Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study

Introduction: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis...

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Detalles Bibliográficos
Autores: Santos, J.R., Casadellà, M., Noguera-Julian, M., Micán-Rivera, R., Domingo, P., Antela López, Antonio, Portilla, J., Sanz, J., Montero-Alonso, M., Navarro, J., Masiá, M., Valcarce Pardeiro, Nieves, Ocampo Hermida, Antonio, Pérez-Martínez, L., García-Vallecillos, C., Vivancos, M.J., Imaz, A., Iribarren, J.A., Hernández-Quero, J., Villar-García, J., Barrufet, P., Paredes, R.
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Servizo Galego de Saúde (SERGAS)
Repositorio:RUNA. Repositorio da Consellería de Sanidade e Sergas
OAI Identifier:oai:runa.sergas.gal:20.500.11940/21402
Acceso en línea:https://portalcientifico.sergas.gal//documentos/64be32643bbfc602eae580d6
http://hdl.handle.net/20.500.11940/21402
Access Level:acceso abierto
Palabra clave:Adult
Humans
Spain
Prospective Studies
Cobicistat
Integrases
HIV Infections
AS Santiago
CHUS
AS Ferrol
CHUF
AS Vigo
CHUVI
Descripción
Sumario:Introduction: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis of the experience with the use of INSTIs in unselected adults living with HIV may be of help to make therapeutic decisions when second-generation INSTIs are not available. This study aimed to evaluate the real-life effectiveness and safety of dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), and raltegravir (RAL) in a large Spanish cohort of HIV-1-infected patients. Methods: Real-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naïve patients, ART-switching, and ART-salvage patients). The primary endpoint was the median time to treatment discontinuation after INSTI-based regimen initiation. Proportion of patients experiencing virological failure (VF) (defined as two consecutive viral loads (VL) ?200 copies/mL at 24 weeks or as a single determination of VL ?1,000 copies/mL while receiving DTG, EVG/c or RAL, and at least 3 months after INSTI initiation) and time to VF were also evaluated. Results: Virological effectiveness of EVG/c- and RAL-based regimens was similar to that of DTG when given as first-line and salvage therapy. Treatment switching for reasons other than virological failure was more frequent in subjects receiving EVG/c and, in particular, RAL. Naïve patients with CD4+ nadir <100 cells/?L were more likely to develop VF, particularly if they initiated RAL or EVG/c. In the ART switching population, initiation of RAL and EVG/c was associated with both VF and INSTI discontinuation. There were no differences in the time to VF and INSTI discontinuation between DTG, EVG/c and RAL. Immunological parameters improved in the three groups and for the three drugs assessed. Safety and tolerability were consistent with expected safety profiles. Discussion: Whereas second-generation INSTIs are preferred treatment options worldwide, and DTG is one of the treatment of choices in resource-limited settings, first-generation INSTIs may still provide high virological and immunological effectiveness when DTG is not available.