Long-term impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals (ACTG 5097s).

TitleLong-term impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals (ACTG 5097s).
Publication TypeJournal Article
Year of Publication2009
AuthorsClifford DB, Evans S, Yang Y, Acosta EP, Ribaudo H, Gulick RM
Corporate AuthorsA5097s Study Team
JournalHIV Clin Trials
Volume10
Issue6
Pagination343-55
Date Published2009 Nov-Dec
ISSN1528-4336
KeywordsAdult, Aged, Anxiety, Benzoxazines, Brain, Depression, Double-Blind Method, Dreams, Female, HIV, HIV Infections, Humans, Male, Medication Adherence, Middle Aged, Neuropsychological Tests, Reverse Transcriptase Inhibitors, Surveys and Questionnaires, Time Factors
Abstract

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.

DOI10.1310/hct1006-343
Alternate JournalHIV Clin Trials
PubMed ID20133265
PubMed Central IDPMC2958039
Grant ListAI069495 / AI / NIAID NIH HHS / United States
AI38858 / AI / NIAID NIH HHS / United States
AI51966 / AI / NIAID NIH HHS / United States
AI68634 / AI / NIAID NIH HHS / United States
NS032228 / NS / NINDS NIH HHS / United States
RR024996 / RR / NCRR NIH HHS / United States
U01 AI069495 / AI / NIAID NIH HHS / United States
U01 AI069495-05 / AI / NIAID NIH HHS / United States
U01 NS032228 / NS / NINDS NIH HHS / United States
U01 NS032228-12 / NS / NINDS NIH HHS / United States
U01AI068636 / AI / NIAID NIH HHS / United States