Neuropsychiatric Adverse Events During 12 Months of Treatment With Efavirenz in Treatment-Naïve HIV-Infected Patients in China: A Prospective Cohort Study

Abstract

Background: Efavirenz (EFV) is widely used in antiretroviral therapy (ART), but the incidence and risk factors of neuropsychiatric adverse events (NPAEs) after EFV treatment have rarely been studied in Chinese ART naïve patients. Methods: This prospective cohort study assessed HIV-infected patients initiating antiretroviral treatment with EFV to determine prevalence of and factors associated with NPAEs over a 12-month follow-up period using the Hospital Anxiety and Depression Scale (HADS) and the Pittsburgh Sleep Quality Index (PSQI). Results: A total of 546 patients were enrolled. Prevalence of anxiety, depression, and sleep disturbances at baseline were 30.4, 22.7, and 68.1%, respectively. Six patients discontinued treatment due to drug related NPAEs. Treatment was associated with improvements in HADS-A, HADS-D, and PSQI scores over the 12-month follow-up, and the frequencies of patients with anxiety, depression, and sleep disturbances significantly decreased after 12 months. Abnormal baseline HADS-A, HADS-D, and PSQI scores and other factors, including high school education or lower income, unemployment, divorce, and WHO III/IV stages, were associated with severe neuropsychiatric disorders over the 12 months. Conclusions: These findings suggested EFV discontinuation due to NAPEs was low, and the HADS-A, HADS-D, and PSQI scores after 12 months of EFV treatment were associated with several risk factors. The clinicians should keep in mind and routinely screen for the risk factors associated with neuropsychiatric disorders in HIV-infected patients.

Keywords: antiretroviral therapy; anxiety; depression; efavirenz; sleep disturbances.

Figure 1

Flow chart of subject enrolment.

Figure 2

The trend of changes in the PSQI (A), HADS-D (B), and HADS-A (C) scores over the 12-months follow-up period. Graphs show the mean values and SDs at each trimester. Comparison between two groups was performed by paired t-tests. p < 0.05 was considered statistically significant. *: 0.01 < p < 0.05 compared to M0; **: 0.001 < p < 0.01 compared to M0; ***p < 0.001 compared to M0. PSQI, Pittsburgh Sleep Quality Index; HADS-D, Hospital Anxiety and Depression Scale-Depression subscale; HADS-A, Hospital Anxiety and Depression Scale-Anxiety subscale; M, month. Dots: individuals with normal HADS-A, HADS-D, or PSQI scores at baseline. Squares: individuals with abnormal HADS-A, HADS-D, or PSQI scores at baseline.

Figure 3

Frequency and severity of depression (A), anxiety (B), and sleep disturbance (C) at each time point in patients with HIV infection. Comparison of depression, anxiety and sleep disturbance rates between paired groups was performed by the McNemar test. Comparison of severity between two groups was performed by Chi-square test. p < 0.05 was considered significant. *: 0.01 < p < 0.05 compared to M0; **: 0.001 <p < 0.01 compared to M0; ***p < 0.001 compared to M0.