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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

The Pediatric Infectious Disease Journal Jun 01, 2018

Tome MI, et al. - Researchers in the PRINCE-2 trial assessed the safety, efficacy, and palatability of once-daily atazanavir powder formulation boosted with ritonavir (ATV + RTV) plus optimized dual nucleos(t)ide reverse transcriptase inhibitors therapy in 99 antiretroviral-naïve/experienced children with screening HIV-1 RNA ≥1000 copies/mL. Until 24 and 48 weeks, 83.8% and 59.6% remained on ATV powder, respectively. The most common adverse events were upper respiratory tract infections (33.3%), gastroenteritis (28.3%), vomiting (21.2%) and hyperbilirubinemia (18.2%; none leading to treatment discontinuation) through 48 weeks. Observations suggest ATV powder as palatable, efficacious and safe supporting its utility for HIV-1-infected children ≥3 months to <11 years.
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