Long-term impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals (ACTG 5097s).
BACKGROUND
Efavirenz (EFV) is an antiretroviral (ARV) drug associated with neuropsychological effects. Limited data describing the long-term impact of EFV-based regimens on neuropsychological performance over more than 3 years are available.


METHODS
We enrolled a subset of participants from a large initially EFV placebo-controlled trial of therapies for HIV subjects naïve to ARV treatment (A5095). Clinical follow-up continued for 184 weeks of study. Subjects were assessed with brief neuropsychological testing, a symptom questionnaire of EFV-associated symptoms, the Pittsburgh Sleep Index, Center for Epidemiologic Studies-Depression Scale, and an anxiety rating interview.


RESULTS
Over 184 weeks on EFV, the median NPZ3 score in 86 evaluable patients improved from baseline by +0.5 (p < .01); all components improved, although higher EFV levels were associated with slightly lower responses. Overall symptom scores did not change, while EFV-associated CNS symptoms increased (p = .01). Median change of bad dream sleep scores and anxiety increased from the baseline while global depression score decreased.


CONCLUSIONS
In participants who continued EFV-based regimens, neuropsychological performance improvement from baseline was maintained over 3 years. EFV-based treatment was generally well tolerated, but small increases from baseline in EFV-associated symptoms, bad dreams, and anxiety were detected.
Clifford
David B
DB
Washington University School of Medicine, St. Louis, MO 63110, USA. cliffordd@neuro.wustl.edu
Evans
Scott
S
Yang
Yijun
Y
Acosta
Edward P
EP
Ribaudo
Heather
H
Gulick
Roy M
RM
D000328:Adult; D000368:Aged; D000480:Alkynes; D001007:Anxiety / Q000139:chemically induced; D048588:Benzoxazines / Q000008:administration & dosage / Q000009:adverse effects*; D001921:Brain / Q000187:drug effects* / Q000503:physiopathology; D003521:Cyclopropanes; D003863:Depression / Q000139:chemically induced; D004311:Double-Blind Method; D004325:Dreams / Q000187:drug effects; D005260:Female; D006678:HIV / Q000187:drug effects; D015658:HIV Infections / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009483:Neuropsychological Tests; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D011795:Surveys and Questionnaires; D013997:Time Factors
D000480:Alkynes; D048588:Benzoxazines; D003521:Cyclopropanes; D018894:Reverse Transcriptase Inhibitors; C098320:efavirenz