810-W. Salvage Therapy with Lopinavir-Ritonavir (Kaletra) in Heavily Pretreated Children

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Session 105 Poster Session
Pediatric HIV Infection: Disease Progression and Responses to Therapy
Session Time: 4:30-6:30 pm
Room 4E-F

810-W.

Salvage Therapy with Lopinavir-Ritonavir (Kaletra) in Heavily Pretreated Children
J. T. Ramos*¹, P. Carreño¹, C. Fortuny², M .D. Gurbindo³, M. L. Navarro³, M. I. De José⁴, I. Pocheville⁵, L. Ciria⁶, J. Dueñas⁶, P. Martín-Fontelos⁷, M. Gracia⁸, R. Gónzalez-Montero⁹, J. M. Bellón³, M. Munoz-Fernández³, and E. Cabrero¹⁰
¹Hosp. 12 Octubre, Madrid; ²Hosp. Sant Joan de Deu; ³Hosp. G. Marañón; ⁴Hosp. La Paz; ⁵Hosp. Cruces; ⁶Hosp. Son Dureta, ⁷Hosp.Carlos III; ⁸Hosp. Clin., Zaragoza; ⁹Hosp. Sant Joan, Alicante; and ¹⁰Abbott Labs., Spain

Background: Today, many HIV-infected children have already been treated with NRTI, NNRTI, and PI. Kaletra (K) is a promising PI because of its durable efficacy and good tolerance. However the experience in heavily pretreated children is scarce. We undertook this study to assess the safety and effectiveness of combination therapy including K in antiretroviral (AR)-experienced HIV-infected children.
Methods: Data of AR-experienced children on treatment with K were retrospectively reviewed in 9 Spanish hospitals. As of October 2001, 39 children had been treated with K a median of 216 days (range 30-375 days). Vertical transmision was the route of infection in 37 patients. 26 children were evaluable at 6 months from the initiation of K. 54 and 38% were on C and 3 categories, respectively. All but 1 had been previously treated with PI for a median of 43 months (21-52), and 69% with NNRTI for a median of 22 months (7-61).
Results: Median age was 8.9 years (range: 1.3-17). K was combined with 2-4 antiretrovirals (in 10 including one NNRTI, and in 6 another PI). Baseline median CD4 count and percentage were 546 cells/mL and 14.5%, respectively. Baseline median plasma VL was 4.82 log₁₀ cp/ml.(4.43-5.39). Median CD4 increase at 6 months was 176 cells/mL (3%). Median VL declines were 1.81 and 1.44 log₁₀ copies/mL at 3 and 6 months. The proportions of children reaching undetectable plasma VL (< 400 copies/mL) were 40% (12/30) and 38% (10/26). Side-effects were reported in 5 children in the first month of therapy: 2 grade 2 diarrhea, 1 vomiting, and 2 a mild rash (one also on EFV). Median increase in cholesterol and triglycerides levels were 0.49 and 0.2 mmol/L (p>0.05). No child discontinued therapy during the follow-up period.
Conclusions: Combination therapy with lopinavir/ritonavir has potent antiretroviral activity in heavily pretreated children. Kaletra has a good safety profile also in these patients. Prospective follow-up will continue from now.