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Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316)

2019; Oxford University Press; Volume: 74; Issue: 10 Linguagem: Inglês

10.1093/jac/dkz254

1460-2091

María Jesús Pérez‐Elías, Belén Alejos, María Jesús Vivancos, Esteban Ribera, Marı́a José Galindo, Lucía Vilanova‐Trillo, Lucio García‐Fraile, S. de la Fuente Moral, J. García de Lomas, Fernando Lozano, M. García García, María Tasias Pitarch, Marcos Díez Martínez, R. Domínguez, Manuel Raya‐Cruz, Marcela Sepúlveda, Jesús Troya, Santos del Campo, Estebán Martínez, Pilar Callau, Ana Moreno, José L. Casado, Javier Martinez Sanchez, Cristina Gómez Ayerbe, Dra. Eugenia Negredo, I Campos, Jordi Puig, Esteban Ribera, Ariadna Torrella, Bibiana Planas, Hernando Knobel, Clinico de Valencia, R Ferrando, Manuel Crespo, Antonio Ocampo, José Sanz, Ignacio de los Santos, A. Moreno, Alberto Díaz, Dra. Luz Martin Carbonero, Javier de la Torre, Mercedes Rivas Reina, Jesús Santos, Carmen María González-Domenech, Dra. Ma Mar Gutierrez, Marta Montero, Sandra Cuéllar, Vicente Boix, Antoni Payeras, Pablo Ryan, Miguel Torralba, Fernando de la Cuadra, E. Ubiña Aznar, Herminia Esteban, Marta de Miguel, Paula González, María Yllescas,

HIV Research and Treatment

Abstract Background Few women have been included in darunavir/cobicistat clinical development studies, and hardly any of them were antiretroviral experienced or treated with anything other than triple-based therapies. Objectives Our aim was to increase our knowledge about women living with HIV undergoing darunavir/cobicistat-based regimens. Methods A multicentre (21 hospitals), retrospective study including a centrally selected random sample of HIV-1 patients starting a darunavir/cobicistat-based regimen from June 2014 to March 2017 was planned. Baseline characteristics, 24 and 48 week viral load response (<50 copies/mL), CD4+ lymphocyte count increase, time to change darunavir/cobicistat and adverse event occurrence were all compared by sex. The study was approved by each of the 21 ethics committees, and patients signed informed consent. Results Out of 761 participants, 193 were women. Similar characteristics were found for both sexes, except that the women had a longer duration of HIV infection (P = 0.001), and were less frequently pre-treated with darunavir/cobicistat in their previous regimen (P = 0.02). The main reason for using a darunavir/cobicistat-based regimen was simplification, without differences by sex, while monotherapy seems to be more frequently prescribed in women than in men (P = 0.067). The main outcomes, HIV viral load response, CD4+ lymphocyte count increase at 24 or 48 weeks, occurrence of adverse events, main reasons for changing and time to the modify darunavir/cobicistat regimen, did not show differences between the sexes. Conclusions No sex disparities were found in the main study outcomes. These results support the use of a darunavir/cobicistat-based regimen in long-term pre-treated women. Clinical Trial.gov No. NCT03042390.