Interesting Statement?

"The next, next thing in hepatitis C already on Wall Street's radar screen is a phase II study of telaprevir in combination with Vertex's other hepatitis C drug VX-222. The importance of this study is that it eliminates treatment with the current standard of care -- long-acting interferon and ribavirin. If successful, hepatitis C patients might be treated with pills only that directly kill the virus -- the holy grail of hepatitis C. "

Read more here: http://www.thestreet.com/story/10767632/vertex-pharma-five-reasons-to-worry-about-telaprevir.html

Magnum

[22hamilton]

Eliminating the current SOC with all its sides and limitations has got to be a good thing. For people without time on their side however it feels frustrating to see what the future may hold.We know there is treatment in the pipeline that will give us that much needed SVR but will we get it in time ?

Thanks Magnum

[Trish77]

More info on upcoming clinical trials on this

http://www.natap.org/2010/HCV/030210_01.htm

Vertex Begins Study of 2 Oral HCV Drugs Telaprevir + VX-222


   Vertex Broadens its Commitment to Improving HCV Care with Clinical Trial to Evaluate Combination Regimens Based on Oral Antiviral Therapies

-Trial will evaluate safety and SVR rates with multiple 12-week response-guided regimens of telaprevir/VX-222-based combination therapy, including two-drug regimens of telaprevir and VX-222-

CAMBRIDGE, Mass., Mar 01, 2010 (BUSINESS WIRE) -- ---Interim clinical data expected in the second half of 2010-

---Multiple clinical trial sites in the U.S. to enroll patients-

Vertex Pharmaceuticals Incorporated today announced that it is initiating the first clinical trial evaluating Vertex's lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, dosed in combination with the company's lead investigational HCV polymerase inhibitor, VX-222. This Phase 2 trial will evaluate sustained viral response rates (SVR; defined as undetectable HCV RNA 24 weeks after the end of treatment) using multiple 12-week response-guided regimens of telaprevir/VX-222-based combination therapy, including two-drug regimens that contain only telaprevir and VX-222. The trial is expected to enroll approximately 100 treatment-naive genotype 1 HCV patients at multiple clinical trial sites, the majority of which will be located in the U.S. Enrollment is expected to be completed in the second quarter of 2010. Vertex expects to obtain interim clinical data, including safety and viral kinetic data, from this trial in the second half of 2010.

"Vertex is committed to improving patient care in HCV, and the announcement of this clinical trial combining two oral agents, telaprevir and VX-222, signifies our first exploration into this combination regimen's potential role to further improve the treatment of HCV," said Peter Mueller, Ph.D., Vertex's Chief Scientific Officer and Executive Vice President, Global Research and Development.

"The completion of the Phase 3 development program for telaprevir remains our primary focus, and we are on track to submit a New Drug Application for telaprevir in the second half of 2010. We believe telaprevir could represent a significant opportunity to improve the treatment of HCV, and simultaneously, we are focused on evaluating additional opportunities to potentially enhance HCV therapy even more in the years ahead using novel combination regimens based on oral antiviral agents. We believe the trial announced today will inform the development path for telaprevir/VX-222-based combination therapy, and we look forward to obtaining the first clinical data from the trial later this year," continued Dr. Mueller.


"About the Phase 2 Trial of Telaprevir and VX-222
The randomized, parallel-group, dose-ranging trial announced today is designed to evaluate the safety and antiviral activity, including SVR, of multiple 12-week response-guided telaprevir/VX-222-based combination regimens. The primary endpoint of this trial is to assess safety and tolerability of telaprevir/VX-222-based combination therapy. A secondary endpoint of this study is to assess the proportion of patients in each study arm who achieve SVR. The trial is expected to enroll approximately 100 treatment-naive genotype 1 HCV patients at approximately 20 clinical trial sites, predominantly in the U.S. Vertex expects to complete enrollment for the trial in the second quarter of 2010. The trial will consist of four arms, as noted below (have to read the link for this part as it doesn't copy well.)

[Cory255]

Vertex has been experimenting with the newly developed polymerase inhibitor VX-222.  So far it has had outstanding results.  It has a potent antiviral effect after 3 days!

One study I reviewed had 32 naive genotype 1 patients.  There was an average RNA HEP C VIRAL PCR QUAN decline of >3log10 at day 4.  There was a a HCV RNA viral load decrease of at least 3 log IU/mL in everyone.  

Pegylated Interferon alfa-2a + Ribavirin + Telaprevir = virus eradication even in prior non responders!  

[DebiS99]

Interesting read! Giving more hope for people waiting .
Thanks

[nygirl7]

Gives hope to people like Mr. Beagle Bailey who couldn't do SOC and yet tried so valiently to do so.......Miss you Beagle. We all do.

[Rockerforlife]

I think they will be adding the SOC with the PI`s for some time yet,maybe a few years.I think the ploymearse inhibitors will be in the lead in this catergory

[banarep]

i have been following this study, it looks promising.  wish it would have come out a year ago.  but the telaprevir worked for me, so no complaints.