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Lopinavir-Ritonavir Monotherapy Versus Lopinavir-Ritonavir and 2 Nucleosides for Maintenance Therapy of HIV: 96-Week Analysis

2009; Lippincott Williams & Wilkins; Volume: 51; Issue: 2 Linguagem: Inglês

10.1097/qai.0b013e3181a56de5

1944-7884

José Ramón Arribas, Rafaël Delgado, Alberto Arranz, R Almendros Muñoz, Joaquín Portilla, Juan Pasquau, María Jesús Pérez‐Elías, José Antonio Iribarren, Rafael Rubio, Antonio Ocampo, Matilde Sánchez‐Conde, Hernando Knobel, Piedad Arazo, Jesús Sanz, José López-Aldeguer, Marisa Montes, Federico Pulido,

HIV/AIDS Research and Interventions

The OK04 trial has shown that 48 weeks of lopinavir-ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy with 2 nucleosides and lopinavir-ritonavir in patients with prior stable suppression. However, it is still uncertain if this experimental strategy can maintain suppression in the long term.Patients entered this noninferiority trial (upper limit 95% confidence interval: +12%) with no history of virological failure while receiving a protease inhibitor and receiving 2 nucleosides plus lopinavir/ritonavir, with HIV RNA 500 copies per milliliter with exclusion of monotherapy patients who resuppressed to <50 copies per milliliter after resuming baseline nucleosides, or loss to follow-up, or change of randomized therapy other than reinduction.Through 96 weeks, percentage of patient without therapeutic failure was 87% (monotherapy, n = 100) vs. 78% (triple therapy, n = 98; 95% confidence interval: -20% to +1.2%). Percentage with HIV RNA <50 copies per milliliter (intention to treat, missing = failure, reinduction = failure): 77% (monotherapy) vs. 78% (triple therapy). Low-level viral rebound was more frequent in the monotherapy group. Twelve patients in the monotherapy group (12%) needed reinduction with nucleosides. Discontinuations due to adverse events were significantly more frequent in the triple therapy group (8%) than in the monotherapy group (0%); P = 0.003.At 96-week lopinavir/ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy. Incidence of adverse events leading to treatment discontinuation was significantly lower with monotherapy. (ClinicalTrials.gov number, NCT00114933).