Pharmacokinetics, safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in children with HIV aged from 2 years and weighing at least 14 kg

• DOI: 10.1002/jia2.26414
• Publication Date: 2025-01-31T07:22:02Z
• Authors: Eva Natukunda; Aditya H. Gaur; Pope Kosalaraksa; Elizabeth Hellström; Renate Strehlau; Afaaf Liberty; Stephanie Cox; Rory Leisegang; Ramesh Palaparthy; Susanne Crowe; Vinicius Vieira; Kathryn Kersey; Natella Rakhmanina
• Keywords: Elvitegravir; Cobicistat; Tenofovir alafenamide; Emtricitabine

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) a Phase 2/3 study. Here, we report data from children aged ≥2 years ≥14-<25 kg. This is an analysis of the youngest cohort open-label, multicentre, multi-cohort, single-group, international study HIV. Participants this were kg at screening able to swallow tablets, on stable antiretroviral therapy virologic suppression (HIV-1 RNA <50 copies/ml for consecutive months) 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 included pharmacokinetic evaluation tablet 2. Safety, efficacy, palatability acceptability also evaluated. Between 16 January 25 November 2019, 27 enrolled median (quartile [Q]1, Q3) age 6 (4, 8) body weight 19.3 (17.0, 20.5) kg, 1061 (895, 1315) cells/µl cell percentage 37.4 (30.6, 40.3). Most (92.6%) acquired vertical transmission. On October 2020 (data-cut), (Q1, exposure 48.3 (48.0, 60.1) weeks. Pharmacokinetic parameters within safe range previous adult paediatric populations. Drug-related treatment-emergent adverse events occurred 4/27 (15%) participants. There no Grade 3/4 events, or leading discontinuation. One participant experienced serious event (Grade 2 pneumonia not considered related). Virologic (US FDA Snapshot algorithm) maintained by 26/27 (96%) Weeks 24 At 48, most reported positive (84.6%) (96.2%). These support use single-tablet regimen treatment NCT01854775.