Positive Simeprevir Data in Multiple Phase 2 and 3 Studies
Janssen announced positive new data from the simeprevir clinical program, including data from cohort 1 and 2 of the Phase 2 COSMOS study and new subgroup analyses of Phase 3 data in European and genotype 4 HCV patients, at the International Liver Congress 2014.
The COSMOS study evaluated simeprevir (Olysio), a protease inhibitor, in combination with once-daily sofosbuvir (Sovaldi; Gilead Sciences), a nucleotide inhibitor, with and without ribavirin (RBV), in adult patients with chronic genotype 1 hepatitis C virus (HCV) infection.
Final results from cohort 2 of the COSMOS study found that overall, 94% of genotype 1 treatment-naïve and prior null-responder HCV patients, with advanced liver fibrosis (METAVIR F3 or F4 scores) treated with simeprevir + sofosbuvir, with or without RBV, for either 12 or 24 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). Those treated with simeprevir and sofosbuvir alone, 93% and 100% of patients achieved SVR12 after 12 weeks and 24 weeks of treatment, respectively. Study authors noted that the addition of RBV did not improve SVR rates. Also, 97% of HCV genotype 1a patients without Q80K achieved SVR12 after 12 or 24 weeks of treatment regardless of treatment regimen.
Data analysis from cohort 1 of the COSMOS study showed that overall 97% and 96% of genotype 1 HCV patients with METAVIR F0–F1 scores and F2 scores, respectively, treated with simeprevir and sofosbuvir alone achieved SVR12 after both 12 and 24 weeks of treatment. All of the patients treated with the ribavirin-containing regimen achieved SVR12 after 12 weeks and 24 weeks of treatment, respectively.
In the Phase 3 RESTORE trial of simeprevir + pegylated interferon (PegIFN) + RBV in HCV genotype 4 treatment-naïve and treatment-experienced patients, overall 65% of patients achieved SVR12, including 83% of treatment-naïve patients, 86% of prior relapsers, 60% of prior partial responders, and 40% of prior null responders. Among those with genotype 4a and 4d HCV, 69% and 52% achieved SVR12, respectively.
QUEST-1 and QUEST-2
Pooled efficacy data from the QUESt-1 and QUEST-2 studies showed that 87% of European patients treated with simeprevir in combination with PegIFN + RBV achieved SVR12, compared to 81% in the overall study population.
An analysis from the PROMISE study showed 88% of European patients treated with simeprevir + PegIFN and RBV achieved SVR12 compared to 79% in the overall study population.
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