OLYSIO (simeprevir), direct-acting antiviral

Minor improvement in the treatment of adults infected with hepatitis C virus genotypes 1 and 4

• OLYSIO has Marketing Authorisation in combination with other medicinal products in the treatment of chronic hepatitis C in adults infected with hepatitis C virus (HCV).
• In combination with sofosbuvir, simeprevir may provide a cure for the majority of patients with hepatitis C, with or without extrahepatic manifestations. Simeprevir treatment should be offered as a priority in all patients whose hepatic disease is at fibrosis stage F3 or F4 and in certain special populations. Patients at fibrosis stage F2 should also receive new treatments within a short time. For F0 or F1 patients, treatment may be delayed depending on the progression of the disease and the patient's background.
• OLYSIO provides a minor therapeutic advance in the treatment of genotype 1 and 4 chronic hepatitis C given:

- the level of virological efficacy in patients infected with genotype 1 and 4 HCV of simeprevir + peginterferon/ribavirin, which is greater than that of peginterferon/ribavirin,

- the number of effects equivalent to that described with the first protease inhibitors (telaprevir and boceprevir) in genotype 1 patients but lower than that described with sofosbuvir + peginterferon/ribavirin triple therapy,

- the safety profile comparable with that of telaprevir,

- the significant risk of developing resistance in the event of treatment failure,

- the possible use without interferon in combination with sofosbuvir (with or without ribavirin) on the basis of clinical data with a non-optimal level of evidence.

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