The US Food and Drug Administration (FDA) has approved Janssen Therapeutics' NS3/4A protease inhibitor 'Olysio (simeprevir)' for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.
According to Janssen Therapeutics, a division of Janssen Products (Janssen), Olysio is expected to benefit patients with chronic hepatitis C, including those who are treatment na?ve or for whom prior treatment wasn't effective.
Olysio blocks the viral protease enzyme allowing the hepatitis C virus (HCV) to replicate in host cells.
Major aim of the treatment for chronic hepatitis C is cure, also called sustained virologic response (SVR), which is defined as undetectable levels of HCV in the patients' blood 12 to 24 weeks after the end of treatment.
A fixed treatment regimen of 12 weeks of Olysio combined with 24 weeks of pegylated interferon and ribavirin is recommended for treatment-na?ve and prior-relapser patients, while for prior partial- and null-responder patients, a treatment regimen of 12 weeks of Olysio combined with 48 weeks of pegylated interferon and ribavirin is recommended.
Olysio is a prescription medicine and must not be taken alone, while its efficacy in combination with peginterferon and ribavirin is greatly decreased in patients who have genotype 1a Q80K, according to Janssen Therapeutics, a division of Janssen Products (Janssen).
The approval is based on efficacy and safety results from three Phase III studies including QUEST-1 and QUEST-2 in treatment-na?ve patients, and PROMISE in patients who have relapsed after prior interferon-based treatment, as well as data from the Phase IIb ASPIRE trial in prior non-responder patients.
In each of the studies, Olysio was evaluated by dosing once daily in combination with pegylated interferon and ribavirin versus treatment with placebo plus pegylated interferon and ribavirin.
