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JAC Advance Access originally published online on March 13, 2008
Journal of Antimicrobial Chemotherapy 2008 61(6):1359-1361; doi:10.1093/jac/dkn103
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© The Author 2008. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Original research

Long-term (4 years) efficacy of lopinavir/ritonavir monotherapy for maintenance of HIV suppression

Federico Pulido1,{dagger},*, Rafael Delgado2, Ignacio Pérez-Valero3, Juan González-García3, Pilar Miralles4, Alberto Arranz5, Asunción Hernando1,6 and José R. Arribas3,{dagger}

1 Unidad HIV, Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain; 2 Laboratorio de Microbiología Molecular, Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain; 3 Servicio de Medicina Interna, Hospital La Paz, Universidad Autónoma de Madrid, Madrid, Spain; 4 Hospital Gregorio Marañón, Madrid, Spain; 5 Hospital Príncipe de Asturias, Alcalá de Henares, Spain; 6 Dpto. Especialidades Medicas, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain

Received 26 November 2007; returned 20 January 2008; revised 28 January 2008; accepted 17 February 2008

* Correspondence address. Unidad HIV, Hospital 12 de Octubre, Av. de Córdoba s/n, 28041 Madrid, Spain. Tel: +34-91-390-82-02; Fax: +34-91-390-86-14; E-mail: pulidof{at}gmail.com

Objectives: Data are scarce on the long-term efficacy of lopinavir/ritonavir monotherapy for the maintenance of HIV suppression. Four years of results of patients randomized to monotherapy in the Only Kaletra (OK) pilot clinical trial are presented.

Patients and methods: Twenty-one HIV-infected patients with suppressed HIV replication (<50 copies/mL) for at least 6 months and without previous failure while receiving a protease inhibitor-based regimen started lopinavir/ritonavir monotherapy. Follow-up was performed within the OK pilot clinical trial during the first 2 years and according to routine clinical practice during the 3rd and 4th years.

Results: Fourteen patients (67%) remain on monotherapy and with RNA <50 copies/mL (intention-to-treat analysis, with missing patients scored as failures). Five patients (24%) had virological rebound and all of them were successfully re-suppressed by adding two nucleosides. No major protease inhibitor mutations were found.

Conclusions: Our data support the long-term efficacy and safety of lopinavir/ritonavir monotherapy for the maintenance of HIV suppression, a finding that must be confirmed in larger studies.

Keywords: simplification , boosted protease inhibitors , antiretroviral therapy

{dagger} F. P. and J. R. A. contributed equally to this study.


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