Preliminary data of a prospective study on neuropsychiatric side effects after initiation of efavirenz.

ABSTRACT

OBJECTIVE: To assess baseline variables able to predict neuropsychiatric side effects (NPSEs) associated with the initiation of an efavirenz (EFV)-containing regimen in HIV-1-infected patients. DESIGN: Open-label, prospective, observational study. METHODS: Consecutive HIV-1-infected outpatients in whom EFV was prescribed underwent a psychiatric interview. At baseline and at 2, 4, and 12 weeks, patients completed the Symptoms Check List-90-Revised (SCL-90-R), the Medical Outcome Study for HIV-positive patients (MOS-HIV), and a standardized questionnaire concerning potential NPSEs. RESULTS: Preliminary data showed that discontinuation of EFV because of NPSEs occurred in 4 of 31 patients (13%). Patients who completed the follow-up showed a decrease in SCL-90-R total score (p =.004) and in several subscales such as Interpersonal Sensitivity (p =.009), Depression (p =.001), and Anxiety (p =.040), whereas no changes in MOS-HIV were observed. Having fewer years of education (p =.006), having fewer baseline central nervous symptoms (p =.000), reporting better baseline physical status (p =.013), and having higher baseline scores in the Heath Transition subscale of the MOS-HIV (p =.000) and in the Somatization subscale of the SCL-90-R (p =.002) were associated with more NPSEs. CONCLUSION: Patients maintained on EFV showed a decrease in psychologic distress related to self-image, depression, and anxiety, without any effect on quality of life. Patients with a lower level of education, those who feel physically and psychologically better at baseline than in the past, and those who suffer from more distress as a result of physical complaints may be at greater risk of reporting more NPSEs after EFV initiation.