Safety, efficacy, and pharmacokinetics of single-tablet elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed, HIV-infected children: a single-arm, open-label trial.

Journal: The Lancet. Child & adolescent health
Published Date: Jun 29, 2017

Abstract

BACKGROUND: No once-daily single-tablet regimen is available for HIV-infected children under 12 years. The single-tablet, fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is a once-daily, integrase strand transfer inhibitor-based regimen approved in the USA and European Union for individuals aged 12 years or older. In this study, we aimed to assess the pharmacokinetics, safety, and efficacy of this regimen in virologically suppressed, HIV-infected children.

Authors

  • Eva Natukunda
    Joint Clinical Research Centre, Kampala, Uganda.
  • Aditya H Gaur
    St Jude Children's Research Hospital, Memphis, TN, USA.
  • Pope Kosalaraksa
    Khon Kaen University, Khon Kaen, Thailand.
  • Jagmohan Batra
    Miller Children's Hospital, Long Beach, CA, USA.
  • Natella Rakhmanina
    Children's Research Institute-Children's National Medical Center, Washington, DC, USA.
  • Danielle Porter
    Gilead Sciences, Foster City, CA, USA.
  • Yongwu Shao
    Gilead Sciences, Foster City, CA, USA.
  • Heather Zhang
    Gilead Sciences, Foster City, CA, USA.
  • Cheryl Pikora
    Gilead Sciences, Foster City, CA, USA.
  • Martin S Rhee
    Gilead Sciences, Foster City, CA, USA. Electronic address: martin.rhee@gilead.com.

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