Neurocognitive safety after 96 weeks on dual therapy with atazanavir/ritonavir plus lamivudine: results of the neurocognitive substudy of the SALT randomized clinical trial
Por:
Perez-Valero, I, Pasquau, J, Rubio, R, Rivero, A, Santos, J, Sanz, J, Marino, A, Crespo, M, Hernandez-Quero, J, Antonio Iribarren, J, Gutierrez, F, Terron, A, Esteban, H and Antonio Perez-Molina, J
Publicada:
1 sep 2018
Resumen:
Background: Concerns have been voiced over the capacity of deintensification strategies to preserve neurocognitive function and prevent neurocognitive impairment.
Methods: We present the 96 week results of a neurocognitive substudy nested within the SALT clinical trial: a randomized, open-label, non-inferiority trial that compares whether atazanavir/ritonavir + lamivudine is non-inferior to atazanavir/ritonavir + two NRTIs in HIV-suppressed patients on stable triple therapy. A global deficit score (GDS) for five neurocognitive tasks was used to assess neurocognitive function. Changes in neurocognitive function (GDS value) were determined at weeks 48 and 96. The effect of atazanavir/ritonavir + lamivudine, adjusted for significant confounders, on the change in neurocognitive function was determined using analysis of covariance (ANCOVA) at week 96.
Results: The per-protocol analysis included 92 participants (47 atazanavir/ritonavir + lamivudine and 45 atazanavir/ritonavir + two NRTIs). All baseline characteristics were comparable in both groups. At weeks 48 and 96, changes in GDS [week 48, atazanavir/ritonavir + lamivudine -0.3 (95% CI -0.5 to -0.1) versus atazanavir/ritonavir + two NRTIs -0.2 (95% CI -0.4 to 0.0), P=0.39; week 96, atazanavir/ritonavir + lamivudine -0.3 (95% CI -0.5 to -0.1) versus atazanavir/ritonavir + two NRTIs -0.2 (95% CI -0.4 to -0.1); P=0.471] were similar. This absence of differences was also observed in all cognitive tasks. Atazanavir/ritonavir + lamivudine did not impact the change in neurocognitive function at week 96; the adjusted effect of atazanavir/ritonavir + lamivudine on GDS change, considering atazanavir/ritonavir + two NRTIs as a reference, was 0.01 (95% CI -0.18 to 0.21) (P=0.90).
Conclusions: Neurocognitive function remained stable after 96 weeks, both in the atazanavir/ritonavir + lamivudine and in the atazanavir/ritonavir + two NRTIs arms, provided HIV remained suppressed.
Filiaciones:
Perez-Valero, I:
Hosp Univ La Paz, Internal Med, Madrid, Spain
Pasquau, J:
Hosp Virgen de las Nieves, Internal Med, Granada, Spain
Rubio, R:
Hosp Univ Doce Octubre, Internal Med, Madrid, Spain
Rivero, A:
Hosp Reina Sofia, Internal Med, Cordoba, Spain
Santos, J:
Hosp Virgen de la Victoria, Internal Med, Malaga, Spain
Sanz, J:
Hosp Alcala De Henares, Internal Med, Alcala De Henares, Spain
Marino, A:
Hosp Arquitecto Marcide, Internal Med, O Ferrol, Spain
Crespo, M:
Hosp Valle De Hebron, Internal Med, Barcelona, Spain
Hernandez-Quero, J:
Hosp San Cecilio, Internal Med, Granada, Spain
Antonio Iribarren, J:
Hosp Donostia, Internal Med, San Sebastian, Spain
:
Hosp Elche, Internal Med, Elche, Spain
Terron, A:
Hosp Jerez, Internal Med, Jerez de la Frontera, Spain
Esteban, H:
Fdn SEIMC GESIDA, Madrid, Spain
Antonio Perez-Molina, J:
Hosp Ramon & Cajal, Infect Dis Dept, Madrid, Spain
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