Arribas, Jose R.Rubio García, RafaelPulido Ortega, Federico2024-07-302024-07-302009-06-01Arribas JR, Delgado R, Arranz A, Muñoz R, Portilla J, Pasquau J, Pérez-Elias MJ, Iribarren JA, Rubio R, Ocampo A, Sánchez-Conde M, Knobel H, Arazo P, Sanz J, López-Aldeguer J, Montes ML, Pulido F; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. J Acquir Immune Defic Syndr1525-413510.1097/QAI.0b013e3181a56de5https://hdl.handle.net/20.500.14352/107233Background: 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. Methods: 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 <50 copies per milliliter for more than 6 months. Primary end point was percent of patients without therapeutic failure, defined as confirmed 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. Results: 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. Conclusions: 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.engjournal article1077-9450https://doi.org/10.1097/QAI.0b013e3181a56de5https://journals.lww.com/jaids/abstract/2009/06010/lopinavir_ritonavir_monotherapy_versus.7.aspxrestricted access616.98VIHLopinavir-ritonavirHIVAntiretroviralesCiencias Biomédicas32 Ciencias Médicas