Where are the Protease Inhibitors?!

Folks,

I've been following HCV news since I was diagnosed in feb 05. There always seems be be a promise of a new breakthrough Protease Inhibitor (PI) coming soon. But most of us have seen nothing and are struggling w/peg & riba combo.

Is there anyone out there on these PI drugs, especially VX950? how are you doing on PI meds? Wehen will they be available to the general public??

thanks
br007

[Upbeat]

They will starting phase 11 trials with vx-950 soon. Here is a copy of an email I received from vertex who is developing vx-950.  Hope this helps.



Enrollment in the Phase 1b Clinical trial with VX-950 is complete.  Planning for the next VX-950 study is underway and we anticipate that the study will start in the Unites States in late 2005 or early 2006.   The Vertex web site (www.vrtx.com) is the best source of current information on the status of the next study.  As the start of the next study nears, the web site will also include information about how to contact participating clinical centers to find out your eligibility to be in the study.   However, we have not selected any sites yet for this study.    

We appreciate your interest in Vertex and in VX-950, and the time you have taken to write to us.  If you are interested in other clinical trials, you can look at the websites for Centerwatch (www.centerwatch.com) and the National Institutes of Health (www.clinicaltrials.gov), which provide comprehensive clinical trial listings, including many Hepatitis C studies.  You can also follow the Vertex website (www.vrtx.com) which will have the most up-to-date news about the status of all of our investigational compounds and clinical studies.
                                                           Ron

[couldn't think of a nickname]

There are currently 2 PI's of note in the clinic, Schering's which started phase 2, and VX-950 which starts phase 2 this month. Neither are available to the general public, and won't be until approval. VRTX's timeline is to file for approval in 2008. If so, expect a decision from the FDA (approval most likely) in less than 6 months from filing, then it would be launched shortly thereafter.
Soon is a relative term, as 3 years for this situation is quite soon, also considering it has been under development for 9 years already, but not soon enough for us.
Results from the phase 2 trials should answer many questions. It is being speculated that SGP might need to do another phase 1b trial, to investigate higher doses, as their viral kinetics need improvement. Yes, 2.06 logs in 2 weeks is much better than SOC, but it not only trails 4.4 logs in 950, but there was a slight rebound between decline slopes, and that is not optimal.
SGP has said in abstracts that their modeling suggests that they can get undetectable in geno 1's in combo with interferon in 8 weeks, suggesting 24 weeks of duration. VRTX, using the same modeling apparently, feels they can do it faster (they got half undetect. in TID in 2 weeks as a mono. as it was), especially with interferon, yet they were criticized by SGP and Bank of America for looking at a shorter timetable.

My suggestion is, that anyone looking to get in a trial, try to wait for phase 3, which is currently scheduled for 2007. There will be a much better chance IMO of getting SVR as that phase would be to get to optimization.
HOWEVER, in the current phase 1b in Europe which is 950 and interferon combo, VRTX will be allowing those who go undetectable during the 2 week trial (TOO SHORT FOR SVR) to roll over to standard of care to try to attain SVR.

The worst sides from these PI's look to be when combined with interferon, as both have been well tolerated, with no discontinuations or adverse events, including cardiac tox. studies.

[couldn't think of a nickname]

I mis-typed on the issue of sides. I meant that the worst of the sides on combo should be the sides experienced with interferon.

[Forseegood]

Just wanted to thank you once again for keeping us all up-to-date on these issues, what a great resource you are!!!The great thing about clinical trials is that they do tend to expand after the first few beginning trials, to many hundreds of participants in their last phases...and that is before estimated time "to market." So this news is hopeful after all. And of course, if these new drugs do as well as they've been doing, and many doctors and researchers are impressed with them so far... the "fast track" process happens... this is what happened with the PI's for HIV.

I would think that if they had some real problems with them, some of those problems would have already manifested...as was the case for that biln..whatever it was. At lease that's what that major researcer told me, but of course he's going to be a bit biased as he was in on 950 from the beginning. Sorry for the fogginess. Your take???

[GoofyDad]

Hey forsee, I was thinking about you last night while out listening to music with the hippies in <href="http://www.gordyo.com/Fairfax/Fairfax.html">Fairfax, CA</a>. Ever been there? I think it may the the antithesis of Hest Hollywood, but I dunno WH enough to say.

Yup, Village Music is still in Mill Valley. No CDs to-date, I don't think.

[susan400]

I'm heard that it will be another 3-5 years before the protease inhibitors will be made available to be prescribed by our own doctors.  Prior to that, you'd probably have to be in a trial for it.  That was what I was told.

Susan

[Forseegood]

Yeah, I tend to know places by their music and book stores...that's a good one. Funkadelic bathroom though, whew!!!Dude, can you love music and still be hygienic! Been to Marin County but unfortunately, don't know the village of Fairfax. What's hanging around with "hippies" code for? he he he.

The only Fairfax I know is Fairfax Ave. in W. Hollwyood...since I consider myself an honorary Jewish woman, go there often, best deli's and comedy clubs around there. Gee, I wish we could all meet up for some kreplach! Significant others, kids, dogs, you name it!!I hope your bloods are improving, I know you were a little worried about them...bloods, what a weird way to refer to something. Keeping my fingers crossed for all you people presently on treatment...

[couldn't think of a nickname]

your welcome, and I do agree. The failures of BILN did IMO help those studying the newer ones. I am guessing that complete cardiac tox studies are unusual for phase 1, but they were done by VRTX because of it. RIGL last week had a debacle with R-112 failing in phase 2 after a previous successful phase 2, but measuring allergy symptoms is quite different than measuring viral kinetics. I have been told phase 1 is a tough phase for anti-virals. Several companies have compounds for HCV, but they are all having a tough time keeping up with potency to the PI's, as we are seeing, latest example, from VPHM.

[couldn't think of a nickname]

guess I should have waited 1 day to post, as I said phase 2 would start shortly for 950. Shortly came today.

http://biz.yahoo.com/prnews/051205/nym050.html?.v=28