Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents

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dc.contributor.authorBlanche, Stéphane
dc.contributor.authorBologna, Rosa
dc.contributor.authorCahn, Pablo
dc.contributor.authorRugina, Sorin
dc.contributor.authorFlynn, Patricia
dc.contributor.authorFortuny, Claudia
dc.contributor.authorVis, Peter
dc.contributor.authorSekar, Vanitha
dc.contributor.authorvan Baelen, Ben
dc.contributor.authorDierynck, Inge
dc.contributor.authorSpinosa-Guzman, Sabrina
dc.date.accessioned2024-05-23T23:49:10Z
dc.date.available2024-05-23T23:49:10Z
dc.date.issued2009-09-24
dc.descriptionFil: Cahn P. Fundación Huésped, Buenos Aires; Argentinaes_ES
dc.description.abstractObjective: To assess pharmacokinetics, safety and efficacy of darunavir/ritonavir (DRV/r) and optimized background regimen in treatment-experienced patients (6–17 years). Design: Forty-eight-week, open-label, two-part, phase II study. Methods: In part I, 44 patients were randomized (1: 1 ratio) to receive a body weight-adjusted, adult-equivalent dose (group A) or a 20–33% higher DRV/r twice daily (b.i.d.) dose (group B). Pharmacokinetics, safety and efficacy were assessed following 2-week dosing (part I), which determined dosing for part II (evaluated 48-week safety and efficacy). Results: In part I, both groups met the protocol-specified criteria for pharmacokinetics and showed favorable tolerability and efficacy. The following body-weight doses were selected: DRV/r 375/50 mg b.i.d. (20–<30 kg), 450/60 mg b.i.d. (30–<40 kg) and 600/100 mg b.i.d. (≥40 kg); these gave an AUC24h, C0h and Cmax of 102, 114 and 112%, respectively, versus the corresponding mean adult pharmacokinetic parameter. In part II, 80 patients received DRV/r (median age: 14 years, mean baseline HIV-1 RNA: 4.64 log10copies/ml). One patient (1%) discontinued (treatment-unrelated grade 3 anxiety). An abnormal mean baseline triglyceride level was normalized at 48 weeks (P < 0.01). At week 48, 65% had at least 1.0 log10HIV-1 RNA reduction; 59 and 48% achieved HIV-1 RNA less than 400 and less than 50 copies/ml, respectively (time-to-loss-of-virologic response). Mean age-adjusted weight z-score increased by 0.2 (P = 0.003). Conclusion: In treatment-experienced children and adolescents, DRV/r showed comparable exposure to adults with appropriate dose selection, favorable safety and tolerability, improved body weight and significant virologic response. DRV/r is a valuable therapeutic option for this population. Introductiones_ES
dc.formatapplication/pdfes_ES
dc.identifier.doihttps://doi.org/10.1097/qad.0b013e328330abaa
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1319
dc.languageENGes_ES
dc.provenancePublishedes_ES
dc.rightsopenAccesses_ES
dc.subjectPharmacokineticses_ES
dc.titlePharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescentses_ES
dc.typeArticuloes_ES

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