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Raltegravir: A Review of Its Use in the Management of HIV-1 Infection in Children and Adolescents

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Abstract

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 log10, 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.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Caroline M. Perry

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Correspondence to Caroline M. Perry.

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The manuscript was reviewed by: B. S. Eley, Paediatric Infectious Diseases Unit, Red Cross War Memorial Children’s Hospital, University of Cape Town, Cape Town, South Africa; V. Giacomet, Infectious Disease Unit, Department of Paediatrics, Luigi Sacco Hospital, Milan, Italy; S. Nachman, Department of Pediatrics, State University of New York at Stony Brook, Stony Brook, New York, USA; J. T. Ramos, Infectious Disease Unit, Hospital Universitario de Getafe, Getafe, Madrid, Spain.

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Perry, C.M. Raltegravir: A Review of Its Use in the Management of HIV-1 Infection in Children and Adolescents. Pediatr Drugs 16, 91–100 (2014). https://doi.org/10.1007/s40272-013-0058-9

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