Response‐guided telaprevir therapy in prior relapsers? The role of bridging data from treatment‐naïve and experienced subjects
Jiang Liu, Pravin R. Jadhav, Shashi Amur, Russell Fleischer, Thomas Hammerstrom, Linda Lewis, Lisa Naeger, Jule O'Rear, Michael Pacanowski, Sarah Robertson, Shirley Seo, Greg Soon, Debra Birnkrant – 6 April 2012 – The purpose of this report is to illustrate the US Food and Drug Administration's rationale for approving response‐guided therapy (RGT) for telaprevir (TVR) in combination with pegylated interferon‐α and ribavirin (P/R) for the treatment of adults with genotype 1 chronic hepatitis C who were prior relapsers.