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Simeprevir/Sofosbuvir Combo Provides Sustained Virologic Response in HCV Patients

Positive mid-stage data published in The Lancet

Results from the phase II COSMOS trial have been published in The Lancet. The findings demonstrate that 92% of adult patients with genotype-1 chronic hepatitis C virus (HCV) infection treated with a combination of simeprevir and sofosbuvir (Medivir/Janssen) achieved a sustained virologic response 12 weeks after the end of treatment (SVR12). The study included patients with compensated cirrhosis.

The trial involved patients with chronic HCV genotype-1 infection who had not responded to pegylated interferon (IFN) and ribavirin or who were treatment-naïve. A total of 168 patients were randomly assigned to receive simeprevir 150 mg daily or sofosbuvir 400 mg daily with (group 1) or without (group 2) ribavirin for 24 weeks or for 12 weeks with (group 3) or without (group 4) ribavirin, in two cohorts: previous non-responders with METAVIR scores of F0 to F2 (cohort 1), and previous non-responders and treatment-naïve patients with METAVIR scores of F3 to F4 (cohort 2). The study’s primary endpoint was SVR12.

According to the study, the all-oral, IFN-free treatment regimen with simeprevir and sofosbuvir resulted in consistent SVR12 rates regardless of the degree of fibrosis, and was an effective and well-tolerated therapeutic regimen in both treatment-naïve and prior null-responder patients.

Based on the new findings, two phase III trials — OPTIMIST-1 and OPTIMIST-2 — have been initiated to investigate the safety and efficacy of the simeprevir/sofosbuvir combo without IFN or ribavirin for the treatment of patients with chronic genotype-1 HCV infection.

Olysio (simeprevir, Medivir/Janssen) is an NS3/4A protease inhibitor approved by the FDA for the treatment of chronic HCV infection as a component of a combination antiviral treatment regimen. The efficacy of simeprevir has been established in patients infected with genotype-1 and genotype-4 HCV in the setting of compensated liver disease, including cirrhosis.

Sovaldi (sofosbuvir, Gilead) is an HCV nucleotide analog NS5B polymerase inhibitor. Like Olysio, it is approved for the treatment of chronic HCV infection as a component of a combination antiviral treatment regimen.

Sources: Medivir; July 28, 2014; and Lancet; July 28, 2014.

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