[54] ACTG 5097s: IMPACT OF EFAVIRENZ (EFV) ON NEUROPSYCHOLOGICAL PERFORMANCE, MOOD, AND SLEEP BEHAVIOUR IN HIV-POSITIVE INDIVIDUALS

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] ACTG 5097s: IMPACT OF EFAVIRENZ (EFV) ON NEUROPSYCHOLOGICAL PERFORMANCE, MOOD, AND SLEEP BEHAVIOUR IN HIV-POSITIVE INDIVIDUALS

[AUTHOR(S):] DB Clifford¹, S Evans², Y Yang², E Acosta³, K Goodkin⁴ and RM Gulick⁵
¹Washington University, St Louis; ²Harvard University, Boston; ³University of Alabama, Birmingham; ⁴University of Miami, Miami; and ⁵Cornell University, New York, USA

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 54
Antiviral Therapy 2003; 8(Suppl. 1):S196

[ABSTRACT:] Objectives: To characterize the EFV-associated neurological symptoms in a controlled treatment initiation protocol.

Methods: A5097 is a substudy of A5095, a phase III, randomized, double-blind, activecontrolled comparison of 3 antiretroviral regimens: 2 are EFV-based and 1 is abacavir-based. Neuropsychological performance was summarized as Z-scores of Digit Symbol Substitution and Trailmaking A and B, (NPZ-3). Additional measures were Pittsburgh Sleep Quality Index (PSQI), Center for Epidemiologic Studies–Depression (CES-D), Spielberger State-Trait Anxiety Inventory (STAI), EFV serum levels and a symptom list. Measures were made at baseline, week (wk) 1, 4, 12 and 24. Changes in test parameters over time were compared in EFV containing and sparing arms.

Results: 303 subjects were randomized (200 EFV-treated). Randomization balanced baseline characteristics. No significant differences in changes of NPZ3 between the EFV and EFV-free arms were seen, nor of the proportion of subjects with neurological deficit. The symptom questionnaire detected significant increases in neurological symptoms at week 1 (P<0.001), but not at wk 4, 12 or 24. Similarly, the PSQI revealed more 'bad dreams' at wk 1 in EFV-treated subjects (P=0.038). However, better global PSQI scores and 'sleep quality' were found in the EFV-containing arm at wk 4. No significant differences in changes in total depressed mood (CES-D) or anxiety (STAI) were noted, nor in the proportion of subjects with clinically significant anxiety or high levels of depressive symptoms. Small negative significant correlations between EFV levels and NPZ3 persisted over time [range of r=(–0.15, –0.25)] but there was no correlation of EFV level and mood.

Conclusions: In a large active-controlled trial, early neurologic symptoms distinct from depression or anxiety were associated with EFV use, and resolved by week 4. Improvement in neuropsychologic performance was comparable in EFV and non-EFVtreated subjects.

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