Psychological symptoms improve, neurocognition unaffected in switch from efavirenz to bictegravir: Pilot study results

An Italian pilot study reported that switching from an efavirenz- to a bictegravir-based regimen was associated with improvements in anxiety, depression, and sleep quality and had little effect on neurocognitive performance in virally suppressed people living with HIV.

About This Study

“Impact of switching from EFV/F/TDF to B/F/TAF on psychiatric symptoms and neurocognition” was published online on Oct. 25, 2024, in AIDS. The lead author is Alessandra Vergori, an infectious disease physician and researcher for the Immunodeficiency Unit at the National Institute for Infectious Diseases “Lazzaro Spallanzani,” IRCCS, in Rome, Italy. The study was funded by Gilead Sciences.

Key Research Findings

This single-arm, prospective, pilot study assessed the effect of switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate to bictegravir/emtricitabine/tenofovir alafenamide on psychiatric and neurocognitive symptoms in 126 people living with HIV. The median age of participants was 53 years; 90% were white and 13% women.

All participants were virally suppressed on the initial treatment regimen and had been taking efavirenz for a median eight years. At switch, 6% of participants reported neuropsychological issues but the assessment showed that 41% of participants had some neurocognitive impairment, mostly mild or asymptomatic.

After 48 weeks, a second neuropsychological assessment was done. Neurocognition improved in 35% of participants with impairment at baseline but worsened in 27% of participants without impairment at the beginning of the study. During that period, anxiety, depression, and sleep quality improved overall.

For example, the proportion of participants reporting no sleep disturbance rose from 4% at baseline to 20% at study end, while that of participants reporting severe sleep disturbance dropped from 18% at baseline to 2% at study end. Reports of mild sleep disturbance increased from 47% of participants at baseline to 64% of participants at study end.

Adverse events on bictegravir included headache (6% of participants), insomnia (3% of participants), and other central nervous system-related issues (6% of participants).

Discussion Highlights and Implications for Practice

Study limitations reported included a potential selection bias in who was available for the assessment, the small sample size, the lack of a control group, and the inability to monitor drug concentrations.

The study authors concluded that while efavirenz has been previously associated with neuropsychiatric effects and potentially with neurocognitive impairment, results from the current study showed switching from efavirenz to bictegravir was associated with better neuropsychological symptoms, without an overall change in neurocognitive performance.

By Barbara Jungwirth