Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study
Por:
Santos J.R., Casadellà M., Noguera-Julian M., Micán-Rivera R., Domingo P., Antela A., Portilla J., Sanz J., Montero-Alonso M., Navarro J., Masiá M., Valcarce-Pardeiro N., Ocampo A., Pérez-Martínez L., García-Vallecillos C., Vivancos M.J., Imaz A., Iribarren J.A., Hernández-Quero J., Villar-García J., Barrufet P., Paredes R.
Publicada:
26 jun 2023
Ahead of Print:
26 jun 2023
Resumen:
IntroductionSecond-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. MethodsReal-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naive 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) & GE;200 copies/mL at 24 weeks or as a single determination of VL & GE;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. ResultsVirological 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. Naive patients with CD4+ nadir <100 cells/& mu;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. DiscussionWhereas 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.
Filiaciones:
Santos J.R.:
Hosp Badalona Germans Trias & Pujol, Fight Infect Fdn, Serv Infect Dis, Badalona, Spain
Casadellà M.:
IrsiCaixa AIDS Res Inst, Badalona, Spain
Noguera-Julian M.:
IrsiCaixa AIDS Res Inst, Badalona, Spain
Micán-Rivera R.:
Univ Hosp La Paz, HIV Unit, Madrid, Spain
Domingo P.:
Hosp Santa Creu & Sant Pau, Infect Dis Unit, Barcelona, Spain
Antela A.:
Santiago De Compostela Clin Univ Hosp, Infect Dis Unit, Santiago De Compostela, Spain
Portilla J.:
Hosp Gen Univ Dr Balmis Alicante, Dept Internal Med, Alicante, Spain
Sanz J.:
Univ Hosp La Princesa, Dept Infect Dis, Madrid, Spain
Montero-Alonso M.:
La Fe Univ & Polytech Hosp, Infect Dis Unit, Valencia, Spain
Navarro J.:
Hosp Univ Vall DHebron, Infect Dis Dept, Barcelona, Spain
Masiá M.:
Elche Univ Gen Hosp, Infect Dis Unit, Elche, Spain
Inst Salud Carlos III, Ctr Invest Biomed Red Enfermedades Infecciosas CIB, Madrid, Spain
Valcarce-Pardeiro N.:
Complexo Hosp Univ Ferrol CHUF, Infect Dis Unit, Ferrol, Spain
Ocampo A.:
Hosp Alvaro Cunqueiro, HIV Unit, Vigo, Spain
Pérez-Martínez L.:
Biomed Res Ctr La Rioja CIBIR, Dept Infect Dis, Logrono, Spain
García-Vallecillos C.:
Univ Hosp Virgen Nieves, Infect Dis Unit, Granada, Spain
Vivancos M.J.:
Inst Salud Carlos III, Ctr Invest Biomed Red Enfermedades Infecciosas CIB, Madrid, Spain
Ramon & Cajal Hosp, Dept Infect Dis, Madrid, Spain
Ramon & Cajal Hosp, Inst Ramon y Cajal Invest Sanitaria IRYCIS, Madrid, Spain
Imaz A.:
Bellvitge Univ Hosp, Bellvitge Biomed Res Inst IDIBELL, Infect Dis Dept, HIV & STI Unit, Lhospitalet De Llobregat, Spain
Iribarren J.A.:
Univ Basque Country, Donostia Univ Hosp, Dept Infect Dis, Inst Invest Sanitaria BioDonostia, San Sebastian, Spain
Hernández-Quero J.:
Univ Hosp San Cecilio, Serv Infect Dis, Granada, Spain
Villar-García J.:
Hosp del Mar, Inst Hosp del Mar Invest Med IMIM, Infect Dis Dept, Barcelona, Spain
Barrufet P.:
Mataro Hosp, Infect Dis Unit, Mataro, Spain
Paredes R.:
Hosp Badalona Germans Trias & Pujol, Fight Infect Fdn, Serv Infect Dis, Badalona, Spain
IrsiCaixa AIDS Res Inst, Badalona, Spain
gold, All Open Access, Gold
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