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

Federico Pulido*, Esteban Ribera, María Lagarde, Ignacio Pérez-Valero, Rosario Palacios, José A. Iribarren, Antoni Payeras, Pere Domingo, José Sanz, Miguel Cervero, Adrián Curran, Francisco J. Rodríguez-Gómez, María J. Téllez, Pablo Ryan, Pilar Barrufet, Hernando Knobel, Antonio Rivero, Belén Alejos, María Yllescas, José R. Arribas

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

59 Citations (Scopus)

Abstract

Background. 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. Methods. 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. Results. A total of 249 participants received study drugs (intention-to-treat exposed). The proportion of participants with HIVRNA <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. Conclusions. Dual therapy with darunavir/ritonavir and lamivudine demonstrated noninferior therapeutic efficacy and similar tolerability compared to triple therapy. Clinical Trials Registration. NCT02159599.

Original languageAmerican English
Pages (from-to)2112-2118
Number of pages7
JournalClinical Infectious Diseases
Volume65
Issue number12
DOIs
Publication statusPublished - 15 Dec 2017

Keywords

  • darunavir/ritonavir
  • dual therapy
  • lamivudine
  • switch

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