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VX-950, Investigational Oral Hepatitis C Protease Inhibitor, Demonstrates Rapid

I know some people don't like the vx-950 posts. This is really to good not to post.



New data announced today by Vertex Pharmaceuticals Incorporated VRTX show that VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor, dosed in combination with pegylated interferon alfa-2a (Pegasys(R); peg-IFN), achieved a rapid and dramatic reduction in plasma viral RNA levels in patients with chronic genotype 1 HCV infection. In this Phase Ib study, the combination of VX-950 and peg-IFN produced an initial median reduction in plasma HCV RNA of more than 3 log10 in the first two days, followed by continued decline to a median 5.5 log10 reduction in HCV RNA at day 14, which equates to a 300,000- fold reduction in viral levels. The majority of patients (6 of 8) receiving the combination achieved HCV RNA levels below the limit of quantitation (30 IU/mL, as measured by the Roche TaqMan(R) assay) at 14 days, with 4 of 8 patients achieving HCV RNA levels below the limit of detection (10 IU/mL, Roche TaqMan(R)). The antiviral activity of the combination through 14 days was significantly greater than the activity of VX-950 administered as a single agent, and much greater than peg-IFN alone. In addition, VX-950 appeared to be well-tolerated when dosed alone and in combination with peg-IFN in the study. The full data set will be presented at a medical conference later this year.

There is more to this story.  Only allowed 1600 Characters.  They do go on to say they are looking at only 3 Months for treatment.  That has got to be good news.
37 Responses
Avatar universal
After watching the stock price rise last week I knew someone had the Europe trial info.  Truly amazing News.  No I do not own the stock or any stock for that matter.  I figured somthing was up with the activity.

                                                     Ron
Avatar universal
Let's all pray that this one finally pans out.  So many disappointments that eventually they HAVE to come up with something better than the current tx and it has to follow all the way through!

As a non-naive person it would not benefit me at this time but for those it would....GO BABY GO!  

GO GO GO!
Avatar universal
maybe I am missing something, but is this not basically the same data that was floating around before? extremely rapid viral load drop? I don't think anything really new has come out yet. It seems to still be Phase 1.
at least the stock talk is left out, ;-]
It does sound extremely hopeful, but until SVR data comes in, none of the new meds have a place in standard tx protocol.I am waiting for Phase III results, in ALL meds on trials, before getting excited.
one person's opinion
Avatar universal
The 2-week period was completed quite some time ago. How come no info since them? Rebound? Rapid resistance?

Also on the horizon with much better data from a ongoing phase IIb trial without the thrombocytopenia and neutropenia safety issues VX950 has shown.

http://tinyurl.com/ak9qz
Idenix Pharmaceuticals Reports Positive 4-Week Data From A Phase IIb Clinical Trial Evaluating Valopicitabine (NM283) Combined with Pegylated Interferon in Treatment-Naive Hepatitis C Patients
SAN FRANCISCO, Jan 09, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) announced partial 4-week data today from an ongoing phase IIb clinical trial demonstrating that treatment with valopicitabine combined with pegylated interferon resulted in rapid and marked reduction in virus levels in treatment-naïve genotype 1 hepatitis C patients. The mean reduction in virus levels was greater than or equal to 4 log10, or 99.99 percent, after 4 weeks of treatment among patients in the two dose groups that began on Day 1 with 800 mg doses of valopicitabine. This trial is almost fully enrolled, with a target enrollment of 175 patients at more than 20 medical centers in the U.S. These partial data will be presented at the 24th Annual JP Morgan Healthcare Conference on Wednesday, January 11 at 2:00 p.m. (PST).

Avatar universal
Just to give everyone a perspective to this news, the L.A. Times reported in October of last year that there were currently over 24 new HCV treatments in developement.
As another added note any new drugs were 3 to 5 years from being FDA approved.   Peace
Avatar universal
thanks for balancing the act,Andy, there are least two people here on that drug, one of them non responder and is now clear and doing very well. all I want to see is some balance. maybe is just me.
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