Single-Tablet Elvitegravir, Cobicistat, Emtricitabine, & Tenofovir Alafenamide in Virologic Suppressed Children with HIV



Title: 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

Natukunda, E et al.


 

What You Need to Know:

According to results of single-arm study, the once-daily, single-tablet combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide approved for patients >12 years old, was also found to be safe and effective in HIV-infected, virologically suppressed children.

Trial Design:

  • Single-arm, open-label study evaluated the safety, efficacy and pharmacokinetic profile of the single-tablet regimen in virologically suppressed, HIV-infected children aged 6-11 years
  • Each patient received 1 single-tablet of 150mg of elvitegravir, 150mg of cobicistat, 200mg of emtricitabine, and 10mg of tenofovir alafenamide daily
  • Inclusion criteria: 6-11 years old, ≥25kg, <50 copies of HIV-1 RNA/mL while taking a stable regimen for ≥6 months, CD4 count of >100 cells/L, no history of resistance to elvitegravir, emtricitabine, tenofovir alafenamide, or tenofovir
  • Primary endpoints: “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”
  • Analysis included all patients who received 1 dose of the study medication

Key Outcomes:

  • 23 children were enrolled in the trial
  • Mean AUCtau of elvitegravir: 33,814 ng x h/mL (58% coefficient of variation)
  • Mean AUClast of tenofovir alafenamide: 333 ng x h/mL (45% coefficient of variation)
  • Compared to exposures in adults that were previously reported, exposures in children were only modestly higher for each component of the fixed-dose regimen
  • No serious adverse events or discontinuations of treatment due to adverse events were reported
  • Virological suppression was maintained at week 24 in all patients
  • CD4 count: reduced by a median of -130 cells/L (range: -472, 266)
  • CD4 cell percentage: little change was observed (-2.1%; range: -8.4, 5.9)