Direct‐acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs

• Published in: Hepatology (Baltimore, Md.) Vol. 62; no. 4; pp. 1298 - 1303
• Main Authors: Mishra, Poonam, Murray, Jeffrey, Birnkrant, Debra
• Format: Journal Article
• Language: English
• Published: United States Wolters Kluwer Health, Inc 01.10.2015
• Subjects: Antiviral Agents - therapeutic use; Clinical Trials as Topic - methods; Clinical Trials as Topic - standards; Drug Approval - methods; Forecasting; Hepatitis; Hepatitis C; Hepatitis C virus; Hepatitis C, Chronic - drug therapy; Humans; Interferon; Pharmaceutical industry; Research Design - standards; Research Design - trends; United States; United States Food and Drug Administration; United States

Therapeutic options for treatment of chronic hepatitis C have improved substantially since the approval of direct‐acting antiviral agents (DAAs). Several interferon (IFN)‐free or IFN‐ and ribavirin (RBV)‐free treatment regimens with shorter durations and improved efficacy and safety profiles are now...