by Bekker A, Rabie H, Salvadori N, du Toit S, Than-in-at K, Groenewald M, Andrieux-Meyer I, Kumar M, Cressey, R, Nielsen J, Capparelli E, Lallemant M, Cotton MF, Cressey TR, for the PETITE Study Team. Journal of Acquired Immune Deficiency Syndromes 2021. doi:10.1097/QAI.0000000000002871
Summary: Antiretroviral options for neonates need to be expanded. The authors evaluated the pharmacokinetics, safety, and acceptability of the 4-in-1 fixed-dose paediatric granule formulation of abacavir/lamivudine/lopinavir/ritonavir (30/15/40/10 mg) in neonates in the PETITE study, an ongoing phase I/II, open-label, single arm, two-stage trial conducted in South Africa. In Stage 1, 16 neonates exposed to HIV on standard antiretroviral prophylaxis (nevirapine +/- zidovudine) received a single dose of the 4-in-1 formulation followed by intensive pharmacokinetic sampling and safety assessments. The high mg/kg abacavir and lamivudine doses and exposures were safe, and the formulation well tolerated; however, lopinavir/ritonavir exposures were extremely low, preventing its use in neonates. Alternative paediatric solid antiretroviral formulations must be studied in neonates.