2009
DOI: 10.1097/qad.0b013e328330abaa
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Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents

Abstract: 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.

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Cited by 54 publications
(65 citation statements)
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“…3,4 Twicedaily darunavir/ritonavir is also indicated for use in combination with other antiretrovirals in treatment-experienced pediatric patients at least 3 years of age, 5 based on the findings of the phase 2 DELPHI (Darunavir EvaLuation in Pediatric, HIV-Infected, treatment-experienced patients; TMC114-C212; NCT00355524) and ARIEL (dArunavir in tReatment experIenced pEdiatric popuLation; TMC114-TiDP29-C228; NCT00919854) trials. 6,7 In the DELPHI trial, weight-adjusted darunavir/ritonavir twice daily, combined with other antiretrovirals, demonstrated a favorable safety/tolerability profile and a significant virologic response in treatment-experienced children and adolescents (6 to <18 years). 6 Weight-adjusted darunavir/ritonavir twice daily also showed good efficacy with no new safety concerns in treatment-experienced pediatric patients 3 to <6 years of age (ARIEL).…”
mentioning
confidence: 98%
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“…3,4 Twicedaily darunavir/ritonavir is also indicated for use in combination with other antiretrovirals in treatment-experienced pediatric patients at least 3 years of age, 5 based on the findings of the phase 2 DELPHI (Darunavir EvaLuation in Pediatric, HIV-Infected, treatment-experienced patients; TMC114-C212; NCT00355524) and ARIEL (dArunavir in tReatment experIenced pEdiatric popuLation; TMC114-TiDP29-C228; NCT00919854) trials. 6,7 In the DELPHI trial, weight-adjusted darunavir/ritonavir twice daily, combined with other antiretrovirals, demonstrated a favorable safety/tolerability profile and a significant virologic response in treatment-experienced children and adolescents (6 to <18 years). 6 Weight-adjusted darunavir/ritonavir twice daily also showed good efficacy with no new safety concerns in treatment-experienced pediatric patients 3 to <6 years of age (ARIEL).…”
mentioning
confidence: 98%
“…6,7 In the DELPHI trial, weight-adjusted darunavir/ritonavir twice daily, combined with other antiretrovirals, demonstrated a favorable safety/tolerability profile and a significant virologic response in treatment-experienced children and adolescents (6 to <18 years). 6 Weight-adjusted darunavir/ritonavir twice daily also showed good efficacy with no new safety concerns in treatment-experienced pediatric patients 3 to <6 years of age (ARIEL). 7 Although darunavir/ritonavir is indicated for use in treatment-experienced pediatric patients, the efficacy and safety of once-daily darunavir/ritonavir in treatment-naïve pediatric patients has not been established.…”
mentioning
confidence: 98%
“…[6][7][8][9][10][11][12][13][14] In addition, DRV/r is not recommended in children <3 years of age owing to toxicity concerns in animal studies, and ETR, a second-generation NNRTI, is not recommended in children <6 years of age owing to lack of safety and efficacy data. Until very recently, DTG was only recommended by the US Food and Drug Administration (FDA) for adolescents >12 years of age and >40 kg body weight.…”
Section: Researchmentioning
confidence: 99%
“…[6] Other than phase 2 trials under controlled conditions, two other retrospective studies involving treatment-experienced adolescents in Spain receiving RALor ETR-based regimens in combination with other ARVs have found comparable safety and efficacy outcomes. [7,8,[10][11][12] Although GRT is a prerequisite for accessing these medications in the SA public sector, specific indications for resistance testing are not included in the 2014 national guidelines, and access to GRT has not been uniform in the SA public sector. Before 2015, GRT was generally only available to patients with private medical insurance or through research studies or donor-funded access programmes in the public sector.…”
Section: Researchmentioning
confidence: 99%
“…Studies of children and adolescents with experience of ART have shown safety and tolerability of DRV/r in these younger populations (8,9). DRV/r has been widely recommended as a salvage therapy for children older than 3 y and adolescents with high levels of treatment experience and ART resistance (9).…”
mentioning
confidence: 99%