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Long-term Neuropsychological Effects of Efavirenz-based Treatment
David Clifford*1, S Evans2, Y Yang2, R Gulick3, and A5097S Team
1Washington Univ, St Louis, MO, US; 2Harvard Sch of Publ Hlth, Cambridge, MA, US; and 3Weill Med Coll of Cornell Univ, New York, NY, US
Background: Efavirenz (EFV) is an ART drug associated with
neuropsychological effects. Now available are limited data, over >3 years, describing
the long-term effect of EFV-based regimens on neuropsychological performance.
Methods: A5097s enrolled a representative subset of
patients entered into A5095, an initially EFV placebo-controlled trial of
therapies for HIV subjects naïve to treatment. Results of a controlled
evaluation of the initial 6 months of this study have been described. Follow-up
of 184 weeks was available on 117 of 200 subjects enrolled in EFV-based arms
initially. An additional 46 subjects enrolled into EFV-based arms and had
extended follow-up on EFV with known baseline performance. Neuropsychological
performance was evaluated with NPZ3 (a composite score from Trailmaking A and B
and Digit Symbol tests); and patient status was evaluated with a symptom
questionnaire, Pittsburgh Sleep Index, CES-Depression Scale, and an anxiety
rating interview. Changes from baseline results were evaluated with sign-rank
test.
Results: In 117 patients treated with EFV-based therapy
for 184 weeks, the median NPZ3 score improved from baseline by +0.56 (p <0.001). Median score changes in
components are +0.81, +0.39, and +0.49 on the Trailmaking A, Trailmaking B, and
Digit Symbol tests, respectively (all p <0.001).
Median change in overall symptom scores was unchanged (median = 0, p = 0.42), while presumptive EFV-associated
symptoms increased slightly (median = +1, p
= 0.03). Median change of bad dream sleep scores and anxiety increased slightly
(p = 0.0002 and p = 0.03, respectively), while global depression and global sleep
scores at 184 weeks were unchanged. Analysis including all 163 subjects on
long-term EFV-based therapy yielded similar results.
Conclusion: Neuropsychological performance improvement from
baseline was maintained over 3 years in HIV-infected subjects taking EFV-based
therapy. Overall sleep and affect was unchanged by long-term EFV-based
treatment. EFV-based treatment was generally well-tolerated, but minimal
increases from baseline in neuropsychological symptoms, bad dreams, and anxiety
could be detected in those remaining on long-term therapy.
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