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Dual Therapy With Darunavir and Ritonavir Plus Lamivudine vs Triple Therapy With Darunavir and Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine or Abacavir and Lamivudine for Maintenance of Human Immunodeficiency Virus Type 1 Viral Suppression: Randomized, Open-Label, Noninferiority DUAL-GESIDA 8014-RIS-EST45 Trial

2017; Oxford University Press; Volume: 65; Issue: 12 Linguagem: Inglês

10.1093/cid/cix734

1537-6591

Federico Pulido, Esteban Ribera, María Lagarde, Ignacio Valero, Rosario Palacios, José Antonio Iribarren, Antoni Payeras, Peré Domingo, José Sanz, Miguel Cervero, Adrián Curran, Francisco Javier Rodríguez‐Gómez, María Jesús Téllez, Pablo Ryan, Pilar Barrufet, Hernando Knobel, Antonio Rivero, Belén Alejos, María Yllescas, José Ramón Arribas, José Ramón Arribas, Rocío Montejano, Juan González‐García, Marisa Montes, José Ignacio Bernardino, Ignacio Valero, Juan Castro, Mario Mayoral, Federico Pulido, María Lagarde, Otilia Bisbal, Mariano Matarranz, Asunción Hernando, Lourdes Domínguez, Rafael Rubio, Esteban Ribera, Adrián Curran, Jordi Navarro, Joaquín Burgos, I Ocaña, Vicenç Falcó, José Ramón Santos, Rosario Palacios, Ignacio Pérez, Carmen María González-Domenech, Maialen Ibarguren, Miguel Ángel Goenaga, Francisco Rodríguez-Arrondo, M. A. von Wichmann, Xabier Kortajarena, M.P. Carmona, H Son Llatzer, Antoni Payeras, Maison Abu Raya, Andrea Salom, Peré Domingo, María Luisa Navarro Gómez, M. Gracia Mateo, M. A. Sambeat, José Sanz, J. de Miguel, E Casas, Alberto Arranz, Miguel Cervero, Rafael Torres, H Infanta Elena, Francisco Javier Rodríguez‐Gómez, J M Fajardó, Francisco Javier Martínez‐Marcos, María de la Paz Valverde Merino, Miguel Raffo, Ignacio Suárez-Lozano, H. Clínico, María Jesús Téllez, Jorge Vergas, Vicente Estrada, H Infanta Leonor, Pablo Ryan, Jesús Troya, Guillermo Cuevas, Victorino Diez-Viñas, Tamar Talaván, F Solís, H de Mataró, Pilar Barrufet, Lluís Force, Hanna Mar, Hernando Knobel, A. M. Maceira Gonzalez, Edgar V. Lerma, J. Villar, H Reina Sofía, Antonio Rivero, Ángela Camacho, Isabel Machuca, Teresa Brieva, Antonio Rivero‐Juárez, JM Gatell, R. Domínguez, Daniel Podzamczer, Eva Van den Eynde, Laura Acerete, Andrés Navarro‐Ruiz, María Silvana DiYacovo, H Virgen de las Nieves, Juan Pasquau, Coral García, J.E. Losa, C Henríquez, Joaquín Portilla, Livia Giner, Irene Portilla, M. Pampliega, Vicente Boix, Esperanza Merino, Sergio Reus, Diego Torrús, Bonaventura Clotet, Eugènia Negredo, A Chamarro, Patricia Corbasi, Desiré Gil‐Pérez, Piedad Arazo, FranciscoJosé Parras, Margarita Ramírez, I Gutiérrez-Cuéllar, H Son Espases, Melchor Riera, L Gil-Alonso, Helem Vílchez, María Yllescas, Belén Alejos, E. Ubiña Aznar, Herminia Esteban, P González, Socorro Gonzalez, Marta de Miguel,

HIV/AIDS Research and Interventions

Our objective was to assess the therapeutic noninferiority of dual therapy with darunavir/ritonavir and lamivudine compared to triple therapy with darunavir/ritonavir plus 2 nucleos(t)ides for maintenance of human immunodeficiency virus type 1 (HIV-1) suppression.This was a multicenter, open-label, noninferiority trial (margin 12%). Patients with HIV-1 RNA <50 copies/mL for 6 months or longer on triple therapy with darunavir/ritonavir and 2 nucleos(t)ides (tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine) and with no resistance were randomized to continue therapy (n = 128) or switch to darunavir/ritonavir and lamivudine (n = 129). The primary endpoint was the proportion of participants with HIV-RNA <50 copies/mL after 48 weeks of follow-up according to the snapshot algorithm.A total of 249 participants received study drugs (intention-to-treat exposed). The proportion of participants with HIV-RNA <50 copies/mL in the dual- and triple-therapy arms was 88.9% (112/126) and 92.7% (114/123; difference, -3.8%; 95% confidence interval, -11.0 to 3.4), respectively. Four participants in the dual-therapy arm and 2 in the triple-therapy arm developed protocol-defined virological failure. Switching to dual therapy was associated with a significant increase in total, low-density lipoprotein, and high-density lipoprotein (HDL) cholesterol, but not in the total-to-HDL cholesterol ratio. Serious adverse events and study drug discontinuations due to adverse events occurred in 4.8% vs 4.9%P = .97) and in 0.8% (1/126) vs 1.6% P = .55) in dual therapy vs triple therapy, respectively.Dual therapy with darunavir/ritonavir and lamivudine demonstrated noninferior therapeutic efficacy and similar tolerability compared to triple therapy.NCT02159599.