In a clinical trial known as PROVE 3 published in this week's New England Journal of Medicine, treatment with telaprevir-based regimens significantly increased rates of sustained viral response (SVR) in patients with genotype 1 hepatitis C virus (HCV) infection who did not achieve SVR with at least one prior course of pegylated-interferon and ribavirin therapy. In the trial, 51 percent and 53 percent of patients who received telaprevir in combination with pegylated-interferon and ribavirin as part of a 24-week or 48-week regimen, respectively, achieved SVR. In the control arm, 14 percent of patients achieved SVR. Discontinuation of study drugs because of adverse events was more frequent in patients who received a telaprevir-based regimen than in patients who received only pegylated-interferon and ribavirin. Telaprevir is an investigational oral HCV protease inhibitor being developed by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) in collaboration with Tibotec and Mitsubishi Tanabe Pharma. A Phase 3 registration program for telaprevir is nearing completion, and Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) for telaprevir in the second half of 2010 for both treatment-naïve and treatment-failure patients.
“More than half our patients with genotype 1 infection don't respond to pegylated-interferon and ribavirin, and they have a very limited chance of achieving permanent viral eradication when re-treated using currently approved therapies”
Chronic HCV infection affects up to 3.9 million individuals in the United States. Approximately 40 to 46 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin achieve SVR, or a viral cure. Patients who do not achieve SVR with an initial regimen of pegylated-interferon and ribavirin have a low likelihood of success with re-treatment with pegylated-interferon and ribavirin.
"More than half our patients with genotype 1 infection don't respond to pegylated-interferon and ribavirin, and they have a very limited chance of achieving permanent viral eradication when re-treated using currently approved therapies," said John McHutchison, M.D., Lead Investigator for the PROVE 3 trial and Associate Director of the Duke Clinical Research Institute. "There is, therefore, a clear need for more effective treatment options in these patients. The significantly higher SVR rates observed in the PROVE 3 trial with telaprevir-based regimens represent an important step forward in the potential future treatment of patients who have failed current therapies."
"More than 50 percent of the treatment-failure patients who received telaprevir in combination with pegylated-interferon and ribavirin in the PROVE 3 trial achieved a sustained viral response - a striking result in this difficult-to-treat patient population," said Robert Kauffman, M.D., Ph.D., Senior Vice President, Clinical Development and Chief Medical Officer for Vertex. "Based on the PROVE 3 data, as well as clinical data from the PROVE 1 and PROVE 2 trials in treatment-naïve patients published in the New England Journal of Medicine in April 2009, Vertex is currently evaluating telaprevir in a global Phase 3 registration program that enrolled more than 2,200 treatment-failure and treatment-naïve HCV patients. Assuming the trials are successful, we expect to submit an application for approval of telaprevir with the U.S. FDA in the second half of 2010."
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