Isentress 400 mg, film-coated tablets

( ARTG ) ISENTRESS or ISENTRESS HD, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients over the age of 2 years and weighing at least 25 kg. This indication is based on analyses of plasma HIV-1 RNA levels in controlled studies of ISENTRESS (see Section 5.1). The indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24 weeks in a multicentre, open label, non-comparative study in HIV-1 infected, treatment-experienced children and adolescents 2 to 18 years of age. The use of other active antiretroviral agents in combination with ISENTRESS is associated with a greater likelihood of treatment response (see Section 5.1). There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.