Stéphane Blanche|Rosa Bologna|Pedro Cahn|Sorin Rugin?|Patricia M. Flynn|Clàudia Fortuny|Peter Vis|Vanitha Sekar|B. Van Baelen|Inge Dierynck|Sabrina Spinosa?Guzman
Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents
Hôpital Necker-Enfants Malades|Assistance Publique – Hôpitaux de Paris|Université Paris Cité|Garrahan Hospital|Fundación Huésped|St. Jude Children's Research Hospital|Hospital Sant Joan de Déu Barcelona|Universitat de Barcelona
objective assess pharmacokinetics safety efficacy darunavirritonavir drvr optimized background regimen treatmentexperienced patients 617 years design fortyeightweek openlabel twopart phase ii study methods part 44 patients randomized 1 1 ratio receive body weightadjusted adultequivalent dose group 2033 higher drvr twice daily bid dose group b pharmacokinetics safety efficacy assessed following 2week dosing part determined dosing part ii evaluated 48week safety efficacy results part groups met protocolspecified criteria pharmacokinetics showed favorable tolerability efficacy following bodyweight doses selected drvr 37550 mg bid 2030 kg 45060 mg bid 3040 kg 600100 mg bid 40 kg gave auc24h c0h cmax 102 114 112 respectively versus corresponding mean adult pharmacokinetic parameter part ii 80 patients received drvr median age 14 years mean baseline hiv1 rna 464 log10copiesml one patient 1 discontinued treatmentunrelated grade 3 anxiety abnormal mean baseline triglyceride level normalized 48 weeks p 001 week 48 65 least 10 log10hiv1 rna reduction 59 48 achieved hiv1 rna less 400 less 50 copiesml respectively timetolossofvirologic response mean ageadjusted weight zscore increased 02 p 0003 conclusion treatmentexperienced children adolescents drvr showed comparable exposure adults appropriate dose selection favorable safety tolerability improved body weight significant virologic response drvr valuable therapeutic option population