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Abstract
Efficacy and safety results of 48 weeks of treatment with APTIVUS oral solution co-administered with low dose ritonavir (APTIVUS/r) in children and teenagers (phase I/IIa study)
J. Salazar1, P. Cahn2, M. Della Negra3, G. Castelli-Gattinara4, C. Fortuny5, P. Flynn6, C. Giaquinto7, R. Yogev8, E. Caparelli9, T. Fenton10, J. Mikl11, A. Jelaska11, PACTG 1051
Background: APTIVUS (tipranavir, TPV) is a recently approved PI, active against multi-PI resistant HIV. We report 48-week results of an open label, international study of an investigational APTIVUS oral solution co-administered with ritonavir (APTIVUS/r) in children.
Patients: 115 children (25 2-<6 years; 38 6-<12 years; 52 12-18 years; 97.4% ARV experienced) were randomized: 58 to low dose APTIVUS/r (290/115 mg/m2) and 57 to high dose APTIVUS/r (375/150 mg/m2), plus OBR. All patients commenced APTIVUS solution; after 4 weeks, patients >12 years taking 500/200 mg could take capsules.
Results: Baseline mean VL: 4.7 log10 copies/mL; CD4 (CD4%): 492 cells/mm3 (20%); median previous ARVs: 6; genotypic resistance to all PIs: 49.6%. 13% of patients took enfuvirtide.
Mean VL reductions at Week 48 are shown in Table 1. At Week 48, 39.7% (23/58) low dose patients and 45.6% (26/57) high dose patients achieved VL <400 copies/mL. 34.5% (20/58) low dose patients and 35.1% (20/57) high dose patients achieved <50 copies/mL.
At Week 48, mean CD4 (CD4%) increased by 157 (5%) and 96 (3%) cells/mm3 in low and high dose groups.
| | Low dose APTIVUS/r | High dose APTIVUS/r | | All patients | -1.34 | -1.33 | | 2-<6 years | -2.46 | -2.00 | | 6-<12 years | -1.27 | -1.36 | | 12-18 years | -0.83 | -0.99 |
APTIVUS/r was well tolerated: 4/115 (3.5%) patients experienced drug-related serious AEs. Ten patients (8.7%) (6 low dose; 4 high dose) discontinued APTIVUS/r because of AEs. Most common AES were gastro-intestinal. Most frequent DAIDS Grade 3/4 laboratory abnormalities were GGT and CPK increases (10.7%).
Conclusions: Clinically relevant virological and immunological improvements were seen with APTIVUS/r therapy in treatment experienced children aged 2-18 years at Week 48. APTIVUS/r provides a potent and well-tolerated therapeutic option for children and teenagers.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
WEAB0301
Suggested Citation
"J.Salazar, et al.
Efficacy and safety results of 48 weeks of treatment with APTIVUS oral solution co-administered with low dose ritonavir (APTIVUS/r) in children and teenagers (phase I/IIa study).
Oral abstract session:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
WEAB0301"
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