New Phase 3 Study Results Presented for Simeprevir
Medivir AB announced new Phase 3 results for once-daily simeprevir at the Conference of the Asian Pacific Association for the Study of the Liver (APASL).
Results from the ATTAIN showed that the study met its primary efficacy endpoint by demonstrating non-inferiority of simeprevir compared to telaprevir when both are given in combination with PegIFN/RBV. In the study, 54% of chronic HCV genotype 1 prior partial- and null-responder patients treated with simeprevir once daily + PegIFN/RBV achieved sustained virologic response 12 weeks after end of treatment (SVR12) compared to 55% of patients treated with telaprevir administered three-times daily + PegIFN/RBV.
Analyses from the QUEST-1 and QUEST-2 studies confirmed efficacy in treatment-naïve genotype 1b HCV patients, with 85% of treatment-naïve patients achieving SVR12 when treated with simeprevir + PegIFN/RBV, compared to 53% when treated with placebo + PegIFN/RBV.
A subgroup analysis of genotype 1b patients in the PROMISE Phase 3 trial demonstrated that 86% of these patients achieved SVR12 when treated with simeprevir + PegIFN/RBV, compared to 43% when treated with placebo + PegIFN/RBV.
Simeprevir (marketed as Olysio; Janssen Therapeutics) is an NS3/4A protease inhibitor approved for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 infected patients with compensated liver disease, including cirrhosis.
For more information call (800) 526-7736 or visit Olysio.com.