Earlier Sustained Virologic Response End Points for Regulatory Approval
Cinnamon Girl said
May 30, 2013
Earlier Sustained Virologic Response End Points for Regulatory Approval
Abstract - Background & Aims
Trials of therapies for chronic hepatitis C have used detection of hepatitis C virus (HCV) at week 24 of follow-up (sustained virologic response [SVR] 24) as a primary end point. However, there is increasing evidence that most patients who have an SVR at earlier time points (such as SVR12) maintain it until week 24. Use of earlier time points for key regulatory decisions (SVR12) and dose selection (SVR4) could facilitate HCV drug development.
Earlier Sustained Virologic Response End Points for Regulatory Approval
Abstract - Background & Aims