Single-tablet regimen shows promise as HIV treatment for young children
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Children with HIV aged between 3 and 9 years maintained virologic suppression on a low-dose, single-tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, researchers reported.
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) is approved for children aged at least 6 years and weighing at least 25 kg, said Cheryl Pikora, MD, PhD, MPH, senior medical director of global clinical research at Gilead Sciences, and colleagues.
“We have moved into this younger group of kids to look at this same investigational drug in [terms of] the pharmacokinetics, safety, tolerability and efficacy over 24 weeks,” Pikora explained to Healio.
Pikora and colleagues enrolled 27 virologically suppressed children in the study (median age, 6 years) weighing between 14 and 25 kg. Each participant began a regimen of single-dose E/C/F/TAF, and was observed for 24 weeks. The findings were presented during AIDS 2020.
“This study showed they maintained virologic suppression over the 24 weeks that we followed them ... and all were able to swallow the tablet, which is kind of huge, because these are children as young as 3 years,” Pikora told Healio.
Adverse events reported were all graded either 1 or 2. Six children showed an adverse event — five with a cough, and four with decreased appetite.
All participants maintained HIV-1 RNA less than 50 c/mL at week 16, whereas at week 24, one child reported HIV-1 RNA between 200 and 400 c/mL. Safety and efficacy of the low-dose single-tablet regimen in young children was consistent with the efficacy of the full-strength regimen in older populations.
“The fact that this regimen leads to high levels of adherence and virologic suppression is so important to this group because they face lifelong treatment. This is really a strong clinical implication,” Pikora said. “In my past life, for 20 plus years, I’ve been a pediatrician caring for children with HIV and I can attest to you that adherence is really frequently an issue with children of all ages.”
The researchers reported that most of the children found swallowability, acceptability and palatability favorable at all assessable time points.
“We're very pleased that all the children were able to swallow this tablet, because a 3-year-old may not be able to take all formulations, especially in tablet form,” Pikora said. “So that was one of the outcomes that we were particularly pleased to see.”
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Natukunda E, et al. Safety, pharmacokinetics and efficacy of low-dose E/C/F/TAF in virologically suppressed children >2 years old living with HIV. Presented at: International AIDS Conference; July 6-10, 2020 (virtual meeting).
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