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."
Mediterranean diet and exercise reshape gut microbiome, aiding weight loss