I am reading up on telaprevir but found that so far there are only tests done with treatment naive patients (in France?!) I have been reading that for non-responders or relapsers this will only be an option in 3 to 5 years- on the other hand I hear from some of you that this is not the case for some of you - who can give me some info???
thanks in advance Béatrice
Vertex has an ongoing trial for non--responders and relapsers. They refer to is as Prove 3. It is a phase 2 trial in FDA terminology.
Vertex is about to start a phase 3 trial (confusing since they called the phase 2 trial Prove 3) and I believe, but I am not sure, that it will include relapsers and non responders. There are rumors that Vertex will apply for approval of the drug based on the success of the Prove 3 trial. These are not substantiated, so it is anyones guess about when the drug will be available to the general public. Some people talk about 2010 - 2011 time frame.
The trial current listed on the clinical trials website is treatment naive only. The trial for non-responders and relapsers comes later, but may be entirely done in Europe. Keep your ears open and your eyes peeled.
- First hepatitis C protease inhibitor to begin Phase 3 clinical development - - Trial designed to confirm potential of telaprevir to increase sustained viral response (SVR) rates with 24-week treatment duration -
CAMBRIDGE, Mass., Mar 13, 2008 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Tibotec today announced that patient screening has begun in the ADVANCE study, a pivotal Phase 3 clinical study with the hepatitis C virus (HCV) protease inhibitor telaprevir in combination therapy for treatment-naive patients with chronic HCV infection. Telaprevir is the most advanced HCV protease inhibitor in clinical development targeting treatment of hepatitis C, a disease that afflicts more than 3 million people in the United States alone, and 170 million worldwide. The ADVANCE trial will enroll 1,050 treatment-naive genotype 1 HCV patients and will evaluate two 24-week telaprevir-based regimens in comparison to a 48-week control arm. The primary endpoint of the study is sustained viral response (SVR), defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks.
"This is the first Phase 3 study conducted to evaluate whether an investigational medicine for HCV may be able to both increase the rate of sustained viral response and shorten the duration of therapy to 24 weeks in patients with genotype 1 HCV infection compared to current treatment of 48 weeks. This is important given the expectation that approximately 40 to 50 percent of people with genotype 1 HCV who undergo treatment with current therapies achieve SVR," said John McHutchison, M.D., Associate Director, Duke Clinical Research Institute and a principal investigator for the ADVANCE study. "We're interested to see whether this trial will confirm the encouraging results seen thus far in Phase 2 studies of telaprevir. This study is another important step forward in the evaluation of novel medicines for the treatment of HCV."
"Following discussions with the U.S. FDA in January, we have been able to rapidly finalize the Phase 3 pivotal trial protocol and begin patient screening at the first sites," said John Alam, M.D., Executive Vice President, Medicines Development and Chief Medical Officer of Vertex. "The initiation of the ADVANCE trial underscores our commitment to evaluating the potential for telaprevir to address significant unmet medical needs in HCV."
The ADVANCE Study
The ADVANCE study (A New Direction in HCV Care: A Study of Treatment-Naive Hepatitis C Patients with telaprevir) will be conducted at more than 100 centers in the U.S., E.U. and certain other countries. Patient recruitment is being initiated in the U.S., while sites in other countries will start recruitment as national Clinical Trial Applications (CTAs) for each country are approved. The study arms will include:
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