3rd International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 23-26 October 2001, Athens, Greece

A PROSPECTIVE STUDY ON THE NEUROPSYCHIATRIC SIDE-EFFECTS AFTER INITIATION OF EFAVIRENZ IN HIV-1- INFECTED PATIENTS

Antiviral Therapy 2001; 6(Suppl. 4):29 (abstract no. 38)

J Blanch, E Martinez, A Rousaud, J-L Blanco, M-Á Garcia-Viejo, J-M Peri, J Mallolas, E De Lazzari, J De Pablo and JM Gatell
Clinical Institute of Psychiatry and Psychology, Hospital Clinic de Barcelona, Barcelona, Spain

BACKGROUND: Neuropsychiatric side-effects (NPSE) have been reported in about 50% of the patients treated with efavirenz on clinical trials. These patients usually present with 'altered sensorium' symptoms such as dizziness, headache, insomnia, depression, concentration impairment, agitation, abnormal dreaming, and somnolence, but in less than 2% of patients there have also been reports of severe depression, delusions and inappropriate behaviour, including suicide attempts. These symptoms have been predominantly reported in patients with a history of mental illness or substance abuse, although risk factors for those symptoms are unknown.

OBJECTIVE: To assess baseline variables able to predict NPSE associated with the initiation of an efavirenz-containing antiretroviral regimen in HIV-linfected patients.

METHODS: Open-label, prospective, observational study. Consecutive HIV-1-infected outpatients in whom efavirenz was prescribed underwent a psychiatric interview. At baseline and at 2, 4 and 12 weeks patients completed the Symptoms Checklist (SCL-90-R), the Medical Outcome Study for HIV-positive patients 3rd International Workshop on Adverse Drug Reactionsand Lipodystrophy in HIV (MOS-HIV), and a standardized questionnaire concerning potential NPSE.

RESULTS: Discontinuation of efavirenz due to NPSE occurred in 4/31 patients (13%). Patients who completed the follow-up showed a decrease in SCL-90-R total score (P=0.004) and in several subscales such as interpersonal sensitivity (P=0.009), depression (P=0.001)and anxiety (P=0.040), whereas no changes in MOS-HIV were observed. Having less years of education (P=0.006), having less baseline central nervous symptoms (P=0.000) reporting better baseline physical status (P=0.013)and higher baseline scores in heath transition subscale of MOS-HIV (P=0.000)and in somatization subscale of SCL-90-R (P=0.002) were associated with more NPSE.

CONCLUSIONS: Patients maintaining efavirenz showed a decrease in psychological distress related to self-image, depression and anxiety, without any effect on quality of life. Patients with lower school level, who feel physically and psychologically better at baseline than in the past, and who suffer from more distress due to physical complaints may be at greater risk to report more NPSE after efavirenz initiation.

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