Population pharmacokinetics of pediatric lopinavir/ritonavir oral pellets in children living with HIV in Africa

By Chupradit S, Wamalwa DC, Maleche-Obimbo E, Kekitiinwa AR, Mwanga-Amumpaire J, Bukusi EA, Nyandiko WM, Mbuthia JK, Swanson A, the DNDi Clinical Team, Cressey TR, Punyawudho B, Musiime V, for the LIVING Study Team. Clinical Pharmacology and Therapeutics 2024. doi: 10.1002/cpt.3174

Summary: Antiretroviral therapy for children living with HIV under 3 years of age commonly includes lopinavir/ritonavir (LPV/r). The original liquid LPV/r formulation tastes bitter and requires refrigeration; an oral pellets LPV/r formulation has been developed to address these challenges. The authors developed a population pharmacokinetic model and assessed drug exposure to LPV/r when the pellets were administered twice daily to children living with HIV per World Health Organization weight bands. The pharmacokinetic analysis included data from 514 Kenyan and Ugandan children participating in the LIVING studies receiving LPV/r pellets (40/10 mg) and ABC/3TC (60/30 mg) dispersible tablets. They found that LPV/r pellets dosed in accordance with World Health Organization weight bands provide adequate LPV exposures in Kenyan and Ugandan children weighing 3.0 to 24.9 kg

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