FDA News

FDA updates labeling for Olysio

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.

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.