The Results of Phase III Clinical Trials With Telaprevir and Boceprevir Presented at the Liver Meeting 2010: A New Standard of Care for Hepatitis C Virus Genotype 1 Infection, But With Issues Still Pending  Jean–Michel Pawlotsky  Gastroenterology  Volume 140, Issue 3, Pages 746-754 (March 2011) DOI: 10.1053/j.gastro.2011.01.028 Copyright © 2011 AGA Institute Terms and Conditions

Figure 1 Design of the 3 Phase III trials with telaprevir. Patients infected with HCV genotype 1 were treated with pegylated IFN-α2a, 180 μg/week, ribavirin, 1.0–1.2 g/d according to body weight, and telaprevir 750 mg every 8 hours. The 3 trials included (A) ADVANCE in treatment-naïve patients,3 (B) ILLUMINATE in treatment-naïve patients,4 and (C) REALIZE in treatment-experienced patients. Telaprevir administration is shown in black, pegylated IFN-α2a and ribavirin administration with or without a telaprevir placebo in gray, and follow-up in white. P, pegylated IFN-α2a; R, ribavirin; T, telaprevir; pl, telaprevir placebo; FU, follow-up; eRVR, extended rapid virologic response, that is, undetectable HCV RNA at week 4 that remains undetectable at week 12 of therapy (lower limit of detection, 25 IU/mL). Gastroenterology 2011 140, 746-754DOI: (10.1053/j.gastro.2011.01.028) Copyright © 2011 AGA Institute Terms and Conditions

Figure 2 Design of the 2 Phase III trials with boceprevir. Patients infected with HCV genotype 1 were treated with pegylated IFN-α2b, 1.5 μg/kg/week, ribavirin, 0.8–1.4 g/d according to body weight, and boceprevir, 800 mg 3 times per day. The 2 trials included (A) SPRINT-2 in treatment-naïve patients,1 and (B) RESPOND-2 in treatment-experienced patients.2 In RESPOND-2, null-responders (i.e., patients who did not achieve a 2-log10 HCV RNA level drop at week 12 of the first course of pegylated IFN-α and ribavirin) were excluded. Boceprevir administration is shown in black, pegylated IFN-α2b and ribavirin administration with or without a boceprevir placebo in gray, and follow-up in white. P, pegylated IFN-α2b; R, ribavirin; B, boceprevir; pl, boceprevir placebo; FU, follow-up; RVR, rapid virologic response, i.e. undetectable HCV RNA at week 4 of boceprevir administration, that is, at week 8 of therapy (lower limit of detection, 9.3 IU/mL); RVR8-24: RVR with HCV still undetectable at week 24. Gastroenterology 2011 140, 746-754DOI: (10.1053/j.gastro.2011.01.028) Copyright © 2011 AGA Institute Terms and Conditions