Thursday, March 19, 2009

Meanwhile, Vertex's Teleprevir Shows a 51 Percent Cure Rate -- in Non-Responders!

While Schering-Plough's boceprevir, to be fair, continues to inch forward, Vertex's competing Teleprevir Next Gen Hep C candidate will post very-impressive "Late Breaking" deveolpments at EASL, in Copenhagen, in a few weeks. Take a look a the EASL PROVE 3 study abstract; then read this snippet from

. . . .The new data come from Vertex's PROVE 3 study, which enrolled 453 patients who had failed prior treatment with the current standard drug regimen for hepatitis C -- a 48-week course of long-acting interferon plus ribavirin. In the phase II study, these patients were randomized to receive either treatment with a combination of telaprevir plus the standard therapy or retreatment with the standard therapy alone.

In all, 51% of patients treated with a 24-week regimen that included 12 weeks of telaprevir reported undetectable levels of the hepatitis C virus six months after treatment. In hepatitis C parlance, that's known as a sustained virologic response, or SVR. Simply stated, these patients are considered cured of hepatitis C.

By comparison, only 14% of the patients retreated with 48 weeks of standard therapy alone achieved an SVR, or cure, six months after treatment. . . .

Wow! So, once again, Vertex "goes yard"!


Anonymous said...

This is an impressive result in a very difficult to treat patient population. I personally will be looking foward to seeing more of this data in Copenhagen next month. Of note, Vertex also recently presented data showing that twice daily telaprevir has a similar pharmacokinetic profile to tid (3xday) dosing. Boceprevir is dosed 3xday. Although a seemingly small point, this may prove a significant differentiator between the molecules as patient compliance is tantamount with direct antiviral therapy to maximize response and minimize the risk of development of resistance. Unfortunate for SP is the Merck acquisition comes at a very bad time in the development program for boceprevir. I have lived through enough mergers/ acquisitions in the industry to know that clinical programs experience serious delays due to higher turnover of clinical research personnel during mergers, the standardization of clinical trial databases such as adverse event reporting systems and the simple reality that many of those involved in the clinical program will need to be reallocated to managing the merger process. All in all this speaks to an additional level of potential delays for the marketing of boceprevir. It appears to me that the gap between telaprevir and boceprevir continues to widen in favour of telaprevir on many different levels.


Condor said...

Well-put, Wolf --

And welcome back!

I will confirm the delay-due-to-merger distraction theory; and will concur that in Hep C treatments -- a land where patient compliance is the difference between good and bad outcomes -- twice a day dosing will be a huge advantage for Vertex (before we even begin to talk about the 51% cure rate -- in previously-failed patients -- isn't boceprevir's comparable data well-below 20%?).


Do stop on back through from time to time. . . .


-- Condor