Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316)
Por:
Perez Elias, MJ, Alejos, B, Vivancos, MJ, Ribera, E, Galindo, MJ, Vilanova-Trillo, L, Fraile, LJGF, Moral, SDL, De Lomas, JG, Lozano, F, Garcia, MGM, Pitarch, MT, Martinez, MD, Rojas, J, Raya-Cruz, M, Sepulveda, MA, Troya, J, Del Campo, S, Martinez, E, Callau, P, Moreno, A, Casado, JL, Sanchez, JM, Ayerbe, CG, Negredo, E, Campos, I, Puig, J, Ribera, E, Torrella, A, Planas, B, Knobel, H, Ferrando, R, Crespo, M, Ocampo, A, Sanz, J, de Los Santos, I, Moreno, A, Diaz, A, Carbonero, LM, de la Torre, J, Reina, MR, Santos, J, Maria, C, Domenech, G, Gutierrez, MM, Montero, M, Cuellar, S, Boix, V, Payeras, A, Ryan, P, Torralba, M, Cuadra, F, Aznar, E, Esteban, H, de Miguel, M, Gonzalez, P, Yllescas, M
Publicada:
1 oct 2019
Resumen:
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 48week 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 48weeks, 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.
Filiaciones:
Perez Elias, MJ:
Hosp Ramon & Cajal, IRYCIS, Infect Dis, Madrid, Spain
Alejos, B:
Inst Salud Carlos III, Madrid, Spain
Vivancos, MJ:
Hosp Ramon & Cajal, IRYCIS, Infect Dis, Madrid, Spain
Ribera, E:
Hosp Univ Vall dHebron, Barcelona, Spain
Hosp Valle De Hebron, Madrid, Spain
Galindo, MJ:
Hosp Clin Univ Valencia, Valencia, Spain
Vilanova-Trillo, L:
Hosp Alvaro Cunqueiro, Vigo, Spain
Fraile, LJGF:
Hosp Univ La Princesa, Madrid, Spain
Moral, SDL:
Hosp Univ Puerta Hierro Majadahonda, Majadahonda, Spain
De Lomas, JG:
Hosp Costa Sol, Marbella, Spain
Lozano, F:
Hosp Virgen Valme, Seville, Spain
Garcia, MGM:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Pitarch, MT:
Hosp Univ & Politecn La Fe, Valencia, Spain
Martinez, MD:
Hosp Gen Univ Alicante, Alicante, Spain
Rojas, J:
Hosp Clin Barcelona, Barcelona, Spain
Raya-Cruz, M:
Hosp Sont Llatzer, Mallorca, Spain
Sepulveda, MA:
Complejo Hosp Toledo, Toledo, Spain
Troya, J:
Hosp Infanta Leonor, Madrid, Spain
Del Campo, S:
Hosp Ramon & Cajal, IRYCIS, Infect Dis, Madrid, Spain
Martinez, E:
Hosp Clin Barcelona, Barcelona, Spain
Callau, P:
Hosp Clin Madrid, Madrid, Spain
Moreno, A:
Hosp Univ Puerta Hierro Majadahonda, Majadahonda, Spain
Ramon & Cajal, Madrid, Spain
Casado, JL:
Ramon & Cajal, Madrid, Spain
Sanchez, JM:
Ramon & Cajal, Madrid, Spain
Ayerbe, CG:
Ramon & Cajal, Madrid, Spain
Negredo, E:
Germans Trias, Barcelona, Spain
Campos, I:
Germans Trias, Barcelona, Spain
Puig, J:
Germans Trias, Barcelona, Spain
Ribera, E:
Hosp Univ Vall dHebron, Barcelona, Spain
Hosp Valle De Hebron, Madrid, Spain
Torrella, A:
Hosp Valle De Hebron, Madrid, Spain
Planas, B:
Hosp Valle De Hebron, Madrid, Spain
Knobel, H:
Hosp Mar, Madrid, Spain
Ferrando, R:
Clin Valencia, Valencia, Spain
Crespo, M:
Hosp Alvaro Cunqueiro, Vigo, Spain
Sanz, J:
Hosp Univ Principe Asturias, Madrid, Spain
de Los Santos, I:
Hosp Univ La Princesa, Madrid, Spain
Moreno, A:
Hosp Univ Puerta Hierro Majadahonda, Majadahonda, Spain
Ramon & Cajal, Madrid, Spain
Diaz, A:
Hosp Univ Puerta Hierro Majadahonda, Majadahonda, Spain
Carbonero, LM:
Hosp Univ La Paz, Madrid, Spain
de la Torre, J:
Hosp Costa Sol, Marbella, Spain
Reina, MR:
Hosp Virgen Valme, Seville, Spain
Santos, J:
Hosp Univ Virgen Victoria, Malaga, Spain
Maria, C:
Hosp Univ Virgen Victoria, Malaga, Spain
Domenech, G:
Hosp Univ Virgen Victoria, Malaga, Spain
Gutierrez, MM:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Montero, M:
Hosp Univ & Politecn La Fe, Valencia, Spain
Cuellar, S:
Hosp Univ & Politecn La Fe, Valencia, Spain
Boix, V:
Hosp Gen Univ Alicante, Alicante, Spain
Payeras, A:
Hosp Sont Llatzer, Mallorca, Spain
Ryan, P:
Hosp Univ Infanta Leonor, Madrid, Spain
Torralba, M:
Hosp Univ Guadalajara, Guadalajara, Spain
Cuadra, F:
Complejo Hosp Toledo, Toledo, Spain
Aznar, E:
Fdn SEIMC GESIDA, Madrid, Spain
Esteban, H:
Fdn SEIMC GESIDA, Madrid, Spain
de Miguel, M:
Fdn SEIMC GESIDA, Madrid, Spain
Gonzalez, P:
Fdn SEIMC GESIDA, Madrid, Spain
Yllescas, M:
Fdn SEIMC GESIDA, Madrid, Spain
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