Indicated in combination with other antiretroviral agents in adults and children aged 12 years and older and weighing at least 40 kg Not recommended in pediatric patients <12 years or weighing < 40 kg Safety and efficacy have not been established in pediatric patients who are integrase strand transfer ibitor (INSTI)-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir) The safety, virologic, and unologic were evaluated in 23 treatment-experienced, INSTI-naïve, HIV-1 infected patients aged 12 - < 18 years in an open-label, multicenter, dose-finding clinical trial Adverse reactions were similar to those observed in adults Information on dosing, clinical trial, and PK New drug
|