Portal de investigación
Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316)
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- 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
- 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
- Boix, V
- Payeras, A
- Ryan, P
- Torralba, M
- Cuadra, F
- Aznar, E
- Esteban, H
- de Miguel, M
- Gonzalez, P
- Yllescas, M
- CODAR Study Grp
Grupos
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 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.
Datos de la publicación
- ISSN/ISSNe:
- 0305-7453, 1460-2091
- Tipo:
- Article
- Páginas:
- 3044-3048
- DOI:
- 10.1093/jac/dkz254
- PubMed:
- 31236601
- Factor de Impacto:
- 2,230 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY OXFORD UNIV PRESS
Citas Recibidas en Web of Science: 2
Documentos
- No hay documentos
Filiaciones
Campos de Estudio
Cita
Perez MJ,Alejos B,Vivancos MJ,Ribera E,Galindo MJ,Vilanova L,Fraile LJGF,Moral SDL,De Lomas JG,Lozano F,Garcia MGM,PITARCH MT,Martinez MD,Rojas J,Raya 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,CODAR GRP. Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316). J. Antimicrob. Chemother. 2019. 74. (10):p. 3044-3048. IF:5,439. (1).