Volume 146, Issue 7, Pages e3 (June 2014)

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Volume 146, Issue 7, Pages 1669-1679.e3 (June 2014) Simeprevir With Peginterferon and Ribavirin Leads to High Rates of SVR in Patients With HCV Genotype 1 Who Relapsed After Previous Therapy: A Phase 3 Trial Xavier Forns, Eric Lawitz, Stefan Zeuzem, Ed Gane, Jean Pierre Bronowicki, Pietro Andreone, Andrzej Horban, Ashley Brown, Monika Peeters, Oliver Lenz, Sivi Ouwerkerk–Mahadevan, Jane Scott, Guy De La Rosa, Ronald Kalmeijer, Rekha Sinha, Maria Beumont– Mauviel Gastroenterology Volume 146, Issue 7, Pages 1669-1679.e3 (June 2014) DOI: 10.1053/j.gastro.2014.02.051 Copyright © 2014 AGA Institute Terms and Conditions

Figure 1 (A) SVR12 rates. (B) Differences in SVR12 by patient subgroup. Differences in the proportions and their respective CIs are derived from a logistic regression model including factors for treatment group, baseline HCV RNA (log10 IU/mL), HCV 1 subtype, and IL28B. Gastroenterology 2014 146, 1669-1679.e3DOI: (10.1053/j.gastro.2014.02.051) Copyright © 2014 AGA Institute Terms and Conditions

Figure 2 Change in score from baseline in (A) patient-reported fatigue, (B) productivity impairment, (C) activity impairment, and (D) absenteeism. Gastroenterology 2014 146, 1669-1679.e3DOI: (10.1053/j.gastro.2014.02.051) Copyright © 2014 AGA Institute Terms and Conditions

Supplementary Figure 1 Study design. Response-guided treatment in simeprevir (SMV) arm: if HCV-RNA level was less than 25 IU/mL at week 4 and undetectable at week 12, complete treatment at week 24. Stopping rules: if HCV-RNA level was greater than 1000 IU/mL at week 4, stop SMV/placebo; if HCV-RNA level was less than 2 log10 IU/mL reduction at week 12, or confirmed 25 IU/mL or greater at week 24 or 36, stop all treatment. PR, peginterferon α-2a 180 μg/week + ribavirin 1000–1200 mg/day; QD, once daily; SMV, simeprevir. Gastroenterology 2014 146, 1669-1679.e3DOI: (10.1053/j.gastro.2014.02.051) Copyright © 2014 AGA Institute Terms and Conditions

Supplementary Figure 2 Patient disposition. Gastroenterology 2014 146, 1669-1679.e3DOI: (10.1053/j.gastro.2014.02.051) Copyright © 2014 AGA Institute Terms and Conditions