Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1

Figure 1 Patient disposition. Efficacy analyses were based on a modified intent-to-treat analysis (included all randomized and treated patients who had received ≥ 1 dose of study medication; patients with missing HCV RNA measurements were considered failures). ¹No longer met study entry criteria during the screening period (n = 139), withdrew consent (n = 28), administrative reason by sponsor (n = 5), lost to follow-up (n = 3), pretreatment AE (n = 2), or other reasons (n = 11); ²All 3 study drugs discontinued; ³Lack of efficacy (n = 15; 11 virologic breakthroughs, 3 futility, and 1 other), AE (n = 14), patient request (n = 6), lost to follow-up (n = 3), and withdrew consent (n = 1); ⁴AE (n = 17), withdrew consent (n = 2), and lost to follow-up (n = 1); ⁵Lack of efficacy (n = 23; 11 virologic breakthroughs, 4 futility, 8 other), adverse event (n = 11), lost to follow-up (n = 6), patient request (n = 1), and other (n = 3); ⁶Lack of efficacy (n = 5; 3 futility, 2 other), AE (n = 8), patient request (n = 3), lost to follow-up (n = 3), and death (n = 1; the death occurred in a patient who had discontinued treatment at week 16 due to bacteremia and died at posttreatment week 4 due to sepsis secondary to HCV-related cirrhosis). DCV: Daclatasvir; GT: Genotype; SVR12: Sustained virologic response (HCV-RNA < LLOQ) at posttreatment week 12; TVR: Telaprevir.

Figure 2 Safety secondary endpoints in GT1b-infected patients (first 12 wk). mITT analysis (patients with missing data at posttreatment week 12 were considered failures). ¹Superior at the 5% significance level; upper bound of the 95%CI was 0%; ²One patient in the TVR arm had no measurement due to discontinuation prior to on-treatment laboratory assessment; ³Includes rash-related SAEs, AEs leading to discontinuation, and grade 3 or 4 AEs. AE: Adverse event; CI: Confidence interval; DCV: Daclatasvir; GT: Genotype; Hgb: Hemoglobin; pegIFN: Peginterferon alfa-2a; RBV: Ribavirin; SAE: Serious adverse event; TVR: Telaprevir.