Janssen Therapeutics announced that the FDA has approved Olysio (simeprevir) 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.
Olysio, an investigational NS3/4A protease inhibitor works by blocking the viral protease enzyme that enables the hepatitis C virus (HCV) to replicate in host cells.
The safety and effectiveness of Olysio were evaluated in five clinical studies of 2,026 treatment-naive and treatment-experienced participants randomly assigned to receive Olysio plus peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa and ribavirin.
The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.
Results showed 80% of treatment-naive participants given Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response, compared to 50% of participants receiving peginterferon-alfa and ribavirin alone.
In one of the studies with treatment-experienced participants whose infection returned (prior relapsers), 79% receiving Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response compared to 37% of participants receiving peginterferon-alfa and ribavirin alone.
Another study examined Olysio’s safety and effectiveness in treatment-experienced participants, including prior relapsers, those who partially responded to prior therapy (partial responders) and those who did not respond to prior therapy (null responders). Adding Olysio improved response rates in each of these subgroups compared to peginterferon-alfa and ribavirin alone.
The efficacy of Olysio is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism at baseline compared to patients infected with HCV genotype 1a without the Q80K polymorphism.
The prescribing information for Olysio includes a recommendation to screen patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism at baseline and to consider alternative therapy for patients infected with this strain.
Olysio will be available as 150mg capsules in 7- or 28-count bottles.
For more information call (800) 526-7736 or visit Olysio.com.