INDICATIONS AND USAGE
is indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
This indication is based on analyses of plasma HIV-1 RNA levels up through 48 weeks in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naïve adults.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies].
The safety and efficacy of ISENTRESS have not been established in pediatric patients.