Response‐guided telaprevir therapy in prior relapsers? The role of bridging data from treatment‐naïve and experienced subjects

• Published in: Hepatology (Baltimore, Md.) Vol. 57; no. 3; pp. 897 - 902
• Main Authors: Liu, Jiang, Jadhav, Pravin R., Amur, Shashi, Fleischer, Russell, Hammerstrom, Thomas, Lewis, Linda, Naeger, Lisa, O'Rear, Jule, Pacanowski, Michael, Robertson, Sarah, Seo, Shirley, Soon, Greg, Birnkrant, Debra
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.03.2013; Wolters Kluwer Health, Inc
• Subjects: Antiviral Agents - therapeutic use; Clinical Trials, Phase II as Topic - methods; Clinical Trials, Phase III as Topic - methods; Drug Approval - methods; Drug Monitoring - methods; Drug Resistance, Viral; Drug Therapy, Combination - standards; Evidence-Based Medicine - methods; Hepatitis C, Chronic - drug therapy; Hepatology; Humans; Interferon-alpha - therapeutic use; Oligopeptides - therapeutic use; Ribavirin - therapeutic use; Secondary Prevention; United States; United States

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 pr...