OPTIMIST-1 Study Results Show Favorable HCV GT1 Combo Therapy
Treatment with simeprevir + sofosbuvir for 12 weeks was highly effective in patients with hepatitis C virus (HCV) genotype (GT) 1 infection without cirrhosis, including those with Q80K, a new study published in Hepatology reported.
Data from the Phase 2 COSMOS study showed high sustained virological response (SVR) rates in treatment-naive and prior null-responder HCV GT1-infected patients receiving simeprevir + sofosbuvir with or without ribavirin for 12/24 weeks.
OPTIMIST-1 (n=310) was a multi-center, randomized, open-label study that evaluated the safety and efficacy of simeprevir + sofosbuvir in HCV GT1-infected treatment-naive and treatment-experienced patients without cirrhosis. Study patients were randomized to simeprevir 150mg once daily + sofosbuvir 400mg once daily for 12 or 8 weeks. The primary efficacy endpoint was SVR rate 12 weeks after end of treatment (SVR12). SVR12 superiority was compared against a composite historical control SVR rate.
Data showed that SVR12 with simeprevir + sofosbuvir for 12 weeks was superior to the historical control (97% vs. 87%). Treatment for 8 weeks, however, was not superior compared to the historical control (83% vs. 83%). Study authors noted the most frequent adverse events were nausea, headache, and fatigue. One patient in the 12-week arm and 3 patients in the 8-week arm experienced a serious adverse event unrelated to study treatment. Study findings support that simeprevir + sofosbuvir for 12 weeks in patients with HCV GT1 infection without cirrhosis is highly effective.
Sofosbuvir, a HCV NS5B polymerase inhibitor, is indicated for the treatment of genotype 1, 2, 3, or 4 HCV infection as part of a combination antiviral treatment regimen. Simeprevir, a HCV NS3/4A protease inhibitor, is indicated for chronic hepatitis C genotype 1 infection as part of a combination antiviral treatment regimen.
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