Avatar universal
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.

thanks,
Lori
Avatar universal
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.
Avatar universal
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....
Avatar universal
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.

Avatar universal
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.
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