Journal Article

Use of lopinavir/ritonavir in HIV-infected patients failing a first-line protease-inhibitor-containing HAART

Marco Bongiovanni, Elisabetta Chiesa, Antonio Di Biagio, Paola Meraviglia, Amedeo Capetti, Federica Tordato, Paola Cicconi, Patrizia Biasi, Teresa Bini and Antonella d'Arminio Monforte

in Journal of Antimicrobial Chemotherapy

Published on behalf of British Society for Antimicrobial Chemotherapy

Volume 55, issue 6, pages 1003-1007
Published in print June 2005 | ISSN: 0305-7453
Published online April 2005 | e-ISSN: 1460-2091 | DOI: http://dx.doi.org/10.1093/jac/dki113
Use of lopinavir/ritonavir in HIV-infected patients failing a first-line protease-inhibitor-containing HAART

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Objectives: The long-term virological efficacy of lopinavir/ritonavir-containing highly active antiretroviral therapy (HAART) in HIV-infected patients failing a first-line protease inhibitor (PI)-based regimen is still unclear.

Methods: An observational study was carried out from December 2000–December 2002 on 111 consecutive patients starting lopinavir/ritonavir. The primary end-point was virological success (HIV RNA <50 copies/mL in two consecutive determinations). CD4 outcome, lipid levels and adverse events were recorded. The Kaplan–Meier method and log-rank test were used to estimate the time-dependent probability of reaching the end-point using intention-to-treat and on-treatment approaches.

Results: Ninety-six patients obtained virological success during follow-up; Kaplan–Meier analysis showed that the time-dependent probability of obtaining this end-point was 78.4% at month 12 and 85.8% at month 24. The median CD4+cell count increased by 118 cells/mm3 from baseline to month 12 and by 153 cells/mm3 to month 24. Thirty-one patients discontinued lopinavir/ritonavir: 16 because of drug-related toxicities, six for simplification, five because of virological failure, one patient was lost at follow-up and three died. An elevation in lipid parameters was observed, but only a minority of patients developed a grade 3 or higher hypertriglyceridaemia and/or hypercholesterolaemia. Among the 15 patients not reaching virological success, five had ≤5 mutations in the protease region known to reduce susceptibility to lopinavir/ritonavir (one discontinued lopinavir/ritonavir because of gastrointestinal intolerance), five had no mutations (two discontinued lopinavir/ritonavir because of gastrointestinal intolerance) and five showed ≥6 mutations (all discontinued lopinavir/ritonavir); however, of the patients who discontinued lopinavir/ritonavir none achieved HIV RNA <50 copies/mL on subsequent regimens.

Conclusions: Lopinavir/ritonavir was highly effective and well tolerated in HIV-infected patients failing a first-line PI-based HAART.

Keywords: HIV therapy; LPV/r; virological failure; genotype resistance

Journal Article.  2663 words.  Illustrated.

Subjects: Medical Oncology ; Critical Care

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