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
Por:
Pulido, F, Ribera, E, Lagarde, M, Perez-Valero, I, Palacios, R, Iribarren, JA, Payeras, A, Domingo, P, Sanz, J, Cervero, M, Curran, A, Rodriguez-Gomez, FJ, Tellez, MJ, Ryan, P, Barrufet, P, Knobel, H, Rivero, A, Alejos, B, Yllescas, M, Arribas, JR
Publicada:
15 dic 2017
Resumen:
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 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.
Conclusions. Dual therapy with darunavir/ritonavir and lamivudine demonstrated noninferior therapeutic efficacy and similar tolerability compared to triple therapy.
Filiaciones:
Pulido, F:
UCM, Imas12, Hosp Univ Doce Octubre, Madrid, Spain
Ribera, E:
Hosp Univ Vall dHebron, Barcelona, Spain
Lagarde, M:
UCM, Imas12, Hosp Univ Doce Octubre, Madrid, Spain
Perez-Valero, I:
Hosp La Paz, IDIPAZ, Madrid, Spain
Palacios, R:
Hosp Clin Univ Virgen de la Victoria, IBIMA, Malaga, Spain
Iribarren, JA:
Hosp Univ Donostia, Inst Invest Biodonostia, San Sebastian, Spain
Payeras, A:
Hosp Son Llatzer, Palma De Mallorca, Spain
Domingo, P:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Sanz, J:
Hosp Principe Asturias, Madrid, Spain
Cervero, M:
Hosp Univ Severo Ochoa, Madrid, Spain
Curran, A:
Hosp Univ Vall dHebron, Barcelona, Spain
Rodriguez-Gomez, FJ:
Hosp Infanta Elena, Huelva, Spain
Tellez, MJ:
Hosp Clin Madrid, Madrid, Spain
Ryan, P:
Hosp Univ Infanta Leonor, Madrid, Spain
Barrufet, P:
Hosp Mataro, Barcelona, Spain
Knobel, H:
Hosp del Mar, Barcelona, Spain
Rivero, A:
Hosp Univ Reina Sofia, IMIBIC, Cordoba, Spain
Alejos, B:
Ctr Nacl Epidemiol, Madrid, Spain
Yllescas, M:
Fdn SEIMC GESIDA, Madrid, Spain
Arribas, JR:
Hosp La Paz, IDIPAZ, Madrid, Spain
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