FDA Approves Olysio Use in HIV Co-Infection, HCV Genotype 4
The Food and Drug Administration (FDA) has approved label changes for Olysio (simeprevir; Janssen) to include dosing recommendations for the treatment of hepatitis C virus (HCV)/HIV-1 co-infection, and to expand the indications and usage to include genotype 4 infection.
The updated label now includes recommended dosage regimens and treatment duration for genotype 1 and HCV/HIV-1 co-infected patients. For treatment-naive patients and prior relapsers without cirrhosis who are co-infected with HIV, 12 weeks of Olysio in combination with peginterferon alfa + ribavirin followed by an additional 12 weeks of peginterferon + ribavirin (total treatment duration of 24 weeks is recommended. For those with cirrhosis who are co-infected with HIV or prior non-responders (including partial and null responders) with or without cirrhosis, with or without HIV co-infection, 12 weeks of Olysio in combination with peginterferon alfa + ribavirin followed by an additional 36 weeks of peginterferon alfa + ribavirin (total treatment duration 48 weeks) is recommended.
The Adverse Reactions section was updated with safety profile information in a study of 106 subjects with HCV genotype 1/HIV-1 co-infection and a study of 107 subjects with HCV genotype 4 infection. In addition, azithromycin, bedaquiline, and dolutegravir were added to the list of drugs without clinically significant interactions with Olysio.
The Pharmacokinetics section includes data regarding slightly lower Olysio exposure in subjects with HCV genotype 1 infection with HIV-1 co-infection compared to subjects with HCV genotype 1 mono-infection. The Microbiology section of the label was updated to include additional data on HCV genotype 4.
The Clinical Studies section was also updated to include trial data from the HCV/HIV co-infected trial and the HCV genotype 4 trials.
Olysio is a HCV NS3/4A protease inhibitor currently approved to treat chronic hepatitis C genotype 1 infection as a component of a combination antiviral treatment regimen.
For more information call (800) 526-7736 or visit Olysio.com.