Aa
Aa
A
A
A
Close
363072 tn?1204982439

)1.3.08 Vertex Press Release

Posted on Wednesday, Jan. 23, 2008


Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational Hepatitis C Protease Inhibitor


Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will begin Phase 3 evaluation of telaprevir, Vertex's lead investigational hepatitis C protease inhibitor. The primary focus will be a global, 3-arm pivotal controlled trial that will evaluate two 24-week telaprevir-based regimens in approximately 1050 treatment-naive genotype 1 HCV patients. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks. A second study of approximately 400-500 HCV patients is planned to evaluate a 48-week telaprevir-based regimen, to confirm the results from Phase 2 studies and provide additional evidence that supports the 24-week regimen that is being evaluated in the primary Phase 3 trial. The Company expects that both studies will run concurrently and that the first trial will begin enrolling patients in March 2008.
"Data presented in late 2007 from two large Phase 2b studies suggest that telaprevir, dosed in combination with pegylated interferon and ribavirin, may be able to meaningfully increase the proportion of treatment-naive genotype 1 HCV patients who achieve a sustained viral response, and also cut the current treatment duration in half, to 24 weeks," said John McHutchison, M.D., Principal Investigator for the primary telaprevir Phase 3 pivotal study and Associate Director of Duke Clinical Research Institute. "Telaprevir is the most advanced protease inhibitor in development for hepatitis C, and the initiation of Phase 3 clinical development for this investigational drug will begin the process of helping to further assess its potential efficacy and the safety in a larger number of patients."

Pivotal Trial to Evaluate 24-Week Telaprevir-Based Treatment Regimens



Read More...

VRTX - Vertex Pharmaceuticals Inc.
Search the Web | Search News
3 Responses
Sort by: Helpful Oldest Newest
189269 tn?1189755825
I believe that is the trial my doctor said I will be in within 2 to 3 months
Helpful - 0
223152 tn?1346978371
Even with the market as crazy as it is today, I have faith in Vertex.  

Andiamo - you are my poster child for doing so well on Vertex considering the number o f times you treated and for treating over the age of 60.  Keep up the great work.  

frijole
Helpful - 0
220090 tn?1379167187
One of the most interesting comments in the web cast was that people with RVR and undetectable at 12 weeks had a 6 percent relapse rate and that didn't change if the duration was 24 weeks or 48 weeks.  I prefer to think about it as a 94% SVR rate :)
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.