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.

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