Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV

Pulido, Federicoa,*; Arribas, José Rb,*; Delgado, Rafaela; Cabrero, Estherc; González-García, Juanb; Pérez-Elias, María Jd; Arranz, Albertoe; Portilla, Joaquínf; Pasquau, Juang; Iribarren, José Ah; Rubio, Rafaela; Norton, Michaeli; for the OK04 Study Group

doi: 10.1097/QAD.0b013e3282f4243b
Fast Track

Background: Prior attempts to reduce the number of drugs needed to maintain viral suppression in patients with suppressed HIV replication while receiving three antiretroviral drugs have been unsuccessful.

Methods: In 205 patients with suppressed HIV replication on lopinavir-ritonavir and two nucleosides, this randomized, open-label, non-inferiority clinical trial compared the strategies of continuation of triple therapy versus lopinavir-ritonavir monotherapy followed by reinduction with two nucleosides if virological rebound occurred without genotypic resistance to lopinavir-ritonavir. The primary endpoint was proportion of patients without therapeutic failure, defined as confirmed HIV RNA higher than 500 copies/mL (with exclusion of patients receiving monotherapy who resuppressed to < 50 copies/mL after resuming baseline nucleosides), or loss to follow-up, or change of randomized therapy other than reinduction.

Results: At week 48, the percentage of patients without therapeutic failure was 94% in the monotherapy group versus 90% in the triple therapy group (difference,-4%; upper limit of 95% confidence interval for difference, 3.4%). The percentage of patients with HIV RNA 50 copies/mL at 48 weeks by intention-to-treat, missing data or reinductions considered as failures, were 85% in the monotherapy group versus 90% in the triple therapy group (P = 0.31; 95% upper limit of 95% confidence interval for difference, 14%).

Conclusion: In this trial, 48 weeks of lopinavir-ritonavir monotherapy with reintroduction of nucleosides as needed was non-inferior to continuation of two nucleosides and lopinavir-ritonavir in patients with prior stable suppression. However, episodes of low level viremia were more common in patients receiving monotherapy. (ClinicalTrials. gov number, NCT00114933).

Author Information

From the aUnidad HIV and Laboratorio de Microbiología Molecular, Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain

bServicio de Medicina Interna, Hospital La Paz, Universidad Autónoma de Madrid, Madrid, Spain

cAbbott Laboratories, Madrid, Spain

dHospital Ramón y Cajal, Madrid, Spain

eHospital Príncipe de Asturias, Alcalá de Henares, Spain

fHospital General de Alicante, Alicante, Spain

gHospital Virgen de las Nieves, Granada, Spain

hHospital Donostia, San Sebastián, Spain

iAbbott Laboratories, Abbott Park, Ill, USA.

* F. Pulido and J.R. Arribas contributed equally to this study.

Correspondence to Jose R. Arribas, Consulta Medicina Interna 2. Hospital La Paz. Paseo de la Castellana 261. 28046. Madrid, Spain. Tel: +34 91 207 1676; fax: +34 91 729 0033; e-mail: jrarribas.hulp@salud.madrid.org

© 2008 Lippincott Williams & Wilkins, Inc.