Medivir AB has announced that Health Canada has approved as a new treatment for hepatitis C.
Simeprevir will be approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment‑naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin. The approval of simeprevir in Canada is based on four pivotal studies of patients with CHC genotype 1 infection: in treatment-naïve patients (QUEST-1 and QUEST-2), and in patients who have failed prior treatment with pegylated interferon and ribavirin; in PROMISE (prior relapsers) and ASPIRE (prior non-responders).
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and its affiliated companies and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the viral protease enzyme that enables the hepatitis C virus to replicate in host cells.