Pediatrics

Powder Therapy Safe, Effective for Children with HIV

Atazanavir powder boosted with ritonavir (ATV + RTV) plus optimized dual nucleos(t)ide reverse transcriptase inhibitors is a palatable, safe, and effective treatment for HIV-infected infants and children, according to results of the PRINCE-2 trial.

The PRINCE-2 trial, conducted by Dr Mark F. Cotton and colleagues, is an ongoing trial aimed to assess ATV + RTV therapy in antiretroviral-naïve and experienced children with HIV-1 RNA 1000 copies/mL or more.


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To conduct their trial, the researchers prescribed ATV + RTV therapy to children aged 3 months to 11 years based on 5 baseline weight classes:

  • Children weighing 5 kg to 10 kg received 150/80 mg.
  • Children weighing 5 kg to 10 kg received 200/80 mg.
  • Children weighing 10 kg to 15 kg received 200/80 mg.
  • Children weighing 15 kg to 25 kg received 250/80 mg.
  • Children weighing 25 kg to 35 kg received 300/100 mg.

The analysis included data from 99 children, of whom 83.8% continued treatment until week 24 and 59.6% continued until week 48.

Virologic suppression, as defined as an HIV-1 RNA less than 50 copies/mL, was 46.5% at week 24 and 43.0% at week 48 overall.

At week 24, the following proportions of children achieving virologic suppression were reported:

  • 43.5% of children weighing 5 kg to 10 kg who received 150/80 mg.
  • 16.5% of children weighing 5 kg to 10 kg who received 200/80 mg.
  • 47.6% of children weighing 10 kg to 15 kg who received 200/80 mg.
  • 54.3% of children weighing 15 kg to 25 kg who received 250/80 mg.
  • 62.5% of children weighing 25 kg to 35 kg who received 300/100 mg.

These results were similar among antiretroviral-naïve and experienced children.

Upper respiratory tract infections, gastroenteritis, vomiting, and hyperbilirubinemia were the most common adverse reactions after 48 weeks.

In addition, no administration issues were reported by the caregivers regarding ATV powder or RTV administration.

“ATV powder palatability, efficacy, and lack of unexpected safety findings support its use for HIV-1-infected children [aged] 3 months to 11 years,” the researchers wrote.

—Amanda Balbi

Reference:

Cotton MF, Liberty A, Torres-Escobar I, et al. Safety and efficacy of atazanavir powder and ritonavir in HIV-1-infected infants and children from 3 months to <11 years of age: the PRINCE-2 study. Pediatr Inf Dis J. 2018;37(6):e149-e156. doi:10.1097/INF.0000000000001856.

 

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