Raltegravir: a review of its use in the management of HIV-1 infection in children and adolescents.

Raltegravir (ISENTRESS(®)) is an HIV-1 integrase strand transfer inhibitor that is well established as a component of highly active antiretroviral therapy regimens for the treatment of adults with HIV-1 infection, and has recently been approved for the treatment of HIV-1-infected children and adolescents aged 2-18 years. A new chewable formulation has been introduced and results of a pharmacokinetic study have led to the establishment of dosages for this formulation for children. In a phase I/II, open-label, multicentre, clinical trial, raltegravir (administered as the chewable or the film-coated tablet) in combination with optimized background antiretroviral therapy was an effective treatment for treatment-experienced children and adolescents with HIV-1 infection, in terms of virologic measures of efficacy (i.e. a decrease of in HIV-1 RNA levels of ≥1 log(10), or an HIV-1 RNA level of <400 copies/mL at the 24-week primary efficacy assessment), with virologic efficacy sustained at the 48-week assessment. Immunologic improvements (increases from baseline in CD4+ cell counts) were also observed. As a component of combination therapy, raltegravir was generally well tolerated over a period of up to 48 weeks. Raltegravir is an important new option for the treatment of children and adolescents with HIV-1 infection, and the introduction of a new chewable formulation (allowing dosage flexibility) extends its benefits to the treatment of younger children.