|
|
Abstract
Efficacy and safety profile of APTIVUS oral solution or capsules co-administered with low dose ritonavir (APTIVUS/r) in treatment experienced children and teenagers after two years of treatment (phase I/IIa study)
J.C. Salazar1, P. Cahn2, C. Giaquinto3, R. Yogev4, J. Mikl5, A. Jelaska5, PACTG1051 study team
Background: Analysis of 2 year follow up of an open label, international study of investigational APTIVUS oral solution (OS) co-administered with low dose ritonavir (APTIVUS/r) in children. Analysis was performed by age group and formulation (OS vs capsules). All patients are now being treated with high dose APTIVUS/r (375/150 mg/m2) plus optimized background regimen.
Results: 78 patients (24 2-<6 years; 26 6-<12 years; 11 12-18 years) entered a long-term safety and efficacy study. 50 patients completed >100 weeks of therapy. Median changes in virological and immunological outcomes from baseline to Week 100 are shown in Table 1. At Week 100, 24.1%-56% of patients achieved VL <400 copies/mL; 20.7%-48% patients achieved <50 copies/mL. Virological responses were similar, regardless of formulation. GI events were the most frequently reported AEs; the majority were mild. 28.7% of patients experienced serious AEs, over 100 weeks of follow up, mostly infections resulting in hospitalization. 13.9% discontinued APTIVUS/r because of AEs. Nine patients (8%) had Grade 3/4 ALT increase; 6 of them were aged 12-18 years. Two patients died; neither death was considered study drug-related.
Conclusions: Sustained virological and immunological responses were seen over two years of APTIVUS/r therapy in treatment experienced children aged 2-18 years. The safety profile of APTIVUS/r was unchanged with long-term therapy. APTIVUS/r (375/150 mg/m2 dose) is a potent and well-tolerated ARV for pediatric patients.
| Age Group | Median number of protease mutations at baseline | % VL <400 copies/mL (ITT NCF) | % VL < 50 Copies/mL (ITT NCF) | Median change from baseline | | | | | | CD4 cell count in cells/mm3 and in CD4% | | 2-<6 years(OS) (N=25) | 10 | 56.0 | 48.0 | +294 (+6) | | 6-<12 years (OS) (N=37) | 13 | 29.7 | 29.7 | +121 (+4) | | 12-18 years (OS) (N=24) | 17 | 25.0 | 20.8 | +12 (+1) | | 12-18 years (capsules) (N=29) | 13 | 24.1 | 20.7 | +45 (0) |
AIDS 2008 - XVII International AIDS Conference
Abstract no.
MOPE0187
Suggested Citation
"J.C.Salazar, et al.
Efficacy and safety profile of APTIVUS oral solution or capsules co-administered with low dose ritonavir (APTIVUS/r) in treatment experienced children and teenagers after two years of treatment (phase I/IIa study).
:
AIDS 2008 - XVII International AIDS Conference:
Abstract no.
MOPE0187"
|
|
|