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- Title
Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316).
- Authors
Pérez Elías, M J; Alejos, B; Vivancos, M J; Ribera, E; Galindo, M J; Vilanova-Trillo, L; García-Fraile Fraile, L J; de La Fuente Moral, S; Garcia De Lomas, J; Lozano, F; Mateo García, M G; Tasias Pitarch, M; Diez Martinez, M; Rojas, J; Raya-Cruz, M; Sepúlveda, M A; Troya, J; Del Campo, S; Martinez, E; CODAR study group
- Abstract
<bold>Background: </bold>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.<bold>Objectives: </bold>Our aim was to increase our knowledge about women living with HIV undergoing darunavir/cobicistat-based regimens.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Publication
Journal of Antimicrobial Chemotherapy (JAC), 2019, Vol 74, Issue 10, p3044
- ISSN
0305-7453
- Publication type
journal article
- DOI
10.1093/jac/dkz254