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
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Date
2017
Journal Title
Journal ISSN
Volume Title
Publisher
The Lancet Child & Adolescent Health
Abstract
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.
Methods In this single-arm, open-label trial, we enrolled virologically suppressed, HIV-infected children from
five hospital clinics in Uganda, the USA, and Thailand. Eligible participants were aged 6–11 years, weighed 25 kg or
more, had virological suppression (<50 copies of HIV-1 RNA per mL) on a stable regimen for at least 6 months,
CD4 count of more than 100 cells per μL, and no history of resistance to elvitegravir, emtricitabine, tenofovir
alafenamide, or tenofovir. All participants received the available fixed-dose oral formulation of elvitegravir 150 mg,
cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg once per day. Primary outcomes were the
pharmacokinetic parameters area under the curve (AUC) concentration at the end of the dosing interval (AUCtau) for
elvitegravir and the AUC from time zero to the last quantifiable concentration (AUClast) of tenofovir alafenamide,
treatment-emergent serious adverse events, and all treatment-emergent adverse events. Results from baseline to
week 24 are reported, unless specified otherwise. Primary and safety analyses included all enrolled participants who
received one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT01854775.
Description
Keywords
pharmacokinetics, HIV-infected children, cobicistat
Citation
Natukunda, E., Gaur, A. H., Kosalaraksa, P., Batra, J., Rakhmanina, N., Porter, D., ... & Rhee, M. S. (2017). 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. The Lancet Child & Adolescent Health, 1(1), 27-34.