The Food and Drug Administration (FDA) has approved label changes for simeprevir; (Olysio, 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 and ribavirin followed by an additional 12 weeks of peginterferon and 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 and ribavirin followed by an additional 36 weeks of peginterferon alfa and 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 exposure in patients with HCV genotype 1 infection with HIV-1 co-infection compared to patients 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.
This article originally appeared on MPR