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Letter to the editor re: Assessing the validity of surrogate endpoints in the context of a controversy about the measurement of effectiveness of hepatitis C virus treatment
  1. Ronald L Koretz1,
  2. Janus Christian Jakobsen2,
  3. Christian Gluud2
  1. 1 Department of Medicine, Olive View-UCLA Medical Center, Sylmar, California, USA
  2. 2 Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen, Denmark
  1. Correspondence to Dr Ronald L Koretz, Department of Medicine, Olive View-UCLA Medical Center, Sylmar, CA 91342, USA; rkoretz{at}msn.com

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After describing the formal methodology for validating surrogate outcomes, Dobler and colleagues conditionally recommend that since there is convincing evidence that direct-acting agents do produce sustained viral responses (SVRs) in patients treated for chronic hepatitis C, such treatment ‘may be appropriate’.1 They did recognise that the SVR, a surrogate outcome, has never been formally validated, but they came to their recommendation anyway based on a strong association between SVRs and important clinical outcomes and a single randomised clinical trial (RCT) of debatable quality that interferon (IFN)-based …

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