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JAC Advance Access originally published online on October 7, 2004
Journal of Antimicrobial Chemotherapy 2004 54(5):921-931; doi:10.1093/jac/dkh431
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JAC vol.54 no.5 © The British Society for Antimicrobial Chemotherapy 2004; all rights reserved

Positive virological outcome after lopinavir/ritonavir salvage therapy in protease inhibitor-experienced HIV-1-infected children: a prospective cohort study

Salvador Resino1, José Ma Bellón1, José Tomás Ramos2, Milagros Gonzalez-Rivera1, Ma Isabel de José3, Ma Isabel González2, Dolores Gurbindo4, Ma José Mellado5, Esther Cabrero6 and Ma Ángeles Muñoz-Fernández1,*

1 Laboratory of Immuno-Molecular Biology, Hospital Gregorio Marañón, Madrid; 2 Department of Paediatrics, Hospital ‘12 de Octubre’, Madrid; 3 Department of Paediatrics, Hospital la Paz, Madrid; 4 Department of Paediatrics, Hospital Gregorio Marañón, Madrid; 5 Department of Paediatrics, Hospital Carlos III, Madrid; 6 Abbott Laboratories, Madrid, Spain

* Corresponding author. Tel: +34-91-5868565; Fax: +34-91-5868018; Email: mmunoz{at}cbm.uam.es

Background: Lopinavir/ritonavir has demonstrated antiviral activity in the HIV-infected patient.

Objective: To analyse virological response to lopinavir/ritonavir therapy in previously protease inhibitor (PI)-experienced HIV-1-infected children.

Materials and methods: Sixty-seven HIV-1-children on lopinavir/ritonavir were studied in a multicentre prospective cohort observational study. The outcome variables were undetectable viral load (uVL; VL ≤400 copies/mL) and virological failure after uVL with a rebound of VL >400 copies/mL. VL and genotype of HIV-1-isolates were measured using standard assays.

Results: 83.5% of children had a 1 log10 VL decrease including 65.6% who reached uVL. Children with >2 changes of antiretroviral therapy (ART) or >5 drugs needed a median time of 3–4 months higher than children with ≤2 changes of ART or ≤5 drugs previous to lopinavir/ritonavir, to reach those values, and the relative proportions (RP) were 2.2 (P =0.038) and 1.9 (P=0.050), respectively. Children with CD4+>15% (P=0.122), VL ≤30 000 (P < 0.001) copies/mL, and age >12 years (P=0.096) achieved an earlier control of VL during the follow-up. The children with virological failure or rebound of VL had higher baseline VL and lower CD4+ T-lymphocytes/mm3 and had taken a greater number of drugs previous to lopinavir/ritonavir. HIV-children with a new nucleoside reverse transcriptase inhibitor (NRTI), or protease inhibitor (PI) or PI plus non-nucleoside reverse transcriptase inhibitors (NNRTI) in the current regimen had a better virological response than children without these new drugs. Also, children with <6 protease mutations had an RP of 2.31 of achieving uVL.

Conclusions: Highly active antiretroviral therapy (HAART) including lopinavir/ritonavir induces beneficial effects in terms of virological outcome responses, and it is an effective option for salvage therapy in PI-experienced HIV-1-infected children.

Keywords: CD4+ T-lymphocytes , viral load , HAART


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