Volume 147, Issue 6, Pages 1196-1200 (December 2014) FDA Perspective on Sofosbuvir Therapy for Patients With Chronic Hepatitis C Virus Genotype 1 Infection Who Did Not Respond to Treatment With Pegylated Interferon and Ribavirin  Poonam Mishra, Jeffry Florian, Karen Qi, Wen Zeng, Lisa K. Naeger, Eric Donaldson, Sarah Connelly, Jules O’Rear, Dionne Price, Jeffrey Murray, Debra Birnkrant  Gastroenterology  Volume 147, Issue 6, Pages 1196-1200 (December 2014) DOI: 10.1053/j.gastro.2014.10.027 Copyright © 2014 AGA Institute Terms and Conditions

Figure 1 NEUTRINO study design. Gastroenterology 2014 147, 1196-1200DOI: (10.1053/j.gastro.2014.10.027) Copyright © 2014 AGA Institute Terms and Conditions

Figure 2 Predicted response rates in genotype 1 (GT1) pegylated interferon plus ribavirin (P/R) treatment-experienced population. (A) Historically, ≥50% treatment-naïve patients did not respond to a PEG+RBV regimen and were classified as P/R treatment failures. (B) Response rates in GT1 subjects (sustained virologic response rate 12 weeks after completing therapy [SVR12] rate of 89%) observed in the NEUTRINO study. (C) Combining these groups, 50% of subjects in the NEUTRINO study were potential P/R treatment failures and the predicted response rate was 39% in these potential P/R treatment failures. The increased response rates seen in GT1 subjects in the NEUTRINO study over that typically observed for PEG+RBV treatment most likely come from the population that would have been classified as PEG+RBV treatment failures. Gastroenterology 2014 147, 1196-1200DOI: (10.1053/j.gastro.2014.10.027) Copyright © 2014 AGA Institute Terms and Conditions