Pharmacokinetics, Safety and Efficacy of Elvitegravir/cobicistat/emtricitabine/tenofovir Alafenamide in Children with HIV Aged from 2 Years and Weighing at Least 14 Kg

Overview

Journal J Int AIDS Soc

Date 2025 Jan 31

PMID 39888251

Authors

Eva Natukunda

Aditya H Gaur

Pope Kosalaraksa

Elizabeth Hellstrom

Renate Strehlau

Afaaf Liberty

Stephanie Cox

Rory Leisegang

Ramesh Palaparthy

Susanne Crowe

Vinicius Vieira

Kathryn Kersey

Natella Rakhmanina

Affiliations

Soon will be listed here.

Abstract

Introduction: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) was efficacious and well tolerated in children/adolescents with HIV (aged ≥6 years, weighing ≥25 kg) in a Phase 2/3 study. Here, we report data from children aged ≥2 years and weighing ≥14-<25 kg.

Methods: This is an analysis of data from the youngest cohort in an open-label, multicentre, multi-cohort, single-group, international study of children/adolescents with HIV. Participants in this cohort were children aged ≥2 years, weighing ≥14-<25 kg at screening and able to swallow tablets, on stable antiretroviral therapy with virologic suppression (HIV-1 RNA <50 copies/ml for ≥6 consecutive months) and a CD4 count ≥400 cells/µl. Eligible participants received low-dose E/C/F/TAF (90/90/120/6 mg) once daily through Week 48. The study included pharmacokinetic evaluation of the low-dose E/C/F/TAF tablet at Week 2. Safety, efficacy, palatability and acceptability were also evaluated.

Results: Between 16 January and 25 November 2019, 27 participants were enrolled with a median (quartile [Q]1, Q3) age of 6 (4, 8) years, body weight of 19.3 (17.0, 20.5) kg, CD4 count of 1061 (895, 1315) cells/µl and CD4 cell percentage of 37.4 (30.6, 40.3). Most (92.6%) participants acquired HIV through vertical transmission. On 6 October 2020 (data-cut), median (Q1, Q3) exposure to E/C/F/TAF was 48.3 (48.0, 60.1) weeks. Pharmacokinetic parameters were within the safe and efficacious range of previous data in adult and paediatric populations. Drug-related treatment-emergent adverse events occurred in 4/27 (15%) participants. There were no Grade 3/4 adverse events, or adverse events leading to E/C/F/TAF discontinuation. One participant experienced a serious treatment-emergent adverse event (Grade 2 pneumonia not considered E/C/F/TAF related). Virologic suppression (US FDA Snapshot algorithm) was maintained by 26/27 (96%) participants at Weeks 24 and 48. At Week 48, most children reported positive palatability (84.6%) and acceptability (96.2%).

Conclusions: These data support the use of single-tablet E/C/F/TAF (90/90/120/6 mg) regimen for the treatment of HIV in children aged ≥2 years and weighing ≥14-<25 kg.

Clinical Trial Number: NCT01854775.

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