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Title: Pharmacokinetics, Safety and Efficacy of Maraviroc in Treatment-experienced Pediatric Patients Infected With CCR5-Tropic HIV-1
Authors: Carlo Giaquinto
Muthuhadini Patience Mawela
Kulkanya Chokephaibulkit
Marinella Della Negra
Ismail Haroon Mitha
Jan Fourie
Annie Fang
Elna van der Ryst
Srinivas Rao Valluri
Manoli Vourvahis
Rebecca Yanhui Zhang-Roper
Charles Craig
Lynn McFadyen
Andrew Clark
Jayvant Heera
ViiV Healthcare
Pfizer Limited, UK
Instituto de Infectologia Emilio Ribas
GlaxoSmithKline plc.
Sefako Makgatho Health Sciences University (SMU)
Faculty of Medicine, Siriraj Hospital, Mahidol University
Pfizer Inc.
Università degli Studi di Padova
Medical Centre
Lakeview Hospital
Keywords: Medicine
Issue Date: 1-May-2018
Citation: The Pediatric infectious disease journal. Vol.37, No.5 (2018), 459-465
Abstract: BACKGROUND: Maraviroc is a CC-chemokine receptor 5 antagonist approved to treat adults infected with CC-chemokine receptor 5-tropic (R5) HIV-1. Study A4001031 was conducted to evaluate the pharmacokinetics, safety and efficacy of maraviroc in combination with optimized background therapy in treatment-experienced pediatric patients infected with R5 HIV-1 and support registration of maraviroc for pediatric use. METHODS: This is an open-label, 2-stage, age-stratified, noncomparative multicenter study. One-hundred and three participants were enrolled into 4 age/formulation cohorts and dosed twice daily. Initial doses were determined by body surface area and optimized background therapy, based on drug interactions with maraviroc in adults. Dose adjustment and pharmacokinetic reevaluation occurred if the average concentrations (Cavg) at Week 2 were <100 ng/mL (Stage 1-dose finding). RESULTS: Data from the Week 48 analysis demonstrated that 49/50 Stage 1 participants rolling over into Stage 2 (safety and efficacy) achieved Cavg ≥100 ng/mL. Doses were identified that achieved similar concentration ranges to those seen in adults. The majority (90/103) received optimized background therapy containing potent cytochrome P450 3A inhibitors. Maraviroc was well tolerated and the safety and efficacy were comparable to those of adults. All cohorts had a mean decrease from baseline in HIV-1 RNA of >1 log10. Increases from baseline in the median CD4+ cell count and percentage were seen for all age groups. CONCLUSIONS: The maraviroc dosing strategy resulted in participants achieving the target Cavg, with exposure ranges similar to those observed in adults on approved doses. The safety and efficacy of maraviroc in this pediatric population were comparable to those seen in adults.
ISSN: 15320987
Appears in Collections:Scopus 2018

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