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

Background: Efavirenz (EFV) is a widely used antiretroviral therapy (ART), but side effect risks of neuropsychiatric adverse events (NPAEs) have not been investigated in Chinese populations receiving rapid ART. 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, unemployment, divorce, and WHO III/IV stages, were associated with severe neuropsychiatric disorders over the 12 months. Conclusions: : These findings suggested EFV-based first-line antiretroviral therapy was well-tolerated and associated with improvements in HADS-A, HADS-D, and PSQI scores. Certain risk factors associated with neuropsychiatric disorders may be useful in identifying HIV-infected patients at higher NPAE risk.