EU approves Olysio for genotype 1 and 4 Hepatitis C as a combination treatment - Janssen-Cilag

Janssen-Cilag has announced that Olysio (simeprevir) has been granted marketing authorisation by the European Commission (EC) for the treatment of adults with genotype 1 and 4 chronic Hepatitis C (CHC), in combination with Solvadi (sofosbuvir), as part of an all oral 12-week IFN-free direct-acting antiviral (DAA) regimen with or without ribavirin (RBV), and with PegIFN + RBV. Patients with HCV genotype 1 or 4, regardless of prior treatment history and who are intolerant to or ineligible for interferon (IFN) treatment may be given simeprevir + sofosbuvir, with or without RBV, for 12 weeks. For treatment-na�ve and prior relapse patients with genotype 1 or 4 with or without cirrhosis and those co-infected with HIV, treatment with simeprevir must be initiated in combination with PegIFN + RBV and administered for 12 weeks, followed by an additional 12 weeks of PegIFN + RBV. For prior non-responder patients (including partial and null responders) with HCV genotype 1 or 4 and those co-infected with HIV, treatment with simeprevir must be initiated in combination with PegIFN + RBV and administered for 12 weeks, followed by an additional 36 weeks of PegIFN + RBV.

Authorisation for simeprevir with PegIFN + RBV is based on a clinical trial programme involving three pivotal Phase III studies, QUEST-1, QUEST-26 and PROMISE7. All three studies met their primary endpoints and demonstrated that simeprevir, in combination with PegIFN + RBV, achieves significant sustained virological response rates when compared with PegIFN + RBV alone. Approval for the combination of simeprevir and sofosbuvir also contains results from the Phase II study, COSMOS, in treatment-na�ve patients. This was based upon prior null responder and treatment-na�ve patients.