Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir/Abacavir/Lamivudine in Antiretroviral-Naive Adults (SYMTRI): A Multicenter Randomized Open-Label Study (PReEC/RIS-57).

Autor: Podzamczer D; Hospital Universitari de Bellvitge, Barcelona, Spain., Micán R; Hospital La Paz, Madrid, Spain., Tiraboschi J; Hospital Universitari de Bellvitge, Barcelona, Spain., Portilla J; Hospital General Universitario de Alicante, Alicante, Spain., Domingo P; Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Llibre JM; Hospital Germans Trias i Pujol, Barcelona, Spain., Ribera E; Hospital Universitario de la Vall d'Hebrón, Barcelona, Spain., Vivancos MJ; Hospital Universitario Ramón y Cajal, Madrid, Universidad de Alcalá, IRYCIS, Madrid, Spain., Morano L; Hospital Universitario Álvaro Cunqueiro, Vigo, Spain., Masiá M; Hospital General Universitario de Elche, Elche, Spain., Gómez C; Hospital Universitario Virgen de la Victoria-IBIMA, Málaga, Spain., Fanjul F; Hospital Universitario Son Espases, Palma, Spain., Payeras A; Hospital Universitario Son Llàtzer, Palma, Spain., Inciarte A; Hospital Clínic, Barcelona, Spain., Estrada V; Hospital Clínico San Carlos-IdiSSC, Madrid, Spain., Rivero A; Hospital Universitario Reina Sofía, Córdoba, Spain., Castro Á; Complejo Hospitalario Universitario, A Coruña, Spain., Bernal E; Hospital Universitario Reina Sofía, Murcia, Spain., Vinuesa D; Hospital Universitario Clínico San Cecilio, Granada, Spain., Knobel H; Hospital del Mar, Barcelona, Spain., Troya J; Hospital Universitario Infanta Leonor, Madrid, Spain., Macías J; Hospital Universitario Virgen de Valme, Sevilla, Spain., Montero M; Hospital Universitari i Politècnic La Fe, Valencia, Spain., Sanz J; Hospital Universitario de La Princesa, Madrid, Spain., Navarro-Alcaraz A; Hospital Universitari de Bellvitge, Barcelona, Spain., Caicedo A; RIS Red de Investigación en SIDA, Madrid, Spain., Fernández G; Hospital Universitari de Bellvitge, Barcelona, Spain., Martínez E; Hospital Clínic, Barcelona, Spain., Moreno S; Hospital Universitario Ramón y Cajal, Madrid, Universidad de Alcalá, IRYCIS, Madrid, Spain.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2021 Nov 25; Vol. 9 (3), pp. ofab595. Date of Electronic Publication: 2021 Nov 25 (Print Publication: 2022).
DOI: 10.1093/ofid/ofab595
Abstrakt: Background: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is the reference for combination therapy based on protease inhibitors due to its efficacy, tolerability, and convenience. Head-to-head randomized comparisons between D/C/F/TAF and combination therapy based on integrase inhibitors in antiretroviral-naive patients are lacking.
Methods: Adult (>18 years old) human immunodeficiency virus-infected antiretroviral-naive patients (HLA-B∗5701 negative and hepatitis B virus negative), with viral load (VL) ≥500 c/mL, were centrally randomized to initiate D/C/F/TAF or dolutegravir/abacavir/lamivudine (DTG/3TC/ABC) after stratifying by VL and CD4 count. Clinical and analytical assessments were performed at weeks 0, 4, 12, 24, and 48. The primary endpoint was VL <50 c/mL at week 48 in the intention-to-treat (ITT)-exposed population (US Food and Drug Administration snapshot analysis, 10% noninferiority margin).
Results: Between September 2018 and 2019, 316 patients were randomized and 306 patients were included in the ITT-exposed analysis (151 D/C/F/TAF and 155 DTG/3TC/ABC). Almost all (94%) participants were male and their median age was 35 years. Forty percent had a baseline VL >100 000 copies/mL, and 13% had <200 CD4 cells/μL. Median weight was 73 kg and median body mass index was 24 kg/m 2 . At 48 weeks, 79% (D/C/F/TAF) versus 82% (DTG/3TC/ABC) had VL <50 c/mL (difference, -2.4%; 95% confidence interval [CI], -11.3 to 6.6). Eight percent versus four percent experienced virologic failure but no resistance-associated mutations emerged. Four percent versus six percent had drug discontinuation due to adverse events. In the per-protocol analysis, 94% versus 96% of patients had VL <50 c/mL (difference, -2%; 95% CI, -8.1 to 3.5). There were no differences in CD4 cell count or weight changes.
Conclusions: We could not demonstrate the noninferiority of D/C/F/TAF relative to DTG/ABC/3TC as initial antiretroviral therapy, although both regimens were similarly well tolerated.
(© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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