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JAC Advance Access published online on April 11, 2005
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dki113
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© The Author 2005. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org
Received October 20, 2004
Revised February 9, 2005
Accepted March 7, 2005

Original article

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

Marco Bongiovanni 1*, Elisabetta Chiesa 1, Antonio Di Biagio 2, Paola Meraviglia 3, Amedeo Capetti 4, Federica Tordato 1, Paola Cicconi 1, Patrizia Biasi 1, Teresa Bini 1, and Antonella d'Arminio Monforte 1

1 Institute of Infectious and Tropical Diseases, Ospedale Luigi Sacco, University of Milan, Via G.B. Grassi 74, 20157 Milano, Italy
2 Institute of Infectious Diseases, University of Genoa, Genoa, Italy
3 Second Division of Infectious Diseases, Ospedale Luigi Sacco, Milan, Italy
4 First Division of Infectious Diseases, Ospedale Luigi Sacco, Milan, Italy

* To whom correspondence should be addressed.
Marco Bongiovanni, E-mail: marco.bongiovanni{at}unimi.it


  Abstract

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.
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