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

AuthorsPérez-Elías, María Jesús; Alejos, Belén; Vivancos-Gallego, María Jesús; Ribera, Esteban; Galindo, María José; Vilanova-Trillo, L.; García-Fraile Fraile, L. J.; Fuente Moral, S. de la; García de Lomas, J.; Lozano, Fernando; Mateo García, M. G.; Tasias Pitarch, M.; Díez Martínez, M.; Rojas, J.; Raya-Cruz, M.; Sepúlveda, M. A.; Troya, Jesús; Campo, S. del; Martínez, Esteban
Issue DateOct-2019
PublisherOxford University Press
CitationJournal of Antimicrobial Chemotherapy 74(10): 3044-3048 (2019)
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.
Publisher version (URL)https://doi.org/10.1093/jac/dkz254
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