A Randomized Trial of Dolutegravir Plus Darunavir/ Cobicistat as a Switch Strategy in HIV-1-Infected Patients With Resistance to at Least 2 Antiretroviral Classes

Suppressed patients with drug-resistant HIV-1 require effective and simple antiretroviral therapy to maintain treatment adherence and viral suppression. This randomized, open-label, noninferiority, multicenter pilot study involved HIV-infected adults who met the following criteria: confirmed HIV-1 R...

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Detalles Bibliográficos
Autores: Santos, José Ramón|||0000-0002-0886-7114, Domingo Pedrol, Pedro|||0000-0003-1138-5770, Portilla, Joaquín|||0000-0002-3676-9511, Gutiérrez, Félix|||0000-0002-9485-6867, Imaz, Arkaitz|||0000-0001-8411-1952, Vilchez, Helem|||0000-0002-4344-693X, Curran, Adrian|||0000-0002-1263-0814, Valcarce-Pardeiro, Nieves, Payeras, Antoni, Bernal, Enrique|||0000-0002-4041-0579, Montero-Alonso, Marta, Yzusqui, Miguel, Clotet Sala, Bonaventura|||0000-0003-3232-4598, Videla, Sebastià, Moltó, José|||0000-0003-4564-1963, Paredes, Roger|||0000-0002-6553-691X
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:296604
Acceso en línea:https://ddd.uab.cat/record/296604
https://dx.doi.org/urn:doi:10.1093/ofid/ofad542
Access Level:acceso abierto
Palabra clave:Darunavir/cobicistat
Dolutegravir
Multidrug resistance HIV-1
Switch strategy
Descripción
Sumario:Suppressed patients with drug-resistant HIV-1 require effective and simple antiretroviral therapy to maintain treatment adherence and viral suppression. This randomized, open-label, noninferiority, multicenter pilot study involved HIV-infected adults who met the following criteria: confirmed HIV-1 RNA <50 copies/mL for ≥6 months preceding the study randomization, treatment with at least 3 antiretroviral drugs, and a history of drug resistance mutations against at least 2 antiretroviral classes but remaining fully susceptible to darunavir (DRV) and integrase inhibitors. Participants were randomized 1:1 to switch to dolutegravir (DTG; 50 mg once per day) plus DRV boosted with cobicistat (DRV/c; 800/150 mg once per day; 2D group) or continue with their baseline regimen (standard-of-care [SOC] group). The primary endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL at week 48 relative to time to loss of virologic response, with a noninferiority margin set at -12.5%. Virologic failure was defined as confirmed HIV-1 RNA ≥50 copies/mL or a single determination of HIV-1 RNA.

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