A new study published in The Lancet Child & Adolescent Health showed that a once-daily fixed-dose coformulation of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide was safe and efficacious in children with HIV.
Researchers enrolled 23 children (age 6-11 years; median age 10; median weight 30.5 kg) with virologic suppression who had been on a stable treatment regimen for ≥6 months. Participants were treated with a fixed-dose formulation of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg once per day for 24 weeks.
Following the final drug dose, the mean average area under the curve (AUC) concentration for elvitegravir was 33,814 ng×h/mL. For tenofovir alafenamide, the AUC from time zero to the last quantifiable concentration was 333 ng×h/mL. According to the researchers, the exposures to elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide were modestly higher in children compared with previous reports for adults.
No serious adverse events or adverse-event-related discontinuations were reported, indicating good tolerability. Drug-related adverse events included abdominal pain (17%) and vomiting (17%).
At week 24, all participants still had virologic suppression (HIV-1 RNA <50 copies/mL), but median CD4 count had decreased by 130 cells/µL. However, by week 32, median CD4 count had increased close to baseline values (849 cells/µL; n=19).
The study authors noted that this combination treatment may “fill an unmet need” by providing a potent, safe, single-tablet option for children with HIV.
Natukunda E, Gaur AH, Kosalaraksa P, et al. 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. Lancet Child Adolesc Health. 2017;1:27-34.