FDA Updates Labeling for Olysio

Issue: December 2015

The FDA recently announced revisions to product labeling for Olysio used in combination with ribavirin and peginterferon alfa for the treatment of adults with hepatitis C virus infection.

Revisions to labeling for Olysio (simeprevir, Janssen Therapeutics) included updates to dosage regimens and treatment durations for patients with HCV genotypes 1 and 4, as well as information for treatment for HCV/HIV co-infection. The updates include:

Treatment-naive patients and those who previously relapsed, patients with or without cirrhosis and without HIV or patients without cirrhosis and co-infected with HIV should be prescribed 12 weeks of simeprevir in combination with PEG-IFN-a and ribavirin, followed by an additional 12 weeks of PEG-IFN-a and ribavirin.
Treatment-naive patients who previously relapsed with cirrhosis and HCV/HIV coinfection should receive a 12-week regimen of simeprevir in combination with PEG-IFN and ribavirin, followed by 36 weeks of PEG-IFN-a and ribavirin.
In prior null responders, patients with or without cirrhosis and with or without HCV/HIV coinfection are recommended a 12-week regimen of simeprevir in combination with PEG-IFN-a and ribavirin, followed by an additional 36 weeks of PEG-IFN-a and ribavirin.

The revisions are supported by clinical data that showed simeprevir in combination with PEG-IFN-a and ribavirin had a positive safety profile among 106 patients with HCV genotype 1/HIV co-infection, as well as among 107 patients with HCV genotype 4 infection, according to the announcement. Both groups of patients had a safety profile similar to those with HCV genotype 1 mono-infection.

Other sections updated on the labeling included:

pharmacokinetics to include information on patients with HCV/HIV co-infection;
microbiology to include data on HCV genotype 4; and
clinical studies to reflect results from the HCV/HIV co-infection and HCV genotype 4 trials.

The updated labeling is available on the DailyMed website.