Neurocognitive safety after 96 weeks on dual therapy with atazanavir/ritonavir plus lamivudine: results of the neurocognitive substudy of the SALT randomized clinical trial
| Autor: | 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, Antonio Perez-Molina, J, GESIDA 7011 Study Grp |
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| Rok vydání: | 2018 |
| Předmět: |
Microbiology (medical)
Adult Male medicine.medical_specialty Anti-HIV Agents Atazanavir Sulfate Human immunodeficiency virus (HIV) Neurocognitive Disorders HIV Infections medicine.disease_cause Gastroenterology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law immune system diseases Internal medicine Medicine Humans Pharmacology (medical) 030212 general & internal medicine Longitudinal Studies Atazanavir/ritonavir Pharmacology Ritonavir business.industry Lamivudine virus diseases Middle Aged Atazanavir Clinical trial Infectious Diseases Female business Neurocognitive 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY r-FISABIO: Repositorio Institucional de Producción Científica Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
| ISSN: | 0305-7453 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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