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Cerebral function parameters in people with HIV switching integrase inhibitors: a randomized controlled trial
Borja Mora-Peris1, Michael R Keegan1, Sujan Dilly Penchala2
1Department of Infectious Diseases, Faculty of Medicine, Imperial College London, London, UK.
HIV Research & Clinical Practice
|November 8, 2021
Summary
Switching integrase inhibitors in people with HIV (PWH) did not significantly alter central nervous system (CNS) function, cognitive performance, or mood. This study found no adverse pharmacodynamic effects when switching from raltegravir to dolutegravir in PWH with suppressed viral loads.
Area of Science:
- Neuroscience
- Pharmacology
- Infectious Diseases
Background:
- Antiretroviral therapies (ARTs) can impact central nervous system (CNS) function in people with HIV (PWH).
- Understanding the CNS pharmacodynamics of different integrase inhibitors is crucial for optimizing treatment strategies.
Purpose of the Study:
- To assess the central nervous system (CNS) pharmacodynamic effects of switching integrase inhibitors in people with HIV (PWH).
- To evaluate changes in cognitive function, patient-reported outcomes, and cerebral metabolites after switching antiretroviral therapy.
Main Methods:
- A randomized study involving PWH on tenofovir-DF/emtricitabine plus raltegravir switched to dolutegravir or continued raltegravir for 120 days.
- Assessed cognitive function (7 domains), patient-reported outcomes (PHQ-9, Beck's depression), cerebral metabolite ratios (H1-MRS), and HIV RNA in plasma and CSF.
- Pharmacokinetic parameters of ARTs were measured in plasma and CSF.
Main Results:
- No statistically significant changes in cognitive function (z-score: -0.004, p=0.98) or patient-reported outcomes (PHQ-9, Beck's depression) were observed between groups.
- Cerebral metabolite ratios and cerebrospinal fluid (CSF) HIV RNA (<5 copies/mL) remained stable throughout the study.
- Achieved therapeutic CSF dolutegravir concentrations (7.6 ng/mL) in the switch arm.
Conclusions:
- Switching integrase inhibitors in virologically suppressed PWH without neuropsychiatric symptoms did not lead to significant changes in CNS pharmacodynamics.
- The study supports the CNS safety profile of switching between integrase inhibitors in this population.
