Tu1015 MALACHITE-II: Phase 3b Trial of Ombitasvir/Paritaprevir/R and Dasabuvir + Ribavirin or Telaprevir + Peginterferon/Ribavirin in Peginterferon/Ribavirin Treatment-Experienced Adults With HCV Genotype 1

Abstract

A S L D A b st ra ct s rates in patients treated with DCV/ASV/BCV combined with RBV and in patients with GT1b subtype. Other baseline factors such as age, gender, BMI, IL28B genotype, HCV RNA >800,000 IU/mL, and platelet count <100 × 109/L did not appear to impact SVR12 rates in either cohort (Table). Similarly, race did not appear to influence SVR12 rates; of the 20 black patients enrolled in the study, all 20 achieved SVR12. Prior null response to pegIFN did not significantly impact outcome in the treatment-experienced cohort. Baseline resistanceassociated variants (RAVs) in NS5A (28, 30, 31, 93) or NS3 (168) did not impact SVR: 26/ 28 patients with NS5A RAVs and 2/2 patients with NS3 RAVs achieved SVR12. NS5B-P495 was not detected at baseline. Among patients with virologic failure, RAVs were detected in NS5A (Q30, Y93, L31), NS3 (R155, D168) and NS5B (P495, P421). Conclusion: The alloral fixed-dose combination of DCV, ASV, and BCV achieved high rates of SVR12 in patients with HCV genotype 1 infection and compensated cirrhosis. The strongest predictors of SVR12 were GT1b and use of RBV. Factors often associated with reduced responses to less potent regimens, such as advanced age, black race, prior null response to pegIFN, high baseline HCV RNA levels, low platelet counts, non-CC IL28B genotype, and baseline NS5A or NS3 RAVs did not appear to impact SVR12 rates.