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
Santos, José Ramón (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Domingo Pedrol, Pedro (Institut d'Investigació Biomèdica Sant Pau)
Portilla, Joaquín (Hospital General Universitario de Alicante (Alacant, País Valencià))
Gutiérrez, Félix (Instituto de Salud Carlos III)
Imaz, Arkaitz (Hospital Universitari de Bellvitge)
Vilchez, Helem (Fundació Institut d'Investigació Sanitària Illes Balears)
Curran, Adrian (Hospital Universitari Vall d'Hebron)
Valcarce-Pardeiro, Nieves (Complejo Hospitalario Universitario de Ferrol)
Payeras, Antoni (Hospital Universitari Son Llàtzer (Palma de Mallorca, Balears))
Bernal, Enrique (Instituto Murciano de Investigación Biosanitaria)
Montero-Alonso, Marta (Hospital Universitari i Politècnic La Fe (València))
Yzusqui, Miguel (Hospital General Nuestra Señora del Prado)
Clotet Sala, Bonaventura (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Videla, Sebastià (Hospital Universitari de Bellvitge)
Moltó, José (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Paredes, Roger (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	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.
Grants:	Ministerio de Sanidad y Consumo RD06/0006
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Darunavir/cobicistat ; Dolutegravir ; Multidrug resistance HIV-1 ; Switch strategy
Published in:	Open Forum Infectious Diseases, Vol. 10 Núm. 11 (january 2023) , p. ofad542, ISSN 2328-8957

DOI: 10.1093/ofid/ofad542
PMID: 38023553

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The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles